-CITE-
21 USC TITLE 21 - FOOD AND DRUGS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
-HEAD-
TITLE 21 - FOOD AND DRUGS
-MISC1-
Chap. Sec.
1. Adulterated or Misbranded Foods or Drugs 1
2. Teas [Repealed] 41
3. Filled Milk 61
4. Animals, Meats, and Meat and Dairy Products 71
5. Viruses, Serums, Toxins, Antitoxins, and Analogous
Products 151
5A. Bureau of Narcotics [Omitted] 161
6. Narcotic Drugs [Repealed or Transferred] 171
7. Practice of Pharmacy and Sale of Poisons in Consular
Districts in China 201
8. Narcotic Farms [Repealed] 221
9. Federal Food, Drug, and Cosmetic Act 301
10. Poultry and Poultry Products Inspection 451
11. Manufacture of Narcotic Drugs [Repealed] 501
12. Meat Inspection 601
13. Drug Abuse Prevention and Control 801
14. Alcohol and Drug Abuse Educational Programs and
Activities [Repealed] 1001
15. Egg Products Inspection 1031
16. Drug Abuse Prevention, Treatment, and Rehabilitation 1101
17. National Drug Enforcement Policy [Repealed] 1201
18. President's Media Commission on Alcohol and Drug
Abuse Prevention [Omitted] 1301
19. Pesticide Monitoring Improvements 1401
20. National Drug Control Program 1501
21. Biomaterials Access Assurance 1601
22. National Drug Control Policy 1701
23. National Youth Anti-Drug Media Campaign [Repealed] 1801
24. International Narcotics Trafficking 1901
25. Miscellaneous Anti-Drug Abuse Provisions 2001
26. Food Safety 2101
27. Food Safety Modernization 2201
-End-
-CITE-
21 USC CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR
DRUGS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
-HEAD-
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
-MISC1-
SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906
Sec.
1 to 15. Repealed or Transferred.
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
16. Introduction into, or sale in, State or Territory or
District of Columbia of dairy or food products
falsely labeled or branded.
17. Penalty for sale or introduction of falsely labeled
dairy or food products; venue.
18. Suspension of importation of adulterated articles.
19. Repealed.
20. Apples in interstate commerce; standard grades.
21. Branding grades on barrels of apples.
22. Barrels misbranded.
23. Penalties.
24. Omitted.
25. Oleomargarine, butterine, or imitation butter or
cheese transported into a State subject to its police
powers.
26. Omitted.
-End-
-CITE-
21 USC SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906
-HEAD-
SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906
-End-
-CITE-
21 USC Secs. 1 to 5 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906
-HEAD-
Secs. 1 to 5. Repealed.
-MISC1-
Secs. 1 to 5. Repealed. June 25, 1938, ch. 675, Sec. 1002(a),
formerly Sec. 902(a), 52 Stat. 1059; renumbered Sec. 1002(a),
Pub. L. 111-31, div. A, title I, Sec. 101(b)(2), June 22, 2009,
123 Stat. 1784.
Section 1, act June 30, 1906, ch. 3915, Sec. 1, 34 Stat. 768,
made it unlawful to manufacture adulterated or misbranded foods or
drugs in Territories or District of Columbia and provided penalty
for violations. See sections 331 and 333 of this title.
Section 2, act June 30, 1906, ch. 3915, Sec. 2, 34 Stat. 768,
prohibited introduction, shipment, delivery or sale of adulterated
or misbranded foods or drugs in interstate or foreign commerce,
provided penalty for violations and exempted exports conforming to
specifications of foreign purchaser and not in conflict with laws
of foreign country importing the same. See sections 331, 333 and
381 of this title.
Section 3, acts June 30, 1906, ch. 3915, Sec. 3, 34 Stat. 768;
Mar. 4, 1913, ch. 141, Sec. 1, 37 Stat. 736, authorized Secretaries
of the Treasury, Agriculture, and Commerce to make uniform rules
and regulations for enforcement of food and drug laws, including
collection and examination of specimens. See section 371 of this
title.
Section 4, act June 30, 1906, ch. 3915, Sec. 12, 34 Stat. 772,
provided that act or omission of officer, agent, and so forth, of
corporation, shall be deemed act or omission of corporation.
Section 5, act June 30, 1906, ch. 3915, Sec. 12, 34 Stat. 772,
defined "territory" and "person". See section 321 of this title and
section 1 of Title 1, General Provisions.
EFFECTIVE DATE OF REPEAL
Act June 25, 1938, ch. 675, Sec. 1002(a), formerly Sec. 902(a),
52 Stat. 1059; renumbered Sec. 1002(a), Pub. L. 111-31, div. A,
title I, Sec. 101(b)(2), June 22, 2009, 123 Stat. 1784, which
repealed sections 1 to 5, 7 to 14, and 15 of this title, provided
that the repeal of those sections should take effect upon the
effective date of act June 25, 1938, which was to take effect
twelve months after the date of its enactment. Act June 23, 1939,
ch. 242, Sec. 2(b), 53 Stat. 854, provided that: "The provisions of
such act of June 30, 1906, as amended, to the extent that they
impose, or authorize the imposition of, any requirement imposed by
section 403(k) of the Federal Food, Drug, and Cosmetic Act [section
343(k) of this title], shall remain in force until January 1,
1940."
-End-
-CITE-
21 USC Sec. 6 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906
-HEAD-
Sec. 6. Transferred
-COD-
CODIFICATION
Section, act Mar. 4, 1923, ch. 268, 42 Stat. 1500, was
transferred to section 321a of this title.
-End-
-CITE-
21 USC Secs. 7 to 14 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906
-HEAD-
Secs. 7 to 14. Repealed.
-MISC1-
Secs. 7 to 14. Repealed. June 25, 1938, ch. 675, Sec. 1002(a),
formerly Sec. 902(a), 52 Stat. 1059; renumbered Sec. 1002(a),
Pub. L. 111-31, div. A, title I, Sec. 101(b)(2), June 22, 2009,
123 Stat. 1784.
Section 7, act June 30, 1906, ch. 3915, Sec. 6, 34 Stat. 769,
defined "drug" and "food". See section 321 of this title.
Section 8, act June 30, 1906, ch. 3915, Sec. 7, 34 Stat. 769,
deemed drugs to be adulterated when sold having a difference from
recognized standards, except where there is an explanatory
statement on or in container, and when sold below professed
standard; confectioneries, when containing mineral substances,
poisonous color or flavors, other deleterious ingredients, liquors
or narcotics; food, when concerned with injurious mixtures, use of
substitutes, abstraction of valuable constituents, concealment of
damage or inferiority, deleterious ingredients, preservatives in
shipment conditionally excepted, animal or vegetable substances
unfit for food and products of animals diseased or having died
otherwise than by slaughter. See sections 342 and 351 of this
title.
Section 9, act June 30, 1906, ch. 3915, Sec. 8, 34 Stat. 771,
defined "misbranded" and provided for its application to drugs and
food. See sections 343 and 352 of this title.
Section 10, acts June 30, 1906, ch. 3915, Sec. 8, 34 Stat. 771;
Aug. 23, 1912, ch. 352, 37 Stat. 416; Mar. 3, 1913, ch. 117, 37
Stat. 732; July 24, 1919, ch. 26, 41 Stat. 271; July 8, 1930, ch.
874, 46 Stat. 1019, deemed drugs to be misbranded when there is an
imitation or use of name of other article, when there is removal
and substitution of contents of package or failure to state on
label quantity or proportion of narcotics therein, and when there
is a false statement of curative or therapeutic effect; and food,
when there is an imitation or use of name of other article, when
there is a false label or brand removal and substitution of
contents of package, or failure to state or label quantity or
proportion of narcotics therein, when the packages are not marked
with weight, with certain variations and exemptions permitted, when
there are false or misleading statements on package or label as to
ingredients or substances; and food, when mixtures or compounds
under distinctive names, the articles are labeled, branded as
compounds, imitations, or blends; construed the term "blend" and
related to disclosure of trade formulas of proprietary foods, and
canned food. See sections 321b, 341, 343 and 352 of this title.
Section 11, acts June 30, 1906, ch. 3915, Sec. 4, 34 Stat. 769;
Jan. 18, 1927, ch. 39, 44 Stat. 1003, provided for examination of
specimens, notice of adulteration or misbranding, hearing,
certification of violations to United States district attorney and
notice of judgment.
Section 12, act June 30, 1906, ch. 3915, Sec. 5, 34 Stat. 769,
provided for prosecution by district attorneys for enforcement of
penalties.
Section 13, act June 30, 1906, ch. 3915, Sec. 9, 34 Stat. 771,
provided for a seller's guaranty as protection to dealer. See
section 333 of this title.
Section 14, act June 30, 1906, ch. 3915, Sec. 10, 34 Stat. 771,
provided for seizure of articles by libel for condemnation, at suit
of and in name of United States, in United States district court
where found, conforming to proceedings in admiralty, with right to
trial by jury, destruction or sale of adulterated or misbranded
articles, bond and payment of proceeds into Treasury of United
States. See sections 332, 334 and 337 of this title.
EFFECTIVE DATE OF REPEAL
For effective date of repeal, see section 1002(a) of act June 25,
1938, set out as a note under sections 1 to 5 of this title.
-End-
-CITE-
21 USC Sec. 14a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906
-HEAD-
Sec. 14a. Transferred
-COD-
CODIFICATION
Section, act June 30, 1906, ch. 3915, Sec. 10A, as added June 22,
1934, ch. 712, 48 Stat. 1204, and amended, which related to
examination of sea food on request of packer, marking of food with
results, fees, and penalties, was successively renumbered section
702A and then 706 of the Federal Food, Drug, and Cosmetic Act by
act July 12, 1943, ch. 221, title II, Sec. 201, 57 Stat. 500, and
by Pub. L. 102-571, title I, Sec. 106(3), Oct. 29, 1992, 106 Stat.
4498, and was successively classified to section 372a and then 376
of this title.
-End-
-CITE-
21 USC Sec. 15 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER I - FEDERAL FOOD AND DRUGS ACT OF 1906
-HEAD-
Sec. 15. Repealed.
-MISC1-
Sec. 15. Repealed. June 25, 1938, ch. 675, Sec. 1002(a), formerly
Sec. 902(a), 52 Stat. 1059; renumbered Sec. 1002(a), Pub. L. 111-
31, div. A, title I, Sec. 101(b)(2), June 22, 2009, 123 Stat.
1784.
Section, act June 30, 1906, ch. 3915, Sec. 11, 34 Stat. 772,
provided for examination of samples of imports, refusal of
admission and delivery to consignee, delivery to consignee pending
examination and decision on bond and charges for storage and lien
therefor. See section 381 of this title.
EFFECTIVE DATE OF REPEAL
For effective date of repeal, see section 1002(a) of act June 25,
1938, set out as a note under sections 1 to 5 of this title.
-End-
-CITE-
21 USC SUBCHAPTER II - MISCELLANEOUS PROVISIONS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-End-
-CITE-
21 USC Sec. 16 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 16. Introduction into, or sale in, State or Territory or
District of Columbia of dairy or food products falsely labeled or
branded
-STATUTE-
No person or persons, company or corporation, shall introduce
into any State or Territory of the United States or the District of
Columbia from any other State or Territory of the United States or
the District of Columbia, or sell in the District of Columbia or in
any Territory any dairy or food products which shall be falsely
labeled or branded as to the State or Territory in which they are
made, produced, or grown, or cause or procure the same to be done
by others.
-SOURCE-
(July 1, 1902, ch. 1357, Sec. 1, 32 Stat. 632.)
-End-
-CITE-
21 USC Sec. 17 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 17. Penalty for sale or introduction of falsely labeled dairy
or food products; venue
-STATUTE-
If any person or persons violate the provisions of section 16 of
this title, either in person or through another, he shall be guilty
of a misdemeanor and shall be punished by a fine of not less than
$500 nor more than $2,000. The jurisdiction for the prosecution of
said misdemeanor shall be within the district of the United States
court in which it is committed.
-SOURCE-
(July 1, 1902, ch. 1357, Sec. 2, 32 Stat. 632.)
-End-
-CITE-
21 USC Sec. 18 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 18. Suspension of importation of adulterated articles
-STATUTE-
Whenever the President is satisfied that there is good reason to
believe that any importation is being made, or is about to be made,
into the United States, from any foreign country, of any article
used for human food or drink that is adulterated to an extent
dangerous to the health or welfare of the people of the United
States, or any of them, he may issue his proclamation suspending
the importation of such articles from such country for such period
of time as he may think necessary to prevent such importation; and
during such period it shall be unlawful to import into the United
States from the countries designated in the proclamation of the
President any of the articles the importation of which is so
suspended.
-SOURCE-
(Aug. 30, 1890, ch. 839, Sec. 4, 26 Stat. 415.)
-End-
-CITE-
21 USC Sec. 19 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 19. Repealed.
-MISC1-
Sec. 19. Repealed. May 29, 1928, ch. 901, Sec. 1(100), 45 Stat. 993.
Section, act May 23, 1908, ch. 192, 35 Stat. 261, related to
report to Congress of expenditures in enforcing food and drug laws.
-End-
-CITE-
21 USC Sec. 20 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 20. Apples in interstate commerce; standard grades
-STATUTE-
The standard grades for apples when packed in barrels which shall
be shipped or delivered for shipment in interstate or foreign
commerce, or which shall be sold or offered for sale within the
District of Columbia or the Territories of the United States shall
be as follows: Apples of one variety, which are well-grown
specimens, hand picked, of good color for the variety, normal
shape, practically free from insect and fungous injury, bruises,
and other defects, except such as are necessarily caused in the
operation of packing, or apples of one variety which are not more
than 10 per centum below the foregoing specifications shall be
"Standard grade minimum size two and one-half inches", if the
minimum size of the apples is two and one-half inches in transverse
diameter; "Standard grade minimum size two and one-fourth inches",
if the minimum size of the apples is two and one-fourth inches in
transverse diameter; or "Standard grade minimum size two inches",
if the minimum size of the apples is two inches in transverse
diameter.
-SOURCE-
(Aug. 3, 1912, ch. 273, Sec. 2, 37 Stat. 250.)
-End-
-CITE-
21 USC Sec. 21 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 21. Branding grades on barrels of apples
-STATUTE-
The barrels in which apples are packed in accordance with the
provisions of sections 20 to 23 of this title may be branded in
accordance with the provisions of section 20 of this title.
-SOURCE-
(Aug. 3, 1912, ch. 273, Sec. 3, 37 Stat. 251.)
-End-
-CITE-
21 USC Sec. 22 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 22. Barrels misbranded
-STATUTE-
Barrels packed with apples shall be deemed to be misbranded
within the meaning of sections 20 to 23 of this title -
First. If the barrel bears any statement, design, or device
indicating that the apples contained therein are "Standard" grade
and the apples when packed do not conform to the requirements
prescribed by section 20 of this title.
Second. If the barrel bears any statement, design, or device
indicating that the apples contained therein are "Standard" grade
and the barrel fails to bear also a statement of the name of the
variety, the name of the locality where grown, and the name of the
packer or the person by whose authority the apples were packed and
the barrel marked.
-SOURCE-
(Aug. 3, 1912, ch. 273, Sec. 5, 37 Stat. 251.)
-End-
-CITE-
21 USC Sec. 23 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 23. Penalties
-STATUTE-
Any person, firm or corporation, or association who shall
knowingly pack or cause to be packed apples in barrels or who shall
knowingly sell or offer for sale such barrels in violation of the
provisions of sections 20 to 23 of this title shall be liable to a
penalty of $1 and costs for each such barrel so sold or offered for
sale, to be recovered at the suit of the United States in any court
of the United States having jurisdiction.
-SOURCE-
(Aug. 3, 1912, ch. 273, Sec. 6, 37 Stat. 251.)
-COD-
CODIFICATION
Section is also set out as section 233 of Title 15, Commerce and
Trade.
-End-
-CITE-
21 USC Sec. 24 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 24. Omitted
-COD-
CODIFICATION
Section, act Mar. 4, 1915, ch. 144, 38 Stat. 1102, related to
payment of the cost of inspection under a provision authorizing the
investigation of the character of chemical and physical tests
applied to American food products in foreign countries and the
inspection of such products before shipment to such countries at
the request of the shippers or owners. That provision was repeated
in subsequent appropriation acts but was omitted from the
appropriation act of July 12, 1943, ch. 221, 57 Stat. 494, and from
all subsequent appropriation acts.
-End-
-CITE-
21 USC Sec. 25 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 25. Oleomargarine, butterine, or imitation butter or cheese
transported into a State subject to its police powers
-STATUTE-
All articles known as oleomargarine, butterine, imitation,
process, renovated, or adulterated butter, or imitation cheese, or
any substance in the semblance of butter or cheese not the usual
product of the dairy and not made exclusively of pure and
unadulterated milk or cream, transported into any State or
Territory or the District of Columbia, and remaining therein for
use, consumption, sale, or storage therein, shall, upon the arrival
within the limits of such State or Territory or the District of
Columbia, be subject to the operation and effect of the laws of
such State or Territory or the District of Columbia, enacted in the
exercise of its police powers to the same extent and in the same
manner as though such articles or substances had been produced in
such State or Territory or the District of Columbia, and shall not
be exempt therefrom by reason of being introduced therein in
original packages or otherwise.
-SOURCE-
(May 9, 1902, ch. 784, Sec. 1, 32 Stat. 193.)
-End-
-CITE-
21 USC Sec. 26 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 1 - ADULTERATED OR MISBRANDED FOODS OR DRUGS
SUBCHAPTER II - MISCELLANEOUS PROVISIONS
-HEAD-
Sec. 26. Omitted
-COD-
CODIFICATION
Section, which was from the appropriation acts of Jan. 18, 1927,
ch. 39, 44 Stat. 984; May 16, 1928, ch. 572, 45 Stat. 548; Feb. 16,
1929, ch. 227, 45 Stat. 1198; May 27, 1930, ch. 341, 46 Stat. 424,
and subsequent Department of Agriculture Appropriation Acts to and
including act June 28, 1944, ch. 296, Sec. 4, 58 Stat. 461, and
related to inspection of food and other products, is covered by
section 2256 of Title 7, Agriculture.
-End-
-CITE-
21 USC CHAPTER 2 - TEAS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 2 - TEAS
-HEAD-
CHAPTER 2 - TEAS
-End-
-CITE-
21 USC Secs. 41 to 50 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 2 - TEAS
-HEAD-
Secs. 41 to 50. Repealed.
-MISC1-
Secs. 41 to 50. Repealed. Pub. L. 104-128, Sec. 2, Apr. 9, 1996,
110 Stat. 1198.
Section 41, acts Mar. 2, 1897, ch. 358, Sec. 1, 29 Stat. 604; May
16, 1908, ch. 170, 35 Stat. 163; May 31, 1920, ch. 217, 41 Stat.
712; 1940 Reorg. Plan No. IV, Sec. 12, eff. June 30, 1940, 5 F.R.
2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, Sec. 5, eff. Apr. 11,
1953, 18 F.R. 2053, 67 Stat. 631; May 24, 1962, Pub. L. 87-456,
title III, Sec. 303(a), 76 Stat. 77; Aug. 23, 1988, Pub. L. 100-
418, title I, Sec. 1214(l), 102 Stat. 1158, prohibited unlawful
importation of substandard tea.
Section 42, acts Mar. 2, 1897, ch. 358, Sec. 2, 29 Stat. 605; May
31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, Sec. 12,
eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; July 12, 1943, ch.
221, title II, 57 Stat. 500; 1953 Reorg. Plan No. 1, Sec. 5, eff.
Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L.
96-88, title V, Sec. 509(b), 93 Stat. 695, related to establishment
and composition of board of experts in teas.
Section 43, acts Mar. 2, 1897, ch. 358, Sec. 3, 29 Stat. 605; May
31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, Sec. 12,
eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan
No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct.
17, 1979, Pub. L. 96-88, title V, Sec. 509(b), 93 Stat. 695,
authorized establishment of purity standards.
Section 44, acts Mar. 2, 1897, ch. 358, Sec. 4, 29 Stat. 605; May
31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, Sec. 12,
eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan
No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct.
17, 1979, Pub. L. 96-88, title V, Sec. 509(b), 93 Stat. 695,
related to bonds of importers, examination of imported teas, and
importation at ports without examiners.
Section 45, act Mar. 2, 1897, ch. 358, Sec. 5, 29 Stat. 605,
related to delivery permits and reexamination and retention of
substandard teas.
Section 46, acts Mar. 2, 1897, ch. 358, Sec. 7, 29 Stat. 606; May
31, 1920, ch. 217, 41 Stat. 712, 713, related to examiners and
examination according to usages of trade.
Section 46a, acts Mar. 2, 1897, ch. 358, Sec. 13, formerly act
July 1, 1941, ch. 269, title II, 55 Stat. 478; renumbered Sec. 13
of act Mar. 2, 1897, and amended Aug. 10, 1993, Pub. L. 103-66,
title IV, Sec. 4401, 107 Stat. 378, related to deposit of fee prior
to examination.
Section 47, acts Mar. 2, 1897, ch. 358, Sec. 6, 29 Stat. 606; May
31, 1920, ch. 217, 41 Stat. 712, 713; 1940 Reorg. Plan No. IV, Sec.
12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631;
Oct. 17, 1979, Pub. L. 96-88, title V, Sec. 509(b), 93 Stat. 695,
required referral of disputes to United States Board of Tea Appeals
and authorized board to permit delivery or order destruction or
exportation of substandard teas.
Section 48, acts Mar. 2, 1897, ch. 358, Sec. 8, 29 Stat. 606; May
31, 1920, ch. 217, 41 Stat. 712, related to reexaminations,
including findings by examiner and assistance of experts.
Section 49, acts Mar. 2, 1897, ch. 358, Sec. 9, 29 Stat. 606; May
31, 1920, ch. 217, 41 Stat. 712, related to reimporting rejected
teas and forfeitures for violation of provisions.
Section 50, acts Mar. 2, 1897, ch. 358, Sec. 10, 29 Stat. 607;
May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, Sec.
12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg.
Plan No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631;
Oct. 17, 1979, Pub. L. 96-88, title V, Sec. 509(b), 93 Stat. 695,
authorized issuance of regulations.
EFFECTIVE DATE OF REPEAL
Section 3 of Pub. L. 104-128 provided that: "This Act [repealing
this chapter] shall take effect on the date of enactment of this
Act [Apr. 9, 1996]."
SHORT TITLE OF REPEAL
Section 1 of Pub. L. 104-128 provided that: "This Act [repealing
this chapter] may be cited as the 'Federal Tea Tasters Repeal Act
of 1996'."
SHORT TITLE
Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in
part that act Mar. 2, 1897, which was classified generally to this
chapter, could be cited as the Tea Importation Act.
-End-
-CITE-
21 USC CHAPTER 3 - FILLED MILK 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 3 - FILLED MILK
-HEAD-
CHAPTER 3 - FILLED MILK
-MISC1-
Sec.
61. Definitions.
62. Manufacture, shipment, or delivery for shipment in
interstate or foreign commerce prohibited.
63. Penalties; acts of agents deemed acts of principals.
64. Regulations for enforcement.
FEDERAL FOOD, DRUG, AND COSMETIC ACT
Nothing contained in chapter 9 (Sec. 301 et seq.) of this title
shall be construed as in any way affecting, modifying, repealing,
or superseding the provisions of sections 61 to 64 of this title,
see section 392(b) of this title.
BUREAU OF DAIRY INDUSTRY
General provisions, see sections 401 to 404 of Title 7,
Agriculture.
-End-
-CITE-
21 USC Sec. 61 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 3 - FILLED MILK
-HEAD-
Sec. 61. Definitions
-STATUTE-
Whenever used in this chapter -
(a) The term "person" includes an individual, partnership,
corporation, or association;
(b) The term "interstate or foreign commerce" means commerce (1)
between any State, Territory, or possession, or the District of
Columbia, and any place outside thereof; (2) between points within
the same State, Territory, or possession, or within the District of
Columbia, but through any place outside thereof; or (3) within any
Territory or possession, or within the District of Columbia; and
(c) The term "filled milk" means any milk, cream, or skimmed
milk, whether or not condensed, evaporated, concentrated, powdered,
dried, or desiccated, to which has been added, or which has been
blended or compounded with, any fat or oil other than milk fat, so
that the resulting product is in imitation or semblance of milk,
cream, or skimmed milk, whether or not condensed, evaporated,
concentrated, powdered, dried, or desiccated. This definition shall
not include any distinctive proprietary food compound not readily
mistaken in taste for milk or cream or for evaporated, condensed,
or powdered milk, or cream where such compound (1) is prepared and
designed for feeding infants and young children and customarily
used on the order of a physician; (2) is packed in individual cans
containing not more than sixteen and one-half ounces and bearing a
label in bold type that the content is to be used only for said
purpose; (3) is shipped in interstate or foreign commerce
exclusively to physicians, wholesale and retail druggists, orphan
asylums, child-welfare associations, hospitals, and similar
institutions and generally disposed of by them.
-SOURCE-
(Mar. 4, 1923, ch. 262, Sec. 1, 42 Stat. 1486.)
-MISC1-
SHORT TITLE
Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in
part that act Mar. 4, 1923, which enacted this chapter, may be
cited as the "Filled Milk Act".
-End-
-CITE-
21 USC Sec. 62 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 3 - FILLED MILK
-HEAD-
Sec. 62. Manufacture, shipment, or delivery for shipment in
interstate or foreign commerce prohibited
-STATUTE-
It is declared that filled milk, as defined in section 61 of this
title, is an adulterated article of food, injurious to the public
health, and its sale constitutes a fraud upon the public. It shall
be unlawful for any person to manufacture within any Territory or
possession, or within the District of Columbia, or to ship or
deliver for shipment in interstate or foreign commerce, any filled
milk.
-SOURCE-
(Mar. 4, 1923, ch. 262, Sec. 2, 42 Stat. 1487.)
-End-
-CITE-
21 USC Sec. 63 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 3 - FILLED MILK
-HEAD-
Sec. 63. Penalties; acts of agents deemed acts of principals
-STATUTE-
Any person violating any provision of this chapter shall upon
conviction thereof be subject to a fine of not more than $1,000 or
imprisonment of not more than one year, or both. When construing
and enforcing the provisions of this chapter, the act, omission, or
failure of any person acting for or employed by any individual,
partnership, corporation, or association, within the scope of his
employment or office, shall in every case be deemed the act,
omission, or failure, of such individual, partnership, corporation,
or association, as well as of such person.
-SOURCE-
(Mar. 4, 1923, ch. 262, Sec. 3, 42 Stat. 1487.)
-COD-
CODIFICATION
The original text of this section contained a further provision
that no penalty should be enforced for any violation occurring
within 30 days after act Mar. 4, 1923 became law and was omitted as
temporary and obsolete.
-End-
-CITE-
21 USC Sec. 64 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 3 - FILLED MILK
-HEAD-
Sec. 64. Regulations for enforcement
-STATUTE-
The Secretary of Health and Human Services is authorized and
directed to make and enforce such regulations as may in his
judgment be necessary to carry out the purposes of this chapter.
-SOURCE-
(Mar. 4, 1923, ch. 262, Sec. 4, as added Aug. 27, 1935, ch. 743, 49
Stat. 885; 1940 Reorg. Plan No. IV, Sec. 12, eff. June 30, 1940, 5
F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, Sec. 5, eff. Apr.
11, 1953, 18 F.R. 2053, 67 Stat. 631; Pub. L. 96-88, title V, Sec.
509(b), Oct. 17, 1979, 93 Stat. 695.)
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted in text for
"Secretary of Health, Education, and Welfare" pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration to Federal Security
Agency, see notes set out under section 321 of this title.
-End-
-CITE-
21 USC CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
-HEAD-
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
-MISC1-
SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
Sec.
71 to 99. Transferred, Repealed, or Omitted.
SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE
101. Suspension of importation of all animals.
102 to 107. Repealed or Omitted.
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
111 to 113. Repealed or Omitted.
113a. Establishment of research laboratories for
foot-and-mouth disease and other animal diseases;
research contracts; employment of technicians and
scientists; appropriations.
114 to 114h. Repealed.
114i. Pseudorabies eradication.
115 to 135b. Repealed, Omitted, or Transferred.
136. Additional inspection services.
136a. Collection of fees for inspection services.
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
141. Prohibition of importation without permit.
142. Milk or cream when unfit for importation.
143. Inspection; certified statement in lieu thereof;
waiver of requirements of section 142; regulations;
suspension and revocation of permits.
144. Unlawful receiving of imported milk or cream.
145. Penalties.
146. Authorization of appropriations.
147. Repeal of inconsistent laws.
148. Powers of State with respect to milk or cream lawfully
imported.
149. Definitions.
-End-
-CITE-
21 USC SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND
MEAT AND DAIRY PRODUCTS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
-HEAD-
SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
-End-
-CITE-
21 USC Secs. 71 to 92 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
-HEAD-
Secs. 71 to 92. Transferred
-COD-
CODIFICATION
Section 71, act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, which
related to inspection of meat and meat food products, examination
of cattle before slaughtering, separate slaughtering of diseased
animals and examination of carcasses, was transferred to section
603 of this title.
Section 72, act Mar. 4, 1907, ch. 2907, 34 Stat. 1260, which
related to post mortem examination of carcasses, marking and
labeling, destruction of condemned carcasses, and reinspection, was
transferred to section 604 of this title.
Section 73, act Mar. 4, 1907, ch. 2907, 34 Stat. 1261, which
related to examination of carcasses brought into slaughtering or
packing establishments and of meat food products issued from and
returned thereto, was transferred to section 605 of this title.
Section 74, act Mar. 4, 1907, ch. 2907, 34 Stat. 1261, which
related to examination and inspection of meat food products, marks
of inspection, destruction of condemned products, and products for
export, was transferred to section 606 of this title and was
subsequently repealed by Pub. L. 110-234, title XI, Sec.
11016(b)(1)(B), May 22, 2008, 122 Stat. 1369, and Pub. L. 110-246,
Sec. 4(a), title XI, Sec. 11016(b)(1)(B), June 18, 2008, 122 Stat.
1664, 2131.
Section 75, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
related to labeling of receptacles and coverings of meat and meat
food products inspected and passed, supervision by inspectors,
prohibition of sales under false names, was transferred to section
607 of this title.
Section 76, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
related to sanitary inspection and regulation of slaughtering and
packing establishments, and rejection of meat or meat food products
unfit for food, was transferred to section 608 of this title.
Section 77, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
related to examination of cattle and food products thereof
slaughtered and prepared during night time, was transferred to
section 609 of this title.
Section 78, act Mar. 4, 1907, ch. 2907, 34 Stat. 1262, which
related to prohibition of transportation of carcasses, meat, or
meat food products not properly inspected and marked, was
transferred to section 610 of this title.
Section 79, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to forgery, alteration, and unauthorized use of marks,
labels, and certificates, was transferred to section 611 of this
title.
Section 80, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to inspection of animals for export, was transferred to
section 612 of this title and was subsequently repealed by Pub. L.
107-171, title X, Sec. 10418(a)(19), May 13, 2002, 116 Stat. 508.
Section 81, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to certificates of condition of animals for export, was
transferred to section 613 of this title and was subsequently
repealed by Pub. L. 107-171, title X, Sec. 10418(a)(19), May 13,
2002, 116 Stat. 508.
Section 82, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to clearance to vessels carrying cattle for export with
proper certificate of inspection, was transferred to section 614 of
this title and was subsequently repealed by Pub. L. 107-171, title
X, Sec. 10418(a)(19), May 13, 2002, 116 Stat. 508.
Section 83, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to inspection of carcasses, the meat of which is intended
for export, was transferred to section 615 of this title.
Section 84, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to certificates of condition of carcasses, the meat of
which is intended for export, was transferred to section 616 of
this title.
Section 85, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to clearance to vessels carrying meat for export with
proper certificate of inspection, was transferred to section 617 of
this title.
Section 86, act Mar. 4, 1907, ch. 2907, 34 Stat. 1263, which
related to official certificates of inspection and delivery of
copies thereof to different parties, was transferred to section 618
of this title.
Section 87, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
related to prohibition of transportation or sale of meat or meat
food products without complying with provisions of inspection law,
was transferred to section 619 of this title.
Section 88, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
related to offenses and penalties, was transferred to section 620
of this title.
Section 89, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
related to appointment of inspectors, their duties, and rule making
authority of the Secretary of Agriculture, was transferred to
section 621 of this title.
Section 90, act Mar. 4, 1907, ch. 2907, 34 Stat. 1264, which
related to penalties for bribery, was transferred to section 622 of
this title.
Section 91, acts Mar. 4, 1907, ch. 2907, 34 Stat. 1265; June 29,
1938, ch. 810, 52 Stat. 1235, which related to definitions,
exceptions to inspection requirements in case of farmers and
retailers, and penalties for sale of meat and meat food products
unfit for food, was transferred to section 623 of this title.
Section 92, act Mar. 4, 1907, ch. 2907, 34 Stat. 1265, which was
a proviso following the first sentence of section 91 of this title,
was restored to that section and has been transferred to section
623 of this title.
-End-
-CITE-
21 USC Sec. 93 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
-HEAD-
Sec. 93. Repealed.
-MISC1-
Sec. 93. Repealed. May 29, 1928, ch. 901, Sec. 1(92), 45 Stat. 993.
Section, act Mar. 4, 1907, ch. 2907, 34 Stat. 1265, related to
statement in annual estimates as to persons employed, their
compensation and expenses.
-End-
-CITE-
21 USC Secs. 94 to 95 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
-HEAD-
Secs. 94 to 95. Transferred
-COD-
CODIFICATION
Section 94, act June 30, 1914, ch. 131, 38 Stat. 420, which
related to inspection of reindeer, was transferred to section 692
of this title.
Section 94a, act May 23, 1908, ch. 192, 35 Stat. 254, which
related to inspection of dairy products for export, was transferred
to section 693 of this title.
Section 95, acts June 30, 1906, ch. 3913, 34 Stat. 679; June 26,
1934, ch. 756, Sec. 2, 48 Stat. 1225, which related to
authorization of appropriations for expenses of inspection, was
transferred to section 694 of this title.
-End-
-CITE-
21 USC Sec. 96 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
-HEAD-
Sec. 96. Repealed.
-MISC1-
Sec. 96. Repealed. Pub. L. 90-201, Sec. 18, Dec. 15, 1967, 81 Stat.
600.
Section, act July 24, 1919, ch. 26, 41 Stat. 241, provided for
marking horse meat transported in interstate commerce. See section
619 of this title.
EFFECTIVE DATE OF REPEAL
Repeal effective Dec. 15, 1967, see section 20 of Pub. L. 90-201,
set out as an Effective Date note under section 601 of this title.
-End-
-CITE-
21 USC Secs. 97 to 97d 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
-HEAD-
Secs. 97 to 97d. Omitted
-COD-
CODIFICATION
Sections 97 to 97d, act July 30, 1947, ch. 356, title I, Sec. 1,
61 Stat. 531, 532, set up a meat inspection fund and provided for
payment for meat inspection service by the persons or organizations
who were furnished such inspection on and after July 1, 1947. These
provisions ceased to be effective on July 1, 1948, under section 98
of this title which requires the cost of such inspection to be
borne by the United States. The unobligated balance in the meat
inspection fund was carried to the general fund of the Treasury by
act June 19, 1948, ch. 543, Sec. 1, 62 Stat. 515.
-End-
-CITE-
21 USC Sec. 98 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
-HEAD-
Sec. 98. Transferred
-COD-
CODIFICATION
Section, act June 5, 1948, ch. 423, 62 Stat. 344, which related
to payment of cost of meat inspection, was transferred to section
695 of this title.
-End-
-CITE-
21 USC Sec. 99 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER I - EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY
PRODUCTS
-HEAD-
Sec. 99. Repealed.
-MISC1-
Sec. 99. Repealed. July 28, 1953, ch. 251, title I, Sec. 101, 67
Stat. 208.
Section, act Aug. 31, 1951, ch. 374, title I, Sec. 101, 65 Stat.
229, related to reimbursement for excess expenses of meat
inspection.
-End-
-CITE-
21 USC SUBCHAPTER II - IMPORTATION OF CATTLE AND
QUARANTINE 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE
-HEAD-
SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE
-End-
-CITE-
21 USC Sec. 101 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE
-HEAD-
Sec. 101. Suspension of importation of all animals
-STATUTE-
Whenever, in the opinion of the President, it shall be necessary
for the protection of animals in the United States against
infectious or contagious diseases, he may, by proclamation, suspend
the importation of all or any class of animals for a limited time,
and may change, modify, revoke, or renew such proclamation, as the
public good may require; and during the time of such suspension the
importation of any such animals shall be unlawful.
-SOURCE-
(Aug. 30, 1890, ch. 839, Sec. 9, 26 Stat. 416.)
-End-
-CITE-
21 USC Secs. 102 to 105 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE
-HEAD-
Secs. 102 to 105. Repealed.
-MISC1-
Secs. 102 to 105. Repealed. Pub. L. 107-171, title X, Sec.
10418(a)(6), May 13, 2002, 116 Stat. 507.
Section 102, act Aug. 30, 1890, ch. 839, Sec. 7, 26 Stat. 416,
related to quarantine of imported animals.
Section 103, act Aug. 30, 1890, ch. 839, Sec. 8, 26 Stat. 416,
related to prohibition of importation of animals except at
quarantine ports, slaughter of infected animals, appraisal, and
payment.
Section 104, act Aug. 30, 1890, ch. 839, Sec. 6, 26 Stat. 416;
June 28, 1926, ch. 700, Sec. 2, 44 Stat. 775; Feb. 28, 1931, ch.
348, 46 Stat. 1460; July 22, 1954, ch. 558, Sec. 32, 68 Stat. 510;
Jan. 28, 1956, ch. 12, Sec. 1, 70 Stat. 5; Pub. L. 97-461, Sec. 4,
Jan. 12, 1983, 96 Stat. 2524; Pub. L. 103-182, title III, Sec.
361(b), Dec. 8, 1993, 107 Stat. 2122; Pub. L. 103-465, title IV,
Sec. 431(h), Dec. 8, 1994, 108 Stat. 4969, related to importation
of animals.
Section 105, act Aug. 30, 1890, ch. 839, Sec. 10, 26 Stat. 417;
Pub. L. 103-182, title III, Sec. 361(c), Dec. 8, 1993, 107 Stat.
2122; Pub. L. 103-465, title IV, Sec. 431(i), Dec. 8, 1994, 108
Stat. 4969, related to inspection of animals.
-End-
-CITE-
21 USC Secs. 106, 107 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER II - IMPORTATION OF CATTLE AND QUARANTINE
-HEAD-
Secs. 106, 107. Omitted
-COD-
CODIFICATION
Sections, acts Aug. 10, 1917, ch. 52, Sec. 9, 40 Stat. 275; Nov.
21, 1918, ch. 212, Sec. 3, 40 Stat. 1048, related to slaughter of
tick-infested cattle. Section 12 of act Aug. 10, 1917, provided
that the act should cease to be in effect when the national
emergency resulting from World War I had passed.
-End-
-CITE-
21 USC SUBCHAPTER III - PREVENTION OF INTRODUCTION AND
SPREAD OF CONTAGION 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-End-
-CITE-
21 USC Secs. 111, 112 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Secs. 111, 112. Repealed.
-MISC1-
Secs. 111, 112. Repealed. Pub. L. 107-171, title X, Sec.
10418(a)(7), (8), May 13, 2002, 116 Stat. 507, 508.
Section 111, act Feb. 2, 1903, ch. 349, Sec. 2, 32 Stat. 792;
July 22, 1954, ch. 558, Sec. 33, 68 Stat. 510; Jan. 28, 1956, ch.
12, Sec. 2, 70 Stat. 5, related to regulations to prevent
contagious diseases.
Section 112, act May 29, 1884, ch. 60, Sec. 4, 23 Stat. 32; Feb.
2, 1903, ch. 349, Sec. 1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45
Stat. 59, related to investigations as to pleuropneumonia and other
diseases and regulations.
SHORT TITLE
Act Feb. 2, 1903, ch. 349, 32 Stat. 791, classified to former
sections 112 and 120 to 122 of this title, is popularly known as
the Cattle Contagious Diseases Act of 1903.
Act May 29, 1884, ch. 60, 23 Stat. 31, classified to former
sections 112, 113 to 114a-1, 115, 116, 117 to 120, and 130 of this
title and section 391 of Title 7, Agriculture, is popularly known
as the Animal Industry Act.
-End-
-CITE-
21 USC Sec. 112a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Sec. 112a. Omitted
-COD-
CODIFICATION
Section, act Feb. 7, 1928, ch. 30, 45 Stat. 59, amended acts May
29, 1884, ch. 60, 23 Stat. 31; Feb. 2, 1903, ch. 349, 32 Stat. 791;
and Mar. 3, 1905, ch. 1496, 33 Stat. 1264, to include live poultry
in their provisions, added "and/or live poultry" following "live
stock" wherever the term "live stock" appeared, and extended the
penalties, terms, and provisions of said acts to live poultry. For
complete classification of such acts to the Code, see Short Title
note set out under section 112 of this title and Tables.
-End-
-CITE-
21 USC Sec. 113 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Sec. 113. Repealed.
-MISC1-
Sec. 113. Repealed. Pub. L. 107-171, title X, Sec. 10418(a)(7),
(8), May 13, 2002, 116 Stat. 507, 508.
Section, act May 29, 1884, ch. 60, Sec. 5, 23 Stat. 32; Feb. 2,
1903, ch. 349, Sec. 1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat.
59, related to measures to prevent exportation of diseased
livestock and live poultry.
-End-
-CITE-
21 USC Sec. 113a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Sec. 113a. Establishment of research laboratories for foot-and-
mouth disease and other animal diseases; research contracts;
employment of technicians and scientists; appropriations
-STATUTE-
The Secretary of Agriculture is authorized to establish research
laboratories, including the acquisition of necessary land,
buildings, or facilities, and also the making of research contracts
under the authority contained in section 427i(a) of title 7, for
research and study, in the United States or elsewhere, of foot-and-
mouth disease and other animal diseases which in the opinion of
the Secretary constitute a threat to the livestock industry of the
United States: Provided, That no live virus of foot-and-mouth
disease may be introduced for any purpose into any part of the
mainland of the United States (except coastal islands separated
therefrom by water navigable for deep-water navigation and which
shall not be connected with the mainland by any tunnel) unless the
Secretary determines that it is necessary and in the public
interest for the conduct of research and study in the United States
(except at Brookhaven National Laboratory in Upton, New York) and
issues a permit under such rules as the Secretary shall promulgate
to protect animal health, except that the Secretary of Agriculture
may transport said virus in the original package across the
mainland under adequate safeguards, and except further, that in the
event of outbreak of foot-and-mouth disease in this country, the
Secretary of Agriculture may, at his discretion, permit said virus
to be brought into the United States under adequate safeguards. To
carry out the provisions of this section, the Secretary is
authorized to employ technical experts or scientists: Provided,
That the number so employed shall not exceed five and that the
maximum compensation for each shall not exceed the highest rate of
grade 18 of the General Schedule. There is authorized to be
appropriated such sums as Congress may deem necessary; in addition,
the Secretary is authorized to utilize in carrying out this
section, funds otherwise available for the control or eradication
of such diseases.
-SOURCE-
(May 29, 1884, ch. 60, Sec. 12, as added Apr. 24, 1948, ch. 229, 62
Stat. 198; amended July 31, 1956, ch. 804, title I, Sec. 119, 70
Stat. 742; Pub. L. 85-573, July 31, 1958, 72 Stat. 454; Pub. L. 87-
793, Sec. 1001(e), Oct. 11, 1962, 76 Stat. 864; Pub. L. 88-426,
title III, Sec. 305(1), Aug. 14, 1964, 78 Stat. 422; Pub. L. 101-
624, title XVI, Sec. 1618(b), Nov. 28, 1990, 104 Stat. 3733.)
-COD-
CODIFICATION
Provisions that authorized the Secretary to employ technical
experts and scientists "without regard to the Classification Act",
meaning the Classification Act of 1923, were omitted as obsolete.
Sections 1202 and 1204 of the Classification Act of 1949, 63 Stat.
972, 973, repealed the 1923 Act and all laws or parts of laws
inconsistent with the 1949 Act. While section 1106(a) of the 1949
Act provided that references in other laws to the 1923 Act should
be held and considered to mean the 1949 Act, it did not have the
effect of continuing the exception contained in this section
because of section 1106(b) which provided that the application of
the 1949 Act to any position, officer, or employee shall not be
affected by section 1106(a). The Classification Act of 1949 was
repealed by Pub. L. 89-554, Sept. 6, 1966, Sec. 8(a), 80 Stat. 632
(the first section of which revised and enacted Title 5, Government
Organization and Employees, into law). Section 5102 of Title 5
contains the applicability provisions of the 1949 Act, and section
5103 of Title 5 authorizes the Office of Personnel Management to
determine the applicability to specific positions and employees.
-MISC1-
AMENDMENTS
1990 - Pub. L. 101-624 substituted "United States (except" for
"United States except" and "tunnel) unless the Secretary determines
that it is necessary and in the public interest for the conduct of
research and study in the United States (except at Brookhaven
National Laboratory in Upton, New York) and issues a permit under
such rules as the Secretary shall promulgate to protect animal
health," for "tunnel, and".
1962 - Pub. L. 87-793 substituted "shall not exceed the highest
rate of grade 18 of the General Schedule" for "shall not exceed
$19,000 per annum".
1958 - Pub. L. 85-573 inserted in proviso clause of first
sentence the exception clause respecting transportation of virus in
original package across mainland under adequate safeguards.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by Pub. L. 87-793 effective on first day of first pay
period which begins on or after Oct. 11, 1962.
REPEALS
Act July 31, 1956, ch. 804, title I, Sec. 119, 70 Stat. 742,
which increased the maximum compensation of technical experts or
scientists, was repealed by Pub. L. 88-426, title III, Sec. 305(1),
Aug. 14, 1964, 78 Stat. 422.
REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES
References in laws to the rates of pay for GS-16, 17, or 18, or
to maximum rates of pay under the General Schedule, to be
considered references to rates payable under specified sections of
Title 5, Government Organization and Employees, see section 529
[title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note
under section 5376 of Title 5.
LIVE VIRUS FOOT AND MOUTH DISEASE RESEARCH
Pub. L. 110-234, title VII, Sec. 7524, May 22, 2008, 122 Stat.
1273, and Pub. L. 110-246, Sec. 4(a), title VII, Sec. 7524, June
18, 2008, 122 Stat. 1664, 2034, provided that:
"(a) In General. - The Secretary [of Agriculture] shall issue a
permit required under section 12 of the Act of May 29, 1884 (21
U.S.C. 113a) to the Secretary of Homeland Security for work on the
live virus of foot and mouth disease at any facility that is a
successor to the Plum Island Animal Disease Center and charged with
researching high-consequence biological threats involving zoonotic
and foreign animal diseases (referred to in this section as the
'successor facility').
"(b) Limitation to Single Facility. - Not more than 1 facility
shall be issued a permit under subsection (a).
"(c) Limitation on Validity. - The permit issued under this
section shall be valid unless the Secretary determines that the
study of live foot and mouth disease virus at the successor
facility is not being carried out in accordance with the
regulations promulgated by the Secretary pursuant to the
Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401 et
seq.).
"(d) Authority. - The suspension, revocation, or other impairment
of the permit issued under this section -
"(1) shall be made by the Secretary; and
"(2) is a nondelegable function."
[Pub. L. 110-234 and Pub. L. 110-246 enacted identical
provisions. Pub. L. 110-234 was repealed by section 4(a) of Pub. L.
110-246, set out as a note under section 8701 of Title 7,
Agriculture.]
-End-
-CITE-
21 USC Secs. 114 to 114d-1 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Secs. 114 to 114d-1. Repealed.
-MISC1-
Secs. 114 to 114d-1. Repealed. Pub. L. 107-171, title X, Sec.
10418(a)(8), (9), May 13, 2002, 116 Stat. 508.
Section 114, act May 29, 1884, ch. 60, Sec. 3, 23 Stat. 32,
related to regulations for suppression of diseases and cooperation
of States and Territories.
Section 114a, act May 29, 1884, ch. 60, Sec. 11, as added Sept.
21, 1944, ch. 412, title I, Sec. 101(a), 58 Stat. 734; amended Oct.
30, 1951, ch. 637, Sec. 1, 65 Stat. 693; Aug. 8, 1953, ch. 381, 67
Stat. 493; Aug. 3, 1956, ch. 950, Sec. 2, 70 Stat. 1032; Pub. L. 87-
518, Sec. 7, July 2, 1962, 76 Stat. 131; Pub. L. 101-624, title
XXV, Sec. 2509(c)(2), Nov. 28, 1990, 104 Stat. 4071, related to
control and eradication of diseases, cooperation of States and
farmers' associations, purchase and destruction of diseased
animals, and defined "State" for statutory purposes.
A prior section 11 of act May 29, 1884, required annual reports
to Congress concerning the suppression of contagious diseases among
domestic animals, and was classified to section 560 of former Title
5, prior to repeal by act May 29, 1928, ch. 901, Sec. 1, 45 Stat.
993.
Section 114a-1, act May 29, 1884, ch. 60, Sec. 13, as added Oct.
30, 1951, ch. 637, Sec. 2, 65 Stat. 693, related to interstate
movement of domestic animals reacting to tests for brucellosis,
immediate slaughter, and rules and regulations.
Section 114b, act Feb. 28, 1947, ch. 8, Sec. 1, 61 Stat. 7; Pub.
L. 89-521, Sec. 1, July 27, 1966, 80 Stat. 330; Pub. L. 92-152,
Sec. 1, Nov. 5, 1971, 85 Stat. 418; Pub. L. 94-231, Sec. 3, Mar.
15, 1976, 90 Stat. 216; Pub. L. 101-255, Sec. 1(1), Mar. 15, 1990,
104 Stat. 114; Pub. L. 101-624, title XXV, Sec. 2505, Nov. 28,
1990, 104 Stat. 4068, related to cooperation in animal disease
control.
Section 114c, act Feb. 28, 1947, ch. 8, Sec. 2, 61 Stat. 7; Aug.
3, 1956, ch. 950, Sec. 3, 70 Stat. 1033; Pub. L. 92-152, Sec. 2,
Nov. 5, 1971, 85 Stat. 419; Pub. L. 101-255, Sec. 1(2), Mar. 15,
1990, 104 Stat. 114, related to use of funds.
Section 114d, act Feb. 28, 1947, ch. 8, Sec. 3, as added Pub. L.
101-255, Sec. 1(3), Mar. 15, 1990, 104 Stat. 114, related to sale
of sterile screwworms.
A prior section 114d, act Feb. 28, 1947, ch. 8, Sec. 3, 61 Stat.
8, related to reports by Secretary of Agriculture to Congress with
respect to activities carried on under sections 114b and 114c of
this title, prior to repeal by Pub. L. 86-533, Sec. 1(20), June 29,
1960, 74 Stat. 249.
Section 114d-1, act Feb. 28, 1947, ch. 8, Sec. 5, as added Pub.
L. 89-521, Sec. 2, July 27, 1966, 80 Stat. 330; amended Pub. L. 101-
255, Sec. 1(5), Mar. 15, 1990, 104 Stat. 114, related to
cooperation with public and private entities.
SHORT TITLE
Section 6 of act Feb. 28, 1947, ch. 8, as added by Pub. L. 101-
255, Sec. 1(6), Mar. 15, 1990, 104 Stat. 114, provided that the
act Feb. 28, 1947, ch. 8, which enacted sections 114b to 114d-1 of
this title and provisions set out as a note under former section
114b of this title, could be referred to as the "Animal Disease
Control Cooperation Act of 1947".
-End-
-CITE-
21 USC Secs. 114d-2 to 114d-6 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Secs. 114d-2 to 114d-6. Repealed.
-MISC1-
Secs. 114d-2 to 114d-6. Repealed. Pub. L. 92-152, Sec. 3, Nov. 5,
1971, 85 Stat. 419.
Section 114d-2, Pub. L. 90-388, Sec. 1, July 6, 1968, 82 Stat.
294, provided for cooperation with Central America in control and
eradication of foot-and-mouth disease or rinderpest.
Section 114d-3, Pub. L. 90-388, Sec. 2, July 6, 1968, 82 Stat.
294, provided for uses of funds.
Section 114d-4, Pub. L. 90-388, Sec. 3, July 6, 1968, 82 Stat.
294, defined governments of Central America.
Section 114d-5, Pub. L. 90-388, Sec. 4, July 6, 1968, 82 Stat.
294, provided for cooperation with public and private organizations
and individuals.
Section 114d-6, Pub. L. 90-388, Sec. 5, July 6, 1968, 82 Stat.
294, provided for authorization of appropriations.
-End-
-CITE-
21 USC Secs. 114e to 114h 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Secs. 114e to 114h. Repealed.
-MISC1-
Secs. 114e to 114h. Repealed. Pub. L. 107-171, title X, Sec.
10418(a)(10), (11), May 13, 2002, 116 Stat. 508.
Section 114e, act June 16, 1948, ch. 477, Sec. 1, 62 Stat. 458,
related to research and investigations into the control and
eradication of cattle grubs.
Section 114f, act June 16, 1948, ch. 477, Sec. 2, 62 Stat. 458,
defined the term "State" and authorized appropriations.
Section 114g, Pub. L. 87-209, Sec. 1, Sept. 6, 1961, 75 Stat.
481, related to hog cholera eradication program.
Section 114h, Pub. L. 87-209, Sec. 2, Sept. 6, 1961, 75 Stat.
481, related to advisory committee.
-End-
-CITE-
21 USC Sec. 114i 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Sec. 114i. Pseudorabies eradication
-STATUTE-
(a) Findings
Congress finds that efforts to eradicate pseudorabies in United
States swine populations by the Department of Agriculture in
cooperation with State agencies and the pork industry have a high
priority and should be continued until pseudorabies is completely
eradicated in the United States.
(b) Establishment of program
The Secretary of Agriculture shall establish and carry out a
program for the eradication of pseudorabies in United States swine
populations.
(c) Use of funds for testing and control of pseudorabies
The Secretary shall ensure that not less than 65 percent of the
funds appropriated for the program established under subsection (b)
of this section shall be used for testing and screening of animals
and for other purposes directly related to the eradication or
control of pseudorabies. This requirement on the use of
appropriated funds for this program shall not be implemented in a
manner that would adversely affect any other animal or plant
disease or pest eradication or control program.
(d) Authorization of appropriations
There are authorized to be appropriated for each of the fiscal
years 1991 through 2007 such sums as may be necessary for the
purpose of carrying out the program established under subsection
(b) of this section.
-SOURCE-
(Pub. L. 101-624, title XXV, Sec. 2506, Nov. 28, 1990, 104 Stat.
4068; Pub. L. 104-127, title IX, Sec. 916, Apr. 4, 1996, 110 Stat.
1187; Pub. L. 107-171, title X, Sec. 10505, May 13, 2002, 116 Stat.
511.)
-MISC1-
AMENDMENTS
2002 - Subsec. (d). Pub. L. 107-171 substituted "2007" for
"2002".
1996 - Subsec. (d). Pub. L. 104-127 substituted "2002" for
"1995".
-End-
-CITE-
21 USC Secs. 115 to 128 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Secs. 115 to 128. Repealed.
-MISC1-
Secs. 115 to 128. Repealed. Pub. L. 107-171, title X, Sec.
10418(a)(7), (8), (12)-(14), May 13, 2002, 116 Stat. 507, 508.
Section 115, act May 29, 1884, ch. 60, Sec. 6, 23 Stat. 32; June
28, 1926, ch. 700, Sec. 1, 44 Stat. 774; Feb. 7, 1928, ch. 30, 45
Stat. 59; Pub. L. 87-763, Oct. 9, 1962, 76 Stat. 762, prohibited
transportation of diseased livestock and live poultry.
Section 116, act May 29, 1884, ch. 60, 23 Stat. 31; May 31, 1920,
ch. 217, 41 Stat. 699, related to excepted shipment of certain
cattle.
Section 117, act May 29, 1884, ch. 60, Sec. 7, 23 Stat. 32; Feb.
7, 1928, ch. 30, 45 Stat. 59; Pub. L. 95-439, Sec. 1, Oct. 10,
1978, 92 Stat. 1061; Pub. L. 97-461, Sec. 5, Jan. 12, 1983, 96
Stat. 2524, related to penalties for transportation of diseased
livestock or live poultry.
Section 118, act May 29, 1884, ch. 60, Sec. 9, 23 Stat. 33; June
25, 1948, ch. 646, Sec. 1, 62 Stat. 909, related to duty of United
States attorneys.
Section 119, act May 29, 1884, ch. 60, Sec. 2, 23 Stat. 31; Feb.
9, 1889, ch. 122, Sec. 1, 25 Stat. 659; July 14, 1890, ch. 707, 26
Stat. 288; Feb. 7, 1928, ch. 30, 45 Stat. 59, related to
appointment of agents to examine and report on methods of treatment
of animals, and means for suppression of diseases.
Section 120, act May 29, 1884, ch. 60, Secs. 4, 5, 23 Stat. 32;
Feb. 2, 1903, ch. 349, Sec. 1, 32 Stat. 791; Feb. 7, 1928, ch. 30,
45 Stat. 59, related to regulation of exportation and
transportation of infected livestock and live poultry.
Section 121, act Feb. 2, 1903, ch. 349, Sec. 1, 32 Stat. 791;
Feb. 7, 1928, ch. 30, 45 Stat. 59, related to shipments from areas
suspected to be infected and to control of animals and live
poultry.
Section 122, act Feb. 2, 1903, ch. 349, Sec. 3, 32 Stat. 792;
Pub. L. 97-461, Sec. 6, Jan. 12, 1983, 96 Stat. 2525, related to
offenses and penalties.
Section 123, act Mar. 3, 1905, ch. 1496, Sec. 1, 33 Stat. 1264;
Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87-518, Sec. 8(a), July
2, 1962, 76 Stat. 131; Pub. L. 95-439, Sec. 2, Oct. 10, 1978, 92
Stat. 1061, related to quarantine.
Section 124, act Mar. 3, 1905, ch. 1496, Sec. 2, 33 Stat. 1264;
Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87-518, Sec. 8(b), July
2, 1962, 76 Stat. 131, prohibited transportation or delivery
therefor from quarantined State or Territory or portion thereof, of
quarantined animals and live poultry.
Section 125, act Mar. 3, 1905, ch. 1496, Sec. 3, 33 Stat. 1265;
Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87-518, Sec. 8(b), July
2, 1962, 76 Stat. 131; Pub. L. 95-439, Sec. 3, Oct. 10, 1978, 92
Stat. 1061, related to regulations for inspection, disinfection,
and certification, and delivery and shipment of quarantined animals
and live poultry from State or Territory.
Section 126, act Mar. 3, 1905, ch. 1496, Sec. 4, 33 Stat. 1265;
Feb. 7, 1928, ch. 30, 45 Stat. 59; Pub. L. 87-518, Sec. 8(b), July
2, 1962, 76 Stat. 131, related to moving quarantined animals and
live poultry from State or Territory, under regulations.
Section 127, act Mar. 3, 1905, ch. 1496, Sec. 6, 33 Stat. 1265;
Pub. L. 97-461, Sec. 7, Jan. 12, 1983, 96 Stat. 2525, related to
penalties for transportation from quarantined State, Territory,
etc.
Section 128, act June 30, 1914, ch. 131, 38 Stat. 419; Pub. L. 87-
518, Sec. 9, July 2, 1962, 76 Stat. 131, related to extension of
quarantine law to carriers in interstate commerce.
SHORT TITLE
Act Mar. 3, 1905, ch. 1496, 33 Stat. 1264, which enacted sections
123 to 127 of this title, was popularly known as the "Cattle
Contagious Diseases Act of 1905".
-End-
-CITE-
21 USC Sec. 129 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Sec. 129. Omitted
-COD-
CODIFICATION
Section, Pub. L. 107-76, title I, Nov. 28, 2001, 115 Stat. 712,
related to transfer of funds for emergency arrest of animal,
poultry, or plant diseases or pests, and was from the Agriculture,
Rural Development, Food and Drug Administration, and Related
Agencies Appropriations Act, 2002. Similar provisions which are
permanent are classified to sections 7772 and 8316 of Title 7,
Agriculture.
-MISC1-
PRIOR PROVISIONS
Provisions similar to those in this section were contained in the
following prior appropriation acts:
Pub. L. 106-387, Sec. 1(a) [title I], Oct. 28, 2000, 114 Stat.
1549, 1549A-9, repealed by Pub. L. 107-171, title X, Sec.
10418(a)(15), May 13, 2002, 116 Stat. 508.
Pub. L. 106-78, title I, Oct. 22, 1999, 113 Stat. 1143.
Pub. L. 105-277, div. A, Sec. 101(a) [title I], Oct. 21, 1998,
112 Stat. 2681, 2681-8.
Pub. L. 105-86, title I, Nov. 18, 1997, 111 Stat. 2086.
Pub. L. 104-180, title I, Aug. 6, 1996, 110 Stat. 1576.
Pub. L. 104-37, title I, Oct. 21, 1995, 109 Stat. 307.
Pub. L. 103-330, title I, Sept. 30, 1994, 108 Stat. 2443.
Pub. L. 103-111, title I, Oct. 21, 1993, 107 Stat. 1054.
Pub. L. 102-341, title I, Aug. 14, 1992, 106 Stat. 882.
Pub. L. 102-142, title I, Oct. 28, 1991, 105 Stat. 886.
Pub. L. 101-506, title I, Nov. 5, 1990, 104 Stat. 1323.
Pub. L. 101-161, title I, Nov. 21, 1989, 103 Stat. 959.
Pub. L. 100-460, title I, Oct. 1, 1988, 102 Stat. 2237.
Pub. L. 100-202, Sec. 101(k) [title I], Dec. 22, 1987, 101 Stat.
1329-322, 1329-331.
Pub. L. 99-500, Sec. 101(a) [title I], Oct. 18, 1986, 100 Stat.
1783, 1783-8, and Pub. L. 99-591, Sec. 101(a) [title I], Oct. 30,
1986, 100 Stat. 3341, 3341-8.
Pub. L. 99-190, Sec. 101(a) [H.R. 3037, title I], Dec. 19, 1985,
99 Stat. 1185; Pub. L. 100-202, Sec. 106, Dec. 22, 1987, 101 Stat.
1329-433.
Pub. L. 97-370, title I, Dec. 18, 1982, 96 Stat. 1792.
Pub. L. 97-103, title I, Dec. 23, 1981, 95 Stat. 1472.
Pub. L. 96-528, title I, Dec. 15, 1980, 94 Stat. 3099.
Pub. L. 96-108, title I, Nov. 9, 1979, 93 Stat. 826.
Pub. L. 95-448, title I, Oct. 11, 1978, 92 Stat. 1076.
Pub. L. 95-97, title I, Aug. 12, 1977, 91 Stat. 813.
Pub. L. 94-351, title I, July 12, 1976, 90 Stat. 854.
Pub. L. 94-122, title I, Oct. 21, 1975, 89 Stat. 645.
Pub. L. 93-563, title I, Dec. 31, 1974, 88 Stat. 1824.
Pub. L. 93-135, title I, Oct. 24, 1973, 87 Stat. 472.
Pub. L. 92-399, title I, Aug. 22, 1972, 86 Stat. 594.
Pub. L. 92-73, title I, Aug. 10, 1971, 85 Stat. 185.
Pub. L. 91-566, title I, Dec. 22, 1970, 84 Stat. 1482.
Pub. L. 91-127, title I, Nov. 26, 1969, 83 Stat. 246.
Pub. L. 90-463, title I, Aug. 8, 1968, 82 Stat. 640.
Pub. L. 90-113, title I, Oct. 24, 1967, 81 Stat. 321.
Pub. L. 89-556, title I, Sept. 7, 1966, 80 Stat. 690.
Pub. L. 89-316, title I, Nov. 2, 1965, 79 Stat. 1166.
Pub. L. 88-573, title I, Sept. 2, 1964, 78 Stat. 863.
Pub. L. 88-250, title I, Dec. 30, 1963, 77 Stat. 821.
Pub. L. 87-879, title I, Oct. 24, 1962, 76 Stat. 1204.
Pub. L. 87-112, title I, July 26, 1961, 75 Stat. 228.
Pub. L. 86-532, title I, June 29, 1960, 74 Stat. 233.
Pub. L. 86-80, title I, July 8, 1959, 73 Stat. 168.
Pub. L. 85-459, title I, June 13, 1958, 72 Stat. 189.
Pub. L. 85-118, title I, Aug. 2, 1957, 71 Stat. 330.
June 4, 1956, ch. 355, title I, 70 Stat. 230.
May 23, 1955, ch. 43, title I, 69 Stat. 52.
June 29, 1954, ch. 409, title I, 68 Stat. 305.
July 28, 1953, ch. 251, title III, 67 Stat. 223.
July 5, 1952, ch. 574, title III, 66 Stat. 354.
Aug. 31, 1951, ch. 374, title II, 65 Stat. 243.
Sept. 6, 1950, ch. 896, Ch. VI, title I, 64 Stat. 661.
June 29, 1949, ch. 280, title I, 63 Stat. 332.
June 19, 1948, ch. 543, 62 Stat. 515.
July 30, 1947, ch. 356, title I, 61 Stat. 532.
June 22, 1946, ch. 445, 60 Stat. 278.
May 5, 1945, ch. 109, 59 Stat. 144.
June 28, 1944, ch. 296, 58 Stat. 434.
July 12, 1943, ch. 215, 57 Stat. 403.
July 22, 1942, ch. 516, 56 Stat. 676.
July 1, 1941, ch. 267, 55 Stat. 418.
June 25, 1940, ch. 421, 54 Stat. 542.
June 30, 1939, ch. 253, title I, 53 Stat. 951.
June 16, 1938, ch. 464, title I, 52 Stat. 722.
June 29, 1937, ch. 404, 50 Stat. 406.
June 4, 1936, ch. 489, 49 Stat. 1432.
May 17, 1935, ch. 131, title I, 49 Stat. 257.
Mar. 26, 1934, ch. 89, 48 Stat. 477.
Mar. 3, 1933, ch. 203, 47 Stat. 1442.
July 7, 1932, ch. 443, 47 Stat. 620.
Feb. 23, 1931, ch. 278, 46 Stat. 1252.
May 27, 1930, ch. 341, 46 Stat. 403.
Feb. 16, 1929, ch. 227, 45 Stat. 1198.
May 16, 1928, ch. 572, 45 Stat. 548.
Jan. 18, 1927, ch. 39, 44 Stat. 1005.
May 11, 1926, ch. 286, 44 Stat. 529.
Feb. 10, 1925, ch. 200, 43 Stat. 851.
Dec. 5, 1924, ch. 4, 43 Stat. 683.
June 5, 1924, ch. 266, 43 Stat. 458.
Apr. 2, 1924, ch. 81, 43 Stat. 40.
Feb. 26, 1923, ch. 119, 42 Stat. 1318.
May 11, 1922, ch. 185, 42 Stat. 536.
Mar. 4, 1917, ch. 179, 39 Stat. 1167.
-End-
-CITE-
21 USC Secs. 129a to 131 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Secs. 129a to 131. Repealed.
-MISC1-
Secs. 129a to 131. Repealed. Pub. L. 107-171, title X, Sec.
10418(a)(1), (8), (16), May 13, 2002, 116 Stat. 507, 508.
Section 129a, Pub. L. 97-46, Sec. 1, Sept. 25, 1981, 95 Stat.
953; Pub. L. 106-224, title IV, Sec. 438(b), June 20, 2000, 114
Stat. 454, related to transfer of funds for emergency arrest of
animal or poultry diseases. Section was formerly classified to
section 147b of Title 7, Agriculture.
Section 130, act May 29, 1884, ch. 60, Sec. 8, 23 Stat. 33; 1967
Reorg. Plan No. 3, Sec. 402(430), eff. Aug. 11, 1967, 32 F.R.
11669, 81 Stat. 948; Pub. L. 93-198, title IV, Sec. 401, Dec. 24,
1973, 87 Stat. 793, related to pleuropneumonia in District of
Columbia and duties of Council of the District of Columbia.
Section 131, act May 26, 1910, ch. 256, 36 Stat. 440, related to
fences along international boundary lines to keep out diseased
animals.
EFFECTIVE DATE
Pub. L. 97-46, Sec. 2, Sept. 25, 1981, 95 Stat. 953, provided
that section 129a of this title was to become effective Sept. 25,
1981, prior to repeal by Pub. L. 107-171, title X, Sec.
10418(a)(1), May 13, 2002, 116 Stat. 507.
-End-
-CITE-
21 USC Sec. 132 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Sec. 132. Transferred
-COD-
CODIFICATION
Section, act May 23, 1908, ch. 192, 35 Stat. 254, which related
to inspection of dairy products for export, was transferred to
section 693 of this title.
-End-
-CITE-
21 USC Sec. 133 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Sec. 133. Repealed.
-MISC1-
Sec. 133. Repealed. July 13, 1949, ch. 307, 63 Stat. 410.
Section, act July 24, 1946, ch. 592, 60 Stat. 633, related to
establishment of a quarantine station on Swan Island.
-End-
-CITE-
21 USC Secs. 134 to 135b 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Secs. 134 to 135b. Repealed.
-MISC1-
Secs. 134 to 135b. Repealed. Pub. L. 107-171, title X, Sec.
10418(a)(17), (18), May 13, 2002, 116 Stat. 508.
Section 134, Pub. L. 87-518, Sec. 1, July 2, 1962, 76 Stat. 129,
related to definitions for Pub. L. 87-518.
Section 134a, Pub. L. 87-518, Sec. 2, July 2, 1962, 76 Stat. 129,
related to seizure, quarantine, and disposal of livestock or
poultry to guard against introduction or dissemination of
communicable disease.
Section 134b, Pub. L. 87-518, Sec. 3, July 2, 1962, 76 Stat. 130,
related to regulations for clean and sanitary movement of animals.
Section 134c, Pub. L. 87-518, Sec. 4, July 2, 1962, 76 Stat. 130,
related to regulations for movement of animals affected or exposed
to communicable disease.
Section 134d, Pub. L. 87-518, Sec. 5, July 2, 1962, 76 Stat. 130,
related to inspections, seizures, and issuance of warrants.
Section 134e, Pub. L. 87-518, Sec. 6, July 2, 1962, 76 Stat. 131;
Pub. L. 97-461, Sec. 8, Jan. 12, 1983, 96 Stat. 2525, related to
enforcement provisions.
Section 134f, Pub. L. 87-518, Sec. 11, July 2, 1962, 76 Stat.
132, related to promulgation of regulations.
Section 134g, Pub. L. 87-518, Sec. 12, July 2, 1962, 76 Stat.
132, related to authority in addition to other laws and repeal of
inconsistent provisions.
Section 134h, Pub. L. 87-518, Sec. 13, July 2, 1962, 76 Stat.
132, related to separability.
Section 135, Pub. L. 91-239, Sec. 1, May 6, 1970, 84 Stat. 202;
Pub. L. 103-465, title IV, Sec. 431(j), Dec. 8, 1994, 108 Stat.
4969, related to the establishment of international animal
quarantine station, acceptance of gifts, cooperation with breeders'
organizations, and collection of fees.
Section 135a, Pub. L. 91-239, Sec. 2, May 6, 1970, 84 Stat. 202;
Pub. L. 97-461, Sec. 9, Jan. 12, 1983, 96 Stat. 2525, related to
smuggling penalties.
Section 135b, Pub. L. 91-239, Sec. 3, May 6, 1970, 84 Stat. 202,
related to authorization of appropriations.
-End-
-CITE-
21 USC Sec. 136 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Sec. 136. Additional inspection services
-STATUTE-
The Secretary of Agriculture, in carrying out regulations
prohibiting or restricting the entry of materials that may harbor
pests, or diseases, is authorized to enter into agreements with
operators or owners of vessels or aircraft for the purpose of
providing inspection services at points of entry in the United
States in addition to the regular or on-call basis currently
available in connection with such vessels or aircraft. Any such
agreement shall provide for the payment by the operator or owner of
an amount determined by the Secretary to be necessary to defray the
costs of providing additional service pursuant to such agreement.
-SOURCE-
(Pub. L. 101-624, title XXV, Sec. 2508, Nov. 28, 1990, 104 Stat.
4069.)
-End-
-CITE-
21 USC Sec. 136a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER III - PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION
-HEAD-
Sec. 136a. Collection of fees for inspection services
-STATUTE-
(a) Quarantine and inspection fees
(1) Fees authorized
The Secretary of Agriculture may prescribe and collect fees
sufficient -
(A) to cover the cost of providing agricultural quarantine
and inspection services in connection with the arrival at a
port in the customs territory of the United States, or the
preclearance or preinspection at a site outside the customs
territory of the United States, of an international passenger,
commercial vessel, commercial aircraft, commercial truck, or
railroad car;
(B) to cover the cost of administering this subsection; and
(C) through fiscal year 2002, to maintain a reasonable
balance in the Agricultural Quarantine Inspection User Fee
Account established under paragraph (5).
(2) Limitation
In setting the fees under paragraph (1), the Secretary shall
ensure that the amount of the fees is commensurate with the costs
of agricultural quarantine and inspection services with respect
to the class of persons or entities paying the fees. The costs of
the services with respect to passengers as a class includes the
costs of related inspections of the aircraft or other vehicle.
(3) Status of fees
Fees collected under this subsection by any person on behalf of
the Secretary are held in trust for the United States and shall
be remitted to the Secretary in such manner and at such times as
the Secretary may prescribe.
(4) Late payment penalties
If a person subject to a fee under this subsection fails to pay
the fee when due, the Secretary shall assess a late payment
penalty, and the overdue fees shall accrue interest, as required
by section 3717 of title 31.
(5) Agricultural quarantine inspection user fee account
(A) Establishment
There is established in the Treasury of the United States a
fund, to be known as the "Agricultural Quarantine Inspection
User Fee Account", which shall contain all of the fees
collected under this subsection and late payment penalties and
interest charges collected under paragraph (4) through fiscal
year 2002.
(B) Use of account
For each of fiscal years 1996 through 2002, funds in the
Agricultural Quarantine Inspection User Fee Account shall be
available, in such amounts as are provided in advance in
appropriations Acts, to cover the costs associated with the
provision of agricultural quarantine and inspection services
and the administration of this subsection. Amounts made
available under this subparagraph shall be available until
expended.
(C) Excess fees
Fees and other amounts collected under this subsection in any
of fiscal years 1996 through 2002 in excess of $100,000,000
shall be available for the purposes specified in subparagraph
(B) until expended, without further appropriation.
(6) Use of amounts collected after fiscal year 2002
After September 30, 2002, the unobligated balance in the
Agricultural Quarantine Inspection User Fee Account and fees and
other amounts collected under this subsection shall be credited
to the Department of Agriculture accounts that incur the costs
associated with the provision of agricultural quarantine and
inspection services and the administration of this subsection.
The fees and other amounts shall remain available to the
Secretary until expended without fiscal year limitation.
(7) Staff years
The number of full-time equivalent positions in the Department
of Agriculture attributable to the provision of agricultural
quarantine and inspection services and the administration of this
subsection shall not be counted toward the limitation on the
total number of full-time equivalent positions in all agencies
specified in section 5(b) of the Federal Workforce Restructuring
Act of 1994 (Public Law 103-226; 5 U.S.C. 3101 note) or other
limitation on the total number of full-time equivalent positions.
(b) Omitted
(c) Animal inspection and veterinary diagnostics
(1) Animal inspection
The Secretary may prescribe and collect fees to reimburse the
Secretary for the cost of carrying out the provisions of the
Federal Animal Quarantine Laws that relate to the importation,
entry, and exportation of animals, articles, or means of
conveyance.
(2) Veterinary diagnostics
The Secretary may prescribe and collect fees to recover the
costs of carrying out the provisions of the Animal Health
Protection Act [7 U.S.C. 8301 et seq.] that relate to veterinary
diagnostics.
(3) Fees
All fees collected pursuant to this subsection and any late
payment penalties or accrued interest collected pursuant to this
subsection shall be credited to the accounts that incur the cost
and shall remain available until expended without fiscal year
limitation.
(4) Liability
Any person for whom an activity related to the importation,
entry, or exportation of an animal, article, or means of
conveyance or relating to veterinary diagnostics, is performed
pursuant to the section, shall be liable for payment of fees
assessed. Upon failure to pay such fees when due, the Secretary
shall assess a late payment penalty, and such overdue fees shall
accrue interest, as required by section 3717 of title 31. All
fees, late payment penalties, and accrued interest collected
shall be credited to such accounts that incur the costs and shall
remain available until expended without fiscal year limitation.
(5) Leins (!1)
(A) In general
The Secretary shall have a lien against the animal, article,
means of conveyance, or facility for which services have been
provided under this section for the fees, any late payment
penalty, and any accrued interest assessed under this
subsection.
(B) Other animals, etc.
In the case of any person who fails to make payment when due
under this subsection, the Secretary shall have a lien against
any animal, article, or means of conveyance thereafter
imported, moved in interstate commerce, or attempted to be
exported by the person after the date of such failure until the
date on which such owner or operator make (!2) full payment to
the Secretary under this subsection.
(C) Sales of animals, etc.
(i) Authority
The Secretary may, if a person does not pay fees, late
payment penalties, or accrued interest on such, after
providing reasonable notice of default to such person, sell
at public sale after reasonable public notice, or otherwise
dispose of, any such animal, article, means of conveyance or
facility on which the Secretary has a lien under this
paragraph.
(ii) Excess proceeds
If the sale proceeds under clause (i) exceed the fees due,
any late payment penalty assessed, any accrued interest on
such, and the expenses associated with the sale, such excess
shall be paid to the owner of the animal, article, means of
conveyance, or facility if such owner submits an application
for such excess together with proof of ownership not later
than 6 months after the date of such sale. If no such
application is made, such excess shall be credited to
accounts that incur the costs associated with the fees
collected and shall remain available until expended, without
fiscal year limitation. The Secretary shall suspend
performance of services to persons who have failed to pay
fees, late payment penalty, or accrued interest under this
section.
(d) Regulations
The Secretary may prescribe such regulations as the Secretary
determines necessary to carry out the provisions of this section.
(e) Recovery of amounts owed
An action may be brought for the recovery of fees, late payment
penalties, and accrued interest which have not been paid in
accordance with this section against any person obligated for
payment of such assessments under this section in any United States
district court or other United States court for any territory or
possession in any jurisdiction in which such person is found or
resides or transacts business, and such court shall have
jurisdiction to hear and decide such action.
(f) Definitions
(1) Animal quarantine laws
For purposes of this section, the term "animal quarantine laws"
means -
(A) section 306 of the Tariff Act of 1930 (!3) (19 U.S.C.
1306);
(B) section 9 of the Act of August 30, 1890 (21 U.S.C. 101);
(C) the Animal Health Protection Act [7 U.S.C. 8301 et seq.];
or
(D) any other Act administered by the Secretary relating to
plant or animal diseases or pests.
(2) Customs territory
For the purposes of subsection (a) of this section, the term
"customs territory of the United States" means the 50 States, the
District of Columbia, and Puerto Rico.
(3) Person
For the purposes of this section, the term "person" means an
individual, corporation, partnership, trust, association, or any
other public or private entity, or any officer, employee, or
agent thereof.
(4) United States
For the purposes of subsection (b) of this section, the term
"United States" means the several States of the United States,
the District of Columbia, Guam, the Commonwealth of the Northern
Mariana Islands, the Commonwealth of Puerto Rico, the Virgin
Islands of the United States, and all other territories and
possessions of the United States.
(5) Vessel
For the purposes of subsection (a) of this section, the term
"vessel" does not include any ferry.
-SOURCE-
(Pub. L. 101-624, title XXV, Sec. 2509, Nov. 28, 1990, 104 Stat.
4069; Pub. L. 101-508, title I, Sec. 1203, Nov. 5, 1990, 104 Stat.
1388-11; Pub. L. 102-237, title X, Sec. 1015, Dec. 13, 1991, 105
Stat. 1902; Pub. L. 104-127, title IX, Sec. 917, Apr. 4, 1996, 110
Stat. 1187; Pub. L. 107-171, title X, Sec. 10418(b)(5), May 13,
2002, 116 Stat. 509.)
-REFTEXT-
REFERENCES IN TEXT
The Animal Health Protection Act, referred to in subsecs. (c)(2),
(f)(1)(C), is subtitle E (Secs. 10401-10418) of title X of Pub. L.
107-171, May 13, 2002, 116 Stat. 494, which is classified
principally to chapter 109 (Sec. 8301 et seq.) of Title 7,
Agriculture. For complete classification of this Act to the Code,
see Short Title note set out under section 8301 of Title 7 and
Tables.
Section 306 of the Tariff Act of 1930 (19 U.S.C. 1306), referred
to in subsec. (f)(1)(A), was repealed by Pub. L. 107-171, title X,
Sec. 10418(a)(5), May 13, 2002, 116 Stat. 507.
-COD-
CODIFICATION
Section is comprised of section 2509 of Pub. L. 101-624. Subsec.
(b) and another subsec. (c)(2) of section 2509 of Pub. L. 101-624
amended section 7759(f) of Title 7, Agriculture, and section 114a
of this title, respectively.
-MISC1-
AMENDMENTS
2002 - Subsec. (c)(2). Pub. L. 107-171, Sec. 10418(b)(5)(A),
added par. (2) relating to veterinary diagnostics.
Subsec. (f)(1)(B) to (O). Pub. L. 107-171, Sec. 10418(b)(5)(B),
added subpars. (B) to (D) and struck out former subpars. (B) to
(O), which read as follows:
"(B) sections 6 through 10 of the Act of August 30, 1890 (26
Stat. 416, chapter 839; 21 U.S.C. 101-105);
"(C) section 2 of the Act of February 2, 1903 (32 Stat. 792,
chapter 349; 21 U.S.C. 111);
"(D) the Act of May 29, 1884 (23 Stat. 32, chapter 60; 21 U.S.C.
112 to 114a-1, 115, 117-119, and 130) (commonly known as the
'Animal Industry Act');
"(E) the Act of February 28, 1947 (61 Stat. 7, chapter 8; 21
U.S.C. 114b, 114c, and 114d-1);
"(F) the Act of June 16, 1948 (62 Stat. 458, chapter 477; 21
U.S.C. 114e and 114f);
"(G) Public Law 87-209 (21 U.S.C. 114g and 114h);
"(H) the Act of May 31, 1920 (41 Stat. 699, chapter 217; 21
U.S.C. 116);
"(I) the Act of February 2, 1903 (32 Stat. 791, chapter 349; 21
U.S.C. 112 and 120-122) (commonly known as the 'Cattle Contagious
Diseases Act of 1903');
"(J) the Act of March 3, 1905 (33 Stat. 1264, chapter 1496; 21
U.S.C. 123-127) (commonly known as the 'Cattle Contagious Diseases
Act of 1905');
"(K) the matter under the heading 'Bureau of Animal Industry' of
the Act of June 30, 1914 (38 Stat. 419, chapter 131; 21 U.S.C.
128);
"(L) section 101 of Public Law 92-73 (21 U.S.C. 129);
"(M) the matter under the heading 'Miscellaneous' of the Act of
May 26, 1910 (36 Stat. 440, chapter 256; 21 U.S.C. 131);
"(N) sections 1 through 6 and 11 through 13 of Public Law 87-518
(21 U.S.C. 134-134h); or
"(O) any other Act administered by the Secretary relating to
plant or animal diseases or pests, other than the first section of
Public Law 91-239 (21 U.S.C. 135)."
1996 - Subsec. (a). Pub. L. 104-127 added subsec. (a) and struck
out heading and text of former subsec. (a) which consisted of pars.
(1) to (4) relating to quarantine, inspection, and transportation
fees.
1991 - Subsec. (a)(1). Pub. L. 102-237, Sec. 1015(1), designated
existing provisions as subpar. (A), realigned margin, added
heading, and added subpars. (B) to (D).
Subsec. (a)(3)(B)(ii). Pub. L. 102-237, Sec. 1015(2), added cl.
(ii) and struck out former cl. (ii) which read as follows: "The
Secretary of Treasury shall use the Account to provide
reimbursements to any appropriations accounts that incur the costs
associated with the services authorized in paragraph (1). Any such
reimbursement shall be subject to appropriations under clause (v)."
Subsec. (a)(4). Pub. L. 102-237, Sec. 1015(3), substituted
"Subject to the limits set forth in paragraph (1), the" for "The".
1990 - Subsec. (a)(1). Pub. L. 101-508, Sec. 1203(1), substituted
"an international passenger, commercial vessel, commercial
aircraft, commercial truck, or railroad car." for "a commercial
vessel, commercial aircraft, commercial truck, or railroad car,".
Subsec. (a)(3)(B)(ii). Pub. L. 101-508, Sec. 1203(2)(A), inserted
at end "Any such reimbursement shall be subject to appropriations
under clause (v)."
Subsec. (a)(3)(B)(v). Pub. L. 101-508, Sec. 1203(2)(B), added cl.
(v).
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101-508 effective Nov. 29, 1990, see section
1301 of Pub. L. 101-508, set out as an Effective Date note under
section 940d of Title 7, Agriculture.
REPORT ON AGRICULTURAL QUARANTINE INSPECTION FUND
Pub. L. 104-66, title I, Sec. 1012(c), Dec. 21, 1995, 109 Stat.
712, provided that: "The Secretary of Agriculture shall not be
required to submit a report to the appropriate committees of
Congress on the status of the Agricultural Quarantine Inspection
fund more frequently than annually."
-FOOTNOTE-
(!1) So in original. Probably should be "Liens".
(!2) So in original. Probably should be "makes".
(!3) See References in Text note below.
-End-
-CITE-
21 USC SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-HEAD-
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-MISC1-
FEDERAL FOOD, DRUG, AND COSMETIC ACT
Nothing contained in chapter 9 (Sec. 301 et seq.) of this title
shall be construed as in any way affecting, modifying, repealing,
or superseding the provisions of this subchapter, see section
392(b) of this title.
-End-
-CITE-
21 USC Sec. 141 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-HEAD-
Sec. 141. Prohibition of importation without permit
-STATUTE-
On and after May 16, 1927, the importation into the United States
of milk and cream is prohibited unless the person by whom such milk
or cream is shipped or transported into the United States holds a
valid permit from the Secretary of Health and Human Services.
-SOURCE-
(Feb. 15, 1927, ch. 155, Sec. 1, 44 Stat. 1101; 1940 Reorg. Plan
No. IV, Sec. 12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237;
1953 Reorg. Plan No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979,
93 Stat. 695.)
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted in text for
"Secretary of Health, Education, and Welfare" pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
-MISC1-
SHORT TITLE
Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in
part that act Feb. 15, 1927, which is classified to this
subchapter, may be cited as "Import Milk Act".
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration to Federal Security
Agency, see notes set out under section 321 of this title.
-End-
-CITE-
21 USC Sec. 142 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-HEAD-
Sec. 142. Milk or cream when unfit for importation
-STATUTE-
Milk or cream shall be considered unfit for importation (1) when
all cows producing such milk or cream are not healthy and a
physical examination of all such cows has not been made within one
year previous to such milk being offered for importation; (2) when
such milk or cream, if raw, is not produced from cows which have
passed a tuberculin test applied by a duly authorized official
veterinarian of the United States, or of the country in which such
milk or cream is produced, within one year previous to the time of
the importation, showing that such cows are free from tuberculosis;
(3) when the sanitary conditions of the dairy farm or plant in
which such milk or cream is produced or handled do not score at
least fifty points out of one hundred points according to the
methods for scoring as provided by the score cards used by the
Bureau of Dairy Industry of the United States Department of
Agriculture at the time such dairy farms or plants are scored; (4)
in the case of raw milk if the number of bacteria per cubic
centimeter exceeds three hundred thousand and in the case of raw
cream seven hundred and fifty thousand, in the case of pasteurized
milk if the number of bacteria per cubic centimeter exceeds one
hundred thousand, and in the case of pasteurized cream five hundred
thousand; (5) when the temperature of milk or cream at the time of
importation exceeds fifty degrees Fahrenheit.
-SOURCE-
(Feb. 15, 1927, ch. 155, Sec. 2, 44 Stat. 1101.)
-TRANS-
TRANSFER OF FUNCTIONS
Agricultural Research Service became the successor to functions
of Bureau of Dairy Industry under Secretary of Agriculture's
Memorandum 1320, Supplement 4, Nov. 2, 1953.
-End-
-CITE-
21 USC Sec. 143 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-HEAD-
Sec. 143. Inspection; certified statement in lieu thereof; waiver
of requirements of section 142; regulations; suspension and
revocation of permits
-STATUTE-
The Secretary of Health and Human Services shall cause such
inspections to be made as are necessary to insure that milk and
cream are so produced and handled as to comply with the provisions
of section 142 of this title, and in all cases when he finds that
such milk and/or cream is produced and handled so as not to be
unfit for importation under clauses 1, 2, and 3 of section 142 of
this title, he shall issue to persons making application therefor
permits to ship milk and/or cream into the United States: Provided,
That in lieu of the inspections to be made by or under the
direction of the Secretary he may, in his discretion, accept a duly
certified statement signed by a duly accredited official of an
authorized department of any foreign government and/or of any State
of the United States or any municipality thereof that the
provisions in clauses 1, 2, and 3 of section 142 of this title have
been complied with. Such certificate of the accredited official of
an authorized department of any foreign government shall be in the
form prescribed by the Secretary, who is authorized and directed to
prescribe such form as well as rules and regulations regulating the
issuance of permits to import milk or cream into the United States.
The Secretary is authorized, in his discretion, to waive the
requirement of clause 4 of section 142 of this title when issuing
permits to operators of condenseries in which milk and/or cream is
used when sterilization of the milk and/or cream is a necessary
process: Provided, however, That no milk and/or cream shall be
imported whose bacterial count per cubic centimeter in any event
exceeds one million two hundred thousand: Provided, further, That
such requirements shall not be waived unless the farm producing
such milk to be imported is within a radius of fifteen miles of the
condensery in which it is to be processed: Provided further, That
if milk and/or cream imported when the requirements of clause 4 of
section 142 of this title, have been so waived, is sold, used, or
disposed of in its raw state or otherwise than as condensed milk by
any person, the permit shall be revoked and the importer shall be
subject to fine, imprisonment, or other penalty prescribed by this
subchapter.
The Secretary is directed to waive the requirements of clauses 2
and 5 of section 142 of this title insofar as the same relate to
milk when issuing permits to operators of, or to producers for
delivery to, creameries and condensing plants in the United States
within twenty miles of the point of production of the milk, and who
import no raw milk except for pasteurization or condensing:
Provided, That if milk imported when the requirements of clauses 2
and 5 of section 142 of this title have been so waived is sold,
used, or disposed of in its raw state, or otherwise than as
pasteurized, condensed, or evaporated milk by any person, the
permit shall be revoked and the importer shall be subjected to
fine, imprisonment, or other penalty prescribed by this subchapter.
The Secretary is authorized and directed to make and enforce such
regulations as may in his judgment be necessary to carry out the
purpose of this subchapter for the handling of milk and cream, for
the inspection of milk, cream, cows, barns, and other facilities
used in the production and handling of milk and/or cream and the
handling, keeping, transporting, and importing of milk and/or
cream: Provided, however, That unless and until the Secretary shall
provide for inspections to ascertain that clauses 1, 2, and 3 of
section 142 of this title have been complied with, the Secretary
shall issue temporary permits to any applicants therefor to ship or
transport milk and/or cream into the United States.
The Secretary is authorized to suspend or revoke any permit for
the shipment of milk or cream into the United States when he shall
find that the holder thereof has failed to comply with the
provisions of or has violated this subchapter or any of the
regulations made hereunder, or that the milk and/or cream brought
or shipped by the holder of such permit into the United States is
not produced and handled in conformity with, or that the quality
thereof does not conform to, all of the provisions of section 142
of this title.
-SOURCE-
(Feb. 15, 1927, ch. 155, Sec. 3, 44 Stat. 1102; 1940 Reorg. Plan
No. IV, Sec. 12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237;
1953 Reorg. Plan No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979,
93 Stat. 695.)
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted in text for
"Secretary of Health, Education, and Welfare" pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration to Federal Security
Agency, see notes set out under section 321 of this title.
-End-
-CITE-
21 USC Sec. 144 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-HEAD-
Sec. 144. Unlawful receiving of imported milk or cream
-STATUTE-
It shall be unlawful for any person in the United States to
receive milk or cream imported into the United States unless the
importation is in accordance with the provisions of this
subchapter.
-SOURCE-
(Feb. 15, 1927, ch. 155, Sec. 4, 44 Stat. 1103.)
-End-
-CITE-
21 USC Sec. 145 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-HEAD-
Sec. 145. Penalties
-STATUTE-
Any person who knowingly violates any provision of this
subchapter shall, in addition to all other penalties prescribed by
law, be punished by a fine of not less than $50 nor more than
$2,000, or by imprisonment for not more than one year, or by both
such fine and imprisonment.
-SOURCE-
(Feb. 15, 1927, ch. 155, Sec. 5, 44 Stat. 1103.)
-End-
-CITE-
21 USC Sec. 146 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-HEAD-
Sec. 146. Authorization of appropriations
-STATUTE-
There is authorized to be appropriated, out of any moneys in the
Treasury not otherwise appropriated, the sum of $50,000 per annum,
to enable the Secretary of Health and Human Services to carry out
the provisions of this subchapter.
-SOURCE-
(Feb. 15, 1927, ch. 155, Sec. 6, 44 Stat. 1103; 1940 Reorg. Plan
No. IV, Sec. 12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237;
1953 Reorg. Plan No. 1, Sec. 5, eff. Apr. 11, 1953, 18 F.R. 2053,
67 Stat. 631; Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979,
93 Stat. 695.)
-CHANGE-
CHANGE OF NAME
"Secretary of Health and Human Services" substituted in text for
"Secretary of Health, Education, and Welfare" pursuant to section
509(b) of Pub. L. 96-88, which is classified to section 3508(b) of
Title 20, Education.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration to Federal Security
Agency, see Transfer of Functions notes set out under section 321
of this title.
