TITLE 21—FOOD AND DRUGS

Chap.
Sec.
1.
Adulterated or Misbranded Foods or Drugs
1
2.
Teas
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Narcotic Drugs [Repealed or Transferred]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Narcotic Farms [Repealed]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Manufacture of Narcotic Drugs [Repealed]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Alcohol and Drug Abuse Educational Programs and Activities [Repealed]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National Drug Enforcement Policy [Repealed]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
1301
19.
Pesticide Monitoring Improvements
1401
20.
National Drug Control Program
1501

        

Cross References

Biological products, regulation, see section 262 of Title 42, The Public Health and Welfare.

Narcotics, instruction as to nature and effect of, see section 111 et seq. of Title 20, Education.

Packers and Stockyards Act, see section 181 et seq. of Title 7, Agriculture.

Title Referred to in Other Sections

This title is referred to in title 18 section 3050.

CHAPTER 1—ADULTERATED OR MISBRANDED FOODS OR DRUGS

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Repealed or Transferred.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Repealed.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.

        

SUBCHAPTER I—FEDERAL FOOD AND DRUGS ACT OF 1906

§§1 to 5. Repealed. June 25, 1938, ch. 675, §902(a), 52 Stat. 1059

Section 1, act June 30, 1906, ch. 3915, §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, §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, §3, 34 Stat. 768; Mar. 4, 1913, ch. 141, §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, §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, §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

Section 902(a) of act June 25, 1938, ch. 675, 52 Stat. 1059, 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, §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.”

§6. Transferred

Codification

Section, act Mar. 4, 1923, ch. 268, 42 Stat. 1500, was transferred to section 321a of this title.

§§7 to 14. Repealed. June 25, 1938, ch. 675, §902(a), 52 Stat. 1059

Section 7, act June 30, 1906, ch. 3915, §6, 34 Stat. 769, defined “drug” and “food”. See section 321 of this title.

Section 8, act June 30, 1906, ch. 3915, §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, §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, §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, §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, §5, 34 Stat. 769, provided for prosecution by district attorneys for enforcement of penalties.

Section 13, act June 30, 1906, ch. 3915, §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, §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 902(a) of act June 25, 1938, set out as a note under sections 1 to 5 of this title.

§14a. Transferred

Codification

Section, act June 30, 1906, ch. 3915, §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, §201, 57 Stat. 500, and by Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498, and was successively classified to section 372a and then 376 of this title.

§15. Repealed. June 25, 1938, ch. 675, §902(a), 52 Stat. 1059

Section, act June 30, 1906, ch. 3915, §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 902(a) of act June 25, 1938, set out as a note under sections 1 to 5 of this title.

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

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.

(July 1, 1902, ch. 1357, §1, 32 Stat. 632.)

Section Referred to in Other Sections

This section is referred to in section 17 of this title.

§17. Penalty for sale or introduction of falsely labeled dairy or food products; venue

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.

(July 1, 1902, ch. 1357, §2, 32 Stat. 632.)

Federal Rules of Criminal Procedure

Special venue provisions of section as not affected by rule 18, see Notes of Advisory Committee on Rules set out under rule 18, Title 18, Appendix, Crimes and Criminal Procedure.

§18. Suspension of importation of adulterated articles

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.

(Aug. 30, 1890, ch. 839, §4, 26 Stat. 415.)

§19. Repealed. May 29, 1928, ch. 901, §1(100), 45 Stat. 993

Section, act May 23, 1908, ch. 192, 35 Stat. 261, related to report to the Congress of expenditures in enforcing food and drug laws.

§20. Apples in interstate commerce; standard grades

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.

(Aug. 3, 1912, ch. 273, §2, 37 Stat. 250.)

Section Referred to in Other Sections

This section is referred to in sections 21, 22, 23 of this title.

§21. Branding grades on barrels of apples

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.

(Aug. 3, 1912, ch. 273, §3, 37 Stat. 251.)

Section Referred to in Other Sections

This section is referred to in sections 22, 23 of this title.

§22. Barrels misbranded

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.

(Aug. 3, 1912, ch. 273, §5, 37 Stat. 251.)

Section Referred to in Other Sections

This section is referred to in sections 21, 23 of this title.

§23. Penalties

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.

(Aug. 3, 1912, ch. 273, §6, 37 Stat. 251.)

Codification

Section is also set out as section 233 of Title 15, Commerce and Trade.

Section Referred to in Other Sections

This section is referred to in sections 21, 22 of this title.

§24. Omitted

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.

§25. Oleomargarine, butterine, or imitation butter or cheese transported into a State subject to its police powers

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.

(May 9, 1902, ch. 784, §1, 32 Stat. 193.)

Cross References

Colored oleomargarine, intrastate sales of, see section 347 et seq. of this title.

§26. Omitted

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, §4, 58 Stat. 461, and related to inspection of food and other products, is covered by section 2256 of Title 7, Agriculture.

CHAPTER 2—TEAS

Sec.
41.
Importation of tea inferior to standard.
42.
Board of experts; appointment; term; vacancies; compensation.
43.
Standards of purity; duplicate samples at customhouses and for importers and dealers.
44.
Bonds of importers; examination; importations at ports having no examiner.
45.
Permit for delivery; retention of inferior grades; reexamination; partial delivery.
46.
Examiners; examination according to usages of trade.
46a.
Deposit of fee before examination of tea.
47.
United States Board of Tea Appeals; permit for delivery; exportation or destruction of inferior grades.
48.
Reexamination; findings by examiner; assistance of experts.
49.
Reimporting rejected teas; forfeiture.
50.
Regulations.

        

§41. Importation of tea inferior to standard

It shall be unlawful for any person or persons or corporation to import or bring into the United States any merchandise as tea which is inferior in purity, quality, and fitness for consumption to the standards provided in section 43 of this title, and the importation of all such merchandise is prohibited, except as provided in the Harmonized Tariff Schedule of the United States.

(Mar. 2, 1897, ch. 358, §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, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; May 24, 1962, Pub. L. 87–456, title III, §303(a), 76 Stat. 77; Aug. 23, 1988, Pub. L. 100–418, title I, §1214(l), 102 Stat. 1158.)

References in Text

The Harmonized Tariff Schedule of the United States, referred to in text, is not set out in the Code. See Publication of Harmonized Tariff Schedule note set out under section 1202 of Title 19, Customs Duties.

Amendments

1988—Pub. L. 100–418 substituted “Harmonized Tariff Schedule of the United States” for “Tariff Schedules of the United States”.

1962—Pub. L. 87–456 inserted “except as provided in the Tariff Schedules of the United States” at end of first sentence, and struck out second sentence which related to the importation under bond of tea inferior to standards, tea waste, tea siftings, or tea sweepings, under regulations prescribed by the Secretary of the Treasury, for the sole purpose of manufacturing theine, caffeine, or other chemical products whereby the identity and character of the original material is entirely destroyed or changed and that the bonds shall be subject to the approval only of the collector of customs at the port of entry.

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–418 effective Jan. 1, 1989, and applicable with respect to articles entered on or after such date, see section 1217(b)(1) of Pub. L. 100–418, set out as an Effective Date note under section 3001 of Title 19, Customs Duties.

Effective Date of 1962 Amendment

Amendment by Pub. L. 87–456 effective with respect to articles entered, or withdrawn from warehouse, for consumption on or after Aug. 31, 1963, see section 501(a) of Pub. L. 87–456.

Short Title

Act July 12, 1943, ch. 221, title II, 57 Stat. 499, provided in part that act Mar. 2, 1897, which is classified generally to this chapter, may be cited as the “Tea Importation Act”.

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, §509(b), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.

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.

The powers and duties of Secretary of the Treasury under this section were conferred upon Secretary of Agriculture by act May 31, 1920.

Section Referred to in Other Sections

This section is referred to in sections 43, 45 of this title.

§42. Board of experts; appointment; term; vacancies; compensation

On or before February 15 of each year, the Secretary of Health and Human Services shall appoint a board, to consist of seven members, each of whom shall be an expert in teas, and who shall prepare and submit to him standard samples of tea. The persons so appointed shall be at all times subject to removal by the said Secretary, and shall serve for the term of one year. Vacancies in the said board occurring by removal, death, resignation, or any other cause shall be forthwith filled by the Secretary of Health and Human Services by appointment, such appointee to hold for the unexpired term. Said board shall appoint a presiding officer, who shall be the medium of all communications to or from such board. Each member of said board shall receive as compensation the sum of $50 per annum, which, together with all necessary expenses while engaged upon the duty herein provided, shall be paid by the Secretary.

(Mar. 2, 1897, ch. 358, §2, 29 Stat. 605; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §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, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695.)

Amendments

1943—Act July 12, 1943, provided that the Administrator should pay the salaries and expenses of the board members.

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.

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 note set out under section 41 of this title.

Section Referred to in Other Sections

This section is referred to in sections 43, 45 of this title.

§43. Standards of purity; duplicate samples at customhouses and for importers and dealers

The Secretary of Health and Human Services, upon the recommendation of the board of experts provided in section 42 of this title, shall fix and establish uniform standards of purity, quality, and fitness for consumption of all kinds of teas imported into the United States, and shall procure and deposit in the customhouses of the ports of New York, Chicago, San Francisco, and such other ports as he may determine, duplicate samples of such standards. Said Secretary shall procure a sufficient number of other duplicate samples of such standards to supply the importers and dealers in tea at all ports desiring the same at cost. All teas, or merchandise described as tea, of inferior purity, quality, and fitness for consumption to such standards shall be deemed within the prohibition of section 41 of this title.

(Mar. 2, 1897, ch. 358, §3, 29 Stat. 605; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695.)

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.

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 note set out under section 41 of this title.

Section Referred to in Other Sections

This section is referred to in sections 41, 45 of this title.

§44. Bonds of importers; examination; importations at ports having no examiner

On making entry at the customhouse of all teas, or merchandise described as tea, imported into the United States, the importer or consignee shall give a bond to the collector of the port that such merchandise shall not be removed from the warehouse until released by the collector, after it shall have been duly examined with reference to its purity, quality, and fitness for consumption. For the purpose of such examination samples of each line in every invoice of tea shall be submitted by the importer or consignee to the examiner, together with the sworn statement of such importer or consignee that such samples represent the true quality of each and every part of the invoice and accord with the specifications therein contained; or in the discretion of the Secretary of Health and Human Services, such samples shall be obtained by the examiner and compared by him with the standards established by this chapter. In cases where said tea, or merchandise described as tea, is entered at ports where there is no qualified examiner as provided in section 46 of this title, the consignee or importer shall in the manner aforesaid furnish under oath a sample of each line of tea to the collector or other revenue officer to whom is committed the collection of duties, and said officer shall also draw or cause to be drawn samples of each line in every invoice and shall forward the same to a duly qualified examiner as provided in said section. The bond required by this section shall also be conditioned for the payment of all customhouse charges which may attach to such merchandise prior to its being released or destroyed (as the case may be) under the provisions of this chapter.

(Mar. 2, 1897, ch. 358, §4, 29 Stat. 605; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695.)

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.

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 note set out under section 41 of this title.

All offices of collector of customs in Bureau of Customs of Department of the Treasury ordered abolished, with such offices to be terminated not later than Dec. 31, 1966, by Reorg. Plan No. 1 of 1965, eff. May 25, 1965, 30 F.R. 7035, 79 Stat. 1317, set out in the Appendix to Title 5, Government Organization and Employees. All functions of offices eliminated were already vested in Secretary of the Treasury by Reorg. Plan No. 26 of 1950, eff. July 31, 1950, 15 F.R. 4935, 64 Stat. 1280, also set out in the Appendix to Title 5.

Section Referred to in Other Sections

This section is referred to in sections 45, 46 of this title.

§45. Permit for delivery; retention of inferior grades; reexamination; partial delivery

If, after an examination as provided in section 44 of this title, the tea is found by the examiner to be equal in purity, quality, and fitness for consumption to the standards provided in sections 41 to 44 of this title, and no reexamination shall be demanded by the collector as provided in section 47 of this title, a permit shall at once be granted to the importer or consignee declaring the tea free from the control of the customs authorities; but if on examination such tea, or merchandise described as tea, is found, in the opinion of the examiner, to be inferior in purity, quality, and fitness for consumption to the said standards the importer or consignee shall be immediately notified, and the tea, or merchandise described as tea, shall not be released by the customhouse, unless on a reexamination called for by the importer or consignee the finding of the examiner shall be found to be erroneous. Should a portion of the invoice be passed by the examiner, a permit shall be granted for that portion and the remainder held for further examination, as provided in said section 47.

(Mar. 2, 1897, ch. 358, §5, 29 Stat. 605.)

Transfer of Functions

For abolition of the offices of collector of customs, see note set out under section 44 of this title.

§46. Examiners; examination according to usages of trade

The examination provided for by this chapter shall be made by a duly qualified examiner at a port where standard samples are established, and where the merchandise is entered at ports where there is no qualified examiner, the examination shall be made at that one of said ports which is nearest the port of entry, and that for this purpose samples of the merchandise, obtained in the manner prescribed by section 44 of this title, shall be forwarded to the proper port by the collector or chief officer at the port of entry. In all cases of examination or reexamination of teas, or merchandise described as tea, by examiners or the United States Board of Tea Appeals under the provisions of this chapter, the purity, quality, and fitness for consumption of the same shall be tested according to the usages and customs of the tea trade, including the testing of an infusion of the same in boiling water and, if necessary, chemical analysis.

(Mar. 2, 1897, ch. 358, §7, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712, 713.)

Transfer of Functions

For abolition of the offices of collector of customs, see note set out under section 44 of this title.