-End-
-CITE-
21 USC Sec. 147 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-HEAD-
Sec. 147. Repeal of inconsistent laws
-STATUTE-
Any laws or parts of laws inconsistent with this subchapter are
repealed.
-SOURCE-
(Feb. 15, 1927, ch. 155, Sec. 7, 44 Stat. 1103.)
-End-
-CITE-
21 USC Sec. 148 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-HEAD-
Sec. 148. Powers of State with respect to milk or cream lawfully
imported
-STATUTE-
Nothing in this subchapter is intended nor shall be construed to
affect the powers of any State, or any political subdivision
thereof, to regulate the shipment of milk or cream into, or the
handling, sale, or other disposition of milk or cream in, such
State or political subdivision after the milk and/or cream shall
have been lawfully imported under the provisions of this
subchapter.
-SOURCE-
(Feb. 15, 1927, ch. 155, Sec. 8, 44 Stat. 1103.)
-End-
-CITE-
21 USC Sec. 149 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 4 - ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
SUBCHAPTER IV - IMPORTATION OF MILK AND CREAM
-HEAD-
Sec. 149. Definitions
-STATUTE-
When used in this subchapter -
(a) The term "person" means an individual, partnership,
association, or corporation.
(b) The term "United States" means the fifty States and the
District of Columbia.
-SOURCE-
(Feb. 15, 1927, ch. 155, Sec. 9, 44 Stat. 1103; Pub. L. 86-70, Sec.
19, June 25, 1959, 73 Stat. 145; Pub. L. 86-624, Sec. 15, July 12,
1960, 74 Stat. 415.)
-MISC1-
AMENDMENTS
1960 - Subsec. (b). Pub. L. 86-624 substituted "means the fifty
States and the District of Columbia" for "means continental United
States, including Alaska".
1959 - Subsec. (b). Pub. L. 86-70 inserted ", including Alaska"
after "continental United States".
-End-
-CITE-
21 USC CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS,
AND ANALOGOUS PRODUCTS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-MISC1-
Sec.
151. Preparation and sale of worthless or harmful products
for domestic animals prohibited; preparation to be in
compliance with rules at licensed establishments.
152. Importation regulated and prohibited.
153. Inspection of imports; denial of entry and
destruction.
154. Regulations for preparation and sale; licenses.
154a. Special licenses for special circumstances; expedited
procedure; conditions; exemptions; criteria.
155. Permits for importation.
156. Licenses conditioned on permitting inspection;
suspension of licenses.
157. Inspection.
158. Offenses; punishment.
159. Enforcement; penalties applicable; Congressional
findings.
FEDERAL FOOD, DRUG, AND COSMETIC ACT
Nothing contained in chapter 9 (Sec. 301 et seq.) of this title
shall be construed as in any way affecting, modifying, repealing,
or superseding the provisions of this chapter, see section 392(b)
of this title.
-End-
-CITE-
21 USC Sec. 151 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
Sec. 151. Preparation and sale of worthless or harmful products for
domestic animals prohibited; preparation to be in compliance with
rules at licensed establishments
-STATUTE-
It shall be unlawful for any person, firm, or corporation to
prepare, sell, barter, or exchange in the District of Columbia, or
in the Territories, or in any place under the jurisdiction of the
United States, or to ship or deliver for shipment in or from the
United States, the District of Columbia, any territory of the
United States, or any place under the jurisdiction of the United
States, any worthless, contaminated, dangerous, or harmful virus,
serum, toxin, or analogous product intended for use in the
treatment of domestic animals, and no person, firm, or corporation
shall prepare, sell, barter, exchange, or ship as aforesaid any
virus, serum, toxin, or analogous product manufactured within the
United States and intended for use in the treatment of domestic
animals, unless and until the said virus, serum, toxin, or
analogous product shall have been prepared, under and in compliance
with regulations prescribed by the Secretary of Agriculture, at an
establishment holding an unsuspended and unrevoked license issued
by the Secretary of Agriculture as hereinafter authorized.
-SOURCE-
(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 832; Pub. L. 99-
198, title XVII, Sec. 1768(a), Dec. 23, 1985, 99 Stat. 1654.)
-COD-
CODIFICATION
The sections of this chapter are comprised of the sentences of
the eighth paragraph under the heading "Bureau of Animal Industry,"
in the Department of Agriculture Appropriation Act, 1914, as
amended.
Another section 1768 of Pub. L. 99-198, cited as a credit to this
section, amended section 136y of Title 7, Agriculture.
-MISC1-
AMENDMENTS
1985 - Pub. L. 99-198 substituted "in or from the United States,
the District of Columbia, any territory of the United States, or
any place under the jurisdiction of the United States" for "from
one State or Territory or the District of Columbia to any other
State or Territory or the District of Columbia".
EFFECTIVE DATE OF 1985 AMENDMENT
Section 1768(f) of Pub. L. 99-198 provided that:
"(1) Except as provided in paragraph (2), the amendments made by
this section [enacting sections 154a and 159 of this title and
amending this section and sections 154 and 157 of this title] shall
become effective on the date of enactment of this Act [Dec. 23,
1985].
"(2)(A) Subject to subparagraphs (B) through (D), in the case of
a person, firm, or corporation preparing, selling, bartering,
exchanging, or shipping a virus, serum, toxin, or analogous product
during the 12-month period ending on the date of enactment of this
Act [Dec. 23, 1985] solely for intrastate commerce or for
exportation, such product shall not after such date of enactment,
as a result of its not having been licensed or produced in a
licensed establishment, be considered in violation of the eighth
paragraph of the matter under the heading 'BUREAU OF ANIMAL
INDUSTRY' of the Act entitled 'An Act making appropriations for the
Department of Agriculture for the fiscal year ending June
thirtieth, nineteen hundred and fourteen', approved March 14, 1913
(as amended by this section) [this chapter], until the first day of
the 49th month following the date of enactment of this Act.
"(B) The exemption granted by subparagraph (A) may be extended by
the Secretary of Agriculture for a period up to 12 months in an
individual case on a showing by a person, firm, or corporation of
good cause and a good faith effort to comply with such eighth
paragraph with due diligence.
"(C) The exemption granted by subparagraph (A) must be claimed by
the person, firm, or corporation preparing such product by the
first day of the 13th month following the date of enactment of this
Act [Dec. 23, 1985], in the form and manner prescribed by the
Secretary, unless the Secretary grants an extension of the time to
claim such exemption in an individual case for good cause shown.
"(D) On the issuance by the Secretary of a license to such
person, firm, or corporation for such product prior to the first
day of the 49th month following the date of enactment of this Act
[Dec. 23, 1985], or the end of an extension of the exemption
granted by the Secretary, the exemption granted by subparagraph (A)
shall terminate with respect to such product."
SHORT TITLE
Act Mar. 4, 1913, ch. 145, Sec. 1 [part], 37 Stat. 832, which is
classified to this chapter, is popularly known as the "Virus-Serum-
Toxin Act".
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of the Secretary of Agriculture
relating to agricultural import and entry inspection activities
under this chapter to the Secretary of Homeland Security, and for
treatment of related references, see sections 231, 551(d), 552(d),
and 557 of Title 6, Domestic Security, and the Department of
Homeland Security Reorganization Plan of November 25, 2002, as
modified, set out as a note under section 542 of Title 6.
-MISC2-
APPROPRIATIONS
An appropriation of $25,000 was made by act Mar. 4, 1913, for the
purpose of carrying into effect these provisions. The appropriation
for the fiscal year 1926 was by act Feb. 10, 1925, ch. 200, 43
Stat. 827.
-End-
-CITE-
21 USC Sec. 152 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
Sec. 152. Importation regulated and prohibited
-STATUTE-
The importation into the United States of any virus, serum,
toxin, or analogous product for use in the treatment of domestic
animals, and the importation of any worthless, contaminated,
dangerous, or harmful virus, serum, toxin, or analogous product for
use in the treatment of domestic animals, is prohibited without (1)
a permit from the Secretary of Agriculture, or (2) in the case of
an article originating in Canada, such permit or, in lieu of such
permit, such certification by Canada as may be prescribed by the
Secretary of Agriculture.
-SOURCE-
(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 832; Pub. L. 100-
449, title III, Sec. 301(d), Sept. 28, 1988, 102 Stat. 1868.)
-COD-
CODIFICATION
See note set out under section 151 of this title.
-MISC1-
AMENDMENTS
1988 - Pub. L. 100-449 amended section generally. Prior to
amendment, section read as follows: "The importation into the
United States, without a permit from the Secretary of Agriculture,
of any virus, serum, toxin, or analogous product for use in the
treatment of domestic animals, and the importation of any
worthless, contaminated, dangerous, or harmful virus, serum, toxin,
or analogous product for use in the treatment of domestic animals,
are prohibited."
EFFECTIVE AND TERMINATION DATES OF 1988 AMENDMENT
Amendment by Pub. L. 100-449 effective on the date the United
States-Canada Free-Trade Agreement enters into force (Jan. 1,
1989), and to cease to have effect on the date the Agreement ceases
to be in force, see section 501(a), (c) of Pub. L. 100-449, set out
in a note under section 2112 of Title 19, Customs Duties.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of the Secretary of Agriculture
relating to agricultural import and entry inspection activities
under this chapter to the Secretary of Homeland Security, and for
treatment of related references, see sections 231, 551(d), 552(d),
and 557 of Title 6, Domestic Security, and the Department of
Homeland Security Reorganization Plan of November 25, 2002, as
modified, set out as a note under section 542 of Title 6.
-End-
-CITE-
21 USC Sec. 153 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
Sec. 153. Inspection of imports; denial of entry and destruction
-STATUTE-
The Secretary of Agriculture is authorized to cause the Bureau of
Animal Industry to examine and inspect all viruses, serums, toxins,
and analogous products, for use in the treatment of domestic
animals, which are being imported or offered for importation into
the United States, to determine whether such viruses, serums,
toxins, and analogous products are worthless, contaminated,
dangerous, or harmful, and if it shall appear that any such virus,
serum, toxin, or analogous product, for use in the treatment of
domestic animals, is worthless, contaminated, dangerous, or
harmful, the same shall be denied entry and shall be destroyed or
returned at the expense of the owner or importer.
-SOURCE-
(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 832.)
-COD-
CODIFICATION
See note set out under section 151 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of the Secretary of Agriculture
relating to agricultural import and entry inspection activities
under this chapter to the Secretary of Homeland Security, and for
treatment of related references, see sections 231, 551(d), 552(d),
and 557 of Title 6, Domestic Security, and the Department of
Homeland Security Reorganization Plan of November 25, 2002, as
modified, set out as a note under section 542 of Title 6.
-End-
-CITE-
21 USC Sec. 154 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
Sec. 154. Regulations for preparation and sale; licenses
-STATUTE-
The Secretary of Agriculture is authorized to make and promulgate
from time to time such rules and regulations as may be necessary to
prevent the preparation, sale, barter, exchange, or shipment as
aforesaid of any worthless, contaminated, dangerous, or harmful
virus, serum, toxin, or analogous product for use in the treatment
of domestic animals, or otherwise to carry out this chapter, and to
issue, suspend, and revoke licenses for the maintenance of
establishments for the preparation of viruses, serums, toxins, and
analogous products, for use in the treatment of domestic animals,
intended for sale, barter, exchange, or shipment as aforesaid.
-SOURCE-
(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 832; Pub. L. 99-
198, title XVII, Sec. 1768(b), Dec. 23, 1985, 99 Stat. 1654.)
-COD-
CODIFICATION
See note set out under section 151 of this title.
Another section 1768 of Pub. L. 99-198, cited as a credit to this
section, amended section 136y of Title 7, Agriculture.
-MISC1-
AMENDMENTS
1985 - Pub. L. 99-198 inserted "or otherwise to carry out this
chapter," after "domestic animals,".
EFFECTIVE DATE OF 1985 AMENDMENT
Amendment by Pub. L. 99-198 effective Dec. 23, 1985, except as
otherwise provided, see section 1768(f) of Pub. L. 99-198, set out
as a note under section 151 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of the Secretary of Agriculture
relating to agricultural import and entry inspection activities
under this chapter to the Secretary of Homeland Security, and for
treatment of related references, see sections 231, 551(d), 552(d),
and 557 of Title 6, Domestic Security, and the Department of
Homeland Security Reorganization Plan of November 25, 2002, as
modified, set out as a note under section 542 of Title 6.
-End-
-CITE-
21 USC Sec. 154a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
Sec. 154a. Special licenses for special circumstances; expedited
procedure; conditions; exemptions; criteria
-STATUTE-
In order to meet an emergency condition, limited market or local
situation, or other special circumstance (including production
solely for intrastate use under a State-operated program), the
Secretary may issue a special license under an expedited procedure
on such conditions as are necessary to assure purity, safety, and a
reasonable expectation of efficacy. The Secretary shall exempt by
regulation from the requirement of preparation pursuant to an
unsuspended and unrevoked license any virus, serum, toxin, or
analogous product prepared by any person, firm, or corporation -
(1) solely for administration to animals of such person, firm,
or corporation;
(2) solely for administration to animals under a veterinarian-
client-patient relationship in the course of the State licensed
professional practice of veterinary medicine by such person,
firm, or corporation; or
(3) solely for distribution within the State of production
pursuant to a license granted by such State under a program
determined by the Secretary to meet criteria under which the
State -
(A) may license virus, serum, toxin, and analogous products
and establishments that produce such products;
(B) may review the purity, safety, potency, and efficacy of
such products prior to licensure;
(C) may review product test results to assure compliance with
applicable standards for purity, safety, and potency, prior to
release to the market;
(D) may deal effectively with violations of State law
regulating virus, serum, toxin, and analogous products; and
(E) exercises the authority referred to in subclauses (A)
through (D) consistent with the intent of this chapter of
prohibiting the preparation, sale, barter, exchange, or
shipment of worthless, contaminated, dangerous, or harmful
virus, serum, toxin, or analogous products.
-SOURCE-
(Mar. 4, 1913, ch. 145, Sec. 1 [part], as added Pub. L. 99-198,
title XVII, Sec. 1768(c), Dec. 23, 1985, 99 Stat. 1654.)
-COD-
CODIFICATION
See note set out under section 151 of this title.
Another section 1768 of Pub. L. 99-198, cited as a credit to this
section, amended section 136y of Title 7, Agriculture.
-MISC1-
EFFECTIVE DATE
Section effective Dec. 23, 1985, except as otherwise provided,
see section 1768(f) of Pub. L. 99-198, set out as an Effective Date
of 1985 Amendment note under section 151 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of the Secretary of Agriculture
relating to agricultural import and entry inspection activities
under this chapter to the Secretary of Homeland Security, and for
treatment of related references, see sections 231, 551(d), 552(d),
and 557 of Title 6, Domestic Security, and the Department of
Homeland Security Reorganization Plan of November 25, 2002, as
modified, set out as a note under section 542 of Title 6.
-End-
-CITE-
21 USC Sec. 155 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
Sec. 155. Permits for importation
-STATUTE-
The Secretary of Agriculture is authorized to issue permits for
the importation into the United States of viruses, serums, toxins,
and analogous products, for use in the treatment of domestic
animals, which are not worthless, contaminated, dangerous, or
harmful.
-SOURCE-
(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 833.)
-COD-
CODIFICATION
See note set out under section 151 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of the Secretary of Agriculture
relating to agricultural import and entry inspection activities
under this chapter to the Secretary of Homeland Security, and for
treatment of related references, see sections 231, 551(d), 552(d),
and 557 of Title 6, Domestic Security, and the Department of
Homeland Security Reorganization Plan of November 25, 2002, as
modified, set out as a note under section 542 of Title 6.
-End-
-CITE-
21 USC Sec. 156 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
Sec. 156. Licenses conditioned on permitting inspection; suspension
of licenses
-STATUTE-
All licenses issued under authority of this chapter to
establishments where such viruses, serums, toxins, or analogous
products are prepared for sale, barter, exchange, or shipment as
aforesaid, shall be issued on condition that the licensee shall
permit the inspection of such establishments and of such products
and their preparation; and the Secretary of Agriculture may suspend
or revoke any permit or license issued under authority of said
chapter, after opportunity for hearing has been granted the
licensee or importer, when the Secretary of Agriculture is
satisfied that such license or permit is being used to facilitate
or effect the preparation, sale, barter, exchange, or shipment as
aforesaid, or the importation into the United States of any
worthless, contaminated, dangerous, or harmful virus, serum, toxin,
or analogous product for use in the treatment of domestic animals.
-SOURCE-
(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 833.)
-REFTEXT-
REFERENCES IN TEXT
This chapter, referred to in text, was in the original "this
Act", meaning act Mar. 4, 1913, ch. 145, 37 Stat. 828, which
enacted this chapter, sections 155 and 393 of Title 7, Agriculture,
section 316 of Title 15, Commerce and Trade, sections 501, 502,
512, 558, and 560 of Title 16, Conservation, and section 630 of
former Title 31, Money and Finance, and amended section 83 of
former Title 5, Executive Departments and Government Officers and
Employees, and sections 518 and 673 of Title 16.
Section 316 of Title 15 was omitted from the Code as superseded
by section 5701 et seq. of Title 5, Government Organization and
Employees. Section 630 of former Title 31 was repealed by act Sept.
12, 1950, ch. 946, title III, Sec. 301(64), 64 Stat. 842. Section
83 of former Title 5 was repealed and reenacted as section 5946 of
Title 5 by Pub. L. 89-554, Sept. 6, 1966, 80 Stat. 514. For
complete classification of act Mar. 4, 1913, to the Code, see
Tables.
-COD-
CODIFICATION
See note set out under section 151 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of the Secretary of Agriculture
relating to agricultural import and entry inspection activities
under this chapter to the Secretary of Homeland Security, and for
treatment of related references, see sections 231, 551(d), 552(d),
and 557 of Title 6, Domestic Security, and the Department of
Homeland Security Reorganization Plan of November 25, 2002, as
modified, set out as a note under section 542 of Title 6.
-End-
-CITE-
21 USC Sec. 157 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
Sec. 157. Inspection
-STATUTE-
Any officer, agent, or employee of the Department of Agriculture
duly authorized by the Secretary of Agriculture for the purpose
may, at any hour during the daytime or nighttime, enter and inspect
any establishment where any virus, serum, toxin, or analogous
product for use in the treatment of domestic animals is prepared
for sale, barter, exchange, or shipment as aforesaid.
-SOURCE-
(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 833; Pub. L. 99-
198, title XVII, Sec. 1768(d), Dec. 23, 1985, 99 Stat. 1655.)
-COD-
CODIFICATION
See note set out under section 151 of this title.
Another section 1768 of Pub. L. 99-198, cited as a credit to this
section, amended section 136y of Title 7, Agriculture.
-MISC1-
AMENDMENTS
1985 - Pub. L. 99-198 struck out "licensed under this chapter"
after "enter and inspect any establishment".
EFFECTIVE DATE OF 1985 AMENDMENT
Amendment by Pub. L. 99-198 effective Dec. 23, 1985, except as
otherwise provided, see section 1768(f) of Pub. L. 99-198, set out
as a note under section 151 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of the Secretary of Agriculture
relating to agricultural import and entry inspection activities
under this chapter to the Secretary of Homeland Security, and for
treatment of related references, see sections 231, 551(d), 552(d),
and 557 of Title 6, Domestic Security, and the Department of
Homeland Security Reorganization Plan of November 25, 2002, as
modified, set out as a note under section 542 of Title 6.
-End-
-CITE-
21 USC Sec. 158 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
Sec. 158. Offenses; punishment
-STATUTE-
Any person, firm, or corporation who shall violate any of the
provisions of this chapter shall be deemed guilty of a misdemeanor,
and shall, upon conviction, be punished by a fine of not exceeding
$1,000 or by imprisonment not exceeding one year, or by both such
fine and imprisonment, in the discretion of the court.
-SOURCE-
(Mar. 4, 1913, ch. 145, Sec. 1 (part), 37 Stat. 833.)
-REFTEXT-
REFERENCES IN TEXT
For explanation of "this chapter", referred to in text, see
References in Text note set out under section 156 of this title.
-COD-
CODIFICATION
See note set out under section 151 of this title.
-End-
-CITE-
21 USC Sec. 159 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5 - VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS
PRODUCTS
-HEAD-
Sec. 159. Enforcement; penalties applicable; Congressional findings
-STATUTE-
The procedures of sections 672, 673, and 674 of this title
(relating to detentions, seizures and condemnations, and
injunctions, respectively) shall apply to the enforcement of this
chapter with respect to any product prepared, sold, bartered,
exchanged, or shipped in violation of this chapter or a regulation
promulgated under this chapter. The provisions (including
penalties) of section 675 of this title shall apply to the
performance of official duties under this chapter. Congress finds
that (i) the products and activities that are regulated under this
chapter are either in interstate or foreign commerce or
substantially affect such commerce or the free flow thereof, and
(ii) regulation of the products and activities as provided in this
chapter is necessary to prevent and eliminate burdens on such
commerce and to effectively regulate such commerce.
-SOURCE-
(Mar. 4, 1913, ch. 145, Sec. 1 (part), as added Pub. L. 99-198,
title XVII, Sec. 1768(e), Dec. 23, 1985, 99 Stat. 1655.)
-COD-
CODIFICATION
See note set out under section 151 of this title.
Another section 1768 of Pub. L. 99-198, cited as a credit to this
section, amended section 136y of Title 7, Agriculture.
-MISC1-
EFFECTIVE DATE
Section effective Dec. 23, 1985, except as otherwise provided,
see section 1768(f) of Pub. L. 99-198, set out as an Effective Date
of 1985 Amendment note under section 151 of this title.
-End-
-CITE-
21 USC CHAPTER 5A - BUREAU OF NARCOTICS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5A - BUREAU OF NARCOTICS
-HEAD-
CHAPTER 5A - BUREAU OF NARCOTICS
-End-
-CITE-
21 USC Secs. 161 to 165 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 5A - BUREAU OF NARCOTICS
-HEAD-
Secs. 161 to 165. Omitted
-COD-
CODIFICATION
Section 161, acts June 14, 1930, ch. 488, Sec. 1, 46 Stat. 585;
Oct. 15, 1949, ch. 695, Sec. 6(a), 63 Stat. 881, established a
Bureau of Narcotics in the Department of the Treasury and provided
for appointment of a Commissioner of Narcotics for the Bureau with
duty of making an annual report to Congress.
Section 162, acts June 14, 1930, ch. 488, Sec. 2, 46 Stat. 585;
June 26, 1930, ch. 623, Sec. 1, 46 Stat. 819; Oct. 27, 1970, Pub.
L. 91-513, title III, Sec. 1101(a)(4), 84 Stat. 1291, provided for
appointment and compensation of a deputy commissioner and other
personnel for the Bureau of Narcotics, required the deputy to be an
acting Commissioner during absence or disability of the
Commissioner or a vacancy in the office, and authorized designation
of a member of the Treasury Department as an acting Commissioner in
event there is no Commissioner or deputy commissioner.
Section 163, act Mar. 3, 1927, ch. 348, Sec. 4(a), 44 Stat. 1382,
provided for transfer of control of narcotic drugs to the Secretary
of the Treasury from the Commissioner of Internal Revenue and his
assistants, agents, and inspectors.
Section 164, acts June 14, 1930, ch. 488, Sec. 3, 46 Stat. 586;
June 26, 1930, ch. 623, Sec. 2, 46 Stat. 819; Ex. Ord. No. 6639,
Mar. 10, 1934, abolished the Federal Narcotics Control Board and
transferred powers of such Board to the Commissioner of Narcotics,
authorized the Secretary of the Treasury to confer or impose his
duties under section 163 of this title upon the Commissioner or
other personnel of the Bureau of Narcotics, continued in effect
orders, rules, and regulations in existence on July 1, 1930, until
modified, superseded, or repealed by the Commissioner, with
approval of the Secretary of the Treasury, and provided for
determination before such Bureau of Narcotics of proceedings,
investigations, and other matters pending on July 1, 1930 before
Bureau of Prohibition or Federal Narcotics Control Board respecting
narcotic drug law administration or enforcement. Bureau of
Prohibition personnel, records, property, and unexpended balances
of appropriations were previously transferred to Bureau of
Narcotics as were powers of the Attorney General respecting the
Bureau of Prohibition to the Commissioner of Internal Revenue.
Section 165, act June 14, 1930, ch. 488, Sec. 5, 46 Stat. 587,
provided for review of decisions of Commissioner of Narcotics by
the Secretary of the Treasury.
-TRANS-
TRANSFER OF FUNCTIONS
Functions of the Secretary of the Treasury administered through
or respecting the Bureau of Narcotics and all functions of the
Bureau, the Commissioner of Narcotics, and the officers, employees
and agencies of the Bureau were transferred to the Attorney General
and the Bureau and the office of Commissioner of Narcotics were
abolished by Reorg. Plan No. 1 of 1968, eff. Apr. 8, 1968, 33 F.R.
5611, 82 Stat. 1367, set out in the Appendix to Title 5, Government
Organization and Employees. All positions, personnel, property,
records, and unexpended balances of appropriations, allocations,
and other funds of the Bureau and the Treasury Department, in
connection with functions transferred under this reorganization
plan, were transferred to the Justice Department.
The Bureau of Narcotics and Dangerous Drugs, including the office
of Director thereof, in the Department of Justice was abolished by
Reorg. Plan No. 2 of 1973, eff. July 1, 1973, 38 F.R. 15932, 87
Stat. 1091, set out in the Appendix to Title 5, Government
Organization and Employees. Reorg. Plan No. 2 of 1973 also created
in the Department of Justice a single, comprehensive agency for the
enforcement of drug laws to be known as the Drug Enforcement
Administration, empowered the Attorney General to authorize the
performance by officers, employees, and agencies of the Department
of functions transferred to him, and directed the Attorney General
to coordinate all drug law enforcement functions to assure maximum
cooperation between the Drug Enforcement Administration, the
Federal Bureau of Investigation, and the other units of the
Department of Justice involved in drug law enforcement.
-End-
-CITE-
21 USC CHAPTER 6 - NARCOTIC DRUGS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
-HEAD-
CHAPTER 6 - NARCOTIC DRUGS
-EXEC-
EXECUTIVE ORDER NO. 10302
Ex. Ord. No. 10302, Nov. 5, 1951, 16 F.R. 11257, formerly set out
as a note preceding section 171, which established the
Interdepartmental Committee on Narcotics, was revoked by Ex. Ord.
No. 11529, Apr. 24, 1970, 35 F.R. 6697.
-End-
-CITE-
21 USC IMPORTATION OR EXPORTATION 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
IMPORTATION OR EXPORTATION
-HEAD-
IMPORTATION OR EXPORTATION
-End-
-CITE-
21 USC Secs. 171 to 174 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
IMPORTATION OR EXPORTATION
-HEAD-
Secs. 171 to 174. Repealed.
-MISC1-
Secs. 171 to 174. Repealed. Pub. L. 91-513, title III, Sec.
1101(a)(2), (4), Oct. 27, 1970, 84 Stat. 1291.
Section 171, acts Feb. 9, 1909, ch. 100, Sec. 1, 35 Stat. 614;
Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, Sec. 1,
42 Stat. 596; June 14, 1930, ch. 488, Sec. 3, 46 Stat. 586; July 1,
1944, ch. 377, Sec. 8, 58 Stat. 721; Mar. 8, 1946, ch. 81, Sec. 7,
60 Stat. 39; Aug. 8, 1953, ch. 394, Sec. 8, 67 Stat. 506, defined
"narcotic drug", "United States", and "person". See section 801 et
seq. of this title.
Section 172, acts Feb. 9, 1909, ch. 100, Sec. 2(a), 35 Stat. 614;
Jan. 17, 1914, ch. 9, 38 Stat. 275; June 7, 1924, ch. 352, 43 Stat.
657, established a Federal Narcotics Control Board. Act May 26,
1922, ch. 202, Sec. 1, 42 Stat. 596, also classified to this
section, was repealed by Pub. L. 89-554, Sec. 8(a), Sept. 6, 1966,
80 Stat. 645.
Section 173, acts Feb. 9, 1909, ch. 100, Sec. 2(b), (d), 35 Stat.
614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202,
Sec. 1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; June 14,
1930, ch. 488, Sec. 3, 46 Stat. 586, prohibited importation of
narcotic drugs. See section 801 et seq. of this title.
Section 173a, act June 14, 1930, ch. 488, Sec. 6, 46 Stat. 587,
provided for importation of additional amounts of coca leaves.
Section 174, acts Feb. 9, 1909, ch. 100, Sec. 2(c), (f), 35 Stat.
614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202,
Sec. 1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; Nov. 2,
1951, ch. 666, Secs. 1, 5(1), 65 Stat. 767; July 18, 1956, ch. 629,
title I, Sec. 105, 70 Stat. 570, set penalties for bringing
narcotic drugs into the United States contrary to law. See chapter
13 of this title.
EFFECTIVE DATE OF REPEAL
Repeal effective on first day of seventh calendar month that
begins after Oct. 27, 1970, see section 1105(a) of Pub. L. 91-513,
set out as an Effective Date note under section 951 of this title.
SAVINGS PROVISION
Section 1103 of Pub. L. 91-513 provided that:
"(a) Prosecutions for any violation of law occurring prior to the
effective date of section 1101 [the first day of the seventh
calendar month that begins after Oct. 26, 1970] shall not be
affected by the repeals or amendments made by such section or
section 1102 [repealing sections 171 to 174, 176 to 185, 188 to
188n, 191 to 193, 197, 198, 199, 501 to 517 of this title, sections
1401 to 1407, and 3616 of Title 18, Crimes and Criminal Procedure,
sections 4701 to 4707, 4711 to 4716, 4721 to 4726, 4731 to 4736,
4741 to 4746, 4751 to 4757, 4761, 4762, 4771 to 4776, 7237, 7238,
and 7491 of Title 26, Internal Revenue Code, sections 529a and 529g
of former Title 31, Money and Finance, and section 1421m of Title
48, Territories and Insular Possessions, and amending sections 162
and 967 of this title, section 4251 of Title 18, section 1584 of
Title 19, Customs Duties, sections 4901, 4905, 6808, 7012, 7103,
7236, 7607, 7609, 7641, 7651, and 7655 of Title 26, section 2901 of
Title 28, Judiciary and Judicial Procedure, sections 529d, 529e,
and 529f of former Title 31, section 304m of former Title 40,
Public Buildings, Property, and Works, section 3411 of Title 42,
The Public Health and Welfare, section 239a of Title 46, Shipping,
and section 787 of former Title 49, Transportation], or abated by
reason thereof.
"(b) Civil seizures or forfeitures and injunctive proceedings
commenced prior to the effective date of section 1101 [the first
day of the seventh calendar month that begins after Oct. 26, 1970]
shall not be affected by the repeals or amendments made by such
section or section 1102, or abated by reason thereof."
-End-
-CITE-
21 USC Sec. 175 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
IMPORTATION OR EXPORTATION
-HEAD-
Sec. 175. Repealed.
-MISC1-
Sec. 175. Repealed. June 27, 1952, ch. 477, title IV, Sec.
403(a)(10), 66 Stat. 279.
Section, acts Feb. 9, 1909, ch. 100, Sec. 2(e), 35 Stat. 614;
Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, Sec. 1,
42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, related to
deportation of convicted aliens. See section 1251 et seq. of Title
8, Aliens and Nationality.
-End-
-CITE-
21 USC Secs. 176 to 185 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
IMPORTATION OR EXPORTATION
-HEAD-
Secs. 176 to 185. Repealed.
-MISC1-
Secs. 176 to 185. Repealed. Pub. L. 91-513, title III, Sec.
1101(a)(2), (9), Oct. 27, 1970, 84 Stat. 1291, 1292.
Section 176, acts Feb. 9, 1909, ch. 100, Sec. 2(g), 35 Stat. 614;
Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202 Sec. 1,
42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, covered
liability of masters of vessels and persons in charge of railroad
cars and other vehicles used to carry narcotic drugs.
Section 176a, act Feb. 9, 1909, ch. 100, Sec. 2(h), as added July
18, 1956, ch. 629, title I, Sec. 106, 70 Stat. 570, covered illegal
importation of marihuana and set penalties for such illegal
importation. See section 801 et seq. of this title.
Section 176b, act Feb. 9, 1909, ch. 100, Sec. 2(i), as added July
18, 1956, ch. 629, title I, Sec. 107, 70 Stat. 571, prohibited sale
of heroin to juveniles and set penalties for such illegal sale. See
section 801 et seq. of this title.
Section 177, acts Feb. 9, 1909, ch. 100, Sec. 2(a), 35 Stat. 614;
Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, Sec. 1,
42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657, vested
administration of Narcotic Drugs Import and Export Act in
Department of the Treasury.
Section 178, act Feb. 9, 1909, ch. 100, Sec. 4, as added Jan. 17,
1914, ch. 9, 38 Stat. 275, prohibited possession of smoking opium.
See section 801 et seq. of this title.
Section 179, act Feb. 9, 1909, ch. 100, Sec. 4, as added Jan. 17,
1914, ch. 9, 38 Stat. 275, covered liability of masters of vessels
and persons in charge of railroad cars or other vehicles for
possession of smoking heroin. See section 801 et seq. of this
title.
Section 180, act Feb. 9, 1909, ch. 100, Sec. 5, as added Jan. 17,
1914, ch. 9, 38 Stat. 275; amended May 26, 1922, ch. 202, Sec. 2,
42 Stat. 597; June 14, 1930, ch. 488, Sec. 3, 46 Stat. 586,
prohibited admission of smoking opium even for transportation to
another country or for transferal from one vessel to another.
Section 181, act Feb. 9, 1909, ch. 100, Sec. 3, as added Jan. 17,
1914, ch. 9, 38 Stat. 275, created a presumption of illegal
importation based upon presence of smoking opium in United States.
Section 182, act Feb. 9, 1909, ch. 100, Sec. 6, as added Jan. 17,
1914, ch. 9, 348 Stat. 275; amended May 26, 1922, ch. 202, Sec. 2,
42 Stat. 597; June 14, 1930, ch. 488, Sec. 3, 46 Stat. 586; Apr.
22, 1960, Pub. L. 86-429, Sec. 15, 74 Stat. 66, forbade exportation
of narcotic drugs. See section 801 et seq. of this title.
Section 183, act Feb. 9, 1909, ch. 100, Sec. 7, as added Jan. 17,
1914, ch. 9, 38 Stat. 277, set out penalties for illegal
exportation of narcotic drugs.
Section 184, act Feb. 9, 1909, ch. 100, Sec. 8, as added Jan. 17,
1914, ch. 9, 38 Stat. 277; amended May 26, 1922, ch. 202, Sec. 3,
42 Stat. 598, provided for seizure and forfeiture of narcotic drugs
found on vessels and not shown on manifest or landed from vessels
without a permit.
Section 184a, acts July 11, 1941, ch. 289, Sec. 1, 55 Stat. 584;
July 18, 1956, ch. 629, title I, Sec. 108, 70 Stat. 571, made
illegal bringing on board a vessel of United States any narcotic
drugs not constituting a part of the cargo.
Section 185, act Feb. 9, 1909, ch. 100, Sec. 9, as added May 26,
1922, ch. 202, Sec. 4, 42 Stat. 598, authorized the citation of act
Feb. 9, 1909, ch. 100, as the "Narcotic Drugs Import and Export
Act".
EFFECTIVE DATE OF REPEAL
Repeal effective on first day of seventh calendar month that
begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
set out as an Effective Date note under section 951 of this title.
SAVINGS PROVISION
Prosecutions for any violation of law occurring, and civil
seizures or forfeitures and injunctive proceedings commenced, prior
to the effective date of repeal of these sections by section 1101
of Pub. L. 91-513 not to be affected or abated by reason thereof,
see section 1103 of Pub. L. 91-513, set out as a note under
sections 171 to 174 of this title.
-End-
-CITE-
21 USC MARIHUANA AND HEALTH REPORTING 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
MARIHUANA AND HEALTH REPORTING
-HEAD-
MARIHUANA AND HEALTH REPORTING
-End-
-CITE-
21 USC Secs. 186, 187 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
MARIHUANA AND HEALTH REPORTING
-HEAD-
Secs. 186, 187. Transferred
-COD-
CODIFICATION
Section 186, Pub. L. 91-296, title V, Sec. 501, June 30, 1970, 84
Stat. 352, which related to congressional findings as to marihuana
use, the need for a better understanding of the health
consequences, and the lack of information thereto, was transferred
and set out as a note under section 242 of Title 42, The Public
Health and Welfare.
Section 187, Pub. L. 91-296, title V, Sec. 502, June 30, 1970, 84
Stat. 352, which directed the Secretary of Health, Education and
Welfare to report to Congress on the current information on the
health consequence of marihuana use, with recommendations for
legislative and administrative action and to submit a preliminary
report no later than 90 days after June 30, 1970, was transferred
and set out as a note under section 242 of Title 42.
-End-
-CITE-
21 USC DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF
THE OPIUM POPPY 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF THE OPIUM POPPY
-HEAD-
DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF THE OPIUM POPPY
-End-
-CITE-
21 USC Secs. 188 to 188n 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF THE OPIUM POPPY
-HEAD-
Secs. 188 to 188n. Repealed.
-MISC1-
Secs. 188 to 188n. Repealed. Pub. L. 91-513, title III, Sec.
1101(a)(7), Oct. 27, 1970, 84 Stat. 1292.
Sections, acts Dec. 11, 1942, ch. 720, 56 Stat. 1045; June 25,
1959, Pub. L. 86-70, Sec. 20, 73 Stat. 145; July 12, 1960, Pub. L.
86-624, Sec. 16, 74 Stat. 415, known as the "Opium Poppy Control
Act of 1942", provided for the domestic control of production and
distribution of the opium poppy. Sections 1 to 17 of said Act of
Dec. 11, 1942, were classified, respectively, to sections 188, 188
notes, and 188a to 188n of this title.
EFFECTIVE DATE OF REPEAL
Repeal effective on first day of seventh calendar month that
begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
set out as an Effective Date note under section 951 of this title.
SAVINGS PROVISION
Prosecutions for any violation of law occurring, and civil
seizures or forfeitures and injunctive proceedings commenced, prior
to the effective date of repeal of these sections by section 1101
of Pub. L. 91-513 not to be affected or abated by reason thereof,
see section 1103 of Pub. L. 91-513, set out as a note under section
171 of this title.
-End-
-CITE-
21 USC IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN,
IN CHINA, BY UNITED STATES CITIZENS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN, IN CHINA, BY
UNITED STATES CITIZENS
-HEAD-
IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN, IN CHINA, BY
UNITED STATES CITIZENS
-End-
-CITE-
21 USC Secs. 191 to 193 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN, IN CHINA, BY
UNITED STATES CITIZENS
-HEAD-
Secs. 191 to 193. Repealed.
-MISC1-
Secs. 191 to 193. Repealed. Pub. L. 91-513, title III, Sec.
1101(a)(1), Oct. 27, 1970, 84 Stat. 1291.
Sections, acts Feb. 23, 1887, ch. 210, 24 Stat. 409; June 25,
1948, ch. 646, Secs. 5, 39, 62 Stat. 986, 992, prohibited
importation of opium by Chinese subjects and the trafficking in, in
China, of opium by United States citizens. Sections 1 to 3 of said
Act of Feb. 23, 1887, were classified to sections 191 to 193,
respectively, of this title.
EFFECTIVE DATE OF REPEAL
Repeal effective on first day of seventh calendar month that
begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
set out as an Effective Date note under section 951 of this title.
SAVINGS PROVISION
Prosecutions for any violation of law occurring, and civil
seizures or forfeitures and injunctive proceedings commenced, prior
to the effective date of repeal of these sections by section 1101
of Pub. L. 91-513 not to be affected or abated by reason thereof,
see section 1103 of Pub. L. 91-513, set out as a Savings Provision
note under section 171 of this title.
-End-
-CITE-
21 USC MISCELLANEOUS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
MISCELLANEOUS
-HEAD-
MISCELLANEOUS
-End-
-CITE-
21 USC Sec. 196 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
MISCELLANEOUS
-HEAD-
Sec. 196. Repealed.
-MISC1-
Sec. 196. Repealed. July 1, 1944, ch. 373, title XIII, Sec. 1313,
58 Stat. 714.
Section, act June 14, 1930, ch. 488, Sec. 4(b), (c), 46 Stat.
587; 1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4
F.R. 2728, 53 Stat. 1424, related to studies and investigations by
Surgeon General of the Public Health Service. See section 242 of
Title 42, The Public Health and Welfare.
RENUMBERING OF REPEALING ACT
Section 611 of act July 1, 1944, which repealed this section, was
renumbered 711 by act Aug. 13, 1946, ch. 958, Sec. 5, 60 Stat.
1049, 713 by act Feb. 28, 1948, ch. 83, Sec. 9(b), 62 Stat. 47, 813
by act July 30, 1956, ch. 779, Sec. 3(b), 70 Stat. 720, 913 by Pub.
L. 88-581, Sec. 4(b), Sept. 4, 1964, 78 Stat. 919, 1013 by Pub. L.
89-239, Sec. 3(b), Oct. 6, 1965, 79 Stat. 931, 1113 by Pub. L. 91-
572, Sec. 6(b), Dec. 24, 1970, 84 Stat. 1506, 1213 by Pub. L. 92-
294, Sec. 3(b), May 16, 1972, 86 Stat. 137, 1313 by Pub. L. 93-
154, Sec. 2(b)(2), Nov. 16, 1973, 87 Stat. 604, and was repealed
by Pub. L. 93-222, Sec. 7(b), Dec. 29, 1973, 87 Stat. 936.
-End-
-CITE-
21 USC Secs. 197, 198 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
MISCELLANEOUS
-HEAD-
Secs. 197, 198. Repealed.
-MISC1-
Secs. 197, 198. Repealed. Pub. L. 91-513, title III, Sec.
1101(a)(4), Oct. 27, 1970, 84 Stat. 1291.
Section 197, act June 14, 1930, ch. 488, Sec. 7, 46 Stat. 587,
directed Secretary of the Treasury to cooperate with Secretary of
State in discharge of international obligations of United States
concerning traffic in narcotic drugs.
Section 198, acts June 14, 1930, ch. 488, Sec. 8, 46 Stat. 587;
July 18, 1956, ch. 629, title III, Sec. 302, 70 Stat. 575, directed
Secretary of the Treasury to cooperate with the several States in
suppression of abuse of narcotic drugs in their respective
jurisdictions.
EFFECTIVE DATE OF REPEAL
Repeal effective on first day of seventh calendar month that
begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
set out as an Effective Date note under section 951 of this title.
SAVINGS PROVISION
Prosecutions for any violation of law occurring, and civil
seizures or forfeitures and injunctive proceedings commenced, prior
to the effective date of repeal of these sections by section 1101
of Pub. L. 91-513 not to be affected or abated by reason thereof,
see section 1103 of Pub. L. 91-513, set out as a note under
sections 171 to 174 of this title.
-End-
-CITE-
21 USC Secs. 198a to 198c 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
MISCELLANEOUS
-HEAD-
Secs. 198a to 198c. Transferred
-COD-
CODIFICATION
Section 198a, act Aug. 11, 1955, ch. 800, Sec. 1, 69 Stat. 684,
as amended, which related to the authority of Secretary of the
Treasury to issue subpenas, administer oaths and compel attendance
of witnesses for purpose of any investigation, was transferred to
section 967 of this title.
Section 198b, act Aug. 11, 1955, ch. 800, Sec. 2, 69 Stat. 685,
which related to service of subpenas and proof of service, was
transferred to section 968 of this title.
Section 198c, act Aug. 11, 1955, ch. 800, Sec. 3, 69 Stat. 685,
which related to contempt proceedings, was transferred to section
969 of this title.
-End-
-CITE-
21 USC Sec. 199 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
MISCELLANEOUS
-HEAD-
Sec. 199. Repealed.
-MISC1-
Sec. 199. Repealed. Pub. L. 91-513, title III, Sec. 1101(a)(5),
Oct. 27, 1970, 84 Stat. 1292.
Section, act July 3, 1930, ch. 829, 46 Stat. 850, authorized
payment to persons giving information concerning violations of
narcotics laws. See section 886(a) of this title.
EFFECTIVE DATE OF REPEAL
Repeal effective on first day of seventh calendar month that
begins after Oct. 26, 1970, see section 1105(a) of Pub. L. 91-513,
set out as an Effective Date note under section 951 of this title.
SAVINGS PROVISION
Prosecutions for any violation of law occurring, and civil
seizures or forfeitures and injunctive proceedings commenced, prior
to the effective date of repeal of this section by section 1101 of
Pub. L. 91-513 not to be affected or abated by reason thereof, see
section 1103 of Pub. L. 91-513, set out as a note under section 171
of this title.
-End-
-CITE-
21 USC Secs. 200 to 200b 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 6 - NARCOTIC DRUGS
MISCELLANEOUS
-HEAD-
Secs. 200 to 200b. Repealed.
-MISC1-
Secs. 200 to 200b. Repealed. Nov. 2, 1951, ch. 666, Sec. 5(2), 65
Stat. 769.
Sections, acts Aug. 12, 1937, ch. 598, Secs. 1-3, 50 Stat. 627;
July 1, 1944, ch. 377, Sec. 9, 58 Stat. 721; Mar. 8, 1946, ch. 81,
Sec. 8, 60 Stat. 39, related to punishment for offenses after first
offense. See section 801 et seq. of this title.
SAVINGS PROVISION
Section 6 of act Nov. 2, 1951, provided that any rights or
liabilities now existing under former sections 200 to 200b of this
title should not be affected by their repeal.
-End-
-CITE-
21 USC CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF
POISONS IN CONSULAR DISTRICTS IN CHINA 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-MISC1-
Sec.
201. Doing business without a license unlawful; employment
of Chinese subjects.
202. Certain classes of persons and corporations excepted;
insecticides.
203. Application for license; requirements; qualifications
for license.
204. Issuance of license.
205. Display of license in pharmacy.
206. Revocation of license.
207. Restrictions on sales; written orders or
prescriptions.
208. Certain preparations and sales excepted.
209. Poisons; book entry of sale; labels.
210. Pharmacist; unauthorized use of title.
211. Preservation of originals of prescriptions compounded
and copies thereof; inspection of prescriptions by
consular officers; marking containers of drugs.
212. Offenses; punishment; duty to enforce provisions.
213. Fraudulent representations to evade or defeat
restrictions.
214. Previous laws unaffected.
215. "Consul" defined.
-End-
-CITE-
21 USC Sec. 201 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 201. Doing business without a license unlawful; employment of
Chinese subjects
-STATUTE-
It shall be unlawful in the consular districts of the United
States in China for any person whose permanent allegiance is due to
the United States not licensed as a pharmacist within the meaning
of this chapter to conduct or manage any pharmacy, drug or chemical
store, apothecary shop, or other place of business for the
retailing, compounding, or dispensing of any drugs, chemicals, or
poisons, or for the compounding of physicians' prescriptions, or to
keep exposed for sale at retail, any drugs, chemicals, or poisons,
except as hereinafter provided, or, except as hereinafter provided,
for any person whose permanent allegiance is due to the United
States not licensed as a pharmacist within the meaning of this
chapter to compound, dispense, or sell, at retail, any drug,
chemical, poison, or pharmaceutical preparation upon the
prescription of a physician, or otherwise, or to compound
physicians' prescriptions, except as an aid to and under the proper
supervision of a pharmacist licensed under this chapter. And it
shall be unlawful for any person, firm, or corporation owing
permanent allegiance to the United States owning partly or wholly
or managing a pharmacy, drug store, or other place of business to
cause or permit any person other than a licensed pharmacist to
compound, dispense, or sell at retail any drug, medicine, or
poison, except as an aid to and under the proper supervision of a
licensed pharmacist. Where it is necessary for a person, firm, or
corporation whose permanent allegiance is due to the United States
and owning partly or wholly or managing a pharmacy, drug store, or
other place of business to employ Chinese subjects to compound,
dispense, or sell at retail any drug, medicine, or poison, such
person, firm, or corporation, owner, part owner, or manager of a
pharmacy, drug store, or other place of business may employ such
Chinese subjects when their character, ability, and age of twenty-
one years or over have been certified to by at least two
recognized and reputable practitioners of medicine, or two
pharmacists licensed under this chapter whose permanent allegiance
is due to the United States.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 1, 38 Stat. 817.)
-COD-
CODIFICATION
Section is comprised of part of section 1 of act Mar. 3, 1915.
Remainder of such section 1 is classified to section 202 of this
title.
-End-
-CITE-
21 USC Sec. 202 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 202. Certain classes of persons and corporations excepted;
insecticides
-STATUTE-
Nothing in section 201 of this title shall be construed to
interfere with any recognized and reputable practitioner of
medicine, dentistry, or veterinary surgery in the compounding of
his own prescriptions, or to prevent him from supplying to his
patients such medicines as he may deem proper, except as
hereinafter provided; nor with the exclusively wholesale business
of any person, firm, or corporation whose permanent allegiance is
due to the United States dealing and licensed as pharmacists, or
having in their employ at least one person who is so licensed,
except as hereinafter provided; nor with the sale by persons,
firms, or corporations whose permanent allegiance is due to the
United States other than pharmacists of poisonous substances sold
exclusively for use in the arts, or as insecticides, when such
substances are sold in unbroken packages bearing labels having
plainly printed upon them the name of the contents, the word
"Poison", when practicable the name of at least one suitable
antidote, and the name and address of the vender.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 1, 38 Stat. 818.)
-COD-
CODIFICATION
Section is comprised of part of section 1 of act Mar. 3, 1915.
Remainder of such section 1 is classified to section 201 of this
title.
-End-
-CITE-
21 USC Sec. 203 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 203. Application for license; requirements; qualifications for
license
-STATUTE-
Every person whose permanent allegiance is due to the United
States desiring to practice as a pharmacist in the consular
districts in China shall file with the consul an application, duly
verified under oath, setting forth the name and age of the
applicant, the place or places at which he pursued and the time
spent in the study of pharmacy, the experience which the applicant
has had in compounding physicians' prescriptions under the
direction of a licensed pharmacist, and the name and location of
the school or college of pharmacy, if any, of which he is a
graduate, and shall submit evidence sufficient to show to the
satisfaction of said consul that he is of good moral character and
not addicted to the use of alcoholic liquors or narcotic drugs so
as to render him unfit to practice pharmacy. Applicants shall be
not less than twenty-one years of age and shall have had at least
four years' experience in the practice of pharmacy or shall have
served three years under the instruction of a regularly licensed
pharmacist, and any applicant who has been graduated from a school
or college of pharmacy recognized by the proper board of his State,
Territory, District of Columbia, or other possession of the United
States as in good standing shall be entitled to practice upon
presentation of his diploma.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 2, 38 Stat. 818.)
-COD-
CODIFICATION
The words "now practicing as a pharmacist or," which preceded
"desiring to practice" in the original text of this section, were
omitted as obsolete.
-End-
-CITE-
21 USC Sec. 204 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 204. Issuance of license
-STATUTE-
If the applicant for license as a pharmacist has complied with
the requirements of section 203 of this title, the consul shall
issue to him a license which shall entitle him to practice pharmacy
in the consular districts of the United States in China, subject to
the provisions of this chapter.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 3, 38 Stat. 819.)
-End-
-CITE-
21 USC Sec. 205 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 205. Display of license in pharmacy
-STATUTE-
Every license to practice pharmacy shall be conspicuously
displayed by the person to whom the same has been issued in the
pharmacy, drug store, or place of business, if any, of which the
said person is the owner or part owner or manager.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 5, 38 Stat. 819.)
-End-
-CITE-
21 USC Sec. 206 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 206. Revocation of license
-STATUTE-
The license of any person whose permanent allegiance is due to
the United States to practice pharmacy in the consular districts of
the United States in China may be revoked by the consul if such
person be found to have obtained such license by fraud, or be
addicted to the use of any narcotic or stimulant, or to be
suffering from physical or mental disease, in such manner and to
such extent as to render it expedient that in the interests of the
public his license be canceled; or to be of an immoral character;
or if such person be convicted in any court of competent
jurisdiction of any offense involving moral turpitude. It shall be
the duty of the consul to investigate any case in which it is
discovered by him or made to appear to his satisfaction that any
license issued under the provisions of this chapter is revocable
and shall, after full hearing, if in his judgment the facts warrant
it, revoke such license.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 4, 38 Stat. 819.)
-End-
-CITE-
21 USC Sec. 207 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 207. Restrictions on sales; written orders or prescriptions
-STATUTE-
It shall be unlawful for any person, firm, or corporation whose
permanent allegiance is due to the United States, either personally
or by servant or agent or as the servant or agent of any other
person or of any firm or corporation, to sell, furnish, or give
away any cocaine, salts of cocaine, or preparation containing
cocaine or salts of cocaine, or morphine or preparation containing
morphine or salts of morphine, or any opium or preparation
containing opium, or any chloral hydrate or preparation containing
chloral hydrate, except upon the original written order or
prescription of a recognized and reputable practitioner of
medicine, dentistry, or veterinary medicine, which order or
prescription shall be dated and shall contain the name of the
person for whom prescribed, or, if ordered by a practitioner of
veterinary medicine, shall state the kind of animal for which
ordered and shall be signed by the person giving the order or
prescription. Such order or prescription shall be, for a period of
three years, retained on file by the person, firm, or corporation
who compounds or dispenses the article ordered or prescribed, and
it shall not be compounded or dispensed after the first time except
upon the written order of the original prescriber.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 6, 38 Stat. 819.)
-COD-
CODIFICATION
Section is comprised of part of section 6 of act Mar. 3, 1915.
Remainder of such section 6 is classified to section 208 of this
title.
-End-
-CITE-
21 USC Sec. 208 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 208. Certain preparations and sales excepted
-STATUTE-
The provisions of section 207 of this title shall not apply to
preparations containing not more than two grains of opium or not
more than one-quarter grain of morphine, or not more than one-
quarter grain of cocaine, or not more than two grains of chloral
hydrate in the fluid ounce, or, of a solid preparation, in one
avoirdupois ounce, nor shall they apply to preparations sold in
good faith for diarrhea and cholera, each bottle or package of
which is accompanied by specific directions for use and caution
against habitual use, nor to liniments or ointments sold in good
faith as such when plainly labeled "for external use only", nor to
powder of ipecac and opium, commonly known as Dover's powder, when
sold in quantities not exceeding twenty grains. The provisions of
this section or section 207 of this title shall not be construed to
permit the selling, furnishing, giving away, or prescribing for the
use of any habitual users of the same any cocaine, salts of
cocaine, or preparation containing cocaine or salts of cocaine, or
morphine or salts of morphine, or preparations containing morphine
or salts of morphine, or any opium or preparation containing opium,
or any chloral hydrate or preparation containing chloral hydrate.
But the preceding sentence shall not be construed to prevent any
recognized or reputable practitioner of medicine whose permanent
allegiance is due to the United States from furnishing in good
faith for the use of any habitual user of narcotic drugs who is
under his professional care such substances as he may deem
necessary for their treatment, when such prescriptions are not
given or substances furnished for the purpose of evading the
provisions of this section. But the provisions of this section or
section 207 of this title shall not apply to sales at wholesale
between jobbers, manufacturers, and retail druggists, hospitals,
and scientific or public institutions.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 6, 38 Stat. 819.)
-COD-
CODIFICATION
Section is comprised of section 6 of act Mar. 3, 1915. Remainder
of such section 6 is classified to section 207 of this title.
-End-
-CITE-
21 USC Sec. 209 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 209. Poisons; book entry of sale; labels
-STATUTE-
It shall be unlawful for any person, firm, or corporation whose
permanent allegiance is due to the United States to sell or deliver
to any other person any of the following-described substances, or
any poisonous compound, combination, or preparation thereof, to
wit: The compounds of and salts of antimony, arsenic, barium,
chromium, copper, gold, lead, mercury, silver, and zinc, the
caustic hydrates of sodium and potassium, solution or water of
ammonia, methyl alcohol, paregoric, the concentrated mineral acids,
oxalic and hydrocyanic acids and their salts, yellow phosphorus,
Paris green, carbolic acid, the essential oils of almonds,
pennyroyal, tansy, rue, and savin; croton oil, creosote,
chloroform, cantharides, or aconite, belladonna, bitter almonds,
colchicum, cotton root, cocculus indicus, conium, cannabis indica,
digitalis, ergot, hyoscyamus, ignatia, lobelia, nux vomica,
physostigma, phytolacca, strophanthus, stramonium, veratrum viride,
or any of the poisonous alkaloids or alkaloidal salts derived from
the foregoing, or any other poisonous alkaloids or their salts, or
any other virulent poison, except in the manner following, and,
moreover, if the applicant be less than eighteen years of age,
except upon the written order of a person known or believed to be
an adult.
It shall first be learned, by due inquiry, that the person to
whom delivery is about to be made is aware of the poisonous
character of the substance and that it is desired for a lawful
purpose, and the box, bottle, or other package shall be plainly
labeled with the name of the substance, the word "Poison", the name
of at least one suitable antidote, when practicable, and the name
and address of the person, firm, or corporation dispensing the
substance. And before delivery be made of any of the foregoing
substances, excepting solution or water of ammonia and sulphate of
copper, there shall be recorded in a book kept for that purpose the
name of the article, the quantity delivered, the purpose for which
it is to be used, the date of delivery, the name and address of the
person for whom it is procured, and the name of the individual
personally dispensing the same; and said book shall be preserved by
the owner thereof for at least three years after the date of the
last entry therein. The foregoing provisions shall not apply to
articles dispensed upon the order of persons believed by the
dispenser to be recognized and reputable practitioners of medicine,
dentistry, or veterinary surgery. When a physician writes upon his
prescription a request that it be marked or labeled "Poison" the
pharmacist shall, in the case of liquids, place the same in a
colored glass, roughened bottle, of the kind commonly known in
trade as a "poison bottle", and, in the case of dry substances, he
shall place a poison label upon the container. The record of sale
and delivery above mentioned shall not be required of manufacturers
and wholesalers who shall sell any of the foregoing substances at
wholesale to licensed pharmacists, but the box, bottle, or other
package containing such substance, when sold at wholesale, shall be
properly labeled with the name of the substance, the word "poison",
and the name and address of the manufacturer or wholesaler. It
shall not be necessary, in sales either at wholesale or at retail,
to place a poison label upon, nor to record the delivery of, the
sulphide of antimony, or the oxide or carbonate of zinc, or of
colors ground in oil and intended for use as paints, or calomel;
nor in the case of preparations containing any of the substances
named in this section, when a single box, bottle, or other package,
or when the bulk of one-half fluid ounce or the weight of one-half
avoirdupois ounce does not contain more than an adult medicinal
dose of such substance; nor in the case of liniments or ointments
sold in good faith as such, when plainly labeled "For external use
only"; nor, in the case of preparations put up and sold in the form
of pills, tablets, or lozenges, containing any of the substances
enumerated in this section and intended for internal use, when the
dose recommended does not contain more than one-fourth of an adult
medicinal dose of such substance.
For the purpose of this and of every other section of this
chapter no box, bottle, or other package shall be regarded as
having been labeled "Poison" unless the word "Poison" appears
conspicuously thereon, printed in plain, uncondensed gothic letters
in red ink.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 7, 38 Stat. 820.)
-End-
-CITE-
21 USC Sec. 210 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 210. Pharmacist; unauthorized use of title
-STATUTE-
It shall be unlawful for any person whose permanent allegiance is
due to the United States, not legally licensed as a pharmacist, to
take, use, or exhibit the title of pharmacist, or licensed or
registered pharmacist, or the title of druggist or apothecary, or
any other title or description of like import.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 10, 38 Stat. 821.)
-End-
-CITE-
21 USC Sec. 211 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 211. Preservation of originals of prescriptions compounded and
copies thereof; inspection of prescriptions by consular officers;
marking containers of drugs
-STATUTE-
Every person, firm, or corporation whose permanent allegiance is
due to the United States owning, partly owning, or managing a drug
store or pharmacy shall keep in his place of business a suitable
book or file, in which shall be preserved for a period of not less
than three years the original of every prescription compounded or
dispensed at such store or pharmacy, or a copy of such
prescription, except when the preservation of the original is
required by section 207 or 208 of this title. Upon request the
owner, part owner, or manager of such store shall furnish to the
prescribing physician, or to the person for whom such prescription
was compounded or dispensed, a true and correct copy thereof. Any
prescription required by section 207 or 208 of this title, and any
prescription for, or register of sales of, substances mentioned in
such sections shall at all times be open to inspection by duly
authorized consular officers in the consular districts of the
United States in China. No person, firm, or corporation whose
permanent allegiance is due to the United States shall, in a
consular district, compound or dispense any drug or drugs or
deliver the same to any other person without marking on the
container thereof the name of the drug or drugs contained therein
and directions for using the same.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 9, 38 Stat. 821.)
-End-
-CITE-
21 USC Sec. 212 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 212. Offenses; punishment; duty to enforce provisions
-STATUTE-
Any person, firm, or corporation, whose permanent allegiance is
due to the United States, violating any of the provisions of this
chapter shall be deemed guilty of a misdemeanor and, upon
conviction thereof, shall be punished by a fine of not less than
$50 and not more than $100 or by imprisonment for not less than one
month and not more than sixty days, or by both such fine and
imprisonment, in the discretion of the court, and if the offense be
continuing in its character, each week or part of a week during
which it continues shall constitute a separate and distinct
offense. And it shall be the duty of the consular and judicial
officers of the United States in China to enforce the provisions of
this chapter.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 11, 38 Stat. 821.)
-End-
-CITE-
21 USC Sec. 213 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 213. Fraudulent representations to evade or defeat
restrictions
-STATUTE-
No person, firm, or corporation whose permanent allegiance is due
to the United States seeking to procure in the consular districts
of the United States in China any substance the sale of which is
regulated by the provisions of this chapter shall make any
fraudulent representations so as to evade or defeat the
restrictions herein imposed.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 8, 38 Stat. 821.)
-End-
-CITE-
21 USC Sec. 214 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 214. Previous laws unaffected
-STATUTE-
Nothing in this chapter shall be construed as modifying or
revoking any of the provisions of sections 191 to 193 (!1) of this
title.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 13, 38 Stat. 822.)
-REFTEXT-
REFERENCES IN TEXT
Sections 191 to 193 of this title, referred to in text, were
repealed by Pub. L. 91-513, title III, Sec. 1101(a)(1), Oct. 27,
1970, 84 Stat. 1291. See section 801 et seq. of this title.
-FOOTNOTE-
(!1) See References in Text note below.
-End-
-CITE-
21 USC Sec. 215 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 7 - PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR
DISTRICTS IN CHINA
-HEAD-
Sec. 215. "Consul" defined
-STATUTE-
The word "consul" as used in this chapter shall mean the consular
officer in charge of the district concerned.
-SOURCE-
(Mar. 3, 1915, ch. 74, Sec. 12, 38 Stat. 822.)
-End-
-CITE-
21 USC CHAPTER 8 - NARCOTIC FARMS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 8 - NARCOTIC FARMS
-HEAD-
CHAPTER 8 - NARCOTIC FARMS
-End-
-CITE-
21 USC Secs. 221 to 237 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 8 - NARCOTIC FARMS
-HEAD-
Secs. 221 to 237. Repealed.
-MISC1-
Secs. 221 to 237. Repealed. July 1, 1944, ch. 373, title XIII, Sec.
1313, 58 Stat. 714.
Section 221, act Jan. 19, 1929, ch. 82, Sec. 1, 45 Stat. 1085,
defined "habit-forming narcotic drug", "narcotic", and "addict".
See section 201 of Title 42, The Public Health and Welfare.
Section 222, act Jan. 19, 1929, ch. 82, Sec. 2, 45 Stat. 1085,
provided for narcotic farms.
Section 222a, act June 23, 1935, ch. 725, Sec. 1, 49 Stat. 1840,
provided name for narcotic farm at Lexington, Ky.
Section 222b, act Mar. 28, 1938, ch. 55, Sec. 1, 52 Stat. 134,
provided name for narcotic farm at Fort Worth, Texas.
Section 223, act Jan. 19, 1929, ch. 82, Sec. 3, 45 Stat. 1085;
1939 Reorg. Plan No. I, Sec. 205(b), eff. July 1, 1939, 4 F.R.
2728, 53 Stat. 1425, provided for an annual estimate of expenses of
maintenance of narcotic farms.
Section 224, act Jan. 19, 1929, ch. 82, Sec. 4, 45 Stat. 1086,
provided for construction of buildings for two of the narcotic
farms.
Section 225, acts Jan. 19, 1929, ch. 82, Sec. 5, 45 Stat. 1086;
June 14, 1930, ch. 488, Sec. 4(a), 46 Stat. 586; 1939 Reorg. Plan
No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat.
1424, provided for control and management of narcotic farms.
Section 226, act Jan. 19, 1929, ch. 82, Sec. 6, 45 Stat. 1086;
1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
2728, 53 Stat. 1424, 1425, provided for care and treatment of
addicts.
Section 227, act Jan. 19, 1929, ch. 82, Sec. 7, 45 Stat. 1086,
provided for transfer to and from farms of addicts who are
prisoners.
Section 228, act Jan. 19, 1929, ch. 82, Sec. 8, 45 Stat. 1087,
provided that it was the duty of prosecuting officers to report
convicted persons believed to be addicts.
Section 229, act Jan. 19, 1929, ch. 82, Sec. 9, 45 Stat. 1087;
1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
2728, 53 Stat. 1424, 1425, provided for employment of addicts.
Section 230, act Jan. 19, 1929, ch. 82, Sec. 10, 45 Stat. 1087,
provided for parole of inmates.
Section 231, act Jan. 19, 1929, ch. 82, Sec. 11, 45 Stat. 1087;
1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
2728, 53 Stat. 1424, 1425, provided for discharge of addicts.
Section 232, act Jan. 19, 1929, ch. 82, Sec. 12, 45 Stat. 1088;
1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
2728, 53 Stat. 1424, 1425, provided for admission of voluntary
patients.
Section 233, act Jan. 19, 1929, ch. 82, Sec. 13, 45 Stat. 1088;
1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
2728, 53 Stat. 1424, 1425, provided for furnishing of gratuities
and transportation to discharged convicts.
Section 234, act. Jan. 19, 1929, ch. 82, Sec. 14, 45 Stat. 1089;
1939 Reorg. Plan No. I, Secs. 201, 205, eff. July 1, 1939, 4 F.R.
2728, 53 Stat. 1424, 1425, provided penalties for introduction of
narcotic drugs into a narcotic farm.
Section 235, act Jan. 19, 1929, ch. 82, Sec. 15, 45 Stat. 1089,
provided penalties for escape of inmates.
Section 236, act Jan. 19, 1929, ch. 82, Sec. 16, 45 Stat. 1089,
provided penalties for procuring of escape by inmates.
Section 237, act Jan. 19, 1929, ch. 82, Sec. 17, 45 Stat. 1089,
provided for deportation of alien inmates who are entitled to a
discharge from narcotic farms.
RENUMBERING OF REPEALING ACT
Section 611 of act July 1, 1944, which repealed this section, was
renumbered Sec. 711 by act Aug. 13, 1946, ch. 958, Sec. 5, 60 Stat.
1049, Sec. 713 by act Feb. 28, 1948, ch. 83, Sec. 9(b), 62 Stat.
47, Sec. 813 by act July 30, 1956, ch. 779, Sec. 3(b), 70 Stat.
720, Sec. 913 by Pub. L. 88-581, Sec. 4(b), Sept. 4, 1964, 78 Stat.
919, Sec. 1013 by Pub. L. 89-239, Sec. 3(b), Oct. 6, 1965, 79 Stat.
931, Sec. 1113 by Pub. L. 91-572, Sec. 6(b), Dec. 24, 1970, 84
Stat. 1506, Sec. 1213 by Pub. L. 92-294, Sec. 3(b), May 16, 1972,
86 Stat. 137, Sec. 1313 by Pub. L. 93-154, Sec. 2(b)(2), Nov. 16,
1973, 87 Stat. 604, and was repealed by Pub. L. 93-222, Sec. 7(b),
Dec. 29, 1973, 87 Stat. 936.
-End-
-CITE-
21 USC CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
-HEAD-
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
-MISC1-
SUBCHAPTER I - SHORT TITLE
Sec.
301. Short title.
SUBCHAPTER II - DEFINITIONS
321. Definitions; generally.
321a. "Butter" defined.
321b. "Package" defined.
321c. Nonfat dry milk; "milk" defined.
321d. Market names for catfish and ginseng.
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
331. Prohibited acts.
332. Injunction proceedings.
333. Penalties.
333a. Repealed.
334. Seizure.
335. Hearing before report of criminal violation.
335a. Debarment, temporary denial of approval, and
suspension.
335b. Civil penalties.
335c. Authority to withdraw approval of abbreviated drug
applications.
336. Report of minor violations.
337. Proceedings in name of United States; provision as to
subpoenas.
SUBCHAPTER IV - FOOD
341. Definitions and standards for food.
342. Adulterated food.
343. Misbranded food.
343-1. National uniform nutrition labeling.
343-2. Dietary supplement labeling exemptions.
343-3. Disclosure.
343a. Repealed.
344. Emergency permit control.
345. Regulations making exemptions.
346. Tolerances for poisonous or deleterious substances in
food; regulations.
346a. Tolerances and exemptions for pesticide chemical
residues.
346b. Authorization of appropriations.
347. Intrastate sales of colored oleomargarine.
347a. Congressional declaration of policy regarding
oleomargarine sales.
347b. Contravention of State laws.
348. Food additives.
349. Bottled drinking water standards; publication in
Federal Register.
350. Vitamins and minerals.
350a. Infant formulas.
350b. New dietary ingredients.
350c. Maintenance and inspection of records.
350d. Registration of food facilities.
350e. Sanitary transportation practices.
350f. Reportable food registry.
350g. Hazard analysis and risk-based preventive controls.
350h. Standards for produce safety.
350i. Protection against intentional adulteration.
350j. Targeting of inspection resources for domestic
facilities, foreign facilities, and ports of entry;
annual report.
350k. Laboratory accreditation for analyses of foods.
350l. Mandatory recall authority.
350l-1. Annual report to Congress.
SUBCHAPTER V - DRUGS AND DEVICES
PART A - DRUGS AND DEVICES
351. Adulterated drugs and devices.
352. Misbranded drugs and devices.
353. Exemptions and consideration for certain drugs,
devices, and biological products.
353a. Pharmacy compounding.
353b. Prereview of television advertisements.
354. Veterinary feed directive drugs.
355. New drugs.
355-1. Risk evaluation and mitigation strategies.
355a. Pediatric studies of drugs.
355b. Adverse-event reporting.
355c. Research into pediatric uses for drugs and biological
products.
355d. Internal committee for review of pediatric plans,
assessments, deferrals, and waivers.
355e. Pharmaceutical security.
356. Fast track products.
356-1. Accelerated approval of priority countermeasures.
356a. Manufacturing changes.
356b. Reports of postmarketing studies.
356c. Discontinuance of life saving product.
357. Repealed.
358. Authority to designate official names.
359. Nonapplicability of subchapter to cosmetics.
360. Registration of producers of drugs or devices.
360a. Clinical trial guidance for antibiotic drugs.
360b. New animal drugs.
360c. Classification of devices intended for human use.
360d. Performance standards.
360e. Premarket approval.
360e-1. Pediatric uses of devices.
360f. Banned devices.
360g. Judicial review.
360h. Notification and other remedies.
360i. Records and reports on devices.
360j. General provisions respecting control of devices
intended for human use.
360k. State and local requirements respecting devices.
360l. Postmarket surveillance.
360m. Accredited persons.
360n. Priority review to encourage treatments for tropical
diseases.
PART B - DRUGS FOR RARE DISEASES OR CONDITIONS
360aa. Recommendations for investigations of drugs for rare
diseases or conditions.
360bb. Designation of drugs for rare diseases or conditions.
360cc. Protection for drugs for rare diseases or conditions.
360dd. Open protocols for investigations of drugs for rare
diseases or conditions.
360ee. Grants and contracts for development of drugs for rare
diseases and conditions.
PART C - ELECTRONIC PRODUCT RADIATION CONTROL
360hh. Definitions.
360ii. Program of control.
360jj. Studies by Secretary.
360kk. Performance standards for electronic products.
360ll. Notification of defects in and repair or replacement
of electronic products.
360mm. Imports.
360nn. Inspection, records, and reports.
360oo. Prohibited acts.
360pp. Enforcement.
360qq. Repealed.
360rr. Federal-State cooperation.
360ss. State standards.
PART D - DISSEMINATION OF TREATMENT INFORMATION
360aaa to 360aaa-6. Omitted
PART E - GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES
360bbb. Expanded access to unapproved therapies and
diagnostics.
360bbb-1. Dispute resolution.
360bbb-2. Classification of products.
360bbb-3. Authorization for medical products for use in
emergencies.
360bbb-4. Technical assistance.
360bbb-5. Critical Path Public-Private Partnerships.
360bbb-6. Risk communication.
PART F - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
360ccc. Conditional approval of new animal drugs for minor use
and minor species.
360ccc-1. Index of legally marketed unapproved new animal drugs
for minor species.
360ccc-2. Designated new animal drugs for minor use or minor
species.
SUBCHAPTER VI - COSMETICS
361. Adulterated cosmetics.
362. Misbranded cosmetics.
363. Regulations making exemptions.
364. Repealed.
SUBCHAPTER VII - GENERAL AUTHORITY
PART A - GENERAL ADMINISTRATIVE PROVISIONS
371. Regulations and hearings.
372. Examinations and investigations.
372a. Transferred.
373. Records.
374. Inspection.
374a. Inspections relating to food allergens.
375. Publicity.
376. Examination of sea food on request of packer; marking
food with results; fees; penalties.
377. Revision of United States Pharmacopoeia; development
of analysis and mechanical and physical tests.
378. Advertising of foods.
379. Confidential information.
379a. Presumption of existence of jurisdiction.
379b. Consolidated administrative and laboratory facility.
379c. Transferred.
379d. Automation of Food and Drug Administration.
379d-1. Conflicts of interest.
379d-2. Policy on the review and clearance of scientific
articles published by FDA employees.
PART B - COLORS
379e. Listing and certification of color additives for
foods, drugs, devices, and cosmetics.
PART C - FEES
SUBPART 1 - FREEDOM OF INFORMATION FEES
379f. Recovery and retention of fees for freedom of
information requests.
SUBPART 2 - FEES RELATING TO DRUGS
379g. Definitions.
379h. Authority to assess and use drug fees.
379h-1. Fees relating to advisory review of prescription-drug
television advertising.
379h-2. Reauthorization; reporting requirements.
SUBPART 3 - FEES RELATING TO DEVICES
379i. Definitions.
379j. Authority to assess and use device fees.
379j-1. Reauthorization; reporting requirements.
SUBPART 4 - FEES RELATING TO ANIMAL DRUGS
379j-11. Definitions.
379j-12. Authority to assess and use animal drug fees.
379j-13. Reauthorization; reporting requirements.
SUBPART 5 - FEES RELATING TO GENERIC NEW ANIMAL DRUGS
379j-21. Authority to assess and use generic new animal drug
fees.
379j-22. Reauthorization; reporting requirements.
SUBPART 6 - FEES RELATED TO FOOD
379j-31. Authority to collect and use fees.
PART D - INFORMATION AND EDUCATION
379k. Information system.
379l. Education.
PART E - ENVIRONMENTAL IMPACT REVIEW
379o. Environmental impact.
PART F - NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS
379r. National uniformity for nonprescription drugs.
379s. Preemption for labeling or packaging of cosmetics.
PART G - SAFETY REPORTS
379v. Safety report disclaimers.
PART H - SERIOUS ADVERSE EVENT REPORTS
379aa. Serious adverse event reporting for nonprescription
drugs.
379aa-1. Serious adverse event reporting for dietary
supplements.
PART I - REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG
ADMINISTRATION
379dd. Establishment and functions of the Foundation.
379dd-1. Location of Foundation.
379dd-2. Activities of the Food and Drug Administration.
SUBCHAPTER VIII - IMPORTS AND EXPORTS
381. Imports and exports.
382. Exports of certain unapproved products.
383. Office of International Relations.
384. Importation of prescription drugs.
384a. Foreign supplier verification program.
384b. Voluntary qualified importer program.
384c. Inspection of foreign food facilities.
384d. Accreditation of third-party auditors.
SUBCHAPTER IX - TOBACCO PRODUCTS
387. Definitions.
387a. FDA authority over tobacco products.
387a-1. Final rule.
387b. Adulterated tobacco products.
387c. Misbranded tobacco products.
387d. Submission of health information to the Secretary.
387e. Annual registration.
387f. General provisions respecting control of tobacco
products.
387f-1. Enforcement action plan for advertising and promotion
restrictions.
387g. Tobacco product standards.
387h. Notification and other remedies.
387i. Records and reports on tobacco products.
387j. Application for review of certain tobacco products.
387k. Modified risk tobacco products.
387l. Judicial review.
387m. Equal treatment of retail outlets.
387n. Jurisdiction of and coordination with the Federal
Trade Commission.
387o. Regulation requirement.
387p. Preservation of State and local authority.
387q. Tobacco Products Scientific Advisory Committee.
387r. Drug products used to treat tobacco dependence.
387s. User fees.
387t. Labeling, recordkeeping, records inspection.
387u. Studies of progress and effectiveness.
SUBCHAPTER X - MISCELLANEOUS
391. Separability clause.
392. Exemption of meats and meat food products.
393. Food and Drug Administration.
393a. Office of Pediatric Therapeutics.
394. Scientific review groups.
395. Loan repayment program.
396. Practice of medicine.
397. Contracts for expert review.
398. Notices to States regarding imported food.
399. Grants to enhance food safety.
399a. Office of the Chief Scientist.
399b. Office of Women's Health.
399c. Improving the training of State, local, territorial,
and tribal food safety officials.
399d. Employee protections.
-End-
-CITE-
21 USC SUBCHAPTER I - SHORT TITLE 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER I - SHORT TITLE
-HEAD-
SUBCHAPTER I - SHORT TITLE
-End-
-CITE-
21 USC Sec. 301 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER I - SHORT TITLE
-HEAD-
Sec. 301. Short title
-STATUTE-
This chapter may be cited as the Federal Food, Drug, and Cosmetic
Act.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 1, 52 Stat. 1040.)
-MISC1-
EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES
Act June 23, 1939, ch. 242, Secs. 1, 2, 53 Stat. 853, 854,
provided that:
"[Sec. 1] (a) The effective date of the following provisions of
the Federal Food, Drug, and Cosmetic Act is hereby postponed until
January 1, 1940: Sections 402(c) [342(c) of this title]; 403(e)(1)
[343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g)
to (k) of this title]; 501(a), (4) [351(a)(4) of this title];
502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this
title]; 601(e) [361(e) of this title]; and 602(b) [362(b) of this
title].
"(b) The Secretary of Agriculture shall promulgate regulations
further postponing to July 1, 1940[,] the effective date of the
provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g),
(h), (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (e), (f), (g),
and (h) [352(b), (d) to (h) of this title]; and 602(b) [362(b) of
this title] of such Act with respect to lithographed labeling which
was manufactured prior to February 1, 1939, and to containers
bearing labeling which, prior to February 1, 1939, was
lithographed, etched, stamped, pressed, printed, fused or blown on
or in such containers, where compliance with such provisions would
be unduly burdensome by reason of causing the loss of valuable
stocks of such labeling or containers, and where such postponement
would not prevent the public interest being adequately served:
Provided, That in no case shall such regulations apply to labeling
which would not have complied with the requirements of the Food and
Drugs Act of June 30, 1906, as amended.
"Sec. 2. (a) The provisions of section 8 [section 10 of this
title], paragraph fifth, under the heading 'In the case of food:',
of the Food and Drugs Act of June 30, 1906, as amended, and
regulations promulgated thereunder, and all other provisions of
such Act to the extent that they may relate to the enforcement of
such section 8 [section 10 of this title] and of such regulations,
shall remain in force until January 1, 1940.
"(b) The provisions of such Act of June 30, 1906, as amended,
[sections 1 to 5, 7 to 15, and 372a of this title] to the extent
that they impose, or authorize the imposition of, any requirement
imposed by section 403(k) of the Federal Food, Drug, and Cosmetic
Act [section 343(k) of this title], shall remain in force until
January 1, 1940.
"(c) Notwithstanding the provisions of section 1 of this Act,
such section shall not apply -
"(1) to the provisions of section 502(d) and (e) of the Federal
Food, Drug, and Cosmetic Act [352(d), (e) of this title], insofar
as such provisions relate to any substance named in section 8
[section 10 of this title], paragraph second, under the heading
'In the case of drugs:', of the Food and Drugs Act of June 30,
1906, as amended, or a derivative of any such substance; or
"(2) to the provisions of section 502(b), (d), (e), (f), (g),
and (h) of the Federal Food, Drug, and Cosmetic Act [352(b), (d)
to (h) of this title], insofar as such provisions relate to drugs
to which section 505 [355 of this title] of such Act applies."
EFFECTIVE DATE
Act June 25, 1938, ch. 675, Sec. 1002(a), formerly Sec. 902(a),
52 Stat. 1059; renumbered Sec. 1002(a), Pub. L. 111-31, div. A,
title I, Sec. 101(b)(2), June 22, 2009, 123 Stat. 1784, provided
that: "This Act [enacting this chapter and repealing sections 1 to
5 and 7 to 15 of this title], shall take effect twelve months after
the date of its enactment [June 25, 1938]. The Federal Food and
Drugs Act of June 30, 1906, as amended (U.S.C., 1934 ed., title 21,
secs. 1-15), shall remain in force until such effective date, and,
except as otherwise provided in this subsection, is hereby repealed
effective upon such date: Provided, That the provisions of section
701 [section 371 of this title] shall become effective on the
enactment of this Act, and thereafter the Secretary is authorized
hereby to (1) conduct hearings and to promulgate regulations which
shall become effective on or after the effective date of this Act
as the Secretary shall direct, and (2) designate prior to the
effective date of this Act food having common or usual names and
exempt such food from the requirements of clause (2) of section
403(i) [section 343(i) of this title] for a reasonable time to
permit the formulation, promulgation, and effective application of
definitions and standards of identity therefor as provided by
section 401 [section 341 of this title]: Provided further, That
sections 502(j), 505, and 601(a) [sections 352(j), 355, 361(a),
respectively of this title], and all other provisions of this Act
to the extent that they may relate to the enforcement of such
sections, shall take effect on the date of the enactment of this
Act, except that in the case of a cosmetic to which the proviso of
section 601(a) [section 361(a) of this title], relates, such
cosmetic shall not, prior to the ninetieth day after such date of
enactment, be deemed adulterated by reason of the failure of its
label to bear the legend prescribed in such proviso: Provided
further, That the Act of March 4, 1923 (U.S.C., 1934 ed., title 21,
sec. 6 [section 321a of this title]; 42 Stat. 1500, ch. 268),
defining butter and providing a standard therefor; the Act of July
24, 1919 (U.S.C., 1934 ed., title 21, sec. 10 [section 321b of this
title]; 41 Stat. 271, ch. 26], defining wrapped meats as in package
form; and the amendment to the Food and Drugs Act, section 10A,
approved August 27, 1935 (U.S.C. 1934 ed., Sup. III, title 21, sec.
14a [section 372a of this title]) shall remain in force and effect
and be applicable to the provisions of this Act."
SHORT TITLE OF 2009 AMENDMENT
Pub. L. 111-31, div. A, Sec. 1(a), June 22, 2009, 123 Stat. 1776,
provided that: "This division [enacting subchapter IX of this
chapter, amending sections 321, 331, 333, 334, 355, 360m, 372 to
374, 375, 379a, 381, 391 to 393, 394 to 399a, and 679 of this title
and sections 1333, 1334, 4402, 4406, and 4408 of Title 15, Commerce
and Trade, enacting provisions set out as notes under sections 331,
333, 387, and 387c of this title and sections 1333 and 4402 of
Title 15, and amending provisions set out as notes under this
section and section 392 of this title] may be cited as the 'Family
Smoking Prevention and Tobacco Control Act'."
SHORT TITLE OF 2008 AMENDMENT
Pub. L. 110-316, title I, Sec. 101(a), Aug. 14, 2008, 122 Stat.
3509, provided that: "This title [enacting section 379j-13 of this
title, amending sections 360b, 379j-11, and 379j-12 of this title,
and enacting provisions set out as notes under sections 360b and
379j-11 of this title] may be cited as the 'Animal Drug User Fee
Amendments of 2008'."
Pub. L. 110-316, title II, Sec. 201(a), Aug. 14, 2008, 122 Stat.
3515, provided that: "This title [enacting sections 379j-21 and
379j-22 of this title, amending sections 379k, 379l, and 379o of
this title, and enacting provisions set out as notes under sections
379j-21 and 379j-22 of this title] may be cited as the 'Animal
Generic Drug User Fee Act of 2008'."
SHORT TITLE OF 2007 AMENDMENT
Pub. L. 110-85, Sec. 1, Sept. 27, 2007, 121 Stat. 823, provided
that: "This Act [enacting part I of subchapter VII of this chapter,
chapter 26 of this title, sections 350f, 353b, 355-1, 355d, 355e,
360a, 360e-1, 360n, 360bbb-5, 360bbb-6, 379d-1, 379d-2, 379h-1,
379h-2, 379j-1, and 399a of this title, and section 247d-5a of
Title 42, The Public Health and Welfare, amending sections 321,
331, 333, 334, 352, 355, 355a, 355c, 360, 360e, 360i, 360j, 360l,
360m, 360ee, 374, 379g, 379h, 379i, 379j, 379j-11, 379l, 381, and
393a of this title and sections 247d-3b, 262, 282, 283, 283a-2,
283a-3, 284m, 285g-10, 288-6, and 290b of Title 42, enacting
provisions set out as notes under this section and sections 331,
350f, 352, 355, 355a, 355c, 360j, 379g, 379h, 379h-2, 379i, and
2110 of this title and section 282 of Title 42, and amending
provisions set out as notes under section 284m of Title 42] may be
cited as the 'Food and Drug Administration Amendments Act of
2007'."
Pub. L. 110-85, title I, Sec. 101(a), Sept. 27, 2007, 121 Stat.
825, provided that: "This title [enacting sections 379h-1 and 379h-
2 of this title, amending sections 379g, 379h, and 379j-11 of this
title, and enacting provisions set out as notes under sections
379g, 379h, and 379h-2 of this title] may be cited as the
'Prescription Drug User Fee Amendments of 2007'."
Pub. L. 110-85, title II, Sec. 201(a), Sept. 27, 2007, 121 Stat.
842, provided that: "This title [enacting section 379j-1 of this
title, amending sections 333, 360, 360i, 360m, 374, 379i, and 379j
of this title, and enacting provisions set out as notes under
section 379i of this title] may be cited as the 'Medical Device
User Fee Amendments of 2007'."
Pub. L. 110-85, title III, Sec. 301, Sept. 27, 2007, 121 Stat.
859, provided that: "This title [enacting section 360e-1 of this
title, amending sections 360j, 360l, and 393a of this title and
section 282 of Title 42, The Public Health and Welfare, enacting
provisions set out as notes under section 360j of this title and
section 282 of Title 42, and amending provisions set out as a note
under section 284m of Title 42] may be cited as the 'Pediatric
Medical Device Safety and Improvement Act of 2007'."
Pub. L. 110-85, title IV, Sec. 401, Sept. 27, 2007, 121 Stat.
866, provided that: "This title [enacting section 355d of this
title, amending section 355c of this title, and enacting provisions
set out as a note under section 355c of this title] may be cited as
the 'Pediatric Research Equity Act of 2007'."
Pub. L. 110-85, title V, Sec. 501, Sept. 27, 2007, 121 Stat. 876,
provided that: "This title [amending section 355a of this title and
sections 284m, 285g-10, 288-6, and 290b of Title 42, The Public
Health and Welfare, enacting provisions set out as a note under
section 355a of this title, and amending provisions set out as a
note under section 284m of Title 42] may be cited as the 'Best
Pharmaceuticals for Children Act of 2007'."
SHORT TITLE OF 2006 AMENDMENT
Pub. L. 109-462, Sec. 1, Dec. 22, 2006, 120 Stat. 3469, provided
that: "This Act [enacting sections 379aa and 379aa-1 of this title,
amending sections 331, 343, 352, and 381 of this title, and
enacting provisions set out as notes under sections 331, 343, 352,
379aa, and 381 of this title] may be cited as the 'Dietary
Supplement and Nonprescription Drug Consumer Protection Act'."
SHORT TITLE OF 2005 AMENDMENTS
Pub. L. 109-59, title VII, Sec. 7201, Aug. 10, 2005, 119 Stat.
1911, provided that: "This subtitle [subtitle B (Secs. 7201-7204)
of title VII of Pub. L. 109-59, enacting section 350e of this
title, amending sections 331, 342, and 373 of this title and
section 5701 of Title 49, Transportation, omitting sections 5702 to
5714 of Title 49, and enacting provisions set out as a note under
section 331 of this title] may be cited as the 'Sanitary Food
Transportation Act of 2005'."
Pub. L. 109-43, Sec. 1, Aug. 1, 2005, 119 Stat. 439, provided
that: "This Act [amending sections 352 and 379j of this title,
enacting provisions set out as a note under section 352 of this
title, and amending provisions set out as notes under sections 352
and 379i of this title] may be cited as the 'Medical Device User
Fee Stabilization Act of 2005'."
SHORT TITLE OF 2004 AMENDMENTS
Pub. L. 108-282, title I, Sec. 101, Aug. 2, 2004, 118 Stat. 891,
provided that: "This title [enacting sections 360ccc to 360ccc-2 of
this title, amending sections 321, 331, 352, 353, 354, and 360b of
this title, enacting provisions set out as notes under sections
360ccc and 393 of this title, and amending provisions set out as a
note under section 360b of this title] may be cited as the 'Minor
Use and Minor Species Animal Health Act of 2004'."
Pub. L. 108-282, title II, Sec. 201, Aug. 2, 2004, 118 Stat. 905,
provided that: "This title [enacting section 374a of this title and
section 242r of Title 42, The Public Health and Welfare, amending
sections 321, 343, and 343-1 of this title, and enacting provisions
set out as notes under sections 321 and 343 of this title and
sections 243 and 300d-2 of Title 42] may be cited as the 'Food
Allergen Labeling and Consumer Protection Act of 2004'."
Pub. L. 108-214, Sec. 1, Apr. 1, 2004, 118 Stat. 572, provided
that: "This Act [amending sections 331, 352, 360, 360e, 374, 379i,
and 379j of this title and provisions set out as notes under
sections 352, 360l, and 379j of this title] may be cited as the
'Medical Devices Technical Corrections Act'."
SHORT TITLE OF 2003 AMENDMENTS
Pub. L. 108-155, Sec. 1, Dec. 3, 2003, 117 Stat. 1936, provided
that: "This Act [enacting section 355c of this title, amending
sections 355, 355a, and 355b of this title and sections 262 and
284m of Title 42, The Public Health and Welfare, enacting
provisions set out as a note under section 355c of this title, and
amending provisions set out as notes under section 355a of this
title and section 284m of Title 42] may be cited as the 'Pediatric
Research Equity Act of 2003'."
Pub. L. 108-130, Sec. 1, Nov. 18, 2003, 117 Stat. 1361, provided
that: "This Act [enacting sections 379j-11 and 379j-12 of this
title and provisions set out as notes under section 379j-11 of this
title] may be cited as the 'Animal Drug User Fee Act of 2003'."
SHORT TITLE OF 2002 AMENDMENTS
Pub. L. 107-281, Sec. 1, Nov. 6, 2002, 116 Stat. 1992, provided
that: "This Act [amending sections 360cc and 360ee of this title
and enacting provisions set out as a note under section 360ee of
this title] may be cited as the 'Rare Diseases Orphan Product
Development Act of 2002'."
Pub. L. 107-250, Sec. 1(a), Oct. 26, 2002, 116 Stat. 1588,
provided that: "This Act [enacting sections 379i and 379j of this
title and section 289g-3 of Title 42, The Public Health and
Welfare, amending sections 321, 331, 333, 335a, 352, 353, 360,
360c, 360e, 360m, and 374 of this title, and enacting provisions
set out as notes under sections 352, 360e, 360j, 360l, 379i, and
379j of this title and section 289g-3 of Title 42] may be cited as
the 'Medical Device User Fee and Modernization Act of 2002'."
Pub. L. 107-188, title V, Sec. 501, June 12, 2002, 116 Stat. 687,
provided that: "This subtitle [subtitle A (Secs. 501-509) of title
V of Pub. L. 107-188, amending sections 356b, 379g, and 379h of
this title and enacting provisions set out as notes under sections
356b and 379g of this title] may be cited as the 'Prescription Drug
User Fee Amendments of 2002'."
Pub. L. 107-109, Sec. 1, Jan. 4, 2002, 115 Stat. 1408, provided
that: "This Act [enacting sections 355b and 393a of this title and
section 284m of Title 42, The Public Health and Welfare, amending
sections 321, 355, 355a, and 379h of this title and sections 282,
284k, 284l, 285a-2, and 290b of Title 42, and enacting provisions
set out as notes under sections 355 and 355a of this title and
sections 284m and 289 of Title 42] may be cited as the 'Best
Pharmaceuticals for Children Act'."
SHORT TITLE OF 2000 AMENDMENT
Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 745(a)], Oct. 28,
2000, 114 Stat. 1549, 1549A-35, provided that: "This section
[enacting section 384 of this title, amending sections 331, 333,
and 381 of this title, and enacting provisions set out as a note
under section 384 of this title] may be cited as the 'Medicine
Equity and Drug Safety Act of 2000'."
Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(a)], Oct. 28,
2000, 114 Stat. 1549, 1549A-40, provided that: "This section
[amending section 381 of this title and enacting provisions set out
as a note under section 381 of this title] may be cited as the
'Prescription Drug Import Fairness Act of 2000'."