Section Referred to in Other Sections

This section is referred to in section 44 of this title.

§46a. Deposit of fee before examination of tea

No tea or merchandise described as tea shall be examined for importation into the United States, or released by the Customs Service, under this chapter unless the importer or consignee of such tea or merchandise has paid, before the examination, a fee in an amount equal to—

(1) 10 cents for each hundred weight or fraction thereof of the tea or merchandise; or

(2) the approximate cost of the examinations;


whichever amount is less. Such fee shall be deposited into the Treasury of the United States as miscellaneous receipts.

(Mar. 2, 1897, ch. 358, §13, formerly act July 1, 1941, ch. 269, title II, 55 Stat. 478; renumbered §13 of act Mar. 2, 1897, and amended Aug. 10, 1993, Pub. L. 103–66, title IV, §4401, 107 Stat. 378.)

Prior Provisions

Provisions similar to those comprising this section were contained in the following appropriation act: June 27, 1940, ch. 437, title I, 54 Stat. 632.

Amendments

1993—Pub. L. 103–66, §4401(2), amended section generally. Prior to amendment, section read as follows: “On and after July 1, 1940, no tea, or merchandise described as tea, shall be examined for importation into the United States, or released by the Collector, under this chapter unless the importer or consignee of such tea or merchandise, prior to such examination, has paid for deposit into the Treasury of the United States as miscellaneous receipts, a fee of 3.5 cents for each hundred weight or fraction thereof of such tea and merchandise.”

§47. United States Board of Tea Appeals; permit for delivery; exportation or destruction of inferior grades

In case the collector, importer, or consignee shall protest against the finding of the examiner, the matter in dispute shall be referred for decision to the United States Board of Tea Appeals, to consist of three employees of the Department of Health and Human Services, to be designated by the Secretary of Health and Human Services. If such board shall, after due examination, find the tea in question to be equal in purity, quality, and fitness for consumption to the proper standards, a permit shall be issued by the collector for its release and delivery to the importer; but if upon such final reexamination by such board the tea shall be found to be inferior in purity, quality, and fitness for consumption to the said standards, the importer or consignee shall give a bond, with security satisfactory to the collector, to export said tea, or merchandise described as tea, out of the limits of the United States within a period of six months after such final reexamination; and if the same shall not have been exported within the time specified, the collector, at the expiration of that time, shall cause the same to be destroyed.

(Mar. 2, 1897, ch. 358, §6, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712, 713; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695.)

Change of Name

“Department of Health and Human Services” substituted in text for “Department of Health, Education, and Welfare” and “Secretary of Health and Human Services” substituted 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.

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 note set out under section 41 of this title.

For abolition of the offices of the collector of customs, see note set out under section 44 of this title.

Section Referred to in Other Sections

This section is referred to in section 45 of this title.

§48. Reexamination; findings by examiner; assistance of experts

In cases of reexamination of teas, or merchandise described as teas, by the United States Board of Tea Appeals in pursuance of the provisions of this chapter, samples of the tea, or merchandise described as tea, in dispute, for transmission to such board for its decision, shall be put up and sealed by the examiner in the presence of the importer or consignee if he so desires, and transmitted to such board, together with a copy of the finding of the examiner, setting forth the cause of condemnation and the claim or ground of the protest of the importer relating to the same, such samples, and the papers therewith, to be distinguished by such mark that the same may be identified. The decision of such board shall be in writing, signed by them, and transmitted, together with the record and samples, within three days after the rendition thereof, to the collector, who shall forthwith furnish the examiner and the importer or consignee with a copy of said decision or finding. The United States Board of Tea Appeals shall be authorized to obtain the advice, when necessary, of persons skilled in the examination of teas, who shall each receive for his services in any particular case a compensation not exceeding $5.

(Mar. 2, 1897, ch. 358, §8, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712.)

Transfer of Functions

For abolition of the offices of the collector of customs, see note set out under section 44 of this title.

§49. Reimporting rejected teas; forfeiture

No imported teas which have been rejected by a customs examiner or by the United States Board of Tea Appeals, and exported under the provisions of this chapter, shall be reimported into the United States under the penalty of forfeiture for a violation of this prohibition.

(Mar. 2, 1897, ch. 358, §9, 29 Stat. 606; May 31, 1920, ch. 217, 41 Stat. 712.)

§50. Regulations

The Secretary of Health and Human Services shall have the power to enforce the provisions of this chapter by appropriate regulations.

(Mar. 2, 1897, ch. 358, §10, 29 Stat. 607; May 31, 1920, ch. 217, 41 Stat. 712; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695.)

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.

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 note set out under section 41 of this title.

CHAPTER 3—FILLED MILK

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

By virtue of act June 25, 1938, ch. 675, §902(c), 52 Stat. 1059 [section 392(b) of this title], nothing contained in section 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.

Bureau of Dairy Industry

General provisions, see sections 401 to 404 of Title 7, Agriculture.

Chapter Referred to in Other Sections

This chapter is referred to in section 392 of this title.

§61. Definitions

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.

(Mar. 4, 1923, ch. 262, §1, 42 Stat. 1486.)

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”.

Section Referred to in Other Sections

This section is referred to in section 62 of this title.

§62. Manufacture, shipment, or delivery for shipment in interstate or foreign commerce prohibited

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.

(Mar. 4, 1923, ch. 262, §2, 42 Stat. 1487.)

§63. Penalties; acts of agents deemed acts of principals

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.

(Mar. 4, 1923, ch. 262, §3, 42 Stat. 1487.)

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.

§64. Regulations for enforcement

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.

(Mar. 4, 1923, ch. 262, §4, as added Aug. 27, 1935, ch. 743, 49 Stat. 885; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695.)

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.

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 note set out under section 41 of this title.

CHAPTER 4—ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS

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.
Quarantine of imported animals.
103.
Importation, except at quarantine ports, prohibited; slaughter of infected animals; appraisal; payment.
104.
Importation of animals.
(a)
In general.
(b)
Penalties.
105.
Inspection of animals.
106, 107.
Omitted.

        

SUBCHAPTER III—PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

111.
Regulations to prevent contagious diseases.
112.
Investigations as to pleuropneumonia, and other diseases; regulations.
112a.
Omitted.
113.
Measures to prevent exportation of diseased livestock and live poultry.
113a.
Establishment of research laboratories for foot-and-mouth disease and other animal diseases; research contracts; employment of technicians and scientists; appropriations.
114.
Regulations for suppression of diseases; cooperation of States and Territories.
114a.
Control and eradication of diseases; cooperation of States and farmers’ associations; purchase and destruction of diseased animals; “State” defined.
114a–1.
Interstate movement of domestic animals reacting to tests for brucellosis; immediate slaughter; rules and regulations.
114b.
Cooperation in animal disease control.
114c.
Use of funds.
114d.
Sale of sterile screwworms.
(a)
In general.
(b)
Terms of sale.
(c)
Deposit of proceeds.
114d–1.
Cooperation with public and private entities.
114d–2 to 114d–6. Repealed.
114e.
Control and eradication of cattle grubs; research and investigations.
114f.
“State” defined; authorization of appropriations.
114g.
Hog cholera eradication program.
114h.
Advisory committee.
(a)
Establishment; membership.
(b)
Functions.
(c)
Employment status; expenses.
114i.
Pseudorabies eradication.
(a)
Findings.
(b)
Establishment of program.
(c)
Use of funds for testing and control of pseudorabies.
(d)
Authorization of appropriations.
115.
Transportation of diseased livestock and live poultry prohibited.
116.
Shipment of certain cattle excepted.
117.
Penalties for transportation of diseased livestock or live poultry.
(a)
Criminal penalty.
(b)
Civil penalty.
118.
Duty of United States attorneys.
119.
Agents to examine and report on methods of treatment of animals, and means for suppression of diseases.
120.
Regulation of exportation and transportation of infected livestock and live poultry.
121.
Shipments from areas suspected infected; control of animals and live poultry.
122.
Offenses; penalty.
123.
Quarantine.
124.
Transportation or delivery therefor from quarantined State or Territory or portion thereof, of quarantined animals and live poultry, forbidden.
125.
Regulations for inspection, disinfection, and certification, and delivery and shipment of quarantined animals and live poultry from State or Territory.
126.
Moving quarantined animals and live poultry from State or Territory, under regulations.
127.
Transportation from quarantined State, Territory, etc.; penalty.
128.
Extension of quarantine law to carriers in interstate commerce.
129.
Expenses for arrest and eradication of contagious or infectious diseases or pests of animals, poultry, or plants.
130.
Pleuropneumonia in District of Columbia; duties of Council of the District of Columbia.
131.
Fences along international boundary lines to keep out diseased animals.
132, 133.
Transferred or Repealed.
134.
Definitions.
134a.
Seizure, quarantine, and disposal of livestock or poultry to guard against introduction or dissemination of communicable disease.
(a)
Authority of Secretary.
(b)
Determination of extraordinary emergency due to dangerous communicable disease; seizure, quarantine, and disposal of animals; action authorized only if adequate measures not taken by State or other jurisdiction; notice to State or other jurisdiction.
(c)
Notice to owner to quarantine or to dispose of animal, carcass, product, or article; action on failure to comply; costs.
(d)
Compensation of owner; fair market value; payments from State or other source; availability of funds.
(e)
Restriction on payment of compensation in cases of violation of law or regulation.
134b.
Regulations for clean and sanitary movement of animals.
134c.
Regulations for movement of animals affected or exposed to communicable disease.
134d.
Inspections and seizures; issuance of warrants.
134e.
Enforcement provisions.
(a)
Criminal and civil penalties.
(b)
Injunctive proceedings.
134f.
Promulgation of regulations.
134g.
Authority in addition to other laws; repeal of inconsistent provisions.
134h.
Separability.
135.
International animal quarantine station; establishment; acceptance of gifts; cooperation with breeders’ organizations; collection of fees.
135a.
Smuggling penalties.
(a)
Criminal penalty.
(b)
Civil penalty.
135b.
Authorization of appropriations.
136.
Additional inspection services.
136a.
Collection of fees for inspection services.
(a)
Quarantine, inspection and transportation fees.
(b)
Omitted.
(c)
Animal inspection and veterinary diagnostics.
(d)
Regulations.
(e)
Recovery of amounts owed.
(f)
Definitions.

        

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.

        

SUBCHAPTER I—EXAMINATION OF ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS

§§71 to 92. Transferred

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.

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.

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.

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.

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.

§93. Repealed. May 29, 1928, ch. 901, §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.

§§94 to 95. Transferred

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, §2, 48 Stat. 1225, which related to authorization of appropriations for expenses of inspection, was transferred to section 694 of this title.

§96. Repealed. Pub. L. 90–201, §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.

§§97 to 97d. Omitted

Codification

Sections 97 to 97d, act July 30, 1947, ch. 356, title I, §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, §1, 62 Stat. 515.

§98. Transferred

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.

§99. Repealed. July 28, 1953, ch. 251, title I, §101, 67 Stat. 208

Section, act Aug. 31, 1951, ch. 374, title I, §101, 65 Stat. 229, related to reimbursement for excess expenses of meat inspection.

SUBCHAPTER II—IMPORTATION OF CATTLE AND QUARANTINE

§101. Suspension of importation of all animals

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.

(Aug. 30, 1890, ch. 839, §9, 26 Stat. 416.)

Section Referred to in Other Sections

This section is referred to in sections 104, 136a of this title; title 16 section 1540.

§102. Quarantine of imported animals

The Secretary of Agriculture is authorized, at the expense of the owner, to place and retain in quarantine all neat cattle, sheep, and other ruminants, and all swine, imported into the United States, at such ports as he may designate for such purpose, and under such conditions as he may by regulation prescribe, respectively, for the several classes of animals above described. For this purpose he may have and maintain possession of all lands, buildings, animals, tools, fixtures, and appurtenances in use on August 3, 1890, for the quarantine of neat cattle, and purchase, construct, or rent as may be necessary, and he may appoint veterinary surgeons, inspectors, officers, and employees by him deemed necessary to maintain such quarantine, and provide for the execution of the other provisions of this subchapter.

(Aug. 30, 1890, ch. 839, §7, 26 Stat. 416.)

References in Text

This subchapter, referred to in text, was in the original “this Act”, meaning act Aug. 30, 1890, ch. 839, 26 Stat. 415, as amended, which is classified to sections 18, and 101 to 105 of this title and section 181 of Title 19, Customs Duties. For complete classification of this Act to the Code, see Tables.

Section Referred to in Other Sections

This section is referred to in sections 104, 136a of this title; title 16 section 1540.

§103. Importation, except at quarantine ports, prohibited; slaughter of infected animals; appraisal; payment

The importation of all animals described in this subchapter into any port in the United States, except such as may be designated by the Secretary of Agriculture, with the approval of the Secretary of the Treasury, as quarantine stations, is prohibited. The Secretary of Agriculture may cause to be slaughtered such of the animals named in this subchapter as may be, under regulations prescribed by him, adjudged to be infected with any contagious disease, or to have been exposed to infection so as to be dangerous to other animals. The value of animals so slaughtered as being so exposed to infection but not infected may be ascertained by agreement of the Secretary of Agriculture and the owners thereof if practicable; otherwise, by the appraisal by two persons familiar with the character and value of such property, to be appointed by the Secretary of Agriculture, whose decision, if they agree, shall be final; otherwise, the Secretary of Agriculture shall decide between them, and his decision shall be final. The amount of the value thus ascertained shall be paid to the owner thereof out of money in the Treasury appropriated for the use of the Bureau of Animal Industry; but no payment shall be made for any animal imported in violation of the provisions of this subchapter. If any animal subject to quarantine according to the provisions of this subchapter are brought into any port of the United States where no quarantine station is established, the collector of such port shall require the same to be conveyed, by the vessel on which they are imported or are found to the nearest quarantine station, at the expense of the owner.

(Aug. 30, 1890, ch. 839, §8, 26 Stat. 416.)

References in Text

This subchapter, referred to in text, was in the original “this Act”, meaning act Aug. 30, 1890, ch. 839, 26 Stat. 415, as amended, which is classified to sections 18, and 101 to 105 of this title and section 181 of Title 19, Customs Duties. For complete classification of this Act to the Code, see Tables.

Transfer of Functions

Functions of Bureau of Animal Industry transferred to Secretary of Agriculture by Reorg. Plan No. 1 of 1947, §301, eff. July 1, 1947, 12 F.R. 4534, 61 Stat. 952, set out in the Appendix to Title 5, Government Organization and Employees.

For abolition of the offices of collector of customs, see note set out under section 44 of this title.

Section Referred to in Other Sections

This section is referred to in sections 104, 136a of this title; title 16 section 1540.

§104. Importation of animals

(a) In general

The Secretary of Agriculture may by regulation prohibit or restrict the importation or entry of any cattle, sheep, or other ruminants, or swine, that are diseased or infected with any disease, or that have been exposed to an infection, into or through the United States to prevent the dissemination into the United States of a disease.

(b) Penalties

(1) Criminal

Any person who knowingly violates any regulation promulgated by the Secretary pursuant to this section, or any provision of sections 101, 102, 103, and 105 of this title or any regulation promulgated by the Secretary pursuant to such sections, shall be fined under title 18 or imprisoned not more than 1 year, or both.

(2) Civil

Any person who violates any such provision or any such regulation may be assessed a civil penalty by the Secretary of Agriculture not exceeding $1,000. The Secretary may issue an order assessing the civil penalty only after notice and an opportunity for an agency hearing on the record. The order shall be treated as a final order reviewable under chapter 158 of title 28. The validity of the order may not be reviewed in an action to collect such civil penalty.

(Aug. 30, 1890, ch. 839, §6, 26 Stat. 416; June 28, 1926, ch. 700, §2, 44 Stat. 775; Feb. 28, 1931, ch. 348, 46 Stat. 1460; July 22, 1954, ch. 558, §32, 68 Stat. 510; Jan. 28, 1956, ch. 12, §1, 70 Stat. 5; Jan. 12, 1983, Pub. L. 97–461, §4, 96 Stat. 2524; Dec. 8, 1993, Pub. L. 103–182, title III, §361(b), 107 Stat. 2122; Dec. 8, 1994, Pub. L. 103–465, title IV, §431(h), 108 Stat. 4969.)

Amendments

1994—Pub. L. 103–465 amended section generally. Prior to amendment, section read as follows: “The importation of cattle, sheep, and other ruminants, and swine, which are diseased or infected with any disease, or which shall have been exposed to such infection within sixty days next before their exportation, is prohibited, except that the Secretary of Agriculture, in accordance with such regulations as the Secretary may issue, may (1) permit the importation of cattle, sheep, or other ruminants, and swine, from Canada or Mexico, and (2) permit the importation from the British Virgin Islands into the Virgin Islands of the United States, for slaughter only, of cattle that have been infested with or exposed to ticks on being freed from the ticks. Any person who knowingly violates any provision of this section or sections 101, 102, 103, and 105 of this title or any regulation prescribed by the Secretary of Agriculture under any such section shall be guilty of a misdemeanor and shall, on conviction, be punished by a fine not exceeding $5,000, by imprisonment not exceeding one year, or both. Any person who violates any such provision or any such regulation may be assessed a civil penalty by the Secretary of Agriculture not exceeding $1,000. The Secretary may issue an order assessing such civil penalty only after notice and an opportunity for an agency hearing on the record. Such order shall be treated as a final order reviewable under chapter 158 of title 28. The validity of such order may not be reviewed in an action to collect such civil penalty.”

1993—Pub. L. 103–182 substituted “, except that the Secretary of Agriculture, in accordance with such regulations as the Secretary may issue, may (1) permit the importation of cattle, sheep, or other ruminants, and swine, from Canada or Mexico, and (2) permit the importation from the British Virgin Islands into the Virgin Islands of the United States, for slaughter only, of cattle that have been infested with or exposed to ticks on being freed from the ticks” for “: Provided, That the Secretary of Agriculture, within his discretion and under such regulations as he may prescribe, is authorized to permit the admission from Mexico into the State of Texas of cattle which have been infested with or exposed to ticks upon being freed therefrom, and the admission from the British Virgin Islands into the Virgin Islands of the United States, for slaughter only, of cattle which have been infested with or exposed to ticks upon being freed therefrom”.

1983—Pub. L. 97–461 substituted reference to violation of this section or sections 101, 102, 103, and 105 of this title or any regulation prescribed by the Secretary of Agriculture under any such section, for reference to violation of the foregoing provisions, substituted imprisonment not exceeding one year for imprisonment not exceeding three years, inserted provisions relating to civil penalties, and struck out provision for forfeiture of any vessel used for such importation if the master or owner knew the importation was diseased or had been exposed to infection.

1956—Act Jan. 28, 1956, struck out “and the admission into the Virgin Islands” in proviso and limited importation of cattle into Virgin Islands of the United States to cattle from the British Virgin Islands intended for slaughter.

1954—Act July 22, 1954, inserted “and the admission into the Virgin Islands” in proviso.

1931—Act Feb. 28, 1931, struck out “meat” and substituted “before their exportation” for “before their importation” in provisions relating to the prohibition of importation of diseased or infected animals.

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–465 effective, except as otherwise provided, on the date of entry into force of the World Trade Organization Agreement with respect to the United States [Jan. 1, 1995], see section 451 of Pub. L. 103–465, set out as an Effective Date note under section 3601 of Title 19, Customs Duties.

Effective Date of 1954 Amendment

For effective date of amendment by act July 22, 1954, see section 34 of act July 22, 1954, set out as an Effective Date note under section 1541 of Title 48, Territories and Insular Possessions.

Cross References

Cattle, sheep, swine and meats; importation prohibited in certain cases, see section 1306 of Title 19, Customs Duties.

Section Referred to in Other Sections

This section is referred to in section 136a of this title; title 16 section 1540.

§105. Inspection of animals

The Secretary of Agriculture may cause careful inspection of any imported animals described in this subchapter, to ascertain whether such animals are infected with contagious diseases or have been exposed to infection so as to be dangerous to other animals, which shall then either be placed in quarantine or dealt with according to the regulations of the Secretary of Agriculture. All food, litter, manure, clothing, utensils, and other appliances that have been so related to such animals on board ship as to be judged liable to convey infection shall be dealt with according to the regulations of the Secretary of Agriculture. The Secretary of Agriculture may cause inspection to be made of all animals described in this subchapter intended for exportation, and provide for the disinfection of all vessels engaged in the transportation thereof, and of all barges or other vessels used in the conveyance of such animals intended for export to the ocean steamer or other vessels, and of all attendants and their clothing, and of all headropes and other appliances used in such exportation, by such orders and regulations as he may prescribe; and if, upon such inspection, any such animals shall be adjudged, under the regulations of the Secretary of Agriculture, to be infected or to have been exposed to infection so as to be dangerous to other animals, the Secretary may prohibit or restrict their placement upon any vessel for exportation; the expense of all the inspection and disinfection provided for in this section to be borne by the owners of the vessels on which such animals are exported.

(Aug. 30, 1890, ch. 839, §10, 26 Stat. 417; Dec. 8, 1993, Pub. L. 103–182, title III, §361(c), 107 Stat. 2122; Dec. 8, 1994, Pub. L. 103–465, title IV, §431(i), 108 Stat. 4969.)

References in Text

This subchapter, referred to in text, was in the original “this Act”, meaning act Aug. 30, 1890, ch. 839, 26 Stat. 415, as amended, which is classified to sections 18 and 101 to 105 of this title and section 181 of Title 19, Customs Duties. For complete classification of this Act to the Code, see Tables.

Amendments

1994—Pub. L. 103–465 struck out subsec. (a) heading “In general”, in first sentence, substituted “The” for “Except as provided in subsection (b) of this section, the” and “may cause careful inspection of any” for “shall cause careful inspection to be made by a suitable officer of all”, in third sentence, substituted “the Secretary may prohibit or restrict their placement” for “they shall not be allowed to be placed”, and struck out heading and text of subsec. (b). Prior to amendment, text read as follows: “The Secretary of Agriculture, in accordance with such regulations as the Secretary may issue, may waive any provision of subsection (a) of this section in the case of shipments between the United States and Canada or Mexico.”

1993—Pub. L. 103–182 inserted section catchline, designated existing provisions as subsec. (a), inserted heading and exception to subsec. (b), and added subsec. (b).

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–465 effective, except as otherwise provided, on the date of entry into force of the World Trade Organization Agreement with respect to the United States [Jan. 1, 1995], see section 451 of Pub. L. 103–465, set out as an Effective Date note under section 3601 of Title 19, Customs Duties.

Cross References

Inspection of animals for export, see section 612 et seq. of this title.

Section Referred to in Other Sections

This section is referred to in sections 104, 136a of this title; title 16 section 1540.

§§106, 107. Omitted

Codification

Sections, acts Aug. 10, 1917, ch. 52, §9, 40 Stat. 275; Nov. 21, 1918, ch. 212, §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.

SUBCHAPTER III—PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION

§111. Regulations to prevent contagious diseases

The Secretary of Agriculture shall have authority to make such regulations and take such measures as he may deem proper to prevent the introduction or dissemination of the contagion of any contagious, infectious, or communicable disease of animals and/or live poultry from a foreign country into the United States or from one State or Territory of the United States or the District of Columbia to another, and to seize, quarantine, and dispose of any hay, straw, forage, or similar material, or any meats, hides, or other animal products coming from an infected foreign country to the United States, or from one State or Territory or the District of Columbia in transit to another State or Territory or the District of Columbia whenever in his judgment such action is advisable in order to guard against the introduction or spread of such contagion.

(Feb. 2, 1903, ch. 349, §2, 32 Stat. 792; Feb. 7, 1928, ch. 30, 45 Stat. 59; July 22, 1954, ch. 558, §33, 68 Stat. 510; Jan. 28, 1956, ch. 12, §2, 70 Stat. 5.)

Amendments

1956—Act Jan. 28, 1956, struck out proviso “that no such regulations or measures shall pertain to the introduction of live poultry into the Virgin Islands of the United States”.

1954—Act July 22, 1954, inserted proviso containing an exception with respect to admission of live poultry into the Virgin Islands.

1928—Act Feb. 7, 1928, inserted “and/or live poultry”.

Effective Date of 1954 Amendment

For effective date of amendment by act July 22, 1954, see section 34 of act July 22, 1954, set out as an Effective Date note under section 1541 of Title 48, Territories and Insular Possessions.

Section Referred to in Other Sections

This section is referred to in sections 114g, 122, 136a of this title; title 16 section 1540.

§112. Investigations as to pleuropneumonia, and other diseases; regulations

In order to promote the exportation of livestock and/or live poultry from the United States the Secretary of Agriculture shall make special investigation as to the existence of pleuropneumonia, or any contagious, infectious, or communicable disease, along the dividing lines between the United States and foreign countries, and along the lines of transportation from all parts of the United States to ports from which livestock and/or live poultry are exported, and shall, from time to time, establish such regulations concerning the exportation and transportation of livestock and/or live poultry as the results of said investigations may require.

(May 29, 1884, ch. 60, §4, 23 Stat. 32; Feb. 2, 1903, ch. 349, §1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59.)

Codification

Originally this section and sections 113, 114, 117, 119, 120, and 130 of this title read “Commissioner” instead of “Secretary” of Agriculture, and this section contained between the words “and” and “shall,” the additional words “make report of the results of such investigation to the Secretary of the Treasury, who”.

Designation of office of Commissioner of Agriculture changed by change of department into an executive department under a Secretary of Agriculture, by act Feb. 9, 1889, ch. 122, §1, 25 Stat. 659, set out as section 2202 of Title 7, Agriculture. Authority granted to Commissioner by act May 29, 1884, vested in Secretary of Agriculture by a provision of act July 14, 1890, ch. 707, 26 Stat. 288, set out as section 2205 of Title 7.

Powers conferred on Secretary of the Treasury by act May 29, 1884, were conferred on Secretary of Agriculture by part of section 1 of act Feb. 2, 1903. Remainder of such section 1 is classified to sections 113, 120, and 121 of this title.

Amendments

1928—Act Feb. 7, 1928, inserted “and/or live poultry” after “livestock” wherever appearing.

Short Title

Act Feb. 2, 1903, classified to sections 112 and 120 to 122 of this title, entitled, “An act to enable the Secretary of Agriculture to more effectually suppress and prevent the spread of contagious and infectious diseases of live stock, and for other purposes” is popularly known as the Cattle Contagious Diseases Act of 1903.

Act May 29, 1884, entitled, “An act for the establishment of a Bureau of Animal Industry, to prevent the exportation of diseased cattle, and to provide means for the suppression and extirpation of pleuro-pneumonia and other contagious diseases among domestic animals” is popularly known as the Animal Industry Act. The Act is classified to sections 112, 113 to 114a–1, 115, 116, 117 to 120, and 130 of this title and section 391 of Title 7, Agriculture.

Section Referred to in Other Sections

This section is referred to in sections 113, 114, 118, 119, 136a of this title; title 16 section 1540.