SHORT TITLE OF 1998 AMENDMENT
Pub. L. 105-324, Sec. 1, Oct. 30, 1998, 112 Stat. 3035, provided
that: "This Act [amending sections 321 and 346a of this title] may
be cited as the 'Antimicrobial Regulation Technical Corrections Act
of 1998'."
SHORT TITLE OF 1997 AMENDMENT
Pub. L. 105-115, Sec. 1(a), Nov. 21, 1997, 111 Stat. 2296,
provided that: "This Act [enacting sections 343-3, 353a, 355a, 356
to 356c, 360m, 360aaa to 360aaa-6, 360bbb to 360bbb-2, 379k, 379l,
379o, 379r, 379s, 379v, 396, and 397 of this title and sections
247b-8 and 299a-3 of Title 42, The Public Health and Welfare,
amending sections 321, 331, 334, 335a, 343, 348, 351 to 353, 355,
360, 360b to 360e, 360g, 360i, 360j, 360l, 360aa to 360cc, 360ee,
371, 374, 379a, 379g, 379h, 381 to 383, 393, and 802 of this title,
section 45C of Title 26, Internal Revenue Code, section 156 of
Title 35, Patents, section 8126 of Title 38, Veterans' Benefits,
and sections 262, 263a, and 282 of Title 42, repealing sections 356
and 357 of this title, and enacting provisions set out as notes
under sections 321, 348, 351, 352, 353a, 355 to 356b, 360i, 360l,
360m, 360aaa, 371, 379g, 379h, 379k, and 393 of this title and
sections 247b-8 and 282 of Title 42] may be cited as the 'Food and
Drug Administration Modernization Act of 1997'."
SHORT TITLE OF 1996 AMENDMENTS
Pub. L. 104-250, Sec. 1(a), Oct. 9, 1996, 110 Stat. 3151,
provided that: "This Act [enacting section 354 of this title,
amending sections 331, 353, and 360b of this title, and enacting
provisions set out as notes under section 360b of this title] may
be cited as the 'Animal Drug Availability Act of 1996'."
Pub. L. 104-170, title IV, Sec. 401(a), Aug. 3, 1996, 110 Stat.
1513, provided that: "This title [amending sections 321, 331, 333,
342, and 346a of this title] may be cited as the 'Food Quality
Protection Act of 1996'."
[Another "Food Quality Protection Act of 1996", was enacted by
Pub. L. 104-170, Sec. 1, 110 Stat. 1489, which is set out as a note
under section 136 of Title 7, Agriculture.]
Pub. L. 104-134, title II, Sec. 2101(a), Apr. 26, 1996, 110 Stat.
1321-313, provided that: "This chapter [chapter 1A (Secs. 2101-
2105) of title II of Pub. L. 104-134, enacting section 382 of this
title and amending sections 331 and 381 of this title and section
262 of Title 42, The Public Health and Welfare] may be cited as the
'FDA Export Reform and Enhancement Act of 1996'."
SHORT TITLE OF 1994 AMENDMENTS
Pub. L. 103-417, Sec. 1(a), Oct. 25, 1994, 108 Stat. 4325,
provided that: "This Act [enacting sections 343-2 and 350b of this
title and section 287c-11 of Title 42, The Public Health and
Welfare, amending sections 321, 331, 342, 343, and 350 of this
title and section 281 of Title 42, and enacting provisions set out
as notes under sections 321 and 343 of this title] may be cited as
the 'Dietary Supplement Health and Education Act of 1994'."
Pub. L. 103-396, Sec. 1, Oct. 22, 1994, 108 Stat. 4153, provided
that: "This Act [amending sections 331, 343-1, 360b, and 371 of
this title and enacting provisions set out as notes under section
360b of this title] may be cited as the 'Animal Medicinal Drug Use
Clarification Act of 1994'."
SHORT TITLE OF 1993 AMENDMENT
Pub. L. 103-80, Sec. 1, Aug. 13, 1993, 107 Stat. 773, provided
that: "This Act [amending sections 321, 331 to 333, 334, 335b, 341
to 343, 346a, 350a, 352, 355 to 358, 360b to 360e, 360i, 360cc,
360hh to 360ss, 361, 371, 372, 373, 374, 376, 379e, and 381 of this
title and section 263b of Title 42, The Public Health and Welfare,
and enacting provisions set out as a note under section 343 of this
title] may be cited as the 'Nutrition Labeling and Education Act
Amendments of 1993'."
SHORT TITLE OF 1992 AMENDMENTS
Pub. L. 102-571, title I, Sec. 101(a), Oct. 29, 1992, 106 Stat.
4491, provided that: "This title [enacting sections 379g and 379h
of this title, transferring sections 372a, 376, and 379c of this
title to sections 376, 379e and 379f, respectively, of this title,
amending sections 321, 331, 342, 343, 346a, 351, 352, 360j, 361,
362, 453, 601, and 1033 of this title, enacting provisions set out
as notes under section 379g of this title, and amending provisions
set out as notes under sections 343 and 343-1 of this title] may be
cited as the 'Prescription Drug User Fee Act of 1992'."
Pub. L. 102-571, title II, Sec. 201, Oct. 29, 1992, 106 Stat.
4500, provided that: "This title [enacting provisions set out as
notes under sections 343 and 393 of this title and amending
provisions set out as notes under sections 343 and 343-1 of this
title] may be cited as the 'Dietary Supplement Act of 1992'."
Pub. L. 102-353, Sec. 1(a), Aug. 26, 1992, 106 Stat. 941,
provided that: "This Act [amending sections 333, 353, and 381 of
this title and enacting provisions set out as a note under section
353 of this title] may be cited as the 'Prescription Drug
Amendments of 1992'."
Pub. L. 102-300, Sec. 1(a), June 16, 1992, 106 Stat. 238,
provided that: "This Act [amending sections 321, 331, 334, 346a,
352, 353, 356, 357, 360c, 360d, 360g to 360i, 360l, 360mm, 371 to
372a, 376, and 381 of this title and section 262 of Title 42, The
Public Health and Welfare and enacting and amending provisions set
out as notes under section 360i of this title] may be cited as the
'Medical Device Amendments of 1992'."
Pub. L. 102-282, Sec. 1(a), May 13, 1992, 106 Stat. 149, provided
that: "This Act [enacting sections 335a to 335c of this title,
amending sections 321, 336, 337, and 355 of this title, and
enacting provisions set out as notes under section 335a of this
title] may be cited as the 'Generic Drug Enforcement Act of 1992'."
SHORT TITLE OF 1990 AMENDMENTS
Pub. L. 101-635, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4583,
provided that: "This Act [enacting sections 379b to 379d and 394 of
this title] may be cited as the 'Food and Drug Administration
Revitalization Act'."
Pub. L. 101-629, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4511,
provided that: "This Act [enacting sections 360l and 383 of this
title, amending sections 321, 333, 351, 353, and 360c to 360j of
this title and sections 263b to 263n of Title 42, The Public Health
and Welfare, redesignating sections 263b to 263n of Title 42 as
sections 360gg to 360ss of this title, repealing section 263b of
Title 42, and enacting provisions set out as notes under sections
333, 360c, 360i, 360j, 360hh and 383 of this title] may be cited as
the 'Safe Medical Devices Act of 1990'."
Pub. L. 101-535, Sec. 1(a), Nov. 8, 1990, 104 Stat. 2353,
provided that: "This Act [enacting section 343-1 of this title,
amending sections 321, 337, 343, 345, and 371 of this title, and
enacting provisions set out as notes under sections 343 and 343-1
of this title] may be cited as the 'Nutrition Labeling and
Education Act of 1990'."
SHORT TITLE OF 1988 AMENDMENTS
Pub. L. 100-670, Sec. 1(a), Nov. 16, 1988, 102 Stat. 3971,
provided that: "This Act [amending sections 321, 353, and 360b of
this title, section 2201 of Title 28, Judiciary and Judicial
Procedure, and sections 156 and 271 of Title 35, Patents, and
enacting provisions set out as notes under section 360b of this
title] may be cited as the 'Generic Animal Drug and Patent Term
Restoration Act'."
Pub. L. 100-607, title V, Sec. 501, Nov. 4, 1988, 102 Stat. 3120,
provided that: "This title [enacting section 393 of this title,
amending sections 5315 and 5316 of Title 5, Government Organization
and Employees, and enacting provisions set out as notes under
section 393 of this title] may be cited as the 'Food and Drug
Administration Act of 1988'."
Pub. L. 100-293, Sec. 1(a), Apr. 22, 1988, 102 Stat. 95, provided
that: "This Act [amending sections 331, 333, 353, and 381 of this
title and enacting provisions set out as notes under section 353 of
this title] may be cited as the 'Prescription Drug Marketing Act of
1987'."
Pub. L. 100-290, Sec. 1, Apr. 18, 1988, 102 Stat. 90, provided
that: "This Act [amending sections 360bb and 360ee of this title,
enacting provisions set out as a note under section 360aa of this
title, and amending provisions set out as a note under section 236
of Title 42, The Public Health and Welfare] may be cited as the
'Orphan Drug Amendments of 1988'."
SHORT TITLE OF 1986 AMENDMENT
Pub. L. 99-660, title I, Sec. 101(a), Nov. 14, 1986, 100 Stat.
3743, provided that: "This title [enacting section 382 of this
title, amending sections 241 and 262 of Title 42, The Public Health
and Welfare, and enacting provisions set out as notes under section
333 of this title and section 262 of Title 42] may be cited as the
'Drug Export Amendments Act of 1986'."
SHORT TITLE OF 1985 AMENDMENT
Pub. L. 99-91, Sec. 1, Aug. 15, 1985, 99 Stat. 387, provided
that: "This Act [amending sections 360aa to 360cc, and 360ee of
this title, and sections 295g-1 and 6022 of Title 42, The Public
Health and Welfare, and enacting provisions set out as notes under
section 360aa of this title and section 236 of Title 42] may be
cited as the 'Orphan Drug Amendments of 1985'."
SHORT TITLE OF 1984 AMENDMENT
Pub. L. 98-417, Sec. 1, Sept. 24, 1984, 98 Stat. 1585, provided:
"That this Act [enacting section 156 of Title 35, Patents, amending
sections 355 and 360cc of this title, sections 68b, 68c, and 70b of
Title 15, Commerce and Trade, section 2201 of Title 28, Judiciary
and Judicial Procedure, and sections 271 and 282 of Title 35, and
enacting provisions set out as notes under section 355 of this
title and section 68b of Title 15] may be cited as the 'Drug Price
Competition and Patent Term Restoration Act of 1984'."
SHORT TITLE OF 1983 AMENDMENTS
Pub. L. 98-22, Sec. 1, Apr. 22, 1983, 97 Stat. 173, provided:
"That this Act [amending provisions set out as a note under section
348 of this title] may be cited as the 'Saccharin Study and
Labeling Act Amendment of 1983'."
Pub. L. 97-414, Sec. 1(a), Jan. 4, 1983, 96 Stat. 2049, provided
that: "This Act [enacting part B of subchapter V of chapter 9 of
this title, section 44H of Title 26, Internal Revenue Code, section
155 of Title 35, Patents, and sections 236, 255, and 298b-4 of
Title 42, The Public Health and Welfare, amending sections 1274,
1472, 2055, 2060, 2064, 2068, and 2080 of Title 15, Commerce and
Trade, section 904 of this title, sections 280C and 6096 of Title
26, and sections 209, 231, 242k, 242m, 243, 254c, 254j, 254m, 254o,
254p, 256, 294j, 295g-1, 295g-4, 295h, 295h-1a, 297-1, 300, 300a-1,
300a-3, 300b, 300e-1, 300m, 300n-5, 300q-2, 300u-5, 300w-3, 300x-1,
300x-4, 300y-11, 4577, and 4588 of Title 42, enacting provisions
set out as notes under section 360aa of this title, section 44H of
Title 26, and sections 241, 255, 287i, and 300x-1 of Title 42, and
repealing provisions set out as a note under section 300t-11 of
Title 42] may be cited as the 'Orphan Drug Act'."
SHORT TITLE OF 1981 AMENDMENT
Pub. L. 97-42, Sec. 1, Aug. 14, 1981, 95 Stat. 946, provided:
"That this Act [amending provisions set out as a note under section
348 of this title] may be cited as the 'Saccharin Study and
Labeling Act Amendment of 1981'."
SHORT TITLE OF 1980 AMENDMENT
Pub. L. 96-359, Sec. 1, Sept. 26, 1980, 94 Stat. 1190, provided:
"That this Act [enacting section 350a of this title, amending
sections 321, 331, 374, 830, 841 to 843, and 873 of this title, and
enacting a provision set out as a note under section 350a of this
title] may be cited as the 'Infant Formula Act of 1980'."
SHORT TITLE OF 1977 AMENDMENT
Pub. L. 95-203, Sec. 1, Nov. 23, 1977, 91 Stat. 1451, provided
that: "This Act [enacting section 343a of this title, amending
sections 321 and 343 of this title, enacting provisions set out as
notes under sections 343 and 348 of this title, and amending
provisions set out as notes under sections 218 and 289l-1 of Title
42, The Public Health and Welfare] may be cited as the 'Saccharin
Study and Labeling Act'."
SHORT TITLE OF 1976 AMENDMENT
Pub. L. 94-295, Sec. 1(a), May 28, 1976, 90 Stat. 539, provided
that: "This Act [enacting sections 360c to 360k, 379, and 379a of
this title and section 3512 of Title 42, The Public Health and
Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360,
374, 379e, and 381 of this title and section 55 of Title 15,
Commerce and Trade] may be cited as the 'Medical Device Amendments
of 1976'."
SHORT TITLE OF 1972 AMENDMENT
Pub. L. 92-387, Sec. 1, Aug. 16, 1972, 86 Stat. 559, provided
that: "This Act [amending sections 331, 335, and 360 of this title
and enacting provisions set out as notes under section 360 of this
title] may be cited as the 'Drug Listing Act of 1972'."
SHORT TITLE OF 1968 AMENDMENTS
Pub. L. 90-602, Sec. 1, Oct. 18, 1968, 82 Stat. 1173, provided
that: "This Act [enacting provisions now comprising part C (Secs.
360hh-360ss) of subchapter III of this chapter and provisions set
out as notes under section 360hh of this title] may be cited as the
'Radiation Control for Health and Safety Act of 1968'."
Pub. L. 90-399, Sec. 1, July 13, 1968, 82 Stat. 342, provided:
"That this Act [enacting section 360b of this title, amending
sections 321, 331, 342, 351, 352, 357, 381, and 392 of this title,
and enacting provisions set out as a note under section 360b of
this title] may be cited as the 'Animal Drug Amendments of 1968'."
SHORT TITLE OF 1965 AMENDMENT
Pub. L. 89-74, Sec. 1, July 15, 1965, 79 Stat. 226, provided:
"That this Act [amending sections 321, 331, 333, 334, 360, and 372
of this title and section 1114 of Title 18, Crimes and Criminal
Procedure, and enacting provisions set out as notes under sections
321 and 352 of this title] may be cited as the 'Drug Abuse Control
Amendments of 1965'."
SHORT TITLE OF 1962 AMENDMENT
Pub. L. 87-781, Sec. 1, Oct. 10, 1962, 76 Stat. 780, provided in
part that such Act [enacting sections 358 to 360 of this title,
amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372,
374, 379e, and 381 of this title, and enacting provisions set out
as notes under sections 321, 331, 332, 352, 355, 358, 360, and 374
of this title] may be cited as the 'Drug Amendments of 1962'."
SHORT TITLE OF 1960 AMENDMENT
Pub. L. 86-618, Sec. 1, July 12, 1960, 74 Stat. 397, provided:
"That this Act [amending sections 321, 331, 333, 342, 346, 351,
352, 361, 362, 371, and 379e of this title, repealing sections 354
and 364 of this title, and enacting notes set out under this
section] may be cited as the 'Color Additive Amendments of 1960'."
SHORT TITLE OF 1958 AMENDMENT
Pub. L. 85-929, Sec. 1, Sept. 6, 1958, 72 Stat. 1784, provided:
"That this Act [amending sections 321, 331, 342, 346, 348 of this
title and section 210 of Title 42, The Public Health and Welfare,
and enacting provisions set out as notes under sections 321, 342,
and 451 of this title] may be cited as the 'Food Additives
Amendment of 1958'."
SEVERABILITY
Pub. L. 110-85, title XI, Sec. 1105, Sept. 27, 2007, 121 Stat.
975, provided that: "If any provision of this Act [see Short Title
of 2007 Amendment note above], an amendment made [by] this Act, or
the application of such provision or amendment to any person or
circumstance is held to be unconstitutional, the remainder of this
Act, the amendments made by this Act, and the application of the
provisions of such to any person or circumstances shall not be
affected thereby."
HAZARDOUS SUBSTANCES
Federal Hazardous Substances Act as not modifying this chapter,
see Pub. L. 86-613, Sec. 18, July 12, 1960, 74 Stat. 380, set out
as an Effect Upon Federal and State Laws note under section 1261 of
Title 15, Commerce and Trade.
-End-
-CITE-
21 USC SUBCHAPTER II - DEFINITIONS 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
SUBCHAPTER II - DEFINITIONS
-End-
-CITE-
21 USC Sec. 321 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
Sec. 321. Definitions; generally
-STATUTE-
For the purposes of this chapter -
(a)(1) The term "State", except as used in the last sentence of
section 372(a) of this title, means any State or Territory of the
United States, the District of Columbia, and the Commonwealth of
Puerto Rico.
(2) The term "Territory" means any Territory or possession of the
United States, including the District of Columbia, and excluding
the Commonwealth of Puerto Rico and the Canal Zone.
(b) The term "interstate commerce" means (1) commerce between any
State or Territory and any place outside thereof, and (2) commerce
within the District of Columbia or within any other Territory not
organized with a legislative body.
(c) The term "Department" means Department of Health and Human
Services.
(d) The term "Secretary" means the Secretary of Health and Human
Services.
(e) The term "person" includes individual, partnership,
corporation, and association.
(f) The term "food" means (1) articles used for food or drink for
man or other animals, (2) chewing gum, and (3) articles used for
components of any such article.
(g)(1) The term "drug" means (A) articles recognized in the
official United States Pharmacopoeia, official Homoeopathic
Pharmacopoeia of the United States, or official National Formulary,
or any supplement to any of them; and (B) articles intended for use
in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals; and (C) articles (other than food)
intended to affect the structure or any function of the body of man
or other animals; and (D) articles intended for use as a component
of any article specified in clause (A), (B), or (C). A food or
dietary supplement for which a claim, subject to sections
343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)
and 343(r)(5)(D) of this title, is made in accordance with the
requirements of section 343(r) of this title is not a drug solely
because the label or the labeling contains such a claim. A food,
dietary ingredient, or dietary supplement for which a truthful and
not misleading statement is made in accordance with section
343(r)(6) of this title is not a drug under clause (C) solely
because the label or the labeling contains such a statement.
(2) The term "counterfeit drug" means a drug which, or the
container or labeling of which, without authorization, bears the
trademark, trade name, or other identifying mark, imprint, or
device, or any likeness thereof, of a drug manufacturer, processor,
packer, or distributor other than the person or persons who in fact
manufactured, processed, packed, or distributed such drug and which
thereby falsely purports or is represented to be the product of, or
to have been packed or distributed by, such other drug
manufacturer, processor, packer, or distributor.
(h) The term "device" (except when used in paragraph (n) of this
section and in sections 331(i), 343(f), 352(c), and 362(c) of this
title) means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related
article, including any component, part, or accessory, which is -
(1) recognized in the official National Formulary, or the
United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention
of disease, in man or other animals, or
(3) intended to affect the structure or any function of the
body of man or other animals, and
which does not achieve its primary intended purposes through
chemical action within or on the body of man or other animals and
which is not dependent upon being metabolized for the achievement
of its primary intended purposes.
(i) The term "cosmetic" means (1) articles intended to be rubbed,
poured, sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appearance,
and (2) articles intended for use as a component of any such
articles; except that such term shall not include soap.
(j) The term "official compendium" means the official United
States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the
United States, official National Formulary, or any supplement to
any of them.
(k) The term "label" means a display of written, printed, or
graphic matter upon the immediate container of any article; and a
requirement made by or under authority of this chapter that any
word, statement, or other information appear on the label shall not
be considered to be complied with unless such word, statement, or
other information also appears on the outside container or wrapper,
if any there be, of the retail package of such article, or is
easily legible through the outside container or wrapper.
(l) The term "immediate container" does not include package
liners.
(m) The term "labeling" means all labels and other written,
printed, or graphic matter (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.
(n) If an article is alleged to be misbranded because the
labeling or advertising is misleading, then in determining whether
the labeling or advertising is misleading there shall be taken into
account (among other things) not only representations made or
suggested by statement, word, design, device, or any combination
thereof, but also the extent to which the labeling or advertising
fails to reveal facts material in the light of such representations
or material with respect to consequences which may result from the
use of the article to which the labeling or advertising relates
under the conditions of use prescribed in the labeling or
advertising thereof or under such conditions of use as are
customary or usual.
(o) The representation of a drug, in its labeling, as an
antiseptic shall be considered to be a representation that it is a
germicide, except in the case of a drug purporting to be, or
represented as, an antiseptic for inhibitory use as a wet dressing,
ointment, dusting powder, or such other use as involves prolonged
contact with the body.
(p) The term "new drug" means -
(1) Any drug (except a new animal drug or an animal feed
bearing or containing a new animal drug) the composition of which
is such that such drug is not generally recognized, among experts
qualified by scientific training and experience to evaluate the
safety and effectiveness of drugs, as safe and effective for use
under the conditions prescribed, recommended, or suggested in the
labeling thereof, except that such a drug not so recognized shall
not be deemed to be a "new drug" if at any time prior to June 25,
1938, it was subject to the Food and Drugs Act of June 30, 1906,
as amended, and if at such time its labeling contained the same
representations concerning the conditions of its use; or
(2) Any drug (except a new animal drug or an animal feed
bearing or containing a new animal drug) the composition of which
is such that such drug, as a result of investigations to
determine its safety and effectiveness for use under such
conditions, has become so recognized, but which has not,
otherwise than in such investigations, been used to a material
extent or for a material time under such conditions.
(q)(1)(A) Except as provided in clause (B), the term "pesticide
chemical" means any substance that is a pesticide within the
meaning of the Federal Insecticide, Fungicide, and Rodenticide Act
[7 U.S.C. 136 et seq.], including all active and inert ingredients
of such pesticide. Notwithstanding any other provision of law, the
term "pesticide" within such meaning includes ethylene oxide and
propylene oxide when such substances are applied on food.
(B) In the case of the use, with respect to food, of a substance
described in clause (A) to prevent, destroy, repel, or mitigate
microorganisms (including bacteria, viruses, fungi, protozoa,
algae, and slime), the following applies for purposes of clause
(A):
(i) The definition in such clause for the term "pesticide
chemical" does not include the substance if the substance is
applied for such use on food, or the substance is included for
such use in water that comes into contact with the food, in the
preparing, packing, or holding of the food for commercial
purposes. The substance is not excluded under this subclause from
such definition if the substance is ethylene oxide or propylene
oxide, and is applied for such use on food. The substance is not
so excluded if the substance is applied for such use on a raw
agricultural commodity, or the substance is included for such use
in water that comes into contact with the commodity, as follows:
(I) The substance is applied in the field.
(II) The substance is applied at a treatment facility where
raw agricultural commodities are the only food treated, and the
treatment is in a manner that does not change the status of the
food as a raw agricultural commodity (including treatment
through washing, waxing, fumigating, and packing such
commodities in such manner).
(III) The substance is applied during the transportation of
such commodity between the field and such a treatment facility.
(ii) The definition in such clause for the term "pesticide
chemical" does not include the substance if the substance is a
food contact substance as defined in section 348(h)(6) of this
title, and any of the following circumstances exist: The
substance is included for such use in an object that has a food
contact surface but is not intended to have an ongoing effect on
any portion of the object; the substance is included for such use
in an object that has a food contact surface and is intended to
have an ongoing effect on a portion of the object but not on the
food contact surface; or the substance is included for such use
in or is applied for such use on food packaging (without regard
to whether the substance is intended to have an ongoing effect on
any portion of the packaging). The food contact substance is not
excluded under this subclause from such definition if any of the
following circumstances exist: The substance is applied for such
use on a semipermanent or permanent food contact surface (other
than being applied on food packaging); or the substance is
included for such use in an object that has a semipermanent or
permanent food contact surface (other than being included in food
packaging) and the substance is intended to have an ongoing
effect on the food contact surface.
With respect to the definition of the term "pesticide" that is
applicable to the Federal Insecticide, Fungicide, and Rodenticide
Act [7 U.S.C. 136 et seq.], this clause does not exclude any
substance from such definition.
(2) The term "pesticide chemical residue" means a residue in or
on raw agricultural commodity or processed food of -
(A) a pesticide chemical; or
(B) any other added substance that is present on or in the
commodity or food primarily as a result of the metabolism or
other degradation of a pesticide chemical.
(3) Notwithstanding subparagraphs (1) and (2), the Administrator
may by regulation except a substance from the definition of
"pesticide chemical" or "pesticide chemical residue" if -
(A) its occurrence as a residue on or in a raw agricultural
commodity or processed food is attributable primarily to natural
causes or to human activities not involving the use of any
substances for a pesticidal purpose in the production, storage,
processing, or transportation of any raw agricultural commodity
or processed food; and
(B) the Administrator, after consultation with the Secretary,
determines that the substance more appropriately should be
regulated under one or more provisions of this chapter other than
sections 342(a)(2)(B) and 346a of this title.
(r) The term "raw agricultural commodity" means any food in its
raw or natural state, including all fruits that are washed,
colored, or otherwise treated in their unpeeled natural form prior
to marketing.
(s) The term "food additive" means any substance the intended use
of which results or may reasonably be expected to result, directly
or indirectly, in its becoming a component or otherwise affecting
the characteristics of any food (including any substance intended
for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food; and
including any source of radiation intended for any such use), if
such substance is not generally recognized, among experts qualified
by scientific training and experience to evaluate its safety, as
having been adequately shown through scientific procedures (or, in
the case of a substance used in food prior to January 1, 1958,
through either scientific procedures or experience based on common
use in food) to be safe under the conditions of its intended use;
except that such term does not include -
(1) a pesticide chemical residue in or on a raw agricultural
commodity or processed food; or
(2) a pesticide chemical; or
(3) a color additive; or
(4) any substance used in accordance with a sanction or
approval granted prior to September 6, 1958, pursuant to this
chapter, the Poultry Products Inspection Act [21 U.S.C. 451 et
seq.] or the Meat Inspection Act of March 4, 1907, as amended and
extended [21 U.S.C. 601 et seq.];
(5) a new animal drug; or
(6) an ingredient described in paragraph (ff) in, or intended
for use in, a dietary supplement.
(t)(1) The term "color additive" means a material which -
(A) is a dye, pigment, or other substance made by a process of
synthesis or similar artifice, or extracted, isolated, or
otherwise derived, with or without intermediate or final change
of identity, from a vegetable, animal, mineral, or other source,
and
(B) when added or applied to a food, drug, or cosmetic, or to
the human body or any part thereof, is capable (alone or through
reaction with other substance) of imparting color thereto;
except that such term does not include any material which the
Secretary, by regulation, determines is used (or intended to be
used) solely for a purpose or purposes other than coloring.
(2) The term "color" includes black, white, and intermediate
grays.
(3) Nothing in subparagraph (1) of this paragraph shall be
construed to apply to any pesticide chemical, soil or plant
nutrient, or other agricultural chemical solely because of its
effect in aiding, retarding, or otherwise affecting, directly or
indirectly, the growth or other natural physiological processes of
produce of the soil and thereby affecting its color, whether before
or after harvest.
(u) The term "safe" as used in paragraph (s) of this section and
in sections 348, 360b, 360ccc, and 379e of this title, has
reference to the health of man or animal.
(v) The term "new animal drug" means any drug intended for use
for animals other than man, including any drug intended for use in
animal feed but not including such animal feed, -
(1) the composition of which is such that such drug is not
generally recognized, among experts qualified by scientific
training and experience to evaluate the safety and effectiveness
of animal drugs, as safe and effective for use under the
conditions prescribed, recommended, or suggested in the labeling
thereof; except that such a drug not so recognized shall not be
deemed to be a "new animal drug" if at any time prior to June 25,
1938, it was subject to the Food and Drug Act of June 30, 1906,
as amended, and if at such time its labeling contained the same
representations concerning the conditions of its use; or
(2) the composition of which is such that such drug, as a
result of investigations to determine its safety and
effectiveness for use under such conditions, has become so
recognized but which has not, otherwise than in such
investigations, been used to a material extent or for a material
time under such conditions.
Provided that any drug intended for minor use or use in a minor
species that is not the subject of a final regulation published by
the Secretary through notice and comment rulemaking finding that
the criteria of paragraphs (1) and (2) have not been met (or that
the exception to the criterion in paragraph (1) has been met) is a
new animal drug.
(w) The term "animal feed", as used in paragraph (w) (!1) of this
section, in section 360b of this title, and in provisions of this
chapter referring to such paragraph or section, means an article
which is intended for use for food for animals other than man and
which is intended for use as a substantial source of nutrients in
the diet of the animal, and is not limited to a mixture intended to
be the sole ration of the animal.
(x) The term "informal hearing" means a hearing which is not
subject to section 554, 556, or 557 of title 5 and which provides
for the following:
(1) The presiding officer in the hearing shall be designated by
the Secretary from officers and employees of the Department who
have not participated in any action of the Secretary which is the
subject of the hearing and who are not directly responsible to an
officer or employee of the Department who has participated in any
such action.
(2) Each party to the hearing shall have the right at all times
to be advised and accompanied by an attorney.
(3) Before the hearing, each party to the hearing shall be
given reasonable notice of the matters to be considered at the
hearing, including a comprehensive statement of the basis for the
action taken or proposed by the Secretary which is the subject of
the hearing and a general summary of the information which will
be presented by the Secretary at the hearing in support of such
action.
(4) At the hearing the parties to the hearing shall have the
right to hear a full and complete statement of the action of the
Secretary which is the subject of the hearing together with the
information and reasons supporting such action, to conduct
reasonable questioning, and to present any oral or written
information relevant to such action.
(5) The presiding officer in such hearing shall prepare a
written report of the hearing to which shall be attached all
written material presented at the hearing. The participants in
the hearing shall be given the opportunity to review and correct
or supplement the presiding officer's report of the hearing.
(6) The Secretary may require the hearing to be transcribed. A
party to the hearing shall have the right to have the hearing
transcribed at his expense. Any transcription of a hearing shall
be included in the presiding officer's report of the hearing.
(y) The term "saccharin" includes calcium saccharin, sodium
saccharin, and ammonium saccharin.
(z) The term "infant formula" means a food which purports to be
or is represented for special dietary use solely as a food for
infants by reason of its simulation of human milk or its
suitability as a complete or partial substitute for human milk.
(aa) The term "abbreviated drug application" means an application
submitted under section 355(j) of this title for the approval of a
drug that relies on the approved application of another drug with
the same active ingredient to establish safety and efficacy, and -
(1) in the case of section 335a of this title, includes a
supplement to such an application for a different or additional
use of the drug but does not include a supplement to such an
application for other than a different or additional use of the
drug, and
(2) in the case of sections 335b and 335c of this title,
includes any supplement to such an application.
(bb) The term "knowingly" or "knew" means that a person, with
respect to information -
(1) has actual knowledge of the information, or
(2) acts in deliberate ignorance or reckless disregard of the
truth or falsity of the information.
(cc) For purposes of section 335a of this title, the term "high
managerial agent" -
(1) means -
(A) an officer or director of a corporation or an
association,
(B) a partner of a partnership, or
(C) any employee or other agent of a corporation,
association, or partnership,
having duties such that the conduct of such officer, director,
partner, employee, or agent may fairly be assumed to represent
the policy of the corporation, association, or partnership, and
(2) includes persons having management responsibility for -
(A) submissions to the Food and Drug Administration regarding
the development or approval of any drug product,
(B) production, quality assurance, or quality control of any
drug product, or
(C) research and development of any drug product.
(dd) For purposes of sections 335a and 335b of this title, the
term "drug product" means a drug subject to regulation under
section 355, 360b, or 382 of this title or under section 262 of
title 42.
(ee) The term "Commissioner" means the Commissioner of Food and
Drugs.
(ff) The term "dietary supplement" -
(1) means a product (other than tobacco) intended to supplement
the diet that bears or contains one or more of the following
dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet
by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or
combination of any ingredient described in clause (A), (B),
(C), (D), or (E);
(2) means a product that -
(A)(i) is intended for ingestion in a form described in
section 350(c)(1)(B)(i) of this title; or
(ii) complies with section 350(c)(1)(B)(ii) of this title;
(B) is not represented for use as a conventional food or as a
sole item of a meal or the diet; and
(C) is labeled as a dietary supplement; and
(3) does -
(A) include an article that is approved as a new drug under
section 355 of this title or licensed as a biologic under
section 262 of title 42 and was, prior to such approval,
certification, or license, marketed as a dietary supplement or
as a food unless the Secretary has issued a regulation, after
notice and comment, finding that the article, when used as or
in a dietary supplement under the conditions of use and dosages
set forth in the labeling for such dietary supplement, is
unlawful under section 342(f) of this title; and
(B) not include -
(i) an article that is approved as a new drug under section
355 of this title, certified as an antibiotic under section
357 of this title, or licensed as a biologic under section
262 of title 42, or
(ii) an article authorized for investigation as a new drug,
antibiotic, or biological for which substantial clinical
investigations have been instituted and for which the
existence of such investigations has been made public,
which was not before such approval, certification, licensing, or
authorization marketed as a dietary supplement or as a food
unless the Secretary, in the Secretary's discretion, has issued a
regulation, after notice and comment, finding that the article
would be lawful under this chapter.(!2)
Except for purposes of paragraph (g) and section 350f of this
title, a dietary supplement shall be deemed to be a food within the
meaning of this chapter.
(gg) The term "processed food" means any food other than a raw
agricultural commodity and includes any raw agricultural commodity
that has been subject to processing, such as canning, cooking,
freezing, dehydration, or milling.
(hh) The term "Administrator" means the Administrator of the
United States Environmental Protection Agency.
(ii) The term "compounded positron emission tomography drug" -
(1) means a drug that -
(A) exhibits spontaneous disintegration of unstable nuclei by
the emission of positrons and is used for the purpose of
providing dual photon positron emission tomographic diagnostic
images; and
(B) has been compounded by or on the order of a practitioner
who is licensed by a State to compound or order compounding for
a drug described in subparagraph (A), and is compounded in
accordance with that State's law, for a patient or for
research, teaching, or quality control; and
(2) includes any nonradioactive reagent, reagent kit,
ingredient, nuclide generator, accelerator, target material,
electronic synthesizer, or other apparatus or computer program to
be used in the preparation of such a drug.
(jj) The term "antibiotic drug" means any drug (except drugs for
use in animals other than humans) composed wholly or partly of any
kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, bacitracin, or any other drug intended for human
use containing any quantity of any chemical substance which is
produced by a micro-organism and which has the capacity to inhibit
or destroy micro-organisms in dilute solution (including a
chemically synthesized equivalent of any such substance) or any
derivative thereof.
(kk) Priority supplement. - The term "priority supplement" means
a drug application referred to in section 101(4) of the Food and
Drug Administration Modernization Act of 1997 (111 Stat. 2298).
(ll)(1) The term "single-use device" means a device that is
intended for one use, or on a single patient during a single
procedure.
(2)(A) The term "reprocessed", with respect to a single-use
device, means an original device that has previously been used on a
patient and has been subjected to additional processing and
manufacturing for the purpose of an additional single use on a
patient. The subsequent processing and manufacture of a reprocessed
single-use device shall result in a device that is reprocessed
within the meaning of this definition.
(B) A single-use device that meets the definition under clause
(A) shall be considered a reprocessed device without regard to any
description of the device used by the manufacturer of the device or
other persons, including a description that uses the term
"recycled" rather than the term "reprocessed".
(3) The term "original device" means a new, unused single-use
device.
(mm)(1) The term "critical reprocessed single-use device" means a
reprocessed single-use device that is intended to contact normally
sterile tissue or body spaces during use.
(2) The term "semi-critical reprocessed single-use device" means
a reprocessed single-use device that is intended to contact intact
mucous membranes and not penetrate normally sterile areas of the
body.
(nn) The term "major species" means cattle, horses, swine,
chickens, turkeys, dogs, and cats, except that the Secretary may
add species to this definition by regulation.
(oo) The term "minor species" means animals other than humans
that are not major species.
(pp) The term "minor use" means the intended use of a drug in a
major species for an indication that occurs infrequently and in
only a small number of animals or in limited geographical areas and
in only a small number of animals annually.
(qq) The term "major food allergen" means any of the following:
(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean
shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g.,
almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
(2) A food ingredient that contains protein derived from a food
specified in paragraph (1), except the following:
(A) Any highly refined oil derived from a food specified in
paragraph (1) and any ingredient derived from such highly
refined oil.
(B) A food ingredient that is exempt under paragraph (6) or
(7) of section 343(w) of this title.
(rr)(1) The term "tobacco product" means any product made or
derived from tobacco that is intended for human consumption,
including any component, part, or accessory of a tobacco product
(except for raw materials other than tobacco used in manufacturing
a component, part, or accessory of a tobacco product).
(2) The term "tobacco product" does not mean an article that is a
drug under subsection (g)(1), a device under subsection (h), or a
combination product described in section 353(g) of this title.
(3) The products described in paragraph (2) shall be subject to
subchapter V of this chapter.
(4) A tobacco product shall not be marketed in combination with
any other article or product regulated under this chapter
(including a drug, biologic, food, cosmetic, medical device, or a
dietary supplement).
-SOURCE-
(June 25, 1938, ch. 675, Sec. 201, 52 Stat. 1040; July 22, 1954,
ch. 559, Sec. 1, 68 Stat. 511; Pub. L. 85-929, Sec. 2, Sept. 6,
1958, 72 Stat. 1784; Pub. L. 86-618, title I, Sec. 101, July 12,
1960, 74 Stat. 397; Pub. L. 87-781, title I, Sec. 102(a), title
III, Sec. 307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89-74,
Secs. 3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90-399,
Sec. 102, July 13, 1968, 82 Stat. 351; Pub. L. 90-639, Secs. 1,
4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91-513, title II,
Sec. 701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92-
516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94-278, title
V, Sec. 502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-295,
Sec. 3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L. 95-203,
Sec. 4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96-359, Sec. 3,
Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100-670, title I, Sec.
107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101-535, Sec.
5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101-629, Sec. 16(b),
Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-282, Sec. 6, May 13,
1992, 106 Stat. 161; Pub. L. 102-300, Sec. 6(a), (b), June 16,
1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(1), Oct.
29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 3(b), (dd)(1),
4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103-417, Secs.
3(a), (b), 10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104-
170, title IV, Sec. 402, Aug. 3, 1996, 110 Stat. 1513; Pub. L. 105-
115, title I, Secs. 121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111
Stat. 2320, 2325, 2327; Pub. L. 105-324, Sec. 2(a), (c), Oct. 30,
1998, 112 Stat. 3035, 3037; Pub. L. 107-109, Sec. 5(b)(1), Jan. 4,
2002, 115 Stat. 1413; Pub. L. 107-250, title III, Sec. 302(d), Oct.
26, 2002, 116 Stat. 1619; Pub. L. 108-282, title I, Sec. 102(b)(1),
(5)(A), (B), title II, Sec. 203(c)(1), Aug. 2, 2004, 118 Stat. 891,
902, 908; Pub. L. 110-85, title X, Sec. 1005(c), Sept. 27, 2007,
121 Stat. 968; Pub. L. 111-31, div. A, title I, Sec. 101(a), June
22, 2009, 123 Stat. 1783.)
-REFTEXT-
REFERENCES IN TEXT
The Food and Drugs Act of June 30, 1906, as amended, referred to
in par. (p)(1), and the Food and Drug Act of June 30, 1906, as
amended, referred to in par. (v)(1), is act June 30, 1906, ch.
3915, 34 Stat. 768, which was classified to subchapter I (Sec. 1 et
seq.) of chapter 1 of this title, was repealed (except for section
14a which was transferred to section 376 of this title) by act June
25, 1938, ch. 675, Sec. 1002(a), formerly Sec. 902(a), 52 Stat.
1059; renumbered Sec. 1002(a), Pub. L. 111-31, div. A, title I,
Sec. 101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by
this chapter.
The Federal Insecticide, Fungicide, and Rodenticide Act, referred
to in par. (q)(1), is act June 25, 1947, ch. 125, as amended
generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is
classified generally to subchapter II (Sec. 136 et seq.) of chapter
6 of Title 7, Agriculture. For complete classification of this Act
to the Code, see Short Title note set out under section 136 of
Title 7 and Tables.
The Poultry Products Inspection Act, referred to in par. (s)(4),
is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which
is classified generally to chapter 10 (Sec. 451 et seq.) of this
title. For complete classification of this Act to the Code, see
Short Title note set out under section 451 of this title and
Tables.
The Meat Inspection Act of March 4, 1907, as amended and
extended, referred to in par. (s)(4), is act Mar. 4, 1907, ch.
2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81
Stat. 584, which are classified generally to subchapters I to IV
(Sec. 601 et seq.) of chapter 12 of this title. For complete
classification of this Act to the Code, see Short Title note set
out under section 601 of this title and Tables.
Section 101(4) of the Food and Drug Administration Modernization
Act of 1997, referred to in par. (kk), is section 101(4) of Pub. L.
105-115, which is set out as a note under section 379g of this
title.
-MISC1-
AMENDMENTS
2009 - Par. (rr). Pub. L. 111-31 added par. (rr).
2007 - Par. (ff). Pub. L. 110-85 substituted "paragraph (g) and
section 350f of this title" for "paragraph (g)" in concluding
provisions.
2004-Par. (u). Pub. L. 108-282, Sec. 102(b)(5)(A), substituted
"360b, 360ccc" for "360b".
Par. (v). Pub. L. 108-282, Sec. 102(b)(5)(B), inserted concluding
provisions.
Pars. (nn) to (pp). Pub. L. 108-282, Sec. 102(b)(1), added pars.
(nn) to (pp).
Par. (qq). Pub. L. 108-282, Sec. 203(c)(1), added par. (qq).
2002 - Par. (kk). Pub. L. 107-109 added par. (kk).
Pars. (ll), (mm). Pub. L. 107-250 added pars. (ll) and (mm).
1998 - Par. (q)(1). Pub. L. 105-324, Sec. 2(a), added subpar. (1)
and struck out former subpar. (1) which read as follows: "The term
'pesticide chemical' means any substance that is a pesticide within
the meaning of the Federal Insecticide, Fungicide, and Rodenticide
Act, including all active and inert ingredients of such pesticide."
Par. (q)(3). Pub. L. 105-324, Sec. 2(c), substituted
"subparagraphs (1) and (2)" for "paragraphs (1) and (2)" in
introductory provisions.
1997 - Par. (aa). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
"or 357" after "section 355(j)".
Par. (dd). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out "357,"
after "section 355,".
Par. (ff)(3)(A). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out
", certified as an antibiotic under section 357 of this title,"
before "or licensed as a biologic".
Par. (ii). Pub. L. 105-115, Sec. 121(a), added par. (ii).
Par. (jj). Pub. L. 105-115, Sec. 125(e), added par. (jj).
1996 - Par. (q). Pub. L. 104-170, Sec. 402(a), amended par. (q)
generally. Prior to amendment, par. (q) read as follows: "The term
'pesticide chemical' means any substance which, alone, in chemical
combination or in formulation with one or more other substances, is
'a pesticide' within the meaning of the Federal Insecticide,
Fungicide, and Rodenticide Act as now in force or as hereafter
amended, and which is used in the production, storage, or
transportation of raw agricultural commodities."
Par. (s)(1), (2). Pub. L. 104-170, Sec. 402(b), amended subpars.
(1) and (2) generally. Prior to amendment, subpars. (1) and (2)
read as follows:
"(1) a pesticide chemical in or on a raw agricultural commodity;
or
"(2) a pesticide chemical to the extent that it is intended for
use or is used in the production, storage, or transportation of any
raw agricultural commodity; or".
Pars. (gg), (hh). Pub. L. 104-170, Sec. 402(c), added pars. (gg)
and (hh).
1994 - Par. (g)(1). Pub. L. 103-417, Sec. 10(a), amended last
sentence generally. Prior to amendment, last sentence read as
follows: "A food for which a claim, subject to sections
343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)
and 343(r)(5)(D) of this title, is made in accordance with the
requirements of section 343(r) of this title is not a drug under
clause (B) solely because the label or labeling contains such a
claim."
Par. (s)(6). Pub. L. 103-417, Sec. 3(b), added subpar. (6).
Par. (ff). Pub. L. 103-417, Sec. 3(a), added par. (ff).
1993 - Pars. (c), (d). Pub. L. 103-80, Sec. 3(dd)(1), substituted
"Health and Human Services" for "Agriculture".
Par. (h). Pub. L. 103-80, Sec. 4(b), amended directory language
of Pub. L. 102-300, Sec. 6(a)(1). See 1992 amendment note below.
Pars. (v) to (ff). Pub. L. 103-80, Sec. 3(b), redesignated pars.
(w) to (ff) as (v) to (ee), respectively.
1992 - Pars. (c), (d). Pub. L. 102-300, Sec. 6(b)(1), which
directed the substitution of "Health and Human Services" for
"Health, Education, and Welfare", could not be executed because
such words did not appear in the original statutory text. See 1993
Amendment note above and Transfer of Functions notes below.
Par. (h). Pub. L. 102-300, Sec. 6(a)(1), as amended by Pub. L.
103-80, Sec. 4(b), substituted "its primary" for "any of its
principal" in two places in concluding provisions.
Par. (u). Pub. L. 102-571 substituted "379e" for "376".
Par. (y)(1). Pub. L. 102-300, Sec. 6(b)(2), struck out "of
Health, Education, and Welfare" after "employees of the
Department".
Pars. (bb) to (ee). Pub. L. 102-282 added pars. (bb) to (ee).
Par. (ff). Pub. L. 102-300, Sec. 6(a)(2), added par. (ff).
1990 - Par. (g)(1). Pub. L. 101-629, Sec. 16(b)(1), struck out ";
but does not include devices or their components, parts, or
accessories" after "clause (A), (B), or (C)".
Pub. L. 101-535 inserted at end "A food for which a claim,
subject to sections 343(r)(1)(B) and 343(r)(3) of this title or
sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in
accordance with the requirements of section 343(r) of this title is
not a drug under clause (B) solely because the label or labeling
contains such a claim."
Par. (h)(3). Pub. L. 101-629, Sec. 16(b)(2), which directed the
amendment of subpar. (3) by substituting "its primary" for "any of
its principal", could not be executed because "any of its
principal" did not appear in subpar. (3).
1988 - Par. (w)(3). Pub. L. 100-670 struck out subpar. (3) which
read as follows: "which drug is composed wholly or partly of any
kind of penicillin, streptomycin, chlortetracycline,
chloramphenicol, or bacitracin, or any derivative thereof, except
when there is in effect a published order of the Secretary
declaring such drug not to be a new animal drug on the grounds that
(A) the requirement of certification of batches of such drug, as
provided for in section 360b(n) of this title, is not necessary to
insure that the objectives specified in paragraph (3) thereof are
achieved and (B) that neither subparagraph (1) nor (2) of this
paragraph (w) applies to such drug."
1980 - Par. (aa). Pub. L. 96-359 added par. (aa).
1977 - Par. (z). Pub. L. 95-203 added par. (z).
1976 - Par. (h). Pub. L. 94-295, Sec. 3(a)(1)(A), expanded
definition of "device" to include implements, machines, implants,
in vitro reagents, and other similar or related articles, added
recognition in the National Formulary or the United States
Pharmacopeia, or any supplement to the Formulary or Pharmacopeia,
to the enumeration of conditions under which a device may qualify
for inclusion under this chapter, and inserted requirements that a
device be one which does not achieve any of its principal intended
purposes through chemical action within or on the body of man or
other animals and which is not dependent upon being metabolized for
the achievement of any of its principal intended purposes.
Par. (n). Pub. L. 94-278 inserted "or advertising" after
"labeling" wherever appearing.
Par. (y). Pub. L. 94-295, Sec. 3(a)(2), added par. (y).
1972 - Par. (q). Pub. L. 92-516 substituted reference to
pesticide for reference to economic poison.
1970 - Par. (a)(2). Pub. L. 91-513, Sec. 701(g), struck out
reference to sections 321, 331(i), 331(p), 331(q), 332, 333, 334,
337, 360, 360a, 372, 373, 374, and 375 of this title as they apply
to depressant or stimulant drugs.
Par. (v). Pub. L. 91-513, Sec. 701(a), struck out par. (v) which
defined "depressant or stimulant drug".
1968 - Par. (a)(2). Pub. L. 90-639, Sec. 4(a), extended
provisions to cover depressant and stimulant drugs, the containers
thereof, and equipment used in manufacturing, compounding, or
processing such drugs, to the Canal Zone.
Par. (p). Pub. L. 90-399, Sec. 102(a), (b), inserted "(except a
new animal drug or an animal feed bearing or containing a new
animal drug)" after "Any drug" in subpars. (1) and (2),
respectively.
Par. (s)(5). Pub. L. 90-399, Sec. 102(c), added subpar. (5).
Par. (u). Pub. L. 90-399, Sec. 102(d), inserted reference to
section 360b of this title.
Par. (v)(3). Pub. L. 90-639, Sec. 1, inserted reference to
lysergic acid diethylamide.
Pars. (w), (x). Pub. L. 90-399, Sec. 102(e), added pars. (w) and
(x).
1965 - Par. (g). Pub. L. 89-74, Sec. 9(b), designated existing
provisions as subpar. (1), redesignated cls. (1) to (4) thereof as
(A) to (D), substituted "(A), (B), or (C)" for "(1), (2), or (3)"
and added subpar. (2).
Par. (v). Pub. L. 89-74, Sec. 3(a), added par. (v).
1962 - Par. (a). Pub. L. 87-781, Sec. 307(a), designated existing
provisions as subpar. (2), inserted "Commonwealth of Puerto Rico
and the", and added subpar. (1).
Par. (p)(1). Pub. L. 87-781, Sec. 102(a)(1), inserted "and
effectiveness" after "to evaluate the safety", and "and effective"
after "as safe".
Par. (p)(2). Pub. L. 87-781, Sec. 102(a)(2), inserted "and
effectiveness" after "safety".
1960 - Par. (s). Pub. L. 86-618, Sec. 101(a), excluded color
additives from definition of "food additive".
Par. (t). Pub. L. 86-618, Sec. 101(c), added par. (t). Former
par. (t) redesignated (u).
Par. (u). Pub. L. 86-618, Sec. 101(b), redesignated par. (t) as
(u) and inserted reference to section 376 of this title.
1958 - Pars. (s), (t). Pub. L. 85-929 added pars. (s) and (t).
1954 - Pars. (q), (r). Act July 22, 1954, added pars. (q) and
(r).
EFFECTIVE DATE OF 2004 AMENDMENT
Pub. L. 108-282, title II, Sec. 203(d), Aug. 2, 2004, 118 Stat.
908, provided that: "The amendments made by this section [amending
this section and sections 343 and 343-1 of this title] shall apply
to any food that is labeled on or after January 1, 2006."
EFFECTIVE DATE OF 1997 AMENDMENT
Section 501 of Pub. L. 105-115 provided that: "Except as
otherwise provided in this Act [see Short Title of 1997 Amendment
note set out under section 301 of this title], this Act and the
amendments made by this Act, other than the provisions of and the
amendments made by sections 111, 121, 125, and 307 [enacting
section 355a of this title, amending this section and sections 331,
335a, 351, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381,
and 382 of this title, section 45C of Title 26, Internal Revenue
Code, section 156 of Title 35, Patents, and section 8126 of Title
38, Veterans' Benefits, repealing sections 356 and 357 of this
title, and enacting provisions set out as notes under sections 351
and 355 of this title], shall take effect 90 days after the date of
enactment of this Act [Nov. 21, 1997]."
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101-535 effective six months after the date
of the promulgation of final regulations to implement section
343(r) of this title, or if such regulations are not promulgated,
the date proposed regulations are to be considered as such final
regulations (Nov. 8, 1992), with exception for persons marketing
food the brand name of which contains a term defined by the
Secretary under section 343(r)(2)(A)(i) of this title, see section
10(a) of Pub. L. 101-535, set out as a note under section 343 of
this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
1976, see section 502(c) of Pub. L. 94-278, set out as a note under
section 334 of this title.
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by Pub. L. 92-516 effective at the close of Oct. 21,
1972, except if regulations are necessary for the implementation of
any provision that becomes effective on Oct. 21, 1972, and
continuation in effect of subchapter I of chapter 6 of Title 7, and
regulations thereunder, relating to the control of economic
poisons, as in existence prior to Oct. 21, 1972, until superseded
by provisions of Pub. L. 92-516, and regulations thereunder, see
section 4 of Pub. L. 92-516, set out as an Effective Date note
under section 136 of Title 7, Agriculture.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
EFFECTIVE DATE OF 1968 AMENDMENTS; TRANSITIONAL PROVISIONS
Section 6 of Pub. L. 90-639 provided that: "The amendments made
by this Act [amending this section, sections 331, 333, 334, and
360a of this title, and provisions set out as a note under section
289a of Title 42, The Public Health and Welfare] shall apply only
with respect to violations of the Federal Food, Drug, and Cosmetic
Act [this chapter] committed after the date of the enactment of
this Act [Oct. 24, 1968]."
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, except that in the case of a
drug (other than one subject to section 360b(n) of this title)
intended for use in animals other than man which, on Oct. 9, 1962,
was commercially used or sold in the United States, was not a new
drug as defined in par. (p) of this section then in force, and was
not covered by an effective application under section 355 of this
title, the words "effectiveness" and "effective" contained in par.
(v) of this section not applicable to such drug when intended
solely for use under conditions prescribed, recommended, or
suggested in labeling with respect to such drug on that day, see
section 108(a), (b)(3) of Pub. L. 90-399, as amended, set out as an
Effective Date and Transitional Provisions note under section 360b
of this title.
EFFECTIVE DATE OF 1965 AMENDMENT
Section 11 of Pub. L. 89-74 provided that: "The foregoing
provisions of this Act [see Short Title of 1965 Amendment note set
out under section 301 of this title] shall take effect on the first
day of the seventh calendar month [Feb. 1, 1966] following the
month in which this Act is enacted [July 15, 1965]; except that (1)
the Secretary shall permit persons, owning or operating any
establishment engaged in manufacturing, preparing, propagating,
compounding, processing, wholesaling, jobbing, or distributing any
depressant or stimulant drug, as referred to in the amendments made
by section 4 of this Act to section 510 of the Federal Food, Drug,
and Cosmetic Act [section 360 of this title], to register their
name, places of business, and establishments, and other information
prescribed by such amendments, with the Secretary prior to such
effective date, and (2) sections 201(v) and 511(g) of the Federal
Food, Drug, and Cosmetic Act, as added by this act [par. (v) of
this section and par. (g) of section 360a of this title], and the
provisions of sections 8 [amending section 372 of this title and
section 1114 of Title 18, Crimes and Criminal Procedure] and 10
[set out as a note under this section] shall take effect upon the
date of enactment of this Act [July 15, 1965]."
EFFECTIVE DATE OF 1962 AMENDMENT
Section 107 of Pub. L. 87-781 provided that:
"(a) Except as otherwise provided in this section, the amendments
made by the foregoing sections of this part A [amending this
section and sections 331, 332, 348, 351 to 353, 355, 357, 379e of
this title, and enacting provisions set out as a note under section
355 of this title] shall take effect on the date of enactment of
this Act [Oct. 10, 1962].
"(b) The amendments made by sections 101, 103, 105, and 106 of
this part A [amending sections 331, 332, 351, 352, 355, and 357 of
this title] shall, with respect to any drug, take effect on the
first day of the seventh calendar month following the month in
which this Act is enacted [Oct. 1962].
"(c)(1) As used in this subsection, the term 'enactment date'
means the date of enactment of this Act; and the term 'basic Act'
means the Federal Food, Drug, and Cosmetic Act [this chapter].
"(2) An application filed pursuant to section 505(b) of the basic
Act [section 355(b) of this title] which was 'effective' within the
meaning of that Act on the day immediately preceding the enactment
date shall be deemed as of the enactment date, to be an application
'approved' by the Secretary within the meaning of the basic Act as
amended by this Act.
"(3) In the case of any drug with respect to which an application
filed under section 505(b) of the basic Act is deemed to be an
approved application on the enactment date by virtue of paragraph
(2) of this subsection -
"(A) the amendments made by this Act to section 201(p), and to
subsections (b) and (d) of section 505, of the basic Act [par.
(p) of this section, and subsecs. (b) and (d) of section 355 of
this title], insofar as such amendments relate to the
effectiveness of drugs, shall not, so long as approval of such
application is not withdrawn or suspended pursuant to section
505(e) of that Act [section 355(e) of this title], apply to such
drug when intended solely for use under conditions prescribed,
recommended, or suggested in labeling covered by such approved
application, but shall apply to any changed use, or conditions of
use, prescribed, recommended, or suggested in its labeling,
including such conditions of use as are the subject of an
amendment or supplement to such application pending on, or filed
after, the enactment date; and
"(B) clause (3) of the first sentence of section 505(e) of the
basic Act, as amended by this Act [section 355(e) of this title],
shall not apply to such drug when intended solely for use under
conditions prescribed, recommended, or suggested in labeling
covered by such approved application (except with respect to such
use, or conditions of use, as are the subject of an amendment or
supplement to such approved application, which amendment or
supplement has been approved after the enactment date under
section 505 of the basic Act as amended by this Act [section 355
of this title]) until whichever of the following first occurs:
(i) the expiration of the two-year period beginning with the
enactment date; (ii) the effective date of an order under section
505(e) of the basic Act [section 355(e) of this title], other
than clause (3) of the first sentence of such section 505(e)
[section 355(e) of this title], withdrawing or suspending the
approval of such application.
"(4) In the case of any drug which, on the day immediately
preceding the enactment date, (A) was commercially used or sold in
the United States, (B) was not a new drug as defined by section
201(p) of the basic Act as then in force [par. (p) of this
section], and (C) was not covered by an effective application under
section 505 of that Act [section 355 of this title], the amendments
to section 201(p) [par. (p) of this section] made by this Act shall
not apply to such drug when intended solely for use under
conditions prescribed, recommended, or suggested in labeling with
respect to such drug on that day."
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE OF 1958 AMENDMENT
Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
6(a) of Pub. L. 85-929, set out as a note under section 342 of this
title.
EFFECTIVE DATE OF 1954 AMENDMENT
For effective date of amendment by act July 22, 1954, see section
5 of that act, set out as a note under section 342 of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 102-282
Amendment by Pub. L. 102-282 not to preclude any other civil,
criminal, or administrative remedy provided under Federal or State
law, including any private right of action against any person for
the same action subject to any action or civil penalty under an
amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
282, set out as a note under section 335a of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Amendments by Pub. L. 101-535 not to be construed to alter
authority of Secretary of Health and Human Services and Secretary
of Agriculture under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.), see section 9 of Pub. L. 101-535, set out as a note under
section 343 of this title.
SAVINGS PROVISION
Section 702 of Pub. L. 91-513, as amended by Pub. L. 93-481, Sec.
2, Oct. 26, 1974, 88 Stat. 1455, provided that:
"(a) Prosecutions for any violation of law occurring prior to the
effective date [see Effective Date of 1970 Amendment note above] of
section 701 [repealing section 360a of this title, and amending
sections 321, 331, 333, 334, 360, 372, and 381 of this title,
sections 1114 and 1952 of Title 18, Crimes and Criminal Procedure,
and section 242 of Title 42, The Public Health and Welfare] shall
not be affected by the repeals or amendments made by such section,
or abated by reason thereof.
"(b) Civil seizures or forfeitures and injunctive proceedings
commenced prior to the effective date of section 701 shall not be
affected by the repeals or amendments made by such section, or
abated by reason thereof.
"(c) All administrative proceedings pending before the Bureau of
Narcotics and Dangerous Drugs [now the Drug Enforcement
Administration] on the date of enactment of this Act [Oct. 27,
1970] shall be continued and brought to final determination in
accord with laws and regulations in effect prior to such date of
enactment. Where a drug is finally determined under such
proceedings to be a depressant or stimulant drug, as defined in
section 201(v) of the Federal Food, Drug, and Cosmetic Act [par.
(v) of this section], such drug shall automatically be controlled
under this title [subchapter I of chapter 13 of this title] by the
Attorney General without further proceedings and listed in the
appropriate schedule after he has obtained the recommendation of
the Secretary. Any drug with respect to which such a final
determination has been made prior to the date of enactment of this
Act which is not listed in section 202 [section 812 of this title]
within schedules I through V shall automatically be controlled
under this title [subchapter I of chapter 13 of this title] by the
Attorney General without further proceedings, and be listed in the
appropriate schedule, after he has obtained the recommendations of
the Secretary.
"(d) Notwithstanding subsection (a) of this section or section
1103 [of Pub. L. 91-513, set out as a note under sections 171 to
174 of this title], section 4202 of title 18, United States Code,
shall apply to any individual convicted under any of the laws
repealed by this title or title III [subchapter I or subchapter II
of chapter 13 of this title] without regard to the terms of any
sentence imposed on such individual under such law."
-TRANS-
TRANSFER OF FUNCTIONS
Secretary and Department of Health, Education, and Welfare
redesignated Secretary and Department of Health and Human Services
by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
695, which is classified to section 3508(b) of Title 20, Education.
Functions of Secretary of Health, Education, and Welfare [now
Health and Human Services] under Federal Food, Drug, and Cosmetic
Act, to the extent such functions related to administration and
enforcement of the Poison Prevention Packaging Act of 1970 (15
U.S.C. 1471 et seq.), transferred to Consumer Product Safety
Commission by section 2079 of Title 15, Commerce and Trade.
Functions of Secretary of Health, Education, and Welfare [now
Health and Human Services] under Drug Abuse Control Amendments of
1965 [see Short Title of 1965 Amendment note set out under section
301 of this title] transferred to Attorney General except function
of regulating counterfeiting of those drugs which are not
"depressant or stimulant" drugs, see section 2 of Reorg. Plan No. 1
of 1968, set out in the Appendix to Title 5, Government
Organization and Employees.
Functions of Federal Security Administrator transferred to
Secretary of Health, Education, and Welfare and all agencies of
Federal Security Agency transferred to Department of Health,
Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953,
set out in the Appendix to Title 5, Government Organization and
Employees. Federal Security Agency and office of Administrator
abolished by section 8 of Reorg. Plan No. 1 of 1953.
Food and Drug Administration in Department of Agriculture and its
functions, except those functions relating to administration of
Insecticide Act of 1910 and Naval Stores Act, transferred to
Federal Security Agency, to be administered under direction and
supervision of Federal Security Administrator, by Reorg. Plan No.
IV of 1940, set out in the Appendix to Title 5.
-MISC2-
REGULATION OF TOBACCO
Section 422 of Pub. L. 105-115 provided that: "Nothing in this
Act [see Short Title of 1997 Amendment note set out under section
301 of this title] or the amendments made by this Act shall be
construed to affect the question of whether the Secretary of Health
and Human Services has any authority to regulate any tobacco
product, tobacco ingredient, or tobacco additive. Such authority,
if any, shall be exercised under the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 301 et seq.] as in effect on the day before
the date of the enactment of this Act [Nov. 21, 1997]."
CONGRESSIONAL FINDINGS RELATING TO PUB. L. 103-417
Section 2 of Pub. L. 103-417 provided that: "Congress finds that -
"(1) improving the health status of United States citizens
ranks at the top of the national priorities of the Federal
Government;
"(2) the importance of nutrition and the benefits of dietary
supplements to health promotion and disease prevention have been
documented increasingly in scientific studies;
"(3)(A) there is a link between the ingestion of certain
nutrients or dietary supplements and the prevention of chronic
diseases such as cancer, heart disease, and osteoporosis; and
"(B) clinical research has shown that several chronic diseases
can be prevented simply with a healthful diet, such as a diet
that is low in fat, saturated fat, cholesterol, and sodium, with
a high proportion of plant-based foods;
"(4) healthful diets may mitigate the need for expensive
medical procedures, such as coronary bypass surgery or
angioplasty;
"(5) preventive health measures, including education, good
nutrition, and appropriate use of safe nutritional supplements
will limit the incidence of chronic diseases, and reduce long-
term health care expenditures;
"(6)(A) promotion of good health and healthy lifestyles
improves and extends lives while reducing health care
expenditures; and
"(B) reduction in health care expenditures is of paramount
importance to the future of the country and the economic well-
being of the country;
"(7) there is a growing need for emphasis on the dissemination
of information linking nutrition and long-term good health;
"(8) consumers should be empowered to make choices about
preventive health care programs based on data from scientific
studies of health benefits related to particular dietary
supplements;
"(9) national surveys have revealed that almost 50 percent of
the 260,000,000 Americans regularly consume dietary supplements
of vitamins, minerals, or herbs as a means of improving their
nutrition;
"(10) studies indicate that consumers are placing increased
reliance on the use of nontraditional health care providers to
avoid the excessive costs of traditional medical services and to
obtain more holistic consideration of their needs;
"(11) the United States will spend over $1,000,000,000,000 on
health care in 1994, which is about 12 percent of the Gross
National Product of the United States, and this amount and
percentage will continue to increase unless significant efforts
are undertaken to reverse the increase;
"(12)(A) the nutritional supplement industry is an integral
part of the economy of the United States;
"(B) the industry consistently projects a positive trade
balance; and
"(C) the estimated 600 dietary supplement manufacturers in the
United States produce approximately 4,000 products, with total
annual sales of such products alone reaching at least
$4,000,000,000;
"(13) although the Federal Government should take swift action
against products that are unsafe or adulterated, the Federal
Government should not take any actions to impose unreasonable
regulatory barriers limiting or slowing the flow of safe products
and accurate information to consumers;
"(14) dietary supplements are safe within a broad range of
intake, and safety problems with the supplements are relatively
rare; and
"(15)(A) legislative action that protects the right of access
of consumers to safe dietary supplements is necessary in order to
promote wellness; and
"(B) a rational Federal framework must be established to
supersede the current ad hoc, patchwork regulatory policy on
dietary supplements."
DISSEMINATION OF INFORMATION REGARDING THE DANGERS OF DRUG ABUSE
Section 5 of Pub. L. 90-639 provided that: "It is the sense of
the Congress that, because of the inadequate knowledge on the part
of the people of the United States of the substantial adverse
effects of misuse of depressant and stimulant drugs, and of other
drugs liable to abuse, on the individual, his family, and the
community, the highest priority should be given to Federal programs
to disseminate information which may be used to educate the public,
particularly young persons, regarding the dangers of drug abuse."
CONGRESSIONAL FINDINGS AND DECLARATION OF POLICY
Section 2 of Pub. L. 89-74 provided that: "The Congress hereby
finds and declares that there is a widespread illicit traffic in
depressant and stimulant drugs moving in or otherwise affecting
interstate commerce; that the use of such drugs, when not under the
supervision of a licensed practitioner, often endangers safety on
the highways (without distinction of interstate and intrastate
traffic thereon) and otherwise has become a threat to the public
health and safety, making additional regulation of such drugs
necessary regardless of the intrastate or interstate origin of such
drugs; that in order to make regulation and protection of
interstate commerce in such drugs effective, regulation of
intrastate commerce is also necessary because, among other things,
such drugs, when held for illicit sale, often do not bear labeling
showing their place of origin and because in the form in which they
are so held or in which they are consumed a determination of their
place of origin is often extremely difficult or impossible; and
that regulation of interstate commerce without the regulation of
intrastate commerce in such drugs, as provided in this Act [see
Short Title of 1965 Amendment note set out under section 301 of
this title], would discriminate against and adversely affect
interstate commerce in such drugs."
EFFECT OF DRUG ABUSE CONTROL AMENDMENTS OF 1965 ON STATE LAWS
Section 10 of Pub. L. 89-74 provided that:
"(a) Nothing in this Act [enacting section 360a of this title,
amending sections 321, 331, 333, 334, 360, and 372 of this title
and section 1114 of Title 18, Crimes and Criminal Procedure, and
enacting provisions set out as notes under sections 321, 352, and
360a of this title] shall be construed as authorizing the
manufacture, compounding, processing, possession, sale, delivery,
or other disposal of any drug in any State in contravention of the
laws of such State.
"(b) No provision of this Act nor any amendment made by it shall
be construed as indicating an intent on the part of the Congress to
occupy the field in which such provision or amendment operates to
the exclusion of any State law on the same subject matter, unless
there is a direct and positive conflict between such provision or
amendment and such State law so that the two cannot be reconciled
or consistently stand together.
"(c) No amendment made by this Act shall be construed to prevent
the enforcement in the courts of any State of any statute of such
State prescribing any criminal penalty for any act made criminal by
any such amendment."
EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS
Section 202 of Pub. L. 87-781 provided that: "Nothing in the
amendments made by this Act [enacting sections 358 to 360, amending
sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e,
and 381 of this title, and enacting provisions set out as notes
under sections 321, 331, 332, 352, 355, 360, and 374 of this title]
to the Federal Food, Drug, and Cosmetic Act [this chapter] shall be
construed as invalidating any provision of State law which would be
valid in the absence of such amendments unless there is a direct
and positive conflict between such amendments and such provision of
State law."
-CROSS-
DEFINITIONS
Section 2 of Pub. L. 105-115 provided that: "In this Act [see
Short Title of 1997 Amendment note set out under section 301 of
this title], the terms 'drug', 'device', 'food', and 'dietary
supplement' have the meaning given such terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)."
-FOOTNOTE-
(!1) So in original. Probably should be paragraph "(v)".
(!2) So in original. Provision probably should be set flush with
subpar. (B).
-End-
-CITE-
21 USC Sec. 321a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
Sec. 321a. "Butter" defined
-STATUTE-
For the purposes of the Food and Drug Act of June 30, 1906
(Thirty-fourth Statutes at Large, page 768) "butter" shall be
understood to mean the food product usually known as butter, and
which is made exclusively from milk or cream, or both, with or
without common salt, and with or without additional coloring
matter, and containing not less than 80 per centum by weight of
milk fat, all tolerances having been allowed for.
-SOURCE-
(Mar. 4, 1923, ch. 268, 42 Stat. 1500.)
-REFTEXT-
REFERENCES IN TEXT
The Food and Drug Act of June 30, 1906, referred to in text, is
act June 30, 1906, ch. 3915, 34 Stat. 768, which was classified to
subchapter I (Sec. 1 et seq.) of chapter 1 of this title, was
repealed (except for section 14a which was transferred to section
376 of this title) by act June 25, 1938, ch. 675, Sec. 1002(a),
formerly Sec. 902(a), 52 Stat. 1059; renumbered Sec. 1002(a), Pub.
L. 111-31, div. A, title I, Sec. 101(b)(2), June 22, 2009, 123
Stat. 1784, and is covered by this chapter.
-COD-
CODIFICATION
Section, which was not enacted as part of the Federal Food, Drug,
and Cosmetic Act which comprises this chapter, was formerly
classified to section 6 of this title. Section 1002(a) of act June
25, 1938, set out as an Effective Date note under section 301 of
this title, provided that this section should remain in force and
effect and be applicable to the provisions of this chapter.
-End-
-CITE-
21 USC Sec. 321b 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
Sec. 321b. "Package" defined
-STATUTE-
The word "package" where it occurs the second and last time in
the act entitled "An act to amend section 8 of an act entitled, 'An
act for preventing the manufacture, sale, or transportation of
adulterated or misbranded or poisonous deleterious foods, drugs,
medicines, and liquors, and for regulating traffic therein, and for
other purposes,' " approved March 3, 1913, shall include and shall
be construed to include wrapped meats inclosed in papers or other
materials as prepared by the manufacturers thereof for sale.
-SOURCE-
(July 24, 1919, ch. 26, 41 Stat. 271.)
-REFTEXT-
REFERENCES IN TEXT
An act approved March 3, 1913, referred to in text, is act Mar.
3, 1913, ch. 117, 37 Stat. 732, which amended section 10 of this
title. For complete classification of this Act to the Code, see
Tables.
"An act for preventing the manufacture, sale, or transportation
of adulterated or misbranded or poisonous deleterious foods, drugs,
medicines, and liquors, and for regulating traffic therein, and for
other purposes", referred to in text, is act June 30, 1906, ch.
3915, 34 Stat. 768, which was classified to subchapter I (Sec. 1 et
seq.) of chapter 1 of this title, was repealed (except for section
14a which was transferred to section 376 of this title) by act June
25, 1938, ch. 675, Sec. 1002(a), formerly Sec. 902(a), 52 Stat.
1059; renumbered Sec. 1002(a), Pub. L. 111-31, div. A, title I,
Sec. 101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by
this chapter.
-COD-
CODIFICATION
Section, which was not enacted as part of the Federal Food, Drug,
and Cosmetic Act which comprises this chapter, was formerly
classified to the last sentence of paragraph third of section 10 of
this title. Section 1002(a) of act June 25, 1938, set out as an
Effective Date note under section 301 of this title, provided that
this section should remain in force and effect and be applicable to
the provisions of this chapter.
-End-
-CITE-
21 USC Sec. 321c 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
Sec. 321c. Nonfat dry milk; "milk" defined
-STATUTE-
For the purposes of the Federal Food, Drug, and Cosmetic Act of
June 26, 1938, (ch. 675, sec. 1, 52 Stat. 1040) [21 U.S.C. 301 et
seq.] nonfat dry milk is the product resulting from the removal of
fat and water from milk, and contains the lactose, milk proteins,
and milk minerals in the same relative proportions as in the fresh
milk from which made. It contains not over 5 per centum by weight
of moisture. The fat content is not over 1 1/2 per centum by
weight unless otherwise indicated.
The term "milk", when used herein, means sweet milk of cows.
-SOURCE-
(Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70
Stat. 486.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch.
675, sec. 1, 52 Stat. 1040), referred to in text, probably means
act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is
classified generally to this chapter (Sec. 301 et seq.). For
complete classification of this Act to the Code, see section 301 of
this title and Tables.
-COD-
CODIFICATION
Section was not enacted as a part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter, but was made applicable
thereto.
-MISC1-
AMENDMENTS
1956 - Act July 2, 1956, substituted "nonfat dry milk" for
"nonfat dry milk solids or defatted milk solids".
-End-
-CITE-
21 USC Sec. 321d 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER II - DEFINITIONS
-HEAD-
Sec. 321d. Market names for catfish and ginseng
-STATUTE-
(a) Catfish labeling
(1) In general
Notwithstanding any other provision of law, for purposes of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) -
(A) the term "catfish" may only be considered to be a common
or usual name (or part thereof) for fish classified within the
family Ictaluridae; and
(B) only labeling or advertising for fish classified within
that family may include the term "catfish".
(2) Omitted
(b) Ginseng labeling
(1) In general
Notwithstanding any other provision of law, for purposes of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) -
(A) the term "ginseng" may only be considered to be a common
or usual name (or part thereof) for any herb or herbal
ingredient derived from a plant classified within the genus
Panax; and
(B) only labeling or advertising for herbs or herbal
ingredients classified within that genus may include the term
"ginseng".
(2) Omitted
-SOURCE-
(Pub. L. 107-171, title X, Sec. 10806, May 13, 2002, 116 Stat.
526.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.
(a)(1), (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, as
amended, which is classified generally to this chapter. For
complete classification of this Act to the Code, see section 301 of
this title and Tables.
-COD-
CODIFICATION
Section is comprised of section 10806 of Pub. L. 107-171.
Subsecs. (a)(2) and (b)(2) of section 10806 of Pub. L. 107-171
amended section 343 of this title.
Section was enacted as part of the Farm Security and Rural
Investment Act of 2002, and not as part of Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
-End-
-CITE-
21 USC SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-End-
-CITE-
21 USC Sec. 331 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 331. Prohibited acts
-STATUTE-
The following acts and the causing thereof are prohibited:
(a) The introduction or delivery for introduction into interstate
commerce of any food, drug, device, tobacco product, or cosmetic
that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device,
tobacco product, or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device,
tobacco product, or cosmetic that is adulterated or misbranded, and
the delivery or proffered delivery thereof for pay or otherwise.
(d) The introduction or delivery for introduction into interstate
commerce of any article in violation of section 344, 350d, 355, or
360bbb-3 of this title.
(e) The refusal to permit access to or copying of any record as
required by section 350a, 350c, 350f(j), 350e, 354, 360bbb-3, 373,
374(a), 379aa, or 379aa-1 of this title; or the failure to
establish or maintain any record, or make any report, required
under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k),
360b(a)(4)(C), 360b(j), (l) or (m), 360ccc-1(i), 360e(f), 360i,
360bbb-3, 379aa, 379aa-1, 387i, or 387t of this title or the
refusal to permit access to or verification or copying of any such
required record; or the violation of any recordkeeping requirement
under section 2223 (!1) of this title (except when such violation
is committed by a farm).
(f) The refusal to permit entry or inspection as authorized by
section 374 of this title.
(g) The manufacture within any Territory of any food, drug,
device, tobacco product, or cosmetic that is adulterated or
misbranded.
(h) The giving of a guaranty or undertaking referred to in
section 333(c)(2) of this title, which guaranty or undertaking is
false, except by a person who relied upon a guaranty or undertaking
to the same effect signed by, and containing the name and address
of, the person residing in the United States from whom he received
in good faith the food, drug, device, tobacco product, or cosmetic;
or the giving of a guaranty or undertaking referred to in section
333(c)(3) of this title, which guaranty or undertaking is false.
(i)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp,
tag, label, or other identification device authorized or required
by regulations promulgated under the provisions of section 344 or
379e of this title.
(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing any punch, die, plate, stone, or
other thing designed to print, imprint, or reproduce the trademark,
trade name, or other identifying mark, imprint, or device of
another or any likeness of any of the foregoing upon any drug or
container or labeling thereof so as to render such drug a
counterfeit drug.
(3) The doing of any act which causes a drug to be a counterfeit
drug, or the sale or dispensing, or the holding for sale or
dispensing, of a counterfeit drug.
(j) The using by any person to his own advantage, or revealing,
other than to the Secretary or officers or employees of the
Department, or to the courts when relevant in any judicial
proceeding under this chapter, any information acquired under
authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c,
360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc-1, 360ccc-2,
374, 379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b) of
this title concerning any method or process which as a trade secret
is entitled to protection; or the violating of section 346a(i)(2)
of this title or any regulation issued under that section..(!2)
This paragraph does not authorize the withholding of information
from either House of Congress or from, to the extent of matter
within its jurisdiction, any committee or subcommittee of such
committee or any joint committee of Congress or any subcommittee of
such joint committee.
(k) The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the doing
of any other act with respect to, a food, drug, device, tobacco
product, or cosmetic, if such act is done while such article is
held for sale (whether or not the first sale) after shipment in
interstate commerce and results in such article being adulterated
or misbranded.
(l) Repealed. Pub. L. 105-115, title IV, Sec. 421, Nov. 21, 1997,
111 Stat. 2380.
(m) The sale or offering for sale of colored oleomargarine or
colored margarine, or the possession or serving of colored
oleomargarine or colored margarine in violation of subsections (b)
or (c) of section 347 of this title.
(n) The using, in labeling, advertising or other sales promotion
of any reference to any report or analysis furnished in compliance
with section 374 of this title.
(o) In the case of a prescription drug distributed or offered for
sale in interstate commerce, the failure of the manufacturer,
packer, or distributor thereof to maintain for transmittal, or to
transmit, to any practitioner licensed by applicable State law to
administer such drug who makes written request for information as
to such drug, true and correct copies of all printed matter which
is required to be included in any package in which that drug is
distributed or sold, or such other printed matter as is approved by
the Secretary. Nothing in this paragraph shall be construed to
exempt any person from any labeling requirement imposed by or under
other provisions of this chapter.
(p) The failure to register in accordance with section 360 or
387e of this title, the failure to provide any information required
by section 360(j), 360(k), 387e(i), or 387e(j) of this title, or
the failure to provide a notice required by section 360(j)(2) or
387e(i)(3) of this title.
(q)(1) The failure or refusal -
(A) to comply with any requirement prescribed under section
360h, 360j(g), 387c(b), 387g, 387h, or 387o of this title;
(B) to furnish any notification or other material or
information required by or under section 360i, 360j(g), 387d,
387i, or 387t of this title; or
(C) to comply with a requirement under section 360l or 387m of
this title.
(2) With respect to any device or tobacco product, the submission
of any report that is required by or under this chapter that is
false or misleading in any material respect.
(r) The movement of a device or tobacco product in violation of
an order under section 334(g) of this title or the removal or
alteration of any mark or label required by the order to identify
the device or tobacco product as detained.
(s) The failure to provide the notice required by section 350a(c)
or 350a(e) of this title, the failure to make the reports required
by section 350a(f)(1)(B) of this title, the failure to retain the
records required by section 350a(b)(4) of this title, or the
failure to meet the requirements prescribed under section
350a(f)(3) of this title.
(t) The importation of a drug in violation of section 381(d)(1)
of this title, the sale, purchase, or trade of a drug or drug
sample or the offer to sell, purchase, or trade a drug or drug
sample in violation of section 353(c) of this title, the sale,
purchase, or trade of a coupon, the offer to sell, purchase, or
trade such a coupon, or the counterfeiting of such a coupon in
violation of section 353(c)(2) of this title, the distribution of a
drug sample in violation of section 353(d) of this title or the
failure to otherwise comply with the requirements of section 353(d)
of this title, or the distribution of drugs in violation of section
353(e) of this title or the failure to otherwise comply with the
requirements of section 353(e) of this title.
(u) The failure to comply with any requirements of the provisions
of, or any regulations or orders of the Secretary, under section
360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this title.
(v) The introduction or delivery for introduction into interstate
commerce of a dietary supplement that is unsafe under section 350b
of this title.
(w) The making of a knowingly false statement in any statement,
certificate of analysis, record, or report required or requested
under section 381(d)(3) of this title; the failure to submit a
certificate of analysis as required under such section; the failure
to maintain records or to submit records or reports as required by
such section; the release into interstate commerce of any article
or portion thereof imported into the United States under such
section or any finished product made from such article or portion,
except for export in accordance with section 381(e) or 382 of this
title, or with section 262(h) of title 42; or the failure to so
export or to destroy such an article or portions thereof, or such a
finished product.
(x) The falsification of a declaration of conformity submitted
under section 360d(c) of this title or the failure or refusal to
provide data or information requested by the Secretary under
paragraph (3) of such section.
(y) In the case of a drug, device, or food -
(1) the submission of a report or recommendation by a person
accredited under section 360m of this title that is false or
misleading in any material respect;
(2) the disclosure by a person accredited under section 360m of
this title of confidential commercial information or any trade
secret without the express written consent of the person who
submitted such information or secret to such person; or
(3) the receipt by a person accredited under section 360m of
this title of a bribe in any form or the doing of any corrupt act
by such person associated with a responsibility delegated to such
person under this chapter.
(z) Omitted.
(aa) The importation of a prescription drug in violation of
section 384 of this title, the falsification of any record required
to be maintained or provided to the Secretary under such section,
or any other violation of regulations under such section.
(bb) The transfer of an article of food in violation of an order
under section 334(h) of this title, or the removal or alteration of
any mark or label required by the order to identify the article as
detained.
(cc) The importing or offering for import into the United States
of an article of food by, with the assistance of, or at the
direction of, a person debarred under section 335a(b)(3) of this
title.
(dd) The failure to register in accordance with section 350d of
this title.
(ee) The importing or offering for import into the United States
of an article of food in violation of the requirements under
section 381(m) of this title.
(ff) The importing or offering for import into the United States
of a drug or device with respect to which there is a failure to
comply with a request of the Secretary to submit to the Secretary a
statement under section 381(o) of this title.
(gg) The knowing failure to comply with paragraph (7)(E) of
section 374(g) of this title; the knowing inclusion by a person
accredited under paragraph (2) of such section of false information
in an inspection report under paragraph (7)(A) of such section; or
the knowing failure of such a person to include material facts in
such a report.
(hh) The failure by a shipper, carrier by motor vehicle or rail
vehicle, receiver, or any other person engaged in the
transportation of food to comply with the sanitary transportation
practices prescribed by the Secretary under section 350e of this
title.
(ii) The falsification of a report of a serious adverse event
submitted to a responsible person (as defined under section 379aa
or 379aa-1 of this title) or the falsification of a serious adverse
event report (as defined under section 379aa or 379aa-1 of this
title) submitted to the Secretary.
(jj)(1) The failure to submit the certification required by
section 282(j)(5)(B) of title 42, or knowingly submitting a false
certification under such section.
(2) The failure to submit clinical trial information required
under subsection (j) of section 282 of title 42.
(3) The submission of clinical trial information under subsection
(j) of section 282 of title 42 that is false or misleading in any
particular under paragraph (5)(D) of such subsection (j).
(kk) The dissemination of a television advertisement without
complying with section 353b of this title.
(ll) The introduction or delivery for introduction into
interstate commerce of any food to which has been added a drug
approved under section 355 of this title, a biological product
licensed under section 262 of title 42, or a drug or a biological
product for which substantial clinical investigations have been
instituted and for which the existence of such investigations has
been made public, unless -
(1) such drug or such biological product was marketed in food
before any approval of the drug under section 355 of this title,
before licensure of the biological product under such section 262
of title 42, and before any substantial clinical investigations
involving the drug or the biological product have been
instituted;
(2) the Secretary, in the Secretary's discretion, has issued a
regulation, after notice and comment, approving the use of such
drug or such biological product in the food;
(3) the use of the drug or the biological product in the food
is to enhance the safety of the food to which the drug or the
biological product is added or applied and not to have
independent biological or therapeutic effects on humans, and the
use is in conformity with -
(A) a regulation issued under section 348 of this title
prescribing conditions of safe use in food;
(B) a regulation listing or affirming conditions under which
the use of the drug or the biological product in food is
generally recognized as safe;
(C) the conditions of use identified in a notification to the
Secretary of a claim of exemption from the premarket approval
requirements for food additives based on the notifier's
determination that the use of the drug or the biological
product in food is generally recognized as safe, provided that
the Secretary has not questioned the general recognition of
safety determination in a letter to the notifier;
(D) a food contact substance notification that is effective
under section 348(h) of this title; or
(E) such drug or biological product had been marketed for
smoking cessation prior to September 27, 2007; or
(4) the drug is a new animal drug whose use is not unsafe under
section 360b of this title.
(mm) The failure to submit a report or provide a notification
required under section 350f(d) of this title.
(nn) The falsification of a report or notification required under
section 350f(d) of this title.
(oo) The sale of tobacco products in violation of a no-tobacco-
sale order issued under section 333(f) of this title.
(pp) The introduction or delivery for introduction into
interstate commerce of a tobacco product in violation of section
387k of this title.
(qq)(1) Forging, counterfeiting, simulating, or falsely
representing, or without proper authority using any mark, stamp
(including tax stamp), tag, label, or other identification device
upon any tobacco product or container or labeling thereof so as to
render such tobacco product a counterfeit tobacco product.
(2) Making, selling, disposing of, or keeping in possession,
control, or custody, or concealing any punch, die, plate, stone, or
other item that is designed to print, imprint, or reproduce the
trademark, trade name, or other identifying mark, imprint, or
device of another or any likeness of any of the foregoing upon any
tobacco product or container or labeling thereof so as to render
such tobacco product a counterfeit tobacco product.
(3) The doing of any act that causes a tobacco product to be a
counterfeit tobacco product, or the sale or dispensing, or the
holding for sale or dispensing, of a counterfeit tobacco product.
(rr) The charitable distribution of tobacco products.
(ss) The failure of a manufacturer or distributor to notify the
Attorney General and the Secretary of the Treasury of their
knowledge of tobacco products used in illicit trade.
(tt) Making any express or implied statement or representation
directed to consumers with respect to a tobacco product, in a label
or labeling or through the media or advertising, that either
conveys, or misleads or would mislead consumers into believing,
that -
(1) the product is approved by the Food and Drug
Administration;
(2) the Food and Drug Administration deems the product to be
safe for use by consumers;
(3) the product is endorsed by the Food and Drug Administration
for use by consumers; or
(4) the product is safe or less harmful by virtue of -
(A) its regulation or inspection by the Food and Drug
Administration; or
(B) its compliance with regulatory requirements set by the
Food and Drug Administration;
including any such statement or representation rendering the
product misbranded under section 387c of this title.
(uu) The operation of a facility that manufactures, processes,
packs, or holds food for sale in the United States if the owner,
operator, or agent in charge of such facility is not in compliance
with section 350g of this title.
(vv) The failure to comply with the requirements under section
350h of this title.
(ww) The failure to comply with section 350i of this title.
(xx) The refusal or failure to follow an order under section 350l
of this title.
(yy) The knowing and willful failure to comply with the
notification requirement under section 350f(h) of this title.
(zz) The importation or offering for importation of a food if the
importer (as defined in section 384a of this title) does not have
in place a foreign supplier verification program in compliance with
such section 384a of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 301, 52 Stat. 1042; Dec. 22, 1941,
ch. 613, Sec. 1, 55 Stat. 851; July 6, 1945, ch. 281, Sec. 1, 59
Stat. 463; Mar. 10, 1947, ch. 16, Sec. 1, 61 Stat. 11; June 24,
1948, ch. 613, Sec. 1, 62 Stat. 582; Mar. 16, 1950, ch. 61, Sec.
3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, Sec. 2, 67 Stat. 477;
Pub. L. 85-929, Sec. 5, Sept. 6, 1958, 72 Stat. 1788; Pub. L. 86-
618, title I, Secs. 104, 105(a), July 12, 1960, 74 Stat. 403; Pub.
L. 87-781, title I, Secs. 103(c), 104(e)(1), 106(c), 114(a), title
III, Sec. 304, Oct. 10, 1962, 76 Stat. 784, 785, 788, 791, 795;
Pub. L. 89-74, Secs. 5, 9(c), July 15, 1965, 79 Stat. 232, 235;
Pub. L. 90-399, Sec. 103, July 13, 1968, 82 Stat. 352; Pub. L. 90-
639, Sec. 2(b), Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91-513,
title II, Sec. 701(a), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 92-
387, Sec. 4(e), Aug. 16, 1972, 86 Stat. 562; Pub. L. 94-295, Secs.
3(b), 4(b)(1), 7(b), May 28, 1976, 90 Stat. 576, 580, 582; Pub. L.
96-359, Sec. 5, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 99-570,
title IV, Sec. 4014(b)(2), Oct. 27, 1986, 100 Stat. 3207-120; Pub.
L. 100-293, Sec. 7(a), Apr. 22, 1988, 102 Stat. 99; Pub. L. 101-
502, Sec. 5(j), Nov. 3, 1990, 104 Stat. 1289; Pub. L. 101-508,
title IV, Sec. 4755(c)(2), Nov. 5, 1990, 104 Stat. 1388-210; Pub.
L. 102-300, Sec. 3(a)(1), June 16, 1992, 106 Stat. 238; Pub. L. 102-
571, title I, Sec. 107(2), (3), Oct. 29, 1992, 106 Stat. 4499;
Pub. L. 103-80, Sec. 3(c), Aug. 13, 1993, 107 Stat. 775; Pub. L.
103-396, Sec. 2(b)(1), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 103-
417, Sec. 10(b), Oct. 25, 1994, 108 Stat. 4332; Pub. L. 104-134,
title II, Sec. 2103, Apr. 26, 1996, 110 Stat. 1321-319; Pub. L. 104-
170, title IV, Sec. 403, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 104-
250, Sec. 5(d), Oct. 9, 1996, 110 Stat. 3156; Pub. L. 105-115,
title I, Sec. 125(a)(2)(A), (C), (b)(2)(B), title II, Secs. 204(b),
210(c), title IV, Secs. 401(b), 421, Nov. 21, 1997, 111 Stat. 2325,
2336, 2345, 2364, 2380; Pub. L. 106-387, Sec. 1(a) [title VII, Sec.
745(d)(1)], Oct. 28, 2000, 114 Stat. 1549, 1549A-39; Pub. L. 107-
188, title III, Secs. 303(b), 304(d), 305(b), 306(c), 307(b),
321(b)(2), 322(b), June 12, 2002, 116 Stat. 664, 666, 668, 670,
672, 676, 677; Pub. L. 107-250, title II, Sec. 201(d), Oct. 26,
2002, 116 Stat. 1609; Pub. L. 108-136, div. A, title XVI, Sec.
1603(c), Nov. 24, 2003, 117 Stat. 1690; Pub. L. 108-173, title XI,
Sec. 1121(b)(1), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 108-214,
Sec. 2(b)(2)(A), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108-282,
title I, Sec. 102(b)(5)(C), (D), Aug. 2, 2004, 118 Stat. 902; Pub.
L. 109-59, title VII, Sec. 7202(d), (e), Aug. 10, 2005, 119 Stat.
1913; Pub. L. 109-462, Secs. 2(c), 3(b), 4(a), Dec. 22, 2006, 120
Stat. 3472, 3475; Pub. L. 110-85, title VIII, Sec. 801(b)(1), title
IX, Secs. 901(d)(1), 912(a), title X, Sec. 1005(d), Sept. 27, 2007,
121 Stat. 920, 939, 951, 968; Pub. L. 111-31, div. A, title I, Sec.
103(b), June 22, 2009, 123 Stat. 1833; Pub. L. 111-353, title I,
Secs. 102(d)(1), 103(e), 105(c), 106(d), title II, Secs. 204(j)(1),
206(d), 211(b), (c), title III, Sec. 301(b), Jan. 4, 2011, 124
Stat. 3889, 3898, 3904, 3906, 3937, 3943, 3953, 3954.)
-REFTEXT-
REFERENCES IN TEXT
Section 2223 of this title, referred to in par. (e), was in the
original "section 204 of the FDA Food Safety Modernization Act",
meaning section 204 of Pub. L. 111-353, which enacted section 2223
of this title and amended this section and section 381 of this
title.
-MISC1-
AMENDMENTS
2011 - Par. (d). Pub. L. 111-353, Sec. 102(d)(1), inserted
"350d," after "344,".