§112a. Omitted

Codification

Section, act Feb. 7, 1928, ch. 30, 45 Stat. 59, amended acts May 29, 1884, ch. 60, 22 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 penalty provisions of said acts to live poultry.

§113. Measures to prevent exportation of diseased livestock and live poultry

In order to prevent the exportation from any port of the United States to any port in a foreign country of livestock and/or live poultry affected with any contagious, infectious, or communicable disease, and especially pleuropneumonia, the Secretary of Agriculture is authorized to take such steps and adopt such measures, not inconsistent with the provisions of this Act, as he may deem necessary.

(May 29, 1884, ch. 60, §5, 23 Stat. 32; Feb. 2, 1903, ch. 349, §1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59.)

References in Text

This Act, referred to in text, is act May 29, 1884, ch. 60, 23 Stat. 31, as amended, which is popularly known as the Animal Industry Act. For complete classification of this Act to the Code, see Short Title note set out under section 112 of this title and Tables.

Codification

Section is comprised of part of section 1 of act Feb. 2, 1903. Remainder of such section 1 is classified to sections 112, 120, and 121 of this title.

Substitution of Secretary of Agriculture for Commissioner of Agriculture, see note set out under section 112 of this title.

Amendments

1928—Act Feb. 7, 1928, inserted “and/or live poultry”.

Section Referred to in Other Sections

This section is referred to in section 136a of this title; title 16 section 1540.

§113a. Establishment of research laboratories for foot-and-mouth disease and other animal diseases; research contracts; employment of technicians and scientists; appropriations

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.

(May 29, 1884, ch. 60, §12, as added Apr. 24, 1948, ch. 229, 62 Stat. 198; amended July 31, 1956, ch. 804, title I, §119, 70 Stat. 742; July 31, 1958, Pub. L. 85–573, 72 Stat. 454; Oct. 11, 1962, Pub. L. 87–793, §1001(e), 76 Stat. 864; Aug. 14, 1964, Pub. L. 88–426, title III, §305(1), 78 Stat. 422; Nov. 28, 1990, Pub. L. 101–624, title XVI, §1618(b), 104 Stat. 3733.)

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, §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.

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, §119, 70 Stat. 742, which increased the maximum compensation of technical experts or scientists, was repealed by Pub. L. 88–426, title III, §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, §101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.

Section Referred to in Other Sections

This section is referred to in sections 113, 114, 118, 119, 136a of this title; title 16 section 1540.

§114. Regulations for suppression of diseases; cooperation of States and Territories

It shall be the duty of the Secretary of Agriculture to prepare such rules and regulations as he may deem necessary for the speedy and effectual suppression and extirpation of pleuropneumonia and other dangerous, contagious, infectious, and communicable diseases, and to certify such rules and regulations to the executive authority of each State and Territory, and invite said authorities to cooperate in the execution and enforcement of the provisions of this Act. Whenever the plans and methods of the Secretary of Agriculture shall be accepted by any State or Territory in which pleuropneumonia or other contagious, infectious, or communicable disease is declared to exist, or such State or Territory shall have adopted plans and methods for the suppression and extirpation of said diseases, and such plans and methods shall be accepted by the Secretary of Agriculture, and whenever the governor of a State or other properly constituted authorities signify their readiness to cooperate for the extinction of any contagious, infectious, or communicable disease in conformity with the provisions of this Act, the Secretary of Agriculture is authorized to expend so much of the money appropriated for carrying out the provisions of this Act as may be necessary in such investigations, and in such disinfection and quarantine measures as may be necessary to prevent the spread of the disease from one State or Territory into another.

(May 29, 1884, ch. 60, §3, 23 Stat. 32.)

References in Text

This Act, referred to in text, is act May 29, 1884, ch. 60, 23 Stat. 31, as amended, which is popularly known as the Animal Industry Act. For complete classification of this Act to the Code, see Short Title note set out under section 112 of this title and Tables.

Codification

Substitution of Secretary of Agriculture for Commissioner of Agriculture, see note set out under section 112 of this title.

Extension of Provisions to Live Poultry

Act Feb. 7, 1928, ch. 30, 45 Stat. 59, extended the provisions of this section to live poultry.

Section Referred to in Other Sections

This section is referred to in sections 113, 118, 119, 136a of this title; title 16 section 1540.

§114a. Control and eradication of diseases; cooperation of States and farmers’ associations; purchase and destruction of diseased animals; “State” defined

The Secretary of Agriculture, either independently or in cooperation with States or political subdivisions thereof, farmers’ associations and similar organizations, and individuals, is authorized to control and eradicate any communicable diseases of livestock or poultry, including, but not limited to, tuberculosis and paratuberculosis of animals, avian tuberculosis, brucellosis of domestic animals, southern cattle ticks, hog cholera and related swine diseases, scabies in sheep and cattle, dourine in horses, scrapie and blue tongue in sheep, incipient or potentially serious minor outbreaks of diseases of animals, and contagious or infectious diseases of animals (such as foot-and-mouth disease, rinderpest, and contagious pleuropneumonia) which in the opinion of the Secretary constitute an emergency and threaten the livestock industry of the country, including the payment of claims growing out of destruction of animals (including poultry), and of materials, affected by or exposed to any such disease, in accordance with such regulations as the Secretary may prescribe. The Secretary of Agriculture is authorized to prescribe and collect fees to recover the costs of carrying out the provisions of this section which relate to veterinary diagnostics. As used in this section, the term “State” includes the District of Columbia, Puerto Rico, and the Territories and possessions of the United States.

(May 29, 1884, ch. 60, §11, as added Sept. 21, 1944, ch. 412, title I, §101(a), 58 Stat. 734; amended Oct. 30, 1951, ch. 637, §1, 65 Stat. 693; Aug. 8, 1953, ch. 381, 67 Stat. 493; Aug. 3, 1956, ch. 950, §2, 70 Stat. 1032; July 2, 1962, Pub. L. 87–518, §7, 76 Stat. 131; Nov. 28, 1990, Pub. L. 101–624, title XXV, §2509(c)(2), 104 Stat. 4071.)

Prior Provisions

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, §1, 45 Stat. 993.

Amendments

1990—Pub. L. 101–624 inserted after first sentence “The Secretary of Agriculture is authorized to prescribe and collect fees to recover the costs of carrying out the provisions of this section which relate to veterinary diagnostics.”

1962—Pub. L. 87–518 inserted “any communicable diseases of livestock or poultry, including, but not limited to,” after “eradicate”.

1956—Act Aug. 3, 1956, authorized payment of claims for destruction of material affected or exposed to disease.

1953—Act Aug. 8, 1953, provided for control and eradication of scrapie and blue tongue in sheep, as well as incipient and potentially serious minor outbreaks of diseases of animals.

1951—Act Oct. 30, 1951, substituted “brucellosis of domestic animals” for “Bang's disease of cattle”.

Appropriations

Section 101(g) of act Sept. 21, 1944, provided that Congress may appropriate such funds as are necessary to accomplish the purpose of this section.

Section Referred to in Other Sections

This section is referred to in sections 113, 114, 114c, 114g, 118, 119, 136a of this title; title 16 section 1540.

§114a–1. Interstate movement of domestic animals reacting to tests for brucellosis; immediate slaughter; rules and regulations

Domestic animals which have reacted to a test recognized by the Secretary of Agriculture for paratuberculosis or which, never having been vaccinated for brucellosis, have reacted to a test recognized by the Secretary of Agriculture for brucellosis, may be shipped, transported, or otherwise moved from one State, Territory, or the District of Columbia to any other State, Territory, or the District of Columbia for immediate slaughter in accordance with such rules and regulations as the Secretary of Agriculture may prescribe to prevent the dissemination of said diseases from one State, Territory, or the District of Columbia to any other State, Territory, or the District of Columbia. The Secretary of Agriculture may, in his discretion and under such rules and regulations as he may prescribe, permit domestic animals which have been moved from one State, Territory, or the District of Columbia to any other State, Territory, or the District of Columbia, for breeding purposes, and which, subsequent to such movement, have reacted to a test for brucellosis or paratuberculosis recognized by the Secretary of Agriculture, to be reshipped in interstate commerce to the original owner at the point of origin.

(May 29, 1884, ch. 80, §13, as added Oct. 30, 1951, ch. 637, §2, 65 Stat. 693.)

Section Referred to in Other Sections

This section is referred to in sections 113, 114, 118, 119, 136a of this title; title 16 section 1540.

§114b. Cooperation in animal disease control

The Secretary of Agriculture is authorized to cooperate with the Governments of foreign countries, and with foreign or international organizations or associations in carrying out operations or measures to eradicate, suppress, or control, or to prevent or retard, any communicable disease of animals or vectors thereof, including but not limited to foot-and-mouth disease, rinderpest, or screwworm in such countries where he deems such action necessary to protect the livestock, poultry, and related industries of the United States. In performing the operations or measures authorized in sections 114b to 114d–1 of this title, the Governments of such countries shall be responsible for the authority necessary to carry out such operations or measures on all lands and properties therein and for such other facilities and means as in the discretion of the Secretary of Agriculture are necessary. The measure and character of cooperation carried out under said sections on the part of the United States and on the part of the Governments of such countries, including the expenditure or use of funds appropriated pursuant to said sections, shall be such as may be prescribed by the Secretary of Agriculture. Arrangements for the cooperation authorized by said sections shall be made through and in consultation with the Secretary of State. The authority contained in said sections is in addition to and not in substitution for the authority of existing law.

(Feb. 28, 1947, ch. 8, §1, 61 Stat. 7; July 27, 1966, Pub. L. 89–521, §1, 80 Stat. 330; Nov. 5, 1971, Pub. L. 92–152, §1, 85 Stat. 418; Mar. 15, 1976, Pub. L. 94–231, §3, 90 Stat. 216; Mar. 15, 1990, Pub. L. 101–255, §1(1), 104 Stat. 114; Nov. 28, 1990, Pub. L. 101–624, title XXV, §2505, 104 Stat. 4068.)

Amendments

1990—Pub. L. 101–624 substituted “foreign countries” for “Mexico, Guatemala, El Salvador, Costa Rica, Honduras, Nicaragua, Belize, Panama, Colombia, and Canada, the Bahama Islands, the Greater Antilles, and the Lesser Antilles” and inserted “foreign or” before “international”.

Pub. L. 101–255 inserted section catchline and substituted “screwworm” for “screw-worm” in text.

1976—Pub. L. 94–231 substituted “Belize” for “British Honduras”, inserted “, the Bahama Islands, the Greater Antilles, and the Lesser Antilles, and with international organizations or associations” after “Canada”, and inserted “or vectors thereof” after “any communicable disease of animals”.

1971—Pub. L. 92–152 made provisions applicable to and authorized cooperation of Secretary of Agriculture with Governments of Guatemala, El Salvador, Costa Rica, Honduras, Nicaragua, British Honduras, Panama, Columbia, and Canada, directed operations and measures to be taken against communicable diseases of animals, and included protection of poultry within its scope.

1966—Pub. L. 89–521 authorized the Secretary of Agriculture to cooperate in screw-worm eradication in Mexico.

Short Title

Section 6 of act Feb. 28, 1947, as added by Pub. L. 101–255, §1(6), Mar. 15, 1990, 104 Stat. 114, provided that: “This Act [enacting this section and sections 114c to 114d–1 of this title and provisions set out as a note under this section] may be referred to as the ‘Animal Disease Control Cooperation Act of 1947’.”

Appropriations

Act Mar. 27, 1947, ch. 22, 61 Stat. 24, provided for an appropriation of $9,000,000 to carry out the provisions of this section during fiscal year 1947.

Section 4 of act Feb. 28, 1947, as amended by Pub. L. 101–255, §1(4), Mar. 15, 1990, 104 Stat. 114, provided: “There are authorized to be appropriated such sums as may be necessary to carry out this Act [sections 114b to 114d of this title].”

Section Referred to in Other Sections

This section is referred to in sections 114c, 114d, 114d–1, 129, 136a of this title; title 7 section 147b; title 16 section 1540.

§114c. Use of funds

For purposes of sections 114a, and 114b to 114d–1 of this title, insofar as sections 114b to 114d–1 of this title relate to diseases which in the opinion of the Secretary constitute an emergency and threaten the livestock industry of the country, funds appropriated pursuant thereto may also be used for the purchase or hire of passenger motor vehicles and aircraft, for printing and binding without regard to section 501 of title 44, for personal services in the District of Columbia and elsewhere without regard to the limitations contained in section 607(g) of the Federal Employees Pay Act of 1945, as amended, including the employment of civilian nationals of Mexico, Guatemala, El Salvador, Costa Rica, Honduras, Nicaragua, British Honduras, Panama, Columbia, and Canada, and for the construction and operation of research laboratories, quarantine stations and other buildings and facilities.

(Feb. 28, 1947, ch. 8, §2, 61 Stat. 7; Aug. 3, 1956, ch. 950, §3, 70 Stat. 1033; Nov. 5, 1971, Pub. L. 92–152, §2, 85 Stat. 419; Mar. 15, 1990, Pub. L. 101–255, §1(2), 104 Stat. 114.)

References in Text

Section 607(g) of the Federal Employees Pay Act of 1945, as amended [former 5 U.S.C. 947(g)], referred to in text, was repealed by act Sept. 12, 1950, ch. 946, title III, §301(85), 64 Stat. 843.

Codification

“Section 501 of title 44” substituted in text for “section 87 of the Act of January 12, 1895, or section 11 of the Act of March 1, 1919 (U.S.C., title 44, sec. 111)” on authority of Pub. L. 90–620, §2(b), Oct. 22, 1968, 82 Stat. 1305, the first section of which enacted Title 44, Public Printing and Documents.