Par. (e). Pub. L. 111-353, Secs. 204(j)(1), 211(c), substituted
"350f(j)" for "350f(g)" and inserted before period at end "; or the
violation of any recordkeeping requirement under section 2223 of
this title (except when such violation is committed by a farm)".
Par. (uu). Pub. L. 111-353, Sec. 103(e), added par. (uu).
Par. (vv). Pub. L. 111-353, Sec. 105(c), added par. (vv).
Par. (ww). Pub. L. 111-353, Sec. 106(d), added par. (ww).
Par. (xx). Pub. L. 111-353, Sec. 206(d), added par. (xx).
Par. (yy). Pub. L. 111-353, Sec. 211(b), added par. (yy).
Par. (zz). Pub. L. 111-353, Sec. 301(b), added par. (zz).
2009 - Pars. (a) to (c). Pub. L. 111-31, Sec. 103(b)(1)-(3),
inserted "tobacco product," after "device,".
Par. (e). Pub. L. 111-31, Sec. 103(b)(4)(B), which directed
substitution of "379aa-1, 387i, or 387t of this title or the
refusal to permit access to" for "or 379aa-1 of this title or the
refusal to permit access to", was executed by making the
substitution for "or 379aa-1 of this title, or the refusal to
permit access to", to reflect the probable intent of Congress.
Pub. L. 111-31, Sec. 103(b)(4)(A), struck out period after
"360ccc-1(i)".
Pars. (g), (h). Pub. L. 111-31, Sec. 103(b)(5), (6), inserted
"tobacco product," after "device,".
Par. (j). Pub. L. 111-31, Sec. 103(b)(7), struck out period after
"360ccc-2" and substituted "379, 379e, 387d, 387e, 387f, 387g,
387h, 387i, or 387t(b)" for "379, or 379e".
Par. (k). Pub. L. 111-31, Sec. 103(b)(8), inserted "tobacco
product," after "device,".
Par. (p). Pub. L. 111-31, Sec. 103(b)(9), added par. (p) and
struck out former par. (p) which read as follows: "The failure to
register in accordance with section 360 of this title, the failure
to provide any information required by section 360(j) or 360(k) of
this title, or the failure to provide a notice required by section
360(j)(2) of this title."
Par. (q)(1). Pub. L. 111-31, Sec. 103(b)(10), added subpar. (1)
and struck out former subpar. (1) which read as follows: "The
failure or refusal to (A) comply with any requirement prescribed
under section 360h or 360j(g) of this title, (B) furnish any
notification or other material or information required by or under
section 360i or 360j(g) of this title, or (C) comply with a
requirement under section 360l of this title."
Par. (q)(2). Pub. L. 111-31, Sec. 103(b)(11), substituted "device
or tobacco product," for "device,".
Par. (r). Pub. L. 111-31, Sec. 103(b)(12), inserted "or tobacco
product" after "device" in two places.
Pars. (oo) to (tt). Pub. L. 111-31, Sec. 103(b)(13), added pars.
(oo) to (tt).
2007 - Par. (e). Pub. L. 110-85, Sec. 1005(d)(1), substituted
"350c, 350f(g)," for "350c," and "350c(b), 350f" for "350c(b)".
Par. (jj). Pub. L. 110-85, Sec. 801(b)(1), added par. (jj).
Par. (kk). Pub. L. 110-85, Sec. 901(d)(1), added par. (kk).
Par. (ll). Pub. L. 110-85, Sec. 912(a), added par. (ll).
Pars. (mm), (nn). Pub. L. 110-85, Sec. 1005(d)(2), added pars.
(mm) and (nn).
2006 - Par. (e). Pub. L. 109-462, Sec. 3(b), substituted "374(a),
379aa, or 379aa-1" for "374(a), or 379aa" and "360bbb-3, 379aa, or
379aa-1" for "360bbb-3, or 379aa".
Pub. L. 109-462, Sec. 2(c), substituted ", 374(a), or 379aa" for
", or 374(a)" and ", 360bbb-3, or 379aa" for ", or 360bbb-3".
Par. (ii). Pub. L. 109-462, Sec. 4(a), added par. (ii).
2005 - Par. (e). Pub. L. 109-59, Sec. 7202(d), inserted "350e,"
before "354," in two places.
Par. (hh). Pub. L. 109-59, Sec. 7202(e), added par. (hh).
2004 - Par. (e). Pub. L. 108-282, Sec. 102(b)(5)(C), which
directed the substitution of "360b(a)(4)(C), 360b (j), (l) or (m),
360ccc-1(i)." for "360b(a)(4)(C), 360b(j), (l) or (m)" was executed
by making the substitution for "360b(a)(4)(C), 360b(j), (l), or
(m)", to reflect the probable intent of Congress.
Par. (j). Pub. L. 108-282, Sec. 102(b)(5)(D), substituted "360j,
360ccc, 360ccc-1, 360ccc-2." for "360j".
Par. (gg). Pub. L. 108-214 amended par. (gg) generally. Prior to
amendment, text read as follows: "The knowing failure of a person
accredited under paragraph (2) of section 374(g) of this title to
comply with paragraph (7)(E) of such section; the knowing inclusion
by such a person of false information in an inspection report under
paragraph (7)(A) of such section; or the knowing failure of such a
person to include material facts in such a report."
2003 - Par. (d). Pub. L. 108-136 substituted "section 344, 355,
or 360bbb-3" for "section 344 or 355".
Par. (e). Pub. L. 108-136 inserted "360bbb-3," after "350c, 354,"
and substituted "360i, or 360bbb-3" for "or 360i".
Par. (aa). Pub. L. 108-173 substituted "prescription drug in
violation of section 384" for "covered product in violation of
section 384".
2002 - Par. (e). Pub. L. 107-188, Sec. 306(c)(1), substituted "by
section 350a, 350c, 354, 373, or 374(a) of this title" for "by
section 350a, 354, or 373 of this title" and "under section 350a,
350c(b)" for "under section 350a".
Par. (j). Pub. L. 107-188, Sec. 306(c)(2), inserted "350c," after
"350a,".
Par. (w). Pub. L. 107-188, Sec. 322(b), amended par. (w)
generally. Prior to amendment, par. (w) read as follows: "The
making of a knowingly false statement in any record or report
required or requested under subparagraph (A) or (B) of section
381(d)(3) of this title, the failure to submit or maintain records
as required by sections 381(d)(3)(A) and 381(d)(3)(B) of this
title, the release into interstate commerce of any article imported
into the United States under section 381(d)(3) of this title or any
finished product made from such article (except for export in
accordance with section 381(e) or 382 of this title or section
262(h) of title 42), or the failure to export or destroy any
component, part or accessory not incorporated into a drug,
biological product or device that will be exported in accordance
with section 381(e) or 382 of this title or section 262(h) of title
42."
Par. (bb). Pub. L. 107-188, Sec. 303(b), added par. (bb).
Par. (cc). Pub. L. 107-188, Sec. 304(d), added par. (cc).
Par. (dd). Pub. L. 107-188, Sec. 305(b), added par. (dd).
Par. (ee). Pub. L. 107-188, Sec. 307(b), added par. (ee).
Par. (ff). Pub. L. 107-188, Sec. 321(b)(2), added par. (ff).
Par. (gg). Pub. L. 107-250 added par. (gg).
2000 - Par. (aa). Pub. L. 106-387 added par. (aa).
1997 - Par. (e). Pub. L. 105-115, Sec. 125(b)(2)(B), struck out
"357(d) or (g)," after "355(i) or (k),".
Par. (i)(1). Pub. L. 105-115, Sec. 125(a)(2)(C), struck out ",
356, 357," before "or 379e of this title".
Par. (j). Pub. L. 105-115, Sec. 125(a)(2)(A), struck out "356,
357," before "360,".
Par. (l). Pub. L. 105-115, Sec. 421, struck out par. (l) which
read as follows: "The using, on the labeling of any drug or device
or in any advertising relating to such drug or device, of any
representation or suggestion that approval of an application with
respect to such drug or device is in effect under section 355,
360e, or 360j(g) of this title, as the case may be, or that such
drug or device complies with the provisions of such section."
Par. (x). Pub. L. 105-115, Sec. 204(b), added par. (x).
Par. (y). Pub. L. 105-115, Sec. 210(c), added par. (y).
Par. (z). Pub. L. 105-115, Sec. 401(b), temporarily added par.
(z) which related to dissemination of information in violation of
section 360aaa of this title. See Effective and Termination Dates
of 1997 Amendment note below.
1996 - Par. (e). Pub. L. 104-250 inserted ", 354," before "or 373
of this title" and "354," before "355(i) or (k)".
Par. (j). Pub. L. 104-170 inserted before period at end of first
sentence "; or the violating of section 346a(i)(2) of this title or
any regulation issued under that section."
Pars. (u) to (w). Pub. L. 104-134 redesignated par. (u) relating
to introduction into interstate commerce of unsafe dietary
supplement as (v) and added par. (w).
1994 - Par. (e). Pub. L. 103-396, Sec. 2(b)(1)(A), substituted
"357(d) or (g), 360b(a)(4)(C)," for "357(d) or (g),".
Par. (u). Pub. L. 103-417 added par. (u) relating to introduction
into interstate commerce of unsafe dietary supplement.
Pub. L. 103-396, Sec. 2(b)(1)(B), added par. (u) relating to
failure to comply with regulations or orders of Secretary.
1993 - Par. (j). Pub. L. 103-80, Sec. 3(c)(1), substituted "379,
or 379e" for "379e, or 379".
Par. (s). Pub. L. 103-80, Sec. 3(c)(2), substituted "350a(e)" for
"350a(d)".
1992 - Pars. (i)(1), (j). Pub. L. 102-571 substituted "379e" for
"376".
Par. (q)(1)(C). Pub. L. 102-300 added cl. (C).
1990 - Par. (e). Pub. L. 101-502 substituted "or (k)" for "or
(j)".
Par. (j). Pub. L. 101-508 inserted at end "This paragraph does
not authorize the withholding of information from either House of
Congress or from, to the extent of matter within its jurisdiction,
any committee or subcommittee of such committee or any joint
committee of Congress or any subcommittee of such joint committee."
1988 - Par. (t). Pub. L. 100-293 added par. (t).
1986 - Par. (s). Pub. L. 99-570 amended par. (s) generally. Prior
to amendment, par. (s) read as follows: "The failure to provide the
notice required by section 350a(b) or 350a(c), the failure to make
the reports required by section 350a(d)(1)(B), or the failure to
meet the requirements prescribed under section 350a(d)(2)."
1980 - Par. (e). Pub. L. 96-359, Sec. 5(b), inserted reference to
section 350a of this title in two places.
Par. (j). Pub. L. 96-359, Sec. 5(c), inserted reference to
section 350a of this title.
Par. (s). Pub. L. 96-359, Sec. 5(a), added par. (s).
1976 - Par. (e). Pub. L. 94-295, Sec. 3(b)(2), inserted
references to sections 360e(f) and 360i of this title.
Par. (j). Pub. L. 94-295, Sec. 3(b)(3), inserted references to
sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of
this title.
Par. (l). Pub. L. 94-295, Sec. 3(b)(4), substituted "drug or
device" for "drug" wherever appearing, and inserted references to
sections 360e and 360j(g) of this title.
Par. (p). Pub. L. 94-295, Sec. 4(b)(1), substituted "section
360(j) or 360(k) of this title," for "section 360(j) of this
title,".
Par. (q). Pub. L. 94-295, Sec. 3(b)(1), added par. (q).
Par. (r). Pub. L. 94-295, Sec. 7(b), added par. (r).
1972 - Par. (p). Pub. L. 92-387 added failure to provide
information required by section 360(j) of this title, and failure
to provide notice required by section 360(j)(2) of this title as
prohibited acts.
1970 - Par. (q). Pub. L. 91-513 struck out par. (q) which set out
penalties for illegal manufacture, sale, disposition, possession
and other traffic in stimulant and depressant drugs. See section
801 et seq. of this title.
1968 - Par. (e). Pub. L. 90-399, Sec. 103(1), struck out "or"
before "357(d) or (g)" and inserted ", or 360b(j), (l), or (m)"
after "357(d) or (g)". Amendment striking out "or" was executed as
described, notwithstanding directory language that "or" before
"357," be stricken out, to reflect the probable intent of Congress.
Par. (j). Pub. L. 90-399, Sec. 103(2), inserted reference to
section 360b of this title.
Par. (q). Pub. L. 90-639 divided cl. (3), which referred simply
to possession in violation of section 360a(c) of this title, into
subcls. (A) and (B) which refer, respectively, to possession in
violation of section 360a(c)(1) of this title and possession in
violation of section 360a(c)(2) of this title.
1965 - Par. (i). Pub. L. 89-74, Sec. 9(c), designated existing
provisions as subpar. (1) and added subpars. (2) and (3).
Par. (q). Pub. L. 89-74, Sec. 5, added par. (q).
1962 - Par. (e). Pub. L. 87-781, Secs. 103(c), 106(c), prohibited
the failure to establish or maintain any record, or make any
report, required under sections 355(i) or (j) and 507(d) or (g) of
this title, or the refusal to permit access to, or verification or
copying of, any such required record.
Par. (l). Pub. L. 87-781, Sec. 104(e)(1), inserted "approval of"
before "an application", and substituted "in effect" for
"effective".
Par. (o). Pub. L. 87-781, Sec. 114(a), added par. (o).
Par. (p). Pub. L. 87-781, Sec. 304, added par. (p).
1960 - Par. (i). Pub. L. 86-618, Sec. 105(a), struck out
references to sections 346(b), 354, and 364 of this title and
inserted reference to section 376 of this title.
Par. (j). Pub. L. 86-618, Sec. 104, inserted reference to section
376 of this title.
1958 - Par. (j). Pub. L. 85-929, inserted reference to section
348 of this title.
1953 - Par. (n). Act Aug. 7, 1953, added par. (n).
1950 - Par. (m). Act Mar. 16, 1950, added par. (m).
1948 - Par. (k). Act June 24, 1948, inserted "(whether or not the
first sale)" so as to make it clear that this subsection is not
limited to the case where the act occurs while the article is held
for the first sale after interstate shipment, and extended coverage
of subsection to acts which result in adulteration.
1947 - Par. (j). Act Mar. 10, 1947, inserted reference to
sections 356 and 357 of this title.
1945 - Par. (i). Act July 6, 1945, inserted reference to section
357 of this title.
1941 - Par. (i). Act Dec. 22, 1941, inserted reference to section
356 of this title.
EFFECTIVE DATE OF 2011 AMENDMENT
Amendment by section 103(e) of Pub. L. 111-353 effective 18
months after Jan. 4, 2011, and applicable to a small business (as
defined in the regulations promulgated under section 350g(n) of
this title) beginning on the date that is 6 months after the
effective date of such regulations and to a very small business (as
defined in such regulations) beginning on the date that is 18
months after the effective date of such regulations, see section
103(i) of Pub. L. 111-353, set out as an Effective Date note under
section 350g of this title.
Pub. L. 111-353, title III, Sec. 301(d), Jan. 4, 2011, 124 Stat.
3955, provided that: "The amendments made by this section [enacting
section 384a of this title and amending this section and section
381 of this title] shall take effect 2 years after the date of
enactment of this Act [Jan. 4, 2011]."
EFFECTIVE DATE OF 2007 AMENDMENT
Pub. L. 110-85, title IX, Sec. 909, Sept. 27, 2007, 121 Stat.
950, provided that:
"(a) Effective Date. - This subtitle [subtitle A (Secs. 901-909)
of title IX of Pub. L. 110-85, enacting sections 353b and 355-1 of
this title, amending this section, sections 333, 352, and 355 of
this title, and section 262 of Title 42, The Public Health and
Welfare, and enacting provisions set out as notes under sections
352, 355, and 355a of this title] takes effect 180 days after the
date of the enactment of this Act [Sept. 27, 2007].
"(b) Drugs Deemed to Have Risk Evaluation and Mitigation
Strategies. -
"(1) In general. - A drug that was approved before the
effective date of this Act [probably means "this subtitle", see
above] is, in accordance with paragraph (2), deemed to have in
effect an approved risk evaluation and mitigation strategy under
section 505-1 of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 355-1] (as added by section 901) (referred to in this
section as the 'Act') if there are in effect on the effective
date of this Act elements to assure safe use -
"(A) required under section 314.520 or section 601.42 of
title 21, Code of Federal Regulations; or
"(B) otherwise agreed to by the applicant and the Secretary
for such drug.
"(2) Elements of strategy; enforcement. - The approved risk
evaluation and mitigation strategy in effect for a drug under
paragraph (1) -
"(A) is deemed to consist of the timetable required under
section 505-1(d) and any additional elements under subsections
(e) and (f) of such section in effect for such drug on the
effective date of this Act; and
"(B) is subject to enforcement by the Secretary to the same
extent as any other risk evaluation and mitigation strategy
under section 505-1 of the Act, except that sections 303(f)(4)
and 502(y) and (z) of the Act [21 U.S.C. 333(f)(4), 352(y),
(z)] (as added by section 902) shall not apply to such strategy
before the Secretary has completed review of, and acted on, the
first assessment of such strategy under such section 505-1.
"(3) Submission. - Not later than 180 days after the effective
date of this Act, the holder of an approved application for which
a risk evaluation and mitigation strategy is deemed to be in
effect under paragraph (1) shall submit to the Secretary a
proposed risk evaluation and mitigation strategy. Such proposed
strategy is subject to section 505-1 of the Act as if included in
such application at the time of submission of the application to
the Secretary."
EFFECTIVE DATE OF 2006 AMENDMENT
Amendment by section 2(c) of Pub. L. 109-462 effective 1 year
after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109-462, set
out as a note under section 352 of this title.
Amendment by section 3(b) of Pub. L. 109-462 effective 1 year
after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109-462, set
out as a note under section 343 of this title.
Pub. L. 109-462, Sec. 4(b), Dec. 22, 2006, 120 Stat. 3475,
provided that: "The amendment made by this section [amending this
section] shall take effect 1 year after the date of enactment of
this Act [Dec. 22, 2006]."
EFFECTIVE DATE OF 2005 AMENDMENT
Pub. L. 109-59, title VII, Sec. 7204, Aug. 10, 2005, 119 Stat.
1914, provided that: "This subtitle [subtitle B (Secs. 7201-7204)
of title VII of Pub. L. 109-59, enacting section 350e of this
title, amending this section, sections 342 and 373 of this title,
and section 5701 of Title 49, Transportation, omitting sections
5702 to 5714 of Title 49, and enacting provisions set out as a note
under section 301 of this title] takes effect on October 1, 2005."
EFFECTIVE DATE OF 2002 AMENDMENT
Pub. L. 107-188, title III, Sec. 321(c), June 12, 2002, 116 Stat.
676, provided that: "The amendments made by this section [amending
this section and sections 360 and 381 of this title] take effect
upon the expiration of the 180-day period beginning on the date of
the enactment of this Act [June 12, 2002]."
Pub. L. 107-188, title III, Sec. 322(c), June 12, 2002, 116 Stat.
678, provided that: "The amendments made by this section [amending
this section and section 381 of this title] take effect upon the
expiration of the 90-day period beginning on the date of the
enactment of this Act [June 12, 2002]."
EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT
Amendment by sections 204, 210, and 421 of Pub. L. 105-115
effective 90 days after Nov. 21, 1997, except as otherwise
provided, see section 501 of Pub. L. 105-115, set out as a note
under section 321 of this title.
Amendment by section 401(b) of Pub. L. 105-115 effective 1 year
after Nov. 21, 1997, or upon Secretary's issuance of final
regulations pursuant to section 401(c) of Pub. L. 105-115,
whichever is sooner, and ceases to be effective Sept. 30, 2006, see
section 401(d), (e) of Pub. L. 105-115, set out as an Effective and
Termination Dates note under former section 360aaa of this title.
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by Pub. L. 103-396 effective upon adoption of final
regulations under section 2(c) of Pub. L. 103-396, set out as a
Regulations note under section 360b of this title, see section 2(d)
of Pub. L. 103-396, set out as a note under section 360b of this
title.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 4755(c)(2) of Pub. L. 101-508 provided that the amendment
made by that section is effective as if included in subtitle D of
title VI of the Omnibus Budget Reconciliation Act of 1989, Pub. L.
101-239, title VI, Secs. 6601, 6602, Dec. 19, 1989, 103 Stat. 2285,
see 42 U.S.C. 300aa-1 note, 300aa-10 note.
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-293 effective upon expiration of 90 days
after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out
as a note under section 353 of this title.
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by Pub. L. 92-387 effective on first day of sixth month
beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set
out as a note under section 360 of this title.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
EFFECTIVE DATE OF 1968 AMENDMENTS
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions
note under section 360b of this title.
Amendment by Pub. L. 90-639 applicable only with respect to
violations of this chapter committed after Oct. 24, 1968, see
section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
Amendments; Transitional Provisions note under section 321 of this
title.
EFFECTIVE DATE OF 1965 AMENDMENT
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
of Pub. L. 89-74, set out as a note under section 321 of this
title.
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by sections 103(c) and 106(c) of Pub. L. 87-781
effective on first day of seventh calendar month following Oct.
1962, and amendment by section 104(e)(1) of Pub. L. 87-781
effective Oct. 10, 1962, see section 107 of Pub. L. 87-781, set out
as a note under section 321 of this title.
Section 114(b) of Pub. L. 87-781 provided that: "This section
[amending this section] shall take effect on the first day of the
seventh calendar month following the month in which this Act is
enacted [October 1962]."
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE OF 1958 AMENDMENT
Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section
6(a) of Pub. L. 85-929, set out as a note under section 342 of this
title.
EFFECTIVE DATE OF 1950 AMENDMENT
Amendment by act Mar. 16, 1950, effective July 1, 1950, see
section 7 of that act, set out as an Effective Date note under
section 347 of this title.
REGULATIONS
Secretary of Health and Human Services to promulgate regulations
to implement amendments made by section 401 of Pub. L. 105-115 not
later than 1 year after Nov. 21, 1997, see section 401(c) of Pub.
L. 105-115, set out as a note under section 360aaa of this title.
SAVINGS PROVISION
Amendment by Pub. L. 91-513 not to affect or abate any
prosecutions for violation of law or any civil seizures or
forfeitures and injunctive proceedings commenced prior to the
effective date of such amendment, and all administrative
proceedings pending before the Bureau of Narcotics and Dangerous
Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
to be continued and brought to final determination in accord with
laws and regulations in effect prior to Oct. 27, 1970, see section
702 of Pub. L. 91-513, set out as a note under section 321 of this
title.
CONSTRUCTION OF 2011 AMENDMENT
Nothing in amendments by sections 103(e), 105(c), 106(d),
204(j)(1), 211(b), (c), and 301(b) of Pub. L. 111-353 to be
construed to apply to certain alcohol-related facilities, see
section 2206 of this title.
Nothing in amendments by Pub. L. 111-353 to be construed to alter
jurisdiction and authorities established under certain other Acts
or in a manner inconsistent with international agreements to which
the United States is a party, see sections 2251 and 2252 of this
title.
CONSTRUCTION OF 2009 AMENDMENTS
Pub. L. 111-31, div. A, title I, Sec. 103(p), June 22, 2009, 123
Stat. 1838, provided that: "Nothing in this section [amending this
section and sections 333, 334, 355, 360m, 372 to 374, 375, 379a,
381, 393, 399, and 679 of this title and enacting provisions set
out as notes under sections 333 and 387c of this title] is intended
or shall be construed to expand, contract, or otherwise modify or
amend the existing limitations on State government authority over
tribal restricted fee or trust lands."
CONSTRUCTION OF 2002 AMENDMENTS
Pub. L. 107-188, title III, Sec. 315, June 12, 2002, 116 Stat.
675, provided that: "Nothing in this title [enacting sections 350c,
350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319,
and 8320 of Title 7, Agriculture, and section 247b-20 of Title 42,
The Public Health and Welfare, amending this section, sections 334,
335a, 342, 343, 360, 372, 374, and 381 of this title, and section
43 of Title 18, Crimes and Criminal Procedure, and enacting
provisions set out as notes under this section and sections 341,
350c, 350d, and 381 of this title], or an amendment made by this
title, shall be construed to alter the jurisdiction between the
Secretaries of Agriculture and of Health and Human Services, under
applicable statutes and regulations."
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-FOOTNOTE-
(!1) See References in Text note below.
(!2) So in original.
-End-
-CITE-
21 USC Sec. 332 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 332. Injunction proceedings
-STATUTE-
(a) Jurisdiction of courts
The district courts of the United States and the United States
courts of the Territories shall have jurisdiction, for cause shown
(!1) to restrain violations of section 331 of this title, except
paragraphs (h), (i), and (j).
(b) Violation of injunction
In case of violation of an injunction or restraining order issued
under this section, which also constitutes a violation of this
chapter, trial shall be by the court, or, upon demand of the
accused, by a jury.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 302, 52 Stat. 1043; Pub. L. 87-781,
title I, Sec. 103(d), title II, Sec. 201(c), Oct. 10, 1962, 76
Stat. 784, 793; Pub. L. 103-80, Sec. 3(d), Aug. 13, 1993, 107 Stat.
775.)
-MISC1-
AMENDMENTS
1993 - Subsec. (a). Pub. L. 103-80, Sec. 3(d)(1), struck out ",
and subject to the provisions of section 17 (relating to notice to
opposite party) of the Act entitled 'An Act to supplement existing
laws against unlawful restraints and monopolies, and for other
purposes', approved October 15, 1914, as amended (U.S.C., 1934 ed.,
title 28, sec. 381)," after "for cause shown".
Subsec. (b). Pub. L. 103-80, Sec. 3(d)(2), struck out at end
"Such trial shall be conducted in accordance with the practice and
procedure applicable in the case of proceedings subject to the
provisions of section 22 of such Act of October 15, 1914, as
amended (U.S.C., 1934 ed., title 28, sec. 387)."
1962 - Subsec. (a). Pub. L. 87-781, Sec. 103(d), struck out
"(e)," after "paragraphs".
Pub. L. 87-781, Sec. 201(c), struck out "(f)," after
"paragraphs".
EFFECTIVE DATE OF 1962 AMENDMENT
Amendment by section 103(c) of Pub. L. 87-781 effective on first
day of seventh calendar month following October 1962, see section
107 of Pub. L. 87-781, set out as a note under section 321 of this
title.
Section 203 of title II of Pub. L. 87-781 provided that: "The
amendments made by this title [amending this section and section
374 of this title and enacting provisions set out as notes under
sections 321 and 374 of this title] shall take effect on the date
of enactment of this Act [Oct. 10, 1962]."
-FOOTNOTE-
(!1) So in original. Probably should be followed by a comma.
-End-
-CITE-
21 USC Sec. 333 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 333. Penalties
-STATUTE-
(a) Violation of section 331 of this title; second violation;
intent to defraud or mislead
(1) Any person who violates a provision of section 331 of this
title shall be imprisoned for not more than one year or fined not
more than $1,000, or both.
(2) Notwithstanding the provisions of paragraph (1) of this
section,(!1) if any person commits such a violation after a
conviction of him under this section has become final, or commits
such a violation with the intent to defraud or mislead, such person
shall be imprisoned for not more than three years or fined not more
than $10,000, or both.
(b) Prescription drug marketing violations
(1) Notwithstanding subsection (a) of this section, any person
who violates section 331(t) of this title by -
(A) knowingly importing a drug in violation of section
381(d)(1) of this title,
(B) knowingly selling, purchasing, or trading a drug or drug
sample or knowingly offering to sell, purchase, or trade a drug
or drug sample, in violation of section 353(c)(1) of this title,
(C) knowingly selling, purchasing, or trading a coupon,
knowingly offering to sell, purchase, or trade such a coupon, or
knowingly counterfeiting such a coupon, in violation of section
353(c)(2) of this title, or
(D) knowingly distributing drugs in violation of section
353(e)(2)(A) of this title,
shall be imprisoned for not more than 10 years or fined not more
than $250,000, or both.
(2) Any manufacturer or distributor who distributes drug samples
by means other than the mail or common carrier whose
representative, during the course of the representative's
employment or association with that manufacturer or distributor,
violated section 331(t) of this title because of a violation of
section 353(c)(1) of this title or violated any State law
prohibiting the sale, purchase, or trade of a drug sample subject
to section 353(b) of this title or the offer to sell, purchase, or
trade such a drug sample shall, upon conviction of the
representative for such violation, be subject to the following
civil penalties:
(A) A civil penalty of not more than $50,000 for each of the
first two such violations resulting in a conviction of any
representative of the manufacturer or distributor in any 10-year
period.
(B) A civil penalty of not more than $1,000,000 for each
violation resulting in a conviction of any representative after
the second conviction in any 10-year period.
For the purposes of this paragraph, multiple convictions of one or
more persons arising out of the same event or transaction, or a
related series of events or transactions, shall be considered as
one violation.
(3) Any manufacturer or distributor who violates section 331(t)
of this title because of a failure to make a report required by
section 353(d)(3)(E) of this title shall be subject to a civil
penalty of not more than $100,000.
(4)(A) If a manufacturer or distributor or any representative of
such manufacturer or distributor provides information leading to
the institution of a criminal proceeding against, and conviction
of, any representative of that manufacturer or distributor for a
violation of section 331(t) of this title because of a sale,
purchase, or trade or offer to purchase, sell, or trade a drug
sample in violation of section 353(c)(1) of this title or for a
violation of State law prohibiting the sale, purchase, or trade or
offer to sell, purchase, or trade a drug sample, the conviction of
such representative shall not be considered as a violation for
purposes of paragraph (2).
(B) If, in an action brought under paragraph (2) against a
manufacturer or distributor relating to the conviction of a
representative of such manufacturer or distributor for the sale,
purchase, or trade of a drug or the offer to sell, purchase, or
trade a drug, it is shown, by clear and convincing evidence -
(i) that the manufacturer or distributor conducted, before the
institution of a criminal proceeding against such representative
for the violation which resulted in such conviction, an
investigation of events or transactions which would have led to
the reporting of information leading to the institution of a
criminal proceeding against, and conviction of, such
representative for such purchase, sale, or trade or offer to
purchase, sell, or trade, or
(ii) that, except in the case of the conviction of a
representative employed in a supervisory function, despite
diligent implementation by the manufacturer or distributor of an
independent audit and security system designed to detect such a
violation, the manufacturer or distributor could not reasonably
have been expected to have detected such violation,
the conviction of such representative shall not be considered as a
conviction for purposes of paragraph (2).
(5) If a person provides information leading to the institution
of a criminal proceeding against, and conviction of, a person for a
violation of section 331(t) of this title because of the sale,
purchase, or trade of a drug sample or the offer to sell, purchase,
or trade a drug sample in violation of section 353(c)(1) of this
title, such person shall be entitled to one-half of the criminal
fine imposed and collected for such violation but not more than
$125,000.
(6) Notwithstanding subsection (a) of this section, any person
who is a manufacturer or importer of a prescription drug under
section 384(b) of this title and knowingly fails to comply with a
requirement of section 384(e) of this title that is applicable to
such manufacturer or importer, respectively, shall be imprisoned
for not more than 10 years or fined not more than $250,000, or
both.
(c) Exceptions in certain cases of good faith, etc.
No person shall be subject to the penalties of subsection (a)(1)
of this section, (1) for having received in interstate commerce any
article and delivered it or proffered delivery of it, if such
delivery or proffer was made in good faith, unless he refuses to
furnish on request of an officer or employee duly designated by the
Secretary the name and address of the person from whom he purchased
or received such article and copies of all documents, if any there
be, pertaining to the delivery of the article to him; or (2) for
having violated section 331(a) or (d) of this title, if he
establishes a guaranty or undertaking signed by, and containing the
name and address of, the person residing in the United States from
whom he received in good faith the article, to the effect, in case
of an alleged violation of section 331(a) of this title, that such
article is not adulterated or misbranded, within the meaning of
this chapter designating this chapter or to the effect, in case of
an alleged violation of section 331(d) of this title, that such
article is not an article which may not, under the provisions of
section 344 or 355 of this title, be introduced into interstate
commerce; or (3) for having violated section 331(a) of this title,
where the violation exists because the article is adulterated by
reason of containing a color additive not from a batch certified in
accordance with regulations promulgated by the Secretary under this
chapter, if such person establishes a guaranty or undertaking
signed by, and containing the name and address of, the manufacturer
of the color additive, to the effect that such color additive was
from a batch certified in accordance with the applicable
regulations promulgated by the Secretary under this chapter; or (4)
for having violated section 331(b), (c) or (k) of this title by
failure to comply with section 352(f) of this title in respect to
an article received in interstate commerce to which neither section
353(a) nor 353(b)(1) of this title is applicable, if the delivery
or proffered delivery was made in good faith and the labeling at
the time thereof contained the same directions for use and warning
statements as were contained in the labeling at the time of such
receipt of such article; or (5) for having violated section
331(i)(2) of this title if such person acted in good faith and had
no reason to believe that use of the punch, die, plate, stone, or
other thing involved would result in a drug being a counterfeit
drug, or for having violated section 331(i)(3) of this title if the
person doing the act or causing it to be done acted in good faith
and had no reason to believe that the drug was a counterfeit drug.
(d) Exceptions involving misbranded food
No person shall be subject to the penalties of subsection (a)(1)
of this section for a violation of section 331 of this title
involving misbranded food if the violation exists solely because
the food is misbranded under section 343(a)(2) of this title
because of its advertising.
(e) Prohibited distribution of human growth hormone
(1) Except as provided in paragraph (2), whoever knowingly
distributes, or possesses with intent to distribute, human growth
hormone for any use in humans other than the treatment of a disease
or other recognized medical condition, where such use has been
authorized by the Secretary of Health and Human Services under
section 355 of this title and pursuant to the order of a physician,
is guilty of an offense punishable by not more than 5 years in
prison, such fines as are authorized by title 18, or both.
(2) Whoever commits any offense set forth in paragraph (1) and
such offense involves an individual under 18 years of age is
punishable by not more than 10 years imprisonment, such fines as
are authorized by title 18, or both.
(3) Any conviction for a violation of paragraphs (1) and (2) of
this subsection shall be considered a felony violation of the
Controlled Substances Act [21 U.S.C. 801 et seq.] for the purposes
of forfeiture under section 413 of such Act [21 U.S.C. 853].
(4) As used in this subsection the term "human growth hormone"
means somatrem, somatropin, or an analogue of either of them.
(5) The Drug Enforcement Administration is authorized to
investigate offenses punishable by this subsection.
(f) Violations related to devices
(1)(A) Except as provided in subparagraph (B), any person who
violates a requirement of this chapter which relates to devices
shall be liable to the United States for a civil penalty in an
amount not to exceed $15,000 for each such violation, and not to
exceed $1,000,000 for all such violations adjudicated in a single
proceeding. For purposes of the preceding sentence, a person
accredited under paragraph (2) of section 374(g) of this title who
is substantially not in compliance with the standards of
accreditation under such section, or who poses a threat to public
health or fails to act in a manner that is consistent with the
purposes of such section, shall be considered to have violated a
requirement of this chapter that relates to devices.
(B) Subparagraph (A) shall not apply -
(i) to any person who violates the requirements of section
360i(a) or 360j(f) of this title unless such violation
constitutes (I) a significant or knowing departure from such
requirements, or (II) a risk to public health,
(ii) to any person who commits minor violations of section
360i(e) or 360i(g) of this title (only with respect to correction
reports) if such person demonstrates substantial compliance with
such section, or
(iii) to violations of section 351(a)(2)(A) of this title which
involve one or more devices which are not defective.
(2)(A) Any person who introduces into interstate commerce or
delivers for introduction into interstate commerce an article of
food that is adulterated within the meaning of section 342(a)(2)(B)
of this title or any person who does not comply with a recall order
under section 350l of this title shall be subject to a civil money
penalty of not more than $50,000 in the case of an individual and
$250,000 in the case of any other person for such introduction or
delivery, not to exceed $500,000 for all such violations
adjudicated in a single proceeding.
(B) This paragraph shall not apply to any person who grew the
article of food that is adulterated. If the Secretary assesses a
civil penalty against any person under this paragraph, the
Secretary may not use the criminal authorities under this section
to sanction such person for the introduction or delivery for
introduction into interstate commerce of the article of food that
is adulterated. If the Secretary assesses a civil penalty against
any person under this paragraph, the Secretary may not use the
seizure authorities of section 334 of this title or the injunction
authorities of section 332 of this title with respect to the
article of food that is adulterated.
(C) In a hearing to assess a civil penalty under this paragraph,
the presiding officer shall have the same authority with regard to
compelling testimony or production of documents as a presiding
officer has under section 346a(g)(2)(B) of this title. The third
sentence of paragraph (5)(A) shall not apply to any investigation
under this paragraph.
(3)(A) Any person who violates section 331(jj) of this title
shall be subject to a civil monetary penalty of not more than
$10,000 for all violations adjudicated in a single proceeding.
(B) If a violation of section 331(jj) of this title is not
corrected within the 30-day period following notification under
section 282(j)(5)(C)(ii) (!2) of title 42, the person shall, in
addition to any penalty under subparagraph (A), be subject to a
civil monetary penalty of not more than $10,000 for each day of the
violation after such period until the violation is corrected.
(4)(A) Any responsible person (as such term is used in section
355-1 of this title) that violates a requirement of section 355(o),
355(p), or 355-1 of this title shall be subject to a civil monetary
penalty of -
(i) not more than $250,000 per violation, and not to exceed
$1,000,000 for all such violations adjudicated in a single
proceeding; or
(ii) in the case of a violation that continues after the
Secretary provides written notice to the responsible person, the
responsible person shall be subject to a civil monetary penalty
of $250,000 for the first 30-day period (or any portion thereof)
that the responsible person continues to be in violation, and
such amount shall double for every 30-day period thereafter that
the violation continues, not to exceed $1,000,000 for any 30-day
period, and not to exceed $10,000,000 for all such violations
adjudicated in a single proceeding.
(B) In determining the amount of a civil penalty under
subparagraph (A)(ii), the Secretary shall take into consideration
whether the responsible person is making efforts toward correcting
the violation of the requirement of section 355(o), 355(p), or 355-
1 of this title for which the responsible person is subject to
such civil penalty.
(5)(A) A civil penalty under paragraph (1), (2), (3), (4), or (9)
shall be assessed, or a no-tobacco-sale order may be imposed, by
the Secretary by an order made on the record after opportunity for
a hearing provided in accordance with this subparagraph and section
554 of title 5. Before issuing such an order, the Secretary shall
give written notice to the person to be assessed a civil penalty,
or upon whom a no-tobacco-sale order is to be imposed, under such
order of the Secretary's proposal to issue such order and provide
such person an opportunity for a hearing on the order. In the
course of any investigation, the Secretary may issue subpoenas
requiring the attendance and testimony of witnesses and the
production of evidence that relates to the matter under
investigation.
(B) In determining the amount of a civil penalty, or the period
to be covered by a no-tobacco-sale order, the Secretary shall take
into account the nature, circumstances, extent, and gravity of the
violation or violations and, with respect to the violator, ability
to pay, effect on ability to continue to do business, any history
of prior such violations, the degree of culpability, and such other
matters as justice may require. A no-tobacco-sale order permanently
prohibiting an individual retail outlet from selling tobacco
products shall include provisions that allow the outlet, after a
specified period of time, to request that the Secretary compromise,
modify, or terminate the order.
(C) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed under
paragraph (1), (2), (3), (4), or (9). The amount of such penalty,
when finally determined, or the amount agreed upon in compromise,
may be deducted from any sums owing by the United States to the
person charged.
(D) The Secretary may compromise, modify, or terminate, with or
without conditions, any no-tobacco-sale order.
(6) Any person who requested, in accordance with paragraph
(5)(A), a hearing respecting the assessment of a civil penalty or
the imposition of a no-tobacco-sale order and who is aggrieved by
an order assessing a civil penalty or the imposition of a no-
tobacco-sale order may file a petition for judicial review of such
order with the United States Court of Appeals for the District of
Columbia Circuit or for any other circuit in which such person
resides or transacts business. Such a petition may only be filed
within the 60-day period beginning on the date the order making
such assessment was issued, or on which the no-tobacco-sale order
was imposed, as the case may be.
(7) If any person fails to pay an assessment of a civil penalty -
(A) after the order making the assessment becomes final, and if
such person does not file a petition for judicial review of the
order in accordance with paragraph (6), or
(B) after a court in an action brought under paragraph (6) has
entered a final judgment in favor of the Secretary,
the Attorney General shall recover the amount assessed (plus
interest at currently prevailing rates from the date of the
expiration of the 60-day period referred to in paragraph (6) or the
date of such final judgment, as the case may be) in an action
brought in any appropriate district court of the United States. In
such an action, the validity, amount, and appropriateness of such
penalty shall not be subject to review.
(8) If the Secretary finds that a person has committed repeated
violations of restrictions promulgated under section 387f(d) of
this title at a particular retail outlet then the Secretary may
impose a no-tobacco-sale order on that person prohibiting the sale
of tobacco products in that outlet. A no-tobacco-sale order may be
imposed with a civil penalty under paragraph (1). Prior to the
entry of a no-sale order under this paragraph, a person shall be
entitled to a hearing pursuant to the procedures established
through regulations of the Food and Drug Administration for
assessing civil money penalties, including at a retailer's request
a hearing by telephone, or at the nearest regional or field office
of the Food and Drug Administration, or at a Federal, State, or
county facility within 100 miles from the location of the retail
outlet, if such a facility is available.
(9) Civil Monetary Penalties for Violation of Tobacco Product
Requirements. -
(A) In general. - Subject to subparagraph (B), any person who
violates a requirement of this chapter which relates to tobacco
products shall be liable to the United States for a civil penalty
in an amount not to exceed $15,000 for each such violation, and
not to exceed $1,000,000 for all such violations adjudicated in a
single proceeding.
(B) Enhanced penalties. -
(i) Any person who intentionally violates a requirement of
section 387b(5), 387b(6), 387d, 387h(c), or 387k(a) of this
title, shall be subject to a civil monetary penalty of -
(I) not to exceed $250,000 per violation, and not to exceed
$1,000,000 for all such violations adjudicated in a single
proceeding; or
(II) in the case of a violation that continues after the
Secretary provides written notice to such person, $250,000
for the first 30-day period (or any portion thereof) that the
person continues to be in violation, and such amount shall
double for every 30-day period thereafter that the violation
continues, not to exceed $1,000,000 for any 30-day period,
and not to exceed $10,000,000 for all such violations
adjudicated in a single proceeding.
(ii) Any person who violates a requirement of section
387k(g)(2)(C)(ii) or 387k(i)(1) of this title, shall be subject
to a civil monetary penalty of -
(I) not to exceed $250,000 per violation, and not to exceed
$1,000,000 for all such violations adjudicated in a single
proceeding; or
(II) in the case of a violation that continues after the
Secretary provides written notice to such person, $250,000
for the first 30-day period (or any portion thereof) that the
person continues to be in violation, and such amount shall
double for every 30-day period thereafter that the violation
continues, not to exceed $1,000,000 for any 30-day period,
and not to exceed $10,000,000 for all such violations
adjudicated in a single proceeding.
(iii) In determining the amount of a civil penalty under
clause (i)(II) or (ii)(II), the Secretary shall take into
consideration whether the person is making efforts toward
correcting the violation of the requirements of the section for
which such person is subject to such civil penalty.
(g) Violations regarding direct-to-consumer advertising
(1) With respect to a person who is a holder of an approved
application under section 355 of this title for a drug subject to
section 353(b) of this title or under section 262 of title 42, any
such person who disseminates or causes another party to disseminate
a direct-to-consumer advertisement that is false or misleading
shall be liable to the United States for a civil penalty in an
amount not to exceed $250,000 for the first such violation in any 3-
year period, and not to exceed $500,000 for each subsequent
violation in any 3-year period. No other civil monetary penalties
in this chapter (including the civil penalty in subsection (f)(4))
shall apply to a violation regarding direct-to-consumer
advertising. For purposes of this paragraph: (A) Repeated
dissemination of the same or similar advertisement prior to the
receipt of the written notice referred to in paragraph (2) for such
advertisements shall be considered one violation. (B) On and after
the date of the receipt of such a notice, all violations under this
paragraph occurring in a single day shall be considered one
violation. With respect to advertisements that appear in magazines
or other publications that are published less frequently than
daily, each issue date (whether weekly or monthly) shall be treated
as a single day for the purpose of calculating the number of
violations under this paragraph.
(2) A civil penalty under paragraph (1) shall be assessed by the
Secretary by an order made on the record after providing written
notice to the person to be assessed a civil penalty and an
opportunity for a hearing in accordance with this paragraph and
section 554 of title 5. If upon receipt of the written notice, the
person to be assessed a civil penalty objects and requests a
hearing, then in the course of any investigation related to such
hearing, the Secretary may issue subpoenas requiring the attendance
and testimony of witnesses and the production of evidence that
relates to the matter under investigation, including information
pertaining to the factors described in paragraph (3).
(3) The Secretary, in determining the amount of the civil penalty
under paragraph (1), shall take into account the nature,
circumstances, extent, and gravity of the violation or violations,
including the following factors:
(A) Whether the person submitted the advertisement or a similar
advertisement for review under section 379h-1 of this title.
(B) Whether the person submitted the advertisement for review
if required under section 353b of this title.
(C) Whether, after submission of the advertisement as described
in subparagraph (A) or (B), the person disseminated or caused
another party to disseminate the advertisement before the end of
the 45-day comment period.
(D) Whether the person incorporated any comments made by the
Secretary with regard to the advertisement into the advertisement
prior to its dissemination.
(E) Whether the person ceased distribution of the advertisement
upon receipt of the written notice referred to in paragraph (2)
for such advertisement.
(F) Whether the person had the advertisement reviewed by
qualified medical, regulatory, and legal reviewers prior to its
dissemination.
(G) Whether the violations were material.
(H) Whether the person who created the advertisement or caused
the advertisement to be created acted in good faith.
(I) Whether the person who created the advertisement or caused
the advertisement to be created has been assessed a civil penalty
under this provision within the previous 1-year period.
(J) The scope and extent of any voluntary, subsequent remedial
action by the person.
(K) Such other matters, as justice may require.
(4)(A) Subject to subparagraph (B), no person shall be required
to pay a civil penalty under paragraph (1) if the person submitted
the advertisement to the Secretary and disseminated or caused
another party to disseminate such advertisement after incorporating
each comment received from the Secretary.
(B) The Secretary may retract or modify any prior comments the
Secretary has provided to an advertisement submitted to the
Secretary based on new information or changed circumstances, so
long as the Secretary provides written notice to the person of the
new views of the Secretary on the advertisement and provides a
reasonable time for modification or correction of the advertisement
prior to seeking any civil penalty under paragraph (1).
(5) The Secretary may compromise, modify, or remit, with or
without conditions, any civil penalty which may be assessed under
paragraph (1). The amount of such penalty, when finally determined,
or the amount charged upon in compromise, may be deducted from any
sums owed by the United States to the person charged.
(6) Any person who requested, in accordance with paragraph (2), a
hearing with respect to the assessment of a civil penalty and who
is aggrieved by an order assessing a civil penalty, may file a
petition for de novo judicial review of such order with the United
States Court of Appeals for the District of Columbia Circuit or for
any other circuit in which such person resides or transacts
business. Such a petition may only be filed within the 60-day
period beginning on the date the order making such assessments was
issued.
(7) If any person fails to pay an assessment of a civil penalty
under paragraph (1) -
(A) after the order making the assessment becomes final, and if
such person does not file a petition for judicial review of the
order in accordance with paragraph (6), or
(B) after a court in an action brought under paragraph (6) has
entered a final judgment in favor of the Secretary,
the Attorney General of the United States shall recover the amount
assessed (plus interest at currently prevailing rates from the date
of the expiration of the 60-day period referred to in paragraph (6)
or the date of such final judgment, as the case may be) in an
action brought in any appropriate district court of the United
States. In such an action, the validity, amount, and
appropriateness of such penalty shall not be subject to review.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 303, 52 Stat. 1043; Oct. 26, 1951,
ch. 578, Sec. 2, 65 Stat. 649; Pub. L. 86-618, title I, Sec.
105(b), July 12, 1960, 74 Stat. 403; Pub. L. 89-74, Secs. 7, 9(d),
July 15, 1965, 79 Stat. 233, 235; Pub. L. 90-639, Sec. 3, Oct. 24,
1968, 82 Stat. 1361; Pub. L. 91-513, title II, Sec. 701(b), Oct.
27, 1970, 84 Stat. 1281; Pub. L. 94-278, title V, Sec.
502(a)(2)(B), Apr. 22, 1976, 90 Stat. 411; Pub. L. 100-293, Sec.
7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100-690, title II, Sec.
2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101-629, Sec. 17(a),
Nov. 28, 1990, 104 Stat. 4526; Pub. L. 101-647, title XIX, Sec.
1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102-353, Sec. 3, Aug.
26, 1992, 106 Stat. 941; Pub. L. 103-80, Sec. 3(e), Aug. 13, 1993,
107 Stat. 775; Pub. L. 103-322, title XXXIII, Sec. 330015, Sept.
13, 1994, 108 Stat. 2146; Pub. L. 104-170, title IV, Sec. 407, Aug.
3, 1996, 110 Stat. 1535; Pub. L. 106-387, Sec. 1(a) [title VII,
Sec. 745(d)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A-40; Pub. L.
107-250, title II, Sec. 201(c), Oct. 26, 2002, 116 Stat. 1609; Pub.
L. 108-173, title XI, Sec. 1121(b)(2), Dec. 8, 2003, 117 Stat.
2469; Pub. L. 110-85, title II, Sec. 226(b), title VIII, Sec.
801(b)(2), title IX, Secs. 901(d)(4), 902(b), Sept. 27, 2007, 121
Stat. 854, 920, 940, 943; Pub. L. 111-31, div. A, title I, Sec.
103(c), June 22, 2009, 123 Stat. 1835; Pub. L. 111-353, title II,
Sec. 206(c), Jan. 4, 2011, 124 Stat. 3943.)
-REFTEXT-
REFERENCES IN TEXT
The Controlled Substances Act, referred to in subsec. (e)(3), is
title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, which is
classified principally to subchapter I (Sec. 801 et seq.) of
chapter 13 of this title. For complete classification of this Act
to the Code, see Short Title note set out under section 801 of this
title and Tables.
Section 282(j)(5)(C)(ii) of title 42, referred to in subsec.
(f)(3)(B), was in the original "section 402(j)(5)(C)(ii)", and was
translated as meaning section 402(j)(5)(C)(ii) of the Public Health
Service Act to reflect the probable intent of Congress because
there is no subsec. (j) of section 402 of the Federal Food, Drug,
and Cosmetic Act and section 402(j)(5)(C)(ii) of the Public Health
Service Act relates to notification of noncompliance with clinical
trial information requirements.
-MISC1-
AMENDMENTS
2011 - Subsec. (f)(2)(A). Pub. L. 111-353 inserted "or any person
who does not comply with a recall order under section 350l of this
title" after "section 342(a)(2)(B) of this title".
2009 - Subsec. (f)(5)(A). Pub. L. 111-31, Sec. 103(c)(1)(A), (B),
substituted "paragraph (1), (2), (3), (4), or (9)" for "paragraph
(1), (2), (3), or (4)", "shall be assessed, or a no-tobacco-sale
order may be imposed," for "shall be assessed", and "assessed a
civil penalty, or upon whom a no-tobacco-sale order is to be
imposed," for "assessed a civil penalty".
Subsec. (f)(5)(B). Pub. L. 111-31, Sec. 103(c)(1)(C), inserted
"or the period to be covered by a no-tobacco-sale order," after
"penalty," and inserted at end "A no-tobacco-sale order permanently
prohibiting an individual retail outlet from selling tobacco
products shall include provisions that allow the outlet, after a
specified period of time, to request that the Secretary compromise,
modify, or terminate the order."
Subsec. (f)(5)(C). Pub. L. 111-31, Sec. 103(c)(1)(A), substituted
"paragraph (1), (2), (3), (4), or (9)" for "paragraph (1), (2),
(3), or (4)".
Subsec. (f)(5)(D). Pub. L. 111-31, Sec. 103(c)(1)(D), added
subpar. (D).
Subsec. (f)(6). Pub. L. 111-31, Sec. 103(c)(2), inserted "or the
imposition of a no-tobacco-sale order" after "penalty" in two
places and substituted "issued, or on which the no-tobacco-sale
order was imposed, as the case may be." for "issued."
Subsec. (f)(8), (9). Pub. L. 111-31, Sec. 103(c)(3), added pars.
(8) and (9).
2007 - Subsec. (f). Pub. L. 110-85, Sec. 226(b)(1), redesignated
subsec. (g) as (f).
Subsec. (f)(1)(B)(ii). Pub. L. 110-85, Sec. 226(b)(2),
substituted "360i(g)" for "360i(f)".
Subsec. (f)(2)(C). Pub. L. 110-85, Sec. 801(b)(2)(C), substituted
"paragraph (5)(A)" for "paragraph (3)(A)".
Subsec. (f)(3). Pub. L. 110-85, Sec. 801(b)(2)(B), added par.
(3). Former par. (3) redesignated (5).
Subsec. (f)(4). Pub. L. 110-85, Sec. 902(b)(1), added par. (4).
Pub. L. 110-85, Sec. 801(b)(2)(A), redesignated par. (4) as (6).
Subsec. (f)(5). Pub. L. 110-85, Sec. 801(b)(2)(A), redesignated
par. (3) as (5). Former par. (5) redesignated (7).
Subsec. (f)(5)(A), (C). Pub. L. 110-85, Sec. 902(b)(2),
substituted "paragraph (1), (2), (3), or (4)" for "paragraph (1),
(2), or (3)".
Pub. L. 110-85, Sec. 801(b)(2)(D), substituted "paragraph (1),
(2), or (3)" for "paragraph (1) or (2)".
Subsec. (f)(6). Pub. L. 110-85, Sec. 801(b)(2)(A), (E),
redesignated par. (4) as (6) and substituted "paragraph (5)(A)" for
"paragraph (3)(A)".
Subsec. (f)(7). Pub. L. 110-85, Sec. 801(b)(2)(A), (F),
redesignated par. (5) as (7) and substituted "paragraph (6)" for
"paragraph (4)" wherever appearing.
Subsec. (g). Pub. L. 110-85, Sec. 901(d)(4), added subsec. (g).
Pub. L. 110-85, Sec. 226(b)(1), redesignated subsec. (g) as (f).
2003 - Subsec. (b)(6). Pub. L. 108-173, which directed amendment
of subsec. (a)(6) by substituting "prescription drug under section
384(b)" for "covered product pursuant to section 384(a)", was
executed by making the substitution in subsec. (b)(6), to reflect
the probable intent of Congress.
2002 - Subsec. (g)(1)(A). Pub. L. 107-250 inserted at end "For
purposes of the preceding sentence, a person accredited under
paragraph (2) of section 374(g) of this title who is substantially
not in compliance with the standards of accreditation under such
section, or who poses a threat to public health or fails to act in
a manner that is consistent with the purposes of such section,
shall be considered to have violated a requirement of this chapter
that relates to devices."
2000 - Subsec. (b)(6). Pub. L. 106-387 added par. (6).
1996 - Subsec. (g)(2). Pub. L. 104-170, Sec. 407(1), (2), added
par. (2). Former par. (2) redesignated (3).
Subsec. (g)(3). Pub. L. 104-170, Sec. 407(1), (3), redesignated
par. (2) as (3) and substituted "paragraph (1) or (2)" for
"paragraph (1)" in subpars. (A) and (C). Former par. (3)
redesignated (4).
Subsec. (g)(4). Pub. L. 104-170, Sec. 407(1), (4), redesignated
par. (3) as (4) and substituted "paragraph (3)(A)" for "paragraph
(2)(A)". Former par. (4) redesignated (5).
Subsec. (g)(5). Pub. L. 104-170, Sec. 407(1), (5), redesignated
par. (4) as (5) and substituted "paragraph (4)" for "paragraph (3)"
wherever appearing.
1994 - Subsec. (e). Pub. L. 103-322 amended directory language of
Pub. L. 101-647. See 1990 Amendment note below.
1993 - Subsecs. (e) to (g). Pub. L. 103-80, which directed the
amendment of this section by redesignating the second subsec. (e)
and subsec. (f) as subsecs. (f) and (g), respectively, could only
be executed by designating subsec. (f) as (g) because this section
did not contain a second subsec. (e) subsequent to amendment of
Pub. L. 101-647 by Pub. L. 103-322. See 1990 and 1994 amendment
notes for subsec. (e) under this section.
1992 - Subsec. (b)(1). Pub. L. 102-353, Sec. 3(a), amended par.
(1) generally. Prior to amendment, par. (1) read as follows:
"Notwithstanding subsection (a) of this section, any person who
violates section 331(t) of this title because of an importation of
a drug in violation of section 381(d)(1) of this title, because of
a sale, purchase, or trade of a drug or drug sample or the offer to
sell, purchase, or trade a drug or drug sample in violation of
section 353(c) of this title, because of the sale, purchase, or
trade of a coupon, the offer to sell, purchase, or trade such a
coupon, or the counterfeiting of such a coupon in violation of
section 353(c)(2) of this title, or the distribution of drugs in
violation of section 353(e)(2)(A) of this title shall be imprisoned
for not more than 10 years or fined not more than $250,000, or
both."
Subsec. (b)(4)(A). Pub. L. 102-353, Sec. 3(b)(1), substituted
"the institution of a criminal proceeding against, and conviction
of," for "the arrest and conviction of".
Subsec. (b)(4)(B)(i). Pub. L. 102-353, Sec. 3(b)(1), (2),
substituted "before the institution of a criminal proceeding
against" for "before the arrest of" and "the institution of a
criminal proceeding against, and conviction of," for "the arrest
and conviction of".
Subsec. (b)(5). Pub. L. 102-353, Sec. 3(b)(3), substituted "the
institution of a criminal proceeding against, and conviction of,"
for "the arrest and conviction of".
Subsec. (c). Pub. L. 102-353, Sec. 3(b)(4), substituted
"subsection (a)(1) of this section" for "subsection (a) of this
section".
Subsec. (d). Pub. L. 102-353, Sec. 3(b)(4), (5), substituted
"subsection (a)(1) of this section" for "subsection (a) of this
section" and struck out ", and no person shall be subject to the
penalties of subsection (b) of this section for such a violation
unless the violation is committed with the intent to defraud or
mislead" after "advertising".
1990 - Subsec. (e). Pub. L. 101-647, as amended by Pub. L. 103-
322, amended subsec. (e) generally. Prior to amendment, subsec.
(e) read as follows:
"(e)(1) Except as provided in paragraph (2), any person who
distributes or possesses with the intent to distribute any anabolic
steroid for any use in humans other than the treatment of disease
pursuant to the order of a physician shall be imprisoned for not
more than three years or fined under title 18, or both.
"(2) Any person who distributes or possesses with the intent to
distribute to an individual under 18 years of age, any anabolic
steroid for any use in humans other than the treatment of disease
pursuant to the order of a physician shall be imprisoned for not
more than six years or fined under title 18, or both."
Subsec. (f). Pub. L. 101-629 added subsec. (f).
1988 - Subsecs. (a), (b). Pub. L. 100-293 designated existing
subsecs. (a) and (b) as pars. (1) and (2) of subsec. (a),
substituted "paragraph (1)" for "subsection (a)" in par. (2), and
added subsec. (b).
Subsec. (e). Pub. L. 100-690 added subsec. (e).
1976 - Subsec. (d). Pub. L. 94-278 added subsec. (d).
1970 - Subsec. (a). Pub. L. 91-513 struck out reference to
subsec. (b) and transferred to subsec. (b) provisions covering
second offenses and offenses committed with intent to defraud or
mislead.
Subsec. (b). Pub. L. 91-513 inserted provisions covering second
offenses and offenses committed with intent to defraud or mislead
formerly set out in subsec. (a) and struck out provisions covering
violations involving depressant and stimulant drugs. See section
801 et seq. of this title.
1968 - Subsecs. (a), (b). Pub. L. 90-639 made a general revision
in the penalties prescribed for offenses involving depressant or
stimulant drugs, set a fine of not to exceed $10,000 or
imprisonment of not more than 5 years for offenses involving the
unlawful manufacturing of, sale, or disposal of, or possession with
intent to sell, a depressant or stimulant drug or involving
counterfeit depressant or stimulant drugs, stiffened the penalties
for unlawful sales or other disposals by persons over 18 to persons
under 21, and set new penalties for possession of a depressant or
stimulant drug for purposes other than sale or other disposal.
1965 - Subsec. (a). Pub. L. 89-74, Sec. 7(a), inserted proviso
limiting the penalties for depressant or stimulant drug violations
to two years imprisonment or $5,000 fine or both for first offense
and to two years imprisonment or $15,000 fine or both for
subsequent offenses.
Subsec. (b). Pub. L. 89-74, Sec. 7(b), inserted parenthetical
exception provision.
Subsec. (c)(5). Pub. L. 89-74, Sec. 9(d), added cl. (5).
1960 - Subsec. (c)(3). Pub. L. 86-618 substituted "a color
additive" for "a coal-tar color", "the color additive" for "the
coal-tar color" and "such color additive was" for "such color was".
1951 - Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).
EFFECTIVE DATE OF 2009 AMENDMENT
Pub. L. 111-31, div. A, title I, Sec. 103(q)(3), (4), June 22,
2009, 123 Stat. 1840, provided that:
"(3) General effective date. - The amendments made by paragraphs
(2) [amending this section], (3) [amending this section], and (4)
[no par. (4) has been enacted] of subsection (c) shall take effect
upon the issuance of guidance described in paragraph (1) of this
subsection [set out as a Guidance note below].
"(4) Special effective date. - The amendment made by subsection
(c)(1) [amending this section] shall take effect on the date of
enactment of this Act [June 22, 2009]."
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by sections 901(d)(4) and 902(b) of Pub. L. 110-85
effective 180 days after Sept. 27, 2007, see section 909 of Pub. L.
110-85, set out as a note under section 331 of this title.
EFFECTIVE DATE OF 1994 AMENDMENT
Section 330015 of Pub. L. 103-322 provided that the amendment
made by that section is effective as of the date on which section
1904 of Pub. L. 101-647, which amended this section, took effect.
EFFECTIVE DATE OF 1990 AMENDMENT
Section 17(b) of Pub. L. 101-629 provided that:
"(b) Effective Date of Application to Device User Facilities. -
"(1) The Secretary of Health and Human Services shall conduct a
study to determine whether there has been substantial compliance
with the requirements of section 519(b) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 360i(b)] by device user
facilities (as defined in section 519(b)(5)(A) of such Act). The
Secretary shall report the results of the study to the Congress
after the expiration of 45 months after the date of the enactment
of this Act [Nov. 28, 1990].
"(2)(A) If upon the expiration of 48 months after the date of
the enactment of this Act [Nov. 28, 1990] the Secretary has not
made the report required by paragraph (1), section 303(f) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333(f)], as added
by the amendment made by subsection (a), shall take effect with
respect to device user facilities (as defined in section
519(b)(5)(A) of such Act). [Secretary of Health and Human
Services had not made the report required by par. (1) on the
expiration of 48 months after Nov. 28, 1990.]
"(B) If in the report under paragraph (1) the Secretary reports
that there has been substantial compliance with the requirements
of such section 519(b) by a type of device user facility and if
the Secretary does not make a determination under subparagraph
(C) with respect to such type of facility, such section 303(f)
shall not take effect with respect to such type of facility.
"(C) If the Secretary determines in the report under paragraph
(1) that there is not substantial compliance with the
requirements of such section 519(b) by a type of device user
facility or if the Secretary makes such a determination after
making the report under paragraph (1), such section 303(f) shall
take effect with respect to such type of facility upon the
effective date of the report."
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-293 effective upon expiration of 90 days
after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out
as a note under section 353 of this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
1976, see section 502(c) of Pub. L. 94-278, set out as a note under
section 334 of this title.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-639 applicable only with respect to
violations of this chapter committed after Oct. 24, 1968, see
section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
Amendments; Transitional Provisions note under section 321 of this
title.
EFFECTIVE DATE OF 1965 AMENDMENT
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
of Pub. L. 89-74, set out as a note under section 321 of this
title.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE OF 1951 AMENDMENT
Section 3 of act Oct. 26, 1951, provided that: "The provisions of
this Act [amending this section and section 353 of this title]
shall take effect six months after the date of its enactment [Oct.
26, 1951]."
SAVINGS PROVISION
Amendment by Pub. L. 91-513 not to affect or abate any
prosecutions for violation of law or any civil seizures or
forfeitures and injunctive proceedings commenced prior to the
effective date of such amendment, and all administrative
proceedings pending before the Bureau of Narcotics and Dangerous
Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
to be continued and brought to final determination in accord with
laws and regulations in effect prior to Oct. 27, 1970, see section
702 of Pub. L. 91-513, set out as a note under section 321 of this
title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-MISC2-
GUIDANCE
Pub. L. 111-31, div. A, title I, Sec. 103(q)(1), (2), June 22,
2009, 123 Stat. 1838, 1839, provided that:
"(1) In general. - The Secretary of Health and Human Services
shall issue guidance [see 76 F.R. 22905, effective Apr. 15, 2011] -
"(A) defining the term 'repeated violation', as used in section
303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
333(f)(8)) as amended by subsection (c), as including at least 5
violations of particular requirements over a 36-month period at a
particular retail outlet that constitute a repeated violation and
providing for civil penalties in accordance with paragraph (2);
"(B) providing for timely and effective notice by certified or
registered mail or personal delivery to the retailer of each
alleged violation at a particular retail outlet prior to
conducting a followup compliance check, such notice to be sent to
the location specified on the retailer's registration or to the
retailer's registered agent if the retailer has provider [sic]
such agent information to the Food and Drug Administration prior
to the violation;
"(C) providing for a hearing pursuant to the procedures
established through regulations of the Food and Drug
Administration for assessing civil money penalties, including at
a retailer's request a hearing by telephone or at the nearest
regional or field office of the Food and Drug Administration, and
providing for an expedited procedure for the administrative
appeal of an alleged violation;
"(D) providing that a person may not be charged with a
violation at a particular retail outlet unless the Secretary has
provided notice to the retailer of all previous violations at
that outlet;
"(E) establishing that civil money penalties for multiple
violations shall increase from one violation to the next
violation pursuant to paragraph (2) within the time periods
provided for in such paragraph;
"(F) providing that good faith reliance on the presentation of
a false government-issued photographic identification that
contains a date of birth does not constitute a violation of any
minimum age requirement for the sale of tobacco products if the
retailer has taken effective steps to prevent such violations,
including -
"(i) adopting and enforcing a written policy against sales to
minors;
"(ii) informing its employees of all applicable laws;
"(iii) establishing disciplinary sanctions for employee
noncompliance; and
"(iv) requiring its employees to verify age by way of
photographic identification or electronic scanning device; and
"(G) providing for the Secretary, in determining whether to
impose a no-tobacco-sale order and in determining whether to
compromise, modify, or terminate such an order, to consider
whether the retailer has taken effective steps to prevent
violations of the minimum age requirements for the sale of
tobacco products, including the steps listed in subparagraph (F).
"(2) Penalties for violations. -
"(A) In general. - The amount of the civil penalty to be
applied for violations of restrictions promulgated under section
906(d) [probably means section 906(d) of the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C. 387f(d)], as described in paragraph
(1), shall be as follows:
"(i) With respect to a retailer with an approved training
program, the amount of the civil penalty shall not exceed -
"(I) in the case of the first violation, $0.00 together
with the issuance of a warning letter to the retailer;
"(II) in the case of a second violation within a 12-month
period, $250;
"(III) in the case of a third violation within a 24-month
period, $500;
"(IV) in the case of a fourth violation within a 24-month
period, $2,000;
"(V) in the case of a fifth violation within a 36-month
period, $5,000; and
"(VI) in the case of a sixth or subsequent violation within
a 48-month period, $10,000 as determined by the Secretary on
a case-by-case basis.
"(ii) With respect to a retailer that does not have an
approved training program, the amount of the civil penalty
shall not exceed -
"(I) in the case of the first violation, $250;
"(II) in the case of a second violation within a 12-month
period, $500;
"(III) in the case of a third violation within a 24-month
period, $1,000;
"(IV) in the case of a fourth violation within a 24-month
period, $2,000;
"(V) in the case of a fifth violation within a 36-month
period, $5,000; and
"(VI) in the case of a sixth or subsequent violation within
a 48-month period, $10,000 as determined by the Secretary on
a case-by-case basis.
"(B) Training program. - For purposes of subparagraph (A), the
term 'approved training program' means a training program that
complies with standards developed by the Food and Drug
Administration for such programs.
"(C) Consideration of state penalties. - The Secretary shall
coordinate with the States in enforcing the provisions of this
Act [probably means div. A of Pub. L. 111-31, see Short Title of
2009 Amendment note set out under section 301 of this title and
Tables for classifications] and, for purposes of mitigating a
civil penalty to be applied for a violation by a retailer of any
restriction promulgated under section 906(d) [21 U.S.C. 387f(d)],
shall consider the amount of any penalties paid by the retailer
to a State for the same violation."
CONSTRUCTION OF 2011 AMENDMENT
Nothing in amendment by Pub. L. 111-353 to be construed to alter
jurisdiction and authorities established under certain other Acts
or in a manner inconsistent with international agreements to which
the United States is a party, see sections 2251 and 2252 of this
title.
ENFORCEMENT
Pub. L. 99-660, title I, Sec. 103, Nov. 14, 1986, 100 Stat. 3751,
provided that: "For the fines authorized to be imposed under
section 303 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
333], see section 3623 of title 18, United States Code, for the
period ending October 31, 1986 [probably should be October 31,
1987], and sections 3559 and 3571 of such title for the period
beginning November 1, 1986 [probably should be November 1, 1987]."
-FOOTNOTE-
(!1) So in original. Words "of this section" probably should not
appear.
(!2) See References in Text note below.
-End-
-CITE-
21 USC Sec. 333a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 333a. Repealed.
-MISC1-
Sec. 333a. Repealed. Pub. L. 101-647, title XIX, Sec. 1905, Nov.
29, 1990, 104 Stat. 4853.
Section, Pub. L. 100-690, title II, Sec. 2401, Nov. 18, 1988, 102
Stat. 4230, related to forfeiture and illegal trafficking in
steroids or human growth hormones.
-End-
-CITE-
21 USC Sec. 334 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 334. Seizure
-STATUTE-
(a) Grounds and jurisdiction
(1) Any article of food, drug, or cosmetic that is adulterated or
misbranded when introduced into or while in interstate commerce or
while held for sale (whether or not the first sale) after shipment
in interstate commerce, or which may not, under the provisions of
section 331(ll), 344, or 355 of this title, be introduced into
interstate commerce, shall be liable to be proceeded against while
in interstate commerce, or at any time thereafter, on libel of
information and condemned in any district court of the United
States or United States court of a Territory within the
jurisdiction of which the article is found. No libel for
condemnation shall be instituted under this chapter, for any
alleged misbranding if there is pending in any court a libel for
condemnation proceeding under this chapter based upon the same
alleged misbranding, and not more than one such proceeding shall be
instituted if no such proceeding is so pending, except that such
limitations shall not apply (A) when such misbranding has been the
basis of a prior judgment in favor of the United States, in a
criminal, injunction, or libel for condemnation proceeding under
this chapter, or (B) when the Secretary has probable cause to
believe from facts found, without hearing, by him or any officer or
employee of the Department that the misbranded article is dangerous
to health, or that the labeling of the misbranded article is
fraudulent, or would be in a material respect misleading to the
injury or damage of the purchaser or consumer. In any case where
the number of libel for condemnation proceedings is limited as
above provided the proceeding pending or instituted shall, on
application of the claimant, seasonably made, be removed for trial
to any district agreed upon by stipulation between the parties, or,
in case of failure to so stipulate within a reasonable time, the
claimant may apply to the court of the district in which the
seizure has been made, and such court (after giving the United
States attorney for such district reasonable notice and opportunity
to be heard) shall by order, unless good cause to the contrary is
shown, specify a district of reasonable proximity to the claimant's
principal place of business, to which the case shall be removed for
trial.
(2) The following shall be liable to be proceeded against at any
time on libel of information and condemned in any district court of
the United States or United States court of a Territory within the
jurisdiction of which they are found: (A) Any drug that is a
counterfeit drug, (B) Any container of a counterfeit drug, (C) Any
punch, die, plate, stone, labeling, container, or other thing used
or designed for use in making a counterfeit drug or drugs, (D) Any
adulterated or misbranded device, and (E) Any adulterated or
misbranded tobacco product.
(3)(A) Except as provided in subparagraph (B), no libel for
condemnation may be instituted under paragraph (1) or (2) against
any food which -
(i) is misbranded under section 343(a)(2) of this title because
of its advertising, and
(ii) is being held for sale to the ultimate consumer in an
establishment other than an establishment owned or operated by a
manufacturer, packer, or distributor of the food.
(B) A libel for condemnation may be instituted under paragraph
(1) or (2) against a food described in subparagraph (A) if -
(i)(I) the food's advertising which resulted in the food being
misbranded under section 343(a)(2) of this title was disseminated
in the establishment in which the food is being held for sale to
the ultimate consumer,
(II) such advertising was disseminated by, or under the
direction of, the owner or operator of such establishment, or
(III) all or part of the cost of such advertising was paid by
such owner or operator; and
(ii) the owner or operator of such establishment used such
advertising in the establishment to promote the sale of the food.
(b) Procedure; multiplicity of pending proceedings
The article, equipment, or other thing proceeded against shall be
liable to seizure by process pursuant to the libel, and the
procedure in cases under this section shall conform, as nearly as
may be, to the procedure in admiralty; except that on demand of
either party any issue of fact joined in any such case shall be
tried by jury. When libel for condemnation proceedings under this
section, involving the same claimant and the same issues of
adulteration or misbranding, are pending in two or more
jurisdictions, such pending proceedings, upon application of the
claimant seasonably made to the court of one such jurisdiction,
shall be consolidated for trial by order of such court, and tried
in (1) any district selected by the claimant where one of such
proceedings is pending; or (2) a district agreed upon by
stipulation between the parties. If no order for consolidation is
so made within a reasonable time, the claimant may apply to the
court of one such jurisdiction and such court (after giving the
United States attorney for such district reasonable notice and
opportunity to be heard) shall by order, unless good cause to the
contrary is shown, specify a district of reasonable proximity to
the claimant's principal place of business, in which all such
pending proceedings shall be consolidated for trial and tried. Such
order of consolidation shall not apply so as to require the removal
of any case the date for trial of which has been fixed. The court
granting such order shall give prompt notification thereof to the
other courts having jurisdiction of the cases covered thereby.
(c) Availability of samples of seized goods prior to trial
The court at any time after seizure up to a reasonable time
before trial shall by order allow any party to a condemnation
proceeding, his attorney or agent, to obtain a representative
sample of the article seized and a true copy of the analysis, if
any, on which the proceeding is based and the identifying marks or
numbers, if any, of the packages from which the samples analyzed
were obtained.
(d) Disposition of goods after decree of condemnation; claims for
remission or mitigation of forfeitures
(1) Any food, drug, device, tobacco product, or cosmetic
condemned under this section shall, after entry of the decree, be
disposed of by destruction or sale as the court may, in accordance
with the provisions of this section, direct and the proceeds
thereof, if sold, less the legal costs and charges, shall be paid
into the Treasury of the United States; but such article shall not
be sold under such decree contrary to the provisions of this
chapter or the laws of the jurisdiction in which sold. After entry
of the decree and upon the payment of the costs of such proceedings
and the execution of a good and sufficient bond conditioned that
such article shall not be sold or disposed of contrary to the
provisions of this chapter or the laws of any State or Territory in
which sold, the court may by order direct that such article be
delivered to the owner thereof to be destroyed or brought into
compliance with the provisions of this chapter, under the
supervision of an officer or employee duly designated by the
Secretary, and the expenses of such supervision shall be paid by
the person obtaining release of the article under bond. If the
article was imported into the United States and the person seeking
its release establishes (A) that the adulteration, misbranding, or
violation did not occur after the article was imported, and (B)
that he had no cause for believing that it was adulterated,
misbranded, or in violation before it was released from customs
custody, the court may permit the article to be delivered to the
owner for exportation in lieu of destruction upon a showing by the
owner that all of the conditions of section 381(e) of this title
can and will be met. The provisions of this sentence shall not
apply where condemnation is based upon violation of section
342(a)(1), (2), or (6), section 351(a)(3), section 352(j), or
section 361(a) or (d) of this title. Where such exportation is made
to the original foreign supplier, then subparagraphs (A) and (B) of
section 381(e)(1) of this title and the preceding sentence shall
not be applicable; and in all cases of exportation the bond shall
be conditioned that the article shall not be sold or disposed of
until the applicable conditions of section 381(e) of this title
have been met. Any person seeking to export an imported article
pursuant to any of the provisions of this subsection shall
establish that the article was intended for export at the time the
article entered commerce. Any article condemned by reason of its
being an article which may not, under section 344 or 355 of this
title, be introduced into interstate commerce, shall be disposed of
by destruction.
(2) The provisions of paragraph (1) of this subsection shall, to
the extent deemed appropriate by the court, apply to any equipment
or other thing which is not otherwise within the scope of such
paragraph and which is referred to in paragraph (2) of subsection
(a) of this section.
(3) Whenever in any proceeding under this section, involving
paragraph (2) of subsection (a) of this section, the condemnation
of any equipment or thing (other than a drug) is decreed, the court
shall allow the claim of any claimant, to the extent of such
claimant's interest, for remission or mitigation of such forfeiture
if such claimant proves to the satisfaction of the court (i) that
he has not committed or caused to be committed any prohibited act
referred to in such paragraph (2) and has no interest in any drug
referred to therein, (ii) that he has an interest in such equipment
or other thing as owner or lienor or otherwise, acquired by him in
good faith, and (iii) that he at no time had any knowledge or
reason to believe that such equipment or other thing was being or
would be used in, or to facilitate, the violation of laws of the
United States relating to counterfeit drugs.
(e) Costs
When a decree of condemnation is entered against the article,
court costs and fees, and storage and other proper expenses, shall
be awarded against the person, if any, intervening as claimant of
the article.
(f) Removal of case for trial
In the case of removal for trial of any case as provided by
subsection (a) or (b) of this section -
(1) The clerk of the court from which removal is made shall
promptly transmit to the court in which the case is to be tried
all records in the case necessary in order that such court may
exercise jurisdiction.
(2) The court to which such case was removed shall have the
powers and be subject to the duties, for purposes of such case,
which the court from which removal was made would have had, or to
which such court would have been subject, if such case had not
been removed.
(g) Administrative restraint; detention orders
(1) If during an inspection conducted under section 374 of this
title of a facility or a vehicle, a device or tobacco product which
the officer or employee making the inspection has reason to believe
is adulterated or misbranded is found in such facility or vehicle,
such officer or employee may order the device or tobacco product
detained (in accordance with regulations prescribed by the
Secretary) for a reasonable period which may not exceed twenty days
unless the Secretary determines that a period of detention greater
than twenty days is required to institute an action under
subsection (a) of this section or section 332 of this title, in
which case he may authorize a detention period of not to exceed
thirty days. Regulations of the Secretary prescribed under this
paragraph shall require that before a device or tobacco product may
be ordered detained under this paragraph the Secretary or an
officer or employee designated by the Secretary approve such order.
A detention order under this paragraph may require the labeling or
marking of a device or tobacco product during the period of its
detention for the purpose of identifying the device or tobacco
product as detained. Any person who would be entitled to claim a
device or tobacco product if it were seized under subsection (a) of
this section may appeal to the Secretary a detention of such device
or tobacco product under this paragraph. Within five days of the
date an appeal of a detention is filed with the Secretary, the
Secretary shall after affording opportunity for an informal hearing
by order confirm the detention or revoke it.
(2)(A) Except as authorized by subparagraph (B), a device or
tobacco product subject to a detention order issued under paragraph
(1) shall not be moved by any person from the place at which it is
ordered detained until -
(i) released by the Secretary, or
(ii) the expiration of the detention period applicable to such
order,
whichever occurs first.
(B) A device subject to a detention order under paragraph (1) may
be moved -
(i) in accordance with regulations prescribed by the Secretary,
and
(ii) if not in final form for shipment, at the discretion of
the manufacturer of the device for the purpose of completing the
work required to put it in such form.
(h) Administrative detention of foods
(1) Detention authority
(A) In general
An officer or qualified employee of the Food and Drug
Administration may order the detention, in accordance with this
subsection, of any article of food that is found during an
inspection, examination, or investigation under this chapter
conducted by such officer or qualified employee, if the officer
or qualified employee has reason to believe that such article
is adulterated or misbranded.
(B) Secretary's approval
An article of food may be ordered detained under subparagraph
(A) only if the Secretary or an official designated by the
Secretary approves the order. An official may not be so
designated unless the official is the director of the district
under this chapter in which the article involved is located, or
is an official senior to such director.
(2) Period of detention
An article of food may be detained under paragraph (1) for a
reasonable period, not to exceed 20 days, unless a greater
period, not to exceed 30 days, is necessary, to enable the
Secretary to institute an action under subsection (a) of this
section or section 332 of this title. The Secretary shall by
regulation provide for procedures for instituting such action on
an expedited basis with respect to perishable foods.
(3) Security of detained article
An order under paragraph (1) with respect to an article of food
may require that such article be labeled or marked as detained,
and shall require that the article be removed to a secure
facility, as appropriate. An article subject to such an order
shall not be transferred by any person from the place at which
the article is ordered detained, or from the place to which the
article is so removed, as the case may be, until released by the
Secretary or until the expiration of the detention period
applicable under such order, whichever occurs first. This
subsection may not be construed as authorizing the delivery of
the article pursuant to the execution of a bond while the article
is subject to the order, and section 381(b) of this title does
not authorize the delivery of the article pursuant to the
execution of a bond while the article is subject to the order.
(4) Appeal of detention order
(A) In general
With respect to an article of food ordered detained under
paragraph (1), any person who would be entitled to be a
claimant for such article if the article were seized under
subsection (a) of this section may appeal the order to the
Secretary. Within five days after such an appeal is filed, the
Secretary, after providing opportunity for an informal hearing,
shall confirm or terminate the order involved, and such
confirmation by the Secretary shall be considered a final
agency action for purposes of section 702 of title 5. If during
such five-day period the Secretary fails to provide such an
opportunity, or to confirm or terminate such order, the order
is deemed to be terminated.
(B) Effect of instituting court action
The process under subparagraph (A) for the appeal of an order
under paragraph (1) terminates if the Secretary institutes an
action under subsection (a) of this section or section 332 of
this title regarding the article of food involved.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 304, 52 Stat. 1044; June 24, 1948,
ch. 613, Sec. 2, 62 Stat. 582; Aug. 7, 1953, ch. 350, Sec. 3, 67
Stat. 477; Pub. L. 85-250, Aug. 31, 1957, 71 Stat. 567; Pub. L. 89-
74, Sec. 6, July 15, 1965, 79 Stat. 232; Pub. L. 90-639, Sec.
4(b), Oct. 24, 1968, 82 Stat. 1362; Pub. L. 91-513, title II, Sec.
701(c), (d), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 94-278,
title V, Sec. 502(a)(2)(C), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-
295, Secs. 3(c), 7(a), May 28, 1976, 90 Stat. 576, 582; Pub. L.
102-300, Sec. 6(c), June 16, 1992, 106 Stat. 240; Pub. L. 103-80,
Sec. 3(f), Aug. 13, 1993, 107 Stat. 775; Pub. L. 105-115, title IV,
Sec. 418, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 107-188, title
III, Sec. 303(a), June 12, 2002, 116 Stat. 663; Pub. L. 110-85,
title IX, Sec. 912(b)(1), Sept. 27, 2007, 121 Stat. 952; Pub. L.
111-31, div. A, title I, Sec. 103(d), June 22, 2009, 123 Stat.
1836; Pub. L. 111-353, title II, Sec. 207(a), Jan. 4, 2011, 124
Stat. 3944.)
-MISC1-
AMENDMENTS
2011 - Subsec. (h)(1)(A). Pub. L. 111-353 substituted "reason to
believe" for "credible evidence or information indicating" and "is
adulterated or misbranded" for "presents a threat of serious
adverse health consequences or death to humans or animals".
2009 - Subsec. (a)(2)(E). Pub. L. 111-31, Sec. 103(d)(1), added
cl. (E).
Subsec. (d)(1). Pub. L. 111-31, Sec. 103(d)(2), inserted "tobacco
product," after "device," in first sentence.
Subsec. (g)(1). Pub. L. 111-31, Sec. 103(d)(3), inserted "or
tobacco product" after "device" wherever appearing.
Subsec. (g)(2)(A). Pub. L. 111-31, Sec. 103(d)(4), inserted "or
tobacco product" after "device" in introductory provisions.
2007 - Subsec. (a)(1). Pub. L. 110-85 substituted "section
331(ll), 344, or 355" for "section 344 or 355".
2002 - Subsec. (h). Pub. L. 107-188 added subsec. (h).
1997 - Subsec. (d)(1). Pub. L. 105-115 substituted "subparagraphs
(A) and (B) of section 381(e)(1) of this title" for "paragraphs (1)
and (2) of section 381(e) of this title" and inserted "Any person
seeking to export an imported article pursuant to any of the
provisions of this subsection shall establish that the article was
intended for export at the time the article entered commerce."
before "Any article condemned by reason".
1993 - Subsec. (a)(1). Pub. L. 103-80, Sec. 3(f)(1), substituted
"found. No libel" for "found: Provided, however, That no libel".
Subsec. (d)(1). Pub. L. 103-80, Sec. 3(f)(2), substituted "sold.
After entry" for "sold: Provided, That after entry", "met. The
provisions of this sentence" for "met: Provided, however, That the
provisions of this sentence", "title. Where such exportation" for
"title: And provided further, That where such exportation", and
"the preceding sentence shall not be applicable" for "the foregoing
proviso shall not be applicable".
1992 - Subsec. (d)(1). Pub. L. 102-300 substituted "381(e)" for
"381(d)" in three places and "paragraphs" for "clauses" before "(1)
and (2) of section 381(e)".
1976 - Subsec. (a)(1). Pub. L. 94-295, Sec. 3(c)(1), struck out
"device," after "Any article of food, drug,".
Subsec. (a)(2). Pub. L. 94-295, Sec. 3(c)(2), (3), added cl. (D)
covering adulterated or misbranded devices.
Subsec. (a)(3). Pub. L. 94-278 added par. (3).
Subsec. (g). Pub. L. 94-295, Sec. 7(a), added subsec. (g).
1970 - Subsec. (a)(2). Pub. L. 91-513, Sec. 701(c), struck out
cls. (A) and (D) which dealt with depressant or stimulant drugs,
struck out reference to depressant or stimulant drugs in cl. (C),
and redesignated cls. (B), (C), and (E) as cls. (A), (B), and (C),
respectively.
Subsec. (d)(3)(iii). Pub. L. 91-513, Sec. 701(d), struck out
reference to depressant or stimulant drugs.
1968 - Subsec. (a). Pub. L. 90-639 inserted references to the
United States courts of Territories.
1965 - Subsec. (a). Pub. L. 89-74, Sec. 6(a), designated existing
provisions as par. (1), redesignated cls. (1) and (2) of proviso as
(A) and (B), and added par. (2).
Subsec. (b). Pub. L. 89-74, Sec. 6(b)(1), inserted "equipment, or
other thing proceeded against" after "article" in first sentence.
Subsec. (d). Pub. L. 89-74, Sec. 6(b)(2), designated existing
provisions as par. (1), redesignated cls. (1) and (2) of the second
sentence thereof as (A) and (B), and added pars. (2) and (3).
1957 - Subsec. (d). Pub. L. 85-250 permitted, under certain
circumstances, reexportation of articles condemned at places other
than original port of entry.
1953 - Subsec. (c). Act Aug. 7, 1953, provided that a true copy
of the analysis in any case shall be furnished the owner.
1948 - Subsec. (a). Act June 24, 1948, inserted "or while held
for sale (whether or not the first sale) after shipment in
interstate commerce" to make this subsection coextensive with
section 331(k) of this title.
EFFECTIVE DATE OF 2011 AMENDMENT
Pub. L. 111-353, title II, Sec. 207(c), Jan. 4, 2011, 124 Stat.
3944, provided that: "The amendment made by this section [amending
this section] shall take effect 180 days after the date of
enactment of this Act [Jan. 4, 2011]."
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1976 AMENDMENT
Section 502(c) of Pub. L. 94-278 provided that: "The amendments
made by subsection (a) [amending this section and sections 321,
333, and 343 of this title] shall take effect 180 days after the
date of the enactment of this Act [Apr. 22, 1976]."
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-639 applicable only with respect to
violations of this chapter committed after Oct. 24, 1968, see
section 6 of Pub. L. 90-639, set out as an Effective Date of 1968
Amendments; Transitional Provisions note under section 321 of this
title.
EFFECTIVE DATE OF 1965 AMENDMENT
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11
of Pub. L. 89-74, set out as a note under section 321 of this
title.
REGULATIONS
Pub. L. 111-353, title II, Sec. 207(b), Jan. 4, 2011, 124 Stat.
3944, provided that: "Not later than 120 days after the date of
enactment of this Act [Jan. 4, 2011], the Secretary shall issue an
interim final rule amending subpart K of part 1 of title 21, Code
of Federal Regulations, to implement the amendment made by this
section [amending this section]."
SAVINGS PROVISION
Amendment by Pub. L. 91-513 not to affect or abate any
prosecutions for any violation of law or any civil seizures or
forfeitures and injunctive proceedings commenced prior to the
effective date of such amendment, and all administrative
proceedings pending before the Bureau of Narcotics and Dangerous
Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970,
to be continued and brought to final determination in accord with
laws and regulations in effect prior to Oct. 27, 1970, see section
702 of Pub. L. 91-513, set out as a note under section 321 of this
title.
CONSTRUCTION OF 2011 AMENDMENT
Nothing in amendment by Pub. L. 111-353 to be construed to alter
jurisdiction and authorities established under certain other Acts
or in a manner inconsistent with international agreements to which
the United States is a party, see sections 2251 and 2252 of this
title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 335 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 335. Hearing before report of criminal violation
-STATUTE-
Before any violation of this chapter is reported by the Secretary
to any United States attorney for institution of a criminal
proceeding, the person against whom such proceeding is contemplated
shall be given appropriate notice and an opportunity to present his
views, either orally or in writing, with regard to such
contemplated proceeding.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 305, 52 Stat. 1045.)
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 335a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 335a. Debarment, temporary denial of approval, and suspension
-STATUTE-
(a) Mandatory debarment; certain drug applications
(1) Corporations, partnerships, and associations
If the Secretary finds that a person other than an individual
has been convicted, after May 13, 1992, of a felony under Federal
law for conduct relating to the development or approval,
including the process for development or approval, of any
abbreviated drug application, the Secretary shall debar such
person from submitting, or assisting in the submission of, any
such application.
(2) Individuals
If the Secretary finds that an individual has been convicted of
a felony under Federal law for conduct -
(A) relating to the development or approval, including the
process for development or approval, of any drug product, or
(B) otherwise relating to the regulation of any drug product
under this chapter,
the Secretary shall debar such individual from providing services
in any capacity to a person that has an approved or pending drug
product application.
(b) Permissive debarment; certain drug applications; food imports
(1) In general
The Secretary, on the Secretary's own initiative or in response
to a petition, may, in accordance with paragraph (2), debar -
(A) a person other than an individual from submitting or
assisting in the submission of any abbreviated drug
application,
(B) an individual from providing services in any capacity to
a person that has an approved or pending drug product
application, or
(C) a person from importing an article of food or offering
such an article for import into the United States.
(2) Persons subject to permissive debarment; certain drug
applications
The following persons are subject to debarment under
subparagraph (A) or (B) of paragraph (1):
(A) Corporations, partnerships, and associations
Any person other than an individual that the Secretary finds
has been convicted -
(i) for conduct that -
(I) relates to the development or approval, including the
process for the development or approval, of any abbreviated
drug application; and
(II) is a felony under Federal law (if the person was
convicted before May 13, 1992), a misdemeanor under Federal
law, or a felony under State law, or
(ii) of a conspiracy to commit, or aiding or abetting, a
criminal offense described in clause (i) or a felony
described in subsection (a)(1) of this section,
if the Secretary finds that the type of conduct which served as
the basis for such conviction undermines the process for the
regulation of drugs.
(B) Individuals
(i) Any individual whom the Secretary finds has been
convicted of -
(I) a misdemeanor under Federal law or a felony under State
law for conduct relating to the development or approval,
including the process for development or approval, of any
drug product or otherwise relating to the regulation of drug
products under this chapter, or
(II) a conspiracy to commit, or aiding or abetting, such
criminal offense or a felony described in subsection (a)(2)
of this section,
if the Secretary finds that the type of conduct which served as
the basis for such conviction undermines the process for the
regulation of drugs.
(ii) Any individual whom the Secretary finds has been
convicted of -
(I) a felony which is not described in subsection (a)(2) of
this section or clause (i) of this subparagraph and which
involves bribery, payment of illegal gratuities, fraud,
perjury, false statement, racketeering, blackmail, extortion,
falsification or destruction of records, or interference
with, obstruction of an investigation into, or prosecution
of, any criminal offense, or
(II) a conspiracy to commit, or aiding or abetting, such
felony,
if the Secretary finds, on the basis of the conviction of such
individual and other information, that such individual has
demonstrated a pattern of conduct sufficient to find that there
is reason to believe that such individual may violate
requirements under this chapter relating to drug products.
(iii) Any individual whom the Secretary finds materially
participated in acts that were the basis for a conviction for
an offense described in subsection (a) of this section or in
clause (i) or (ii) for which a conviction was obtained, if the
Secretary finds, on the basis of such participation and other
information, that such individual has demonstrated a pattern of
conduct sufficient to find that there is reason to believe that
such individual may violate requirements under this chapter
relating to drug products.
(iv) Any high managerial agent whom the Secretary finds -
(I) worked for, or worked as a consultant for, the same
person as another individual during the period in which such
other individual took actions for which a felony conviction
was obtained and which resulted in the debarment under
subsection (a)(2) of this section, or clause (i), of such
other individual,
(II) had actual knowledge of the actions described in
subclause (I) of such other individual, or took action to
avoid such actual knowledge, or failed to take action for the
purpose of avoiding such actual knowledge,
(III) knew that the actions described in subclause (I) were
violative of law, and
(IV) did not report such actions, or did not cause such
actions to be reported, to an officer, employee, or agent of
the Department or to an appropriate law enforcement officer,
or failed to take other appropriate action that would have
ensured that the process for the regulation of drugs was not
undermined, within a reasonable time after such agent first
knew of such actions,
if the Secretary finds that the type of conduct which served as
the basis for such other individual's conviction undermines the
process for the regulation of drugs.
(3) Persons subject to permissive debarment; food importation
A person is subject to debarment under paragraph (1)(C) if -
(A) the person has been convicted of a felony for conduct
relating to the importation into the United States of any food;
or
(B) the person has engaged in a pattern of importing or
offering for import adulterated food that presents a threat of
serious adverse health consequences or death to humans or
animals.
(4) Stay of certain orders
An order of the Secretary under clause (iii) or (iv) of
paragraph (2)(B) shall not take effect until 30 days after the
order has been issued.
(c) Debarment period and considerations
(1) Effect of debarment
The Secretary -
(A) shall not accept or review (other than in connection with
an audit under this section) any abbreviated drug application
submitted by or with the assistance of a person debarred under
subsection (a)(1) or (b)(2)(A) of this section during the
period such person is debarred,
(B) shall, during the period of a debarment under subsection
(a)(2) or (b)(2)(B) of this section, debar an individual from
providing services in any capacity to a person that has an
approved or pending drug product application and shall not
accept or review (other than in connection with an audit under
this section) an abbreviated drug application from such
individual, and
(C) shall, if the Secretary makes the finding described in
paragraph (6) or (7) of section 335b(a) of this title, assess a
civil penalty in accordance with section 335b of this title.
(2) Debarment periods
(A) In general
The Secretary shall debar a person under subsection (a) or
(b) of this section for the following periods:
(i) The period of debarment of a person (other than an
individual) under subsection (a)(1) of this section shall not
be less than 1 year or more than 10 years, but if an act
leading to a subsequent debarment under subsection (a) of
this section occurs within 10 years after such person has
been debarred under subsection (a)(1) of this section, the
period of debarment shall be permanent.
(ii) The debarment of an individual under subsection (a)(2)
of this section shall be permanent.
(iii) The period of debarment of any person under paragraph
(2) or (3) of subsection (b) of this section shall not be
more than 5 years.
The Secretary may determine whether debarment periods shall run
concurrently or consecutively in the case of a person debarred
for multiple offenses.
(B) Notification
Upon a conviction for an offense described in subsection (a)
or (b) of this section or upon execution of an agreement with
the United States to plead guilty to such an offense, the
person involved may notify the Secretary that the person
acquiesces to debarment and such person's debarment shall
commence upon such notification.
(3) Considerations
In determining the appropriateness and the period of a
debarment of a person under subsection (b) of this section and
any period of debarment beyond the minimum specified in
subparagraph (A)(i) of paragraph (2), the Secretary shall
consider where applicable -
(A) the nature and seriousness of any offense involved,
(B) the nature and extent of management participation in any
offense involved, whether corporate policies and practices
encouraged the offense, including whether inadequate
institutional controls contributed to the offense,
(C) the nature and extent of voluntary steps to mitigate the
impact on the public of any offense involved, including the
recall or the discontinuation of the distribution of suspect
drugs, full cooperation with any investigations (including the
extent of disclosure to appropriate authorities of all
wrongdoing), the relinquishing of profits on drug approvals
fraudulently obtained, and any other actions taken to
substantially limit potential or actual adverse effects on the
public health,
(D) whether the extent to which changes in ownership,
management, or operations have corrected the causes of any
offense involved and provide reasonable assurances that the
offense will not occur in the future,
(E) whether the person to be debarred is able to present
adequate evidence that current production of drugs subject to
abbreviated drug applications and all pending abbreviated drug
applications are free of fraud or material false statements,
and
(F) prior convictions under this chapter or under other Acts
involving matters within the jurisdiction of the Food and Drug
Administration.
(d) Termination of debarment
(1) Application
Any person that is debarred under subsection (a) of this
section (other than a person permanently debarred) or any person
that is debarred under subsection (b) of this section may apply
to the Secretary for termination of the debarment under this
subsection. Any information submitted to the Secretary under this
paragraph does not constitute an amendment or supplement to
pending or approved abbreviated drug applications.
(2) Deadline
The Secretary shall grant or deny any application respecting a
debarment which is submitted under paragraph (1) within 180 days
of the date the application is submitted.
(3) Action by the Secretary
(A) Corporations
(i) Conviction reversal
If the conviction which served as the basis for the
debarment of a person under subsection (a)(1) of this section
or paragraph (2)(A) or (3) of subsection (b) of this section
is reversed, the Secretary shall withdraw the order of
debarment.
(ii) Application
Upon application submitted under paragraph (1), the
Secretary shall terminate the debarment of a person if the
Secretary finds that -
(I) changes in ownership, management, or operations have
fully corrected the causes of the offense involved and
provide reasonable assurances that the offense will not
occur in the future, and
(II) in applicable cases, sufficient audits, conducted by
the Food and Drug Administration or by independent experts
acceptable to the Food and Drug Administration, demonstrate
that pending applications and the development of drugs
being tested before the submission of an application are
free of fraud or material false statements.
In the case of persons debarred under subsection (a)(1) of
this section, such termination shall take effect no earlier
than the expiration of one year from the date of the
debarment.
(B) Individuals
(i) Conviction reversal
If the conviction which served as the basis for the
debarment of an individual under subsection (a)(2) of this
section or clause (i), (ii), (iii), or (iv) of subsection
(b)(2)(B) or subsection (b)(3) of this section is reversed,
the Secretary shall withdraw the order of debarment.
(ii) Application
Upon application submitted under paragraph (1), the
Secretary shall terminate the debarment of an individual who
has been debarred under subsection (b)(2)(B) or subsection
(b)(3) of this section if such termination serves the
interests of justice and adequately protects the integrity of
the drug approval process or the food importation process, as
the case may be.
(4) Special termination
(A) Application
Any person that is debarred under subsection (a)(1) of this
section (other than a person permanently debarred under
subsection (c)(2)(A)(i) of this section) or any individual who
is debarred under subsection (a)(2) of this section may apply
to the Secretary for special termination of debarment under
this subsection. Any information submitted to the Secretary
under this subparagraph does not constitute an amendment or
supplement to pending or approved abbreviated drug
applications.
(B) Corporations
Upon an application submitted under subparagraph (A), the
Secretary may take the action described in subparagraph (D) if
the Secretary, after an informal hearing, finds that -
(i) the person making the application under subparagraph
(A) has demonstrated that the felony conviction which was the
basis for such person's debarment involved the commission of
an offense which was not authorized, requested, commanded,
performed, or recklessly tolerated by the board of directors
or by a high managerial agent acting on behalf of the person
within the scope of the board's or agent's office or
employment,
(ii) all individuals who were involved in the commission of
the offense or who knew or should have known of the offense
have been removed from employment involving the development
or approval of any drug subject to sections (!1) 355 of this
title,
(iii) the person fully cooperated with all investigations
and promptly disclosed all wrongdoing to the appropriate
authorities, and
(iv) the person acted to mitigate any impact on the public
of any offense involved, including the recall, or the
discontinuation of the distribution, of any drug with respect
to which the Secretary requested a recall or discontinuation
of distribution due to concerns about the safety or efficacy
of the drug.
(C) Individuals
Upon an application submitted under subparagraph (A), the
Secretary may take the action described in subparagraph (D) if
the Secretary, after an informal hearing, finds that such
individual has provided substantial assistance in the
investigations or prosecutions of offenses which are described
in subsection (a) or (b) of this section or which relate to any
matter under the jurisdiction of the Food and Drug
Administration.
(D) Secretarial action
The action referred to in subparagraphs (B) and (C) is -
(i) in the case of a person other than an individual -
(I) terminating the debarment immediately, or
(II) limiting the period of debarment to less than one
year, and
(ii) in the case of an individual, limiting the period of
debarment to less than permanent but to no less than 1 year,
whichever best serves the interest of justice and protects the
integrity of the drug approval process.
(e) Publication and list of debarred persons
The Secretary shall publish in the Federal Register the name of
any person debarred under subsection (a) or (b) of this section,
the effective date of the debarment, and the period of the
debarment. The Secretary shall also maintain and make available to
the public a list, updated no less often than quarterly, of such
persons, of the effective dates and minimum periods of such
debarments, and of the termination of debarments.
(f) Temporary denial of approval
(1) In general
The Secretary, on the Secretary's own initiative or in response
to a petition, may, in accordance with paragraph (3), refuse by
order, for the period prescribed by paragraph (2), to approve any
abbreviated drug application submitted by any person -
(A) if such person is under an active Federal criminal
investigation in connection with an action described in
subparagraph (B),
(B) if the Secretary finds that such person -
(i) has bribed or attempted to bribe, has paid or attempted
to pay an illegal gratuity, or has induced or attempted to
induce another person to bribe or pay an illegal gratuity to
any officer, employee, or agent of the Department of Health
and Human Services or to any other Federal, State, or local
official in connection with any abbreviated drug application,
or has conspired to commit, or aided or abetted, such
actions, or
(ii) has knowingly made or caused to be made a pattern or
practice of false statements or misrepresentations with
respect to material facts relating to any abbreviated drug
application, or the production of any drug subject to an
abbreviated drug application, to any officer, employee, or
agent of the Department of Health and Human Services, or has
conspired to commit, or aided or abetted, such actions, and
(C) if a significant question has been raised regarding -
(i) the integrity of the approval process with respect to
such abbreviated drug application, or
(ii) the reliability of data in or concerning such person's
abbreviated drug application.
Such an order may be modified or terminated at any time.
(2) Applicable period
(A) In general
Except as provided in subparagraph (B), a denial of approval
of an application of a person under paragraph (1) shall be in
effect for a period determined by the Secretary but not to
exceed 18 months beginning on the date the Secretary finds that
the conditions described in subparagraphs (A), (B), and (C) of
paragraph (1) exist. The Secretary shall terminate such denial -
(i) if the investigation with respect to which the finding
was made does not result in a criminal charge against such
person, if criminal charges have been brought and the charges
have been dismissed, or if a judgment of acquittal has been
entered, or
(ii) if the Secretary determines that such finding was in
error.
(B) Extension
If, at the end of the period described in subparagraph (A),
the Secretary determines that a person has been criminally
charged for an action described in subparagraph (B) of
paragraph (1), the Secretary may extend the period of denial of
approval of an application for a period not to exceed 18
months. The Secretary shall terminate such extension if the
charges have been dismissed, if a judgment of acquittal has
been entered, or if the Secretary determines that the finding
described in subparagraph (A) was in error.
(3) Informal hearing
Within 10 days of the date an order is issued under paragraph
(1), the Secretary shall provide such person with an opportunity
for an informal hearing, to be held within such 10 days, on the
decision of the Secretary to refuse approval of an abbreviated
drug application. Within 60 days of the date on which such
hearing is held, the Secretary shall notify the person given such
hearing whether the Secretary's refusal of approval will be
continued, terminated, or otherwise modified. Such notification
shall be final agency action.
(g) Suspension authority
(1) In general
If -
(A) the Secretary finds -
(i) that a person has engaged in conduct described in
subparagraph (B) of subsection (f)(1) of this section in
connection with 2 or more drugs under abbreviated drug
applications, or
(ii) that a person has engaged in flagrant and repeated,
material violations of good manufacturing practice or good
laboratory practice in connection with the development,
manufacturing, or distribution of one or more drugs approved
under an abbreviated drug application during a 2-year period,
and -
(I) such violations may undermine the safety and efficacy
of such drugs, and
(II) the causes of such violations have not been
corrected within a reasonable period of time following
notice of such violations by the Secretary, and
(B) such person is under an active investigation by a Federal
authority in connection with a civil or criminal action
involving conduct described in subparagraph (A),
the Secretary shall issue an order suspending the distribution of
all drugs the development or approval of which was related to
such conduct described in subparagraph (A) or suspending the
distribution of all drugs approved under abbreviated drug
applications of such person if the Secretary finds that such
conduct may have affected the development or approval of a
significant number of drugs which the Secretary is unable to
identify. The Secretary shall exclude a drug from such order if
the Secretary determines that such conduct was not likely to have
influenced the safety or efficacy of such drug.
(2) Public health waiver
The Secretary shall, on the Secretary's own initiative or in
response to a petition, waive the suspension under paragraph (1)
(involving an action described in paragraph (1)(A)(i)) with
respect to any drug if the Secretary finds that such waiver is
necessary to protect the public health because sufficient
quantities of the drug would not otherwise be available. The
Secretary shall act on any petition seeking action under this
paragraph within 180 days of the date the petition is submitted
to the Secretary.
(h) Termination of suspension
The Secretary shall withdraw an order of suspension of the
distribution of a drug under subsection (g) of this section if the
person with respect to whom the order was issued demonstrates in a
petition to the Secretary -
(1)(A) on the basis of an audit by the Food and Drug
Administration or by experts acceptable to the Food and Drug
Administration, or on the basis of other information, that the
development, approval, manufacturing, and distribution of such
drug is in substantial compliance with the applicable
requirements of this chapter, and
(B) changes in ownership, management, or operations -
(i) fully remedy the patterns or practices with respect to
which the order was issued, and
(ii) provide reasonable assurances that such actions will not
occur in the future, or
(2) the initial determination was in error.
The Secretary shall act on a submission of a petition under this
subsection within 180 days of the date of its submission and the
Secretary may consider the petition concurrently with the
suspension proceeding. Any information submitted to the Secretary
under this subsection does not constitute an amendment or
supplement to a pending or approved abbreviated drug application.
(i) Procedure
The Secretary may not take any action under subsection (a), (b),
(c), (d)(3), (g), or (h) of this section with respect to any person
unless the Secretary has issued an order for such action made on
the record after opportunity for an agency hearing on disputed
issues of material fact. In the course of any investigation or
hearing under this subsection, the Secretary may administer oaths
and affirmations, examine witnesses, receive evidence, and issue
subpoenas requiring the attendance and testimony of witnesses and
the production of evidence that relates to the matter under
investigation.
(j) Judicial review
(1) In general
Except as provided in paragraph (2), any person that is the
subject of an adverse decision under subsection (a), (b), (c),
(d), (f), (g), or (h) of this section may obtain a review of such
decision by the United States Court of Appeals for the District
of Columbia or for the circuit in which the person resides, by
filing in such court (within 60 days following the date the
person is notified of the Secretary's decision) a petition
requesting that the decision be modified or set aside.
(2) Exception
Any person that is the subject of an adverse decision under
clause (iii) or (iv) of subsection (b)(2)(B) of this section may
obtain a review of such decision by the United States District
Court for the District of Columbia or a district court of the
United States for the district in which the person resides, by
filing in such court (within 30 days following the date the
person is notified of the Secretary's decision) a complaint
requesting that the decision be modified or set aside. In such an
action, the court shall determine the matter de novo.
(k) Certification
Any application for approval of a drug product shall include -
(1) a certification that the applicant did not and will not use
in any capacity the services of any person debarred under
subsection (a) or (b) of this section, in connection with such
application, and
(2) if such application is an abbreviated drug application, a
list of all convictions, described in subsections (a) and (b) of
this section which occurred within the previous 5 years, of the
applicant and affiliated persons responsible for the development
or submission of such application.
(l) Applicability
(1) Conviction
For purposes of this section, a person is considered to have
been convicted of a criminal offense -
(A) when a judgment of conviction has been entered against
the person by a Federal or State court, regardless of whether
there is an appeal pending,
(B) when a plea of guilty or nolo contendere by the person
has been accepted by a Federal or State court, or
(C) when the person has entered into participation in a first
offender, deferred adjudication, or other similar arrangement
or program where judgment of conviction has been withheld.
(2) Effective dates
Subsection (a) of this section, subparagraph (A) of subsection
(b)(2) of this section, clauses (i) and (ii) of subsection
(b)(2)(B) of this section, and subsection (b)(3)(A) of this
section shall not apply to a conviction which occurred more than
5 years before the initiation of an agency action proposed to be
taken under subsection (a) or (b) of this section. Clauses (iii)
and (iv) of subsection (b)(2)(B) of this section, subsection
(b)(3)(B) of this section, and subsections (f) and (g) of this
section shall not apply to an act or action which occurred more
than 5 years before the initiation of an agency action proposed
to be taken under subsection (b), (f), or (g) of this section.
Clause (iv) of subsection (b)(2)(B) of this section shall not
apply to an action which occurred before June 1, 1992. Subsection
(k) of this section shall not apply to applications submitted to
the Secretary before June 1, 1992.
(m) Devices; mandatory debarment regarding third-party inspections
and reviews
(1) In general
If the Secretary finds that a person has been convicted of a
felony under section 331(gg) of this title, the Secretary shall
debar such person from being accredited under section 360m(b) or
374(g)(2) of this title and from carrying out activities under an
agreement described in section 383(b) of this title.
(2) Debarment period
The Secretary shall debar a person under paragraph (1) for the
following periods:
(A) The period of debarment of a person (other than an
individual) shall not be less than 1 year or more than 10
years, but if an act leading to a subsequent debarment under
such paragraph occurs within 10 years after such person has
been debarred under such paragraph, the period of debarment
shall be permanent.
(B) The debarment of an individual shall be permanent.
(3) Termination of debarment; judicial review; other matters
Subsections (c)(3), (d), (e), (i), (j), and (l)(1) of this
section apply with respect to a person (other than an individual)
or an individual who is debarred under paragraph (1) to the same
extent and in the same manner as such subsections apply with
respect to a person who is debarred under subsection (a)(1) of
this section, or an individual who is debarred under subsection
(a)(2) of this section, respectively.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 306, as added Pub. L. 102-282, Sec.
2, May 13, 1992, 106 Stat. 150; amended Pub. L. 105-115, title I,
Sec. 125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107-188,
title III, Sec. 304(a)-(c), June 12, 2002, 116 Stat. 665, 666; Pub.
L. 107-250, title II, Sec. 203, Oct. 26, 2002, 116 Stat. 1610.)
-MISC1-
PRIOR PROVISIONS
A prior section 306 of act June 25, 1938, was renumbered section
309 and is classified to section 336 of this title.
AMENDMENTS
2002 - Subsec. (a). Pub. L. 107-188, Sec. 304(b)(1), substituted
"Mandatory debarment; certain drug applications" for "Mandatory
debarment" in heading.
Subsec. (b). Pub. L. 107-188, Sec. 304(b)(2)(A), substituted
"Permissive debarment; certain drug applications; food imports" for
"Permissive debarment" in heading.
Subsec. (b)(1)(C). Pub. L. 107-188, Sec. 304(a)(1), added subpar.
(C).
Subsec. (b)(2). Pub. L. 107-188, Sec. 304(b)(2)(B), substituted
"permissive debarment; certain drug applications" for "permissive
debarment" in heading.
Pub. L. 107-188, Sec. 304(a)(2)(A), inserted "subparagraph (A) or
(B) of" before "paragraph (1)" in introductory provisions.
Subsec. (b)(3), (4). Pub. L. 107-188, Sec. 304(a)(2)(B), (C),
added par. (3) and redesignated former par. (3) as (4).
Subsec. (c)(2)(A)(iii). Pub. L. 107-188, Sec. 304(b)(3),
substituted "paragraph (2) or (3) of subsection (b)" for
"subsection (b)(2)".
Subsec. (d)(3)(A)(i). Pub. L. 107-188, Sec. 304(b)(4)(A),
substituted "subsection (a)(1) of this section or paragraph (2)(A)
or (3) of subsection (b)" for "subsection (a)(1) or (b)(2)(A)".
Subsec. (d)(3)(A)(ii)(II). Pub. L. 107-188, Sec. 304(b)(4)(B),
inserted "in applicable cases," before "sufficient audits".
Subsec. (d)(3)(B)(i). Pub. L. 107-188, Sec. 304(b)(4)(C),
inserted "or subsection (b)(3)" after "subsection (b)(2)(B)".
Subsec. (d)(3)(B)(ii). Pub. L. 107-188, Sec. 304(b)(4)(C), (D),
inserted "or subsection (b)(3)" after "subsection (b)(2)(B)" and
"or the food importation process, as the case may be" before
period.
Subsec. (l)(2). Pub. L. 107-188, Sec. 304(c), in first sentence
struck out "and" after "subsection (b)(2) of this section," and
inserted ", and subsection (b)(3)(A) of this section" after
"subsection (b)(2)(B) of this section" and in second sentence
inserted ", subsection (b)(3)(B) of this section," after
"subsection (b)(2)(B) of this section".
Subsec. (m). Pub. L. 107-250 added subsec. (m).
1997 - Subsec. (d)(4)(B)(ii). Pub. L. 105-115 struck out "or 357"
after "355".
CONSTRUCTION
Section 7 of Pub. L. 102-282 provided that: "No amendment made by
this Act [enacting this section and sections 335b and 335c of this
title and amending sections 321, 336, 337, and 355 of this title]
shall preclude any other civil, criminal, or administrative remedy
provided under Federal or State law, including any private right of
action against any person for the same action subject to any action
or civil penalty under an amendment made by this Act."
CONGRESSIONAL FINDINGS
Section 1(c) of Pub. L. 102-282 provided that: "The Congress
finds that -
"(1) there is substantial evidence that significant corruption
occurred in the Food and Drug Administration's process of
approving drugs under abbreviated drug applications,
"(2) there is a need to establish procedures designed to
restore and to ensure the integrity of the abbreviated drug
application approval process and to protect the public health,
and
"(3) there is a need to establish procedures to bar individuals
who have been convicted of crimes pertaining to the regulation of
drug products from working for companies that manufacture or
distribute such products."
-FOOTNOTE-
(!1) So in original. Probably should be "section".
-End-
-CITE-
21 USC Sec. 335b 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 335b. Civil penalties
-STATUTE-
(a) In general
Any person that the Secretary finds -
(1) knowingly made or caused to be made, to any officer,
employee, or agent of the Department of Health and Human
Services, a false statement or misrepresentation of a material
fact in connection with an abbreviated drug application,
(2) bribed or attempted to bribe or paid or attempted to pay an
illegal gratuity to any officer, employee, or agent of the
Department of Health and Human Services in connection with an
abbreviated drug application,
(3) destroyed, altered, removed, or secreted, or procured the
destruction, alteration, removal, or secretion of, any material
document or other material evidence which was the property of or
in the possession of the Department of Health and Human Services
for the purpose of interfering with that Department's discharge
of its responsibilities in connection with an abbreviated drug
application,
(4) knowingly failed to disclose, to an officer or employee of
the Department of Health and Human Services, a material fact
which such person had an obligation to disclose relating to any
drug subject to an abbreviated drug application,
(5) knowingly obstructed an investigation of the Department of
Health and Human Services into any drug subject to an abbreviated
drug application,
(6) is a person that has an approved or pending drug product
application and has knowingly -
(A) employed or retained as a consultant or contractor, or
(B) otherwise used in any capacity the services of,
a person who was debarred under section 335a of this title, or
(7) is an individual debarred under section 335a of this title
and, during the period of debarment, provided services in any
capacity to a person that had an approved or pending drug product
application,
shall be liable to the United States for a civil penalty for each
such violation in an amount not to exceed $250,000 in the case of
an individual and $1,000,000 in the case of any other person.
(b) Procedure
(1) In general
(A) Action by the Secretary
A civil penalty under subsection (a) of this section shall be
assessed by the Secretary on a person by an order made on the
record after an opportunity for an agency hearing on disputed
issues of material fact and the amount of the penalty. In the
course of any investigation or hearing under this subparagraph,
the Secretary may administer oaths and affirmations, examine
witnesses, receive evidence, and issue subpoenas requiring the
attendance and testimony of witnesses and the production of
evidence that relates to the matter under investigation.
(B) Action by the Attorney General
In lieu of a proceeding under subparagraph (A), the Attorney
General may, upon request of the Secretary, institute a civil
action to recover a civil money penalty in the amount and for
any of the acts set forth in subsection (a) of this section.
Such an action may be instituted separately from or in
connection with any other claim, civil or criminal, initiated
by the Attorney General under this chapter.
(2) Amount
In determining the amount of a civil penalty under paragraph
(1), the Secretary or the court shall take into account the
nature, circumstances, extent, and gravity of the act subject to
penalty, the person's ability to pay, the effect on the person's
ability to continue to do business, any history of prior, similar
acts, and such other matters as justice may require.
(3) Limitation on actions
No action may be initiated under this section -
(A) with respect to any act described in subsection (a) of
this section that occurred before May 13, 1992, or
(B) more than 6 years after the date when facts material to
the act are known or reasonably should have been known by the
Secretary but in no event more than 10 years after the date the
act took place.
(c) Judicial review
Any person that is the subject of an adverse decision under
subsection (b)(1)(A) of this section may obtain a review of such
decision by the United States Court of Appeals for the District of
Columbia or for the circuit in which the person resides, by filing
in such court (within 60 days following the date the person is
notified of the Secretary's decision) a petition requesting that
the decision be modified or set aside.
(d) Recovery of penalties
The Attorney General may recover any civil penalty (plus interest
at the currently prevailing rates from the date the penalty became
final) assessed under subsection (b)(1)(A) of this section in an
action brought in the name of the United States. The amount of such
penalty may be deducted, when the penalty has become final, from
any sums then or later owing by the United States to the person
against whom the penalty has been assessed. In an action brought
under this subsection, the validity, amount, and appropriateness of
the penalty shall not be subject to judicial review.
(e) Informants
The Secretary may award to any individual (other than an officer
or employee of the Federal Government or a person who materially
participated in any conduct described in subsection (a) of this
section) who provides information leading to the imposition of a
civil penalty under this section an amount not to exceed -
(1) $250,000, or
(2) one-half of the penalty so imposed and collected,
whichever is less. The decision of the Secretary on such award
shall not be reviewable.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 307, as added Pub. L. 102-282, Sec.
3, May 13, 1992, 106 Stat. 159; amended Pub. L. 103-80, Sec. 3(g),
Aug. 13, 1993, 107 Stat. 776.)
-MISC1-
PRIOR PROVISIONS
A prior section 307 of act June 25, 1938, was renumbered section
310 and is classified to section 337 of this title.
AMENDMENTS
1993 - Subsec. (b)(3)(A). Pub. L. 103-80 made technical amendment
to reference to May 13, 1992, to reflect correction of
corresponding provision of original act.
CONSTRUCTION
This section not to preclude any other civil, criminal, or
administrative remedy provided under Federal or State law,
including any private right of action against any person for the
same action subject to any action or civil penalty under an
amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
282, set out as a note under section 335a of this title.
-End-
-CITE-
21 USC Sec. 335c 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 335c. Authority to withdraw approval of abbreviated drug
applications
-STATUTE-
(a) In general
The Secretary -
(1) shall withdraw approval of an abbreviated drug application
if the Secretary finds that the approval was obtained, expedited,
or otherwise facilitated through bribery, payment of an illegal
gratuity, or fraud or material false statement, and
(2) may withdraw approval of an abbreviated drug application if
the Secretary finds that the applicant has repeatedly
demonstrated a lack of ability to produce the drug for which the
application was submitted in accordance with the formulations or
manufacturing practice set forth in the abbreviated drug
application and has introduced, or attempted to introduce, such
adulterated or misbranded drug into commerce.
(b) Procedure
The Secretary may not take any action under subsection (a) of
this section with respect to any person unless the Secretary has
issued an order for such action made on the record after
opportunity for an agency hearing on disputed issues of material
fact. In the course of any investigation or hearing under this
subsection, the Secretary may administer oaths and affirmations,
examine witnesses, receive evidence, and issue subpoenas requiring
the attendance and testimony of witnesses and the production of
evidence that relates to the matter under investigation.
(c) Applicability
Subsection (a) of this section shall apply with respect to
offenses or acts regardless of when such offenses or acts occurred.
(d) Judicial review
Any person that is the subject of an adverse decision under
subsection (a) of this section may obtain a review of such decision
by the United States Court of Appeals for the District of Columbia
or for the circuit in which the person resides, by filing in such
court (within 60 days following the date the person is notified of
the Secretary's decision) a petition requesting that the decision
be modified or set aside.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 308, as added Pub. L. 102-282, Sec.
4, May 13, 1992, 106 Stat. 160.)
-MISC1-
CONSTRUCTION
This section not to preclude any other civil, criminal, or
administrative remedy provided under Federal or State law,
including any private right of action against any person for the
same action subject to any action or civil penalty under an
amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-
282, set out as a note under section 335a of this title.
-End-
-CITE-
21 USC Sec. 336 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 336. Report of minor violations
-STATUTE-
Nothing in this chapter shall be construed as requiring the
Secretary to report for prosecution, or for the institution of
libel or injunction proceedings, minor violations of this chapter
whenever he believes that the public interest will be adequately
served by a suitable written notice or warning.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 309, formerly Sec. 306, 52 Stat.
1045; renumbered Sec. 309, Pub. L. 102-282, Sec. 2, May 13, 1992,
106 Stat. 150.)
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 337 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES
-HEAD-
Sec. 337. Proceedings in name of United States; provision as to
subpoenas
-STATUTE-
(a) Except as provided in subsection (b) of this section, all
such proceedings for the enforcement, or to restrain violations, of
this chapter shall be by and in the name of the United States.
Subpoenas for witnesses who are required to attend a court of the
United States, in any district, may run into any other district in
any proceeding under this section.
(b)(1) A State may bring in its own name and within its
jurisdiction proceedings for the civil enforcement, or to restrain
violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f),
343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if
the food that is the subject of the proceedings is located in the
State.
(2) No proceeding may be commenced by a State under paragraph (1)
-
(A) before 30 days after the State has given notice to the
Secretary that the State intends to bring such proceeding,
(B) before 90 days after the State has given notice to the
Secretary of such intent if the Secretary has, within such 30
days, commenced an informal or formal enforcement action
pertaining to the food which would be the subject of such
proceeding, or
(C) if the Secretary is diligently prosecuting a proceeding in
court pertaining to such food, has settled such proceeding, or
has settled the informal or formal enforcement action pertaining
to such food.
In any court proceeding described in subparagraph (C), a State may
intervene as a matter of right.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 310, formerly Sec. 307, 52 Stat.
1046; Sept. 3, 1954, ch. 1263, Sec. 37, 68 Stat. 1239; Pub. L. 101-
535, Sec. 4, Nov. 8, 1990, 104 Stat. 2362; renumbered Sec. 310,
Pub. L. 102-282, Sec. 2, May 13, 1992, 106 Stat. 150.)
-MISC1-
AMENDMENTS
1990 - Pub. L. 101-535 substituted "(a) Except as provided in
subsection (b) of this section, all" for "All" and "any proceeding
under this section" for "any such proceeding" and added subsec.
(b).
1954 - Act Sept. 3, 1954, struck out reference to section 654 of
title 28.
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101-535 effective 24 months after Nov. 8,
1990, except that such amendment effective Dec. 31, 1993, with
respect to dietary supplements of vitamins, minerals, herbs, or
other similar nutritional substances, see section 10(a)(1)(C) of
Pub. L. 101-535, set out as a note under section 343 of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Amendments by Pub. L. 101-535 not to be construed to alter
authority of Secretary of Health and Human Services and Secretary
of Agriculture under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.), see section 9 of Pub. L. 101-535, set out as a note under
section 343 of this title.
-End-
-CITE-
21 USC SUBCHAPTER IV - FOOD 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
SUBCHAPTER IV - FOOD
-End-
-CITE-
21 USC Sec. 341 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 341. Definitions and standards for food
-STATUTE-
Whenever in the judgment of the Secretary such action will
promote honesty and fair dealing in the interest of consumers, he
shall promulgate regulations fixing and establishing for any food,
under its common or usual name so far as practicable, a reasonable
definition and standard of identity, a reasonable standard of
quality, or reasonable standards of fill of container. No
definition and standard of identity and no standard of quality
shall be established for fresh or dried fruits, fresh or dried
vegetables, or butter, except that definitions and standards of
identity may be established for avocadoes, cantaloupes, citrus
fruits, and melons. In prescribing any standard of fill of
container, the Secretary shall give due consideration to the
natural shrinkage in storage and in transit of fresh natural food
and to need for the necessary packing and protective material. In
the prescribing of any standard of quality for any canned fruit or
canned vegetable, consideration shall be given and due allowance
made for the differing characteristics of the several varieties of
such fruit or vegetable. In prescribing a definition and standard
of identity for any food or class of food in which optional
ingredients are permitted, the Secretary shall, for the purpose of
promoting honesty and fair dealing in the interest of consumers,
designate the optional ingredients which shall be named on the
label. Any definition and standard of identity prescribed by the
Secretary for avocadoes, cantaloupes, citrus fruits, or melons
shall relate only to maturity and to the effects of freezing.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 401, 52 Stat. 1046; Apr. 15, 1954,
ch. 143, Sec. 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, Sec. 1, 70
Stat. 919; Pub. L. 103-80, Sec. 3(h), Aug. 13, 1993, 107 Stat.
776.)
-MISC1-
AMENDMENTS
1993 - Pub. L. 103-80 substituted "or reasonable standards of
fill of container. No definition" for "and/or reasonable standards
of fill of container: Provided, That no definition".
1956 - Act Aug. 1, 1956, designated provisions constituting
subsec. (a) as entire section and repealed subsec. (b) which
provided the procedure for establishment of regulations and is
covered by section 371(e) of this title.
1954 - Act Apr. 15, 1954, designated existing provisions as
subsec. (a) and added subsec. (b).
SAVINGS PROVISION
Section 3 of act Aug. 1, 1956, provided that: "In any case in
which, prior to the enactment of this Act [Aug. 1, 1956], a public
hearing has been begun in accordance with section 401 of the
Federal Food, Drug, and Cosmetic Act [341 of this title] upon a
proposal to issue, amend, or repeal any regulation contemplated by
such section, or has been begun in accordance with section 701(e)
of such Act [section 371(e) of this title] upon a proposal to
issue, amend, or repeal any regulation contemplated by section
403(j), 404(a), 406(a) or (b), 501(b), 502(d), 502(h), 504 or 604
of such Act [section 343(j), 344(a), 346(a) or (b), 351(b), 352(d),
352(h), 354, or 364 of this title], the provisions of such section
401 or 701(e), as the case may be, as in force immediately prior to
the date of the enactment of this Act [Aug. 1, 1956], shall be
applicable as though this Act [amending this section and section
371(e) of this title] had not been enacted."
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-MISC2-
FOOD SAFETY AND SECURITY STRATEGY
Pub. L. 107-188, title III, Sec. 301, June 12, 2002, 116 Stat.
662, provided that:
"(a) In General. - The President's Council on Food Safety (as
established by Executive Order No. 13100 [set out below]) shall, in
consultation with the Secretary of Transportation, the Secretary of
the Treasury, other relevant Federal agencies, the food industry,
consumer and producer groups, scientific organizations, and the
States, develop a crisis communications and education strategy with
respect to bioterrorist threats to the food supply. Such strategy
shall address threat assessments; technologies and procedures for
securing food processing and manufacturing facilities and modes of
transportation; response and notification procedures; and risk
communications to the public.
"(b) Authorization of Appropriations. - For the purpose of
implementing the strategy developed under subsection (a), there are
authorized to be appropriated $750,000 for fiscal year 2002, and
such sums as may be necessary for each subsequent fiscal year."
FOOD SAFETY COMMISSION
Pub. L. 107-171, title X, Sec. 10807, May 13, 2002, 116 Stat.
527, provided that:
"(a) Establishment. -
"(1) In general. - There is established a commission to be
known as the 'Food Safety Commission' (referred to in this
section as the 'Commission').
"(2) Membership. -
"(A) Composition. - The Commission shall be composed of 15
members (including a Chairperson, appointed by the
President[)].
"(B) Eligibility. -
"(i) In general. - Members of the Commission -
"(I) shall have specialized training or significant experience
in matters under the jurisdiction of the Commission; and
"(II) shall represent, at a minimum -
"(aa) consumers;
"(bb) food scientists;
"(cc) the food industry; and
"(dd) health professionals.
"(ii) Federal employees. - Not more than 3 members of the
Commission may be Federal employees.
"(C) Date of appointments. - The appointment of the members
of the Commission shall be made as soon as practicable after
the date on which funds authorized to be appropriated under
subsection (e)(1) are made available.
"(D) Vacancies. - A vacancy on the Commission -
"(i) shall not affect the powers of the Commission; and
"(ii) shall be filled -
"(I) not later than 60 days after the date on which the
vacancy occurs; and
"(II) in the same manner as the original appointment was made.
"(3) Meetings. -
"(A) Initial meeting. - The initial meeting of the Commission
shall be conducted not later than 30 days after the date of
appointment of the final member of the Commission.
"(B) Other meetings. - The Commission shall meet at the call
of the Chairperson.
"(4) Quorum; standing rules. -
"(A) Quorum. - A majority of the members of the Commission
shall constitute a quorum to conduct business.
"(B) Standing rules. - At the first meeting of the
Commission, the Commission shall adopt standing rules of the
Commission to guide the conduct of business and decisionmaking
of the Commission.
"(b) Duties. -
"(1) Recommendations. - The Commission shall make specific
recommendations to enhance the food safety system of the United
States, including a description of how each recommendation would
improve food safety.
"(2) Components. - Recommendations made by the Commission under
paragraph (1) shall address all food available commercially in
the United States.
"(3) Report. - Not later than 1 year after the date on which
the Commission first meets, the Commission shall submit to the
President and Congress -
"(A) the findings, conclusions, and recommendations of the
Commission, including a description of how each recommendation
would improve food safety;
"(B) a summary of any other material used by the Commission
in the preparation of the report under this paragraph; and
"(C) if requested by 1 or more members of the Commission, a
statement of the minority views of the Commission.
"(c) Powers of the Commission. -
"(1) Hearings. - The Commission may, for the purpose of
carrying out this section, hold such hearings, meet and act at
such times and places, take such testimony, and receive such
evidence as the Commission considers advisable.
"(2) Information from federal agencies. -
"(A) In general. - The Commission may secure directly, from
any Federal agency, such information as the Commission
considers necessary to carry out this section.
"(B) Provision of information. -
"(i) In general. - Subject to subparagraph (C), on the
request of the Commission, the head of a Federal agency
described in subparagraph (A) may furnish information
requested by the Commission to the Commission.
"(ii) Administration. - The furnishing of information by a
Federal agency to the Commission shall not be considered a
waiver of any exemption available to the agency under section
552 of title 5, United States Code.
"(C) Information to be kept confidential. -
"(i) In general. - For purposes of section 1905 of title
18, United States Code -
"(I) the Commission shall be considered an agency of the
Federal Government; and
"(II) any individual employed by an individual, entity, or
organization that is a party to a contract with the
Commission under this section shall be considered an employee
of the Commission.
"(ii) Prohibition on disclosure. - Information obtained by
the Commission, other than information that is available to
the public, shall not be disclosed to any person in any
manner except to an employee of the Commission as described
in clause (i), for the purpose of receiving, reviewing, or
processing the information.
"(d) Commission Personnel Matters. -
"(1) Members. -
"(A) Compensation. - A member of the Commission shall serve
without compensation for the services of the member on the
Commission.
"(B) Travel expenses. - A member of the Commission shall be
allowed travel expenses, including per diem in lieu of
subsistence, at rates authorized for an employee of an agency
under subchapter I of chapter 57 of title 5, United States
Code, while away from the home or regular place of business of
the member in the performance of the duties of the Commission.
"(2) Staff. -
"(A) In general. - The Chairperson of the Commission may,
without regard to the civil service laws (including
regulations), appoint and terminate the appointment of an
executive director and such other additional personnel as are
necessary to enable the Commission to perform the duties of the
Commission.
"(B) Confirmation of executive director. - The employment of
an executive director shall be subject to confirmation by the
Commission.
"(C) Compensation. -
"(i) In general. - Except as provided in clause (ii), the
Chairperson of the Commission may fix the compensation of the
executive director and other personnel without regard to the
provisions of chapter 51 and subchapter III of chapter 53 of
title 5, United States Code, relating to classification of
positions and General Schedule pay rates.
"(ii) Maximum rate of pay. - The rate of pay for the
executive director and other personnel shall not exceed the
rate payable for level II of the Executive Schedule under
section 5316 of title 5, United States Code.
"(3) Detail of federal government employees. -
"(A) In general. - An employee of the Federal Government may
be detailed to the Commission, without reimbursement, for such
period of time as is permitted by law.
"(B) Civil service status. - The detail of the employee shall
be without interruption or loss of civil service status or
privilege.
"(4) Procurement of temporary and intermittent services. - The
Chairperson of the Commission may procure temporary and
intermittent services in accordance with section 3109(b) of title
5, United States Code, at rates for individuals that do not
exceed the daily equivalent of the annual rate of basic pay
prescribed for level II of the Executive Schedule under section
5316 of that title.
"(e) Authorization of Appropriations. -
"(1) In general. - There is authorized to be appropriated such
sums as are necessary to carry out this section.
"(2) Limitation. - No payment may be made under subsection (d)
except to the extent provided for in advance in an appropriations
Act.
"(f) Termination. - The Commission shall terminate on the date
that is 60 days after the date on which the Commission submits the
recommendations and report under subsection (b)(3)."
-EXEC-
EX. ORD. NO. 13100. PRESIDENT'S COUNCIL ON FOOD SAFETY
Ex. Ord. No. 13100, Aug. 25, 1998, 63 F.R. 45661, as amended by
Ex. Ord. No. 13286, Sec. 16, Feb. 28, 2003, 68 F.R. 10623,
provided:
By the authority vested in me as President by the Constitution
and the laws of the United States of America, and in order to
improve the safety of the food supply through science-based
regulation and well-coordinated inspection, enforcement, research,
and education programs, it is hereby ordered as follows:
Section 1. Establishment of President's Council on Food Safety.
(a) There is established the President's Council on Food Safety
("Council"). The Council shall comprise the Secretaries of
Agriculture, Commerce, Health and Human Services, and Homeland
Security, the Director of the Office of Management and Budget
(OMB), the Administrator of the Environmental Protection Agency,
the Assistant to the President for Science and Technology/Director
of the Office of Science and Technology Policy, the Assistant to
the President for Domestic Policy, and the Director of the National
Partnership for Reinventing Government. The Council shall consult
with other Federal agencies and State, local, and tribal government
agencies, and consumer, producer, scientific, and industry groups,
as appropriate.
(b) The Secretaries of Agriculture and of Health and Human
Services and the Assistant to the President for Science and
Technology/Director of the Office of Science and Technology Policy
shall serve as Joint Chairs of the Council.
Sec. 2. Purpose. The purpose of the Council shall be to develop a
comprehensive strategic plan for Federal food safety activities,
taking into consideration the findings and recommendations of the
National Academy of Sciences report "Ensuring Safe Food from
Production to Consumption" and other input from the public on how
to improve the effectiveness of the current food safety system. The
Council shall make recommendations to the President on how to
advance Federal efforts to implement a comprehensive science-based
strategy to improve the safety of the food supply and to enhance
coordination among Federal agencies, State, local, and tribal
governments, and the private sector. The Council shall advise
Federal agencies in setting priority areas for investment in food
safety.
Sec. 3. Specific Activities and Functions. (a) The Council shall
develop a comprehensive strategic Federal food safety plan that
contains specific recommendations on needed changes, including
measurable outcome goals. The principal goal of the plan should be
the establishment of a seamless, science-based food safety system.
The plan should address the steps necessary to achieve this goal,
including the key public health, resource, and management issues
regarding food safety. The planning process should consider both
short-term and long-term issues including new and emerging threats
and the special needs of vulnerable populations such as children
and the elderly. In developing this plan, the Council shall consult
with all interested parties, including State and local agencies,
tribes, consumers, producers, industry, and academia.
(b) Consistent with the comprehensive strategic Federal food
safety plan described in section 3(a) of this order, the Council
shall advise agencies of priority areas for investment in food
safety and ensure that Federal agencies annually develop
coordinated food safety budgets for submission to the OMB that
sustain and strengthen existing capacities, eliminate duplication,
and ensure the most effective use of resources for improving food
safety. The Council shall also ensure that Federal agencies
annually develop a unified budget for submission to the OMB for the
President's Food Safety Initiative and such other food safety
issues as the Council determines appropriate.
(c) The Council shall ensure that the Joint Institute for Food
Safety Research (JIFSR), in consultation with the National Science
and Technology Council, establishes mechanisms to guide Federal
research efforts toward the highest priority food safety needs. The
JIFSR shall report to the Council on a regular basis on its
efforts: (i) to develop a strategic plan for conducting food safety
research activities consistent with the President's Food Safety
Initiative and such other food safety activities as the JIFSR
determines appropriate; and (ii) to coordinate efficiently, within
the executive branch and with the private sector and academia, all
Federal food safety research.
Sec. 4. Cooperation. All actions taken by the Council shall, as
appropriate, promote partnerships and cooperation with States,
tribes, and other public and private sector efforts wherever
possible to improve the safety of the food supply.
Sec. 5. General Provisions. This order is intended only to
improve the internal management of the executive branch and is not
intended to, nor does it, create any right or benefit, substantive
or procedural, enforceable at law by a party against the United
States, its agencies, its officers or any person. Nothing in this
order shall affect or alter the statutory responsibilities of any
Federal agency charged with food safety responsibilities.
-End-
-CITE-
21 USC Sec. 342 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 342. Adulterated food
-STATUTE-
A food shall be deemed to be adulterated -
(a) Poisonous, insanitary, etc., ingredients
(1) If it bears or contains any poisonous or deleterious
substance which may render it injurious to health; but in case the
substance is not an added substance such food shall not be
considered adulterated under this clause if the quantity of such
substance in such food does not ordinarily render it injurious to
health.(!1) (2)(A) if it bears or contains any added poisonous or
added deleterious substance (other than a substance that is a
pesticide chemical residue in or on a raw agricultural commodity or
processed food, a food additive, a color additive, or a new animal
drug) that is unsafe within the meaning of section 346 of this
title; or (B) if it bears or contains a pesticide chemical residue
that is unsafe within the meaning of section 346a(a) of this title;
or (C) if it is or if it bears or contains (i) any food additive
that is unsafe within the meaning of section 348 of this title; or
(ii) a new animal drug (or conversion product thereof) that is
unsafe within the meaning of section 360b of this title; or (3) if
it consists in whole or in part of any filthy, putrid, or
decomposed substance, or if it is otherwise unfit for food; or (4)
if it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health; or (5) if it
is, in whole or in part, the product of a diseased animal or of an
animal which has died otherwise than by slaughter; or (6) if its
container is composed, in whole or in part, of any poisonous or
deleterious substance which may render the contents injurious to
health; or (7) if it has been intentionally subjected to radiation,
unless the use of the radiation was in conformity with a regulation
or exemption in effect pursuant to section 348 of this title.
(b) Absence, substitution, or addition of constituents
(1) If any valuable constituent has been in whole or in part
omitted or abstracted therefrom; or (2) if any substance has been
substituted wholly or in part therefor; or (3) if damage or
inferiority has been concealed in any manner; or (4) if any
substance has been added thereto or mixed or packed therewith so as
to increase its bulk or weight, or reduce its quality or strength,
or make it appear better or of greater value than it is.
(c) Color additives
If it is, or it bears or contains, a color additive which is
unsafe within the meaning of section 379e(a) of this title.
(d) Confectionery containing alcohol or nonnutritive substance
If it is confectionery, and -
(1) has partially or completely imbedded therein any
nonnutritive object, except that this subparagraph shall not
apply in the case of any nonnutritive object if, in the judgment
of the Secretary as provided by regulations, such object is of
practical functional value to the confectionery product and would
not render the product injurious or hazardous to health;
(2) bears or contains any alcohol other than alcohol not in
excess of one-half of 1 per centum by volume derived solely from
the use of flavoring extracts, except that this clause shall not
apply to confectionery which is introduced or delivered for
introduction into, or received or held for sale in, interstate
commerce if the sale of such confectionery is permitted under the
laws of the State in which such confectionery is intended to be
offered for sale;
(3) bears or contains any nonnutritive substance, except that
this subparagraph shall not apply to a safe nonnutritive
substance which is in or on confectionery by reason of its use
for some practical functional purpose in the manufacture,
packaging, or storage of such confectionery if the use of the
substance does not promote deception of the consumer or otherwise
result in adulteration or misbranding in violation of any
provision of this chapter, except that the Secretary may, for the
purpose of avoiding or resolving uncertainty as to the
application of this subparagraph, issue regulations allowing or
prohibiting the use of particular nonnutritive substances.
(e) Oleomargarine containing filthy, putrid, etc., matter
If it is oleomargarine or margarine or butter and any of the raw
material used therein consisted in whole or in part of any filthy,
putrid, or decomposed substance, or such oleomargarine or margarine
or butter is otherwise unfit for food.
(f) Dietary supplement or ingredient: safety
(1) If it is a dietary supplement or contains a dietary
ingredient that -
(A) presents a significant or unreasonable risk of illness or
injury under -
(i) conditions of use recommended or suggested in labeling,
or
(ii) if no conditions of use are suggested or recommended in
the labeling, under ordinary conditions of use;
(B) is a new dietary ingredient for which there is inadequate
information to provide reasonable assurance that such ingredient
does not present a significant or unreasonable risk of illness or
injury;
(C) the Secretary declares to pose an imminent hazard to public
health or safety, except that the authority to make such
declaration shall not be delegated and the Secretary shall
promptly after such a declaration initiate a proceeding in
accordance with sections 554 and 556 of title 5 to affirm or
withdraw the declaration; or
(D) is or contains a dietary ingredient that renders it
adulterated under paragraph (a)(1) under the conditions of use
recommended or suggested in the labeling of such dietary
supplement.
In any proceeding under this subparagraph, the United States shall
bear the burden of proof on each element to show that a dietary
supplement is adulterated. The court shall decide any issue under
this paragraph on a de novo basis.
(2) Before the Secretary may report to a United States attorney a
violation of paragraph (!2) (1)(A) for a civil proceeding, the
person against whom such proceeding would be initiated shall be
given appropriate notice and the opportunity to present views,
orally and in writing, at least 10 days before such notice, with
regard to such proceeding.
(g) Dietary supplement: manufacturing practices
(1) If it is a dietary supplement and it has been prepared,
packed, or held under conditions that do not meet current good
manufacturing practice regulations, including regulations
requiring, when necessary, expiration date labeling, issued by the
Secretary under subparagraph (2).
(2) The Secretary may by regulation prescribe good manufacturing
practices for dietary supplements. Such regulations shall be
modeled after current good manufacturing practice regulations for
food and may not impose standards for which there is no current and
generally available analytical methodology. No standard of current
good manufacturing practice may be imposed unless such standard is
included in a regulation promulgated after notice and opportunity
for comment in accordance with chapter 5 of title 5.
(h) Reoffer of food previously denied admission
If it is an article of food imported or offered for import into
the United States and the article of food has previously been
refused admission under section 381(a) of this title, unless the
person reoffering the article affirmatively establishes, at the
expense of the owner or consignee of the article, that the article
complies with the applicable requirements of this chapter, as
determined by the Secretary.
(i) Noncompliance with sanitary transportation practices
If it is transported or offered for transport by a shipper,
carrier by motor vehicle or rail vehicle, receiver, or any other
person engaged in the transportation of food under conditions that
are not in compliance with regulations promulgated under section
350e of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 402, 52 Stat. 1046; Mar. 16, 1950,
ch. 61, Sec. 3(d), 64 Stat. 21; July 22, 1954, ch. 559, Sec. 2, 68
Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Pub. L. 85-929,
Sec. 3(a), (b), Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86-2, Mar.
17, 1959, 73 Stat. 3; Pub. L. 86-618, title I, Secs. 102(a)(1),
(2), 105(c), July 12, 1960, 74 Stat. 397, 398, 404; Pub. L. 89-477,
June 29, 1966, 80 Stat. 231; Pub. L. 90-399, Sec. 104, July 13,
1968, 82 Stat. 352; Pub. L. 99-252, Sec. 10, Feb. 27, 1986, 100
Stat. 35; Pub. L. 102-571, title I, Sec. 107(4), Oct. 29, 1992, 106
Stat. 4499; Pub. L. 103-80, Sec. 3(i), Aug. 13, 1993, 107 Stat.
776; Pub. L. 103-417, Secs. 4, 9, Oct. 25, 1994, 108 Stat. 4328,
4332; Pub. L. 104-170, title IV, Sec. 404, Aug. 3, 1996, 110 Stat.
1514; Pub. L. 107-188, title III, Sec. 309, June 12, 2002, 116
Stat. 673; Pub. L. 109-59, title VII, Sec. 7202(a), Aug. 10, 2005,
119 Stat. 1911.)
-MISC1-
AMENDMENTS
2005 - Par. (i). Pub. L. 109-59 added par. (i).
2002 - Par. (h). Pub. L. 107-188 added par. (h).
1996 - Par. (a). Pub. L. 104-170 added subpar. (2) and struck out
former subpar. (2) which read as follows: "(2)(A) if it bears or
contains any added poisonous or added deleterious substance (other
than one which is (i) a pesticide chemical in or on a raw
agricultural commodity; (ii) a food additive; (iii) a color
additive; or (iv) a new animal drug) which is unsafe within the
meaning of section 346 of this title, or (B) if it is a raw
agricultural commodity and it bears or contains a pesticide
chemical which is unsafe within the meaning of section 346a(a) of
this title, or (C) if it is, or if it bears or contains, any food
additive which is unsafe within the meaning of section 348 of this
title: Provided, That where a pesticide chemical has been used in
or on a raw agricultural commodity in conformity with an exemption
granted or a tolerance prescribed under section 346a of this title
and such raw agricultural commodity has been subjected to
processing such as canning, cooking, freezing, dehydrating, or
milling, the residue of such pesticide chemical remaining in or on
such processed food shall, notwithstanding the provisions of
sections 346 and 348 of this title, not be deemed unsafe if such
residue in or on the raw agricultural commodity has been removed to
the extent possible in good manufacturing practice and the
concentration of such residue in the processed food when ready to
eat is not greater than the tolerance prescribed for the raw
agricultural commodity, or (D) if it is, or it bears or contains, a
new animal drug (or conversion product thereof) which is unsafe
within the meaning of section 360b of this title;". That part of
Pub. L. 104-170 which directed the substitution of "or (3) if it
consists" for "(3) if it consists" was executed by making the
substitution for "(3) If it consists" to reflect the probable
intent of Congress.
1994 - Par. (f). Pub. L. 103-417, Sec. 4, added par. (f).
Par. (g). Pub. L. 103-417, Sec. 9, added par. (g).
1993 - Par. (a). Pub. L. 103-80, Sec. 3(i)(1), substituted a
period for "; or" at end of subpar. (1) and "If it" for "if it" at
beginning of par. (3). That part of Pub. L. 103-80, Sec. 3(i)(1),
which directed the substitution of a period for "; or" at end of
subpar. (2) could not be executed because "; or" did not appear.
Par. (d)(1). Pub. L. 103-80, Sec. 3(i)(2), substituted ", except
that this subparagraph" for ": Provided, That this clause".
Par. (d)(3). Pub. L. 103-80, Sec. 3(i)(3), substituted ", except
that this subparagraph shall not apply" for ": Provided, That this
clause shall not apply" and ", except that the Secretary may, for
the purpose of avoiding or resolving uncertainty as to the
application of this subparagraph" for ": And provided further, That
the Secretary may, for the purpose of avoiding or resolving
uncertainty as to the application of this clause".
1992 - Par. (c). Pub. L. 102-571 substituted "379e(a)" for
"376(a)".
1986 - Par. (d)(2). Pub. L. 99-252 inserted provision that this
clause not apply to confectionery introduced or delivered for
introduction into or received or held for sale in, interstate
commerce if the sale is permitted under the laws of the State in
which the confectionery is intended to be offered for sale.
1968 - Par. (a)(2). Pub. L. 90-399 added cls. (A)(iv) and (D).
1966 - Par. (d). Pub. L. 89-477 permitted the imbedding of
nonnutritive objects in confectionery foods if in the judgment of
the Secretary of Health, Education, and Welfare, as provided by
regulation, the imbedding of the object is of practical functional
value to the confectionery product and would not render it
injurious or hazardous to health, raised to one-half of 1 per
centum by volume the upper limit for the allowable use of alcohol
derived solely from the use of flavoring extracts, allowed the use
of safe nonnutritive substances in and on confectionery foods by
reason of their use for some practical and functional purpose in
the manufacture, packaging, or storage of the confectionery foods
if the use of the substances does not promote deception of the
consumer or otherwise result in adulteration or misbranding,
authorized the Secretary to issue regulations on the use of
particular nonnutritive substances, and removed reference to
nonnutritive masticatory substances added to chewing gum and
harmless flavoring, harmless resinous glaze not in excess of four-
tenths of 1 per centum, natural gum, authorized coloring, and
pectin.
1960 - Par. (a). Pub. L. 86-618, Sec. 102(a)(1), substituted
"other than one which is (i) a pesticide chemical in or on a raw
agricultural commodity; (ii) a food additive; or (iii) a color
additive" for "(except a pesticide chemical in or on a raw
agricultural commodity and except a food additive)" in cl. (2)(A).
Par. (c). Pub. L. 86-618, Sec. 102(a)(2), amended par. (c)
generally, substituting provisions deeming a food adulterated if it
is, or it bears or contains, a color additive which is unsafe
within the meaning of section 376 of this title for provisions
which related to food that bears or contains a coal-tar color other
than one from a batch that has been certified in accordance with
regulations as provided by section 346 of this title, and struck
out provisos which related to the use of color on oranges.
Par. (d). Pub. L. 86-618, Sec. 105(c), substituted "authorized
coloring" for "harmless coloring".
1959 - Par. (c). Pub. L. 86-2 extended from Mar. 1, 1959, to May
1, 1959, the period during which par. is inapplicable to oranges
which have been colored with F.D. & C. Red 32, and inserted proviso
requiring Secretary to establish regulations prescribing the
conditions under which Citrus Red No. 2 may be safely used in
coloring certain mature oranges, and providing for separately
listing and for certification of batches of such color.
1958 - Par. (a). Pub. L. 85-929, among other changes, inserted
cl. (2)(C) relating to food additive unsafe within the meaning of
section 348 of this title, and to pesticide chemical, and added cl.
(7) relating to radiated food.
1956 - Par. (c). Act July 9, 1956, inserted second proviso
relating to coloring of oranges.
1954 - Par. (a)(2). Act July 22, 1954, provided in the case of
any raw agricultural commodity bearing or containing a pesticide
chemical, that such commodity shall be deemed to be adulterated if
such pesticide chemical is unsafe within the meaning of section
346a of this title.
1950 - Par. (e). Act Mar. 16, 1950, added par. (e).
EFFECTIVE DATE OF 2005 AMENDMENT
Amendment by Pub. L. 109-59 effective Oct. 1, 2005, see section
7204 of Pub. L. 109-59, set out as a note under section 331 of this
title.
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L.
90-399, set out as an Effective Date and Transitional Provisions
note under section 360b of this title.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND
DESICCANT AMENDMENT OF 1959
Effective date of par. (a)(2) as in force prior to July 22, 1954,
with respect to particular commercial use of a nematocide, plant
regulator, defoliant, or desiccant in or on a raw agricultural
commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-
139, Aug. 7, 1959, 73 Stat. 288.
EFFECTIVE DATE OF 1958 AMENDMENT
Section 6 of Pub. L. 85-929, as amended by Pub. L. 87-19, Sec. 2,
Apr. 7, 1961, 75 Stat. 42; Pub. L. 88-625, Sec. 2, Oct. 3, 1964, 78
Stat. 1002, provided that:
"(a) Except as provided in subsections (b) and (c) of this
section, this Act [amending this section, sections 321, 331, 346,
and 348 of this title, and section 210 of Title 42, The Public
Health and Welfare, and enacting provisions set out as notes under
sections 321 and 451 of this title] shall take effect on the date
of its enactment [Sept. 6, 1958].
"(b) Except as provided in subsection (c) of this section,
section 3 of this Act [amending this section and section 346 of
this title] shall take effect on the one hundred and eightieth day
after the date of enactment of this Act [Sept. 6, 1958].
"(c) With respect to any particular commercial use of a food
additive, if such use was made of such additive before January 1,
1958, section 3 of this Act [amending this section and section 346
of this title] shall take effect -
"(1) Either (A) one year after the effective date established
in subsection (b) of this section, or (B) at the end of such
additional period (but not later than two years from such
effective date established in subsection (b)) as the Secretary of
Health, Education, and Welfare [now Health and Human Services]
may prescribe on the basis of a finding that such extension
involves no undue risk to the public health and that conditions
exist which necessitate the prescribing of such an additional
period, or
"(2) on the date on which an order with respect to such use
under section 409 of the Federal Food, Drug, and Cosmetic Act
[section 348 of this title] becomes effective,
whichever date first occurs. Whenever the Secretary has, pursuant
to clause (1)(B) of this subsection, extended the effective date of
section 3 of this Act [amending this section] to March 5, 1961, or
has on that date a request for such extension pending before him,
with respect to any such particular use of a food additive, he may,
notwithstanding the parenthetical time limitation in that clause,
further extend such effective date, not beyond June 30, 1964, under
the authority of that clause (but subject to clause (2)) with
respect to such use of the additive (or a more limited specified
use or uses thereof) if, in addition to making the findings
required by clause (1)(B), he finds (i) that bona fide action to
determine the applicability of such section 409 [section 348 of
this title] to such use or uses, or to develop the scientific data
necessary for action under such section, was commenced by an
interested person before March 6, 1960, and was thereafter pursued
with reasonable diligence, and (ii) that in the Secretary's
judgment such extension is consistent with the objective of
carrying to completion in good faith, as soon as reasonably
practicable, the scientific investigations necessary as a basis for
action under such section 409 [section 348 of this title]:
Provided, That if the Secretary has, pursuant to this sentence,
granted an extension to June 30, 1964, he may, upon making the
findings required by clause (1)(B) of this subsection and clauses
(i) and (ii) of this sentence, further extend such effective date,
but not beyond December 31, 1965. The Secretary may at any time
terminate an extension so granted if he finds that it should not
have been granted, or that by reason of a change in circumstances
the basis for such extension no longer exists, or that there has
been a failure to comply with a requirement for submission of
progress reports or with other conditions attached to such
extension."
EFFECTIVE DATE OF 1954 AMENDMENT
Section 5 of act July 22, 1954, provided that: "This Act
[amending this section and section 321 of this title and enacting
sections 346a and 346b of this title] shall take effect upon the
date of its enactment [July 22, 1954], except that with respect to
pesticide chemicals for which tolerances or exemptions have not
been established under section 408 of the Federal Food, Drug, and
Cosmetic Act [section 346a of this title], the amendment to section
402(a) of such Act [par. (a) of this section] made by section 2 of
this Act shall not be effective -
"(1) for the period of one year following the date of the
enactment of this Act [July 22, 1954]; or
"(2) for such additional period following such period of one
year, but not extending beyond two years after the date of the
enactment of this Act [July 22, 1954] as the Secretary of Health,
Education, and Welfare [now Health and Human Services] may
prescribe on the basis of a finding that conditions exist which
necessitate the prescribing of such additional period."
EFFECTIVE DATE OF 1950 AMENDMENT
Amendment by act Mar. 16, 1950, effective July 1, 1950, see
section 7 of act Mar. 16, 1950, set out as an Effective Date note
under section 347 of this title.
EFFECTIVE DATE; POSTPONEMENT
Par. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,
53 Stat. 853, set out as an Effective Date; Postponement in Certain
Cases note under section 301 of this title.
SHORT TITLE
Pub. L. 88-625, Sec. 1, Oct. 3, 1964, 78 Stat. 1002, provided:
"That this Act [amending provisions set out as a note under this
section and section 135 of Title 7, Agriculture] may be cited as
the 'Food Additives Transitional Provisions Amendment of 1964'."
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-MISC2-
UPDATING GUIDANCE RELATING TO FISH AND FISHERIES PRODUCTS HAZARDS
AND CONTROLS
Pub. L. 111-353, title I, Sec. 103(h), Jan. 4, 2011, 124 Stat.
3898, provided that: "The Secretary shall, not later than 180 days
after the date of enactment of this Act [Jan. 4, 2011], update the
Fish and Fisheries Products Hazards and Control Guidance to take
into account advances in technology that have occurred since the
previous publication of such Guidance by the Secretary."
GUIDANCE RELATING TO POST HARVEST PROCESSING OF RAW OYSTERS
Pub. L. 111-353, title I, Sec. 114, Jan. 4, 2011, 124 Stat. 3921,
provided that:
"(a) In General. - Not later than 90 days prior to the issuance
of any guidance, regulation, or suggested amendment by the Food and
Drug Administration to the National Shellfish Sanitation Program's
Model Ordinance, or the issuance of any guidance or regulation by
the Food and Drug Administration relating to the Seafood Hazard
Analysis Critical Control Points Program of the Food and Drug
Administration (parts 123 and 1240 of title 21, Code of Federal
Regulations (or any successor regulations)[)], where such guidance,
regulation or suggested amendment relates to post harvest
processing for raw oysters, the Secretary shall prepare and submit
to the Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives a report which shall include -
"(1) an assessment of how post harvest processing or other
equivalent controls feasibly may be implemented in the fastest,
safest, and most economical manner;
"(2) the projected public health benefits of any proposed post
harvest processing;
"(3) the projected costs of compliance with such post harvest
processing measures;
"(4) the impact post harvest processing is expected to have on
the sales, cost, and availability of raw oysters;
"(5) criteria for ensuring post harvest processing standards
will be applied equally to shellfish imported from all nations of
origin;
"(6) an evaluation of alternative measures to prevent,
eliminate, or reduce to an acceptable level the occurrence of
foodborne illness; and
"(7) the extent to which the Food and Drug Administration has
consulted with the States and other regulatory agencies, as
appropriate, with regard to post harvest processing measures.
"(b) Limitation. - Subsection (a) shall not apply to the guidance
described in section 103(h) [section 103(h) of Pub. L. 111-353, set
out as a note above].
"(c) Review and Evaluation. - Not later than 30 days after the
Secretary issues a proposed regulation or guidance described in
subsection (a), the Comptroller General of the United States shall -
"(1) review and evaluate the report described in (a) and report
to Congress on the findings of the estimates and analysis in the
report;
"(2) compare such proposed regulation or guidance to similar
regulations or guidance with respect to other regulated foods,
including a comparison of risks the Secretary may find associated
with seafood and the instances of those risks in such other
regulated foods; and
"(3) evaluate the impact of post harvest processing on the
competitiveness of the domestic oyster industry in the United
States and in international markets.
"(d) Waiver. - The requirement of preparing a report under
subsection (a) shall be waived if the Secretary issues a guidance
that is adopted as a consensus agreement between Federal and State
regulators and the oyster industry, acting through the Interstate
Shellfish Sanitation Conference.
"(e) Public Access. - Any report prepared under this section
shall be made available to the public."
DOMESTIC FISH OR FISH PRODUCT COMPLIANCE WITH FOOD SAFETY STANDARDS
OR PROCEDURES DEEMED TO HAVE MET REQUIREMENTS FOR FEDERAL COMMODITY
PURCHASE PROGRAMS
Pub. L. 104-180, title VII, Sec. 733, Aug. 6, 1996, 110 Stat.
1601, provided that: "Hereafter, notwithstanding any other
provision of law, any domestic fish or fish product produced in
compliance with food safety standards or procedures accepted by the
Food and Drug Administration as satisfying the requirements of the
'Procedures for the Safe and Sanitary Processing and Importing of
Fish and Fish Products' (published by the Food and Drug
Administration as a final regulation in the Federal Register of
December 18, 1995), shall be deemed to have met any inspection
requirements of the Department of Agriculture or other Federal
agency for any Federal commodity purchase program, including the
program authorized under section 32 of the Act of August 24, 1935
(7 U.S.C. 612c) except that the Department of Agriculture or other
Federal agency may utilize lot inspection to establish a reasonable
degree of certainty that fish or fish products purchased under a
Federal commodity purchase program, including the program
authorized under section 32 of the Act of August 24, 1935 (7 U.S.C.
612c), meet Federal product specifications."
-FOOTNOTE-
(!1) So in original. The period probably should be "; or".
(!2) So in original. Probably should be "subparagraph".
-End-
-CITE-
21 USC Sec. 343 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 343. Misbranded food
-STATUTE-
A food shall be deemed to be misbranded -
(a) False or misleading label
If (1) its labeling is false or misleading in any particular, or
(2) in the case of a food to which section 350 of this title
applies, its advertising is false or misleading in a material
respect or its labeling is in violation of section 350(b)(2) of
this title.
(b) Offer for sale under another name
If it is offered for sale under the name of another food.
(c) Imitation of another food
If it is an imitation of another food, unless its label bears, in
type of uniform size and prominence, the word "imitation" and,
immediately thereafter, the name of the food imitated.
(d) Misleading container
If its container is so made, formed, or filled as to be
misleading.
(e) Package form
If in package form unless it bears a label containing (1) the
name and place of business of the manufacturer, packer, or
distributor; and (2) an accurate statement of the quantity of the
contents in terms of weight, measure, or numerical count, except
that under clause (2) of this paragraph reasonable variations shall
be permitted, and exemptions as to small packages shall be
established, by regulations prescribed by the Secretary.
(f) Prominence of information on label
If any word, statement, or other information required by or under
authority of this chapter to appear on the label or labeling is not
prominently placed thereon with such conspicuousness (as compared
with other words, statements, designs, or devices, in the labeling)
and in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(g) Representation as to definition and standard of identity
If it purports to be or is represented as a food for which a
definition and standard of identity has been prescribed by
regulations as provided by section 341 of this title, unless (1) it
conforms to such definition and standard, and (2) its label bears
the name of the food specified in the definition and standard, and,
insofar as may be required by such regulations, the common names of
optional ingredients (other than spices, flavoring, and coloring)
present in such food.
(h) Representation as to standards of quality and fill of container
If it purports to be or is represented as -
(1) a food for which a standard of quality has been prescribed
by regulations as provided by section 341 of this title, and its
quality falls below such standard, unless its label bears, in
such manner and form as such regulations specify, a statement
that it falls below such standard;
(2) a food for which a standard or standards of fill of
container have been prescribed by regulations as provided by
section 341 of this title, and it falls below the standard of
fill of container applicable thereto, unless its label bears, in
such manner and form as such regulations specify, a statement
that it falls below such standard; or
(3) a food that is pasteurized unless -
(A) such food has been subjected to a safe process or
treatment that is prescribed as pasteurization for such food in
a regulation promulgated under this chapter; or
(B)(i) such food has been subjected to a safe process or
treatment that -
(I) is reasonably certain to achieve destruction or
elimination in the food of the most resistant microorganisms
of public health significance that are likely to occur in the
food;
(II) is at least as protective of the public health as a
process or treatment described in subparagraph (A);
(III) is effective for a period that is at least as long as
the shelf life of the food when stored under normal and
moderate abuse conditions; and
(IV) is the subject of a notification to the Secretary,
including effectiveness data regarding the process or
treatment; and
(ii) at least 120 days have passed after the date of receipt
of such notification by the Secretary without the Secretary
making a determination that the process or treatment involved
has not been shown to meet the requirements of subclauses (I)
through (III) of clause (i).
For purposes of paragraph (3), a determination by the Secretary
that a process or treatment has not been shown to meet the
requirements of subclauses (I) through (III) of subparagraph (B)(i)
shall constitute final agency action under such subclauses.
(i) Label where no representation as to definition and standard of
identity
Unless its label bears (1) the common or usual name of the food,
if any there be, and (2) in case it is fabricated from two or more
ingredients, the common or usual name of each such ingredient and
if the food purports to be a beverage containing vegetable or fruit
juice, a statement with appropriate prominence on the information
panel of the total percentage of such fruit or vegetable juice
contained in the food; except that spices, flavorings, and colors
not required to be certified under section 379e(c) of this title
(!1) unless sold as spices, flavorings, or such colors, may be
designated as spices, flavorings, and colorings without naming
each. To the extent that compliance with the requirements of clause
(2) of this paragraph is impracticable, or results in deception or
unfair competition, exemptions shall be established by regulations
promulgated by the Secretary.
(j) Representation for special dietary use
If it purports to be or is represented for special dietary uses,
unless its label bears such information concerning its vitamin,
mineral, and other dietary properties as the Secretary determines
to be, and by regulations prescribes as, necessary in order fully
to inform purchasers as to its value for such uses.
(k) Artificial flavoring, artificial coloring, or chemical
preservatives
If it bears or contains any artificial flavoring, artificial
coloring, or chemical preservative, unless it bears labeling
stating that fact, except that to the extent that compliance with
the requirements of this paragraph is impracticable, exemptions
shall be established by regulations promulgated by the Secretary.
The provisions of this paragraph and paragraphs (g) and (i) with
respect to artificial coloring shall not apply in the case of
butter, cheese, or ice cream. The provisions of this paragraph with
respect to chemical preservatives shall not apply to a pesticide
chemical when used in or on a raw agricultural commodity which is
the produce of the soil.
(l) Pesticide chemicals on raw agricultural commodities
If it is a raw agricultural commodity which is the produce of the
soil, bearing or containing a pesticide chemical applied after
harvest, unless the shipping container of such commodity bears
labeling which declares the presence of such chemical in or on such
commodity and the common or usual name and the function of such
chemical, except that no such declaration shall be required while
such commodity, having been removed from the shipping container, is
being held or displayed for sale at retail out of such container in
accordance with the custom of the trade.
(m) Color additives
If it is a color additive, unless its packaging and labeling are
in conformity with such packaging and labeling requirements,
applicable to such color additive, as may be contained in
regulations issued under section 379e of this title.
(n) Packaging or labeling of drugs in violation of regulations
If its packaging or labeling is in violation of an applicable
regulation issued pursuant to section 1472 or 1473 of title 15.
(o) Repealed. Pub. L. 106-554, Sec. 1(a)(1) [title V, Sec. 517],
Dec. 21, 2000, 114 Stat. 2763, 2763A-73
(p) Repealed. Pub. L. 104-124, Sec. 1, Apr. 1, 1996, 110 Stat. 882
(q) Nutrition information
(1) Except as provided in subparagraphs (3), (4), and (5), if it
is a food intended for human consumption and is offered for sale,
unless its label or labeling bears nutrition information that
provides -
(A)(i) the serving size which is an amount customarily consumed
and which is expressed in a common household measure that is
appropriate to the food, or
(ii) if the use of the food is not typically expressed in a
serving size, the common household unit of measure that expresses
the serving size of the food,
(B) the number of servings or other units of measure per
container,
(C) the total number of calories -
(i) derived from any source, and
(ii) derived from the total fat,
in each serving size or other unit of measure of the food,
(D) the amount of the following nutrients: Total fat, saturated
fat, cholesterol, sodium, total carbohydrates, complex
carbohydrates, sugars, dietary fiber, and total protein contained
in each serving size or other unit of measure,
(E) any vitamin, mineral, or other nutrient required to be
placed on the label and labeling of food under this chapter
before October 1, 1990, if the Secretary determines that such
information will assist consumers in maintaining healthy dietary
practices.
The Secretary may by regulation require any information required to
be placed on the label or labeling by this subparagraph or
subparagraph (2)(A) to be highlighted on the label or labeling by
larger type, bold type, or contrasting color if the Secretary
determines that such highlighting will assist consumers in
maintaining healthy dietary practices.
(2)(A) If the Secretary determines that a nutrient other than a
nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should
be included in the label or labeling of food subject to
subparagraph (1) for purposes of providing information regarding
the nutritional value of such food that will assist consumers in
maintaining healthy dietary practices, the Secretary may by
regulation require that information relating to such additional
nutrient be included in the label or labeling of such food.
(B) If the Secretary determines that the information relating to
a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or
clause (A) of this subparagraph to be included in the label or
labeling of food is not necessary to assist consumers in
maintaining healthy dietary practices, the Secretary may by
regulation remove information relating to such nutrient from such
requirement.
(3) For food that is received in bulk containers at a retail
establishment, the Secretary may, by regulation, provide that the
nutrition information required by subparagraphs (1) and (2) be
displayed at the location in the retail establishment at which the
food is offered for sale.
(4)(A) The Secretary shall provide for furnishing the nutrition
information required by subparagraphs (1) and (2) with respect to
raw agricultural commodities and raw fish by issuing voluntary
nutrition guidelines, as provided by clause (B) or by issuing
regulations that are mandatory as provided by clause (D).
(B)(i) Upon the expiration of 12 months after November 8, 1990,
the Secretary, after providing an opportunity for comment, shall
issue guidelines for food retailers offering raw agricultural
commodities or raw fish to provide nutrition information specified
in subparagraphs (1) and (2). Such guidelines shall take into
account the actions taken by food retailers during such 12-month
period to provide to consumers nutrition information on raw
agricultural commodities and raw fish. Such guidelines shall only
apply -
(I) in the case of raw agricultural commodities, to the 20
varieties of vegetables most frequently consumed during a year
and the 20 varieties of fruit most frequently consumed during a
year, and
(II) to the 20 varieties of raw fish most frequently consumed
during a year.
The vegetables, fruits, and raw fish to which such guidelines apply
shall be determined by the Secretary by regulation and the
Secretary may apply such guidelines regionally.
(ii) Upon the expiration of 12 months after November 8, 1990, the
Secretary shall issue a final regulation defining the circumstances
that constitute substantial compliance by food retailers with the
guidelines issued under subclause (i). The regulation shall provide
that there is not substantial compliance if a significant number of
retailers have failed to comply with the guidelines. The size of
the retailers and the portion of the market served by retailers in
compliance with the guidelines shall be considered in determining
whether the substantial-compliance standard has been met.
(C)(i) Upon the expiration of 30 months after November 8, 1990,
the Secretary shall issue a report on actions taken by food
retailers to provide consumers with nutrition information for raw
agricultural commodities and raw fish under the guidelines issued
under clause (A). Such report shall include a determination of
whether there is substantial compliance with the guidelines.
(ii) If the Secretary finds that there is substantial compliance
with the guidelines, the Secretary shall issue a report and make a
determination of the type required in subclause (i) every two
years.
(D)(i) If the Secretary determines that there is not substantial
compliance with the guidelines issued under clause (A), the
Secretary shall at the time such determination is made issue
proposed regulations requiring that any person who offers raw
agricultural commodities or raw fish to consumers provide, in a
manner prescribed by regulations, the nutrition information
required by subparagraphs (1) and (2). The Secretary shall issue
final regulations imposing such requirements 6 months after issuing
the proposed regulations. The final regulations shall become
effective 6 months after the date of their promulgation.
(ii) Regulations issued under subclause (i) may require that the
nutrition information required by subparagraphs (1) and (2) be
provided for more than 20 varieties of vegetables, 20 varieties of
fruit, and 20 varieties of fish most frequently consumed during a
year if the Secretary finds that a larger number of such products
are frequently consumed. Such regulations shall permit such
information to be provided in a single location in each area in
which raw agricultural commodities and raw fish are offered for
sale. Such regulations may provide that information shall be
expressed as an average or range per serving of the same type of
raw agricultural commodity or raw fish. The Secretary shall develop
and make available to the persons who offer such food to consumers
the information required by subparagraphs (1) and (2).
(iii) Regulations issued under subclause (i) shall permit the
required information to be provided in each area of an
establishment in which raw agricultural commodities and raw fish
are offered for sale. The regulations shall permit food retailers
to display the required information by supplying copies of the
information provided by the Secretary, by making the information
available in brochure, notebook or leaflet form, or by posting a
sign disclosing the information. Such regulations shall also permit
presentation of the required information to be supplemented by a
video, live demonstration, or other media which the Secretary
approves.
(E) For purposes of this subparagraph, the term "fish" includes
freshwater or marine fin fish, crustaceans, and mollusks, including
shellfish, amphibians, and other forms of aquatic animal life.
(F) No person who offers raw agricultural commodities or raw fish
to consumers may be prosecuted for minor violations of this
subparagraph if there has been substantial compliance with the
requirements of this paragraph.
(5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to
food -
(i) except as provided in clause (H)(ii)(III), which is served
in restaurants or other establishments in which food is served
for immediate human consumption or which is sold for sale or use
in such establishments,
(ii) except as provided in clause (H)(ii)(III), which is
processed and prepared primarily in a retail establishment, which
is ready for human consumption, which is of the type described in
subclause (i), and which is offered for sale to consumers but not
for immediate human consumption in such establishment and which
is not offered for sale outside such establishment,
(iii) which is an infant formula subject to section 350a of
this title,
(iv) which is a medical food as defined in section 360ee(b) of
this title, or
(v) which is described in section 345(2) of this title.
(B) Subparagraphs (1) and (2) shall not apply to the label of a
food if the Secretary determines by regulations that compliance
with such subparagraphs is impracticable because the package of
such food is too small to comply with the requirements of such
subparagraphs and if the label of such food does not contain any
nutrition information.
(C) If a food contains insignificant amounts, as determined by
the Secretary, of all the nutrients required by subparagraphs (1)
and (2) to be listed in the label or labeling of food, the
requirements of such subparagraphs shall not apply to such food if
the label, labeling, or advertising of such food does not make any
claim with respect to the nutritional value of such food. If a food
contains insignificant amounts, as determined by the Secretary, of
more than one-half the nutrients required by subparagraphs (1) and
(2) to be in the label or labeling of the food, the Secretary shall
require the amounts of such nutrients to be stated in a simplified
form prescribed by the Secretary.
(D) If a person offers food for sale and has annual gross sales
made or business done in sales to consumers which is not more than
$500,000 or has annual gross sales made or business done in sales
of food to consumers which is not more than $50,000, the
requirements of subparagraphs (1), (2), (3), and (4) shall not
apply with respect to food sold by such person to consumers unless
the label or labeling of food offered by such person provides
nutrition information or makes a nutrition claim.
(E)(i) During the 12-month period for which an exemption from
subparagraphs (1) and (2) is claimed pursuant to this subclause,
the requirements of such subparagraphs shall not apply to any food
product if -
(I) the labeling for such product does not provide nutrition
information or make a claim subject to paragraph (r),
(II) the person who claims for such product an exemption from
such subparagraphs employed fewer than an average of 100 full-
time equivalent employees,
(III) such person provided the notice described in subclause
(iii), and
(IV) in the case of a food product which was sold in the 12-
month period preceding the period for which an exemption was
claimed, fewer than 100,000 units of such product were sold in
the United States during such preceding period, or in the case of
a food product which was not sold in the 12-month period
preceding the period for which such exemption is claimed, fewer
than 100,000 units of such product are reasonably anticipated to
be sold in the United States during the period for which such
exemption is claimed.
(ii) During the 12-month period after the applicable date
referred to in this sentence, the requirements of subparagraphs (1)
and (2) shall not apply to any food product which was first
introduced into interstate commerce before May 8, 1994, if the
labeling for such product does not provide nutrition information or
make a claim subject to paragraph (r), if such person provided the
notice described in subclause (iii), and if -
(I) during the 12-month period preceding May 8, 1994, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 300 full-time
equivalent employees and fewer than 600,000 units of such product
were sold in the United States,
(II) during the 12-month period preceding May 8, 1995, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 300 full-time
equivalent employees and fewer than 400,000 units of such product
were sold in the United States, or
(III) during the 12-month period preceding May 8, 1996, the
person who claims for such product an exemption from such
subparagraphs employed fewer than an average of 200 full-time
equivalent employees and fewer than 200,000 units of such product
were sold in the United States.
(iii) The notice referred to in subclauses (i) and (ii) shall be
given to the Secretary prior to the beginning of the period during
which the exemption under subclause (i) or (ii) is to be in effect,
shall state that the person claiming such exemption for a food
product has complied with the applicable requirements of subclause
(i) or (ii), and shall -
(I) state the average number of full-time equivalent employees
such person employed during the 12 months preceding the date such
person claims such exemption,
(II) state the approximate number of units the person claiming
the exemption sold in the United States,
(III) if the exemption is claimed for a food product which was
sold in the 12-month period preceding the period for which the
exemption was claimed, state the approximate number of units of
such product which were sold in the United States during such
preceding period, and, if the exemption is claimed for a food
product which was not sold in such preceding period, state the
number of units of such product which such person reasonably
anticipates will be sold in the United States during the period
for which the exemption was claimed, and
(IV) contain such information as the Secretary may require to
verify the information required by the preceding provisions of
this subclause if the Secretary has questioned the validity of
such information.
If a person is not an importer, has fewer than 10 full-time
equivalent employees, and sells fewer than 10,000 units of any food
product in any year, such person is not required to file a notice
for such product under this subclause for such year.
(iv) In the case of a person who claimed an exemption under
subclause (i) or (ii), if, during the period of such exemption, the
number of full-time equivalent employees of such person exceeds the
number in such subclause or if the number of food products sold in
the United States exceeds the number in such subclause, such
exemption shall extend to the expiration of 18 months after the
date the number of full-time equivalent employees or food products
sold exceeded the applicable number.
(v) For any food product first introduced into interstate
commerce after May 8, 2002, the Secretary may by regulation lower
the employee or units of food products requirement of subclause (i)
if the Secretary determines that the cost of compliance with such
lower requirement will not place an undue burden on persons subject
to such lower requirement.
(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v) -
(I) the term "unit" means the packaging or, if there is no
packaging, the form in which a food product is offered for sale
to consumers,
(II) the term "food product" means food in any sized package
which is manufactured by a single manufacturer or which bears the
same brand name, which bears the same statement of identity, and
which has similar preparation methods, and
(III) the term "person" in the case of a corporation includes
all domestic and foreign affiliates of the corporation.
(F) A dietary supplement product (including a food to which
section 350 of this title applies) shall comply with the
requirements of subparagraphs (1) and (2) in a manner which is
appropriate for the product and which is specified in regulations
of the Secretary which shall provide that -
(i) nutrition information shall first list those dietary
ingredients that are present in the product in a significant
amount and for which a recommendation for daily consumption has
been established by the Secretary, except that a dietary
ingredient shall not be required to be listed if it is not
present in a significant amount, and shall list any other dietary
ingredient present and identified as having no such
recommendation;
(ii) the listing of dietary ingredients shall include the
quantity of each such ingredient (or of a proprietary blend of
such ingredients) per serving;
(iii) the listing of dietary ingredients may include the source
of a dietary ingredient; and
(iv) the nutrition information shall immediately precede the
ingredient information required under subclause (i), except that
no ingredient identified pursuant to subclause (i) shall be
required to be identified a second time.
(G) Subparagraphs (1), (2), (3), and (4) shall not apply to food
which is sold by a food distributor if the food distributor
principally sells food to restaurants or other establishments in
which food is served for immediate human consumption and does not
manufacture, process, or repackage the food it sells.
(H) Restaurants, Retail Food Establishments, and Vending
Machines. -
(i) General requirements for restaurants and similar retail
food establishments. - Except for food described in subclause
(vii), in the case of food that is a standard menu item that is
offered for sale in a restaurant or similar retail food
establishment that is part of a chain with 20 or more locations
doing business under the same name (regardless of the type of
ownership of the locations) and offering for sale substantially
the same menu items, the restaurant or similar retail food
establishment shall disclose the information described in
subclauses (ii) and (iii).
(ii) Information required to be disclosed by restaurants and
retail food establishments. - Except as provided in subclause
(vii), the restaurant or similar retail food establishment shall
disclose in a clear and conspicuous manner -
(I)(aa) in a nutrient content disclosure statement adjacent
to the name of the standard menu item, so as to be clearly
associated with the standard menu item, on the menu listing the
item for sale, the number of calories contained in the standard
menu item, as usually prepared and offered for sale; and
(bb) a succinct statement concerning suggested daily caloric
intake, as specified by the Secretary by regulation and posted
prominently on the menu and designed to enable the public to
understand, in the context of a total daily diet, the
significance of the caloric information that is provided on the
menu;
(II)(aa) in a nutrient content disclosure statement adjacent
to the name of the standard menu item, so as to be clearly
associated with the standard menu item, on the menu board,
including a drive-through menu board, the number of calories
contained in the standard menu item, as usually prepared and
offered for sale; and
(bb) a succinct statement concerning suggested daily caloric
intake, as specified by the Secretary by regulation and posted
prominently on the menu board, designed to enable the public to
understand, in the context of a total daily diet, the
significance of the nutrition information that is provided on
the menu board;
(III) in a written form, available on the premises of the
restaurant or similar retail establishment and to the consumer
upon request, the nutrition information required under clauses
(C) and (D) of subparagraph (1); and
(IV) on the menu or menu board, a prominent, clear, and
conspicuous statement regarding the availability of the
information described in item (III).
(iii) Self-service food and food on display. - Except as
provided in subclause (vii), in the case of food sold at a salad
bar, buffet line, cafeteria line, or similar self-service
facility, and for self-service beverages or food that is on
display and that is visible to customers, a restaurant or similar
retail food establishment shall place adjacent to each food
offered a sign that lists calories per displayed food item or per
serving.
(iv) Reasonable basis. - For the purposes of this clause, a
restaurant or similar retail food establishment shall have a
reasonable basis for its nutrient content disclosures, including
nutrient databases, cookbooks, laboratory analyses, and other
reasonable means, as described in section 101.10 of title 21,
Code of Federal Regulations (or any successor regulation) or in a
related guidance of the Food and Drug Administration.
(v) Menu variability and combination meals. - The Secretary
shall establish by regulation standards for determining and
disclosing the nutrient content for standard menu items that come
in different flavors, varieties, or combinations, but which are
listed as a single menu item, such as soft drinks, ice cream,
pizza, doughnuts, or children's combination meals, through means
determined by the Secretary, including ranges, averages, or other
methods.
(vi) Additional information. - If the Secretary determines that
a nutrient, other than a nutrient required under subclause
(ii)(III), should be disclosed for the purpose of providing
information to assist consumers in maintaining healthy dietary
practices, the Secretary may require, by regulation, disclosure
of such nutrient in the written form required under subclause
(ii)(III).
(vii) Nonapplicability to certain food. -
(I) In general. - Subclauses (i) through (vi) do not apply to
-
(aa) items that are not listed on a menu or menu board
(such as condiments and other items placed on the table or
counter for general use);
(bb) daily specials, temporary menu items appearing on the
menu for less than 60 days per calendar year, or custom
orders; or
(cc) such other food that is part of a customary market
test appearing on the menu for less than 90 days, under terms
and conditions established by the Secretary.
(II) Written forms. - Subparagraph (5)(C) shall apply to any
regulations promulgated under subclauses (ii)(III) and (vi).
(viii) Vending machines. -
(I) In general. - In the case of an article of food sold from
a vending machine that -
(aa) does not permit a prospective purchaser to examine the
Nutrition Facts Panel before purchasing the article or does
not otherwise provide visible nutrition information at the
point of purchase; and
(bb) is operated by a person who is engaged in the business
of owning or operating 20 or more vending machines,
the vending machine operator shall provide a sign in close
proximity to each article of food or the selection button that
includes a clear and conspicuous statement disclosing the
number of calories contained in the article.
(ix) Voluntary provision of nutrition information. -
(I) In general. - An authorized official of any restaurant or
similar retail food establishment or vending machine operator
not subject to the requirements of this clause may elect to be
subject to the requirements of such clause, by registering
biannually the name and address of such restaurant or similar
retail food establishment or vending machine operator with the
Secretary, as specified by the Secretary by regulation.
(II) Registration. - Within 120 days of March 23, 2010, the
Secretary shall publish a notice in the Federal Register
specifying the terms and conditions for implementation of item
(I), pending promulgation of regulations.
(III) Rule of construction. - Nothing in this subclause shall
be construed to authorize the Secretary to require an
application, review, or licensing process for any entity to
register with the Secretary, as described in such item.
(x) Regulations. -
(I) Proposed regulation. - Not later than 1 year after March
23, 2010, the Secretary shall promulgate proposed regulations
to carry out this clause.
(II) Contents. - In promulgating regulations, the Secretary
shall -
(aa) consider standardization of recipes and methods of
preparation, reasonable variation in serving size and
formulation of menu items, space on menus and menu boards,
inadvertent human error, training of food service workers,
variations in ingredients, and other factors, as the
Secretary determines; and
(bb) specify the format and manner of the nutrient content
disclosure requirements under this subclause.
(III) Reporting. - The Secretary shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives a quarterly report that describes the
Secretary's progress toward promulgating final regulations
under this subparagraph.
(xi) Definition. - In this clause, the term "menu" or "menu
board" means the primary writing of the restaurant or other
similar retail food establishment from which a consumer makes an
order selection.
(r) Nutrition levels and health-related claims
(1) Except as provided in clauses (A) through (C) of subparagraph
(5), if it is a food intended for human consumption which is
offered for sale and for which a claim is made in the label or
labeling of the food which expressly or by implication -
(A) characterizes the level of any nutrient which is of the
type required by paragraph (q)(1) or (q)(2) to be in the label or
labeling of the food unless the claim is made in accordance with
subparagraph (2), or
(B) characterizes the relationship of any nutrient which is of
the type required by paragraph (q)(1) or (q)(2) to be in the
label or labeling of the food to a disease or a health-related
condition unless the claim is made in accordance with
subparagraph (3) or (5)(D).
A statement of the type required by paragraph (q) that appears as
part of the nutrition information required or permitted by such
paragraph is not a claim which is subject to this paragraph and a
claim subject to clause (A) is not subject to clause (B).