Amendments

1990—Pub. L. 101–255 inserted section catchline.

1971—Pub. L. 92–152 provided for use of funds for employment of civilian nationals of Guatemala, El Salvador, Costa Rica, Honduras, Nicaragua, British Honduras, Panama, Columbia, and Canada.

1956—Act Aug. 3, 1956, inserted “and section 114a of this title, insofar as sections 114b–114d of this title relate to diseases which in the opinion of the Secretary constitute an emergency and threaten the livestock industry of the country” in first sentence.

Section Referred to in Other Sections

This section is referred to in sections 114b, 114d–1, 129, 136a of this title; title 16 section 1540.

§114d. Sale of sterile screwworms

(a) In general

Notwithstanding section 114b of this title, the Secretary of Agriculture may, independently or in cooperation with any foreign government or any international organization or association, produce and sell sterile screwworms to any foreign government or to any international organization or association, if the Secretary determines that the protection of livestock and related industries of the United States will not be adversely affected by such production and sale.

(b) Terms of sale

The Secretary may provide for the sale of screwworms under subsection (a) of this section under such terms and conditions as the Secretary considers appropriate.

(c) Deposit of proceeds

(1) Independent sales

If the Secretary independently produces and sells screwworms under subsection (a) of this section, the proceeds of such sales shall be deposited in the Treasury of the United States and be credited to the appropriation from which the operating expenses of the facility producing the screwworms have been paid.

(2) Cooperative sales

If the Secretary produces and sells screwworms in cooperation with a foreign government or an international organization or association, the proceeds of such sale shall be divided between the United States and such government, organization, or association, as determined by the Secretary, and the United States portion of such proceeds shall be deposited into the Treasury of the United States and be credited to the appropriation from which the operating expenses of the facility producing the screwworms have been paid.

(Feb. 28, 1947, ch. 8, §3, as added Mar. 15, 1990, Pub. L. 101–255, §1(3), 104 Stat. 114.)

Prior Provisions

A prior section 114d, act Feb. 28, 1947, ch. 8, §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, §1(20), June 29, 1960, 74 Stat. 249.

§114d–1. Cooperation with public and private entities

In carrying out sections 114b to 114d–1 of this title the Secretary of Agriculture is further authorized to cooperate with other public and private organizations and individuals.

(Feb. 28, 1947, ch. 8, §5, as added July 27, 1966, Pub. L. 89–521, §2, 80 Stat. 330; amended Mar. 15, 1990, Pub. L. 101–255, §1(5), 104 Stat. 114.)

Amendments

1990—Pub. L. 101–255 inserted section catchline.

Section Referred to in Other Sections

This section is referred to in sections 114b, 114c, 129, 136a of this title; title 16 section 1540.

§§114d–2 to 114d–6. Repealed. Pub. L. 92–152, §3, Nov. 5, 1971, 85 Stat. 419

Section 114d–2, Pub. L. 90–388, §1, July 6, 1968, 82 Stat. 294, provided for cooperation with Central America in control and eradication of foot-and-mouth disease or rinderpest. See section 114b of this title.

Section 114d–3, Pub. L. 90–388, §2, July 6, 1968, 82 Stat. 294, provided for uses of funds. See section 114c of this title.

Section 114d–4, Pub. L. 90–388, §3, July 6, 1968, 82 Stat. 294, defined governments of Central America. See sections 114b and 114c of this title.

Section 114d–5, Pub. L. 90–388, §4, July 6, 1968, 82 Stat. 294, provided for cooperation with public and private organizations and individuals. See section 114d–1 of this title.

Section 114d–6, Pub. L. 90–388, §5, July 6, 1968, 82 Stat. 294, provided for authorization of appropriations. See Appropriations note set out under section 114b of this title.

§114e. Control and eradication of cattle grubs; research and investigations

In order to protect, promote, and conserve livestock and livestock products and to minimize losses, the Secretary of Agriculture, either independently or in cooperation with States or subdivisions thereof, farmers’ associations, and other organizations and individuals, it 1 is authorized to increase and intensify research and investigations into problems and methods relating to the eradication of cattle grubs and to undertake measures to eradicate these parasites.

(June 16, 1948, ch. 477, §1, 62 Stat. 458.)

Section Referred to in Other Sections

This section is referred to in sections 114f, 136a of this title; title 16 section 1540.

1 So in original.

§114f. “State” defined; authorization of appropriations

As used in section 114e of this title, the term “State” includes the District of Columbia and the Territories and possessions of the United States. There is authorized to be appropriated such sums as may be necessary to carry out section 114e of this title. Funds appropriated pursuant to this section shall be expended in accordance with procedures prescribed by the Secretary.

(June 16, 1948, ch. 477, §2, 62 Stat. 458.)

Section Referred to in Other Sections

This section is referred to in section 136a of this title; title 16 section 1540.

§114g. Hog cholera eradication program

In order to safeguard the health of the swine herds of the Nation, to prevent the spread of hog cholera, to decrease substantially the estimated $50,000,000 annual loss from hog cholera, to expand export markets for pork and pork products now restricted on account of hog cholera, and to otherwise protect the public interest, the Secretary of Agriculture is directed (1) to initiate a national hog cholera eradication program in cooperation with the several States under the provisions of section 114a of this title and related legislation, and (2) to prohibit or restrict, pursuant to the authority vested in him under the provisions of section 111 of this title the interstate movement of virulent hog cholera virus or other hog cholera virus to the extent he determines necessary in order to effectuate such eradication program.

(Pub. L. 87–209, §1, Sept. 6, 1961, 75 Stat. 481.)

Section Referred to in Other Sections

This section is referred to in sections 114h, 136a of this title; title 16 section 1540.

§114h. Advisory committee

(a) Establishment; membership

The Secretary of Agriculture is authorized and directed to establish an advisory committee composed of (1) eleven members selected from representatives of the swine and related industries, State and local government agencies, professional and scientific groups, and the general public, and (2) one member selected from the officers and employees of the Department of Agriculture who shall serve as chairman of the Committee. The Committee shall meet at the call of the Secretary.

(b) Functions

It shall be the function of the Committee to advise the Secretary with respect to the initiation of the national hog cholera eradication program referred to in section 114g of this title, and with respect to the development of plans and procedures for carrying out such program.

(c) Employment status; expenses

Committee members other than the chairman shall not be deemed to be employees of the United States and shall not be entitled to compensation, but the Secretary is authorized to pay their travel and subsistence expenses (or per diem in lieu thereof) in connection with their attendance at meetings of the Committee.

(Pub. L. 87–209, §2, Sept. 6, 1961, 75 Stat. 481.)

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by the Congress, its duration is otherwise provided by law. See section 14 of Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title 5, Government Organization and Employees.

Section Referred to in Other Sections

This section is referred to in section 136a of this title; title 16 section 1540.

§114i. Pseudorabies eradication

(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 1995 such sums as may be necessary for the purpose of carrying out the program established under subsection (b) of this section.

(Pub. L. 101–624, title XXV, §2506, Nov. 28, 1990, 104 Stat. 4068.)

§115. Transportation of diseased livestock and live poultry prohibited

No railroad company within the United States, or the owners or masters of any steam or sailing or other vessel or boat, shall receive for transportation or transport from one State or Territory to another, or from any State into the District of Columbia, or from the District into any State, any livestock and/or live poultry affected with any contagious, infectious, or communicable disease, and especially the disease known as pleuropneumonia; nor shall any person, company, or corporation deliver for such transportation to any railroad company, or master or owner of any boat or vessel, any livestock and/or live poultry, knowing them to be affected with any contagious, infectious, or communicable disease; nor shall any person, company, or corporation drive on foot, or transport in private conveyance from one State or Territory to another, or from any State into the District of Columbia, or from the District into any State, any livestock and/or live poultry, knowing them to be affected with any contagious, infectious, or communicable disease, and especially the disease known as pleuropneumonia: Provided, That such livestock or poultry may be so delivered and received for such transportation and so transported and moved if the Secretary of Agriculture determines that such action will not endanger the livestock or poultry of the United States and authorizes such action, and such delivery, receipt, transportation, and movement are made in strict compliance with such rules and regulations as the Secretary of Agriculture may prescribe to protect the livestock and poultry of the United States.

(May 29, 1884, ch. 60, §6, 23 Stat. 32; June 28, 1926, ch. 700, §1, 44 Stat. 774; Feb. 7, 1928, ch. 30, 45 Stat. 59; Oct. 9, 1962, Pub. L. 87–763, 76 Stat. 762.)

Codification

Act May 29, 1884, as amended by act June 28, 1926, also contained the following proviso: “That until May 1, 1928, cattle infested with or exposed to cattle fever ticks may be shipped in interstate commerce for immediate slaughter after one dipping in accordance with such regulations as the Secretary of Agriculture may prescribe.”

Amendments

1962—Pub. L. 87–763 inserted proviso permitting such livestock or poultry to be delivered and received for transportation and so transported and moved if the Secretary determines that such action will not endanger the livestock or poultry of the United States and authorizes such action, and such delivery, receipt, transportation, and movement are made in strict compliance with such rules and regulations as the Secretary may prescribe.

1928—Act Feb. 7, 1928, inserted “and/or live poultry” after “livestock” wherever appearing.

1926—Act June 28, 1926, struck out provision deeming splenetic or Texas fever not a communicable disease as to cattle unloaded only to be fed and watered on the way by rail to market for slaughter.

Section Referred to in Other Sections

This section is referred to in sections 113, 114, 117, 118, 119, 136a of this title; title 16 section 1540.

§116. Shipment of certain cattle excepted

Cattle which have reacted to the tuberculin test may be shipped, transported, or moved from one State, Territory, or the District of Columbia to any other State, Territory, or the District of Columbia, for immediate slaughter, in accordance with such rules and regulations as shall be prescribed by the Secretary of Agriculture. The said Secretary of Agriculture may, in his discretion, and under such rules and regulations as he may prescribe, permit cattle which have been shipped for breeding or feeding purposes from one State, Territory, or the District of Columbia to another State, Territory, or the District of Columbia, and which have reacted to the tuberculin test subsequent to such shipment, to be reshipped in interstate commerce to the original owner.

(May 29, 1884, ch. 60, 23 Stat. 31; May 31, 1920, ch. 217, 41 Stat. 699.)

Amendments

1920—Act May 31, 1920, amended act May 29, 1884, without amending any particular section thereof, by enacting provisions set out as this section. For classification of act May 29, 1884, to the Code, see Short Title note set out under section 112 of this title and Tables.

Section Referred to in Other Sections

This section is referred to in section 136a of this title; title 16 section 1540.

§117. Penalties for transportation of diseased livestock or live poultry

(a) Criminal penalty

Any person or persons operating any railroad, or master or owner of any boat or vessel, or owner or custodian of, or person having control over, cattle or other livestock or live poultry who shall knowingly violate the provisions of section 115 of this title or the rules and regulations prescribed by the Secretary of Agriculture under such section shall be guilty of a misdemeanor and, upon conviction, shall be punished by a fine of not more than $5,000 or by imprisonment for not more than one year, or by both such fine and imprisonment.

(b) Civil penalty

Any person or persons operating any railroad, or master or owner of any boat or vessel, or owner or custodian of, or person having control over, cattle or other livestock or live poultry who shall violate the provisions of section 115 of this title or the rules and regulations prescribed by the Secretary of Agriculture under such section may be assessed a civil penalty by the Secretary of not more than $1,000. The Secretary may issue an order assessing such civil penalty only after notice and an opportunity for an agency hearing on the record. Such order shall be treated as a final order reviewable under chapter 158 of title 28. The validity of such order may not be reviewed in an action to collect such civil penalty.

(May 29, 1884, ch. 60, §7, 23 Stat. 32; Feb. 7, 1928, ch. 30, 45 Stat. 59; Oct. 10, 1978, Pub. L. 95–439, §1, 92 Stat. 1061; Jan. 12, 1983, Pub. L. 97–461, §5, 96 Stat. 2524.)

Amendments

1983—Pub. L. 97–461 designated existing provisions as subsec. (a), inserted “or the rules and regulations prescribed by the Secretary of Agriculture under such section” after “title”, and added subsec. (b).

1978—Pub. L. 95–439 struck out provision requiring the Secretary of Agriculture to notify in writing the proper officials of any railroad, steamboat, or other transportation company doing business in an infected area of the existence of a contagion and to publish in newspapers the existence of a contagion.

1928—Act Feb. 7, 1928, inserted “and/or live poultry” after “livestock”.

Section Referred to in Other Sections

This section is referred to in sections 113, 114, 118, 119, 136a of this title; title 16 section 1540.

§118. Duty of United States attorneys

It shall be the duty of the several United States attorneys to prosecute all violations of this Act which shall be brought to their notice or knowledge by any person making the complaint under oath; and the same shall be heard before any district court of the United States or Territorial court holden within the district in which such violation of this Act has been committed.

(May 29, 1884, ch. 60, §9, 23 Stat. 33; June 25, 1948, ch. 646, §1, 62 Stat. 909.)

References in Text

This Act, referred to in text, is act May 29, 1884, ch. 60, 23 Stat. 31, as amended, which is popularly known as the Animal Industry Act. For complete classification of this Act to the Code, see Short Title note set out under section 112 of this title and Tables.

Change of Name

Act June 25, 1948, eff. Sept. 1, 1948, substituted “United States attorneys” for “United States district attorneys”. See section 541 of Title 28, Judiciary and Judicial Procedure.

Repeals

Act June 25, 1948, ch. 646, §39, 62 Stat. 992, repealed act Mar. 3, 1911, ch. 231, §289, 36 Stat. 1167, formerly cited as a credit to this section.

Extension of Provisions to Live Poultry

Act Feb. 7, 1928, ch. 30, 45 Stat. 59, extended the provisions of this section to live poultry.

Federal Rules of Criminal Procedure

Special venue provisions of section as not affected by rule 18, see Notes of Advisory Committee on Rules set out under rule 18, Title 18, Appendix, Crimes and Criminal Procedure.

Section Referred to in Other Sections

This section is referred to in section 136a of this title; title 16 section 1540.

§119. Agents to examine and report on methods of treatment of animals, and means for suppression of diseases

The Secretary of Agriculture is authorized to appoint two competent agents, who shall be practical stock raisers or experienced business men familiar with questions pertaining to commercial transactions in livestock and/or live poultry, whose duty it shall be, under the instructions of the said Secretary of Agriculture, to examine and report upon the best methods of treating, transporting, and caring for animals, and the means to be adopted for the suppression and extirpation of contagious pleuropneumonia, and to provide against the spread of other dangerous contagious, infectious, and communicable diseases. The compensation of said agents shall be at the rate of $10 per diem, with all necessary expenses, while engaged in the actual performance of their duties under this Act, when absent from their usual place of business or residence as such agent.

(May 29, 1884, ch. 60, §2, 23 Stat. 31; Feb. 9, 1889, ch. 122, §1, 25 Stat. 659; July 14, 1890, ch. 707, 26 Stat. 288; Feb. 7, 1928, ch. 30, 45 Stat. 59.)

References in Text

This Act, referred to in text, is act May 29, 1884, ch. 60, 23 Stat. 31, as amended, which is popularly known as the Animal Industry Act. For complete classification of this Act to the Code, see Short Title note set out under section 112 of this title and Tables.

Codification

Substitution of Secretary of Agriculture for Commissioner of Agriculture, see note set out under section 112 of this title.

Amendments

1928—Act Feb. 7, 1928, inserted “and/or live poultry” after “livestock”.

Section Referred to in Other Sections

This section is referred to in sections 113, 114, 118, 136a of this title; title 16 section 1540.

§120. Regulation of exportation and transportation of infected livestock and live poultry

In order to enable the Secretary of Agriculture to effectually suppress and extirpate contagious pleuropneumonia, foot-and-mouth disease, and other dangerous contagious, infectious, and communicable diseases in cattle and other livestock and/or live poultry, and to prevent the spread of such diseases, he is authorized and directed from time to time to establish such rules and regulations concerning the exportation and transportation of livestock and/or live poultry from any place within the United States where he may have reason to believe such diseases may exist into and through any State or Territory, and into and through the District of Columbia and to foreign countries as he may deem necessary, and all such rules and regulations shall have the force of law.

(May 29, 1884, ch. 60, §§4, 5, 23 Stat. 32; Feb. 2, 1903, ch. 349, §1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59.)

Codification

Section is comprised of part of section 1 of act Feb. 2, 1903. Remainder of such section 1 is classified to sections 112, 113, and 121 of this title. The words “including the Indian Territory” which followed the word “Territory” in the original text of this section were omitted as obsolete.

Substitution of Secretary of Agriculture for Commissioner of Agriculture, see note set out under section 112 of this title.

Amendments

1928—Act Feb. 7, 1928, inserted “and/or live poultry” after “livestock” wherever appearing.

Section Referred to in Other Sections

This section is referred to in sections 113, 114, 118, 119, 121, 122, 136a of this title; title 16 section 1540.

§121. Shipments from areas suspected infected; control of animals and live poultry

Whenever any inspector or assistant inspector of the Bureau of Animal Industry shall issue a certificate showing that such officer had inspected any cattle or other livestock and/or live poultry which were about to be shipped, driven, or transported from such locality to another as stated in section 120 of this title, and had found them free from Texas or splenetic fever infection, pleuropneumonia, foot-and-mouth disease, or any other infectious, contagious, or communicable disease, such animals, so inspected and certified, may be shipped, driven, or transported from such place into and through any State or Territory, and into and through the District of Columbia, or they may be exported from the United States without further inspection or the exaction of fees of any kind, except such as may at any time be ordered or exacted by the Secretary of Agriculture; and all such animals shall at all times be under the control and supervision of the Bureau of Animal Industry of the Agricultural Department for the purposes of such inspection.

(Feb. 2, 1903, ch. 349, §1, 32 Stat. 791; Feb. 7, 1928, ch. 30, 45 Stat. 59.)

Codification

Section is comprised of part of section 1 of act Feb. 2, 1903. Remainder of such section 1 is classified to sections 112, 113 and 120 of this title.

The words “including the Indian territory” which followed “Territory” in the original text of this section were omitted as obsolete.

Amendments

1928—Act Feb. 7, 1928, inserted “and/or live poultry” after “livestock”.

Section Referred to in Other Sections

This section is referred to in sections 122, 136a of this title; title 16 section 1540.

§122. Offenses; penalty

Any person, company, or corporation knowingly violating the provisions of this Act or the orders or regulations made in pursuance thereof shall be guilty of a misdemeanor, and on conviction shall be punished by a fine of not less than one hundred dollars nor more than five thousand dollars, or by imprisonment not more than one year, or by both such fine and imprisonment. Any person, company, or corporation violating such provisions, orders, or regulations may be assessed a civil penalty by the Secretary of Agriculture of not more than one thousand dollars. The Secretary may issue an order assessing such civil penalty only after notice and an opportunity for an agency hearing on the record. Such order shall be treated as a final order reviewable under chapter 158 of title 28. The validity of such order may not be reviewed in an action to collect such civil penalty.

(Feb. 2, 1903, ch. 349, §3, 32 Stat. 792; Jan. 12, 1983, Pub. L. 97–461, §6, 96 Stat. 2525.)

References in Text

This Act, referred to in text, is act Feb. 2, 1903, ch. 349, 32 Stat. 791, as amended, which enacted sections 111, 121, and 122 of this title and amended sections 112, 113, and 120 of this title. For complete classification of this Act to the Code, see Tables.

Amendments

1983—Pub. L. 97–461 substituted “five thousand dollars” for “one thousand dollars” and inserted provisions relating to a civil penalty.

Extension of Provisions to Live Poultry

Act Feb. 7, 1928, ch. 30, 45 Stat. 59, extended the provisions of this section to live poultry.

Section Referred to in Other Sections

This section is referred to in section 136a of this title; title 16 section 1540.

§123. Quarantine

The Secretary of Agriculture is authorized to quarantine by regulation any State or Territory or the District of Columbia, or any portion of any State or Territory or the District of Columbia, when he shall determine the fact that any animals or live poultry in such State or Territory or District of Columbia are affected with any contagious, infectious, or communicable disease of livestock or poultry or that the contagion of any such disease exists or that vectors which may disseminate any such disease exist in such State or Territory or the District of Columbia.

(Mar. 3, 1905, ch. 1496, §1, 33 Stat. 1264; Feb. 7, 1928, ch. 30, 45 Stat. 59; July 2, 1962, Pub. L. 87–518, §8(a), 76 Stat. 131; Oct. 10, 1978, Pub. L. 95–439, §2, 92 Stat. 1061.)

Amendments

1978—Pub. L. 95–439 struck out provision requiring the Secretary of Agriculture to give written notice of the establishment of quarantine to the proper officials of railroads, steamboats, or other transportation systems and to publish notice of the establishment of quarantine in newspapers in the quarantined State or Territory or the District of Columbia.

1962—Pub. L. 87–518 authorized quarantine upon the determination that any animals or poultry are affected with a communicable disease of livestock or poultry or that the contagion of any such disease exists or that vectors which may disseminate any such disease exist.

1928—Act Feb. 7, 1928, inserted “and/or live poultry” after “livestock”.

Short Title

This section and sections 124 to 127 of this title are from act Mar. 3, 1905, entitled “An act to enable the Secretary of Agriculture to establish and maintain quarantine districts, to permit and regulate the movement of cattle and other live stock therefrom, and for other purposes and constitute the Cattle Contagious Diseases Act of 1905.”

Section Referred to in Other Sections

This section is referred to in sections 128, 136a of this title; title 16 section 1540.

§124. Transportation or delivery therefor from quarantined State or Territory or portion thereof, of quarantined animals and live poultry, forbidden

No railroad company or the owners or masters of any steam or sailing or other vessel or boat shall receive for transportation or transport from any quarantined State or Territory or the District of Columbia, or from the quarantined portion of any State or Territory or the District of Columbia, into any other State or Territory or the District of Columbia, any quarantined animals, and/or live poultry, except as hereinafter provided; nor shall any person, company, or corporation deliver for such transportation to any railroad company, or to the master or owner of any boat or vessel, any quarantined animals and/or live poultry, except as hereinafter provided; nor shall any person, company, or corporation drive on foot, or cause to be driven on foot, or transport in private conveyance or cause to be transported in private conveyance, from a quarantined State or Territory or the District of Columbia, or from the quarantined portion of any State or Territory or the District of Columbia, into any other State or Territory or the District of Columbia, and quarantined animals and/or live poultry, except as hereinafter provided.

(Mar. 3, 1905, ch. 1496, §2, 33 Stat. 1264; Feb. 7, 1928, ch. 30, 45 Stat. 59; July 2, 1962, Pub. L. 87–518, §8(b), 76 Stat. 131.)

Amendments

1962—Pub. L. 87–518 substituted “quarantined animals” for “cattle or other livestock” wherever appearing.

1928—Act Feb. 7, 1928, inserted “and/or live poultry” after “livestock” wherever appearing.

Section Referred to in Other Sections

This section is referred to in sections 127, 128, 136a of this title; title 16 section 1540.

§125. Regulations for inspection, disinfection, and certification, and delivery and shipment of quarantined animals and live poultry from State or Territory

It shall be the duty of the Secretary of Agriculture, and he is authorized and directed, when the public safety will permit, to make and promulgate rules and regulations which shall permit and govern the inspection, disinfection, certification, treatment, handling, and method and manner of delivery and shipment of quarantined animals or live poultry from a quarantined State or Territory or the District of Columbia, and from the quarantined portion of any State or Territory or the District of Columbia, into any other State or Territory or the District of Columbia.

(Mar. 3, 1905, ch. 1496, §3, 33 Stat. 1265; Feb. 7, 1928, ch. 30, 45 Stat. 59; July 2, 1962, Pub. L. 87–518, §8(b), 76 Stat. 131; Oct. 10, 1978, Pub. L. 95–439, §3, 92 Stat. 1061.)

Amendments

1978—Pub. L. 95–439 struck out provision requiring the Secretary of Agriculture to give notice of rules and regulations in the manner prescribed in section 123 of this title for notice of establishment of quarantine.

1962—Pub. L. 87–518 substituted “quarantined animals” for “cattle or other livestock”.

1928—Act Feb. 7, 1928, inserted “and/or live poultry” after “livestock”.

Section Referred to in Other Sections

This section is referred to in sections 126, 128, 136a of this title; title 16 section 1540.

§126. Moving quarantined animals and live poultry from State or Territory, under regulations

Quarantined animals and/or live poultry may be moved from a quarantined State or Territory or the District of Columbia, or from the quarantined portion of any State or Territory or the District of Columbia, into any other State or Territory or the District of Columbia, under and in compliance with the rules and regulations of the Secretary of Agriculture, made and promulgated in pursuance of the provisions of section 125 of this title; but it shall be unlawful to move, or to allow to be moved, any quarantined animals and/or live poultry from any quarantined State or Territory or the District of Columbia, or from the quarantined portion of any State or Territory or the District of Columbia, into any other State or Territory or the District of Columbia, in manner or method or under conditions other than those prescribed by the Secretary of Agriculture.

(Mar. 3, 1905, ch. 1496, §4, 33 Stat. 1265; Feb. 7, 1928, ch. 30, 45 Stat. 59; July 2, 1962, Pub. L. 87–518, §8(b), 76 Stat. 131.)

Amendments

1962—Pub. L. 87–518 substituted “quarantined animals” for “cattle or other livestock” wherever appearing.

1928—Act Feb. 7, 1928, inserted “and/or live poultry” after “livestock” wherever appearing.

Section Referred to in Other Sections

This section is referred to in sections 127, 128, 136a of this title; title 16 section 1540.

§127. Transportation from quarantined State, Territory, etc.; penalty

Any person, company, or corporation violating the provisions of sections 124 or 126 of this title shall be guilty of a misdemeanor, and on conviction shall be punished by a fine of not less than one hundred dollars nor more than five thousand dollars, or by imprisonment not more than one year, or by both such fine and imprisonment. Any person, company, or corporation violating such provisions may be assessed a civil penalty by the Secretary of Agriculture of not more than one thousand dollars. The Secretary may issue an order assessing such civil penalty only after notice and an opportunity for an agency hearing on the record. Such order shall be treated as a final order reviewable under chapter 158 of title 28. The validity of such order may not be reviewed in an action to collect such civil penalty.

(Mar. 3, 1905, ch. 1496, §6, 33 Stat. 1265; Jan. 12, 1983, Pub. L. 97–461, §7, 96 Stat. 2525.)

Amendments

1983—Pub. L. 97–461 substituted “five thousand dollars” for “one thousand dollars” and inserted provisions relating to a civil penalty.

Extension of Provisions to Live Poultry

Act Feb. 7, 1928, ch. 30, 45 Stat. 59, extended the provisions of this section to live poultry.

Section Referred to in Other Sections

This section is referred to in sections 128, 136a of this title; title 16 section 1540.