(2)(A) Except as provided in subparagraphs (4)(A)(ii) and
(4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a
claim described in subparagraph (1)(A) -
(i) may be made only if the characterization of the level made
in the claim uses terms which are defined in regulations of the
Secretary,
(ii) may not state the absence of a nutrient unless -
(I) the nutrient is usually present in the food or in a food
which substitutes for the food as defined by the Secretary by
regulation, or
(II) the Secretary by regulation permits such a statement on
the basis of a finding that such a statement would assist
consumers in maintaining healthy dietary practices and the
statement discloses that the nutrient is not usually present in
the food,
(iii) may not be made with respect to the level of cholesterol
in the food if the food contains, as determined by the Secretary
by regulation, fat or saturated fat in an amount which increases
to persons in the general population the risk of disease or a
health related condition which is diet related unless -
(I) the Secretary finds by regulation that the level of
cholesterol is substantially less than the level usually
present in the food or in a food which substitutes for the food
and which has a significant market share, or the Secretary by
regulation permits a statement regarding the absence of
cholesterol on the basis of a finding that cholesterol is not
usually present in the food and that such a statement would
assist consumers in maintaining healthy dietary practices and
the regulation requires that the statement disclose that
cholesterol is not usually present in the food, and
(II) the label or labeling of the food discloses the level of
such fat or saturated fat in immediate proximity to such claim
and with appropriate prominence which shall be no less than one-
half the size of the claim with respect to the level of
cholesterol,
(iv) may not be made with respect to the level of saturated fat
in the food if the food contains cholesterol unless the label or
labeling of the food discloses the level of cholesterol in the
food in immediate proximity to such claim and with appropriate
prominence which shall be no less than one-half the size of the
claim with respect to the level of saturated fat,
(v) may not state that a food is high in dietary fiber unless
the food is low in total fat as defined by the Secretary or the
label or labeling discloses the level of total fat in the food in
immediate proximity to such statement and with appropriate
prominence which shall be no less than one-half the size of the
claim with respect to the level of dietary fiber, and
(vi) may not be made if the Secretary by regulation prohibits
the claim because the claim is misleading in light of the level
of another nutrient in the food.
(B) If a claim described in subparagraph (1)(A) is made with
respect to a nutrient in a food and the Secretary makes a
determination that the food contains a nutrient at a level that
increases to persons in the general population the risk of a
disease or health-related condition that is diet related, the label
or labeling of such food shall contain, prominently and in
immediate proximity to such claim, the following statement: "See
nutrition information for ___ content." The blank shall identify
the nutrient associated with the increased disease or health-
related condition risk. In making the determination described in
this clause, the Secretary shall take into account the significance
of the food in the total daily diet.
(C) Subparagraph (2)(A) does not apply to a claim described in
subparagraph (1)(A) and contained in the label or labeling of a
food if such claim is contained in the brand name of such food and
such brand name was in use on such food before October 25, 1989,
unless the brand name contains a term defined by the Secretary
under subparagraph (2)(A)(i). Such a claim is subject to paragraph
(a).
(D) Subparagraph (2) does not apply to a claim described in
subparagraph (1)(A) which uses the term "diet" and is contained in
the label or labeling of a soft drink if (i) such claim is
contained in the brand name of such soft drink, (ii) such brand
name was in use on such soft drink before October 25, 1989, and
(iii) the use of the term "diet" was in conformity with section
105.66 of title 21 of the Code of Federal Regulations. Such a claim
is subject to paragraph (a).
(E) Subclauses (i) through (v) of subparagraph (2)(A) do not
apply to a statement in the label or labeling of food which
describes the percentage of vitamins and minerals in the food in
relation to the amount of such vitamins and minerals recommended
for daily consumption by the Secretary.
(F) Subclause (i) clause (A) does not apply to a statement in the
labeling of a dietary supplement that characterizes the percentage
level of a dietary ingredient for which the Secretary has not
established a reference daily intake, daily recommended value, or
other recommendation for daily consumption.
(G) A claim of the type described in subparagraph (1)(A) for a
nutrient, for which the Secretary has not promulgated a regulation
under clause (A)(i), shall be authorized and may be made with
respect to a food if -
(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease Control and
Prevention) or the National Academy of Sciences or any of its
subdivisions has published an authoritative statement, which is
currently in effect, which identifies the nutrient level to which
the claim refers;
(ii) a person has submitted to the Secretary, at least 120 days
(during which the Secretary may notify any person who is making a
claim as authorized by clause (C) that such person has not
submitted all the information required by such clause) before the
first introduction into interstate commerce of the food with a
label containing the claim, (I) a notice of the claim, which
shall include the exact words used in the claim and shall include
a concise description of the basis upon which such person relied
for determining that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in subclause
(i) upon which such person relied in making the claim, and (III)
a balanced representation of the scientific literature relating
to the nutrient level to which the claim refers;
(iii) the claim and the food for which the claim is made are in
compliance with clauses (A) and (B), and are otherwise in
compliance with paragraph (a) and section 321(n) of this title;
and
(iv) the claim is stated in a manner so that the claim is an
accurate representation of the authoritative statement referred
to in subclause (i) and so that the claim enables the public to
comprehend the information provided in the claim and to
understand the relative significance of such information in the
context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an
authoritative statement of a scientific body described in subclause
(i) only if the statement is published by the scientific body and
shall not include a statement of an employee of the scientific body
made in the individual capacity of the employee.
(H) A claim submitted under the requirements of clause (G) may be
made until -
(i) such time as the Secretary issues a regulation -
(I) prohibiting or modifying the claim and the regulation has
become effective, or
(II) finding that the requirements of clause (G) have not
been met, including finding that the petitioner had not
submitted all the information required by such clause; or
(ii) a district court of the United States in an enforcement
proceeding under subchapter III of this chapter has determined
that the requirements of clause (G) have not been met.
(3)(A) Except as provided in subparagraph (5), a claim described
in subparagraph (1)(B) may only be made -
(i) if the claim meets the requirements of the regulations of
the Secretary promulgated under clause (B), and
(ii) if the food for which the claim is made does not contain,
as determined by the Secretary by regulation, any nutrient in an
amount which increases to persons in the general population the
risk of a disease or health-related condition which is diet
related, taking into account the significance of the food in the
total daily diet, except that the Secretary may by regulation
permit such a claim based on a finding that such a claim would
assist consumers in maintaining healthy dietary practices and
based on a requirement that the label contain a disclosure of the
type required by subparagraph (2)(B).
(B)(i) The Secretary shall promulgate regulations authorizing
claims of the type described in subparagraph (1)(B) only if the
Secretary determines, based on the totality of publicly available
scientific evidence (including evidence from well-designed studies
conducted in a manner which is consistent with generally recognized
scientific procedures and principles), that there is significant
scientific agreement, among experts qualified by scientific
training and experience to evaluate such claims, that the claim is
supported by such evidence.
(ii) A regulation described in subclause (i) shall describe -
(I) the relationship between a nutrient of the type required in
the label or labeling of food by paragraph (q)(1) or (q)(2) and a
disease or health-related condition, and
(II) the significance of each such nutrient in affecting such
disease or health-related condition.
(iii) A regulation described in subclause (i) shall require such
claim to be stated in a manner so that the claim is an accurate
representation of the matters set out in subclause (ii) and so that
the claim enables the public to comprehend the information provided
in the claim and to understand the relative significance of such
information in the context of a total daily diet.
(C) Notwithstanding the provisions of clauses (A)(i) and (B), a
claim of the type described in subparagraph (1)(B) which is not
authorized by the Secretary in a regulation promulgated in
accordance with clause (B) shall be authorized and may be made with
respect to a food if -
(i) a scientific body of the United States Government with
official responsibility for public health protection or research
directly relating to human nutrition (such as the National
Institutes of Health or the Centers for Disease Control and
Prevention) or the National Academy of Sciences or any of its
subdivisions has published an authoritative statement, which is
currently in effect, about the relationship between a nutrient
and a disease or health-related condition to which the claim
refers;
(ii) a person has submitted to the Secretary, at least 120 days
(during which the Secretary may notify any person who is making a
claim as authorized by clause (C) that such person has not
submitted all the information required by such clause) before the
first introduction into interstate commerce of the food with a
label containing the claim, (I) a notice of the claim, which
shall include the exact words used in the claim and shall include
a concise description of the basis upon which such person relied
for determining that the requirements of subclause (i) have been
satisfied, (II) a copy of the statement referred to in subclause
(i) upon which such person relied in making the claim, and (III)
a balanced representation of the scientific literature relating
to the relationship between a nutrient and a disease or health-
related condition to which the claim refers;
(iii) the claim and the food for which the claim is made are in
compliance with clause (A)(ii) and are otherwise in compliance
with paragraph (a) and section 321(n) of this title; and
(iv) the claim is stated in a manner so that the claim is an
accurate representation of the authoritative statement referred
to in subclause (i) and so that the claim enables the public to
comprehend the information provided in the claim and to
understand the relative significance of such information in the
context of a total daily diet.
For purposes of this clause, a statement shall be regarded as an
authoritative statement of a scientific body described in subclause
(i) only if the statement is published by the scientific body and
shall not include a statement of an employee of the scientific body
made in the individual capacity of the employee.
(D) A claim submitted under the requirements of clause (C) may be
made until -
(i) such time as the Secretary issues a regulation under the
standard in clause (B)(i) -
(I) prohibiting or modifying the claim and the regulation has
become effective, or
(II) finding that the requirements of clause (C) have not
been met, including finding that the petitioner has not
submitted all the information required by such clause; or
(ii) a district court of the United States in an enforcement
proceeding under subchapter III of this chapter has determined
that the requirements of clause (C) have not been met.
(4)(A)(i) Any person may petition the Secretary to issue a
regulation under subparagraph (2)(A)(i) or (3)(B) relating to a
claim described in subparagraph (1)(A) or (1)(B). Not later than
100 days after the petition is received by the Secretary, the
Secretary shall issue a final decision denying the petition or file
the petition for further action by the Secretary. If the Secretary
does not act within such 100 days, the petition shall be deemed to
be denied unless an extension is mutually agreed upon by the
Secretary and the petitioner. If the Secretary denies the petition
or the petition is deemed to be denied, the petition shall not be
made available to the public. If the Secretary files the petition,
the Secretary shall deny the petition or issue a proposed
regulation to take the action requested in the petition not later
than 90 days after the date of such decision. If the Secretary does
not act within such 90 days, the petition shall be deemed to be
denied unless an extension is mutually agreed upon by the Secretary
and the petitioner. If the Secretary issues a proposed regulation,
the rulemaking shall be completed within 540 days of the date the
petition is received by the Secretary. If the Secretary does not
issue a regulation within such 540 days, the Secretary shall
provide the Committee on Commerce of the House of Representatives
and the Committee on Labor and Human Resources of the Senate the
reasons action on the regulation did not occur within such 540
days.
(ii) Any person may petition the Secretary for permission to use
in a claim described in subparagraph (1)(A) terms that are
consistent with the terms defined by the Secretary under
subparagraph (2)(A)(i). Within 90 days of the submission of such a
petition, the Secretary shall issue a final decision denying the
petition or granting such permission.
(iii) Any person may petition the Secretary for permission to use
an implied claim described in subparagraph (1)(A) in a brand name.
After publishing notice of an opportunity to comment on the
petition in the Federal Register and making the petition available
to the public, the Secretary shall grant the petition if the
Secretary finds that such claim is not misleading and is consistent
with terms defined by the Secretary under subparagraph (2)(A)(i).
The Secretary shall grant or deny the petition within 100 days of
the date it is submitted to the Secretary and the petition shall be
considered granted if the Secretary does not act on it within such
100 days.
(B) A petition under clause (A)(i) respecting a claim described
in subparagraph (1)(A) or (1)(B) shall include an explanation of
the reasons why the claim meets the requirements of this paragraph
and a summary of the scientific data which supports such reasons.
(C) If a petition for a regulation under subparagraph (3)(B)
relies on a report from an authoritative scientific body of the
United States, the Secretary shall consider such report and shall
justify any decision rejecting the conclusions of such report.
(5)(A) This paragraph does not apply to infant formulas subject
to section 350a(h) of this title and medical foods as defined in
section 360ee(b) of this title.
(B) Subclauses (iii) through (v) of subparagraph (2)(A) and
subparagraph (2)(B) do not apply to food which is served in
restaurants or other establishments in which food is served for
immediate human consumption or which is sold for sale or use in
such establishments.
(C) A subparagraph (1)(A) claim made with respect to a food which
claim is required by a standard of identity issued under section
341 of this title shall not be subject to subparagraph (2)(A)(i) or
(2)(B).
(D) A subparagraph (1)(B) claim made with respect to a dietary
supplement of vitamins, minerals, herbs, or other similar
nutritional substances shall not be subject to subparagraph (3) but
shall be subject to a procedure and standard, respecting the
validity of such claim, established by regulation of the Secretary.
(6) For purposes of paragraph (r)(1)(B), a statement for a
dietary supplement may be made if -
(A) the statement claims a benefit related to a classical
nutrient deficiency disease and discloses the prevalence of such
disease in the United States, describes the role of a nutrient or
dietary ingredient intended to affect the structure or function
in humans, characterizes the documented mechanism by which a
nutrient or dietary ingredient acts to maintain such structure or
function, or describes general well-being from consumption of a
nutrient or dietary ingredient,
(B) the manufacturer of the dietary supplement has
substantiation that such statement is truthful and not
misleading, and
(C) the statement contains, prominently displayed and in
boldface type, the following: "This statement has not been
evaluated by the Food and Drug Administration. This product is
not intended to diagnose, treat, cure, or prevent any disease.".
A statement under this subparagraph may not claim to diagnose,
mitigate, treat, cure, or prevent a specific disease or class of
diseases. If the manufacturer of a dietary supplement proposes to
make a statement described in the first sentence of this
subparagraph in the labeling of the dietary supplement, the
manufacturer shall notify the Secretary no later than 30 days after
the first marketing of the dietary supplement with such statement
that such a statement is being made.
(7) The Secretary may make proposed regulations issued under this
paragraph effective upon publication pending consideration of
public comment and publication of a final regulation if the
Secretary determines that such action is necessary -
(A) to enable the Secretary to review and act promptly on
petitions the Secretary determines provide for information
necessary to -
(i) enable consumers to develop and maintain healthy dietary
practices;
(ii) enable consumers to be informed promptly and effectively
of important new knowledge regarding nutritional and health
benefits of food; or
(iii) ensure that scientifically sound nutritional and health
information is provided to consumers as soon as possible; or
(B) to enable the Secretary to act promptly to ban or modify a
claim under this paragraph.
Such proposed regulations shall be deemed final agency action for
purposes of judicial review.
(s) Dietary supplements
If -
(1) it is a dietary supplement; and
(2)(A) the label or labeling of the supplement fails to list -
(i) the name of each ingredient of the supplement that is
described in section 321(ff) of this title; and
(ii)(I) the quantity of each such ingredient; or
(II) with respect to a proprietary blend of such ingredients,
the total quantity of all ingredients in the blend;
(B) the label or labeling of the dietary supplement fails to
identify the product by using the term "dietary supplement",
which term may be modified with the name of such an ingredient;
(C) the supplement contains an ingredient described in section
321(ff)(1)(C) of this title, and the label or labeling of the
supplement fails to identify any part of the plant from which the
ingredient is derived;
(D) the supplement -
(i) is covered by the specifications of an official
compendium;
(ii) is represented as conforming to the specifications of an
official compendium; and
(iii) fails to so conform; or
(E) the supplement -
(i) is not covered by the specifications of an official
compendium; and
(ii)(I) fails to have the identity and strength that the
supplement is represented to have; or
(II) fails to meet the quality (including tablet or capsule
disintegration), purity, or compositional specifications, based
on validated assay or other appropriate methods, that the
supplement is represented to meet.
A dietary supplement shall not be deemed misbranded solely because
its label or labeling contains directions or conditions of use or
warnings.
(t) Catfish
If it purports to be or is represented as catfish, unless it is
fish classified within the family Ictaluridae.
(u) Ginseng
If it purports to be or is represented as ginseng, unless it is
an herb or herbal ingredient derived from a plant classified within
the genus Panax.
(v) Failure to label; health threat
If -
(1) it fails to bear a label required by the Secretary under
section 381(n)(1) of this title (relating to food refused
admission into the United States);
(2) the Secretary finds that the food presents a threat of
serious adverse health consequences or death to humans or
animals; and
(3) upon or after notifying the owner or consignee involved
that the label is required under section 381 of this title, the
Secretary informs the owner or consignee that the food presents
such a threat.
(w) Major food allergen labeling requirements
(1) If it is not a raw agricultural commodity and it is, or it
contains an ingredient that bears or contains, a major food
allergen, unless either -
(A) the word "Contains", followed by the name of the food
source from which the major food allergen is derived, is printed
immediately after or is adjacent to the list of ingredients (in a
type size no smaller than the type size used in the list of
ingredients) required under subsections (g) and (i) of this
section; or
(B) the common or usual name of the major food allergen in the
list of ingredients required under subsections (g) and (i) of
this section is followed in parentheses by the name of the food
source from which the major food allergen is derived, except that
the name of the food source is not required when -
(i) the common or usual name of the ingredient uses the name
of the food source from which the major food allergen is
derived; or
(ii) the name of the food source from which the major food
allergen is derived appears elsewhere in the ingredient list,
unless the name of the food source that appears elsewhere in
the ingredient list appears as part of the name of a food
ingredient that is not a major food allergen under section
321(qq)(2)(A) or (B) of this title.
(2) As used in this subsection, the term "name of the food source
from which the major food allergen is derived" means the name
described in section 321(qq)(1) of this title; provided that in the
case of a tree nut, fish, or Crustacean shellfish, the term "name
of the food source from which the major food allergen is derived"
means the name of the specific type of nut or species of fish or
Crustacean shellfish.
(3) The information required under this subsection may appear in
labeling in lieu of appearing on the label only if the Secretary
finds that such other labeling is sufficient to protect the public
health. A finding by the Secretary under this paragraph (including
any change in an earlier finding under this paragraph) is effective
upon publication in the Federal Register as a notice.
(4) Notwithstanding subsection (g), (i), or (k) of this section,
or any other law, a flavoring, coloring, or incidental additive
that is, or that bears or contains, a major food allergen shall be
subject to the labeling requirements of this subsection.
(5) The Secretary may by regulation modify the requirements of
subparagraph (A) or (B) of paragraph (1), or eliminate either the
requirement of subparagraph (A) or the requirements of subparagraph
(B) of paragraph (1), if the Secretary determines that the
modification or elimination of the requirement of subparagraph (A)
or the requirements of subparagraph (B) is necessary to protect the
public health.
(6)(A) Any person may petition the Secretary to exempt a food
ingredient described in section 321(qq)(2) of this title from the
allergen labeling requirements of this subsection.
(B) The Secretary shall approve or deny such petition within 180
days of receipt of the petition or the petition shall be deemed
denied, unless an extension of time is mutually agreed upon by the
Secretary and the petitioner.
(C) The burden shall be on the petitioner to provide scientific
evidence (including the analytical method used to produce the
evidence) that demonstrates that such food ingredient, as derived
by the method specified in the petition, does not cause an allergic
response that poses a risk to human health.
(D) A determination regarding a petition under this paragraph
shall constitute final agency action.
(E) The Secretary shall promptly post to a public site all
petitions received under this paragraph within 14 days of receipt
and the Secretary shall promptly post the Secretary's response to
each.
(7)(A) A person need not file a petition under paragraph (6) to
exempt a food ingredient described in section 321(qq)(2) of this
title from the allergen labeling requirements of this subsection,
if the person files with the Secretary a notification containing -
(i) scientific evidence (including the analytical method used)
that demonstrates that the food ingredient (as derived by the
method specified in the notification, where applicable) does not
contain allergenic protein; or
(ii) a determination by the Secretary that the ingredient does
not cause an allergic response that poses a risk to human health
under a premarket approval or notification program under section
348 of this title.
(B) The food ingredient may be introduced or delivered for
introduction into interstate commerce as a food ingredient that is
not a major food allergen 90 days after the date of receipt of the
notification by the Secretary, unless the Secretary determines
within the 90-day period that the notification does not meet the
requirements of this paragraph, or there is insufficient scientific
evidence to determine that the food ingredient does not contain
allergenic protein or does not cause an allergenic response that
poses a risk to human health.
(C) The Secretary shall promptly post to a public site all
notifications received under this subparagraph within 14 days of
receipt and promptly post any objections thereto by the Secretary.
(x) Nonmajor food allergen labeling requirements
Notwithstanding subsection (g), (i), or (k) of this section, or
any other law, a spice, flavoring, coloring, or incidental additive
that is, or that bears or contains, a food allergen (other than a
major food allergen), as determined by the Secretary by regulation,
shall be disclosed in a manner specified by the Secretary by
regulation.
(y) Dietary supplements
If it is a dietary supplement that is marketed in the United
States, unless the label of such dietary supplement includes a
domestic address or domestic phone number through which the
responsible person (as described in section 379aa-1 of this title)
may receive a report of a serious adverse event with such dietary
supplement.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 403, 52 Stat. 1047; Pub. L. 86-537,
Sec. 1, June 29, 1960, 74 Stat. 251; Pub. L. 86-618, title I, Sec.
102(a)(3), July 12, 1960, 74 Stat. 398; Pub. L. 91-601, Sec. 6(c),
formerly Sec. 7(c), Dec. 30, 1970, 84 Stat. 1673, renumbered Pub.
L. 97-35, title XII, Sec. 1205(c), Aug. 13, 1981, 95 Stat. 716;
Pub. L. 94-278, title V, Sec. 502(a)(1), Apr. 22, 1976, 90 Stat.
411; Pub. L. 95-203, Sec. 4(a)(1), (b)(1), Nov. 23, 1977, 91 Stat.
1452, 1453; Pub. L. 101-535, Secs. 2(a), 3(a), 7, Nov. 8, 1990, 104
Stat. 2353, 2357, 2364; Pub. L. 102-108, Sec. 2(a), (c), Aug. 17,
1991, 105 Stat. 549; Pub. L. 102-571, title I, Sec. 107(5), (6),
Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Secs. 2(b), 3(j),
Aug. 13, 1993, 107 Stat. 773, 776; Pub. L. 103-417, Secs. 6, 7(a)-
(c), 10(c), Oct. 25, 1994, 108 Stat. 4329, 4330, 4332; Pub. L. 104-
124, Sec. 1, Apr. 1, 1996, 110 Stat. 882; Pub. L. 105-115, title
III, Secs. 301-305, Nov. 21, 1997, 111 Stat. 2350-2353; Pub. L. 106-
554, Sec. 1(a)(1) [title V, Sec. 517], Dec. 21, 2000, 114 Stat.
2763, 2763A-73; Pub. L. 107-171, title X, Secs. 10806(a)(2),
(b)(2), 10808(b), May 13, 2002, 116 Stat. 526, 527, 530; Pub. L.
107-188, title III, Sec. 308(b), June 12, 2002, 116 Stat. 672; Pub.
L. 108-282, title II, Sec. 203(a), Aug. 2, 2004, 118 Stat. 906;
Pub. L. 109-462, Sec. 3(c), Dec. 22, 2006, 120 Stat. 3475; Pub. L.
111-148, title IV, Sec. 4205(a), (b), Mar. 23, 2010, 124 Stat.
573.)
-MISC1-
AMENDMENTS
2010 - Par. (q)(5)(A)(i). Pub. L. 111-148, Sec. 4205(a)(1),
inserted "except as provided in clause (H)(ii)(III)," before "which
is served".
Par. (q)(5)(A)(ii). Pub. L. 111-148, Sec. 4205(a)(2), inserted
"except as provided in clause (H)(ii)(III)," before "which is
processed".
Par. (q)(5)(H). Pub. L. 111-148, Sec. 4205(b), added cl. (H).
2006 - Par. (y). Pub. L. 109-462 added par. (y).
2004 - Pars. (w), (x). Pub. L. 108-282 added pars. (w) and (x).
2002 - Par. (h). Pub. L. 107-171, Sec. 10808(b), added subpar.
(3) and concluding provisions.
Par. (t). Pub. L. 107-171, Sec. 10806(a)(2), added par. (t).
Par. (u). Pub. L. 107-171, Sec. 10806(b)(2), added par. (u).
Par. (v). Pub. L. 107-188 added par. (v).
2000 - Par. (o). Pub. L. 106-554, which directed repeal of
section 403(o) of the Food, Drug, and Cosmetic Act, was executed by
repealing par. (o) of this section, which is section 403 of the
Federal Food, Drug, and Cosmetic Act, to reflect the probable
intent of Congress. Prior to repeal, par. (o) provided that a food
containing saccharin was to be deemed misbranded unless a specified
warning statement was placed in a conspicuous place on its label.
1997 - Par. (r)(2)(B). Pub. L. 105-115, Sec. 305, amended cl. (B)
generally. Prior to amendment, cl. (B) read as follows: "If a claim
described in subparagraph (1)(A) is made with respect to a nutrient
in a food, the label or labeling of such food shall contain,
prominently and in immediate proximity to such claim, the following
statement: 'See _____ for nutrition information.'. In the statement
-
"(i) the blank shall identify the panel on which the
information described in the statement may be found, and
"(ii) if the Secretary determines that the food contains a
nutrient at a level which increases to persons in the general
population the risk of a disease or health-related condition
which is diet related, taking into account the significance of
the food in the total daily diet, the statement shall also
identify such nutrient."
Par. (r)(2)(G), (H). Pub. L. 105-115, Sec. 304, added cls. (G)
and (H).
Par. (r)(3)(C), (D). Pub. L. 105-115, Sec. 303, added cls. (C)
and (D).
Par. (r)(4)(A)(i). Pub. L. 105-115, Sec. 302, inserted after
second sentence "If the Secretary does not act within such 100
days, the petition shall be deemed to be denied unless an extension
is mutually agreed upon by the Secretary and the petitioner.",
inserted "or the petition is deemed to be denied" after "If the
Secretary denies the petition", and inserted at end "If the
Secretary does not act within such 90 days, the petition shall be
deemed to be denied unless an extension is mutually agreed upon by
the Secretary and the petitioner. If the Secretary issues a
proposed regulation, the rulemaking shall be completed within 540
days of the date the petition is received by the Secretary. If the
Secretary does not issue a regulation within such 540 days, the
Secretary shall provide the Committee on Commerce of the House of
Representatives and the Committee on Labor and Human Resources of
the Senate the reasons action on the regulation did not occur
within such 540 days."
Par. (r)(7). Pub. L. 105-115, Sec. 301, added subpar. (7).
1996 - Par. (p). Pub. L. 104-124 struck out par. (p), which
deemed products containing saccharin and offered for sale, but not
for immediate consumption, by retail establishment, to be
misbranded, unless notice of information required by subsec. (o)
was provided by manufacturer and prominently displayed near
product.
1994 - Par. (q)(5)(F). Pub. L. 103-417, Sec. 7(b), amended cl.
(F) generally. Prior to amendment, cl. (F) read as follows: "If a
food to which section 350 of this title applies (as defined in
section 350(c) of this title) contains one or more of the nutrients
required by subparagraph (1) or (2) to be in the label or labeling
of the food, the label or labeling of such food shall comply with
the requirements of subparagraphs (1) and (2) in a manner which is
appropriate for such food and which is specified in regulations of
the Secretary."
Par. (r)(2)(F). Pub. L. 103-417, Sec. 7(c), added cl. (F).
Par. (r)(6). Pub. L. 103-417, Sec. 6, added subpar. (6).
Par. (s). Pub. L. 103-417, Sec. 10(c), inserted at end: "A
dietary supplement shall not be deemed misbranded solely because
its label or labeling contains directions or conditions of use or
warnings."
Pub. L. 103-417, Sec. 7(a), added par. (s).
1993 - Par. (e). Pub. L. 103-80, Sec. 3(j)(1), substituted
"count, except that" for "count: Provided, That".
Par. (i). Pub. L. 103-80, Sec. 3(j)(2), substituted "unless sold
as spices, flavorings, or such colors" for ", other than those sold
as such" and "naming each. To the extent" for "naming each:
Provided, That, to the extent".
Par. (k). Pub. L. 103-80, Sec. 3(j)(3), substituted ", except
that" for ": Provided, That".
Par. (l). Pub. L. 103-80, Sec. 3(j)(4), substituted "chemical,
except that" for "chemical: Provided, however, That".
Par. (q)(5)(E) to (G). Pub. L. 103-80, Sec. 2(b), added cl. (E)
and redesignated former cls. (E) and (F) as (F) and (G),
respectively.
Par. (r)(1)(B). Pub. L. 103-80, Sec. 3(j)(5), substituted
"(5)(D)" for "5(D)".
Par. (r)(4)(B). Pub. L. 103-80, Sec. 3(j)(6), substituted
"paragraph" for "subsection".
1992 - Par. (i). Pub. L. 102-571, Sec. 107(5), substituted
"379e(c)" for "376(c)".
Par. (m). Pub. L. 102-571, Sec. 107(6), substituted "379e" for
"376".
1991 - Par. (i). Pub. L. 102-108, Sec. 2(c), amended directory
language of Pub. L. 101-535, Sec. 7(1), (3). See 1990 Amendment
note below.
Par. (q)(4)(A). Pub. L. 102-108, Sec. 2(a), substituted "(D)" for
"(C)".
1990 - Par. (i). Pub. L. 101-535, Sec. 7, as amended by Pub. L.
102-108, Sec. 2(c), substituted "Unless" for "If it is not subject
to the provisions of paragraph (g) unless", inserted "and if the
food purports to be a beverage containing vegetable or fruit juice,
a statement with appropriate prominence on the information panel of
the total percentage of such fruit or vegetable juice contained in
the food", and substituted "colors not required to be certified
under section 376(c) of this title" for "colorings" the first time
appearing.
Par. (q). Pub. L. 101-535, Sec. 2(a), added par. (q).
Par. (r). Pub. L. 101-535, Sec. 3(a), added par. (r).
1977 - Par. (o). Pub. L. 95-203, Sec. 4(a)(1), added par. (o).
Par. (p). Pub. L. 95-203, Sec. 4(b)(1), added par. (p).
1976 - Par. (a). Pub. L. 94-278 inserted "(1)" after "If" and
inserted ", or (2) in the case of a food to which section 350 of
this title applies, its advertising is false or misleading in a
material respect or its labeling is in violation of section
350(b)(2) of this title" after "any particular".
1970 - Par. (n). Pub. L. 91-601 added par. (n).
1960 - Par. (k). Pub. L. 86-537, Sec. 1(1), exempted pesticide
chemicals when used in or on a raw agricultural commodity which is
the produce of the soil.
Par. (l). Pub. L. 86-537, Sec. 1(2), added par. (l).
Par. (m). Pub. L. 86-618 added par. (m).
-CHANGE-
CHANGE OF NAME
Committee on Commerce of House of Representatives changed to
Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and
insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5, One Hundred
Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate changed to
Committee on Health, Education, Labor, and Pensions of Senate by
Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
1999.
-MISC2-
EFFECTIVE DATE OF 2006 AMENDMENT
Pub. L. 109-462, Sec. 3(d)(1), (2), Dec. 22, 2006, 120 Stat.
3475, provided that:
"(1) In general. - Except as provided in paragraph (2), the
amendments made by this section [enacting section 379aa-1 of this
title and amending this section and section 331 of this title]
shall take effect 1 year after the date of enactment of this Act
[Dec. 22, 2006].
"(2) Misbranding. - Section 403(y) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 343(y)] (as added by this section) shall
apply to any dietary supplement labeled on or after the date that
is 1 year after the date of enactment of this Act [Dec. 22, 2006]."
EFFECTIVE DATE OF 2004 AMENDMENT
Amendment by Pub. L. 108-282 applicable to any food that is
labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108-
282, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1994 AMENDMENT
Section 7(e) of Pub. L. 103-417 provided that: "Dietary
supplements -
"(1) may be labeled after the date of the enactment of this Act
[Oct. 25, 1994] in accordance with the amendments made by this
section [amending this section and section 350 of this title],
and
"(2) shall be labeled after December 31, 1996, in accordance
with such amendments."
EFFECTIVE DATE OF 1990 AMENDMENT
Section 10(a) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(3), Oct. 29, 1992, 106 Stat. 4501, provided
that:
"(1) Except as provided in paragraph (2) -
"(A) the amendments made by section 2 [amending this section]
shall take effect 6 months after -
"(i) the date of the promulgation of all final regulations
required to implement section 403(q) of the Federal Food, Drug,
and Cosmetic Act [21 U.S.C. 343(q)], or
"(ii) if such regulations are not promulgated, the date
proposed regulations are to be considered as such final
regulations [Nov. 8, 1992, see 57 F.R. 56347],
except that section 403(q)(4) of such Act shall take effect as
prescribed by such section,
"(B) the amendments made by section 3 [amending this section]
shall take effect 6 months after -
"(i) the date of the promulgation of final regulations to
implement section 403(r) of the Federal Food, Drug, and
Cosmetic Act, or
"(ii) if such regulations are not promulgated, the date
proposed regulations are to be considered as such final
regulations [Nov. 8, 1992, see 57 F.R. 56347], except that any
person marketing a food the brand name of which contains a term
defined by the Secretary under section 403(r)(2)(A)(i) of the
Federal Food, Drug, and Cosmetic Act shall be given an
additional 6 months to comply with section 3,
"(C) the amendments made by section 4 [amending section 337 of
this title] shall take effect 24 months after the date of the
enactment of this Act [Nov. 8, 1990], except that such amendments
shall take effect with respect to such dietary supplements
[probably means dietary supplements of vitamins, minerals, herbs,
or other similar nutritional substances, see section 202(a)(1) of
Pub. L. 102-571, set out below] on December 31, 1993, and
"(D) the amendments made by section 5 [amending sections 321
and 345 of this title] shall take effect on the date the
amendments made by section 3 take effect.
"(2) Section 403(q) of the Federal Food, Drug, and Cosmetic Act
(as added by section 2) shall not apply with respect to food which
was labeled before the effective date of the amendments made by
section 2 and section 403(r) of the Federal Food, Drug, and
Cosmetic Act (as added by section 3) shall not apply with respect
to food which was labeled before the effective date of the
amendments made by section 3.
"(3)(A) If the Secretary finds that a person who is subject to
section 403(q)(4) of such Act is unable to comply with the
requirements of such section upon the effective date of final
regulations to implement section 403(q) of such Act or of proposed
regulations to be considered as such final regulations because the
Secretary has not made available to such person the information
required by such section, the Secretary shall delay the application
of such section to such person for such time as the Secretary may
require to provide such information.
"(B) If the Secretary finds that compliance with section 403(q)
or 403(r)(2) of such Act would cause an undue economic hardship,
the Secretary may delay the application of such sections for no
more than one year."
Section 10(c) of Pub. L. 101-535, as amended by Pub. L. 102-108,
Sec. 1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102-571, title I,
Sec. 107(17), Oct. 29, 1992, 106 Stat. 4500, provided that:
"(1) Except as provided in paragraphs (2) and (3), the amendments
made by section 7 [amending this section] shall take effect one
year after the date of the enactment of this Act [Nov. 8, 1990].
"(2)(A) If a food subject to section 403(g) of the Federal Food,
Drug, and Cosmetic Act [21 U.S.C. 343(g)] or a food with one or
more colors required to be certified under section 721(c) [of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 379e(c)] bears a
label which was printed before July 1, 1991, and which is attached
to the food before May 8, 1993, such food shall not be subject to
the amendments made by section 7(1) and section 7(3) [amending this
section].
"(B) If a food described in subparagraph (A) -
"(i) bears a label which was printed after July 1, 1991, but
before the date the proposed regulation described in clause (ii)
takes effect as a final regulation and which was attached to the
food before May 8, 1993, and
"(ii) meets the requirements of the proposed regulation of the
Secretary of Health and Human Services published in 56 Fed. Reg.
28592-28636 (June 21, 1991) as it pertains to the amendments made
by this Act [see Short Title of 1990 Amendment note set out under
section 301 of this title],
such food shall not be subject to the amendments made by section
7(1) and section 7(3) [amending this section].
"(3) A food purported to be a beverage containing a vegetable or
fruit juice which bears a label attached to the food before May 8,
1993, shall not be subject to the amendments made by section 7(2)
[amending this section]."
EFFECTIVE DATE OF 1977 AMENDMENT
Section 4(a)(2) of Pub. L. 95-203 provided that: "The amendment
made by paragraph (1) [amending this section] shall apply only with
respect to food introduced or delivered for introduction in
interstate commerce on and after the 90th day after the date of the
enactment of this Act [Nov. 23, 1977]."
Section 4(b)(2) of Pub. L. 95-203 provided that: "The amendment
made by paragraph (1) [amending this section] shall apply with
respect to food which is sold in retail establishments on or after
the 90th day after the effective date of the regulations of the
Secretary of Health, Education, and Welfare [now Secretary of
Health and Human Services] under paragraph (p)(4) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 343(p)(4)]."
EFFECTIVE DATE OF 1976 AMENDMENT
Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,
1976, see section 502(c) of Pub. L. 94-278, set out as a note under
section 334 of this title.
EFFECTIVE DATE OF 1970 AMENDMENT
Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and
regulations establishing special packaging standards effective no
sooner than 180 days or later than one year from date regulations
are final, or an earlier date published in Federal Register, see
section 8 of Pub. L. 91-601, set out as an Effective Date note
under section 1471 of Title 15, Commerce and Trade.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE; POSTPONEMENT
Subsecs. (e)(1) and (g) to (k) effective Jan. 1, 1940, and such
subsections effective July 1, 1940, as provided by regulations for
certain lithographed labeling and containers bearing certain
labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as
an Effective Date; Postponement in Certain Cases note under section
301 of this title.
CONSTRUCTION OF AMENDMENT BY PUB. L. 111-148
Pub. L. 111-148, title IV, Sec. 4205(d), Mar. 23, 2010, 124 Stat.
576, provided that: "Nothing in the amendments made by this section
[amending this section and section 343-1 of this title] shall be
construed -
"(1) to preempt any provision of State or local law, unless
such provision establishes or continues into effect nutrient
content disclosures of the type required under section
403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 343(q)(5)(H)] (as added by subsection (b)) and is
expressly preempted under subsection (a)(4) of such section;
"(2) to apply to any State or local requirement respecting a
statement in the labeling of food that provides for a warning
concerning the safety of the food or component of the food; or
"(3) except as provided in section 403(q)(5)(H)(ix) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)(5)(H)(ix)]
(as added by subsection (b)), to apply to any restaurant or
similar retail food establishment other than a restaurant or
similar retail food establishment described in section
403(q)(5)(H)(i) of such Act [21 U.S.C. 343(q)(5)(H)(i)]."
CONSTRUCTION OF AMENDMENT BY PUB. L. 108-282
Pub. L. 108-282, title II, Sec. 203(b), Aug. 2, 2004, 118 Stat.
908, provided that: "The amendments made by this section [amending
this section and sections 321 and 343-1 of this title] that require
a label or labeling for major food allergens do not alter the
authority of the Secretary of Health and Human Services under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to
require a label or labeling for other food allergens."
CONSTRUCTION OF AMENDMENT BY PUB. L. 107-188
Nothing in amendment by Pub. L. 107-188 to be construed to limit
authority of Secretary of Health and Human Services or Secretary of
the Treasury to require marking of articles of food imported or
offered for import into the United States which are refused
admission, see section 308(c) of Pub. L. 107-188, set out as a note
under section 381 of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Section 9 of Pub. L. 101-535 provided that: "The amendments made
by this Act [enacting section 343-1 of this title and amending this
section and sections 321, 337, 345, and 371 of this title] shall
not be construed to alter the authority of the Secretary of Health
and Human Services and the Secretary of Agriculture under the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], the
Federal Meat Inspection Act [21 U.S.C. 601 et seq.], the Poultry
Products Inspection Act [21 U.S.C. 451 et seq.], and the Egg
Products Inspection Act [21 U.S.C. 1031 et seq.]."
FINDINGS
Pub. L. 108-282, title II, Sec. 202, Aug. 2, 2004, 118 Stat. 905,
provided that: "Congress finds that -
"(1) it is estimated that -
"(A) approximately 2 percent of adults and about 5 percent of
infants and young children in the United States suffer from
food allergies; and
"(B) each year, roughly 30,000 individuals require emergency
room treatment and 150 individuals die because of allergic
reactions to food;
"(2)(A) eight major foods or food groups - milk, eggs, fish,
Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans -
account for 90 percent of food allergies;
"(B) at present, there is no cure for food allergies; and
"(C) a food allergic consumer must avoid the food to which the
consumer is allergic;
"(3)(A) in a review of the foods of randomly selected
manufacturers of baked goods, ice cream, and candy in Minnesota
and Wisconsin in 1999, the Food and Drug Administration found
that 25 percent of sampled foods failed to list peanuts or eggs
as ingredients on the food labels; and
"(B) nationally, the number of recalls because of unlabeled
allergens rose to 121 in 2000 from about 35 a decade earlier;
"(4) a recent study shows that many parents of children with a
food allergy were unable to correctly identify in each of several
food labels the ingredients derived from major food allergens;
"(5)(A) ingredients in foods must be listed by their 'common or
usual name';
"(B) in some cases, the common or usual name of an ingredient
may be unfamiliar to consumers, and many consumers may not
realize the ingredient is derived from, or contains, a major food
allergen; and
"(C) in other cases, the ingredients may be declared as a
class, including spices, flavorings, and certain colorings, or
are exempt from the ingredient labeling requirements, such as
incidental additives; and
"(6)(A) celiac disease is an immune-mediated disease that
causes damage to the gastrointestinal tract, central nervous
system, and other organs;
"(B) the current recommended treatment is avoidance of glutens
in foods that are associated with celiac disease; and
"(C) a multicenter, multiyear study estimated that the
prevalence of celiac disease in the United States is 0.5 to 1
percent of the general population."
REGULATIONS
Section 2(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,
4501, provided that:
"(1) The Secretary of Health and Human Services shall issue
proposed regulations to implement section 403(q) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 343(q)] within 12 months
after the date of the enactment of this Act [Nov. 8, 1990], except
that the Secretary shall issue, not later than June 15, 1993,
proposed regulations that are applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances
to implement such section. Not later than 24 months after the date
of the enactment of this Act, the Secretary shall issue final
regulations to implement the requirements of such section, except
that the Secretary shall issue, not later than December 31, 1993,
such a final regulation applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional
substances..[sic] Such regulations shall -
"(A) require the required information to be conveyed to the
public in a manner which enables the public to readily observe
and comprehend such information and to understand its relative
significance in the context of a total daily diet,
"(B) include regulations which establish standards, in
accordance with paragraph (1)(A), to define serving size or other
unit of measure for food,
"(C) permit the label or labeling of food to include nutrition
information which is in addition to the information required by
such section 403(q) and which is of the type described in
subparagraph (1) or (2) of such section, and
"(D) permit the nutrition information on the label or labeling
of a food to remain the same or permit the information to be
stated as a range even though (i) there are minor variations in
the nutritional value of the food which occur in the normal
course of the production or processing of the food, or (ii) the
food is comprised of an assortment of similar foods which have
variations in nutritional value.
"(2) If the Secretary of Health and Human Services does not
promulgate final regulations under paragraph (1) upon the
expiration of 24 months after the date of the enactment of this
Act, the proposed regulations issued in accordance with paragraph
(1) shall be considered as the final regulations upon the
expiration of such 24 months, except that the proposed regulations
applicable to dietary supplements of vitamins, minerals, herbs, or
other similar nutritional substances shall not be considered to be
final regulations until December 31, 1993. There shall be promptly
published in the Federal Register notice of new status of the
proposed regulations [see 57 F.R. 56347].
"(3) If the Secretary of Health and Human Services does not
promulgate final regulations under section 403(q)(4) of the Federal
Food, Drug, and Cosmetic Act upon the expiration of 6 months after
the date on which the Secretary makes a finding that there has been
no substantial compliance with section 403(q)(4)(C) of such Act,
the proposed regulations issued in accordance with such section
shall be considered as the final regulations upon the expiration of
such 6 months. There shall be promptly published in the Federal
Register notice of new status of the proposed regulations."
[Section 202(a)(2)(C) of Pub. L. 102-571 provided that: "The
amendments made by subparagraph (B) [amending sections 2(b) and
3(b) of Pub. L. 101-535, set out above and below] shall not be
construed to modify the effective date of final regulations under
sections 2(b) and 3(b) of the Nutrition Labeling and Education Act
of 1990 [Pub. L. 101-535] (21 U.S.C. 343 note) with respect to
foods that are not such dietary supplements."]
Section 3(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title II, Sec. 202(a)(2)(A), (B), Oct. 29, 1992, 106 Stat. 4500,
4501, provided that:
"(1)(A) Within 12 months of the date of the enactment of this Act
[Nov. 8, 1990], the Secretary of Health and Human Services shall
issue proposed regulations to implement section 403(r) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 343(r)], except
that the Secretary shall issue, not later than June 15, 1993,
proposed regulations that are applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances
to implement such section. Such regulations -
"(i) shall identify claims described in section 403(r)(1)(A) of
such Act which comply with section 403(r)(2) of such Act,
"(ii) shall identify claims described in section 403(r)(1)(B)
of such Act which comply with section 403(r)(3) of such Act,
"(iii) shall, in defining terms used to characterize the level
of any nutrient in food under section 403(r)(2)(A)(i) of such
Act, define -
"(I) free,
"(II) low,
"(III) light or lite,
"(IV) reduced,
"(V) less, and
"(VI) high,
unless the Secretary finds that the use of any such term would be
misleading,
"(iv) shall permit statements describing the amount and
percentage of nutrients in food which are not misleading and are
consistent with the terms defined in section 403(r)(2)(A)(i) of
such Act,
"(v) shall provide that if multiple claims subject to section
403(r)(1)(A) of such Act are made on a single panel of the food
label or page of a labeling brochure, a single statement may be
made to satisfy section 403(r)(2)(B) of such Act,
"(vi) shall determine whether claims respecting the following
nutrients and diseases meet the requirements of section 403(r)(3)
of such Act: Calcium and osteoporosis, dietary fiber and cancer,
lipids and cardiovascular disease, lipids and cancer, sodium and
hypertension, and dietary fiber and cardiovascular disease,
"(vii) shall not require a person who proposes to make a claim
described in section 403(r)(1)(B) of such Act which is in
compliance with such regulations to secure the approval of the
Secretary before making such claim,
"(viii) may permit a claim described in section 403(r)(1)(A) of
such Act to be made for butter,
"(ix) may, in defining terms under section 403(r)(2)(A)(i),
include similar terms which are commonly understood to have the
same meaning, and
"(x) shall establish, as required by section 403(r)(5)(D), the
procedure and standard respecting the validity of claims made
with respect to a dietary supplement of vitamins, minerals,
herbs, or other similar nutritional substances and shall
determine whether claims respecting the following nutrients and
diseases meet the requirements of section 403(r)(5)(D) of such
Act: folic acid and neural tube defects, antioxident [sic]
vitamins and cancer, zinc and immune function in the elderly, and
omega-3 fatty acids and heart disease.
"(B) Not later than 24 months after the date of the enactment of
this Act, the Secretary shall issue final regulations to implement
section 403(r) of the Federal Food, Drug, and Cosmetic Act, except
that the Secretary shall issue, not later than December 31, 1993,
such a final regulation applicable to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional
substances..[sic]
"(2) If the Secretary does not promulgate final regulations under
paragraph (1)(B) upon the expiration of 24 months after the date of
the enactment of this Act, the proposed regulations issued in
accordance with paragraph (1)(A) shall be considered as the final
regulations upon the expiration of such 24 months, except that the
proposed regulations applicable to dietary supplements of vitamins,
minerals, herbs, or other similar nutritional substances shall not
be considered to be final regulations until December 31, 1993.
There shall be promptly published in the Federal Register notice of
the new status of the proposed regulations [see 57 F.R. 56347]."
[For construction of amendment made by section 202(a)(2)(B) of
Pub. L. 102-571 to section 3(b) of Pub. L. 101-535 set out above,
see section 202(a)(2)(C) of Pub. L. 102-571 set out above following
section 2(b) of Pub. L. 101-535.]
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-MISC3-
RULEMAKING ON LABELING
Pub. L. 108-282, title II, Sec. 206, Aug. 2, 2004, 118 Stat. 910,
provided that: "Not later than 2 years after the date of enactment
of this Act [Aug. 2, 2004], the Secretary of Health and Human
Services, in consultation with appropriate experts and
stakeholders, shall issue a proposed rule to define, and permit use
of, the term 'gluten-free' on the labeling of foods. Not later than
4 years after the date of enactment of this Act, the Secretary
shall issue a final rule to define, and permit use of, the term
'gluten-free' on the labeling of foods."
Pub. L. 107-171, title X, Sec. 10809, May 13, 2002, 116 Stat.
531, provided that: "The Secretary of Health and Human Services
(referred to in this section as the 'Secretary') shall publish a
proposed rule and, with due consideration to public comment, a
final rule to revise, as appropriate, the current regulation
governing the labeling of foods that have been treated to reduce
pest infestation or pathogens by treatment by irradiation using
radioactive isotope, electronic beam, or x-ray. Pending
promulgation of the final rule required by this subsection
[probably should be "this section"], any person may petition the
Secretary for approval of labeling, which is not false or
misleading in any material respect, of a food which has been
treated by irradiation using radioactive isotope, electronic beam,
or x-ray. The Secretary shall approve or deny such a petition
within 180 days of receipt of the petition, or the petition shall
be deemed denied, except to the extent additional agency review is
mutually agreed upon by the Secretary and the petitioner. Any
denial of a petition under this subsection shall constitute final
agency action subject to judicial review by the United States Court
of Appeals for the District of Columbia Circuit. Any labeling
approved through the foregoing petition process shall be subject to
the provisions of the final rule referred to in the first sentence
of the subparagraph on the effective date of such final rule."
COMMISSION ON DIETARY SUPPLEMENT LABELS
Section 12 of Pub. L. 103-417 provided that:
"(a) Establishment. - There shall be established as an
independent agency within the executive branch a commission to be
known as the Commission on Dietary Supplement Labels (hereafter in
this section referred to as the 'Commission').
"(b) Membership. -
"(1) Composition. - The Commission shall be composed of 7
members who shall be appointed by the President.
"(2) Expertise requirement. - The members of the Commission
shall consist of individuals with expertise and experience in
dietary supplements and in the manufacture, regulation,
distribution, and use of such supplements. At least three of the
members of the Commission shall be qualified by scientific
training and experience to evaluate the benefits to health of the
use of dietary supplements and one of such three members shall
have experience in pharmacognosy, medical botany, traditional
herbal medicine, or other related sciences. Members and staff of
the Commission shall be without bias on the issue of dietary
supplements.
"(c) Functions of the Commission. - The Commission shall conduct
a study on, and provide recommendations for, the regulation of
label claims and statements for dietary supplements, including the
use of literature in connection with the sale of dietary
supplements and procedures for the evaluation of such claims. In
making such recommendations, the Commission shall evaluate how best
to provide truthful, scientifically valid, and not misleading
information to consumers so that such consumers may make informed
and appropriate health care choices for themselves and their
families.
"(d) Administrative Powers of the Commission. -
"(1) Hearings. - The Commission may hold hearings, sit and act
at such times and places, take such testimony, and receive such
evidence as the Commission considers advisable to carry out the
purposes of this section.
"(2) Information from federal agencies. - The Commission may
secure directly from any Federal department or agency such
information as the Commission considers necessary to carry out
the provisions of this section.
"(3) Authorization of appropriations. - There are authorized to
be appropriated such sums as may be necessary to carry out this
section.
"(e) Reports and Recommendations. -
"(1) Final report required. - Not later than 24 months after
the date of enactment of this Act [Oct. 25, 1994], the Commission
shall prepare and submit to the President and to the Congress a
final report on the study required by this section.
"(2) Recommendations. - The report described in paragraph (1)
shall contain such recommendations, including recommendations for
legislation, as the Commission deems appropriate.
"(3) Action on recommendations. - Within 90 days of the
issuance of the report under paragraph (1), the Secretary of
Health and Human Services shall publish in the Federal Register a
notice of any recommendation of Commission for changes in
regulations of the Secretary for the regulation of dietary
supplements and shall include in such notice a notice of proposed
rulemaking on such changes together with an opportunity to
present views on such changes. Such rulemaking shall be completed
not later than 2 years after the date of the issuance of such
report. If such rulemaking is not completed on or before the
expiration of such 2 years, regulations of the Secretary
published in 59 FR 395-426 on January 4, 1994, shall not be in
effect."
EXTENSION OF COMPLIANCE DEADLINE FOR CERTAIN FOOD PRODUCTS PACKAGED
PRIOR TO AUGUST 8, 1994
Pub. L. 103-261, May 26, 1994, 108 Stat. 705, provided: "That
before August 8, 1994, sections 403(q) and 403(r)(2) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 343(q), (r)(2)] and the
provision of section 403(i) of such Act added by section 7(2) of
the Nutrition Labeling and Education Act of 1990 [Pub. L. 101-535],
shall not apply with respect to a food product which is contained
in a package for which the label was printed before May 8, 1994 (or
before August 8, 1994, in the case of a juice or milk food product
if the person responsible for the labeling of such food product
exercised due diligence in obtaining before such date labels which
are in compliance with such sections 403(q) and 403(r)(2) and such
provision of section 403(i)), if, before June 15, 1994, the person
who introduces or delivers for introduction such food product into
interstate commerce submits to the Secretary of Health and Human
Services a certification that such person will comply with this
section and will comply with such sections 403(q) and 403(r)(2) and
such provision of section 403(i) after August 8, 1994."
LIMITATIONS ON APPLICATION OF SMALL BUSINESS EXEMPTION
Section 2(a) of Pub. L. 103-80 provided that:
"(1) Before may 8, 1995. - Before May 8, 1995, the exemption
provided by section 403(q)(5)(D) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 343(q)(5)(D)] shall be available in
accordance with the regulations of the Secretary of Health and
Human Services published at 21 C.F.R. 101.9(j)(1)(i)(1993).
"(2) After may 8, 1995. - After May 8, 1995, the exemption
provided by section 403(q)(5)(D) of the Federal Food, Drug, and
Cosmetic Act shall only be available with respect to food when it
is sold to consumers."
PROHIBITION ON IMPLEMENTATION OF PUB. L. 101-535 WITH RESPECT TO
DIETARY SUPPLEMENTS
Section 202(a)(1) of Pub. L. 102-571 provided that:
"Notwithstanding any other provision of law and except as provided
in subsection (b) [set out as a note below] and in the amendment
made by paragraph (2)(A) [amending provisions set out as notes
above], the Secretary of Health and Human Services may not
implement the Nutrition Labeling and Education Act of 1990 (Public
Law 101-535; 104 Stat. 2353) [see Short Title of 1990 Amendments
note set out under section 301 of this title], or any amendment
made by such Act, earlier than December 15, 1993, with respect to
dietary supplements of vitamins, minerals, herbs, or other similar
nutritional substances."
HEALTH CLAIMS MADE WITH RESPECT TO DIETARY SUPPLEMENTS
Section 202(b) of Pub. L. 102-571 provided that: "Notwithstanding
section 403(r)(5)(D) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 343(r)(5)(D)) and subsection (a) [enacting provisions
set out as notes above and amending provisions set out as notes
above and under section 343-1 of this title], the Secretary of
Health and Human Services may, earlier than December 15, 1993,
approve claims made with respect to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional substances
that are claims described in clauses (vi) and (x) of section
3(b)(1)(A) of the Nutrition Labeling and Education Act of 1990
[Pub. L. 101-535] (21 U.S.C. 343 note)."
UNITED STATES RECOMMENDED DAILY ALLOWANCES OF VITAMINS OR MINERALS
Section 203 of Pub. L. 102-571 provided that: "Notwithstanding
any other provision of Federal law, no regulations that require the
use of, or are based upon, recommended daily allowances of vitamins
or minerals may be promulgated before November 8, 1993 (other than
regulations establishing the United States recommended daily
allowances specified at section 101.9(c)(7)(iv) of title 21, Code
of Federal Regulations, as in effect on October 6, 1992, or
regulations under section 403(r)(1)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 343(r)(1)(A)) that are based on such
recommended daily allowances)."
CONSUMER EDUCATION
Section 2(c) of Pub. L. 101-535 provided that: "The Secretary of
Health and Human Services shall carry out activities which educate
consumers about -
"(1) the availability of nutrition information in the label or
labeling of food, and
"(2) the importance of that information in maintaining healthy
dietary practices."
STUDIES CONCERNING CARCINOGENIC AND OTHER TOXIC SUBSTANCES IN FOOD
AND IMPURITIES IN AND TOXICITY OF SACCHARIN
Section 2 of Pub. L. 95-203 directed Secretary of Health,
Education, and Welfare to conduct a study concerning carcinogenic
and other toxic substances in food and impurities in and toxicity
of saccharin and make a report respecting the carcinogenic and
other substances to Committee on Human Resources of the Senate
within 12 months of Nov. 23, 1977, and a report respecting
saccharin to such committee within 15 months of Nov. 23, 1977.
REPORT TO CONGRESSIONAL COMMITTEES RESPECTING ACTION TAKEN PURSUANT
TO FORMER PAR. (O)(2)
Section 4(a)(3) of Pub. L. 95-203 provided that the Secretary was
to report to specified congressional committees any action taken
under former par. (o)(2) of this section.
STATE OR TERRITORIAL REQUIREMENTS
Section 2 of Pub. L. 86-537 provided that: "Nothing in the
amendments made by the first section of this Act [amending this
section] shall affect any requirement of the laws of any State or
Territory."
-FOOTNOTE-
(!1) So in original. Probably should be followed by a comma.
-End-
-CITE-
21 USC Sec. 343-1 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 343-1. National uniform nutrition labeling
-STATUTE-
(a) Except as provided in subsection (b) of this section, no
State or political subdivision of a State may directly or
indirectly establish under any authority or continue in effect as
to any food in interstate commerce -
(1) any requirement for a food which is the subject of a
standard of identity established under section 341 of this title
that is not identical to such standard of identity or that is not
identical to the requirement of section 343(g) of this title,
except that this paragraph does not apply to a standard of
identity of a State or political subdivision of a State for maple
syrup that is of the type required by sections 341 and 343(g) of
this title,
(2) any requirement for the labeling of food of the type
required by section 343(c), 343(e), 343(i)(2), 343(w), or 343(x)
of this title that is not identical to the requirement of such
section, except that this paragraph does not apply to a
requirement of a State or political subdivision of a State that
is of the type required by section 343(c) of this title and that
is applicable to maple syrup,
(3) any requirement for the labeling of food of the type
required by section 343(b), 343(d), 343(f), 343(h), 343(i)(1), or
343(k) of this title that is not identical to the requirement of
such section, except that this paragraph does not apply to a
requirement of a State or political subdivision of a State that
is of the type required by section 343(h)(1) of this title and
that is applicable to maple syrup,
(4) any requirement for nutrition labeling of food that is not
identical to the requirement of section 343(q) of this title,
except that this paragraph does not apply to food that is offered
for sale in a restaurant or similar retail food establishment
that is not part of a chain with 20 or more locations doing
business under the same name (regardless of the type of ownership
of the locations) and offering for sale substantially the same
menu items unless such restaurant or similar retail food
establishment complies with the voluntary provision of nutrition
information requirements under section 343(q)(5)(H)(ix) of this
title, or
(5) any requirement respecting any claim of the type described
in section 343(r)(1) of this title made in the label or labeling
of food that is not identical to the requirement of section
343(r) of this title, except a requirement respecting a claim
made in the label or labeling of food which is exempt under
section 343(r)(5)(B) of this title.
Paragraph (3) shall take effect in accordance with section 6(b) of
the Nutrition Labeling and Education Act of 1990.
(b) Upon petition of a State or a political subdivision of a
State, the Secretary may exempt from subsection (a) of this
section, under such conditions as may be prescribed by regulation,
any State or local requirement that -
(1) would not cause any food to be in violation of any
applicable requirement under Federal law,
(2) would not unduly burden interstate commerce, and
(3) is designed to address a particular need for information
which need is not met by the requirements of the sections
referred to in subsection (a) of this section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 403A, as added Pub. L. 101-535, Sec.
6(a), Nov. 8, 1990, 104 Stat. 2362; amended Pub. L. 102-108, Sec.
2(b), Aug. 17, 1991, 105 Stat. 549; Pub. L. 103-396, Sec. 3(a),
Oct. 22, 1994, 108 Stat. 4154; Pub. L. 108-282, title II, Sec.
203(c)(2), Aug. 2, 2004, 118 Stat. 908; Pub. L. 111-148, title IV,
Sec. 4205(c), Mar. 23, 2010, 124 Stat. 576.)
-REFTEXT-
REFERENCES IN TEXT
Section 6(b) of the Nutrition Labeling and Education Act of 1990
[Pub. L. 101-535], referred to in subsec. (a), is set out below.
-MISC1-
AMENDMENTS
2010 - Subsec. (a)(4). Pub. L. 111-148 substituted "except that
this paragraph does not apply to food that is offered for sale in a
restaurant or similar retail food establishment that is not part of
a chain with 20 or more locations doing business under the same
name (regardless of the type of ownership of the locations) and
offering for sale substantially the same menu items unless such
restaurant or similar retail food establishment complies with the
voluntary provision of nutrition information requirements under
section 343(q)(5)(H)(ix) of this title" for "except a requirement
for nutrition labeling of food which is exempt under subclause (i)
or (ii) of section 343(q)(5)(A) of this title".
2004 - Subsec. (a)(2). Pub. L. 108-282 substituted "343(i)(2),
343(w), or 343(x)" for "or 343(i)(2)".
1994 - Subsec. (a)(1). Pub. L. 103-396, Sec. 3(a)(1), inserted at
end "except that this paragraph does not apply to a standard of
identity of a State or political subdivision of a State for maple
syrup that is of the type required by sections 341 and 343(g) of
this title,".
Subsec. (a)(2). Pub. L. 103-396, Sec. 3(a)(2), inserted at end
"except that this paragraph does not apply to a requirement of a
State or political subdivision of a State that is of the type
required by section 343(c) of this title and that is applicable to
maple syrup,".
Subsec. (a)(3). Pub. L. 103-396, Sec. 3(a)(3), inserted at end
"except that this paragraph does not apply to a requirement of a
State or political subdivision of a State that is of the type
required by section 343(h)(1) of this title and that is applicable
to maple syrup,".
1991 - Subsec. (a)(5). Pub. L. 102-108 substituted "section
343(r)(5)(B) of this title" for "clause (B) of such section".
EFFECTIVE DATE OF 2004 AMENDMENT
Amendment by Pub. L. 108-282 applicable to any food that is
labeled on or after Jan. 1, 2006, see section 203(d) of Pub. L. 108-
282, set out as a note under section 321 of this title.
EFFECTIVE DATE
Section 10(b) of Pub. L. 101-535, as amended by Pub. L. 102-571,
title I, Sec. 107(16), title II, Sec. 202(a)(4), Oct. 29, 1992, 106
Stat. 4499, 4501, provided that:
"(1) In general. - Except as provided in paragraph (2), the
amendments made by section 6 [enacting this section] shall take
effect -
"(A) with respect to a requirement of a State or political
subdivision described in paragraph (1) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act [subsec. (a)(1) of this
section], on the date of the enactment of this Act [Nov. 8,
1990],
"(B) with respect to a requirement of a State or political
subdivision described in paragraph (2) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, one year after the date of
the enactment of this Act,
"(C) with respect to a requirement of a State or political
subdivision described in paragraph (3) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, as prescribed by section
6(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L.
101-535, set out below],
"(D) with respect to a requirement of a State or political
subdivision described in paragraph (4) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, on the date regulations to
implement section 403(q) of such Act [21 U.S.C. 343(q)] take
effect, and
"(E) with respect to a requirement of a State or political
subdivision described in paragraph (5) of section 403A(a) of the
Federal Food, Drug, and Cosmetic Act, on the date regulations to
implement section 403(r) of such Act take effect.
"(2) Exception. - If a State or political subdivision submits a
petition under section 403A(b) of the Federal Food, Drug, and
Cosmetic Act for a requirement described in section 403A(a) of such
Act within 18 months of the date of the enactment of this Act,
paragraphs (3) through (5) of such section 403A(a) shall not apply
with respect to such State or political subdivision requirement
until -
"(A) 24 months after the date of the enactment of this Act, or
"(B) action on the petition,
whichever occurs later.
"(3) Requirements pertaining to certain claims. - Notwithstanding
subparagraphs (D) and (E) of paragraph (1) and except with respect
to claims approved in accordance with section 202(b) of the Dietary
Supplement Act of 1992 [Pub. L. 102-571, set out as a note under
section 343 of this title], the requirements described in
paragraphs (4) and (5) of section 403A(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 343-1(a)(4) and (5)) that pertain
to dietary supplements of vitamins, minerals, herbs, or other
similar nutritional substances shall not take effect until the date
final regulations take effect to implement subsection (q) or (r),
as appropriate, of section 403 of such Act with respect to such
dietary supplements."
Section 6(b) of Pub. L. 101-535 provided that:
"(1) For the purpose of implementing section 403A(a)(3) [21
U.S.C. 343-1(a)(3)], the Secretary of Health and Human Services
shall enter into a contract with a public or nonprofit private
entity to conduct a study of -
"(A) State and local laws which require the labeling of food
that is of the type required by sections 403(b), 403(d), 403(f),
403(h), 403(i)(1), and 403(k) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 343(b), (d), (f), (h), (i)(1), (k)], and
"(B) the sections of the Federal Food, Drug, and Cosmetic Act
referred to in subparagraph (A) and the regulations issued by the
Secretary to enforce such sections to determine whether such
sections and regulations adequately implement the purposes of
such sections.
"(2) The contract under paragraph (1) shall provide that the
study required by such paragraph shall be completed within 6 months
of the date of the enactment of this Act [Nov. 8, 1990].
"(3)(A) Within 9 months of the date of the enactment of this Act,
the Secretary shall publish a proposed list of sections which are
adequately being implemented by regulations as determined under
paragraph (1)(B) and sections which are not adequately being
implemented by regulations as so determined. After publication of
the lists, the Secretary shall provide 60 days for comments on such
lists.
"(B) Within 24 months of the date of the enactment of this Act,
the Secretary shall publish a final list of sections which are
adequately being implemented by regulations and a list of sections
which are not adequately being implemented by regulations. With
respect to a section which is found by the Secretary to be
adequately implemented, no State or political subdivision of a
State may establish or continue in effect as to any food in
interstate commerce any requirement which is not identical to the
requirement of such section.
"(C) Within 24 months of the date of the enactment of this Act,
the Secretary shall publish proposed revisions to the regulations
found to be inadequate under subparagraph (B) and within 30 months
of such date shall issue final revisions. Upon the effective date
of such final revisions, no State or political subdivision may
establish or continue in effect any requirement which is not
identical to the requirement of the section which had its
regulations revised in accordance with this subparagraph.
"(D)(i) If the Secretary does not issue a final list in
accordance with subparagraph (B), the proposed list issued under
subparagraph (A) shall be considered the final list and States and
political subdivisions shall be preempted with respect to sections
found to be adequate in such proposed list in accordance with
subparagraph (B).
"(ii) If the Secretary does not issue final revisions of
regulations in accordance with subparagraph (C), the proposed
revisions issued under such subparagraph shall be considered the
final revisions and States and political subdivisions shall be
preempted with respect to sections the regulations of which are
revised by the proposed revisions.
"(E) Subsection (b) of section 403A of the Federal Food, Drug,
and Cosmetic Act shall apply with respect to the prohibition
prescribed by subparagraphs (B) and (C)."
CONSTRUCTION OF PUB. L. 101-535
Section 6(c) of Pub. L. 101-535 provided that:
"(1) The Nutrition Labeling and Education Act of 1990 [Pub. L.
101-535, see Short Title of 1990 Amendment note set out under
section 301 of this title] shall not be construed to preempt any
provision of State law, unless such provision is expressly
preempted under section 403A of the Federal Food, Drug, and
Cosmetic Act [this section].
"(2) The amendment made by subsection (a) [enacting this section]
and the provisions of subsection (b) [set out as a note above]
shall not be construed to apply to any requirement respecting a
statement in the labeling of food that provides for a warning
concerning the safety of the food or component of the food.
"(3) The amendment made by subsection (a), the provisions of
subsection (b) and paragraphs (1) and (2) of this subsection shall
not be construed to affect preemption, express or implied, of any
such requirement of a State or political subdivision, which may
arise under the Constitution, any provision of the Federal Food,
Drug, and Cosmetic Act [this chapter] not amended by subsection
(a), any other Federal law, or any Federal regulation, order, or
other final agency action reviewable under chapter 7 of title 5,
United States Code."
Amendments by Pub. L. 101-535 not to be construed to alter the
authority of the Secretary of Health and Human Services and the
Secretary of Agriculture under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21
U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C.
451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031
et seq.), see section 9 of Pub. L. 101-535, set out as a note under
section 343 of this title.
DELAYED APPLICABILITY OF CERTAIN PROVISIONS
Pub. L. 102-408, title III, Sec. 310, Oct. 13, 1992, 106 Stat.
2090, provided that: "Notwithstanding any other provision of law,
section 403A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 343-1(a)(1)) shall not apply with respect to any requirement
of any State or political subdivision regarding maple syrup until
September 1, 1994."
-End-
-CITE-
21 USC Sec. 343-2 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 343-2. Dietary supplement labeling exemptions
-STATUTE-
(a) In general
A publication, including an article, a chapter in a book, or an
official abstract of a peer-reviewed scientific publication that
appears in an article and was prepared by the author or the editors
of the publication, which is reprinted in its entirety, shall not
be defined as labeling when used in connection with the sale of a
dietary supplement to consumers when it -
(1) is not false or misleading;
(2) does not promote a particular manufacturer or brand of a
dietary supplement;
(3) is displayed or presented, or is displayed or presented
with other such items on the same subject matter, so as to
present a balanced view of the available scientific information
on a dietary supplement;
(4) if displayed in an establishment, is physically separate
from the dietary supplements; and
(5) does not have appended to it any information by sticker or
any other method.
(b) Application
Subsection (a) of this section shall not apply to or restrict a
retailer or wholesaler of dietary supplements in any way whatsoever
in the sale of books or other publications as a part of the
business of such retailer or wholesaler.
(c) Burden of proof
In any proceeding brought under subsection (a) of this section,
the burden of proof shall be on the United States to establish that
an article or other such matter is false or misleading.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 403B, as added Pub. L. 103-417, Sec.
5, Oct. 25, 1994, 108 Stat. 4328.)
-End-
-CITE-
21 USC Sec. 343-3 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 343-3. Disclosure
-STATUTE-
(a) No provision of section 321(n), 343(a), or 348 of this title
shall be construed to require on the label or labeling of a food a
separate radiation disclosure statement that is more prominent than
the declaration of ingredients required by section 343(i)(2) of
this title.
(b) In this section, the term "radiation disclosure statement"
means a written statement that discloses that a food has been
intentionally subject to radiation.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 403C, as added Pub. L. 105-115, title
III, Sec. 306, Nov. 21, 1997, 111 Stat. 2353.)
-MISC1-
EFFECTIVE DATE
Section effective 90 days after Nov. 21, 1997, except as
otherwise provided, see section 501 of Pub. L. 105-115, set out as
an Effective Date of 1997 Amendment note under section 321 of this
title.
-End-
-CITE-
21 USC Sec. 343a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 343a. Repealed.
-MISC1-
Sec. 343a. Repealed. Pub. L. 106-554, Sec. 1(a)(1) [title V, Sec.
517], Dec. 21, 2000, 114 Stat. 2763, 2763A-73.
Section, Pub. L. 95-203, Sec. 4(c), (d), Nov. 23, 1977, 91 Stat.
1453, 1454, related to distribution of information on health risks
of saccharin.
-End-
-CITE-
21 USC Sec. 344 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 344. Emergency permit control
-STATUTE-
(a) Conditions on manufacturing, processing, etc., as health
measure
Whenever the Secretary finds after investigation that the
distribution in interstate commerce of any class of food may, by
reason of contamination with micro-organisms during the
manufacture, processing, or packing thereof in any locality, be
injurious to health, and that such injurious nature cannot be
adequately determined after such articles have entered interstate
commerce, he then, and in such case only, shall promulgate
regulations providing for the issuance, to manufacturers,
processors, or packers of such class of food in such locality, of
permits to which shall be attached such conditions governing the
manufacture, processing, or packing of such class of food, for such
temporary period of time, as may be necessary to protect the public
health; and after the effective date of such regulations, and
during such temporary period, no person shall introduce or deliver
for introduction into interstate commerce any such food
manufactured, processed, or packed by any such manufacturer,
processor, or packer unless such manufacturer, processor, or packer
holds a permit issued by the Secretary as provided by such
regulations.
(b) Violation of permit; suspension and reinstatement
The Secretary is authorized to suspend immediately upon notice
any permit issued under authority of this section if it is found
that any of the conditions of the permit have been violated. The
holder of a permit so suspended shall be privileged at any time to
apply for the reinstatement of such permit, and the Secretary
shall, immediately after prompt hearing and an inspection of the
establishment, reinstate such permit if it is found that adequate
measures have been taken to comply with and maintain the conditions
of the permit, as originally issued or as amended.
(c) Inspection of permit-holding establishments
Any officer or employee duly designated by the Secretary shall
have access to any factory or establishment, the operator of which
holds a permit from the Secretary, for the purpose of ascertaining
whether or not the conditions of the permit are being complied
with, and denial of access for such inspection shall be ground for
suspension of the permit until such access is freely given by the
operator.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 404, 52 Stat. 1048.)
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 345 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 345. Regulations making exemptions
-STATUTE-
The Secretary shall promulgate regulations exempting from any
labeling requirement of this chapter (1) small open containers of
fresh fruits and fresh vegetables and (2) food which is, in
accordance with the practice of the trade, to be processed,
labeled, or repacked in substantial quantities at establishments
other than those where originally processed or packed, on condition
that such food is not adulterated or misbranded under the
provisions of this chapter upon removal from such processing,
labeling, or repacking establishment. This section does not apply
to the labeling requirements of sections 343(q) and 343(r) of this
title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 405, 52 Stat. 1049; Pub. L. 101-535,
Sec. 5(a), Nov. 8, 1990, 104 Stat. 2362.)
-MISC1-
AMENDMENTS
1990 - Pub. L. 101-535 inserted at end "This section does not
apply to the labeling requirements of sections 343(q) and 343(r) of
this title."
EFFECTIVE DATE OF 1990 AMENDMENT
Amendment by Pub. L. 101-535 effective six months after the date
of the promulgation of final regulations to implement section
343(r) of this title, or if such regulations are not promulgated,
the date proposed regulations are to be considered as such final
regulations (Nov. 8, 1992), with exception for persons marketing
food the brand name of which contains a term defined by the
Secretary under section 343(r)(2)(A)(i) of this title, see section
10(a) of Pub. L. 101-535, set out as a note under section 343 of
this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535
Amendments by Pub. L. 101-535 not to be construed to alter
authority of Secretary of Health and Human Services and Secretary
of Agriculture under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et
seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et
seq.), see section 9 of Pub. L. 101-535, set out as a note under
section 343 of this title.
-TRANS-
TRANSFER OF FUNCTIONS
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration in the Department of
Agriculture to Federal Security Agency, see notes set out under
section 321 of this title.
-End-
-CITE-
21 USC Sec. 346 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 346. Tolerances for poisonous or deleterious substances in
food; regulations
-STATUTE-
Any poisonous or deleterious substance added to any food, except
where such substance is required in the production thereof or
cannot be avoided by good manufacturing practice shall be deemed to
be unsafe for purposes of the application of clause (2)(A) of
section 342(a) of this title; but when such substance is so
required or cannot be so avoided, the Secretary shall promulgate
regulations limiting the quantity therein or thereon to such extent
as he finds necessary for the protection of public health, and any
quantity exceeding the limits so fixed shall also be deemed to be
unsafe for purposes of the application of clause (2)(A) of section
342(a) of this title. While such a regulation is in effect limiting
the quantity of any such substance in the case of any food, such
food shall not, by reason of bearing or containing any added amount
of such substance, be considered to be adulterated within the
meaning of clause (1) of section 342(a) of this title. In
determining the quantity of such added substance to be tolerated in
or on different articles of food the Secretary shall take into
account the extent to which the use of such substance is required
or cannot be avoided in the production of each such article, and
the other ways in which the consumer may be affected by the same or
other poisonous or deleterious substances.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 406, 52 Stat. 1049; Pub. L. 85-929,
Sec. 3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L. 86-618, title I,
Sec. 103(a)(1), July 12, 1960, 74 Stat. 398.)
-MISC1-
AMENDMENTS
1960 - Pub. L. 86-618 repealed subsec. (b) which required
Secretary to promulgate regulations for listing of coal-tar colors.
1958 - Subsec. (a). Pub. L. 85-929 substituted "clause (2)(A)"
for "clause (2)" in first sentence.
EFFECTIVE DATE OF 1960 AMENDMENT
Amendment by Pub. L. 86-618 effective July 12, 1960, subject to
the provisions of section 203 of Pub. L. 86-618, see section 202 of
Pub. L. 86-618, set out as a note under section 379e of this title.
EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND
DESICCANT AMENDMENT OF 1959
Effective date of subsec. (a) as in force prior to July 22, 1954,
with respect to particular commercial use of a nematocide, plant
regulator, defoliant, or desiccant in or on a raw agricultural
commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-
139, Aug. 7, 1959, 73 Stat. 288.
EFFECTIVE DATE OF 1958 AMENDMENT
For effective date of amendment by Pub. L. 85-929, see section
6(b), (c) of Pub. L. 85-929, set out as a note under section 342 of
this title.
-TRANS-
TRANSFER OF FUNCTIONS
Functions vested in Secretary of Health, Education, and Welfare
[now Health and Human Services] in establishing tolerances for
pesticide chemicals under this section together with authority to
monitor compliance with tolerances and effectiveness of
surveillance and enforcement and to provide technical assistance to
States and conduct research under this chapter and section 201 et
seq. of Title 42, The Public Health and Welfare, transferred to
Administrator of Environmental Protection Agency by Reorg. Plan No.
3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat.
2086, set out in the Appendix to Title 5, Government Organization
and Employees.
For transfer of functions of Federal Security Administrator to
Secretary of Health, Education, and Welfare [now Health and Human
Services], and of Food and Drug Administration to Federal Security
Agency, see notes set out under section 321 of this title.
-End-
-CITE-
21 USC Sec. 346a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 346a. Tolerances and exemptions for pesticide chemical
residues
-STATUTE-
(a) Requirement for tolerance or exemption
(1) General rule
Except as provided in paragraph (2) or (3), any pesticide
chemical residue in or on a food shall be deemed unsafe for the
purpose of section 342(a)(2)(B) of this title unless -
(A) a tolerance for such pesticide chemical residue in or on
such food is in effect under this section and the quantity of
the residue is within the limits of the tolerance; or
(B) an exemption from the requirement of a tolerance is in
effect under this section for the pesticide chemical residue.
For the purposes of this section, the term "food", when used as a
noun without modification, shall mean a raw agricultural
commodity or processed food.
(2) Processed food
Notwithstanding paragraph (1) -
(A) if a tolerance is in effect under this section for a
pesticide chemical residue in or on a raw agricultural
commodity, a pesticide chemical residue that is present in or
on a processed food because the food is made from that raw
agricultural commodity shall not be considered unsafe within
the meaning of section 342(a)(2)(B) of this title despite the
lack of a tolerance for the pesticide chemical residue in or on
the processed food if the pesticide chemical has been used in
or on the raw agricultural commodity in conformity with a
tolerance under this section, such residue in or on the raw
agricultural commodity has been removed to the extent possible
in good manufacturing practice, and the concentration of the
pesticide chemical residue in the processed food is not greater
than the tolerance prescribed for the pesticide chemical
residue in the raw agricultural commodity; or
(B) if an exemption for the requirement for a tolerance is in
effect under this section for a pesticide chemical residue in
or on a raw agricultural commodity, a pesticide chemical
residue that is present in or on a processed food because the
food is made from that raw agricultural commodity shall not be
considered unsafe within the meaning of section 342(a)(2)(B) of
this title.
(3) Residues of degradation products
If a pesticide chemical residue is present in or on a food
because it is a metabolite or other degradation product of a
precursor substance that itself is a pesticide chemical or
pesticide chemical residue, such a residue shall not be
considered to be unsafe within the meaning of section
342(a)(2)(B) of this title despite the lack of a tolerance or
exemption from the need for a tolerance for such residue in or on
such food if -
(A) the Administrator has not determined that the degradation
product is likely to pose any potential health risk from
dietary exposure that is of a different type than, or of a
greater significance than, any risk posed by dietary exposure
to the precursor substance;
(B) either -
(i) a tolerance is in effect under this section for
residues of the precursor substance in or on the food, and
the combined level of residues of the degradation product and
the precursor substance in or on the food is at or below the
stoichiometrically equivalent level that would be permitted
by the tolerance if the residue consisted only of the
precursor substance rather than the degradation product; or
(ii) an exemption from the need for a tolerance is in
effect under this section for residues of the precursor
substance in or on the food; and
(C) the tolerance or exemption for residues of the precursor
substance does not state that it applies only to particular
named substances and does not state that it does not apply to
residues of the degradation product.
(4) Effect of tolerance or exemption
While a tolerance or exemption from the requirement for a
tolerance is in effect under this section for a pesticide
chemical residue with respect to any food, the food shall not by
reason of bearing or containing any amount of such a residue be
considered to be adulterated within the meaning of section
342(a)(1) of this title.
(b) Authority and standard for tolerance
(1) Authority
The Administrator may issue regulations establishing,
modifying, or revoking a tolerance for a pesticide chemical
residue in or on a food -
(A) in response to a petition filed under subsection (d) of
this section; or
(B) on the Administrator's own initiative under subsection
(e) of this section.
As used in this section, the term "modify" shall not mean
expanding the tolerance to cover additional foods.
(2) Standard
(A) General rule
(i) Standard
The Administrator may establish or leave in effect a
tolerance for a pesticide chemical residue in or on a food
only if the Administrator determines that the tolerance is
safe. The Administrator shall modify or revoke a tolerance if
the Administrator determines it is not safe.
(ii) Determination of safety
As used in this section, the term "safe", with respect to a
tolerance for a pesticide chemical residue, means that the
Administrator has determined that there is a reasonable
certainty that no harm will result from aggregate exposure to
the pesticide chemical residue, including all anticipated
dietary exposures and all other exposures for which there is
reliable information.
(iii) Rule of construction
With respect to a tolerance, a pesticide chemical residue
meeting the standard under clause (i) is not an eligible
pesticide chemical residue for purposes of subparagraph (B).
(B) Tolerances for eligible pesticide chemical residues
(i) Definition
As used in this subparagraph, the term "eligible pesticide
chemical residue" means a pesticide chemical residue as to
which -
(I) the Administrator is not able to identify a level of
exposure to the residue at which the residue will not cause
or contribute to a known or anticipated harm to human
health (referred to in this section as a "nonthreshold
effect");
(II) the lifetime risk of experiencing the nonthreshold
effect is appropriately assessed by quantitative risk
assessment; and
(III) with regard to any known or anticipated harm to
human health for which the Administrator is able to
identify a level at which the residue will not cause such
harm (referred to in this section as a "threshold effect"),
the Administrator determines that the level of aggregate
exposure is safe.
(ii) Determination of tolerance
Notwithstanding subparagraph (A)(i), a tolerance for an
eligible pesticide chemical residue may be left in effect or
modified under this subparagraph if -
(I) at least one of the conditions described in clause
(iii) is met; and
(II) both of the conditions described in clause (iv) are
met.
(iii) Conditions regarding use
For purposes of clause (ii), the conditions described in
this clause with respect to a tolerance for an eligible
pesticide chemical residue are the following:
(I) Use of the pesticide chemical that produces the
residue protects consumers from adverse effects on health
that would pose a greater risk than the dietary risk from
the residue.
(II) Use of the pesticide chemical that produces the
residue is necessary to avoid a significant disruption in
domestic production of an adequate, wholesome, and
economical food supply.
(iv) Conditions regarding risk
For purposes of clause (ii), the conditions described in
this clause with respect to a tolerance for an eligible
pesticide chemical residue are the following:
(I) The yearly risk associated with the nonthreshold
effect from aggregate exposure to the residue does not
exceed 10 times the yearly risk that would be allowed under
subparagraph (A) for such effect.
(II) The tolerance is limited so as to ensure that the
risk over a lifetime associated with the nonthreshold
effect from aggregate exposure to the residue is not
greater than twice the lifetime risk that would be allowed
under subparagraph (A) for such effect.
(v) Review
Five years after the date on which the Administrator makes
a determination to leave in effect or modify a tolerance
under this subparagraph, and thereafter as the Administrator
deems appropriate, the Administrator shall determine, after
notice and opportunity for comment, whether it has been
demonstrated to the Administrator that a condition described
in clause (iii)(I) or clause (iii)(II) continues to exist
with respect to the tolerance and that the yearly and
lifetime risks from aggregate exposure to such residue
continue to comply with the limits specified in clause (iv).
If the Administrator determines by such date that such
demonstration has not been made, the Administrator shall, not
later than 180 days after the date of such determination,
issue a regulation under subsection (e)(1) of this section to
modify or revoke the tolerance.
(vi) Infants and children
Any tolerance under this subparagraph shall meet the
requirements of subparagraph (C).
(C) Exposure of infants and children
In establishing, modifying, leaving in effect, or revoking a
tolerance or exemption for a pesticide chemical residue, the
Administrator -
(i) shall assess the risk of the pesticide chemical residue
based on -
(I) available information about consumption patterns
among infants and children that are likely to result in
disproportionately high consumption of foods containing or
bearing such residue among infants and children in
comparison to the general population;
(II) available information concerning the special
susceptibility of infants and children to the pesticide
chemical residues, including neurological differences
between infants and children and adults, and effects of in
utero exposure to pesticide chemicals; and
(III) available information concerning the cumulative
effects on infants and children of such residues and other
substances that have a common mechanism of toxicity; and
(ii) shall -
(I) ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate
exposure to the pesticide chemical residue; and
(II) publish a specific determination regarding the
safety of the pesticide chemical residue for infants and
children.
The Secretary of Health and Human Services and the Secretary of
Agriculture, in consultation with the Administrator, shall
conduct surveys to document dietary exposure to pesticides
among infants and children. In the case of threshold effects,
for purposes of clause (ii)(I) an additional tenfold margin of
safety for the pesticide chemical residue and other sources of
exposure shall be applied for infants and children to take into
account potential pre- and post-natal toxicity and completeness
of the data with respect to exposure and toxicity to infants
and children. Notwithstanding such requirement for an
additional margin of safety, the Administrator may use a
different margin of safety for the pesticide chemical residue
only if, on the basis of reliable data, such margin will be
safe for infants and children.
(D) Factors
In establishing, modifying, leaving in effect, or revoking a
tolerance or exemption for a pesticide chemical residue, the
Administrator shall consider, among other relevant factors -
(i) the validity, completeness, and reliability of the
available data from studies of the pesticide chemical and
pesticide chemical residue;
(ii) the nature of any toxic effect shown to be caused by
the pesticide chemical or pesticide chemical residue in such
studies;
(iii) available information concerning the relationship of
the results of such studies to human risk;
(iv) available information concerning the dietary
consumption patterns of consumers (and major identifiable
subgroups of consumers);
(v) available information concerning the cumulative effects
of such residues and other substances that have a common
mechanism of toxicity;
(vi) available information concerning the aggregate
exposure levels of consumers (and major identifiable
subgroups of consumers) to the pesticide chemical residue and
to other related substances, including dietary exposure under
the tolerance and all other tolerances in effect for the
pesticide chemical residue, and exposure from other non-
occupational sources;
(vii) available information concerning the variability of
the sensitivities of major identifiable subgroups of
consumers;
(viii) such information as the Administrator may require on
whether the pesticide chemical may have an effect in humans
that is similar to an effect produced by a naturally
occurring estrogen or other endocrine effects; and
(ix) safety factors which in the opinion of experts
qualified by scientific training and experience to evaluate
the safety of food additives are generally recognized as
appropriate for the use of animal experimentation data.
(E) Data and information regarding anticipated and actual
residue levels
(i) Authority
In establishing, modifying, leaving in effect, or revoking
a tolerance for a pesticide chemical residue, the
Administrator may consider available data and information on
the anticipated residue levels of the pesticide chemical in
or on food and the actual residue levels of the pesticide
chemical that have been measured in food, including residue
data collected by the Food and Drug Administration.
(ii) Requirement
If the Administrator relies on anticipated or actual
residue levels in establishing, modifying, or leaving in
effect a tolerance, the Administrator shall pursuant to
subsection (f)(1) of this section require that data be
provided five years after the date on which the tolerance is
established, modified, or left in effect, and thereafter as
the Administrator deems appropriate, demonstrating that such
residue levels are not above the levels so relied on. If such
data are not so provided, or if the data do not demonstrate
that the residue levels are not above the levels so relied
on, the Administrator shall, not later than 180 days after
the date on which the data were required to be provided,
issue a regulation under subsection (e)(1) of this section,
or an order under subsection (f)(2) of this section, as
appropriate, to modify or revoke the tolerance.
(F) Percent of food actually treated
In establishing, modifying, leaving in effect, or revoking a
tolerance for a pesticide chemical residue, the Administrator
may, when assessing chronic dietary risk, consider available
data and information on the percent of food actually treated
with the pesticide chemical (including aggregate pesticide use
data collected by the Department of Agriculture) only if the
Administrator -
(i) finds that the data are reliable and provide a valid
basis to show what percentage of the food derived from such
crop is likely to contain such pesticide chemical residue;
(ii) finds that the exposure estimate does not understate
exposure for any significant subpopulation group;
(iii) finds that, if data are available on pesticide use
and consumption of food in a particular area, the population
in such area is not dietarily exposed to residues above those
estimated by the Administrator; and
(iv) provides for the periodic reevaluation of the estimate
of anticipated dietary exposure.
(3) Detection methods
(A) General rule
A tolerance for a pesticide chemical residue in or on a food
shall not be established or modified by the Administrator
unless the Administrator determines, after consultation with
the Secretary, that there is a practical method for detecting
and measuring the levels of the pesticide chemical residue in
or on the food.
(B) Detection limit
A tolerance for a pesticide chemical residue in or on a food
shall not be established at or modified to a level lower than
the limit of detection of the method for detecting and
measuring the pesticide chemical residue specified by the
Administrator under subparagraph (A).
(4) International standards
In establishing a tolerance for a pesticide chemical residue in
or on a food, the Administrator shall determine whether a maximum
residue level for the pesticide chemical has been established by
the Codex Alimentarius Commission. If a Codex maximum residue
level has been established for the pesticide chemical and the
Administrator does not propose to adopt the Codex level, the
Administrator shall publish for public comment a notice
explaining the reasons for departing from the Codex level.
(c) Authority and standard for exemptions
(1) Authority
The Administrator may issue a regulation establishing,
modifying, or revoking an exemption from the requirement for a
tolerance for a pesticide chemical residue in or on food -
(A) in response to a petition filed under subsection (d) of
this section; or
(B) on the Administrator's initiative under subsection (e) of
this section.
(2) Standard
(A) General rule
(i) Standard
The Administrator may establish or leave in effect an
exemption from the requirement for a tolerance for a
pesticide chemical residue in or on food only if the
Administrator determines that the exemption is safe. The
Administrator shall modify or revoke an exemption if the
Administrator determines it is not safe.
(ii) Determination of safety
The term "safe", with respect to an exemption for a
pesticide chemical residue, means that the Administrator has
determined that there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all
other exposures for which there is reliable information.
(B) Factors
In making a determination under this paragraph, the
Administrator shall take into account, among other relevant
considerations, the considerations set forth in subparagraphs
(C) and (D) of subsection (b)(2) of this section.
(3) Limitation
An exemption from the requirement for a tolerance for a
pesticide chemical residue in or on food shall not be established
or modified by the Administrator unless the Administrator
determines, after consultation with the Secretary -
(A) that there is a practical method for detecting and
measuring the levels of such pesticide chemical residue in or
on food; or
(B) that there is no need for such a method, and states the
reasons for such determination in issuing the regulation
establishing or modifying the exemption.
(d) Petition for tolerance or exemption
(1) Petitions and petitioners
Any person may file with the Administrator a petition proposing
the issuance of a regulation -
(A) establishing, modifying, or revoking a tolerance for a
pesticide chemical residue in or on a food; or
(B) establishing, modifying, or revoking an exemption from
the requirement of a tolerance for such a residue.
(2) Petition contents
(A) Establishment
A petition under paragraph (1) to establish a tolerance or
exemption for a pesticide chemical residue shall be supported
by such data and information as are specified in regulations
issued by the Administrator, including -
(i)(I) an informative summary of the petition and of the
data, information, and arguments submitted or cited in
support of the petition; and
(II) a statement that the petitioner agrees that such
summary or any information it contains may be published as a
part of the notice of filing of the petition to be published
under this subsection and as part of a proposed or final
regulation issued under this section;
(ii) the name, chemical identity, and composition of the
pesticide chemical residue and of the pesticide chemical that
produces the residue;
(iii) data showing the recommended amount, frequency,
method, and time of application of that pesticide chemical;
(iv) full reports of tests and investigations made with
respect to the safety of the pesticide chemical, including
full information as to the methods and controls used in
conducting those tests and investigations;
(v) full reports of tests and investigations made with
respect to the nature and amount of the pesticide chemical
residue that is likely to remain in or on the food, including
a description of the analytical methods used;
(vi) a practical method for detecting and measuring the
levels of the pesticide chemical residue in or on the food,
or for exemptions, a statement why such a method is not
needed;
(vii) a proposed tolerance for the pesticide chemical
residue, if a tolerance is proposed;
(viii) if the petition relates to a tolerance for a
processed food, reports of investigations conducted using the
processing method(s) used to produce that food;
(ix) such information as the Administrator may require to
make the determination under subsection (b)(2)(C) of this
section;
(x) such information as the Administrator may require on
whether the pesticide chemical may have an effect in humans
that is similar to an effect produced by a naturally
occurring estrogen or other endocrine effects;
(xi) information regarding exposure to the pesticide
chemical residue due to any tolerance or exemption already
granted for such residue;
(xii) practical methods for removing any amount of the
residue that would exceed any proposed tolerance; and
(xiii) such other data and information as the Administrator
requires by regulation to support the petition.
If information or data required by this subparagraph is
available to the Administrator, the person submitting the
petition may cite the availability of the information or data
in lieu of submitting it. The Administrator may require a
petition to be accompanied by samples of the pesticide chemical
with respect to which the petition is filed.
(B) Modification or revocation
The Administrator may by regulation establish the
requirements for information and data to support a petition to
modify or revoke a tolerance or to modify or revoke an
exemption from the requirement for a tolerance.
(3) Notice
A notice of the filing of a petition that the Administrator
determines has met the requirements of paragraph (2) shall be
published by the Administrator within 30 days after such
determination. The notice shall announce the availability of a
description of the analytical methods available to the
Administrator for the detection and measurement of the pesticide
chemical residue with respect to which the petition is filed or
shall set forth the petitioner's statement of why such a method
is not needed. The notice shall include the summary required by
paragraph (2)(A)(i)(I).
(4) Actions by the Administrator
(A) In general
The Administrator shall, after giving due consideration to a
petition filed under paragraph (1) and any other information
available to the Administrator -
(i) issue a final regulation (which may vary from that
sought by the petition) establishing, modifying, or revoking
a tolerance for the pesticide chemical residue or an
exemption of the pesticide chemical residue from the
requirement of a tolerance (which final regulation shall be
issued without further notice and without further period for
public comment);
(ii) issue a proposed regulation under subsection (e) of
this section, and thereafter issue a final regulation under
such subsection; or
(iii) issue an order denying the petition.
(B) Priorities
The Administrator shall give priority to petitions for the
establishment or modification of a tolerance or exemption for a
pesticide chemical residue that appears to pose a significantly
lower risk to human health from dietary exposure than pesticide
chemical residues that have tolerances in effect for the same
or similar uses.
(C) Expedited review of certain petitions
(i) Date certain for review
If a person files a complete petition with the
Administrator proposing the issuance of a regulation
establishing a tolerance or exemption for a pesticide
chemical residue that presents a lower risk to human health
than a pesticide chemical residue for which a tolerance has
been left in effect or modified under subsection (b)(2)(B) of
this section, the Administrator shall complete action on such
petition under this paragraph within 1 year.
(ii) Required determinations
If the Administrator issues a final regulation establishing
a tolerance or exemption for a safer pesticide chemical
residue under clause (i), the Administrator shall, not later
than 180 days after the date on which the regulation is
issued, determine whether a condition described in subclause
(I) or (II) of subsection (b)(2)(B)(iii) of this section
continues to exist with respect to a tolerance that has been
left in effect or modified under subsection (b)(2)(B) of this
section. If such condition does not continue to exist, the
Administrator shall, not later than 180 days after the date
on which the determination under the preceding sentence is
made, issue a regulation under subsection (e)(1) of this
section to modify or revoke the tolerance.
(e) Action on Administrator's own initiative
(1) General rule
The Administrator may issue a regulation -
(A) establishing, modifying, suspending under subsection
(l)(3) of this section, or revoking a tolerance for a pesticide
chemical or a pesticide chemical residue;
(B) establishing, modifying, suspending under subsection
(l)(3) of this section, or revoking an exemption of a pesticide
chemical residue from the requirement of a tolerance; or
(C) establishing general procedures and requirements to
implement this section.
(2) Notice
Before issuing a final regulation under paragraph (1), the
Administrator shall issue a notice of proposed rulemaking and
provide a period of not less than 60 days for public comment on
the proposed regulation, except that a shorter period for comment
may be provided if the Administrator for good cause finds that it
would be in the public interest to do so and states the reasons
for the finding in the notice of proposed rulemaking.
(f) Special data requirements
(1) Requiring submission of additional data
If the Administrator determines that additional data or
information are reasonably required to support the continuation
of a tolerance or exemption that is in effect under this section
for a pesticide chemical residue on a food, the Administrator
shall -
(A) issue a notice requiring the person holding the pesticide
registrations associated with such tolerance or exemption to
submit the data or information under section 3(c)(2)(B) of the
Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.
136a(c)(2)(B)];
(B) issue a rule requiring that testing be conducted on a
substance or mixture under section 4 of the Toxic Substances
Control Act [15 U.S.C. 2603]; or
(C) publish in the Federal Register, after first providing
notice and an opportunity for comment of not less than 60 days'
duration, an order -
(i) requiring the submission to the Administrator by one or
more interested persons of a notice identifying the person or
persons who will submit the required data and information;
(ii) describing the type of data and information required
to be submitted to the Administrator and stating why the data
and information could not be obtained under the authority of
section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136a(c)(2)(B)] or section 4 of the
Toxic Substances Control Act [15 U.S.C. 2603];
(iii) describing the reports of the Administrator required
to be prepared during and after the collection of the data
and information;
(iv) requiring the submission to the Administrator of the
data, information, and reports referred to in clauses (ii)
and (iii); and
(v) establishing dates by which the submissions described
in clauses (i) and (iv) must be made.
The Administrator may under subparagraph (C) revise any such
order to correct an error. The Administrator may under this
paragraph require data or information pertaining to whether the
pesticide chemical may have an effect in humans that is similar
to an effect produced by a naturally occurring estrogen or
other endocrine effects.
(2) Noncompliance
If a submission required by a notice issued in accordance with
paragraph (1)(A), a rule issued under paragraph (1)(B), or an
order issued under paragraph (1)(C) is not made by the time
specified in such notice, rule, or order, the Administrator may
by order published in the Federal Register modify or revoke the
tolerance or exemption in question. In any review of such an
order under subsection (g)(2) of this section, the only material
issue shall be whether a submission required under paragraph (1)
was not made by the time specified.
(g) Effective date, objections, hearings, and administrative review
(1) Effective date
A regulation or order issued under subsection (d)(4), (e)(1),
or (f)(2) of this section shall take effect upon publication
unless the regulation or order specifies otherwise. The
Administrator may stay the effectiveness of the regulation or
order if, after issuance of such regulation or order, objections
are filed with respect to such regulation or order pursuant to
paragraph (2).
(2) Further proceedings
(A) Objections
Within 60 days after a regulation or order is issued under
subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or
(n)(5)(C) of this section, any person may file objections
thereto with the Administrator, specifying with particularity
the provisions of the regulation or order deemed objectionable
and stating reasonable grounds therefor. If the regulation or
order was issued in response to a petition under subsection
(d)(1) of this section, a copy of each objection filed by a
person other than the petitioner shall be served by the
Administrator on the petitioner.
(B) Hearing
An objection may include a request for a public evidentiary
hearing upon the objection. The Administrator shall, upon the
initiative of the Administrator or upon the request of an
interested person and after due notice, hold a public
evidentiary hearing if and to the extent the Administrator
determines that such a public hearing is necessary to receive
factual evidence relevant to material issues of fact raised by
the objections. The presiding officer in such a hearing may
authorize a party to obtain discovery from other persons and
may upon a showing of good cause made by a party issue a
subpoena to compel testimony or production of documents from
any person. The presiding officer shall be governed by the
Federal Rules of Civil Procedure in making any order for the
protection of the witness or the content of documents produced
and shall order the payment of reasonable fees and expenses as
a condition to requiring testimony of the witness. On contest,
such a subpoena may be enforced by a Federal district court.
(C) Final decision
As soon as practicable after receiving the arguments of the
parties, the Administrator shall issue an order stating the
action taken upon each such objection and setting forth any
revision to the regulation or prior order that the
Administrator has found to be warranted. If a hearing was held
under subparagraph (B), such order and any revision to the
regulation or prior order shall, with respect to questions of
fact at issue in the hearing, be based only on substantial
evidence of record at such hearing, and shall set forth in
detail the findings of facts and the conclusions of law or
policy upon which the order or regulation is based.
(h) Judicial review
(1) Petition
In a case of actual controversy as to the validity of any
regulation issued under subsection (e)(1)(C) of this section, or
any order issued under subsection (f)(1)(C) or (g)(2)(C) of this
section, or any regulation that is the subject of such an order,
any person who will be adversely affected by such order or
regulation may obtain judicial review by filing in the United
States Court of Appeals for the circuit wherein that person
resides or has its principal place of business, or in the United
States Court of Appeals for the District of Columbia Circuit,
within 60 days after publication of such order or regulation, a
petition praying that the order or regulation be set aside in
whole or in part.
(2) Record and jurisdiction
A copy of the petition under paragraph (1) shall be forthwith
transmitted by the clerk of the court to the Administrator, or
any officer designated by the Administrator for that purpose, and
thereupon the Administrator shall file in the court the record of
the proceedings on which the Administrator based the order or
regulation, as provided in section 2112 of title 28. Upon the
filing of such a petition, the court shall have exclusive
jurisdiction to affirm or set aside the order or regulation
complained of in whole or in part. As to orders issued following
a public evidentiary hearing, the findings of the Administrator
with respect to questions of fact shall be sustained only if
supported by substantial evidence when considered on the record
as a whole.
(3) Additional evidence
If a party applies to the court for leave to adduce additional
evidence and shows to the satisfaction of the court that the
additional evidence is material and that there were reasonable
grounds for the failure to adduce the evidence in the proceeding
before the Administrator, the court may order that the additional
evidence (and evidence in rebuttal thereof) shall be taken before
the Administrator in the manner and upon the terms and conditions
the court deems proper. The Administrator may modify prior
findings as to the facts by reason of the additional evidence so
taken and may modify the order or regulation accordingly. The
Administrator shall file with the court any such modified
finding, order, or regulation.
(4) Final judgment; Supreme Court review
The judgment of the court affirming or setting aside, in whole
or in part, any regulation or any order and any regulation which
is the subject of such an order shall be final, subject to review
by the Supreme Court of the United States as provided in section
1254 of title 28. The commencement of proceedings under this
subsection shall not, unless specifically ordered by the court to
the contrary, operate as a stay of a regulation or order.
(5) Application
Any issue as to which review is or was obtainable under this
subsection shall not be the subject of judicial review under any
other provision of law.
(i) Confidentiality and use of data
(1) General rule
Data and information that are or have been submitted to the
Administrator under this section or section 348 of this title in
support of a tolerance or an exemption from a tolerance shall be
entitled to confidential treatment for reasons of business
confidentiality and to exclusive use and data compensation to the
same extent provided by sections 3 and 10 of the Federal
Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a,
136h].
(2) Exceptions
(A) In general
Data and information that are entitled to confidential
treatment under paragraph (1) may be disclosed, under such
security requirements as the Administrator may provide by
regulation, to -
(i) employees of the United States authorized by the
Administrator to examine such data and information in the
carrying out of their official duties under this chapter or
other Federal statutes intended to protect the public health;
or
(ii) contractors with the United States authorized by the
Administrator to examine such data and information in the
carrying out of contracts under this chapter or such
statutes.
(B) Congress
This subsection does not authorize the withholding of data or
information from either House of Congress or from, to the
extent of matter within its jurisdiction, any committee or
subcommittee of such committee or any joint committee of
Congress or any subcommittee of such joint committee.
(3) Summaries
Notwithstanding any provision of this subsection or other law,
the Administrator may publish the informative summary required by
subsection (d)(2)(A)(i) of this section and may, in issuing a
proposed or final regulation or order under this section, publish
an informative summary of the data relating to the regulation or
order.
(j) Status of previously issued regulations
(1) Regulations under section 346
Regulations affecting pesticide chemical residues in or on raw
agricultural commodities promulgated, in accordance with section
371(e) of this title, under the authority of section 346(a) (!1)
of this title upon the basis of public hearings instituted before
January 1, 1953, shall be deemed to be regulations issued under
this section and shall be subject to modification or revocation
under subsections (d) and (e) of this section, and shall be
subject to review under subsection (q) of this section.
(2) Regulations under section 348
Regulations that established tolerances for substances that are
pesticide chemical residues in or on processed food, or that
otherwise stated the conditions under which such pesticide
chemicals could be safely used, and that were issued under
section 348 of this title on or before August 3, 1996, shall be
deemed to be regulations issued under this section and shall be
subject to modification or revocation under subsection (d) or (e)
of this section, and shall be subject to review under subsection
(q) of this section.
(3) Regulations under section 346a
Regulations that established tolerances or exemptions under
this section that were issued on or before August 3, 1996, shall
remain in effect unless modified or revoked under subsection (d)
or (e) of this section, and shall be subject to review under
subsection (q) of this section.
(4) Certain substances
With respect to a substance that is not included in the
definition of the term "pesticide chemical" under section
321(q)(1) of this title but was so included on the day before
October 30, 1998, the following applies as of October 30, 1998:
(A) Notwithstanding paragraph (2), any regulation applying to
the use of the substance that was in effect on the day before
October 30, 1998, and was on such day deemed in such paragraph
to have been issued under this section, shall be considered to
have been issued under section 348 of this title.
(B) Notwithstanding paragraph (3), any regulation applying to
the use of the substance that was in effect on such day and was
issued under this section (including any such regulation issued
before August 3, 1996) is deemed to have been issued under
section 348 of this title.
(k) Transitional provision
If, on the day before August 3, 1996, a substance that is a
pesticide chemical was, with respect to a particular pesticidal use
of the substance and any resulting pesticide chemical residue in or
on a particular food -
(1) regarded by the Administrator or the Secretary as generally
recognized as safe for use within the meaning of the provisions
of subsection (a) of this section or section 321(s) of this title
as then in effect; or
(2) regarded by the Secretary as a substance described by
section 321(s)(4) of this title;
such a pesticide chemical residue shall be regarded as exempt from
the requirement for a tolerance, as of August 3, 1996. The
Administrator shall by regulation indicate which substances are
described by this subsection. Any exemption under this subsection
may be modified or revoked as if it had been issued under
subsection (c) of this section.
(l) Harmonization with action under other laws
(1) Coordination with FIFRA
To the extent practicable and consistent with the review
deadlines in subsection (q) of this section, in issuing a final
rule under this subsection that suspends or revokes a tolerance
or exemption for a pesticide chemical residue in or on food, the
Administrator shall coordinate such action with any related
necessary action under the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136 et seq.].
(2) Revocation of tolerance or exemption following cancellation
of associated registrations
If the Administrator, acting under the Federal Insecticide,
Fungicide, and Rodenticide Act, cancels the registration of each
pesticide that contains a particular pesticide chemical and that
is labeled for use on a particular food, or requires that the
registration of each such pesticide be modified to prohibit its
use in connection with the production, storage, or transportation
of such food, due in whole or in part to dietary risks to humans
posed by residues of that pesticide chemical on that food, the
Administrator shall revoke any tolerance or exemption that allows
the presence of the pesticide chemical, or any pesticide chemical
residue that results from its use, in or on that food. Subsection
(e) of this section shall apply to actions taken under this
paragraph. A revocation under this paragraph shall become
effective not later than 180 days after -
(A) the date by which each such cancellation of a
registration has become effective; or
(B) the date on which the use of the canceled pesticide
becomes unlawful under the terms of the cancellation, whichever
is later.
(3) Suspension of tolerance or exemption following suspension of
associated registrations
(A) Suspension
If the Administrator, acting under the Federal Insecticide,
Fungicide, and Rodenticide Act, suspends the use of each
registered pesticide that contains a particular pesticide
chemical and that is labeled for use on a particular food, due
in whole or in part to dietary risks to humans posed by
residues of that pesticide chemical on that food, the
Administrator shall suspend any tolerance or exemption that
allows the presence of the pesticide chemical, or any pesticide
chemical residue that results from its use, in or on that food.
Subsection (e) of this section shall apply to actions taken
under this paragraph. A suspension under this paragraph shall
become effective not later than 60 days after the date by which
each such suspension of use has become effective.
(B) Effect of suspension
The suspension of a tolerance or exemption under subparagraph
(A) shall be effective as long as the use of each associated
registration of a pesticide is suspended under the Federal
Insecticide, Fungicide, and Rodenticide Act. While a suspension
of a tolerance or exemption is effective the tolerance or
exemption shall not be considered to be in effect. If the
suspension of use of the pesticide under that Act is
terminated, leaving the registration of the pesticide for such
use in effect under that Act, the Administrator shall rescind
any associated suspension of tolerance or exemption.
(4) Tolerances for unavoidable residues
In connection with action taken under paragraph (2) or (3), or
with respect to pesticides whose registrations were suspended or
canceled prior to August 3, 1996, under the Federal Insecticide,
Fungicide, and Rodenticide Act, if the Administrator determines
that a residue of the canceled or suspended pesticide chemical
will unavoidably persist in the environment and thereby be
present in or on a food, the Administrator may establish a
tolerance for the pesticide chemical residue. In establishing
such a tolerance, the Administrator shall take into account both
the factors set forth in subsection (b)(2) of this section and
the unavoidability of the residue. Subsection (e) of this section
shall apply to the establishment of such tolerance. The
Administrator shall review any such tolerance periodically and
modify it as necessary so that it allows no greater level of the
pesticide chemical residue than is unavoidable.
(5) Pesticide residues resulting from lawful application of
pesticide
Notwithstanding any other provision of this chapter, if a
tolerance or exemption for a pesticide chemical residue in or on
a food has been revoked, suspended, or modified under this
section, an article of that food shall not be deemed unsafe
solely because of the presence of such pesticide chemical residue
in or on such food if it is shown to the satisfaction of the
Secretary that -
(A) the residue is present as the result of an application or
use of a pesticide at a time and in a manner that was lawful
under the Federal Insecticide, Fungicide, and Rodenticide Act;
and
(B) the residue does not exceed a level that was authorized
at the time of that application or use to be present on the
food under a tolerance, exemption, food additive regulation, or
other sanction then in effect under this chapter;
unless, in the case of any tolerance or exemption revoked,
suspended, or modified under this subsection or subsection (d) or
(e) of this section, the Administrator has issued a determination
that consumption of the legally treated food during the period of
its likely availability in commerce will pose an unreasonable
dietary risk.
(6) Tolerance for use of pesticides under an emergency exemption
If the Administrator grants an exemption under section 18 of
the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
136p) for a pesticide chemical, the Administrator shall establish
a tolerance or exemption from the requirement for a tolerance for
the pesticide chemical residue. Such a tolerance or exemption
from a tolerance shall have an expiration date. The Administrator
may establish such a tolerance or exemption without providing
notice or a period for comment on the tolerance or exemption. The
Administrator shall promulgate regulations within 365 days after
August 3, 1996, governing the establishment of tolerances and
exemptions under this paragraph. Such regulations shall be
consistent with the safety standard under subsections (b)(2) and
(c)(2) of this section and with section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act.
(m) Fees
(1) Amount
The Administrator shall by regulation require the payment of
such fees as will in the aggregate, in the judgment of the
Administrator, be sufficient over a reasonable term to provide,
equip, and maintain an adequate service for the performance of
the Administrator's functions under this section. Under the
regulations, the performance of the Administrator's services or
other functions under this section, including -
(A) the acceptance for filing of a petition submitted under
subsection (d) of this section;
(B) establishing, modifying, leaving in effect, or revoking a
tolerance or establishing, modifying, leaving in effect, or
revoking an exemption from the requirement for a tolerance
under this section;
(C) the acceptance for filing of objections under subsection
(g) of this section; or
(D) the certification and filing in court of a transcript of
the proceedings and the record under subsection (h) of this
section;
may be conditioned upon the payment of such fees. The regulations
may further provide for waiver or refund of fees in whole or in
part when in the judgment of the Administrator such a waiver or
refund is equitable and not contrary to the purposes of this
subsection.
(2) Deposit
All fees collected under paragraph (1) shall be deposited in
the Reregistration and Expedited Processing Fund created by
section 4(k) of the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136a-1(k)]. Such fees shall be
available to the Administrator, without fiscal year limitation,
for the performance of the Administrator's services or functions
as specified in paragraph (1).
(3) Prohibition
During the period beginning on October 1, 2007, and ending on
September 30, 2012, the Administrator shall not collect any
tolerance fees under paragraph (1).
(n) National uniformity of tolerances
(1) "Qualifying pesticide chemical residue" defined
For purposes of this subsection, the term "qualifying pesticide
chemical residue" means a pesticide chemical residue resulting
from the use, in production, processing, or storage of a food, of
a pesticide chemical that is an active ingredient and that -
(A) was first approved for such use in a registration of a
pesticide issued under section 3(c)(5) of the Federal
Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.
136a(c)(5)] on or after April 25, 1985, on the basis of data
determined by the Administrator to meet all applicable
requirements for data prescribed by regulations in effect under
that Act [7 U.S.C. 136 et seq.] on April 25, 1985; or
(B) was approved for such use in a reregistration eligibility
determination issued under section 4(g) of that Act [7 U.S.C.
136a-1(g)] on or after August 3, 1996.
(2) "Qualifying Federal determination" defined
For purposes of this subsection, the term "qualifying Federal
determination" means a tolerance or exemption from the
requirement for a tolerance for a qualifying pesticide chemical
residue that -
(A) is issued under this section after August 3, 1996, and
determined by the Administrator to meet the standard under
subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in
the case of an exemption) of this section; or
(B)(i) pursuant to subsection (j) of this section is
remaining in effect or is deemed to have been issued under this
section, or is regarded under subsection (k) of this section as
exempt from the requirement for a tolerance; and
(ii) is determined by the Administrator to meet the standard
under subsection (b)(2)(A) (in the case of a tolerance) or
(c)(2) (in the case of an exemption) of this section.
(3) Limitation
The Administrator may make the determination described in
paragraph (2)(B)(ii) only by issuing a rule in accordance with
the procedure set forth in subsection (d) or (e) of this section
and only if the Administrator issues a proposed rule and allows a
period of not less than 30 days for comment on the proposed rule.
Any such rule shall be reviewable in accordance with subsections
(g) and (h) of this section.
(4) State authority
Except as provided in paragraphs (5), (6), and (8) no State or
political subdivision may establish or enforce any regulatory
limit on a qualifying pesticide chemical residue in or on any
food if a qualifying Federal determination applies to the
presence of such pesticide chemical residue in or on such food,
unless such State regulatory limit is identical to such
qualifying Federal determination. A State or political
subdivision shall be deemed to establish or enforce a regulatory
limit on a pesticide chemical residue in or on a food if it
purports to prohibit or penalize the production, processing,
shipping, or other handling of a food because it contains a
pesticide residue (in excess of a prescribed limit).
(5) Petition procedure
(A) In general
Any State may petition the Administrator for authorization to
establish in such State a regulatory limit on a qualifying
pesticide chemical residue in or on any food that is not
identical to the qualifying Federal determination applicable to
such qualifying pesticide chemical residue.
(B) Petition requirements
Any petition under subparagraph (A) shall -
(i) satisfy any requirements prescribed, by rule, by the
Administrator; and
(ii) be supported by scientific data about the pesticide
chemical residue that is the subject of the petition or about
chemically related pesticide chemical residues, data on the
consumption within such State of food bearing the pesticide
chemical residue, and data on exposure of humans within such
State to the pesticide chemical residue.
(C) Authorization
The Administrator may, by order, grant the authorization
described in subparagraph (A) if the Administrator determines
that the proposed State regulatory limit -
(i) is justified by compelling local conditions; and
(ii) would not cause any food to be a violation of Federal
law.
(D) Treatment
In lieu of any action authorized under subparagraph (C), the
Administrator may treat a petition under this paragraph as a
petition under subsection (d) of this section to modify or
revoke a tolerance or an exemption. If the Administrator
determines to treat a petition under this paragraph as a
petition under subsection (d) of this section, the
Administrator shall thereafter act on the petition pursuant to
subsection (d) of this section.
(E) Review
Any order of the Administrator granting or denying the
authorization described in subparagraph (A) shall be subject to
review in the manner described in subsections (g) and (h) of
this section.
(6) Urgent petition procedure
Any State petition to the Administrator pursuant to paragraph
(5) that demonstrates that consumption of a food containing such
pesticide residue level during the period of the food's likely
availability in the State will pose a significant public health
threat from acute exposure shall be considered an urgent
petition. If an order by the Administrator to grant or deny the
requested authorization in an urgent petition is not made within
30 days of receipt of the petition, the petitioning State may
establish and enforce a temporary regulatory limit on a
qualifying pesticide chemical residue in or on the food. The
temporary regulatory limit shall be validated or terminated by
the Administrator's final order on the petition.
(7) Residues from lawful application
No State or political subdivision may enforce any regulatory
limit on the level of a pesticide chemical residue that may
appear in or on any food if, at the time of the application of
the pesticide that resulted in such residue, the sale of such
food with such residue level was lawful under this section and
under the law of such State, unless the State demonstrates that
consumption of the food containing such pesticide residue level
during the period of the food's likely availability in the State
will pose an unreasonable dietary risk to the health of persons
within such State.
(8) Savings
Nothing in this chapter preempts the authority of any State or
political subdivision to require that a food containing a
pesticide chemical residue bear or be the subject of a warning or
other statement relating to the presence of the pesticide
chemical residue in or on such food.
(o) Consumer right to know
Not later than 2 years after August 3, 1996, and annually
thereafter, the Administrator shall, in consultation with the
Secretary of Agriculture and the Secretary of Health and Human
Services, publish in a format understandable to a lay person, and
distribute to large retail grocers for public display (in a manner
determined by the grocer), the following information, at a minimum:
(1) A discussion of the risks and benefits of pesticide
chemical residues in or on food purchased by consumers.
(2) A listing of actions taken under subparagraph (B) of
subsection (b)(2) of this section that may result in pesticide
chemical residues in or on food that present a yearly or lifetime
risk above the risk allowed under subparagraph (A) of such
subsection, and the food on which the pesticide chemicals
producing the residues are used.
(3) Recommendations to consumers for reducing dietary exposure
to pesticide chemical residues in a manner consistent with
maintaining a healthy diet, including a list of food that may
reasonably substitute for food listed under paragraph (2).
Nothing in this subsection shall prevent retail grocers from
providing additional information.
(p) Estrogenic substances screening program
(1) Development
Not later than 2 years after August 3, 1996, the Administrator
shall in consultation with the Secretary of Health and Human
Services develop a screening program, using appropriate validated
test systems and other scientifically relevant information, to
determine whether certain substances may have an effect in humans
that is similar to an effect produced by a naturally occurring
estrogen, or such other endocrine effect as the Administrator may
designate.
(2) Implementation
Not later than 3 years after August 3, 1996, after obtaining
public comment and review of the screening program described in
paragraph (1) by the scientific advisory panel established under
section 25(d) of the Federal Insecticide, Fungicide, and
Rodenticide Act [7 U.S.C. 136w(d)] or the science advisory board
established by section 4365 (!2) of title 42, the Administrator
shall implement the program.
(3) Substances
In carrying out the screening program described in paragraph
(1), the Administrator -
(A) shall provide for the testing of all pesticide chemicals;
and
(B) may provide for the testing of any other substance that
may have an effect that is cumulative to an effect of a
pesticide chemical if the Administrator determines that a
substantial population may be exposed to such substance.
(4) Exemption
Notwithstanding paragraph (3), the Administrator may, by order,
exempt from the requirements of this section a biologic substance
or other substance if the Administrator determines that the
substance is anticipated not to produce any effect in humans
similar to an effect produced by a naturally occurring estrogen.
(5) Collection of information
(A) In general
The Administrator shall issue an order to a registrant of a
substance for which testing is required under this subsection,
or to a person who manufactures or imports a substance for
which testing is required under this subsection, to conduct
testing in accordance with the screening program described in
paragraph (1), and submit information obtained from the testing
to the Administrator, within a reasonable time period that the
Administrator determines is sufficient for the generation of
the information.
(B) Procedures
To the extent practicable the Administrator shall minimize
duplicative testing of the same substance for the same
endocrine effect, develop, as appropriate, procedures for fair
and equitable sharing of test costs, and develop, as necessary,
procedures for handling of confidential business information.
(C) Failure of registrants to submit information
(i) Suspension
If a registrant of a substance referred to in paragraph
(3)(A) fails to comply with an order under subparagraph (A)
of this paragraph, the Administrator shall issue a notice of
intent to suspend the sale or distribution of the substance
by the registrant. Any suspension proposed under this
paragraph shall become final at the end of the 30-day period
beginning on the date that the registrant receives the notice
of intent to suspend, unless during that period a person
adversely affected by the notice requests a hearing or the
Administrator determines that the registrant has complied
fully with this paragraph.
(ii) Hearing
If a person requests a hearing under clause (i), the
hearing shall be conducted in accordance with section 554 of
title 5. The only matter for resolution at the hearing shall
be whether the registrant has failed to comply with an order
under subparagraph (A) of this paragraph. A decision by the
Administrator after completion of a hearing shall be
considered to be a final agency action.
(iii) Termination of suspensions
The Administrator shall terminate a suspension under this
subparagraph issued with respect to a registrant if the
Administrator determines that the registrant has complied
fully with this paragraph.
(D) Noncompliance by other persons
Any person (other than a registrant) who fails to comply with
an order under subparagraph (A) shall be liable for the same
penalties and sanctions as are provided under section 16 of the
Toxic Substances Control Act [15 U.S.C. 2615] in the case of a
violation referred to in that section. Such penalties and
sanctions shall be assessed and imposed in the same manner as
provided in such section 16.
(6) Agency action
In the case of any substance that is found, as a result of
testing and evaluation under this section, to have an endocrine
effect on humans, the Administrator shall, as appropriate, take
action under such statutory authority as is available to the
Administrator, including consideration under other sections of
this chapter, as is necessary to ensure the protection of public
health.
(7) Report to Congress
Not later than 4 years after August 3, 1996, the Administrator
shall prepare and submit to Congress a report containing -
(A) the findings of the Administrator resulting from the
screening program described in paragraph (1);
(B) recommendations for further testing needed to evaluate
the impact on human health of the substances tested under the
screening program; and
(C) recommendations for any further actions (including any
action described in paragraph (6)) that the Administrator
determines are appropriate based on the findings.
(q) Schedule for review
(1) In general
The Administrator shall review tolerances and exemptions for
pesticide chemical residues in effect on the day before August 3,
1996, as expeditiously as practicable, assuring that -
(A) 33 percent of such tolerances and exemptions are reviewed
within 3 years of August 3, 1996;
(B) 66 percent of such tolerances and exemptions are reviewed
within 6 years of August 3, 1996; and
(C) 100 percent of such tolerances and exemptions are
reviewed within 10 years of August 3, 1996.
In conducting a review of a tolerance or exemption, the
Administrator shall determine whether the tolerance or exemption
meets the requirements of subsections (!3) (b)(2) or (c)(2) of
this section and shall, by the deadline for the review of the
tolerance or exemption, issue a regulation under subsection
(d)(4) or (e)(1) of this section to modify or revoke the
tolerance or exemption if the tolerance or exemption does not
meet such requirements.
(2) Priorities
In determining priorities for reviewing tolerances and
exemptions under paragraph (1), the Administrator shall give
priority to the review of the tolerances or exemptions that
appear to pose the greatest risk to public health.
(3) Publication of schedule
Not later than 12 months after August 3, 1996, the
Administrator shall publish a schedule for review of tolerances
and exemptions established prior to August 3, 1996. The
determination of priorities for the review of tolerances and
exemptions pursuant to this subsection is not a rulemaking and
shall not be subject to judicial review, except that failure to
take final action pursuant to the schedule established by this
paragraph shall be subject to judicial review.
(r) Temporary tolerance or exemption
The Administrator may, upon the request of any person who has
obtained an experimental permit for a pesticide chemical under the
Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136
et seq.] or upon the Administrator's own initiative, establish a
temporary tolerance or exemption for the pesticide chemical residue
for the uses covered by the permit. Subsections (b)(2), (c)(2),
(d), and (e) of this section shall apply to actions taken under
this subsection.
(s) Savings clause
Nothing in this section shall be construed to amend or modify the
provisions of the Toxic Substances Control Act [15 U.S.C. 2601 et
seq.] or the Federal Insecticide, Fungicide, and Rodenticide Act [7
U.S.C. 136 et seq.].
-SOURCE-
(June 25, 1938, ch. 675, Sec. 408, as added July 22, 1954, ch. 559,
Sec. 3, 68 Stat. 511; amended Pub. L. 85-791, Sec. 20, Aug. 28,
1958, 72 Stat. 947; Pub. L. 91-515, title VI, Sec. 601(d)(1), Oct.
30, 1970, 84 Stat. 1311; Pub. L. 92-157, title III, Sec. 303(a),
Nov. 18, 1971, 85 Stat. 464; Pub. L. 92-516, Sec. 3(3), Oct. 21,
1972, 86 Stat. 998; Pub. L. 98-620, title IV, Sec. 402(25)(A), Nov.
8, 1984, 98 Stat. 3359; Pub. L. 102-300, Sec. 6(b)(1), June 16,
1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(7), Oct.
29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(k), Aug. 13, 1993,
107 Stat. 776; Pub. L. 104-170, title IV, Sec. 405, Aug. 3, 1996,
110 Stat. 1514; Pub. L. 105-324, Sec. 2(b), Oct. 30, 1998, 112
Stat. 3036; Pub. L. 110-94, Sec. 4(d)(2), Oct. 9, 2007, 121 Stat.
1002.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Rules of Civil Procedure, referred to in subsec.
(g)(2)(B), are set out in the Appendix to Title 28, Judiciary and
Judicial Procedure.
Section 346 of this title, referred to in subsec. (j)(1),
originally consisted of subsecs. (a) and (b). Subsec. (a) was
redesignated as the entire section 346 and subsec. (b) was repealed
by Pub. L. 86-618, title I, Sec. 103(a)(1), 74 Stat. 398.
The Federal Insecticide, Fungicide, and Rodenticide Act, referred
to in subsecs. (l), (n)(1)(A), (r), and (s), is act June 25, 1947,
ch. 125, as amended generally by Pub. L. 92-516, Oct. 21, 1972, 86
Stat. 973, which is classified generally to subchapter II (Sec. 136
et seq.) of chapter 6 of Title 7, Agriculture. For complete
classification of this Act to the Code, see Short Title note set
out under section 136 of Title 7 and Tables.
Section 4365 of title 42, referred to in subsec. (p)(2), was in
the original "section 8 of the Environmental Research, Development,
and Demonstration Act of 1978", and was translated as meaning
section 8 of the Environmental Research, Development, and
Demonstration Authorization Act of 1978, to reflect the probable
intent of Congress.
The Toxic Substances Control Act, referred to in subsec. (s), is
Pub. L. 94-469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is
classified generally to chapter 53 (Sec. 2601 et seq.) of Title 15,
Commerce and Trade. For complete classification of this Act to the
Code, see Short Title note set out under section 2601 of Title 15
and Tables.
-COD-
CODIFICATION
August 3, 1996, referred to in subsecs. (k), (n)(1)(B), (2)(A),
and (p)(1), (2), (7), was in the original references to the date of
enactment of this subsection and the date of enactment of this
section, which was translated as meaning the date of enactment of
Pub. L. 104-170, which amended this section generally, to reflect
the probable intent of Congress.
-MISC1-
AMENDMENTS
2007 - Subsec. (m)(3). Pub. L. 110-94 added par. (3).
1998 - Subsec. (j)(4). Pub. L. 105-324 added par. (4).
1996 - Pub. L. 104-170 amended section generally, substituting,
in subsec. (a), provisions relating to requirement for tolerance or
exemption for provisions relating to conditions for safety; in
subsec. (b), provisions relating to authority and standard for
tolerance for provisions relating to establishment of tolerances;
in subsec. (c), provisions relating to authority and standard for
exemptions for provisions relating to exemptions; in subsec. (d),
provisions relating to petition for tolerance or exemption for
provisions relating to regulations pursuant to petition,
publication of notice, time for issuance, referral to advisory
committees, effective date, and hearings; in subsec. (e),
provisions relating to action on Administrator's own initiative for
provisions relating to regulations pursuant to Administrator's
proposals; in subsec. (f), provisions relating to special data
requirements for provisions relating to data submitted as
confidential; in subsec. (g), provisions relating to effective
date, objections, hearings, and administrative review for
provisions relating to advisory committees and their appointment,
composition, compensation, and clerical assistance; in subsec. (h),
provisions relating to judicial review for provisions relating to
right of consultation; in subsec. (i), provisions relating to
confidentiality and use of data for provisions relating to judicial
review; in subsec. (j), provisions relating to status of previously
issued regulations for provisions relating to temporary tolerances;
in subsec. (k), provisions relating to transitions for provisions
relating to regulations based on public hearings before January 1,
1953; in subsec. (l), provisions relating to harmonization with
action under other laws for provisions relating to pesticides under
Federal Insecticide, Fungicide, and Rodenticide Act, functions of
Administrator of Environmental Protection Agency, certifications,
hearings, time limitations, opinions, and regulations; in subsec.
(m), provisions relating to fees for provisions relating to
amendment of regulations; in subsec. (n), provisions relating to
national uniformity of tolerances for provisions relating to
guaranties; in subsec. (o), provisions relating to consumer right
to know for provisions relating to payment of fees, services or
functions conditioned on payment, and waiver or refund of fees; and
adding subsecs. (p) to (s).
1993 - Pub. L. 103-80, Sec. 3(k)(6), substituted "Administrator"
for "Secretary" wherever appearing except when followed by "of
Agriculture".
Subsec. (a)(1). Pub. L. 103-80, Sec. 3(k)(1), substituted
"Administrator of the Environmental Protection Agency (hereinafter
in this section referred to as the 'Administrator')" for "Secretary
of Health and Human Services".
Subsec. (d)(5). Pub. L. 103-80, Sec. 3(k)(2), substituted
"section 556(c) of title 5" for "section 7(c) of the Administrative
Procedure Act (5 U.S.C., sec. 1006(c))".
Subsec. (l). Pub. L. 103-80, Sec. 3(k)(3), substituted "In the
event" for "It the event" before "a hearing is requested".
Subsec. (n). Pub. L. 103-80, Sec. 3(k)(4), made technical
amendment to reference to section 333(c) of this title to reflect
amendment of corresponding provision of original act.
Subsec. (o). Pub. L. 103-80, Sec. 3(k)(5), which directed the
substitution of "Administrator" for "Secretary of Health and Human
Services" wherever appearing in the original text, was executed by
making the substitution in the first sentence before "shall by
regulation require", the only place "Secretary of Health and Human
Services" appeared in the original text.
1992 - Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L. 102-
300 substituted "Health and Human Services" for "Health,
Education, and Welfare" wherever appearing in the original
statutory text.
Subsec. (g). Pub. L. 102-571 substituted "379e" for "376".
1984 - Subsec. (i)(5). Pub. L. 98-620 struck out provision that
required the court to advance on the docket and expedite the
disposition of all causes filed therein pursuant to this section.
1972 - Subsecs. (d)(1), (e), (l). Pub. L. 92-516 substituted
references to pesticide for references to economic poison wherever
appearing therein.
1971 - Subsec. (g). Pub. L. 92-157 struck out ", which the
Secretary shall by rules and regulations prescribe," after "as
compensation for their services a reasonable per diem" prior to
amendment in 1970, by Pub. L. 91-515, which overlooked such
language when amending subsec. (g) as provided in 1970 Amendment
note.
1970 - Subsec. (g). Pub. L. 91-515 substituted provisions
authorizing members of an advisory committee to receive
compensation and travel expenses in accordance with section
376(b)(5)(D) of this title, for provisions authorizing such members
to receive as compensation a reasonable per diem for time actually
spent on committee work, and necessary traveling and subsistence
expenses while serving away from their places of residence.
1958 - Subsec. (i)(2). Pub. L. 85-791, Sec. 20(a), in first
sentence, substituted "transmitted by the clerk of the court to the
Secretary, or" for "served upon the Secretary, or upon",
substituted "file in the court the record of the proceedings" for
"certify and file in the court a transcript of the proceedings and
the record", and inserted "as provided in section 2112 of title
28", and which, in second sentence, substituted "the filing of such
petition" for "such filing".
Subsec. (i)(3). Pub. L. 85-791, Sec. 20(b), in first sentence,
substituted "transmitted by the clerk of the court to the Secretary
of Agriculture, or" for "served upon the Secretary of Agriculture,
or upon", substituted "file in the court the record of the
proceedings" for "certify and file in the court a transcript of the
proceedings and the record", and inserted "as provided in section
2112 of title 28", and, in second sentence, substituted "the filing
of such petition" for "such filing".
EFFECTIVE DATE OF 2007 AMENDMENT
Amendment by Pub. L. 110-94 effective Oct. 1, 2007, see section 6
of Pub. L. 110-94, set out as a note under section 136a of Title 7,
Agriculture.
EFFECTIVE DATE OF 1984 AMENDMENT
Amendment by Pub. L. 98-620 not applicable to cases pending on
Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an
Effective Date note under section 1657 of Title 28, Judiciary and
Judicial Procedure.
EFFECTIVE DATE OF 1972 AMENDMENT
Amendment by Pub. L. 92-516 effective at close of Oct. 21, 1972,
except if regulations are necessary for implementation of any
provision that becomes effective on Oct. 21, 1972, and continuation
in effect of subchapter I of chapter 6 of Title 7, Agriculture, and
regulations thereunder, relating to control of economic poisons, as
in existence prior to Oct. 21, 1972, until superseded by provisions
of Pub. L. 92-516 and regulations thereunder, see section 4 of Pub.
L. 92-516, set out as an Effective Date note under section 136 of
Title 7.
TOLERANCE FEES
Pub. L. 108-199, div. G, title V, Sec. 501(d)(2), Jan. 23, 2004,
118 Stat. 422, provided that: "Notwithstanding section 408(m)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(1)),
during the period beginning on October 1, 2003, and ending on
September 30, 2008, the Administrator of the Environmental
Protection Agency shall not collect any tolerance fees under that
section."
DATA COLLECTION ACTIVITIES TO ASSURE HEALTH OF INFANTS AND CHILDREN
Section 301 of Pub. L. 104-170 provided that:
"(a) In General. - The Secretary of Agriculture, in consultation
with the Administrator of the Environmental Protection Agency and
the Secretary of Health and Human Services, shall coordinate the
development and implementation of survey procedures to ensure that
adequate data on food consumption patterns of infants and children
are collected.
"(b) Procedures. - To the extent practicable, the procedures
referred to in subsection (a) shall include the collection of data
on food consumption patterns of a statistically valid sample of
infants and children.
"(c) Residue Data Collection. - The Secretary of Agriculture
shall ensure that the residue data collection activities conducted
by the Department of Agriculture in cooperation with the
Environmental Protection Agency and the Department of Health and
Human Services, provide for the improved data collection of
pesticide residues, including guidelines for the use of comparable
analytical and standardized reporting methods, and the increased
sampling of foods most likely consumed by infants and children."
-FOOTNOTE-
(!1) See References in Text note below.
(!2) See References in Text note below.
(!3) So in original. Probably should be "subsection".
-End-
-CITE-
21 USC Sec. 346b 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 346b. Authorization of appropriations
-STATUTE-
There are authorized to be appropriated, out of any moneys in the
Treasury not otherwise appropriated, such sums as may be necessary
for the purpose and administration of sections 321(q), (r),
342(a)(2), and 346a of this title.
-SOURCE-
(July 22, 1954, ch. 559, Sec. 4, 68 Stat. 517.)
-COD-
CODIFICATION
Section was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
-End-
-CITE-
21 USC Sec. 347 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 347. Intrastate sales of colored oleomargarine
-STATUTE-
(a) Law governing
Colored oleomargarine or colored margarine which is sold in the
same State or Territory in which it is produced shall be subject in
the same manner and to the same extent to the provisions of this
chapter as if it had been introduced in interstate commerce.
(b) Labeling and packaging requirements
No person shall sell, or offer for sale, colored oleomargarine or
colored margarine unless -
(1) such oleomargarine or margarine is packaged,
(2) the net weight of the contents of any package sold in a
retail establishment is one pound or less,
(3) there appears on the label of the package (A) the word
"oleomargarine" or "margarine" in type or lettering at least as
large as any other type or lettering on such label, and (B) a
full and accurate statement of all the ingredients contained in
such oleomargarine or margarine, and
(4) each part of the contents of the package is contained in a
wrapper which bears the word "oleomargarine" or "margarine" in
type or lettering not smaller than 20-point type.
The requirements of this subsection shall be in addition to and not
in lieu of any of the other requirements of this chapter.
(c) Sales in public eating places
No person shall possess in a form ready for serving colored
oleomargarine or colored margarine at a public eating place unless
a notice that oleomargarine or margarine is served is displayed
prominently and conspicuously in such place and in such manner as
to render it likely to be read and understood by the ordinary
individual being served in such eating place or is printed or is
otherwise set forth on the menu in type or lettering not smaller
than that normally used to designate the serving of other food
items. No person shall serve colored oleomargarine or colored
margarine at a public eating place, whether or not any charge is
made therefor, unless (1) each separate serving bears or is
accompanied by labeling identifying it as oleomargarine or
margarine, or (2) each separate serving thereof is triangular in
shape.
(d) Exemption from labeling requirements
Colored oleomargarine or colored margarine when served with meals
at a public eating place shall at the time of such service be
exempt from the labeling requirements of section 343 of this title
(except paragraphs (a) and (f)) if it complies with the
requirements of subsection (b) of this section.
(e) Color content of oleomargarine
For the purpose of this section colored oleomargarine or colored
margarine is oleomargarine or margarine having a tint or shade
containing more than one and six-tenths degrees of yellow, or of
yellow and red collectively, but with an excess of yellow over red,
measured in terms of Lovibond tintometer scale or its equivalent.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 407, as added Mar. 16, 1950, ch. 61,
Sec. 3(c), 64 Stat. 20.)
-MISC1-
EFFECTIVE DATE
Section 7 of act Mar. 16, 1950, provided that: "This Act
[enacting this section and sections 347a and 347b of this title and
amending sections 331 and 342 of this title and sections 45 and 55
of Title 15, Commerce and Trade] shall become effective on July 1,
1950."
TRANSFER OF APPROPRIATIONS
Section 5 of act Mar. 16, 1950, provided that: "So much of the
unexpended balances of appropriations, allocations, or other funds
(including funds available for the fiscal year ending June 30,
1950) for the use of the Bureau of Internal Revenue of the Treasury
Department in the exercise of functions under the Oleomargarine Tax
Act (26 U.S.C., Sec. 2300, subchapter A) [now section 4591 et seq.
of Title 26, Internal Revenue Code], as the Director of the Bureau
of the Budget [now Director of the Office of Management and Budget]
may determine, shall be transferred to the Federal Security Agency
(Food and Drug Administration) [now the Department of Health and
Human Services] for use in the enforcement of this Act [see
Effective Date note above]."
-End-
-CITE-
21 USC Sec. 347a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 347a. Congressional declaration of policy regarding
oleomargarine sales
-STATUTE-
The Congress finds and declares that the sale, or the serving in
public eating places, of colored oleomargarine or colored margarine
without clear identification as such or which is otherwise
adulterated or misbranded within the meaning of this chapter
depresses the market in interstate commerce for butter and for
oleomargarine or margarine clearly identified and neither
adulterated nor misbranded, and constitutes a burden on interstate
commerce in such articles. Such burden exists, irrespective of
whether such oleomargarine or margarine originates from an
interstate source or from the State in which it is sold.
-SOURCE-
(Mar. 16, 1950, ch. 61, Sec. 3(a), 64 Stat. 20.)
-COD-
CODIFICATION
Section was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
-MISC1-
EFFECTIVE DATE
Section effective July 1, 1950, see section 7 of act Mar. 16,
1950, set out as a note under section 347 of this title.
-End-
-CITE-
21 USC Sec. 347b 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 347b. Contravention of State laws
-STATUTE-
Nothing in this Act shall be construed as authorizing the
possession, sale, or serving of colored oleomargarine or colored
margarine in any State or Territory in contravention of the laws of
such State or Territory.
-SOURCE-
(Mar. 16, 1950, ch. 61, Sec. 6, 64 Stat. 22.)
-REFTEXT-
REFERENCES IN TEXT
This Act, referred to in text, is act Mar. 16, 1950, ch. 61, 64
Stat. 20, which is classified to sections 331, 342, 347 to 347b of
this title, and sections 45 and 55 of Title 15, Commerce and Trade.
For complete classification of this Act to the Code, see Tables.
-COD-
CODIFICATION
Section was not enacted as part of the Federal Food, Drug, and
Cosmetic Act which comprises this chapter.
-MISC1-
EFFECTIVE DATE
Section effective July 1, 1950, see section 7 of act Mar. 16,
1950, set out as a note under section 347 of this title.
-End-
-CITE-
21 USC Sec. 348 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 348. Food additives
-STATUTE-
(a) Unsafe food additives; exception for conformity with exemption
or regulation
A food additive shall, with respect to any particular use or
intended use of such additives, be deemed to be unsafe for the
purposes of the application of clause (2)(C) of section 342(a) of
this title, unless -
(1) it and its use or intended use conform to the terms of an
exemption which is in effect pursuant to subsection (j) of this
section;
(2) there is in effect, and it and its use or intended use are
in conformity with, a regulation issued under this section
prescribing the conditions under which such additive may be
safely used; or
(3) in the case of a food additive as defined in this chapter
that is a food contact substance, there is -
(A) in effect, and such substance and the use of such
substance are in conformity with, a regulation issued under
this section prescribing the conditions under which such
additive may be safely used; or
(B) a notification submitted under subsection (h) of this
section that is effective.
While such a regulation relating to a food additive, or such a
notification under subsection (h)(1) of this section relating to a
food additive that is a food contact substance, is in effect, and
has not been revoked pursuant to subsection (i) of this section, a
food shall not, by reason of bearing or containing such a food
additive in accordance with the regulation or notification, be
considered adulterated under section 342(a)(1) of this title.
(b) Petition for regulation prescribing conditions of safe use;
contents; description of production methods and controls;
samples; notice of regulation
(1) Any person may, with respect to any intended use of a food
additive, file with the Secretary a petition proposing the issuance
of a regulation prescribing the conditions under which such
additive may be safely used.
(2) Such petition shall, in addition to any explanatory or
supporting data, contain -
(A) the name and all pertinent information concerning such food
additive, including, where available, its chemical identity and
composition;
(B) a statement of the conditions of the proposed use of such
additive, including all directions, recommendations, and
suggestions proposed for the use of such additive, and including
specimens of its proposed labeling;
(C) all relevant data bearing on the physical or other
technical effect such additive is intended to produce, and the
quantity of such additive required to produce such effect;
(D) a description of practicable methods for determining the
quantity of such additive in or on food, and any substance formed
in or on food, because of its use; and
(E) full reports of investigations made with respect to the
safety for use of such additive, including full information as to
the methods and controls used in conducting such investigations.
(3) Upon request of the Secretary, the petitioner shall furnish
(or, if the petitioner is not the manufacturer of such additive,
the petitioner shall have the manufacturer of such additive
furnish, without disclosure to the petitioner) a full description
of the methods used in, and the facilities and controls used for,
the production of such additive.
(4) Upon request of the Secretary, the petitioner shall furnish
samples of the food additive involved, or articles used as
components thereof, and of the food in or on which the additive is
proposed to be used.
(5) Notice of the regulation proposed by the petitioner shall be
published in general terms by the Secretary within thirty days
after filing.
(c) Approval or denial of petition; time for issuance of order;
evaluation of data; factors
(1) The Secretary shall -
(A) by order establish a regulation (whether or not in accord
with that proposed by the petitioner) prescribing, with respect
to one or more proposed uses of the food additive involved, the
conditions under which such additive may be safely used
(including, but not limited to, specifications as to the
particular food or classes of food in or in which such additive
may be used, the maximum quantity which may be used or permitted
to remain in or on such food, the manner in which such additive
may be added to or used in or on such food, and any directions or
other labeling or packaging requirements for such additive deemed
necessary by him to assure the safety of such use), and shall
notify the petitioner of such order and the reasons for such
action; or
(B) by order deny the petition, and shall notify the petitioner
of such order and of the reasons for such action.
(2) The order required by paragraph (1)(A) or (B) of this
subsection shall be issued within ninety days after the date of
filing of the petition, except that the Secretary may (prior to
such ninetieth day), by written notice to the petitioner, extend
such ninety-day period to such time (not more than one hundred and
eighty days after the date of filing of the petition) as the
Secretary deems necessary to enable him to study and investigate
the petition.
(3) No such regulation shall issue if a fair evaluation of the
data before the Secretary -
(A) fails to establish that the proposed use of the food
additive, under the conditions of use to be specified in the
regulation, will be safe: Provided, That no additive shall be
deemed to be safe if it is found to induce cancer when ingested
by man or animal, or if it is found, after tests which are
appropriate for the evaluation of the safety of food additives,
to induce cancer in man or animal, except that this proviso shall
not apply with respect to the use of a substance as an ingredient
of feed for animals which are raised for food production, if the
Secretary finds (i) that, under the conditions of use and feeding
specified in proposed labeling and reasonably certain to be
followed in practice, such additive will not adversely affect the
animals for which such feed is intended, and (ii) that no residue
of the additive will be found (by methods of examination
prescribed or approved by the Secretary by regulations, which
regulations shall not be subject to subsections (f) and (g) of
this section) in any edible portion of such animal after
slaughter or in any food yielded by or derived from the living
animal; or
(B) shows that the proposed use of the additive would promote
deception of the consumer in violation of this chapter or would
otherwise result in adulteration or in misbranding of food within
the meaning of this chapter.
(4) If, in the judgment of the Secretary, based upon a fair
evaluation of the data before him, a tolerance limitation is
required in order to assure that the proposed use of an additive
will be safe, the Secretary -
(A) shall not fix such tolerance limitation at a level higher
than he finds to be reasonably required to accomplish the
physical or other technical effect for which such additive is
intended; and
(B) shall not establish a regulation for such proposed use if
he finds upon a fair evaluation of the data before him that such
data do not establish that such use would accomplish the intended
physical or other technical effect.
(5) In determining, for the purposes of this section, whether a
proposed use of a food additive is safe, the Secretary shall
consider among other relevant factors -
(A) the probable consumption of the additive and of any
substance formed in or on food because of the use of the
additive;
(B) the cumulative effect of such additive in the diet of man
or animals, taking into account any chemically or
pharmacologically related substance or substances in such diet;
and
(C) safety factors which in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food
additives are generally recognized as appropriate for the use of
animal experimentation data.
(d) Regulation issued on Secretary's initiative
The Secretary may at any time, upon his own initiative, propose
the issuance of a regulation prescribing, with respect to any
particular use of a food additive, the conditions under which such
additive may be safely used, and the reasons therefor. After the
thirtieth day following publication of such a proposal, the
Secretary may by order establish a regulation based upon the
proposal.
(e) Publication and effective date of orders
Any order, including any regulation established by such order,
issued under subsection (c) or (d) of this section, shall be
published and shall be effective upon publication, but the
Secretary may stay such effectiveness if, after issuance of such
order, a hearing is sought with respect to such order pursuant to
subsection (f) of this section.
(f) Objections and public hearing; basis and contents of order;
statement
(1) Within thirty days after publication of an order made
pursuant to subsection (c) or (d) of this section, any person
adversely affected by such an order may file objections thereto
with the Secretary, specifying with particularity the provisions of
the order deemed objectionable, stating reasonable grounds
therefor, and requesting a public hearing upon such objections. The
Secretary shall, after due notice, as promptly as possible hold
such public hearing for the purpose of receiving evidence relevant
and material to the issues raised by such objections. As soon as
practicable after completion of the hearing, the Secretary shall by
order act upon such objections and make such order public.
(2) Such order shall be based upon a fair evaluation of the
entire record at such hearing, and shall include a statement
setting forth in detail the findings and conclusions upon which the
order is based.
(3) The Secretary shall specify in the order the date on which it
shall take effect, except that it shall not be made to take effect
prior to the ninetieth day after its publication, unless the
Secretary finds that emergency conditions exist necessitating an
earlier effective date, in which event the Secretary shall specify
in the order his findings as to such conditions.
(g) Judicial review
(1) In a case of actual controversy as to the validity of any
order issued under subsection (f) of this section, including any
order thereunder with respect to amendment or repeal of a
regulation issued under this section, any person who will be
adversely affected by such order may obtain judicial review by
filing in the United States Court of Appeals for the circuit
wherein such person resides or has his principal place of business,
or in the United States Court of Appeals for the District of
Columbia Circuit, within sixty days after the entry of such order,
a petition praying that the order be set aside in whole or in part.
(2) A copy of such petition shall be forthwith transmitted by the
clerk of the court to the Secretary, or any officer designated by
him for that purpose, and thereupon the Secretary shall file in the
court the record of the proceedings on which he based his order, as
provided in section 2112 of title 28. Upon the filing of such
petition the court shall have jurisdiction, which upon the filing
of the record with it shall be exclusive, to affirm or set aside
the order complained of in whole or in part. Until the filing of
the record the Secretary may modify or set aside his order. The
findings of the Secretary with respect to questions of fact shall
be sustained if based upon a fair evaluation of the entire record
at such hearing.
(3) The court, on such judicial review, shall not sustain the
order of the Secretary if he failed to comply with any requirement
imposed on him by subsection (f)(2) of this section.
(4) If application is made to the court for leave to adduce
additional evidence, the court may order such additional evidence
to be taken before the Secretary and to be adduced upon the hearing
in such manner and upon such terms and conditions as to the court
may seem proper, if such evidence is material and there were
reasonable grounds for failure to adduce such evidence in the
proceedings below. The Secretary may modify his findings as to the
facts and order by reason of the additional evidence so taken, and
shall file with the court such modified findings and order.
(5) The judgment of the court affirming or setting aside, in
whole or in part, any order under this section shall be final,
subject to review by the Supreme Court of the United States upon
certiorari or certification as provided in section 1254 of title
28. The commencement of proceedings under this section shall not,
unless specifically ordered by the court to the contrary, operate
as a stay of an order.
(h) Notification relating to food contact substance
(1) Subject to such regulations as may be promulgated under
paragraph (3), a manufacturer or supplier of a food contact
substance may, at least 120 days prior to the introduction or
delivery for introduction into interstate commerce of the food
contact substance, notify the Secretary of the identity and
intended use of the food contact substance, and of the
determination of the manufacturer or supplier that the intended use
of such food contact substance is safe under the standard described
in subsection (c)(3)(A) of this section. The notification shall
contain the information that forms the basis of the determination
and all information required to be submitted by regulations
promulgated by the Secretary.
(2)(A) A notification submitted under paragraph (1) shall become
effective 120 days after the date of receipt by the Secretary and
the food contact substance may be introduced or delivered for
introduction into interstate commerce, unless the Secretary makes a
determination within the 120-day period that, based on the data and
information before the Secretary, such use of the food contact
substance has not been shown to be safe under the standard
described in subsection (c)(3)(A) of this section, and informs the
manufacturer or supplier of such determination.
(B) A decision by the Secretary to object to a notification shall
constitute final agency action subject to judicial review.
(C) In this paragraph, the term "food contact substance" means
the substance that is the subject of a notification submitted under
paragraph (1), and does not include a similar or identical
substance manufactured or prepared by a person other than the
manufacturer identified in the notification.
(3)(A) The process in this subsection shall be utilized for
authorizing the marketing of a food contact substance except where
the Secretary determines that submission and review of a petition
under subsection (b) of this section is necessary to provide
adequate assurance of safety, or where the Secretary and any
manufacturer or supplier agree that such manufacturer or supplier
may submit a petition under subsection (b) of this section.
(B) The Secretary is authorized to promulgate regulations to
identify the circumstances in which a petition shall be filed under
subsection (b) of this section, and shall consider criteria such as
the probable consumption of such food contact substance and
potential toxicity of the food contact substance in determining the
circumstances in which a petition shall be filed under subsection
(b) of this section.
(4) The Secretary shall keep confidential any information
provided in a notification under paragraph (1) for 120 days after
receipt by the Secretary of the notification. After the expiration
of such 120 days, the information shall be available to any
interested party except for any matter in the notification that is
a trade secret or confidential commercial information.
(5)(A)(i) Except as provided in clause (ii), the notification
program established under this subsection shall not operate in any
fiscal year unless -
(I) an appropriation equal to or exceeding the applicable
amount under clause (iv) is made for such fiscal year for
carrying out such program in such fiscal year; and
(II) the Secretary certifies that the amount appropriated for
such fiscal year for the Center for Food Safety and Applied
Nutrition of the Food and Drug Administration (exclusive of the
appropriation referred to in subclause (I)) equals or exceeds the
amount appropriated for the Center for fiscal year 1997,
excluding any amount appropriated for new programs.
(ii) The Secretary shall, not later than April 1, 1999, begin
accepting and reviewing notifications submitted under the
notification program established under this subsection if -
(I) an appropriation equal to or exceeding the applicable
amount under clause (iii) is made for the last six months of
fiscal year 1999 for carrying out such program during such
period; and
(II) the Secretary certifies that the amount appropriated for
such period for the Center for Food Safety and Applied Nutrition
of the Food and Drug Administration (exclusive of the
appropriation referred to in subclause (I)) equals or exceeds an
amount equivalent to one-half the amount appropriated for the
Center for fiscal year 1997, excluding any amount appropriated
for new programs.
(iii) For the last six months of fiscal year 1999, the applicable
amount under this clause is $1,500,000, or the amount specified in
the budget request of the President for the six-month period
involved for carrying out the notification program in fiscal year
1999, whichever is less.
(iv) For fiscal year 2000 and subsequent fiscal years, the
applicable amount under this clause is $3,000,000, or the amount
specified in the budget request of the President for the fiscal
year involved for carrying out the notification program under this
subsection, whichever is less.
(B) For purposes of carrying out the notification program under
this subsection, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 1999 through
fiscal year 2003, except that such authorization of appropriations
is not effective for a fiscal year for any amount that is less than
the applicable amount under clause (iii) or (iv) of subparagraph
(A), whichever is applicable.
(C) Not later than April 1 of fiscal year 1998 and February 1 of
each subsequent fiscal year, the Secretary shall submit a report to
the Committees on Appropriations of the House of Representatives
and the Senate, the Committee on Commerce of the House of
Representatives, and the Committee on Labor and Human Resources of
the Senate that provides an estimate of the Secretary of the costs
of carrying out the notification program established under this
subsection for the next fiscal year.
(6) In this section, the term "food contact substance" means any
substance intended for use as a component of materials used in
manufacturing, packing, packaging, transporting, or holding food if
such use is not intended to have any technical effect in such food.
(i) Amendment or repeal of regulations
The Secretary shall by regulation prescribe the procedure by
which regulations under the foregoing provisions of this section
may be amended or repealed, and such procedure shall conform to the
procedure provided in this section for the promulgation of such
regulations. The Secretary shall by regulation prescribe the
procedure by which the Secretary may deem a notification under
subsection (h) of this section to no longer be effective.
(j) Exemptions for investigational use
Without regard to subsections (b) to (i), inclusive, of this
section, the Secretary shall by regulation provide for exempting
from the requirements of this section any food additive, and any
food bearing or containing such additive, intended solely for
investigational use by qualified experts when in his opinion such
exemption is consistent with the public health.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 409, as added Pub. L. 85-929, Sec. 4,
Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86-546, Sec. 2, June
29, 1960, 74 Stat. 255; Pub. L. 87-781, title I, Sec. 104(f)(1),
Oct. 10, 1962, 76 Stat. 785; Pub. L. 98-620, title IV, Sec.
402(25)(B), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 105-115, title
III, Sec. 309, Nov. 21, 1997, 111 Stat. 2354.)
-MISC1-
AMENDMENTS
1997 - Subsec. (a). Pub. L. 105-115, Sec. 309(a)(4), in closing
provisions, substituted "While such a regulation relating to a food
additive, or such a notification under subsection (h)(1) of this
section relating to a food additive that is a food contact
substance, is in effect, and has not been revoked pursuant to
subsection (i) of this section, a food shall not, by reason of
bearing or containing such a food additive in accordance with the
regulation or notification, be considered adulterated under section
342(a)(1) of this title." for "While such a regulation relating to
a food additive is in effect, a food shall not, by reason of
bearing or containing such an additive in accordance with the
regulation, be considered adulterated within the meaning of clause
(1) of section 342(a) of this title."
Subsec. (a)(1). Pub. L. 105-115, Sec. 309(a)(1), substituted
"subsection (j)" for "subsection (i)".
Subsec. (a)(3). Pub. L. 105-115, Sec. 309(a)(1)(B), (2), (3),
added par. (3).
Subsec. (h). Pub. L. 105-115, Sec. 309(b)(2), added subsec. (h).
Former subsec. (h) redesignated (i).
Subsec. (i). Pub. L. 105-115, Sec. 309(b)(1), (3), redesignated
subsec. (h) as (i) and inserted at end "The Secretary shall by
regulation prescribe the procedure by which the Secretary may deem
a notification under subsection (h) of this section to no longer be
effective."
Subsec. (j). Pub. L. 105-115, Sec. 309(b)(1), (4), redesignated
subsec. (i) as (j) and substituted "subsections (b) to (i)" for
"subsections (b) to (h)".
1984 - Subsec. (g)(2). Pub. L. 98-620 struck out provision that
required the court to advance on the docket and expedite the
disposition of all causes filed therein pursuant to this section.
1962 - Subsec. (c)(3)(A). Pub. L. 87-781 excepted proviso from
applying to use of a substance as an ingredient of feed for animals
raised for food production, if under conditions of use specified in
proposed labeling, and which conditions are reasonably certain to
be followed in practice, such additive will not adversely affect
the animals and no residue will be found in any edible portion of
such animal after slaughter, or in any food from the living animal.
1960 - Subsec. (g)(2). Pub. L. 86-546 substituted "forthwith
transmitted by the clerk of the court to the Secretary, or any
officer" for "served upon the Secretary, or upon any officer",
"shall file in the court the record of the proceedings on which he
based his order, as provided in section 2112 of title 28" for
"shall certify and file in the court a transcript of the
proceedings and the record on which he based his order", and "Upon
the filing of such petition the court shall have jurisdiction,
which upon the filing of the record with it shall be exclusive,"
for "Upon such filing, the court shall have exclusive
jurisdiction", and inserted sentence authorizing the Secretary to
modify or set aside his order until the filing of the record.
-CHANGE-
CHANGE OF NAME
Committee on Commerce of House of Representatives changed to
Committee on Energy and Commerce of House of Representatives, and
jurisdiction over matters relating to securities and exchanges and
insurance generally transferred to Committee on Financial Services
of House of Representatives by House Resolution No. 5, One Hundred
Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate changed to
Committee on Health, Education, Labor, and Pensions of Senate by
Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19,
1999.
-MISC2-
EFFECTIVE DATE OF 1997 AMENDMENT
Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,
1997, except as otherwise provided, see section 501 of Pub. L. 105-
115, set out as a note under section 321 of this title.
EFFECTIVE DATE OF 1984 AMENDMENT
Amendment by Pub. L. 98-620 not applicable to cases pending on
Nov. 8, 1984, see section 403 of Pub. L. 98-620, set out as an
Effective Date note under section 1657 of Title 28, Judiciary and
Judicial Procedure.
EFFECTIVE DATE OF 1962 AMENDMENT; EXCEPTIONS
Amendment by Pub. L. 87-781 effective Oct. 10, 1962, see section
107 of Pub. L. 87-781, set out as an Effective Date of 1962
Amendment note under section 321 of this title.
EFFECTIVE DATE
Section effective Sept. 6, 1958, see section 6(a) of Pub. L. 85-
929, set out as an Effective Date of 1958 Amendment note under
section 342 of this title.
GLASS AND CERAMIC WARE
Section 308 of Pub. L. 105-115 provided that:
"(a) In General. - The Secretary may not implement any
requirement which would ban, as an unapproved food additive, lead
and cadmium based enamel in the lip and rim area of glass and
ceramic ware before the expiration of one year after the date such
requirement is published.
"(b) Lead and Cadmium Based Enamel. - Unless the Secretary
determines, based on available data, that lead and cadmium based
enamel on glass and ceramic ware -
"(1) which has less than 60 millimeters of decorating area
below the external rim, and
"(2) which is not, by design, representation, or custom of
usage intended for use by children,
is unsafe, the Secretary shall not take any action before January
1, 2003, to ban lead and cadmium based enamel on such glass and
ceramic ware. Any action taken after January 1, 2003, to ban such
enamel on such glass and ceramic ware as an unapproved food
additive shall be taken by regulation and such regulation shall
provide that such products shall not be removed from the market
before 1 year after publication of the final regulation."
MORATORIUM ON AUTHORITY OF SECRETARY WITH RESPECT TO SACCHARIN
Pub. L. 95-203, Sec. 3, Nov. 23, 1977, 91 Stat. 1452, as amended
by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.
695; Pub. L. 96-273, June 17, 1980, 94 Stat. 536; Pub. L. 97-42,
Sec. 2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98-22, Sec. 2, Apr.
22, 1983, 97 Stat. 173; Pub. L. 99-46, May 24, 1985, 99 Stat. 81;
Pub. L. 100-71, title I, Sec. 101, July 11, 1987, 101 Stat. 431;
Pub. L. 102-142, title VI, Oct. 28, 1991, 105 Stat. 910; Pub. L.
104-180, title VI, Sec. 602, Aug. 6, 1996, 110 Stat. 1594, provided
that: "During the period ending May 1, 2002, the Secretary -
"(1) may not amend or revoke the interim food additive
regulation of the Food and Drug Administration of the Department
of Health and Human Services applicable to saccharin and
published on March 15, 1977 (section 180.37 of part 180,
subchapter B, chapter 1, title 21, Code of Federal Regulations
(42 Fed. Reg. 14638)), or
"(2) may, except as provided in section 4 [enacting section
343a of this title, amending sections 321 and 343 of this title,
and enacting provisions set out as notes under section 343 of
this title] and the amendments made by such section, not take any
other action under the Federal Food, Drug, and Cosmetic Act [this
chapter] to prohibit or restrict the sale or distribution of
saccharin, any food permitted by such interim food additive
regulation to contain saccharin, or any drug or cosmetic
containing saccharin,
solely on the basis of the carcinogenic or other toxic effect of
saccharin as determined by any study made available to the
Secretary before the date of the enactment of this Act [Nov. 23,
1977] which involved human studies or animal testing, or both."
For definition of "saccharin" as used in this note, see section
2(d) of Pub. L. 95-203.
-End-
-CITE-
21 USC Sec. 349 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 349. Bottled drinking water standards; publication in Federal
Register
-STATUTE-
(a) Except as provided in subsection (b) of this section,
whenever the Administrator of the Environmental Protection Agency
prescribes interim or revised national primary drinking water
regulations under section 1412 of the Public Health Service Act [42
U.S.C. 300g-1], the Secretary shall consult with the Administrator
and within 180 days after the promulgation of such drinking water
regulations either promulgate amendments to regulations under this
chapter applicable to bottled drinking water or publish in the
Federal Register his reasons for not making such amendments.
(b)(1) Not later than 180 days before the effective date of a
national primary drinking water regulation promulgated by the
Administrator of the Environmental Protection Agency for a
contaminant under section 1412 of the Safe Drinking Water Act (42
U.S.C. 300g-1), the Secretary shall promulgate a standard of
quality regulation under this subsection for that contaminant in
bottled water or make a finding that such a regulation is not
necessary to protect the public health because the contaminant is
contained in water in public water systems (as defined under
section 1401(4) of such Act (42 U.S.C. 300f(4))) but not in water
used for bottled drinking water. The effective date for any such
standard of quality regulation shall be the same as the effective
date for such national primary drinking water regulation, except
for any standard of quality of regulation promulgated by the
Secretary before August 6, 1996, for which (as of August 6, 1996)
an effective date had not been established. In the case of a
standard of quality regulation to which such exception applies, the
Secretary shall promulgate monitoring requirements for the
contaminants covered by the regulation not later than 2 years after
August 6, 1996.
(2) A regulation issued by the Secretary as provided in this
subsection shall include any monitoring requirements that the
Secretary determines appropriate for bottled water.
(3) A regulation issued by the Secretary as provided in this
subsection shall require the following:
(A) In the case of contaminants for which a maximum contaminant
level is established in a national primary drinking water
regulation under section 1412 of the Safe Drinking Water Act (42
U.S.C. 300g-1), the regulation under this subsection shall
establish a maximum contaminant level for the contaminant in
bottled water which is no less stringent than the maximum
contaminant level provided in the national primary drinking water
regulation.
(B) In the case of contaminants for which a treatment technique
is established in a national primary drinking water regulation
under section 1412 of the Safe Drinking Water Act (42 U.S.C. 300g-
1), the regulation under this subsection shall require that
bottled water be subject to requirements no less protective of
the public health than those applicable to water provided by
public water systems using the treatment technique required by
the national primary drinking water regulation.
(4)(A) If the Secretary does not promulgate a regulation under
this subsection within the period described in paragraph (1), the
national primary drinking water regulation referred to in paragraph
(1) shall be considered, as of the date on which the Secretary is
required to establish a regulation under paragraph (1), as the
regulation applicable under this subsection to bottled water.
(B) In the case of a national primary drinking water regulation
that pursuant to subparagraph (A) is considered to be a standard of
quality regulation, the Secretary shall, not later than the
applicable date referred to in such subparagraph, publish in the
Federal Register a notice -
(i) specifying the contents of such regulation, including
monitoring requirements; and
(ii) providing that for purposes of this paragraph the
effective date for such regulation is the same as the effective
date for the regulation for purposes of the Safe Drinking Water
Act [42 U.S.C. 300f et seq.] (or, if the exception under
paragraph (1) applies to the regulation, that the effective date
for the regulation is not later than 2 years and 180 days after
August 6, 1996).
-SOURCE-
(June 25, 1938, ch. 675, Sec. 410, as added Pub. L. 93-523, Sec. 4,
Dec. 16, 1974, 88 Stat. 1694; amended Pub. L. 104-182, title III,
Sec. 305, Aug. 6, 1996, 110 Stat. 1684.)
-REFTEXT-
REFERENCES IN TEXT
The Safe Drinking Water Act, referred to in subsec.
(b)(4)(B)(ii), is title XIV of act July 1, 1944, as added Dec. 16,
1974, Pub. L. 93-523, Sec. 2(a), 88 Stat. 1660, as amended, which
is classified generally to subchapter XII (Sec. 300f et seq.) of
chapter 6A of Title 42, The Public Health and Welfare. For complete
classification of this Act to the Code, see Short Title note set
out under section 201 of Title 42 and Tables.
-MISC1-
AMENDMENTS
1996 - Pub. L. 104-182 substituted "(a) Except as provided in
subsection (b) of this section, whenever" for "Whenever" and added
subsec. (b).
BOTTLED WATER STUDY
Section 114(b) of Pub. L. 104-182 provided that: "Not later than
18 months after the date of enactment of this Act [Aug. 6, 1996],
the Administrator of the Food and Drug Administration, in
consultation with the Administrator of the Environmental Protection
Agency, shall publish for public notice and comment a draft study
on the feasibility of appropriate methods, if any, of informing
customers of the contents of bottled water. The Administrator of
the Food and Drug Administration shall publish a final study not
later than 30 months after the date of enactment of this Act."
-End-
-CITE-
21 USC Sec. 350 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350. Vitamins and minerals
-STATUTE-
(a) Authority and limitations of Secretary; applicability
(1) Except as provided in paragraph (2) -
(A) the Secretary may not establish, under section 321(n), 341,
or 343 of this title, maximum limits on the potency of any
synthetic or natural vitamin or mineral within a food to which
this section applies;
(B) the Secretary may not classify any natural or synthetic
vitamin or mineral (or combination thereof) as a drug solely
because it exceeds the level of potency which the Secretary
determines is nutritionally rational or useful;
(C) the Secretary may not limit, under section 321(n), 341, or
343 of this title, the combination or number of any synthetic or
natural -
(i) vitamin,
(ii) mineral, or
(iii) other ingredient of food,
within a food to which this section applies.
(2) Paragraph (1) shall not apply in the case of a vitamin,
mineral, other ingredient of food, or food, which is represented
for use by individuals in the treatment or management of specific
diseases or disorders, by children, or by pregnant or lactating
women. For purposes of this subparagraph,(!1) the term "children"
means individuals who are under the age of twelve years.
(b) Labeling and advertising requirements for foods
(1) A food to which this section applies shall not be deemed
under section 343 of this title to be misbranded solely because its
label bears, in accordance with section 343(i)(2) of this title,
all the ingredients in the food or its advertising contains
references to ingredients in the food which are not vitamins or
minerals.
(2) The labeling for any food to which this section applies may
not list its ingredients which are not dietary supplement
ingredients described in section 321(ff) of this title (i) except
as a part of a list of all the ingredients of such food, and (ii)
unless such ingredients are listed in accordance with applicable
regulations under section 343 of this title. To the extent that
compliance with clause (i) of this subparagraph is impracticable or
results in deception or unfair competition, exemptions shall be
established by regulations promulgated by the Secretary.
(c) Definitions
(1) For purposes of this section, the term "food to which this
section applies" means a food for humans which is a food for
special dietary use -
(A) which is or contains any natural or synthetic vitamin or
mineral, and
(B) which -
(i) is intended for ingestion in tablet, capsule, powder,
softgel, gelcap, or liquid form, or
(ii) if not intended for ingestion in such a form, is not
represented as conventional food and is not represented for use
as a sole item of a meal or of the diet.
(2) For purposes of paragraph (1)(B)(i), a food shall be
considered as intended for ingestion in liquid form only if it is
formulated in a fluid carrier and it is intended for ingestion in
daily quantities measured in drops or similar small units of
measure.
(3) For purposes of paragraph (1) and of section 343(j) of this
title insofar as that section is applicable to food to which this
section applies, the term "special dietary use" as applied to food
used by man means a particular use for which a food purports or is
represented to be used, including but not limited to the following:
(A) Supplying a special dietary need that exists by reason of a
physical, physiological, pathological, or other condition,
including but not limited to the condition of disease,
convalescence, pregnancy, lactation, infancy, allergic
hypersensitivity to food, underweight, overweight, or the need to
control the intake of sodium.
(B) Supplying a vitamin, mineral, or other ingredient for use
by man to supplement his diet by increasing the total dietary
intake.
(C) Supplying a special dietary need by reason of being a food
for use as the sole item of the diet.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 411, as added Pub. L. 94-278, title
V, Sec. 501(a), Apr. 22, 1976, 90 Stat. 410; amended Pub. L. 103-
417, Secs. 3(c), 7(d), Oct. 25, 1994, 108 Stat. 4328, 4331.)
-MISC1-
AMENDMENTS
1994 - Subsec. (b)(2). Pub. L. 103-417, Sec. 7(d), redesignated
subpar. (A) as par. (2), substituted "dietary supplement
ingredients described in section 321(ff) of this title" for
"vitamins or minerals", and struck out former subpar. (B), which
read as follows: "Notwithstanding the provisions of subparagraph
(A), the labeling and advertising for any food to which this
section applies may not give prominence to or emphasize ingredients
which are not -
"(i) vitamins,
"(ii) minerals, or
"(iii) represented as a source of vitamins or minerals."
Subsec. (c)(1)(B)(i). Pub. L. 103-417, Sec. 3(c)(1), inserted
"powder, softgel, gelcap," after "capsule,".
Subsec. (c)(1)(B)(ii). Pub. L. 103-417, Sec. 3(c)(2), struck out
"does not simulate and" after "in such a form,".
EFFECTIVE DATE OF 1994 AMENDMENT
For provision that dietary supplements may be labeled after Oct.
25, 1994, in accordance with amendments made by section 7(d) of
Pub. L. 103-417, and shall be so labeled after Dec. 31, 1996, see
section 7(e) of Pub. L. 103-417, set out as a note under section
343 of this title.
AMENDMENT OF INCONSISTENT REGULATIONS BY SECRETARY
Section 501(b) of Pub. L. 94-278, as amended by Pub. L. 96-88,
title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, provided that:
"The Secretary of Health and Human Services shall amend any
regulation promulgated under the Federal Food, Drug, and Cosmetic
Act [this chapter] which is inconsistent with section 411 of such
Act [section 350 of this title] (as added by subsection (a)) and
such amendments shall be promulgated in accordance with section 553
of title 5, United States Code."
-FOOTNOTE-
(!1) So in original. Probably should be "paragraph".
-End-
-CITE-
21 USC Sec. 350a 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350a. Infant formulas
-STATUTE-
(a) Adulteration
An infant formula, including an infant formula powder, shall be
deemed to be adulterated if -
(1) such infant formula does not provide nutrients as required
by subsection (i) of this section,
(2) such infant formula does not meet the quality factor
requirements prescribed by the Secretary under subsection (b)(1)
of this section, or
(3) the processing of such infant formula is not in compliance
with the good manufacturing practices and the quality control
procedures prescribed by the Secretary under subsection (b)(2) of
this section.
(b) Requirements for quality factors, good manufacturing practices,
and retention of records
(1) The Secretary shall by regulation establish requirements for
quality factors for infant formulas to the extent possible
consistent with current scientific knowledge, including quality
factor requirements for the nutrients required by subsection (i) of
this section.
(2)(A) The Secretary shall by regulation establish good
manufacturing practices for infant formulas, including quality
control procedures that the Secretary determines are necessary to
assure that an infant formula provides nutrients in accordance with
this subsection and subsection (i) of this section and is
manufactured in a manner designed to prevent adulteration of the
infant formula.
(B) The good manufacturing practices and quality control
procedures prescribed by the Secretary under subparagraph (A) shall
include requirements for -
(i) the testing, in accordance with paragraph (3) and by the
manufacturer of an infant formula or an agent of such
manufacturer, of each batch of infant formula for each nutrient
required by subsection (i) of this section before the
distribution of such batch,
(ii) regularly scheduled testing, by the manufacturer of an
infant formula or an agent of such manufacturer, of samples of
infant formulas during the shelf life of such formulas to ensure
that such formulas are in compliance with this section,
(iii) in-process controls including, where necessary, testing
required by good manufacturing practices designed to prevent
adulteration of each batch of infant formula, and
(iv) the conduct by the manufacturer of an infant formula or an
agent of such manufacturer of regularly scheduled audits to
determine that such manufacturer has complied with the
regulations prescribed under subparagraph (A).
In prescribing requirements for audits under clause (iv), the
Secretary shall provide that such audits be conducted by
appropriately trained individuals who do not have any direct
responsibility for the manufacture or production of infant formula.
(3)(A) At the final product stage, each batch of infant formula
shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E
to ensure that such infant formula is in compliance with the
requirements of this subsection and subsection (i) of this section
relating to such vitamins.
(B) Each nutrient premix used in the manufacture of an infant
formula shall be tested for each relied upon nutrient required by
subsection (i) of this section which is contained in such premix to
ensure that such premix is in compliance with its specifications or
certifications by a premix supplier.
(C) During the manufacturing process or at the final product
stage and before distribution of an infant formula, an infant
formula shall be tested for all nutrients required to be included
in such formula by subsection (i) of this section for which testing
has not been conducted pursuant to subparagraph (A) or (B). Testing
under this subparagraph shall be conducted to -
(i) ensure that each batch of such infant formula is in
compliance with the requirements of subsection (i) of this
section relating to such nutrients, and
(ii) confirm that nutrients contained in any nutrient premix
used in such infant formula are present in each batch of such
infant formula in the proper concentration.
(D) If the Secretary adds a nutrient to the list of nutrients in
the table in subsection (i) of this section, the Secretary shall by
regulation require that the manufacturer of an infant formula test
each batch of such formula for such new nutrient in accordance with
subparagraph (A), (B), or (C).
(E) For purposes of this paragraph, the term "final product
stage" means the point in the manufacturing process, before
distribution of an infant formula, at which an infant formula is
homogenous and is not subject to further degradation.
(4)(A) The Secretary shall by regulation establish requirements
respecting the retention of records. Such requirements shall
provide for -
(i) the retention of all records necessary to demonstrate
compliance with the good manufacturing practices and quality
control procedures prescribed by the Secretary under paragraph
(2), including records containing the results of all testing
required under paragraph (2)(B),
(ii) the retention of all certifications or guarantees of
analysis by premix suppliers,
(iii) the retention by a premix supplier of all records
necessary to confirm the accuracy of all premix certifications
and guarantees of analysis,
(iv) the retention of -
(I) all records pertaining to the microbiological quality and
purity of raw materials used in infant formula powder and in
finished infant formula, and
(II) all records pertaining to food packaging materials which
show that such materials do not cause an infant formula to be
adulterated within the meaning of section 342(a)(2)(C) of this
title,
(v) the retention of all records of the results of regularly
scheduled audits conducted pursuant to the requirements
prescribed by the Secretary under paragraph (2)(B)(iv), and
(vi) the retention of all complaints and the maintenance of
files with respect to, and the review of, complaints concerning
infant formulas which may reveal the possible existence of a
hazard to health.
(B)(i) Records required under subparagraph (A) with respect to an
infant formula shall be retained for at least one year after the
expiration of the shelf life of such infant formula. Except as
provided in clause (ii), such records shall be made available to
the Secretary for review and duplication upon request of the
Secretary.
(ii) A manufacturer need only provide written assurances to the
Secretary that the regularly scheduled audits required by paragraph
(2)(B)(iv) are being conducted by the manufacturer, and need not
make available to the Secretary the actual written reports of such
audits.
(c) Registration of persons distributing new infant formula
(1) No person shall introduce or deliver for introduction into
interstate commerce any new infant formula unless -
(A) such person has, before introducing such new infant
formula, or delivering such new infant formula for introduction,
into interstate commerce, registered with the Secretary the name
of such person, the place of business of such person, and all
establishments at which such person intends to manufacture such
new infant formula, and
(B) such person has at least 90 days before marketing such new
infant formula, made the submission to the Secretary required by
subsection (c)(1) of this section.
(2) For purposes of paragraph (1), the term "new infant formula"
includes -
(A) an infant formula manufactured by a person which has not
previously manufactured an infant formula, and
(B) an infant formula manufactured by a person which has
previously manufactured infant formula and in which there is a
major change, in processing or formulation, from a current or any
previous formulation produced by such manufacturer.
For purposes of this paragraph, the term "major change" has the
meaning given to such term in section 106.30(c)(2) of title 21,
Code of Federal Regulations (as in effect on August 1, 1986), and
guidelines issued thereunder.
(d) Submission of information about new infant formula required
(1) A person shall, with respect to any infant formula subject to
subsection (c) of this section, make a submission to the Secretary
which shall include -
(A) the quantitative formulation of the infant formula,
(B) a description of any reformulation of the formula or change
in processing of the infant formula,
(C) assurances that the infant formula will not be marketed
unless it meets the requirements of subsections (b)(1) and (i) of
this section, as demonstrated by the testing required under
subsection (b)(3) of this section, and
(D) assurances that the processing of the infant formula
complies with subsection (b)(2) of this section.
(2) After the first production of an infant formula subject to
subsection (c) of this section, and before the introduction into
interstate commerce of such formula, the manufacturer of such
formula shall submit to the Secretary, in such form as may be
prescribed by the Secretary, a written verification which
summarizes test results and records demonstrating that such formula
complies with the requirements of subsections (b)(1), (b)(2)(A),
(b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i) of this
section.
(3) If the manufacturer of an infant formula for commercial or
charitable distribution for human consumption determines that a
change in the formulation of the formula or a change in the
processing of the formula may affect whether the formula is
adulterated under subsection (a) of this section, the manufacturer
shall, before the first processing of such formula, make the
submission to the Secretary required by paragraph (1).
(e) Additional notice requirements for manufacturer
(1) If the manufacturer of an infant formula has knowledge which
reasonably supports the conclusion that an infant formula which has
been processed by the manufacturer and which has left an
establishment subject to the control of the manufacturer -
(A) may not provide the nutrients required by subsection (i) of
this section, or
(B) may be otherwise adulterated or misbranded,
the manufacturer shall promptly notify the Secretary of such
knowledge. If the Secretary determines that the infant formula
presents a risk to human health, the manufacturer shall immediately
take all actions necessary to recall shipments of such infant
formula from all wholesale and retail establishments, consistent
with recall regulations and guidelines issued by the Secretary.
(2) For purposes of paragraph (1), the term "knowledge" as
applied to a manufacturer means (A) the actual knowledge that the
manufacturer had, or (B) the knowledge which a reasonable person
would have had under like circumstances or which would have been
obtained upon the exercise of due care.
(f) Procedures applicable to recalls by manufacturer; regulatory
oversight
(1) If a recall of infant formula is begun by a manufacturer, the
recall shall be carried out in accordance with such requirements as
the Secretary shall prescribe under paragraph (2) and -
(A) the Secretary shall, not later than the 15th day after the
beginning of such recall and at least once every 15 days
thereafter until the recall is terminated, review the actions
taken under the recall to determine whether the recall meets the
requirements prescribed under paragraph (2), and
(B) the manufacturer shall, not later than the 14th day after
the beginning of such recall and at least once every 14 days
thereafter until the recall is terminated, report to the
Secretary the actions taken to implement the recall.
(2) The Secretary shall by regulation prescribe the scope and
extent of recalls of infant formulas necessary and appropriate for
the degree of risks to human health presented by the formula
subject to the recall.
(3) The Secretary shall by regulation require each manufacturer
of an infant formula who begins a recall of such formula because of
a risk to human health to request each retail establishment at
which such formula is sold or available for sale to post at the
point of purchase of such formula a notice of such recall at such
establishment for such time that the Secretary determines necessary
to inform the public of such recall.
(g) Recordkeeping requirements for manufacturer; regulatory
oversight and enforcement
(1) Each manufacturer of an infant formula shall make and retain
such records respecting the distribution of the infant formula
through any establishment owned or operated by such manufacturer as
may be necessary to effect and monitor recalls of the formula. Such
records shall be retained for at least one year after the
expiration of the shelf life of the infant formula.
(2) To the extent that the Secretary determines that records are
not being made or maintained in accordance with paragraph (1), the
Secretary may by regulation prescribe the records required to be
made under paragraph (1) and requirements respecting the retention
of such records under such paragraph. Such regulations shall take
effect on such date as the Secretary prescribes but not sooner than
the 180th day after the date such regulations are promulgated. Such
regulations shall apply only with respect to distributions of
infant formulas made after such effective date.
(h) Exemptions; regulatory oversight
(1) Any infant formula which is represented and labeled for use
by an infant -
(A) who has an inborn error of metabolism or a low birth
weight, or
(B) who otherwise has an unusual medical or dietary problem,
is exempt from the requirements of subsections (a), (b), and (c) of
this section. The manufacturer of an infant formula exempt under
this paragraph shall, in the case of the exempt formula, be
required to provide the notice required by subsection (e)(1) of
this section only with respect to adulteration or misbranding
described in subsection (e)(1)(B) of this section and to comply
with the regulations prescribed by the Secretary under paragraph
(2).
(2) The Secretary may by regulation establish terms and
conditions for the exemption of an infant formula from the
requirements of subsections (a), (b), and (c) of this section. An
exemption of an infant formula under paragraph (1) may be withdrawn
by the Secretary if such formula is not in compliance with
applicable terms and conditions prescribed under this paragraph.
(i) Nutrient requirements
(1) An infant formula shall contain nutrients in accordance with
the table set out in this subsection or, if revised by the
Secretary under paragraph (2), as so revised.
(2) The Secretary may by regulation -
(A) revise the list of nutrients in the table in this
subsection, and
(B) revise the required level for any nutrient required by the
table.
NUTRIENTS
--------------------------------------------------------------------
Nutrient Minimum Maximum
a a
--------------------------------------------------------------------
Protein (gm) 1.8 4.5.
b
Fat:
gm 3.3 6.0.
percent cal 30.0 54.0.
Essential fatty acids
(linoeate):
percent cal 2.7
mg 300.0
Vitamins:
A (IU) 250.0 (75 750.0 (225
µg µ
)c ;g).c
D (IU) 40.0 100.0.
K (µg) 4.0
E (IU) 0.7 (with 0.7
IU/gm
linoleic acid)
C (ascorbic acid) (mg) 8.0
B1 (thiamine) 40.0
(µg)
B2 (riboflavin) 60.0
(µg)
B6 (pyridoxine) 35.0 (with 15
(µg) µg/gm
of protein in
formula)
B12 (µg) 0.15
Niacin (µg) 250.0
Folic acid (µg) 4.0
Pantothenic acid (µg) 300.0
Biotin (µg) 1.5
d
Choline (mg) 7.0
d
Inositol (mg) 4.0
d
Minerals:
Calcium (mg) 50.0
e
Phosphorus (mg) 25.0
e
Magnesium (mg) 6.0
Iron (mg) 0.15
Iodine (µg) 5.0
Zinc (mg) 0.5
Copper (µg) 60.0
Manganese (µg) 5.0
Sodium (mg) 20.0 60.0.
Potassium (mg) 80.0 200.0.
Chloride (mg) 55.0 150.0.
a Stated per 100 kilocalories.
b The source of protein shall be at least
nutritionally equivalent to casein.
c Retinol equivalents.
d Required to be included in this amount only in
formulas which are not milk-based.
e Calcium to phosphorus ratio must be no less than 1.1
nor more than 2.0.
--------------------------------------------------------------------
-SOURCE-
(June 25, 1938, ch. 675, Sec. 412, as added Pub. L. 96-359, Sec. 2,
Sept. 26, 1980, 94 Stat. 1190; amended Pub. L. 99-570, title IV,
Sec. 4014(a), (b)(1), Oct. 27, 1986, 100 Stat. 3207-116, 3207-120;
Pub. L. 103-80, Sec. 3(l), Aug. 13, 1993, 107 Stat. 777.)
-MISC1-
AMENDMENTS
1993 - Subsec. (h)(1). Pub. L. 103-80 substituted "(e)(1)(B) of
this section" for "(c)(1)(B) of this section," in concluding
provisions.
1986 - Subsecs. (a) to (d). Pub. L. 99-570, Sec. 4014(a)(7),
added subsecs. (a) to (d) and struck out former subsecs. (a)
relating to adulteration and regulatory oversight, (b) relating to
notice to the Secretary by a manufacturer and requirements and
scope of that notice, (c) relating to additional notice
requirements for the manufacturer, and (d) relating to procedures
applicable to recalls by a manufacturer.
Subsecs. (e), (f). Pub. L. 99-570, Sec. 4014(a)(1), (7), added
subsecs. (e) and (f) and redesignated former subsecs. (e) and (f)
as (g) and (h), respectively.
Subsec. (g). Pub. L. 99-570, Sec. 4014(a)(1), (2), redesignated
subsec. (e) as (g) and substituted "Such records shall be retained
for at least one year after the expiration of the shelf life of the
infant formula" for "No manufacturer shall be required under this
subsection to retain any record respecting the distribution of an
infant formula for a period of longer than 2 years from the date
the record was made". Former subsec. (g) redesignated (i).