§128. Extension of quarantine law to carriers in interstate commerce

The provisions of sections 123 to 127 of this title shall apply to any railroad company or other common carrier whose road or line forms any part of a route over which quarantined animals are transported in the course of shipment from any quarantined State or Territory or the District of Columbia, or from the quarantined portion of any State or Territory or the District of Columbia into any other State or Territory or the District of Columbia.

(June 30, 1914, ch. 131, 38 Stat. 419; July 2, 1962, Pub. L. 87–518, §9, 76 Stat. 131.)

Codification

Section is from the Department of Agriculture Appropriation Act, 1915.

Amendments

1962—Pub. L. 87–518 substituted “quarantined animals” for “cattle or other livestock”.

Section Referred to in Other Sections

This section is referred to in section 136a of this title; title 16 section 1540.

§129. Expenses for arrest and eradication of contagious or infectious diseases or pests of animals, poultry, or plants

In emergencies which threaten any segment of the agricultural production industry of this country, the Secretary may transfer from other appropriations or funds available to the agencies or corporations of the Department such sums as he may deem necessary, to be available only in such emergencies for the arrest and eradication of contagious or infectious diseases or pests of animals, poultry, or plants, and for expenses in accordance with sections 114b to 114d–1 of this title and section 147a of title 7, and any unexpended balances of funds transferred for such emergency purposes in the next preceding fiscal year shall be merged with such transferred amounts.

(Oct. 21, 1995, Pub. L. 104–37, title I, 109 Stat. 307.)

Codification

Section is from the appropriation act cited as the credit to this section.

Prior Provisions

Provisions similar to those in this section were contained in the following prior appropriation acts:

Sept. 30, 1994, Pub. L. 103–330, title I, 108 Stat. 2443.

Oct. 21, 1993, Pub. L. 103–111, title I, 107 Stat. 1054.

Aug. 14, 1992, Pub. L. 102–341, title I, 106 Stat. 882.

Oct. 28, 1991, Pub. L. 102–142, title I, 105 Stat. 886.

Nov. 5, 1990, Pub. L. 101–506, title I, 104 Stat. 1323.

Nov. 21, 1989, Pub. L. 101–161, title I, 103 Stat. 959.

Oct. 1, 1988, Pub. L. 100–460, title I, 102 Stat. 2237.

Dec. 22, 1987, Pub. L. 100–202, §101(k) [title I], 101 Stat. 1329–322, 1329–331.

Oct. 18, 1986, Pub. L. 99–500, §101(a) [title I], 100 Stat. 1783, 1783–8, and Oct. 30, 1986, Pub. L. 99–591, §101(a) [title I], 100 Stat. 3341, 3341–8.

Dec. 19, 1985, Pub. L. 99–190, §101(a) [H.R. 3037, title I], 99 Stat. 1185.

Oct. 12, 1984, Pub. L. 98–473, title I, §101(a) [H.R. 5743, title I], 98 Stat. 1837.

Nov. 14, 1983, Pub. L. 98–151, §101(d) [H.R. 3223, title I], 97 Stat. 972.

Dec. 18, 1982, Pub. L. 97–370, title I, 96 Stat. 1792.

Dec. 23, 1981, Pub. L. 97–103, title I, 95 Stat. 1472.

Dec. 15, 1980, Pub. L. 96–528, title I, 94 Stat. 3099.

Nov. 9, 1979, Pub. L. 96–108, title I, 93 Stat. 826.

Oct. 11, 1978, Pub. L. 95–448, title I, 92 Stat. 1076.

Aug. 12, 1977, Pub. L. 95–97, title I, 91 Stat. 813.

July 12, 1976, Pub. L. 94–351, title I, 90 Stat. 854.

Oct. 21, 1975, Pub. L. 94–122, title I, 89 Stat. 645.

Dec. 31, 1974, Pub. L. 93–563, title I, 88 Stat. 1824.

Oct. 24, 1973, Pub. L. 93–135, title I, 87 Stat. 472.

Aug. 22, 1972, Pub. L. 92–399, title I, 86 Stat. 594.

Aug. 10, 1971, Pub. L. 92–73, title I, 85 Stat. 185.

Dec. 22, 1970, Pub. L. 91–566, title I, 84 Stat. 1482.

Nov. 26, 1969, Pub. L. 91–127, title I, 83 Stat. 246.

Aug. 8, 1968, Pub. L. 90–463, title I, 82 Stat. 640.

Oct. 24, 1967, Pub. L. 90–113, title I, 81 Stat. 321.

Sept. 7, 1966, Pub. L. 89–556, title I, 80 Stat. 690.

Nov. 2, 1965, Pub. L. 89–316, title I, 79 Stat. 1166.

Sept. 2, 1964, Pub. L. 88–573, title I, 78 Stat. 863.

Dec. 30, 1963, Pub. L. 88–250, title I, 77 Stat. 821.

Oct. 24, 1962, Pub. L. 87–879, title I, 76 Stat. 1204.

July 26, 1961, Pub. L. 87–112, title I, 75 Stat. 228.

June 29, 1960, Pub. L. 86–532, title I, 74 Stat. 233.

July 8, 1959, Pub. L. 86–80, title I, 73 Stat. 168.

June 13, 1958, Pub. L. 85–459, title I, 72 Stat. 189.

Aug. 2, 1957, Pub. L. 85–118, title I, 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.

Section Referred to in Other Sections

This section is referred to in section 136a of this title; title 16 section 1540.

§130. Pleuropneumonia in District of Columbia; duties of Council of the District of Columbia

Whenever any contagious, infectious, or communicable disease affecting domestic animals or live poultry, and especially the disease known as pleuropneumonia, shall be brought into or shall break out in the District of Columbia, it shall be the duty of the Council of the District of Columbia to take measures to suppress the same promptly and to prevent the same from spreading; and for this purpose the said Council is empowered to order and require that any premises, farm, or farms where such disease exists, or has existed, be put in quarantine; to order all or any animals coming into the District to be detained at any place or places for the purpose of inspection and examination; to prescribe regulations for and to require the destruction of animals or live poultry affected with contagious, infectious, or communicable disease, and for the proper disposition of their hides and carcasses; to prescribe regulations for disinfection, and such other regulations as they may deem necessary to prevent infection or contagion being communicated, and shall report to the Secretary of Agriculture whatever it may do in pursuance of the provisions of this section.

(May 29, 1884, ch. 60, §8, 23 Stat. 33; 1967 Reorg. Plan No. 3, §402(430), eff. Aug. 11, 1967, 32 F.R. 11669, 81 Stat. 948; Pub. L. 93–198, title IV, §401, Dec. 24, 1973, 87 Stat. 793.)

Codification

Substitution of Secretary of Agriculture for Commissioner of Agriculture, see note set out under section 112 of this title.

Section is also set out in D.C. Code §1–324.

Transfer of Functions

“Council of the District of Columbia” substituted in text for “District of Columbia Council” pursuant to section 401 of Pub. L. 93–198. District of Columbia Council, as established by Reorg. Plan No. 3 of 1967, abolished as of noon Jan. 2, 1975, by Pub. L. 93–198, title VII, §711, Dec. 24, 1973, 87 Stat. 818, classified to section 1–211 of the District of Columbia Code, and replaced by Council of the District of Columbia, as provided by section 401 of Pub. L. 93–198, classified to section 1–221 of the District of Columbia Code.

Previously, references to Commissioners of District of Columbia had been changed to District of Columbia Council pursuant to section 402(430) of Reorganization Plan No. 3 of 1967, 32 F.R. 11669, effective Aug. 11, 1967, set out in the Appendix to Title 5, Government Organization and Employees, which transferred regulatory and other functions of Board of Commissioners relating to prescribing of regulations for destruction of animals or live poultry affected by contagious, infectious, or communicable disease, and for proper disposition of their hides and carcasses, and prescribing of regulations for disinfection and other regulations under this section to District of Columbia Council, subject to right of Commissioner as provided by section 406 of Plan. For provisions establishing District of Columbia Council, see section 201 of Reorg. Plan No. 3 of 1967.

Extension of Provisions to Live Poultry

Act Feb. 7, 1928, ch. 30, 45 Stat. 59, extended the provisions of this section to live poultry.

Cross References

Diseases and quarantine in the District of Columbia, see sections 111 and 123 to 127 of this title.

Section Referred to in Other Sections

This section is referred to in sections 113, 114, 118, 119, 136a of this title; title 16 section 1540.

§131. Fences along international boundary lines to keep out diseased animals

The Secretary of Agriculture may permit the erection of fences along international boundary lines, but entirely within the territory of the United States, for the purpose of keeping out diseased animals.

(May 26, 1910, ch. 256, 36 Stat. 440.)

Section Referred to in Other Sections

This section is referred to in section 136a of this title; title 16 section 1540.

§132. Transferred

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.

§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.

§134. Definitions

As used in this Act unless the context indicates otherwise—

(a) The term “Secretary” means the Secretary of Agriculture.

(b) The term “animals” means all members of the animal kingdom including birds, whether domesticated or wild, but not including man.

(c) The term “United States” means the States, Puerto Rico, Guam, the Virgin Islands of the United States, and the District of Columbia.

(d) The term “interstate” means from a State or other area included in the definition of “United States” to or through any other State or other such area.

(Pub. L. 87–518, §1, July 2, 1962, 76 Stat. 129.)

References in Text

This Act, referred to in text, is Pub. L. 87–518, July 2, 1962, 76 Stat. 129, as amended, which enacted sections 134 to 134h of this title and amended sections 114a, 123 to 126, and 128 of this title and section 1114 of Title 18, Crimes and Criminal Procedure. For complete classification of this Act to the Code, see Tables.

Section Referred to in Other Sections

This section is referred to in sections 134e, 134f, 134g, 134h, 136a of this title; title 16 section 1540.

§134a. Seizure, quarantine, and disposal of livestock or poultry to guard against introduction or dissemination of communicable disease

(a) Authority of Secretary

The Secretary, whenever he deems it necessary in order to guard against the introduction or dissemination of a communicable disease of livestock or poultry, may seize, quarantine, and dispose of, in a reasonable manner taking into consideration the nature of the disease and the necessity of such action to protect the livestock or poultry of the United States: (1) any animals which he finds are moving or are being handled or have moved or have been handled in interstate or foreign commerce contrary to any law or regulation administered by him for the prevention of the introduction or dissemination of any communicable disease of livestock or poultry; (2) any animals which he finds are moving into the United States, or interstate, and are affected with or have been exposed to any communicable disease dangerous to livestock or poultry; and (3) any animals which he finds have moved into the United States, or interstate, and at the time of such movement were so affected or exposed.

(b) Determination of extraordinary emergency due to dangerous communicable disease; seizure, quarantine, and disposal of animals; action authorized only if adequate measures not taken by State or other jurisdiction; notice to State or other jurisdiction

Whereas the existence of any dangerous, communicable disease of livestock or poultry, such as foot-and-mouth disease, rinderpest, or European fowl pest, on any premises in the United States would constitute a threat to livestock and poultry of the Nation and would seriously burden interstate and foreign commerce, whenever the Secretary determines that an extraordinary emergency exists because of the outbreak of such a disease anywhere in the United States, and that such outbreak threatens the livestock or poultry of the United States, he may seize, quarantine, and dispose of, in such manner as he deems necessary or appropriate, any animals in the United States which he finds are or have been affected with or exposed to any such disease and the carcasses of any such animals and any products and articles which he finds were so related to such animals as to be likely to be a means of disseminating any such disease: Provided, That action shall be taken under this subsection only if the Secretary finds that adequate measures are not being taken by the State or other jurisdiction. The Secretary shall notify the appropriate official of the State or other jurisdiction before any action is taken in any such State or other jurisdiction pursuant to this subsection.

(c) Notice to owner to quarantine or to dispose of animal, carcass, product, or article; action on failure to comply; costs

The Secretary in writing may order the owner of any animal, carcass, product, or article referred to in subsection (a) or (b) of this section, or the agent of such owner, to maintain in quarantine, and to dispose of such animal, carcass, product, or article in such manner as the Secretary may direct pursuant to authority vested in him by such subsections. If such owner or agent fails to do so after receipt of such notice, the Secretary may take action as authorized by said subsections (a) and (b) and recover from such owner or agent the reasonable costs of any care, handling, and disposal incurred by the Secretary in connection therewith. Such costs shall not constitute a lien against the animals, carcasses, products, or articles involved. Costs collected under this section shall be credited to the current appropriation for carrying out animal disease control activities of the Department.

(d) Compensation of owner; fair market value; payments from State or other source; availability of funds

Except as provided in subsection (e) of this section, the Secretary shall compensate the owner of any animal, carcass, product, or article destroyed pursuant to the provisions of this section. Such compensation shall be based upon the fair market value as determined by the Secretary, of any such animal, carcass, product, or article at the time of the destruction thereof. Compensation paid any owner under this subsection shall not exceed the difference between any compensation received by such owner from a State or other source and such fair market value of the animal, carcass, product, or article. Funds in the Treasury available for carrying out animal disease control activities of the Department of Agriculture shall be used for carrying out this subsection.

(e) Restriction on payment of compensation in cases of violation of law or regulation

No such payment shall be made by the Secretary for any animal, carcass, product, or article which has been moved or handled by the owner thereof or his agent knowingly in violation of a law or regulation administered by the Secretary for the prevention of the interstate dissemination of the communicable disease, for which the animal, carcass, product, or article was destroyed or a law or regulation for the enforcement of which the Secretary enters or has entered into a cooperative agreement for the control and eradication of such disease, or for any animal which has moved into the United States contrary to such law or regulation administered by the Secretary for the prevention of the introduction of a communicable disease of livestock or poultry.