Subsec. (h). Pub. L. 99-570, Sec. 4014(a)(1), redesignated
subsec. (f) as (h).
Subsec. (h)(1). Pub. L. 99-570, Sec. 4014(a)(3), (4), substituted
"(a), (b), and (c)" for "(a) and (b)" and "(e)(1)" for "(c)(1)".
Pub. L. 99-570, Sec. 4014(a)(5), which directed that "(d)(1)(B)"
be substituted for "(e)(1)(B)" in second sentence could not be
executed because "(e)(1)(B)" did not appear. See 1993 Amendment
note above.
Subsec. (h)(2). Pub. L. 99-570, Sec. 4014(a)(6), substituted
"(a), (b), and (c)" for "(a) and (b)".
Subsec. (i). Pub. L. 99-570, Sec. 4014(a)(1), (b)(1),
redesignated subsec. (g) as (i), designated existing provisions as
par. (1), substituted "paragraph (2)" for "subsection (a)(2) of
this section", substituted a period for the colon after "as so
revised", and added par. (2).
EFFECTIVE DATE OF 1980 AMENDMENT
Section 6 of Pub. L. 96-359 provided that: "Section 412 of the
Federal Food, Drug, and Cosmetic Act (added by section 2) [this
section] shall apply with respect to infant formulas manufactured
on or after the 90th day after the date of the enactment of this
Act [Sept. 26, 1980]."
-End-
-CITE-
21 USC Sec. 350b 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350b. New dietary ingredients
-STATUTE-
(a) In general
A dietary supplement which contains a new dietary ingredient
shall be deemed adulterated under section 342(f) of this title
unless it meets one of the following requirements:
(1) The dietary supplement contains only dietary ingredients
which have been present in the food supply as an article used for
food in a form in which the food has not been chemically altered.
(2) There is a history of use or other evidence of safety
establishing that the dietary ingredient when used under the
conditions recommended or suggested in the labeling of the
dietary supplement will reasonably be expected to be safe and, at
least 75 days before being introduced or delivered for
introduction into interstate commerce, the manufacturer or
distributor of the dietary ingredient or dietary supplement
provides the Secretary with information, including any citation
to published articles, which is the basis on which the
manufacturer or distributor has concluded that a dietary
supplement containing such dietary ingredient will reasonably be
expected to be safe.
The Secretary shall keep confidential any information provided
under paragraph (2) for 90 days following its receipt. After the
expiration of such 90 days, the Secretary shall place such
information on public display, except matters in the information
which are trade secrets or otherwise confidential, commercial
information.
(b) Petition
Any person may file with the Secretary a petition proposing the
issuance of an order prescribing the conditions under which a new
dietary ingredient under its intended conditions of use will
reasonably be expected to be safe. The Secretary shall make a
decision on such petition within 180 days of the date the petition
is filed with the Secretary. For purposes of chapter 7 of title 5,
the decision of the Secretary shall be considered final agency
action.
(c) Notification
(1) In general
If the Secretary determines that the information in a new
dietary ingredient notification submitted under this section for
an article purported to be a new dietary ingredient is inadequate
to establish that a dietary supplement containing such article
will reasonably be expected to be safe because the article may
be, or may contain, an anabolic steroid or an analogue of an
anabolic steroid, the Secretary shall notify the Drug Enforcement
Administration of such determination. Such notification by the
Secretary shall include, at a minimum, the name of the dietary
supplement or article, the name of the person or persons who
marketed the product or made the submission of information
regarding the article to the Secretary under this section, and
any contact information for such person or persons that the
Secretary has.
(2) Definitions
For purposes of this subsection -
(A) the term "anabolic steroid" has the meaning given such
term in section 802(41) of this title; and
(B) the term "analogue of an anabolic steroid" means a
substance whose chemical structure is substantially similar to
the chemical structure of an anabolic steroid.
(d) "New dietary ingredient" defined
For purposes of this section, the term "new dietary ingredient"
means a dietary ingredient that was not marketed in the United
States before October 15, 1994 and does not include any dietary
ingredient which was marketed in the United States before October
15, 1994.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 413, as added Pub. L. 103-417, Sec.
8, Oct. 25, 1994, 108 Stat. 4331; amended Pub. L. 111-353, title I,
Sec. 113(a), Jan. 4, 2011, 124 Stat. 3920.)
-MISC1-
AMENDMENTS
2011 - Subsecs. (c), (d). Pub. L. 111-353 added subsec. (c) and
redesignated former subsec. (c) as (d).
GUIDANCE
Pub. L. 111-353, title I, Sec. 113(b), Jan. 4, 2011, 124 Stat.
3921, provided that: "Not later than 180 days after the date of
enactment of this Act [Jan. 4, 2011], the Secretary shall publish
guidance that clarifies when a dietary supplement ingredient is a
new dietary ingredient, when the manufacturer or distributor of a
dietary ingredient or dietary supplement should provide the
Secretary with information as described in section 413(a)(2) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350b(a)(2)], the
evidence needed to document the safety of new dietary ingredients,
and appropriate methods for establishing the identify [sic] of a
new dietary ingredient."
CONSTRUCTION OF 2011 AMENDMENT
Nothing in amendment by Pub. L. 111-353 to be construed to apply
to certain alcohol-related facilities, to alter jurisdiction and
authorities established under certain other Acts, or in a manner
inconsistent with international agreements to which the United
States is a party, see sections 2206, 2251, and 2252 of this title.
-End-
-CITE-
21 USC Sec. 350c 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350c. Maintenance and inspection of records
-STATUTE-
(a) Records inspection
(1) Adulterated food
If the Secretary has a reasonable belief that an article of
food, and any other article of food that the Secretary reasonably
believes is likely to be affected in a similar manner, is
adulterated and presents a threat of serious adverse health
consequences or death to humans or animals, each person
(excluding farms and restaurants) who manufactures, processes,
packs, distributes, receives, holds, or imports such article
shall, at the request of an officer or employee duly designated
by the Secretary, permit such officer or employee, upon
presentation of appropriate credentials and a written notice to
such person, at reasonable times and within reasonable limits and
in a reasonable manner, to have access to and copy all records
relating to such article, and to any other article of food that
the Secretary reasonably believes is likely to be affected in a
similar manner, that are needed to assist the Secretary in
determining whether the food is adulterated and presents a threat
of serious adverse health consequences or death to humans or
animals.
(2) Use of or exposure to food of concern
If the Secretary believes that there is a reasonable
probability that the use of or exposure to an article of food,
and any other article of food that the Secretary reasonably
believes is likely to be affected in a similar manner, will cause
serious adverse health consequences or death to humans or
animals, each person (excluding farms and restaurants) who
manufactures, processes, packs, distributes, receives, holds, or
imports such article shall, at the request of an officer or
employee duly designated by the Secretary, permit such officer or
employee, upon presentation of appropriate credentials and a
written notice to such person, at reasonable times and within
reasonable limits and in a reasonable manner, to have access to
and copy all records relating to such article and to any other
article of food that the Secretary reasonably believes is likely
to be affected in a similar manner, that are needed to assist the
Secretary in determining whether there is a reasonable
probability that the use of or exposure to the food will cause
serious adverse health consequences or death to humans or
animals.
(3) Application
The requirement under paragraphs (1) and (2) applies to all
records relating to the manufacture, processing, packing,
distribution, receipt, holding, or importation of such article
maintained by or on behalf of such person in any format
(including paper and electronic formats) and at any location.
(b) Regulations concerning recordkeeping
The Secretary, in consultation and coordination, as appropriate,
with other Federal departments and agencies with responsibilities
for regulating food safety, may by regulation establish
requirements regarding the establishment and maintenance, for not
longer than two years, of records by persons (excluding farms and
restaurants) who manufacture, process, pack, transport, distribute,
receive, hold, or import food, which records are needed by the
Secretary for inspection to allow the Secretary to identify the
immediate previous sources and the immediate subsequent recipients
of food, including its packaging, in order to address credible
threats of serious adverse health consequences or death to humans
or animals. The Secretary shall take into account the size of a
business in promulgating regulations under this section.
(c) Protection of sensitive information
The Secretary shall take appropriate measures to ensure that
there are in effect effective procedures to prevent the
unauthorized disclosure of any trade secret or confidential
information that is obtained by the Secretary pursuant to this
section.
(d) Limitations
This section shall not be construed -
(1) to limit the authority of the Secretary to inspect records
or to require establishment and maintenance of records under any
other provision of this chapter;
(2) to authorize the Secretary to impose any requirements with
respect to a food to the extent that it is within the exclusive
jurisdiction of the Secretary of Agriculture pursuant to the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg
Products Inspection Act (21 U.S.C. 1031 et seq.);
(3) to have any legal effect on section 552 of title 5 or
section 1905 of title 18; or
(4) to extend to recipes for food, financial data, pricing
data, personnel data, research data, or sales data (other than
shipment data regarding sales).
-SOURCE-
(June 25, 1938, ch. 675, Sec. 414, as added Pub. L. 107-188, title
III, Sec. 306(a), June 12, 2002, 116 Stat. 669; amended Pub. L. 111-
353, title I, Sec. 101(a), Jan. 4, 2011, 124 Stat. 3886.)
-REFTEXT-
REFERENCES IN TEXT
The Federal Meat Inspection Act, referred to in subsec. (d)(2),
is titles I to IV of act Mar. 4, 1907, ch. 2907, as added Pub. L.
90-201, Dec. 15, 1967, 81 Stat. 584, which are classified generally
to subchapters I to IV (Sec. 601 et seq.) of chapter 12 of this
title. For complete classification of this Act to the Code, see
Short Title note set out under section 601 of this title and
Tables.
The Poultry Products Inspection Act, referred to in subsec.
(d)(2), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, which is
classified generally to chapter 10 (Sec. 451 et seq.) of this
title. For complete classification of this Act to the Code, see
Short Title note set out under section 451 of this title and
Tables.
The Egg Products Inspection Act, referred to in subsec. (d)(2),
is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, which is
classified principally to chapter 15 (Sec. 1031 et seq.) of this
title. For complete classification of this Act to the Code, see
Short Title note set out under section 1031 of this title and
Tables.
-MISC1-
AMENDMENTS
2011 - Subsec. (a). Pub. L. 111-353 reenacted heading without
change, designated existing provisions as par. (1) and inserted
heading, substituted "If the Secretary has a reasonable belief that
an article of food, and any other article of food that the
Secretary reasonably believes is likely to be affected in a similar
manner, is" for "If the Secretary has a reasonable belief that an
article of food is", inserted ", and to any other article of food
that the Secretary reasonably believes is likely to be affected in
a similar manner," after "relating to such article", struck out at
end "The requirement under the preceding sentence applies to all
records relating to the manufacture, processing, packing,
distribution, receipt, holding, or importation of such article
maintained by or on behalf of such person in any format (including
paper and electronic formats) and at any location.", and added
pars. (2) and (3).
EXPEDITED RULEMAKING
Pub. L. 107-188, title III, Sec. 306(d), June 12, 2002, 116 Stat.
670, provided that: "Not later than 18 months after the date of the
enactment of this Act [June 12, 2002], the Secretary shall
promulgate proposed and final regulations establishing
recordkeeping requirements under subsection 414(b) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 350c(b)] (as added by
subsection (a))."
CONSTRUCTION OF 2011 AMENDMENT
Nothing in amendment by Pub. L. 111-353 to be construed to apply
to certain alcohol-related facilities, to alter jurisdiction and
authorities established under certain other Acts, or in a manner
inconsistent with international agreements to which the United
States is a party, see sections 2206, 2251, and 2252 of this title.
-End-
-CITE-
21 USC Sec. 350d 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350d. Registration of food facilities
-STATUTE-
(a) Registration
(1) In general
The Secretary shall by regulation require that any facility
engaged in manufacturing, processing, packing, or holding food
for consumption in the United States be registered with the
Secretary. To be registered -
(A) for a domestic facility, the owner, operator, or agent in
charge of the facility shall submit a registration to the
Secretary; and
(B) for a foreign facility, the owner, operator, or agent in
charge of the facility shall submit a registration to the
Secretary and shall include with the registration the name of
the United States agent for the facility.
(2) Registration
An entity (referred to in this section as the "registrant")
shall submit a registration under paragraph (1) to the Secretary
containing information necessary to notify the Secretary of the
name and address of each facility at which, and all trade names
under which, the registrant conducts business, the e-mail address
for the contact person of the facility or, in the case of a
foreign facility, the United States agent for the facility, and,
when determined necessary by the Secretary through guidance, the
general food category (as identified under section 170.3 of title
21, Code of Federal Regulations, or any other food categories as
determined appropriate by the Secretary, including by guidance)
of any food manufactured, processed, packed, or held at such
facility. The registration shall contain an assurance that the
Secretary will be permitted to inspect such facility at the times
and in the manner permitted by this chapter. The registrant shall
notify the Secretary in a timely manner of changes to such
information.
(3) Biennial registration renewal
During the period beginning on October 1 and ending on December
31 of each even-numbered year, a registrant that has submitted a
registration under paragraph (1) shall submit to the Secretary a
renewal registration containing the information described in
paragraph (2). The Secretary shall provide for an abbreviated
registration renewal process for any registrant that has not had
any changes to such information since the registrant submitted
the preceding registration or registration renewal for the
facility involved.
(4) Procedure
Upon receipt of a completed registration described in paragraph
(1), the Secretary shall notify the registrant of the receipt of
such registration and assign a registration number to each
registered facility.
(5) List
The Secretary shall compile and maintain an up-to-date list of
facilities that are registered under this section. Such list and
any registration documents submitted pursuant to this subsection
shall not be subject to disclosure under section 552 of title 5.
Information derived from such list or registration documents
shall not be subject to disclosure under section 552 of title 5
to the extent that it discloses the identity or location of a
specific registered person.
(b) Suspension of registration
(1) In general
If the Secretary determines that food manufactured, processed,
packed, received, or held by a facility registered under this
section has a reasonable probability of causing serious adverse
health consequences or death to humans or animals, the Secretary
may by order suspend the registration of a facility -
(A) that created, caused, or was otherwise responsible for
such reasonable probability; or
(B)(i) that knew of, or had reason to know of, such
reasonable probability; and
(ii) packed, received, or held such food.
(2) Hearing on suspension
The Secretary shall provide the registrant subject to an order
under paragraph (1) with an opportunity for an informal hearing,
to be held as soon as possible but not later than 2 business days
after the issuance of the order or such other time period, as
agreed upon by the Secretary and the registrant, on the actions
required for reinstatement of registration and why the
registration that is subject to suspension should be reinstated.
The Secretary shall reinstate a registration if the Secretary
determines, based on evidence presented, that adequate grounds do
not exist to continue the suspension of the registration.
(3) Post-hearing corrective action plan; vacating of order
(A) Corrective action plan
If, after providing opportunity for an informal hearing under
paragraph (2), the Secretary determines that the suspension of
registration remains necessary, the Secretary shall require the
registrant to submit a corrective action plan to demonstrate
how the registrant plans to correct the conditions found by the
Secretary. The Secretary shall review such plan not later than
14 days after the submission of the corrective action plan or
such other time period as determined by the Secretary.
(B) Vacating of order
Upon a determination by the Secretary that adequate grounds
do not exist to continue the suspension actions required by the
order, or that such actions should be modified, the Secretary
shall promptly vacate the order and reinstate the registration
of the facility subject to the order or modify the order, as
appropriate.
(4) Effect of suspension
If the registration of a facility is suspended under this
subsection, no person shall import or export food into the United
States from such facility, offer to import or export food into
the United States from such facility, or otherwise introduce food
from such facility into interstate or intrastate commerce in the
United States.
(5) Regulations
(A) In general
The Secretary shall promulgate regulations to implement this
subsection. The Secretary may promulgate such regulations on an
interim final basis.
(B) Registration requirement
The Secretary may require that registration under this
section be submitted in an electronic format. Such requirement
may not take effect before the date that is 5 years after
January 4, 2011.
(6) Application date
Facilities shall be subject to the requirements of this
subsection beginning on the earlier of -
(A) the date on which the Secretary issues regulations under
paragraph (5); or
(B) 180 days after January 4, 2011.
(7) No delegation
The authority conferred by this subsection to issue an order to
suspend a registration or vacate an order of suspension shall not
be delegated to any officer or employee other than the
Commissioner.
(c) Facility
For purposes of this section:
(1) The term "facility" includes any factory, warehouse, or
establishment (including a factory, warehouse, or establishment
of an importer) that manufactures, processes, packs, or holds
food. Such term does not include farms; restaurants; other retail
food establishments; nonprofit food establishments in which food
is prepared for or served directly to the consumer; or fishing
vessels (except such vessels engaged in processing as defined in
section 123.3(k) of title 21, Code of Federal Regulations).
(2) The term "domestic facility" means a facility located in
any of the States or Territories.
(3)(A) The term "foreign facility" means a facility that
manufacturers, processes, packs, or holds food, but only if food
from such facility is exported to the United States without
further processing or packaging outside the United States.
(B) A food may not be considered to have undergone further
processing or packaging for purposes of subparagraph (A) solely
on the basis that labeling was added or that any similar activity
of a de minimis nature was carried out with respect to the food.
(d) Rule of construction
Nothing in this section shall be construed to authorize the
Secretary to require an application, review, or licensing process
for a facility to be registered, except with respect to the
reinstatement of a registration that is suspended under subsection
(b).
-SOURCE-
(June 25, 1938, ch. 675, Sec. 415, as added Pub. L. 107-188, title
III, Sec. 305(a), June 12, 2002, 116 Stat. 667; amended Pub. L. 111-
353, title I, Sec. 102(a)-(b)(1), (d)(2), Jan. 4, 2011, 124 Stat.
3887, 3889.)
-MISC1-
AMENDMENTS
2011 - Subsec. (a)(2). Pub. L. 111-353, Sec. 102(a)(1),
(b)(1)(A), substituted "conducts business, the e-mail address for
the contact person of the facility or, in the case of a foreign
facility, the United States agent for the facility, and" for
"conducts business and", inserted ", or any other food categories
as determined appropriate by the Secretary, including by guidance"
after "Code of Federal Regulations", and inserted after first
sentence "The registration shall contain an assurance that the
Secretary will be permitted to inspect such facility at the times
and in the manner permitted by this chapter."
Subsec. (a)(3) to (5). Pub. L. 111-353, Sec. 102(a)(2), (3),
added par. (3) and redesignated former pars. (3) and (4) as (4) and
(5), respectively.
Subsecs. (b), (c). Pub. L. 111-353, Sec. 102(b)(1)(B), (C), added
subsec. (b) and redesignated former subsec. (b) as (c). Former
subsec. (c) redesignated (d).
Subsec. (d). Pub. L. 111-353, Sec. 102(b)(1)(B), (d)(2),
redesignated subsec. (c) as (d) and inserted "for a facility to be
registered, except with respect to the reinstatement of a
registration that is suspended under subsection (b)" before period
at end.
REGULATIONS
Pub. L. 111-353, title I, Sec. 102(c), Jan. 4, 2011, 124 Stat.
3889, provided that:
"(1) Retail food establishment. - The Secretary shall amend the
definition of the term 'retail food establishment' in section in
[sic] 1.227(b)(11) of title 21, Code of Federal Regulations[,] to
clarify that, in determining the primary function of an
establishment or a retail food establishment under such section,
the sale of food products directly to consumers by such
establishment and the sale of food directly to consumers by such
retail food establishment include -
"(A) the sale of such food products or food directly to
consumers by such establishment at a roadside stand or farmers'
market where such stand or market is located other than where the
food was manufactured or processed;
"(B) the sale and distribution of such food through a community
supported agriculture program; and
"(C) the sale and distribution of such food at any other such
direct sales platform as determined by the Secretary.
"(2) Definitions. - For purposes of paragraph (1) -
"(A) the term 'community supported agriculture program' has the
same meaning given the term 'community supported agriculture
(CSA) program' in section 249.2 of title 7, Code of Federal
Regulations (or any successor regulation); and
"(B) the term 'consumer' does not include a business."
Pub. L. 111-353, title I, Sec. 103(c), Jan. 4, 2011, 124 Stat.
3896, provided that:
"(1) Proposed rulemaking. -
"(A) In general. - Not later than 9 months after the date of
enactment of this Act [Jan. 4, 2011], the Secretary of Health and
Human Services (referred to in this subsection as the
'Secretary') shall publish a notice of proposed rulemaking in the
Federal Register to promulgate regulations with respect to -
"(i) activities that constitute on-farm packing or holding of
food that is not grown, raised, or consumed on such farm or
another farm under the same ownership for purposes of section
415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350d), as amended by this Act; and
"(ii) activities that constitute on-farm manufacturing or
processing of food that is not consumed on that farm or on
another farm under common ownership for purposes of such
section 415.
"(B) Clarification. - The rulemaking described under
subparagraph (A) shall enhance the implementation of such section
415 and clarify the activities that are included as part of the
definition of the term 'facility' under such section 415. Nothing
in this Act [see Short Title note set out under section 2201 of
this title] authorizes the Secretary to modify the definition of
the term 'facility' under such section.
"(C) Science-based risk analysis. - In promulgating regulations
under subparagraph (A), the Secretary shall conduct a science-
based risk analysis of -
"(i) specific types of on-farm packing or holding of food
that is not grown, raised, or consumed on such farm or another
farm under the same ownership, as such packing and holding
relates to specific foods; and
"(ii) specific on-farm manufacturing and processing
activities as such activities relate to specific foods that are
not consumed on that farm or on another farm under common
ownership.
"(D) Authority with respect to certain facilities. -
"(i) In general. - In promulgating the regulations under
subparagraph (A), the Secretary shall consider the results of
the science-based risk analysis conducted under subparagraph
(C), and shall exempt certain facilities from the requirements
in section 418 of the Federal Food, Drug, and Cosmetic Act [21
U.S.C. 350g] (as added by this section), including hazard
analysis and preventive controls, and the mandatory inspection
frequency in section 421 of such Act [21 U.S.C. 350j] (as added
by section 201), or modify the requirements in such sections
418 or 421, as the Secretary determines appropriate, if such
facilities are engaged only in specific types of on-farm
manufacturing, processing, packing, or holding activities that
the Secretary determines to be low risk involving specific
foods the Secretary determines to be low risk.
"(ii) Limitation. - The exemptions or modifications under
clause (i) shall not include an exemption from the requirement
to register under section 415 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 350d), as amended by this Act, if
applicable, and shall apply only to small businesses and very
small businesses, as defined in the regulation promulgated
under section 418(n) of the Federal Food, Drug, and Cosmetic
Act (as added under subsection (a)).
"(2) Final regulations. - Not later than 9 months after the close
of the comment period for the proposed rulemaking under paragraph
(1), the Secretary shall adopt final rules with respect to -
"(A) activities that constitute on-farm packing or holding of
food that is not grown, raised, or consumed on such farm or
another farm under the same ownership for purposes of section 415
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as
amended by this Act;
"(B) activities that constitute on-farm manufacturing or
processing of food that is not consumed on that farm or on
another farm under common ownership for purposes of such section
415; and
"(C) the requirements under sections 418 and 421 of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 350g, 350j], as added by
this Act, from which the Secretary may issue exemptions or
modifications of the requirements for certain types of
facilities."
Pub. L. 107-188, title III, Sec. 305(e), June 12, 2002, 116 Stat.
669, provided that: "Not later than 18 months after the date of the
enactment of this Act [June 12, 2002], the Secretary of Health and
Human Services shall promulgate proposed and final regulations for
the requirement of registration under section 415 of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 350d] (as added by
subsection (a) of this section). Such requirement of registration
takes effect -
"(1) upon the effective date of such final regulations; or
"(2) upon the expiration of such 18-month period if the final
regulations have not been made effective as of the expiration of
such period, subject to compliance with the final regulations
when the final regulations are made effective."
CONSTRUCTION OF 2011 AMENDMENT
Nothing in amendments by Pub. L. 111-353 to be construed to alter
jurisdiction and authorities established under certain other Acts
or in a manner inconsistent with international agreements to which
the United States is a party, see sections 2251 and 2252 of this
title.
SMALL ENTITY COMPLIANCE POLICY GUIDE
Pub. L. 111-353, title I, Sec. 102(b)(2), Jan. 4, 2011, 124 Stat.
3888, provided that: "Not later than 180 days after the issuance of
the regulations promulgated under section 415(b)(5) of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 350d(b)(5)] (as added by
this section), the Secretary shall issue a small entity compliance
policy guide setting forth in plain language the requirements of
such regulations to assist small entities in complying with
registration requirements and other activities required under such
section."
ELECTRONIC FILING
Pub. L. 107-188, title III, Sec. 305(d), June 12, 2002, 116 Stat.
668, provided that: "For the purpose of reducing paperwork and
reporting burdens, the Secretary of Health and Human Services may
provide for, and encourage the use of, electronic methods of
submitting to the Secretary registrations required pursuant to this
section [enacting this section, amending sections 331 and 381 of
this title, and enacting provisions set out as a note under this
section]. In providing for the electronic submission of such
registrations, the Secretary shall ensure adequate authentication
protocols are used to enable identification of the registrant and
validation of the data as appropriate."
-End-
-CITE-
21 USC Sec. 350e 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350e. Sanitary transportation practices
-STATUTE-
(a) Definitions
In this section:
(1) Bulk vehicle
The term "bulk vehicle" includes a tank truck, hopper truck,
rail tank car, hopper car, cargo tank, portable tank, freight
container, or hopper bin, and any other vehicle in which food is
shipped in bulk, with the food coming into direct contact with
the vehicle.
(2) Transportation
The term "transportation" means any movement in commerce by
motor vehicle or rail vehicle.
(b) Regulations
The Secretary shall by regulation require shippers, carriers by
motor vehicle or rail vehicle, receivers, and other persons engaged
in the transportation of food to use sanitary transportation
practices prescribed by the Secretary to ensure that food is not
transported under conditions that may render the food adulterated.
(c) Contents
The regulations under subsection (b) of this section shall -
(1) prescribe such practices as the Secretary determines to be
appropriate relating to -
(A) sanitation;
(B) packaging, isolation, and other protective measures;
(C) limitations on the use of vehicles;
(D) information to be disclosed -
(i) to a carrier by a person arranging for the transport of
food; and
(ii) to a manufacturer or other person that -
(I) arranges for the transportation of food by a carrier;
or
(II) furnishes a tank vehicle or bulk vehicle for the
transportation of food; and
(E) recordkeeping; and
(2) include -
(A) a list of nonfood products that the Secretary determines
may, if shipped in a bulk vehicle, render adulterated food that
is subsequently transported in the same vehicle; and
(B) a list of nonfood products that the Secretary determines
may, if shipped in a motor vehicle or rail vehicle (other than
a tank vehicle or bulk vehicle), render adulterated food that
is simultaneously or subsequently transported in the same
vehicle.
(d) Waivers
(1) In general
The Secretary may waive any requirement under this section,
with respect to any class of persons, vehicles, food, or nonfood
products, if the Secretary determines that the waiver -
(A) will not result in the transportation of food under
conditions that would be unsafe for human or animal health; and
(B) will not be contrary to the public interest.
(2) Publication
The Secretary shall publish in the Federal Register any waiver
and the reasons for the waiver.
(e) Preemption
(1) In general
A requirement of a State or political subdivision of a State
that concerns the transportation of food is preempted if -
(A) complying with a requirement of the State or political
subdivision and a requirement of this section, or a regulation
prescribed under this section, is not possible; or
(B) the requirement of the State or political subdivision as
applied or enforced is an obstacle to accomplishing and
carrying out this section or a regulation prescribed under this
section.
(2) Applicability
This subsection applies to transportation that occurs on or
after the effective date of the regulations promulgated under
subsection (b) of this section.
(f) Assistance of other agencies
The Secretary of Transportation, the Secretary of Agriculture,
the Administrator of the Environmental Protection Agency, and the
heads of other Federal agencies, as appropriate, shall provide
assistance on request, to the extent resources are available, to
the Secretary for the purposes of carrying out this section.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 416, as added Pub. L. 109-59, title
VII, Sec. 7202(b), Aug. 10, 2005, 119 Stat. 1911.)
-MISC1-
EFFECTIVE DATE
Section effective Oct. 1, 2005, see section 7204 of Pub. L. 109-
59, set out as an Effective Date of 2005 Amendment note under
section 331 of this title.
REGULATIONS
Pub. L. 111-353, title I, Sec. 111(a), Jan. 4, 2011, 124 Stat.
3916, provided that: "Not later than 18 months after the date of
enactment of this Act [Jan. 4, 2011], the Secretary shall
promulgate regulations described in section 416(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b))."
-End-
-CITE-
21 USC Sec. 350f 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350f. Reportable food registry
-STATUTE-
(a) Definitions
In this section:
(1) Responsible party
The term "responsible party", with respect to an article of
food, means a person that submits the registration under section
350d(a) of this title for a food facility that is required to
register under section 350d(a) of this title, at which such
article of food is manufactured, processed, packed, or held.
(2) Reportable food
The term "reportable food" means an article of food (other than
infant formula) for which there is a reasonable probability that
the use of, or exposure to, such article of food will cause
serious adverse health consequences or death to humans or
animals.
(b) Establishment
(1) In general
Not later than 1 year after September 27, 2007, the Secretary
shall establish within the Food and Drug Administration a
Reportable Food Registry to which instances of reportable food
may be submitted by the Food and Drug Administration after
receipt of reports under subsection (d), via an electronic
portal, from -
(A) Federal, State, and local public health officials; or
(B) responsible parties.
(2) Review by Secretary
The Secretary shall promptly review and assess the information
submitted under paragraph (1) for the purposes of identifying
reportable food, submitting entries to the Reportable Food
Registry, acting under subsection (c), and exercising other
existing food safety authorities under this chapter to protect
the public health.
(c) Issuance of an alert by the Secretary
(1) In general
The Secretary shall issue, or cause to be issued, an alert or a
notification with respect to a reportable food using information
from the Reportable Food Registry as the Secretary deems
necessary to protect the public health.
(2) Effect
Paragraph (1) shall not affect the authority of the Secretary
to issue an alert or a notification under any other provision of
this chapter.
(d) Reporting and notification
(1) In general
Except as provided in paragraph (2), as soon as practicable,
but in no case later than 24 hours after a responsible party
determines that an article of food is a reportable food, the
responsible party shall -
(A) submit a report to the Food and Drug Administration
through the electronic portal established under subsection (b)
that includes the data elements described in subsection (e)
(except the elements described in paragraphs (8), (9), and (10)
of such subsection); and
(B) investigate the cause of the adulteration if the
adulteration of the article of food may have originated with
the responsible party.
(2) No report required
A responsible party is not required to submit a report under
paragraph (1) if -
(A) the adulteration originated with the responsible party;
(B) the responsible party detected the adulteration prior to
any transfer to another person of such article of food; and
(C) the responsible party -
(i) corrected such adulteration; or
(ii) destroyed or caused the destruction of such article of
food.
(3) Reports by public health officials
A Federal, State, or local public health official may submit a
report about a reportable food to the Food and Drug
Administration through the electronic portal established under
subsection (b) that includes the data elements described in
subsection (e) that the official is able to provide.
(4) Report number
The Secretary shall ensure that, upon submission of a report
under paragraph (1) or (3), a unique number is issued through the
electronic portal established under subsection (b) to the person
submitting such report, by which the Secretary is able to link
reports about the reportable food submitted and amended under
this subsection and identify the supply chain for such reportable
food.
(5) Review
The Secretary shall promptly review a report submitted under
paragraph (1) or (3).
(6) Response to report submitted by a responsible party
After consultation with the responsible party that submitted a
report under paragraph (1), the Secretary may require such
responsible party to perform, as soon as practicable, but in no
case later than a time specified by the Secretary, 1 or more of
the following:
(A) Amend the report submitted by the responsible party under
paragraph (1) to include the data element described in
subsection (e)(9).
(B) Provide a notification -
(i) to the immediate previous source of the article of
food, if the Secretary deems necessary;
(ii) to the immediate subsequent recipient of the article
of food, if the Secretary deems necessary; and
(iii) that includes -
(I) the data elements described in subsection (e) that
the Secretary deems necessary;
(II) the actions described under paragraph (7) that the
recipient of the notification shall perform, as required by
the Secretary; and
(III) any other information that the Secretary may
require.
(7) Subsequent reports and notifications
Except as provided in paragraph (8), the Secretary may require
a responsible party to perform, as soon as practicable, but in no
case later than a time specified by the Secretary, after the
responsible party receives a notification under subparagraph (C)
or paragraph (6)(B), 1 or more of the following:
(A) Submit a report to the Food and Drug Administration
through the electronic portal established under subsection (b)
that includes those data elements described in subsection (e)
and other information that the Secretary deems necessary.
(B) Investigate the cause of the adulteration if the
adulteration of the article of food may have originated with
the responsible party.
(C) Provide a notification -
(i) to the immediate previous source of the article of
food, if the Secretary deems necessary;
(ii) to the immediate subsequent recipient of the article
of food, if the Secretary deems necessary; and
(iii) that includes -
(I) the data elements described in subsection (e) that
the Secretary deems necessary;
(II) the actions described under this paragraph that the
recipient of the notification shall perform, as required by
the Secretary; and
(III) any other information that the Secretary may
require.
(8) Amended report
If a responsible party receives a notification under paragraph
(6)(B) or paragraph (7)(C) with respect to an article of food
after the responsible party has submitted a report to the Food
and Drug Administration under paragraph (1) with respect to such
article of food -
(A) the responsible party is not required to submit an
additional report or make a notification under paragraph (7);
and
(B) the responsible party shall amend the report submitted by
the responsible party under paragraph (1) to include the data
elements described in paragraph (9), and, with respect to both
such notification and such report, paragraph (11) of subsection
(e).
(e) Data elements
The data elements described in this subsection are the following:
(1) The registration numbers of the responsible party under
section 350d(a)(3) (!1) of this title.
(2) The date on which an article of food was determined to be a
reportable food.
(3) A description of the article of food including the quantity
or amount.
(4) The extent and nature of the adulteration.
(5) If the adulteration of the article of food may have
originated with the responsible party, the results of the
investigation required under paragraph (1)(B) or (7)(B) of
subsection (d), as applicable and when known.
(6) The disposition of the article of food, when known.
(7) Product information typically found on packaging including
product codes, use-by dates, and names of manufacturers, packers,
or distributors sufficient to identify the article of food.
(8) Contact information for the responsible party.
(9) The contact information for parties directly linked in the
supply chain and notified under paragraph (6)(B) or (7)(C) of
subsection (d), as applicable.
(10) The information required by the Secretary to be included
in a notification provided by the responsible party involved
under paragraph (6)(B) or (7)(C) of subsection (d) or required in
a report under subsection (d)(7)(A).
(11) The unique number described in subsection (d)(4).
(f) Critical information
Except with respect to fruits and vegetables that are raw
agricultural commodities, not more than 18 months after January 4,
2011, the Secretary may require a responsible party to submit to
the Secretary consumer-oriented information regarding a reportable
food, which shall include -
(1) a description of the article of food as provided in
subsection (e)(3);
(2) as provided in subsection (e)(7), affected product
identification codes, such as UPC, SKU, or lot or batch numbers
sufficient for the consumer to identify the article of food;
(3) contact information for the responsible party as provided
in subsection (e)(8); and
(4) any other information the Secretary determines is necessary
to enable a consumer to accurately identify whether such consumer
is in possession of the reportable food.
(g) Grocery store notification
(1) Action by Secretary
The Secretary shall -
(A) prepare the critical information described under
subsection (f) for a reportable food as a standardized one-page
summary;
(B) publish such one-page summary on the Internet website of
the Food and Drug Administration in a format that can be easily
printed by a grocery store for purposes of consumer
notification.
(2) Action by grocery store
A notification described under paragraph (1)(B) shall include
the date and time such summary was posted on the Internet website
of the Food and Drug Administration.
(h) Consumer notification
(1) In general
If a grocery store sold a reportable food that is the subject
of the posting and such establishment is part of (!2) chain of
establishments with 15 or more physical locations, then such
establishment shall, not later than 24 hours after a one page
summary described in subsection (g) is published, prominently
display such summary or the information from such summary via at
least one of the methods identified under paragraph (2) and
maintain the display for 14 days.
(2) List of conspicuous locations
Not more than 1 year after January 4, 2011, the Secretary shall
develop and publish a list of acceptable conspicuous locations
and manners, from which grocery stores shall select at least one,
for providing the notification required in paragraph (1). Such
list shall include -
(A) posting the notification at or near the register;
(B) providing the location of the reportable food;
(C) providing targeted recall information given to customers
upon purchase of a food; and
(D) other such prominent and conspicuous locations and
manners utilized by grocery stores as of January 4, 2011, to
provide notice of such recalls to consumers as considered
appropriate by the Secretary.
(i) Coordination of Federal, State, and local efforts
(1) Department of Agriculture
In implementing this section, the Secretary shall -
(A) share information and coordinate regulatory efforts with
the Department of Agriculture; and
(B) if the Secretary receives a report submitted about a food
within the jurisdiction of the Department of Agriculture,
promptly provide such report to the Department of Agriculture.
(2) States and localities
In implementing this section, the Secretary shall work with the
State and local public health officials to share information and
coordinate regulatory efforts, in order to -
(A) help to ensure coverage of the safety of the food supply
chain, including those food establishments regulated by the
States and localities that are not required to register under
section 350d of this title; and
(B) reduce duplicative regulatory efforts.
(j) Maintenance and inspection of records
The responsible party shall maintain records related to each
report received, notification made, and report submitted to the
Food and Drug Administration under this section for 2 years. A
responsible party shall, at the request of the Secretary, permit
inspection of such records as provided for section (!3) 350c of
this title.
(k) Request for information
Except as provided by section 350d(a)(4) (!1) of this title,
section 552 of title 5 shall apply to any request for information
regarding a record in the Reportable Food Registry.
(l) Safety report
A report or notification under subsection (d) shall be considered
to be a safety report under section 379v of this title and may be
accompanied by a statement, which shall be part of any report
released for public disclosure, that denies that the report or the
notification constitutes an admission that the product involved
caused or contributed to a death, serious injury, or serious
illness.
(m) Admission
A report or notification under this section shall not be
considered an admission that the article of food involved is
adulterated or caused or contributed to a death, serious injury, or
serious illness.
(n) Homeland Security notification
If, after receiving a report under subsection (d), the Secretary
believes such food may have been deliberately adulterated, the
Secretary shall immediately notify the Secretary of Homeland
Security. The Secretary shall make relevant information from the
Reportable Food Registry available to the Secretary of Homeland
Security.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 417, as added Pub. L. 110-85, title
X, Sec. 1005(b), Sept. 27, 2007, 121 Stat. 965; amended Pub. L. 111-
353, title II, Sec. 211(a), Jan. 4, 2011, 124 Stat. 3951.)
-REFTEXT-
REFERENCES IN TEXT
Section 350d(a)(3), (4) of this title, referred to in subsecs.
(e)(1) and (k), was redesignated section 350d(a)(4), (5),
respectively, of this title by Pub. L. 111-353, title I, Sec.
102(a)(2), Jan. 4, 2011, 124 Stat. 3887.
-MISC1-
AMENDMENTS
2011 - Subsecs. (f) to (n). Pub. L. 111-353 added subsecs. (f) to
(h) and redesignated former subsecs. (f) to (k) as (i) to (n),
respectively.
EFFECTIVE DATE
Pub. L. 110-85, title X, Sec. 1005(e), Sept. 27, 2007, 121 Stat.
969, provided that: "The requirements of section 417(d) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f(d)], as added
by subsection (a) [probably should be (b)], shall become effective
1 year after the date of the enactment of this Act [Sept. 27,
2007]."
CONSTRUCTION OF 2011 AMENDMENT
Nothing in amendment by Pub. L. 111-353 to be construed to apply
to certain alcohol-related facilities, to alter jurisdiction and
authorities established under certain other Acts, or in a manner
inconsistent with international agreements to which the United
States is a party, see sections 2206, 2251, and 2252 of this title.
FINDINGS
Pub. L. 110-85, title X, Sec. 1005(a), Sept. 27, 2007, 121 Stat.
964, provided that: "Congress makes the following findings:
"(1) In 1994, Congress passed the Dietary Supplement Health and
Education Act of 1994 (Public Law 103-417) [see Short Title of
1994 Amendments note set out under section 301 of this title] to
provide the Food and Drug Administration the legal framework
which is intended to ensure that dietary supplements are safe and
properly labeled foods.
"(2) In 2006, Congress passed the Dietary Supplement and
Nonprescription Drug Consumer Protection Act (Public Law 109-462)
[see Short Title of 2006 Amendment note set out under section 301
of this title] to establish a mandatory reporting system of
serious adverse events for nonprescription drugs and dietary
supplements sold and consumed in the United States.
"(3) The adverse event reporting system created under the
Dietary Supplement and Nonprescription Drug Consumer Protection
Act is intended to serve as an early warning system for potential
public health issues associated with the use of these products.
"(4) A reliable mechanism to track patterns of adulteration in
food would support efforts by the Food and Drug Administration to
target limited inspection resources to protect the public
health."
GUIDANCE
Pub. L. 110-85, title X, Sec. 1005(f), Sept. 27, 2007, 121 Stat.
969, provided that: "Not later than 9 months after the date of the
enactment of this Act [Sept. 27, 2007], the Secretary [of Health
and Human Services] shall issue a guidance to industry about
submitting reports to the electronic portal established under
section 417 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
350f] (as added by this section) and providing notifications to
other persons in the supply chain of an article of food under such
section 417."
-FOOTNOTE-
(!1) See References in Text note below.
(!2) So in original. Probably should be followed by "a".
(!3) So in original. Probably should be "in section".
-End-
-CITE-
21 USC Sec. 350g 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350g. Hazard analysis and risk-based preventive controls
-STATUTE-
(a) In general
The owner, operator, or agent in charge of a facility shall, in
accordance with this section, evaluate the hazards that could
affect food manufactured, processed, packed, or held by such
facility, identify and implement preventive controls to
significantly minimize or prevent the occurrence of such hazards
and provide assurances that such food is not adulterated under
section 342 of this title or misbranded under section 343(w) of
this title, monitor the performance of those controls, and maintain
records of this monitoring as a matter of routine practice.
(b) Hazard analysis
The owner, operator, or agent in charge of a facility shall -
(1) identify and evaluate known or reasonably foreseeable
hazards that may be associated with the facility, including -
(A) biological, chemical, physical, and radiological hazards,
natural toxins, pesticides, drug residues, decomposition,
parasites, allergens, and unapproved food and color additives;
and
(B) hazards that occur naturally, or may be unintentionally
introduced; and
(2) identify and evaluate hazards that may be intentionally
introduced, including by acts of terrorism; and
(3) develop a written analysis of the hazards.
(c) Preventive controls
The owner, operator, or agent in charge of a facility shall
identify and implement preventive controls, including at critical
control points, if any, to provide assurances that -
(1) hazards identified in the hazard analysis conducted under
subsection (b)(1) will be significantly minimized or prevented;
(2) any hazards identified in the hazard analysis conducted
under subsection (b)(2) will be significantly minimized or
prevented and addressed, consistent with section 350i of this
title, as applicable; and
(3) the food manufactured, processed, packed, or held by such
facility will not be adulterated under section 342 of this title
or misbranded under section 343(w) of this title.
(d) Monitoring of effectiveness
The owner, operator, or agent in charge of a facility shall
monitor the effectiveness of the preventive controls implemented
under subsection (c) to provide assurances that the outcomes
described in subsection (c) shall be achieved.
(e) Corrective actions
The owner, operator, or agent in charge of a facility shall
establish procedures to ensure that, if the preventive controls
implemented under subsection (c) are not properly implemented or
are found to be ineffective -
(1) appropriate action is taken to reduce the likelihood of
recurrence of the implementation failure;
(2) all affected food is evaluated for safety; and
(3) all affected food is prevented from entering into commerce
if the owner, operator or agent in charge of such facility cannot
ensure that the affected food is not adulterated under section
342 of this title or misbranded under section 343(w) of this
title.
(f) Verification
The owner, operator, or agent in charge of a facility shall
verify that -
(1) the preventive controls implemented under subsection (c)
are adequate to control the hazards identified under subsection
(b);
(2) the owner, operator, or agent is conducting monitoring in
accordance with subsection (d);
(3) the owner, operator, or agent is making appropriate
decisions about corrective actions taken under subsection (e);
(4) the preventive controls implemented under subsection (c)
are effectively and significantly minimizing or preventing the
occurrence of identified hazards, including through the use of
environmental and product testing programs and other appropriate
means; and
(5) there is documented, periodic reanalysis of the plan under
subsection (i) to ensure that the plan is still relevant to the
raw materials, conditions and processes in the facility, and new
and emerging threats.
(g) Recordkeeping
The owner, operator, or agent in charge of a facility shall
maintain, for not less than 2 years, records documenting the
monitoring of the preventive controls implemented under subsection
(c), instances of nonconformance material to food safety, the
results of testing and other appropriate means of verification
under subsection (f)(4), instances when corrective actions were
implemented, and the efficacy of preventive controls and corrective
actions.
(h) Written plan and documentation
The owner, operator, or agent in charge of a facility shall
prepare a written plan that documents and describes the procedures
used by the facility to comply with the requirements of this
section, including analyzing the hazards under subsection (b) and
identifying the preventive controls adopted under subsection (c) to
address those hazards. Such written plan, together with the
documentation described in subsection (g), shall be made promptly
available to a duly authorized representative of the Secretary upon
oral or written request.
(i) Requirement to reanalyze
The owner, operator, or agent in charge of a facility shall
conduct a reanalysis under subsection (b) whenever a significant
change is made in the activities conducted at a facility operated
by such owner, operator, or agent if the change creates a
reasonable potential for a new hazard or a significant increase in
a previously identified hazard or not less frequently than once
every 3 years, whichever is earlier. Such reanalysis shall be
completed and additional preventive controls needed to address the
hazard identified, if any, shall be implemented before the change
in activities at the facility is operative. Such owner, operator,
or agent shall revise the written plan required under subsection
(h) if such a significant change is made or document the basis for
the conclusion that no additional or revised preventive controls
are needed. The Secretary may require a reanalysis under this
section to respond to new hazards and developments in scientific
understanding, including, as appropriate, results from the
Department of Homeland Security biological, chemical, radiological,
or other terrorism risk assessment.
(j) Exemption for seafood, juice, and low-acid canned food
facilities subject to HACCP
(1) In general
This section shall not apply to a facility if the owner,
operator, or agent in charge of such facility is required to
comply with, and is in compliance with, 1 of the following
standards and regulations with respect to such facility:
(A) The Seafood Hazard Analysis Critical Control Points
Program of the Food and Drug Administration.
(B) The Juice Hazard Analysis Critical Control Points Program
of the Food and Drug Administration.
(C) The Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers standards of the Food and Drug
Administration (or any successor standards).
(2) Applicability
The exemption under paragraph (1)(C) shall apply only with
respect to microbiological hazards that are regulated under the
standards for Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers under part 113 of chapter (!1) 21,
Code of Federal Regulations (or any successor regulations).
(k) Exception for activities of facilities subject to section 350h
of this title
This section shall not apply to activities of a facility that are
subject to section 350h of this title.
(l) Modified requirements for qualified facilities
(1) Qualified facilities
(A) In general
A facility is a qualified facility for purposes of this
subsection if the facility meets the conditions under
subparagraph (B) or (C).
(B) Very small business
A facility is a qualified facility under this subparagraph -
(i) if the facility, including any subsidiary or affiliate
of the facility, is, collectively, a very small business (as
defined in the regulations promulgated under subsection (n));
and
(ii) in the case where the facility is a subsidiary or
affiliate of an entity, if such subsidiaries or affiliates,
are, collectively, a very small business (as so defined).
(C) Limited annual monetary value of sales
(i) In general
A facility is a qualified facility under this subparagraph
if clause (ii) applies -
(I) to the facility, including any subsidiary or
affiliate of the facility, collectively; and
(II) to the subsidiaries or affiliates, collectively, of
any entity of which the facility is a subsidiary or
affiliate.
(ii) Average annual monetary value
This clause applies if -
(I) during the 3-year period preceding the applicable
calendar year, the average annual monetary value of the
food manufactured, processed, packed, or held at such
facility (or the collective average annual monetary value
of such food at any subsidiary or affiliate, as described
in clause (i)) that is sold directly to qualified end-users
during such period exceeded the average annual monetary
value of the food manufactured, processed, packed, or held
at such facility (or the collective average annual monetary
value of such food at any subsidiary or affiliate, as so
described) sold by such facility (or collectively by any
such subsidiary or affiliate) to all other purchasers
during such period; and
(II) the average annual monetary value of all food sold
by such facility (or the collective average annual monetary
value of such food sold by any subsidiary or affiliate, as
described in clause (i)) during such period was less than
$500,000, adjusted for inflation.
(2) Exemption
A qualified facility -
(A) shall not be subject to the requirements under
subsections (a) through (i) and subsection (n) in an applicable
calendar year; and
(B) shall submit to the Secretary -
(i)(I) documentation that demonstrates that the owner,
operator, or agent in charge of the facility has identified
potential hazards associated with the food being produced, is
implementing preventive controls to address the hazards, and
is monitoring the preventive controls to ensure that such
controls are effective; or
(II) documentation (which may include licenses, inspection
reports, certificates, permits, credentials, certification by
an appropriate agency (such as a State department of
agriculture), or other evidence of oversight), as specified
by the Secretary, that the facility is in compliance with
State, local, county, or other applicable non-Federal food
safety law; and
(ii) documentation, as specified by the Secretary in a
guidance document issued not later than 1 year after January
4, 2011, that the facility is a qualified facility under
paragraph (1)(B) or (1)(C).
(3) Withdrawal; rule of construction
(A) In general
In the event of an active investigation of a foodborne
illness outbreak that is directly linked to a qualified
facility subject to an exemption under this subsection, or if
the Secretary determines that it is necessary to protect the
public health and prevent or mitigate a foodborne illness
outbreak based on conduct or conditions associated with a
qualified facility that are material to the safety of the food
manufactured, processed, packed, or held at such facility, the
Secretary may withdraw the exemption provided to such facility
under this subsection.
(B) Rule of construction
Nothing in this subsection shall be construed to expand or
limit the inspection authority of the Secretary.
(4) Definitions
In this subsection:
(A) Affiliate
The term "affiliate" means any facility that controls, is
controlled by, or is under common control with another
facility.
(B) Qualified end-user
The term "qualified end-user", with respect to a food, means -
(i) the consumer of the food; or
(ii) a restaurant or retail food establishment (as those
terms are defined by the Secretary for purposes of section
350d of this title) that -
(I) is located -
(aa) in the same State as the qualified facility that
sold the food to such restaurant or establishment; or
(bb) not more than 275 miles from such facility; and
(II) is purchasing the food for sale directly to
consumers at such restaurant or retail food establishment.
(C) Consumer
For purposes of subparagraph (B), the term "consumer" does
not include a business.
(D) Subsidiary
The term "subsidiary" means any company which is owned or
controlled directly or indirectly by another company.
(5) Study
(A) In general
The Secretary, in consultation with the Secretary of
Agriculture, shall conduct a study of the food processing
sector regulated by the Secretary to determine -
(i) the distribution of food production by type and size of
operation, including monetary value of food sold;
(ii) the proportion of food produced by each type and size
of operation;
(iii) the number and types of food facilities co-located on
farms, including the number and proportion by commodity and
by manufacturing or processing activity;
(iv) the incidence of foodborne illness originating from
each size and type of operation and the type of food
facilities for which no reported or known hazard exists; and
(v) the effect on foodborne illness risk associated with
commingling, processing, transporting, and storing food and
raw agricultural commodities, including differences in risk
based on the scale and duration of such activities.
(B) Size
The results of the study conducted under subparagraph (A)
shall include the information necessary to enable the Secretary
to define the terms "small business" and "very small business",
for purposes of promulgating the regulation under subsection
(n). In defining such terms, the Secretary shall include
consideration of harvestable acres, income, the number of
employees, and the volume of food harvested.
(C) Submission of report
Not later than 18 months after January 4, 2011, the Secretary
shall submit to Congress a report that describes the results of
the study conducted under subparagraph (A).
(6) No preemption
Nothing in this subsection preempts State, local, county, or
other non-Federal law regarding the safe production of food.
Compliance with this subsection shall not relieve any person from
liability at common law or under State statutory law.
(7) Notification to consumers
(A) In general
A qualified facility that is exempt from the requirements
under subsections (a) through (i) and subsection (n) and does
not prepare documentation under paragraph (2)(B)(i)(I) shall -
(i) with respect to a food for which a food packaging label
is required by the Secretary under any other provision of
this chapter, include prominently and conspicuously on such
label the name and business address of the facility where the
food was manufactured or processed; or
(ii) with respect to a food for which a food packaging
label is not required by the Secretary under any other
provisions of this chapter, prominently and conspicuously
display, at the point of purchase, the name and business
address of the facility where the food was manufactured or
processed, on a label, poster, sign, placard, or documents
delivered contemporaneously with the food in the normal
course of business, or, in the case of Internet sales, in an
electronic notice.
(B) No additional label
Subparagraph (A) does not provide authority to the Secretary
to require a label that is in addition to any label required
under any other provision of this chapter.
(m) Authority with respect to certain facilities
The Secretary may, by regulation, exempt or modify the
requirements for compliance under this section with respect to
facilities that are solely engaged in the production of food for
animals other than man, the storage of raw agricultural commodities
(other than fruits and vegetables) intended for further
distribution or processing, or the storage of packaged foods that
are not exposed to the environment.
(n) Regulations
(1) In general
Not later than 18 months after January 4, 2011, the Secretary
shall promulgate regulations -
(A) to establish science-based minimum standards for
conducting a hazard analysis, documenting hazards, implementing
preventive controls, and documenting the implementation of the
preventive controls under this section; and
(B) to define, for purposes of this section, the terms "small
business" and "very small business", taking into consideration
the study described in subsection (l)(5).
(2) Coordination
In promulgating the regulations under paragraph (1)(A), with
regard to hazards that may be intentionally introduced, including
by acts of terrorism, the Secretary shall coordinate with the
Secretary of Homeland Security, as appropriate.
(3) Content
The regulations promulgated under paragraph (1)(A) shall -
(A) provide sufficient flexibility to be practicable for all
sizes and types of facilities, including small businesses such
as a small food processing facility co-located on a farm;
(B) comply with chapter 35 of title 44 (commonly known as the
"Paperwork Reduction Act"), with special attention to
minimizing the burden (as defined in section 3502(2) of such
title) on the facility, and collection of information (as
defined in section 3502(3) of such title), associated with such
regulations;
(C) acknowledge differences in risk and minimize, as
appropriate, the number of separate standards that apply to
separate foods; and
(D) not require a facility to hire a consultant or other
third party to identify, implement, certify, or audit
preventative controls, except in the case of negotiated
enforcement resolutions that may require such a consultant or
third party.
(4) Rule of construction
Nothing in this subsection shall be construed to provide the
Secretary with the authority to prescribe specific technologies,
practices, or critical controls for an individual facility.
(5) Review
In promulgating the regulations under paragraph (1)(A), the
Secretary shall review regulatory hazard analysis and preventive
control programs in existence on January 4, 2011, including the
Grade "A" Pasteurized Milk Ordinance to ensure that such
regulations are consistent, to the extent practicable, with
applicable domestic and internationally-recognized standards in
existence on such date.
(o) Definitions
For purposes of this section:
(1) Critical control point
The term "critical control point" means a point, step, or
procedure in a food process at which control can be applied and
is essential to prevent or eliminate a food safety hazard or
reduce such hazard to an acceptable level.
(2) Facility
The term "facility" means a domestic facility or a foreign
facility that is required to register under section 350d of this
title.
(3) Preventive controls
The term "preventive controls" means those risk-based,
reasonably appropriate procedures, practices, and processes that
a person knowledgeable about the safe manufacturing, processing,
packing, or holding of food would employ to significantly
minimize or prevent the hazards identified under the hazard
analysis conducted under subsection (b) and that are consistent
with the current scientific understanding of safe food
manufacturing, processing, packing, or holding at the time of the
analysis. Those procedures, practices, and processes may include
the following:
(A) Sanitation procedures for food contact surfaces and
utensils and food-contact surfaces of equipment.
(B) Supervisor, manager, and employee hygiene training.
(C) An environmental monitoring program to verify the
effectiveness of pathogen controls in processes where a food is
exposed to a potential contaminant in the environment.
(D) A food allergen control program.
(E) A recall plan.
(F) Current Good Manufacturing Practices (cGMPs) under part
110 of title 21, Code of Federal Regulations (or any successor
regulations).
(G) Supplier verification activities that relate to the
safety of food.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 418, as added Pub. L. 111-353, title
I, Sec. 103(a), Jan. 4, 2011, 124 Stat. 3889.)
-MISC1-
EFFECTIVE DATE
Pub. L. 111-353, title I, Sec. 103(i), Jan. 4, 2011, 124 Stat.
3898, provided that:
"(1) General rule. - The amendments made by this section
[enacting this section and amending section 331 of this title]
shall take effect 18 months after the date of enactment of this Act
[Jan. 4, 2011].
"(2) Flexibility for small businesses. - Notwithstanding
paragraph (1) -
"(A) the amendments made by this section shall apply to a small
business (as defined in the regulations promulgated under section
418(n) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
350g(n)] (as added by this section)) beginning on the date that
is 6 months after the effective date of such regulations; and
"(B) the amendments made by this section shall apply to a very
small business (as defined in such regulations) beginning on the
date that is 18 months after the effective date of such
regulations."
CONSTRUCTION
Nothing in this section to be construed to apply to certain
alcohol-related facilities, to alter jurisdiction and authorities
established under certain other Acts, or in a manner inconsistent
with international agreements to which the United States is a
party, see sections 2206, 2251, and 2252 of this title.
GUIDANCE DOCUMENT
Pub. L. 111-353, title I, Sec. 103(b), Jan. 4, 2011, 124 Stat.
3896, provided that: "The Secretary shall issue a guidance document
related to the regulations promulgated under subsection (b)(1)
[probably means 21 U.S.C. 350g(n)(1)] with respect to the hazard
analysis and preventive controls under section 418 of the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 350g] (as added by
subsection (a))."
SMALL ENTITY COMPLIANCE POLICY GUIDE
Pub. L. 111-353, title I, Sec. 103(d), Jan. 4, 2011, 124 Stat.
3898, provided that: "Not later than 180 days after the issuance of
the regulations promulgated under subsection (n) of section 418 of
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g(n)] (as
added by subsection (a)), the Secretary shall issue a small entity
compliance policy guide setting forth in plain language the
requirements of such section 418 and this section [enacting this
section, amending section 331 of this title, and enacting
provisions set out as notes under this section and sections 342 and
350d of this title] to assist small entities in complying with the
hazard analysis and other activities required under such section
418 and this section."
NO EFFECT ON HACCP AUTHORITIES
Pub. L. 111-353, title I, Sec. 103(f), Jan. 4, 2011, 124 Stat.
3898, provided that: "Nothing in the amendments made by this
section [enacting this section and amending section 331 of this
title] limits the authority of the Secretary under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public
Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or
enforce Hazard Analysis Critical Control [Points] programs and the
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed
Containers standards."
DIETARY SUPPLEMENTS
Pub. L. 111-353, title I, Sec. 103(g), Jan. 4, 2011, 124 Stat.
3898, provided that: "Nothing in the amendments made by this
section [enacting this section and amending section 331 of this
title] shall apply to any facility with regard to the
manufacturing, processing, packing, or holding of a dietary
supplement that is in compliance with the requirements of sections
402(g)(2) and 761 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 342(g)(2), 379aa-1)."
-FOOTNOTE-
(!1) So in original. Probably should be "title".
-End-
-CITE-
21 USC Sec. 350h 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350h. Standards for produce safety
-STATUTE-
(a) Proposed rulemaking
(1) In general
(A) Rulemaking
Not later than 1 year after January 4, 2011, the Secretary,
in coordination with the Secretary of Agriculture and
representatives of State departments of agriculture (including
with regard to the national organic program established under
the Organic Foods Production Act of 1990 [7 U.S.C. 6501 et
seq.]), and in consultation with the Secretary of Homeland
Security, shall publish a notice of proposed rulemaking to
establish science-based minimum standards for the safe
production and harvesting of those types of fruits and
vegetables, including specific mixes or categories of fruits
and vegetables, that are raw agricultural commodities for which
the Secretary has determined that such standards minimize the
risk of serious adverse health consequences or death.
(B) Determination by Secretary
With respect to small businesses and very small businesses
(as such terms are defined in the regulation promulgated under
subparagraph (A)) that produce and harvest those types of
fruits and vegetables that are raw agricultural commodities
that the Secretary has determined are low risk and do not
present a risk of serious adverse health consequences or death,
the Secretary may determine not to include production and
harvesting of such fruits and vegetables in such rulemaking, or
may modify the applicable requirements of regulations
promulgated pursuant to this section.
(2) Public input
During the comment period on the notice of proposed rulemaking
under paragraph (1), the Secretary shall conduct not less than 3
public meetings in diverse geographical areas of the United
States to provide persons in different regions an opportunity to
comment.
(3) Content
The proposed rulemaking under paragraph (1) shall -
(A) provide sufficient flexibility to be applicable to
various types of entities engaged in the production and
harvesting of fruits and vegetables that are raw agricultural
commodities, including small businesses and entities that sell
directly to consumers, and be appropriate to the scale and
diversity of the production and harvesting of such commodities;
(B) include, with respect to growing, harvesting, sorting,
packing, and storage operations, science-based minimum
standards related to soil amendments, hygiene, packaging,
temperature controls, animals in the growing area, and water;
(C) consider hazards that occur naturally, may be
unintentionally introduced, or may be intentionally introduced,
including by acts of terrorism;
(D) take into consideration, consistent with ensuring
enforceable public health protection, conservation and
environmental practice standards and policies established by
Federal natural resource conservation, wildlife conservation,
and environmental agencies;
(E) in the case of production that is certified organic, not
include any requirements that conflict with or duplicate the
requirements of the national organic program established under
the Organic Foods Production Act of 1990, while providing the
same level of public health protection as the requirements
under guidance documents, including guidance documents
regarding action levels, and regulations under the FDA Food
Safety Modernization Act; and
(F) define, for purposes of this section, the terms "small
business" and "very small business".
(4) Prioritization
The Secretary shall prioritize the implementation of the
regulations under this section for specific fruits and vegetables
that are raw agricultural commodities based on known risks which
may include a history and severity of foodborne illness
outbreaks.
(b) Final regulation
(1) In general
Not later than 1 year after the close of the comment period for
the proposed rulemaking under subsection (a), the Secretary shall
adopt a final regulation to provide for minimum science-based
standards for those types of fruits and vegetables, including
specific mixes or categories of fruits or vegetables, that are
raw agricultural commodities, based on known safety risks, which
may include a history of foodborne illness outbreaks.
(2) Final regulation
The final regulation shall -
(A) provide for coordination of education and enforcement
activities by State and local officials, as designated by the
Governors of the respective States or the appropriate elected
State official as recognized by State statute; and
(B) include a description of the variance process under
subsection (c) and the types of permissible variances the
Secretary may grant.
(3) Flexibility for small businesses
Notwithstanding paragraph (1) -
(A) the regulations promulgated under this section shall
apply to a small business (as defined in the regulation
promulgated under subsection (a)(1)) after the date that is 1
year after the effective date of the final regulation under
paragraph (1); and
(B) the regulations promulgated under this section shall
apply to a very small business (as defined in the regulation
promulgated under subsection (a)(1)) after the date that is 2
years after the effective date of the final regulation under
paragraph (1).
(c) Criteria
(1) In general
The regulations adopted under subsection (b) shall -
(A) set forth those procedures, processes, and practices that
the Secretary determines to minimize the risk of serious
adverse health consequences or death, including procedures,
processes, and practices that the Secretary determines to be
reasonably necessary to prevent the introduction of known or
reasonably foreseeable biological, chemical, and physical
hazards, including hazards that occur naturally, may be
unintentionally introduced, or may be intentionally introduced,
including by acts of terrorism, into fruits and vegetables,
including specific mixes or categories of fruits and
vegetables, that are raw agricultural commodities and to
provide reasonable assurances that the produce is not
adulterated under section 342 of this title;
(B) provide sufficient flexibility to be practicable for all
sizes and types of businesses, including small businesses such
as a small food processing facility co-located on a farm;
(C) comply with chapter 35 of title 44 (commonly known as the
"Paperwork Reduction Act"), with special attention to
minimizing the burden (as defined in section 3502(2) of such
title) on the business, and collection of information (as
defined in section 3502(3) of such title), associated with such
regulations;
(D) acknowledge differences in risk and minimize, as
appropriate, the number of separate standards that apply to
separate foods; and
(E) not require a business to hire a consultant or other
third party to identify, implement, certify, compliance (!1)
with these procedures, processes, and practices, except in the
case of negotiated enforcement resolutions that may require
such a consultant or third party; and
(F) permit States and foreign countries from which food is
imported into the United States to request from the Secretary
variances from the requirements of the regulations, subject to
paragraph (2), where the State or foreign country determines
that the variance is necessary in light of local growing
conditions and that the procedures, processes, and practices to
be followed under the variance are reasonably likely to ensure
that the produce is not adulterated under section 342 of this
title and to provide the same level of public health protection
as the requirements of the regulations adopted under subsection
(b).
(2) Variances
(A) Requests for variances
A State or foreign country from which food is imported into
the United States may in writing request a variance from the
Secretary. Such request shall describe the variance requested
and present information demonstrating that the variance does
not increase the likelihood that the food for which the
variance is requested will be adulterated under section 342 of
this title, and that the variance provides the same level of
public health protection as the requirements of the regulations
adopted under subsection (b). The Secretary shall review such
requests in a reasonable timeframe.
(B) Approval of variances
The Secretary may approve a variance in whole or in part, as
appropriate, and may specify the scope of applicability of a
variance to other similarly situated persons.
(C) Denial of variances
The Secretary may deny a variance request if the Secretary
determines that such variance is not reasonably likely to
ensure that the food is not adulterated under section 342 of
this title and is not reasonably likely to provide the same
level of public health protection as the requirements of the
regulation adopted under subsection (b). The Secretary shall
notify the person requesting such variance of the reasons for
the denial.
(D) Modification or revocation of a variance
The Secretary, after notice and an opportunity for a hearing,
may modify or revoke a variance if the Secretary determines
that such variance is not reasonably likely to ensure that the
food is not adulterated under section 342 of this title and is
not reasonably likely to provide the same level of public
health protection as the requirements of the regulations
adopted under subsection (b).
(d) Enforcement
The Secretary may coordinate with the Secretary of Agriculture
and, as appropriate, shall contract and coordinate with the agency
or department designated by the Governor of each State to perform
activities to ensure compliance with this section.
(e) Guidance
(1) In general
Not later than 1 year after January 4, 2011, the Secretary
shall publish, after consultation with the Secretary of
Agriculture, representatives of State departments of agriculture,
farmer representatives, and various types of entities engaged in
the production and harvesting or importing of fruits and
vegetables that are raw agricultural commodities, including small
businesses, updated good agricultural practices and guidance for
the safe production and harvesting of specific types of fresh
produce under this section.
(2) Public meetings
The Secretary shall conduct not fewer than 3 public meetings in
diverse geographical areas of the United States as part of an
effort to conduct education and outreach regarding the guidance
described in paragraph (1) for persons in different regions who
are involved in the production and harvesting of fruits and
vegetables that are raw agricultural commodities, including
persons that sell directly to consumers and farmer
representatives, and for importers of fruits and vegetables that
are raw agricultural commodities.
(3) Paperwork reduction
The Secretary shall ensure that any updated guidance under this
section will -
(A) provide sufficient flexibility to be practicable for all
sizes and types of facilities, including small businesses such
as a small food processing facility co-located on a farm; and
(B) acknowledge differences in risk and minimize, as
appropriate, the number of separate standards that apply to
separate foods.
(f) Exemption for direct farm marketing
(1) In general
A farm shall be exempt from the requirements under this section
in a calendar year if -
(A) during the previous 3-year period, the average annual
monetary value of the food sold by such farm directly to
qualified end-users during such period exceeded the average
annual monetary value of the food sold by such farm to all
other buyers during such period; and
(B) the average annual monetary value of all food sold during
such period was less than $500,000, adjusted for inflation.
(2) Notification to consumers
(A) In general
A farm that is exempt from the requirements under this
section shall -
(i) with respect to a food for which a food packaging label
is required by the Secretary under any other provision of
this chapter, include prominently and conspicuously on such
label the name and business address of the farm where the
produce was grown; or
(ii) with respect to a food for which a food packaging
label is not required by the Secretary under any other
provision of this chapter, prominently and conspicuously
display, at the point of purchase, the name and business
address of the farm where the produce was grown, on a label,
poster, sign, placard, or documents delivered
contemporaneously with the food in the normal course of
business, or, in the case of Internet sales, in an electronic
notice.
(B) No additional label
Subparagraph (A) does not provide authority to the Secretary
to require a label that is in addition to any label required
under any other provision of this chapter.
(3) Withdrawal; rule of construction
(A) In general
In the event of an active investigation of a foodborne
illness outbreak that is directly linked to a farm subject to
an exemption under this subsection, or if the Secretary
determines that it is necessary to protect the public health
and prevent or mitigate a foodborne illness outbreak based on
conduct or conditions associated with a farm that are material
to the safety of the food produced or harvested at such farm,
the Secretary may withdraw the exemption provided to such farm
under this subsection.
(B) Rule of construction
Nothing in this subsection shall be construed to expand or
limit the inspection authority of the Secretary.
(4) Definitions
(A) Qualified end-user
In this subsection, the term "qualified end-user", with
respect to a food means -
(i) the consumer of the food; or
(ii) a restaurant or retail food establishment (as those
terms are defined by the Secretary for purposes of section
350d of this title) that is located -
(I) in the same State as the farm that produced the food;
or
(II) not more than 275 miles from such farm.
(B) Consumer
For purposes of subparagraph (A), the term "consumer" does
not include a business.
(5) No preemption
Nothing in this subsection preempts State, local, county, or
other non-Federal law regarding the safe production, harvesting,
holding, transportation, and sale of fresh fruits and vegetables.
Compliance with this subsection shall not relieve any person from
liability at common law or under State statutory law.
(6) Limitation of effect
Nothing in this subsection shall prevent the Secretary from
exercising any authority granted in the other sections of this
chapter.
(g) Clarification
This section shall not apply to produce that is produced by an
individual for personal consumption.
(h) Exception for activities of facilities subject to section 350g
of this title
This section shall not apply to activities of a facility that are
subject to section 350g of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 419, as added Pub. L. 111-353, title
I, Sec. 105(a), Jan. 4, 2011, 124 Stat. 3899.)
-REFTEXT-
REFERENCES IN TEXT
The Organic Foods Production Act of 1990, referred to in subsec.
(a)(1)(A), (3)(E), is title XXI of Pub. L. 101-624, Nov. 28, 1990,
104 Stat. 3935, which is classified generally to chapter 94 (Sec.
6501 et seq.) of Title 7, Agriculture. For complete classification
of this Act to the Code, see Short Title note set out under section
6501 of Title 7 and Tables.
The FDA Food Safety Modernization Act, referred to in subsec.
(a)(3)(E), is Pub. L. 111-353, Jan. 4, 2011, 124 Stat. 3885, which
enacted chapter 27 (Sec. 2201 et seq.) and sections 350g to 350l-1,
379j-31, 384a to 384d, 399c, and 399d of this title, section 7625
of Title 7, Agriculture, and section 280g-16 of Title 42, The
Public Health and Welfare, amended sections 331, 333, 334, 350b to
350d, 350f, 374, 381, 393, and 399 of this title and section 247b-
20 of Title 42, and enacted provisions set out as notes under
sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and
381 of this title. For complete classification of this Act to the
Code, see Short Title note set out under section 2201 of this title
and Tables.
-MISC1-
CONSTRUCTION
Nothing in this section to be construed to apply to certain
alcohol-related facilities, to alter jurisdiction and authorities
established under certain other Acts, or in a manner inconsistent
with international agreements to which the United States is a
party, see sections 2206, 2251, and 2252 of this title.
SMALL ENTITY COMPLIANCE POLICY GUIDE
Pub. L. 111-353, title I, Sec. 105(b), Jan. 4, 2011, 124 Stat.
3904, provided that: "Not later than 180 days after the issuance of
regulations under section 419 of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 350h] (as added by subsection (a)), the
Secretary of Health and Human Services shall issue a small entity
compliance policy guide setting forth in plain language the
requirements of such section 419 and to assist small entities in
complying with standards for safe production and harvesting and
other activities required under such section."
NO EFFECT ON HACCP AUTHORITIES
Pub. L. 111-353, title I, Sec. 105(d), Jan. 4, 2011, 124 Stat.
3905, provided that: "Nothing in the amendments made by this
section [enacting this section and amending section 331 of this
title] limits the authority of the Secretary [of Health and Human
Services] under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et
seq.) to revise, issue, or enforce product and category-specific
regulations, such as the Seafood Hazard Analysis Critical Controls
Points Program, the Juice Hazard Analysis Critical Control [Points]
Program, and the Thermally Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers standards."
-FOOTNOTE-
(!1) So in original. Probably should be "or certify compliance".
-End-
-CITE-
21 USC Sec. 350i 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350i. Protection against intentional adulteration
-STATUTE-
(a) Determinations
(1) In general
The Secretary shall -
(A) conduct a vulnerability assessment of the food system,
including by consideration of the Department of Homeland
Security biological, chemical, radiological, or other terrorism
risk assessments;
(B) consider the best available understanding of
uncertainties, risks, costs, and benefits associated with
guarding against intentional adulteration of food at vulnerable
points; and
(C) determine the types of science-based mitigation
strategies or measures that are necessary to protect against
the intentional adulteration of food.
(2) Limited distribution
In the interest of national security, the Secretary, in
consultation with the Secretary of Homeland Security, may
determine the time, manner, and form in which determinations made
under paragraph (1) are made publicly available.
(b) Regulations
Not later than 18 months after January 4, 2011, the Secretary, in
coordination with the Secretary of Homeland Security and in
consultation with the Secretary of Agriculture, shall promulgate
regulations to protect against the intentional adulteration of food
subject to this chapter. Such regulations shall -
(1) specify how a person shall assess whether the person is
required to implement mitigation strategies or measures intended
to protect against the intentional adulteration of food; and
(2) specify appropriate science-based mitigation strategies or
measures to prepare and protect the food supply chain at specific
vulnerable points, as appropriate.
(c) Applicability
Regulations promulgated under subsection (b) shall apply only to
food for which there is a high risk of intentional contamination,
as determined by the Secretary, in consultation with the Secretary
of Homeland Security, under subsection (a), that could cause
serious adverse health consequences or death to humans or animals
and shall include those foods -
(1) for which the Secretary has identified clear
vulnerabilities (including short shelf-life or susceptibility to
intentional contamination at critical control points); and
(2) in bulk or batch form, prior to being packaged for the
final consumer.
(d) Exception
This section shall not apply to farms, except for those that
produce milk.
(e) Definition
For purposes of this section, the term "farm" has the meaning
given that term in section 1.227 of title 21, Code of Federal
Regulations (or any successor regulation).
-SOURCE-
(June 25, 1938, ch. 675, Sec. 420, as added Pub. L. 111-353, title
I, Sec. 106(a), Jan. 4, 2011, 124 Stat. 3905.)
-MISC1-
CONSTRUCTION
Nothing in this section to be construed to apply to certain
alcohol-related facilities, to alter jurisdiction and authorities
established under certain other Acts, or in a manner inconsistent
with international agreements to which the United States is a
party, see sections 2206, 2251, and 2252 of this title.
GUIDANCE DOCUMENTS
Pub. L. 111-353, title I, Sec. 106(b), Jan. 4, 2011, 124 Stat.
3906, provided that:
"(1) In general. - Not later than 1 year after the date of
enactment of this Act [Jan. 4, 2011], the Secretary of Health and
Human Services, in consultation with the Secretary of Homeland
Security and the Secretary of Agriculture, shall issue guidance
documents related to protection against the intentional
adulteration of food, including mitigation strategies or measures
to guard against such adulteration as required under section 420 of
the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450i], as added
by subsection (a).
"(2) Content. - The guidance documents issued under paragraph (1)
shall -
"(A) include a model assessment for a person to use under
subsection (b)(1) of section 420 of the Federal Food, Drug, and
Cosmetic Act, as added by subsection (a);
"(B) include examples of mitigation strategies or measures
described in subsection (b)(2) of such section; and
"(C) specify situations in which the examples of mitigation
strategies or measures described in subsection (b)(2) of such
section are appropriate.
"(3) Limited distribution. - In the interest of national
security, the Secretary of Health and Human Services, in
consultation with the Secretary of Homeland Security, may determine
the time, manner, and form in which the guidance documents issued
under paragraph (1) are made public, including by releasing such
documents to targeted audiences."
PERIODIC REVIEW
Pub. L. 111-353, title I, Sec. 106(c), Jan. 4, 2011, 124 Stat.
3906, provided that: "The Secretary of Health and Human Services
shall periodically review and, as appropriate, update the
regulations under section 420(b) of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 450i(b)], as added by subsection (a), and
the guidance documents under subsection (b) [section 106(b) of Pub.
L. 111-353, set out above]."
-End-
-CITE-
21 USC Sec. 350j 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350j. Targeting of inspection resources for domestic
facilities, foreign facilities, and ports of entry; annual report
-STATUTE-
(a) Identification and inspection of facilities
(1) Identification
The Secretary shall identify high-risk facilities and shall
allocate resources to inspect facilities according to the known
safety risks of the facilities, which shall be based on the
following factors:
(A) The known safety risks of the food manufactured,
processed, packed, or held at the facility.
(B) The compliance history of a facility, including with
regard to food recalls, outbreaks of foodborne illness, and
violations of food safety standards.
(C) The rigor and effectiveness of the facility's hazard
analysis and risk-based preventive controls.
(D) Whether the food manufactured, processed, packed, or held
at the facility meets the criteria for priority under section
381(h)(1) of this title.
(E) Whether the food or the facility that manufactured,
processed, packed, or held such food has received a
certification as described in section 381(q) or 384b of this
title, as appropriate.
(F) Any other criteria deemed necessary and appropriate by
the Secretary for purposes of allocating inspection resources.
(2) Inspections
(A) In general
Beginning on January 4, 2011, the Secretary shall increase
the frequency of inspection of all facilities.
(B) Domestic high-risk facilities
The Secretary shall increase the frequency of inspection of
domestic facilities identified under paragraph (1) as high-risk
facilities such that each such facility is inspected -
(i) not less often than once in the 5-year period following
January 4, 2011; and
(ii) not less often than once every 3 years thereafter.
(C) Domestic non-high-risk facilities
The Secretary shall ensure that each domestic facility that
is not identified under paragraph (1) as a high-risk facility
is inspected -
(i) not less often than once in the 7-year period following
January 4, 2011; and
(ii) not less often than once every 5 years thereafter.
(D) Foreign facilities
(i) Year 1
In the 1-year period following January 4, 2011, the
Secretary shall inspect not fewer than 600 foreign
facilities.
(ii) Subsequent years
In each of the 5 years following the 1-year period
described in clause (i), the Secretary shall inspect not
fewer than twice the number of foreign facilities inspected
by the Secretary during the previous year.
(E) Reliance on Federal, State, or local inspections
In meeting the inspection requirements under this subsection
for domestic facilities, the Secretary may rely on inspections
conducted by other Federal, State, or local agencies under
interagency agreement, contract, memoranda of understanding, or
other obligation.
(b) Identification and inspection at ports of entry
The Secretary, in consultation with the Secretary of Homeland
Security, shall allocate resources to inspect any article of food
imported into the United States according to the known safety risks
of the article of food, which shall be based on the following
factors:
(1) The known safety risks of the food imported.
(2) The known safety risks of the countries or regions of
origin and countries through which such article of food is
transported.
(3) The compliance history of the importer, including with
regard to food recalls, outbreaks of foodborne illness, and
violations of food safety standards.
(4) The rigor and effectiveness of the activities conducted by
the importer of such article of food to satisfy the requirements
of the foreign supplier verification program under section 384a
of this title.
(5) Whether the food importer participates in the voluntary
qualified importer program under section 384b of this title.
(6) Whether the food meets the criteria for priority under
section 381(h)(1) of this title.
(7) Whether the food or the facility that manufactured,
processed, packed, or held such food received a certification as
described in section 381(q) or 384b of this title.
(8) Any other criteria deemed necessary and appropriate by the
Secretary for purposes of allocating inspection resources.
(c) Interagency agreements with respect to seafood
(1) In general
The Secretary of Health and Human Services, the Secretary of
Commerce, the Secretary of Homeland Security, the Chairman of the
Federal Trade Commission, and the heads of other appropriate
agencies may enter into such agreements as may be necessary or
appropriate to improve seafood safety.
(2) Scope of agreements
The agreements under paragraph (1) may include -
(A) cooperative arrangements for examining and testing
seafood imports that leverage the resources, capabilities, and
authorities of each party to the agreement;
(B) coordination of inspections of foreign facilities to
increase the percentage of imported seafood and seafood
facilities inspected;
(C) standardization of data on seafood names, inspection
records, and laboratory testing to improve interagency
coordination;
(D) coordination to detect and investigate violations under
applicable Federal law;
(E) a process, including the use or modification of existing
processes, by which officers and employees of the National
Oceanic and Atmospheric Administration may be duly designated
by the Secretary to carry out seafood examinations and
investigations under section 381 of this title or section 203
of the Food Allergen Labeling and Consumer Protection Act of
2004;
(F) the sharing of information concerning observed non-
compliance with United States food requirements domestically
and in foreign nations and new regulatory decisions and
policies that may affect the safety of food imported into the
United States;
(G) conducting joint training on subjects that affect and
strengthen seafood inspection effectiveness by Federal
authorities; and
(H) outreach on Federal efforts to enhance seafood safety and
compliance with Federal food safety requirements.
(d) Coordination
The Secretary shall improve coordination and cooperation with the
Secretary of Agriculture and the Secretary of Homeland Security to
target food inspection resources.
(e) Facility
For purposes of this section, the term "facility" means a
domestic facility or a foreign facility that is required to
register under section 350d of this title.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 421, as added Pub. L. 111-353, title
II, Sec. 201(a), Jan. 4, 2011, 124 Stat. 3923.)
-REFTEXT-
REFERENCES IN TEXT
Section 203 of the Food Allergen Labeling and Consumer Protection
Act of 2004, referred to in subsec. (c)(2)(E), is section 203 of
Pub. L. 108-282, Aug. 2, 2004, 118 Stat. 906, which amended
sections 321, 343, and 343-1 of this title and enacted provisions
set out as notes under sections 321 and 343 of this title.
-MISC1-
CONSTRUCTION
Nothing in this section to be construed to apply to certain
alcohol-related facilities, to alter jurisdiction and authorities
established under certain other Acts, or in a manner inconsistent
with international agreements to which the United States is a
party, see sections 2206, 2251, and 2252 of this title.
ADVISORY COMMITTEE CONSULTATION
Pub. L. 111-353, title II, Sec. 201(c), Jan. 4, 2011, 124 Stat.
3926, provided that: "In allocating inspection resources as
described in section 421 of the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 450j] (as added by subsection (a)), the Secretary
may, as appropriate, consult with any relevant advisory committee
within the Department of Health and Human Services."
-End-
-CITE-
21 USC Sec. 350k 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350k. Laboratory accreditation for analyses of foods
-STATUTE-
(a) Recognition of laboratory accreditation
(1) In general
Not later than 2 years after January 4, 2011, the Secretary
shall -
(A) establish a program for the testing of food by accredited
laboratories;
(B) establish a publicly available registry of accreditation
bodies recognized by the Secretary and laboratories accredited
by a recognized accreditation body, including the name of,
contact information for, and other information deemed
appropriate by the Secretary about such bodies and
laboratories; and
(C) require, as a condition of recognition or accreditation,
as appropriate, that recognized accreditation bodies and
accredited laboratories report to the Secretary any changes
that would affect the recognition of such accreditation body or
the accreditation of such laboratory.
(2) Program requirements
The program established under paragraph (1)(A) shall provide
for the recognition of laboratory accreditation bodies that meet
criteria established by the Secretary for accreditation of
laboratories, including independent private laboratories and
laboratories run and operated by a Federal agency (including the
Department of Commerce), State, or locality with a demonstrated
capability to conduct 1 or more sampling and analytical testing
methodologies for food.
(3) Increasing the number of qualified laboratories
The Secretary shall work with the laboratory accreditation
bodies recognized under paragraph (1), as appropriate, to
increase the number of qualified laboratories that are eligible
to perform testing under subparagraph (!1) (b) beyond the number
so qualified on January 4, 2011.
(4) Limited distribution
In the interest of national security, the Secretary, in
coordination with the Secretary of Homeland Security, may
determine the time, manner, and form in which the registry
established under paragraph (1)(B) is made publicly available.
(5) Foreign laboratories
Accreditation bodies recognized by the Secretary under
paragraph (1) may accredit laboratories that operate outside the
United States, so long as such laboratories meet the
accreditation standards applicable to domestic laboratories
accredited under this section.
(6) Model laboratory standards
The Secretary shall develop model standards that a laboratory
shall meet to be accredited by a recognized accreditation body
for a specified sampling or analytical testing methodology and
included in the registry provided for under paragraph (1). In
developing the model standards, the Secretary shall consult
existing standards for guidance. The model standards shall
include -
(A) methods to ensure that -
(i) appropriate sampling, analytical procedures (including
rapid analytical procedures), and commercially available
techniques are followed and reports of analyses are certified
as true and accurate;
(ii) internal quality systems are established and
maintained;
(iii) procedures exist to evaluate and respond promptly to
complaints regarding analyses and other activities for which
the laboratory is accredited; and
(iv) individuals who conduct the sampling and analyses are
qualified by training and experience to do so; and
(B) any other criteria determined appropriate by the
Secretary.
(7) Review of recognition
To ensure compliance with the requirements of this section, the
Secretary -
(A) shall periodically, and in no case less than once every 5
years, reevaluate accreditation bodies recognized under
paragraph (1) and may accompany auditors from an accreditation
body to assess whether the accreditation body meets the
criteria for recognition; and
(B) shall promptly revoke the recognition of any
accreditation body found not to be in compliance with the
requirements of this section, specifying, as appropriate, any
terms and conditions necessary for laboratories accredited by
such body to continue to perform testing as described in this
section.
(b) Testing procedures
(1) In general
Not later than 30 months after January 4, 2011, food testing
shall be conducted by Federal laboratories or non-Federal
laboratories that have been accredited for the appropriate
sampling or analytical testing methodology or methodologies by a
recognized accreditation body on the registry established by the
Secretary under subsection (a)(1)(B) whenever such testing is
conducted -
(A) by or on behalf of an owner or consignee -
(i) in response to a specific testing requirement under
this chapter or implementing regulations, when applied to
address an identified or suspected food safety problem; and
(ii) as required by the Secretary, as the Secretary deems
appropriate, to address an identified or suspected food
safety problem; or
(B) on behalf of an owner or consignee -
(i) in support of admission of an article of food under
section 381(a) of this title; and
(ii) under an Import Alert that requires successful
consecutive tests.
(2) Results of testing
The results of any such testing shall be sent directly to the
Food and Drug Administration, except the Secretary may by
regulation exempt test results from such submission requirement
if the Secretary determines that such results do not contribute
to the protection of public health. Test results required to be
submitted may be submitted to the Food and Drug Administration
through electronic means.
(3) Exception
The Secretary may waive requirements under this subsection if -
(A) a new methodology or methodologies have been developed
and validated but a laboratory has not yet been accredited to
perform such methodology or methodologies; and
(B) the use of such methodology or methodologies are
necessary to prevent, control, or mitigate a food emergency or
foodborne illness outbreak.
(c) Review by Secretary
If food sampling and testing performed by a laboratory run and
operated by a State or locality that is accredited by a recognized
accreditation body on the registry established by the Secretary
under subsection (a) result in a State recalling a food, the
Secretary shall review the sampling and testing results for the
purpose of determining the need for a national recall or other
compliance and enforcement activities.
(d) No limit on Secretarial authority
Nothing in this section shall be construed to limit the ability
of the Secretary to review and act upon information from food
testing, including determining the sufficiency of such information
and testing.
-SOURCE-
(June 25, 1938, ch. 675, Sec. 422, as added Pub. L. 111-353, title
II, Sec. 202(a), Jan. 4, 2011, 124 Stat. 3926.)
-MISC1-
CONSTRUCTION
Nothing in this section to be construed to apply to certain
alcohol-related facilities, to alter jurisdiction and authorities
established under certain other Acts, or in a manner inconsistent
with international agreements to which the United States is a
party, see sections 2206, 2251, and 2252 of this title.
-FOOTNOTE-
(!1) So in original. Probably should be "subsection".
-End-
-CITE-
21 USC Sec. 350l 01/03/2012 (112-90)
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV - FOOD
-HEAD-
Sec. 350l. Mandatory recall authority
-STATUTE-
(a) Voluntary procedures
If the Secretary determines, based on information gathered
through the reportable food registry under section 350f of this
title or through any other means, that there is a reasonable
probability that an article of food (other than infant formula) is
adulterated under section 342 of this title or misbranded under
section 343(w) of this title and the use of or exposure to such
article will cause serious adverse health consequences or death to
humans or animals, the Secretary shall provide the responsible
party (as defined in section 350f of this title) with an
opportunity to cease distribution and recall such article.
(b) Prehearing order to cease distribution and give notice
(1) In general
If the responsible party refuses to or does not voluntarily
cease distribution or recall such article within the time and in
the manner prescribed by the Secretary (if so prescribed), the
Secretary may, by order require, as the Secretary deems
necessary, such person to -
(A) immediately cease distribution of such article; and
(B) as applicable, immediately notify all persons -
(i) manufacturing, processing, packing, transporting,
distributing, receiving, holding, or importing and selling
such article; and
(ii) to which such article has been distributed,
transported, or sold, to immediately cease distribution of
such article.(!1)
(2) Required additional information
(A) In general
If an article of food covered by a recall order issued under
paragraph (1)(B) has been distributed to a warehouse-based
third party logistics provider without providing such provider
sufficient information to know or reasonably determine the
precise identity of the article of food covered by a recall
order that is in its possession, the notice provided by the
responsible party subject to the order issued under paragraph
(1)(B) shall include such information as is necessary for the
warehouse-based third party logistics provider to identify the
food.
(B) Rules of construction
Nothing in this paragraph shall be construed -
(i) to exempt a warehouse-based third party logistics
provider from the requirements of this chapter, including the
requirements in this section and section 350c of this title;
or
(ii) to exempt a warehouse-based third party logistics
provider from being the subject of a mandatory recall order.
(3) Determination to limit areas affected
If the Secretary requires a responsible party to cease
distribution under paragraph (1)(A) of an article of food
identified in subsection (a), the Secretary may limit the size of
the geographic area and the markets affected by such cessation if
such limitation would not compromise the public health.
(c) Hearing on order
The Secretary shall provide the responsible party subject to an
order under subsection (b) with an opportunity for an informal
hearing, to be held as soon as possible, but not later than 2 days
after the issuance of the order, on the actions required by the
order and on why the article that is the subject of the order
should not be recalled.
(d) Post-hearing recall order and modification of order
(1) Amendment of order
If, after providing opportunity for an informal hearing under
subsection (c), the Secretary determines that removal of the
article from commerce is necessary, the Secretary shall, as
appropriate -
(A) amend the order to require recall of such article or
other appropriate action;
(B) specify a timetable in which the recall shall occur;
(C) require periodic reports to the Secretary describing the
progress of the recall; and
(D) provide notice to consumers to whom such article was, or
may have been, distributed.
(2) Vacating of order
If, after such hearing, the Secretary determines that adequate
grounds do not exist to continue the actions required by the
order, or that such actions should be modified, the Secretary
shall vacate the order or modify the order.
(e) Rule regarding alcoholic beverages
The Secretary shall not initiate a mandatory recall or take any
other action under this section with respect to any alcohol
beverage until the Secretary has provided the Alcohol and Tobacco
Tax and Trade Bureau with a reasonable opportunity to cease
distribution and recall such article under the Alcohol and Tobacco
Tax and Trade Bureau authority.
(f) Cooperation and consultation
The Secretary shall work with State and local public health
officials in carrying out this section, as appropriate.
(g) Public notification
In conducting a recall under this section, the Secretary shall -
(1) ensure that a press release is published regarding the
recall, as well as alerts and public notices, as appropriate, in
order to provide notification -
(A) of the recall to consumers and retailers to whom such
article was, or may have been, distributed; and
(B) that includes, at a minimum -
(i) the name of the article of food subject to the recall;
(ii) a description of the risk associated with such
article; and
(iii) to the extent practicable, information for consumers
about similar articles of food that are not affected by the
recall;
(2) consult the policies of the Department of Agriculture
regarding providing to the public a list of retail consignees
receiving products involved in a Class I recall and shall
consider providing such a list to the public, as determined
appropriate by the Secretary; and
(3) if available, publish on the Internet Web site of the Food
and Drug Administration an image of the article that is the
subject of the press release described in (1).(!2)
(h) No delegation
The authority conferred by this section to order a recall or
vacate a recall order shall not be delegated to any officer or
employee other than the Commissioner.
(i) Effect
Nothing in this section shall affect the authority of the
Secretary to request or participate in a voluntary recall, or to
issue an order to cease distribution or to recall under any other
provision of this chapter or under the Public Health Service Act
[42 U.S.C. 201 et seq.].
(j) Coordinated communication
(1) In general
To assist in carrying out the requirements of this subsection,
the Secretary shall establish an incident command operation or a
similar operation within the Department of Health and Human
Services that will operate not later than 24 hours after the
initiation of a mandatory recall or the recall of an article of
food for which the use of, or exposure to, such article will
cause serious adverse health consequences or death to humans or
animals.
(2) Requirements
To reduce