(Pub. L. 87–518, §2, July 2, 1962, 76 Stat. 129.)

Section Referred to in Other Sections

This section is referred to in sections 134, 134e, 134f, 134g, 134h, 136a of this title; title 16 section 1540.

§134b. Regulations for clean and sanitary movement of animals

The Secretary, in order to protect the health of the livestock or poultry of the Nation, may promulgate regulations requiring that railway cars; vessels; airplanes; trucks; and other means of conveyance; stockyards; feed, water, and rest stations; and other facilities, used in connection with the movement of animals into or from the United States, or interstate, be maintained in a clean and sanitary condition, including requirements for inspection, cleaning, and disinfection.

(Pub. L. 87–518, §3, July 2, 1962, 76 Stat. 130.)

Section Referred to in Other Sections

This section is referred to in sections 134, 134e, 134f, 134g, 134h, 136a of this title; title 16 section 1540.

§134c. Regulations for movement of animals affected or exposed to communicable disease

The Secretary is authorized to promulgate regulations prohibiting or regulating the movement into the United States of any animals which are or have been affected with or exposed to any communicable animal disease, or which have been vaccinated or otherwise treated for any such disease, or which he finds would otherwise be likely to introduce or disseminate any such disease, when he determines that such action is necessary to protect the livestock or poultry of the United States.

(Pub. L. 87–518, §4, July 2, 1962, 76 Stat. 130.)

Section Referred to in Other Sections

This section is referred to in sections 134, 134e, 134f, 134g, 134h, 136a of this title; title 16 section 1540.

§134d. Inspections and seizures; issuance of warrants

Employees of the Department of Agriculture designated by the Secretary for the purpose, when properly identified, shall have authority (1) to stop and inspect, without a warrant, any person or means of conveyance, moving into the United States from a foreign country, to determine whether such person or means of conveyance is carrying any animal, carcass, product, or article regulated or subject to disposal under any law or regulation administered by the Secretary for prevention of the introduction or dissemination of any communicable animal disease; (2) to stop and inspect, without a warrant, any means of conveyance moving interstate upon probable cause to believe that such means of conveyance is carrying any animal, carcass, product, or article regulated or subject to disposal under any law or regulation administered by the Secretary for the prevention of the introduction or dissemination of any communicable animal disease; and (3) to enter upon, with a warrant, any premises for the purpose of making inspections and seizures necessary under such laws and regulations. Any Federal judge, or any judge of a court of record in the United States, or any United States magistrate judge, may, within his jurisdiction, upon proper oath or affirmation indicating probable cause to believe that there is on certain premises any animal, carcass, product, or article regulated or subject to disposal under any law or regulation administered by the Secretary for the prevention of the introduction or dissemination of any communicable animal disease, issue warrants for the entry upon such premises and for inspections and seizures necessary under such laws and regulations. Such warrants may be executed by any authorized employee of the Department of Agriculture.

(Pub. L. 87–518, §5, July 2, 1962, 76 Stat. 130; Pub. L. 90–578, title IV, §402(b)(2), Oct. 17, 1968, 82 Stat. 1118; Pub. L. 101–650, title III, §321, Dec. 1, 1990, 104 Stat. 5117.)

Change of Name

“United States magistrate judge” substituted in text for “United States magistrate” pursuant to section 321 of Pub. L. 101–650, set out as a note under section 631 of Title 28, Judiciary and Judicial Procedure. Previously, “United States magistrate” substituted for “United States commissioner” pursuant to Pub. L. 90–578. See chapter 43 (§631 et seq.) of Title 28.

Section Referred to in Other Sections

This section is referred to in sections 134, 134e, 134f, 134g, 134h, 136a of this title; title 16 section 1540.

§134e. Enforcement provisions

(a) Criminal and civil penalties

(1) Whoever knowingly violates any regulation promulgated pursuant to the provisions of sections 134 through 134d of this title shall be punished by a fine not exceeding $5,000 or by imprisonment not exceeding one year, or both.

(2) Whoever violates any such regulation may be assessed a civil penalty by the Secretary not exceeding $1,000. The Secretary may issue an order assessing such civil penalty only after notice and an opportunity for an agency hearing on the record. Such order shall be treated as a final order reviewable under chapter 158 of title 28. The validity of such order may not be reviewed in an action to collect such civil penalty.

(b) Injunctive proceedings

The Secretary may bring an action to enjoin the violation of, or to compel compliance with, any regulation promulgated or order issued under said sections, or to enjoin any interference by any person with an employee of the Department of Agriculture in carrying out any duties under said sections, whenever the Secretary has reason to believe that such person has violated, or is about to violate, any such regulation or order, or has interfered, or is about to interfere, with any such employee. Such action shall be brought in the United States district court, or the United States court of any Territory or possession, for the judicial district in which such person resides or transacts business or in which the violation, omission, or interference has occurred or is about to occur. Process in such cases may be served in any judicial district wherein the defendant resides or transacts business or wherever the defendant may be found, and subpenas for witnesses who are required to attend the court in any judicial district in any such cases may run into any other judicial district.

(Pub. L. 87–518, §6, July 2, 1962, 76 Stat. 131; Pub. L. 97–461, §8, Jan. 12, 1983, 96 Stat. 2525.)

Amendments

1983—Subsec. (a). Pub. L. 97–461 designated existing provisions as par. (1), substituted “$5,000” for “$1,000”, and added par. (2).

Section Referred to in Other Sections

This section is referred to in sections 134, 134f, 134g, 134h, 136a of this title; title 16 section 1540.

§134f. Promulgation of regulations

The Secretary is authorized to issue such regulations as he deems necessary to carry out the provisions of this Act.

(Pub. L. 87–518, §11, July 2, 1962, 76 Stat. 132.)

References in Text

This Act, referred to in text, is Pub. L. 87–518, July 2, 1962, 76 Stat. 129, as amended, which enacted sections 134 to 134h of this title and amended sections 114a, 123 to 126, and 128 of this title and section 1114 of Title 18, Crimes and Criminal Procedure. For complete classification of this Act to the Code, see Tables.

Section Referred to in Other Sections

This section is referred to in sections 134, 134g, 134h, 136a of this title; title 16 section 1540.

§134g. Authority in addition to other laws; repeal of inconsistent provisions

The authority conferred by this Act shall be in addition to authority conferred by other statutes. Any provision of any other Act inconsistent with the provisions of this Act is repealed.

(Pub. L. 87–518, §12, July 2, 1962, 76 Stat. 132.)

References in Text

This Act, referred to in text, is Pub. L. 87–518, July 2, 1962, 76 Stat. 129, as amended, which enacted sections 134 to 134h of this title and amended sections 114a, 123 to 126, and 128 of this title and section 1114 of Title 18, Crimes and Criminal Procedure. For complete classification of this Act to the Code, see Tables.

Section Referred to in Other Sections

This section is referred to in sections 134, 134f, 134h, 136a of this title; title 16 section 1540.

§134h. Separability

If any provision of this Act or application thereof to any person or circumstances is held invalid, the remainder of the Act and the application of such provision to other persons and circumstances shall not be affected thereby.

(Pub. L. 87–518, §13, July 2, 1962, 76 Stat. 132.)

References in Text

This Act, referred to in text, is Pub. L. 87–518, July 2, 1962, 76 Stat. 129, as amended, which enacted sections 134 to 134h of this title and amended sections 114a, 123 to 126, and 128 of this title and section 1114 of Title 18, Crimes and Criminal Procedure. For complete classification of this Act to the Code, see Tables.

Section Referred to in Other Sections

This section is referred to in sections 134, 134f, 134g, 136a of this title; title 16 section 1540.

§135. International animal quarantine station; establishment; acceptance of gifts; cooperation with breeders’ organizations; collection of fees

The Secretary of Agriculture is authorized, in his discretion, to establish and maintain an international animal quarantine station within the territory of the United States. The quarantine station shall be located on an island selected by the Secretary of Agriculture where, in his judgment, maximum animal disease and pest security measures can be maintained. The Secretary of Agriculture is authorized to acquire land or any interest therein, by purchase, donation, exchange, or otherwise and construct or lease buildings, improvements, and other facilities as may be necessary for the establishment and maintenance of such quarantine station. The Secretary of Agriculture, on behalf of the United States, is authorized to accept any gift or donation of money, personal property, buildings, improvements, and other facilities for the purpose of conducting the functions authorized under sections 135 to 135b of this title. Notwithstanding the provisions of any other law to prevent the introduction or dissemination of livestock or poultry disease or pests, animals may be brought into the quarantine station from any country, including but not limited to those countries in which the Secretary of Agriculture determines that rinderpest or foot-and-mouth disease exists, and subsequently moved into other parts of the United States in accordance with such conditions as the Secretary of Agriculture shall determine are adequate in order to prevent the introduction into and the dissemination within the United States of livestock or poultry diseases or pests. The Secretary of Agriculture is authorized to cooperate in such manner as he deems appropriate, with other countries or with breeders’ organizations or similar organizations or with individuals regarding importation of animals into and through the quarantine station and to charge and collect reasonable fees for use of the facilities of such station from importers. Such fees shall be deposited into the Treasury of the United States to the credit of the appropriation charged with the operating expenses of the quarantine station. The Secretary is authorized to issue such regulations as he deems necessary to carry out the provisions of sections 135 to 135b of this title.

(Pub. L. 91–239, §1, May 6, 1970, 84 Stat. 202; Pub. L. 103–465, title IV, §431(j), Dec. 8, 1994, 108 Stat. 4969.)

Amendments

1994—Pub. L. 103–465, in sixth sentence, struck out “North American” before “countries” and “within the United States” after “individuals”.

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–465 effective, except as otherwise provided, on the date of entry into force of the World Trade Organization Agreement with respect to the United States [Jan. 1, 1995], see section 451 of Pub. L. 103–465, set out as an Effective Date note under section 3601 of Title 19, Customs Duties.

Section Referred to in Other Sections

This section is referred to in sections 135a, 135b, 136a of this title; title 16 section 1540.

§135a. Smuggling penalties

(a) Criminal penalty

The provisions and penalties of section 545 of title 18 shall apply to the bringing of animals to the quarantine station or the subsequent movement of animals to other parts of the United States, including Puerto Rico, Guam, and the Virgin Islands, contrary to the conditions prescribed by the Secretary in regulations issued hereunder.

(b) Civil penalty

Any person who brings any animal to the quarantine station or moves any animal from the quarantine station, contrary to the conditions prescribed by the Secretary in regulations issued hereunder, may be assessed a civil penalty by the Secretary not to exceed $1,000. The Secretary may issue an order assessing such civil penalty only after notice and an opportunity for an agency hearing on the record. Such order shall be treated as a final order reviewable under chapter 158 of title 28. The validity of such order may not be reviewed in an action to collect such civil penalty.

(Pub. L. 91–239, §2, May 6, 1970, 84 Stat. 202; Pub. L. 97–461, §9, Jan. 12, 1983, 96 Stat. 2525.)

Amendments

1983—Pub. L. 97–461 designated existing provisions as subsec. (a) and added subsec. (b).

Section Referred to in Other Sections

This section is referred to in sections 135, 135b of this title; title 16 section 1540.

§135b. Authorization of appropriations

There are hereby authorized to be appropriated such sums as are necessary to carry out the provisions of sections 135 to 135b of this title.

(Pub. L. 91–239, §3, May 6, 1970, 84 Stat. 202.)

Section Referred to in Other Sections

This section is referred to in sections 135, 135a of this title; title 16 section 1540.

§136. Additional inspection services

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.

(Pub. L. 101–624, title XXV, §2508, Nov. 28, 1990, 104 Stat. 4069.)

§136a. Collection of fees for inspection services

(a) Quarantine, inspection and transportation fees

(1) Quarantine and inspection

(A) In general

The Secretary of Agriculture (hereafter referred to in this section as the “Secretary”) may prescribe and collect fees 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) Airport inspection services

For airport inspection services, the Secretary shall collect no more than $69,000,000 in fiscal year 1992 and $75,000,000 in fiscal year 1993 from international airline passengers and commercial aircraft operators.

(C) Commercial truck and railroad car inspection services

For commercial truck and railroad car inspection services, the Secretary shall collect no more than $3,667,000 in fiscal year 1992 and $3,890,000 in fiscal year 1993 from commercial truck and railroad car operators.

(D) Costs

Fees, including fees from international airline passengers and commercial aircraft operators, may only be collected to the extent that the Secretary reasonably estimates that the amount of the fees are 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 such services with respect to passengers as a class includes the costs of related inspections of the aircraft.

(2) Treasury

Any person who collects a fee under this subsection shall remit such fee to the Treasury of the United States prior to the date that is 31 days after the close of the calendar quarter in which such fee is collected.

(3) Agricultural Quarantine Inspection User Fee Account

(A) Establishment

There is established in the Treasury of the United States a no-year fund, to be known as the “Agricultural Quarantine Inspection User Fee Account” (hereafter referred to in this section as the “Account”), for the use of the Secretary for quarantine or inspection services under this section.

(B) Amounts in Account

(i) Deposits

All of the fees collected under this subsection shall be deposited in the Account.

(ii) Reimbursement

The Secretary of the Treasury shall use the Account to provide reimbursements to any appropriation accounts that incur the costs associated with the administration of this subsection and all other activities carried out by the Secretary at ports in the customs territory of the United States and at preclearance or preinspection sites outside the customs territory of the United States in connection with the enforcement of the animal quarantine laws. Any such reimbursement shall be subject to appropriations under clause (v).

(iii) Procedure

The Secretary of the Treasury shall make reimbursement under clause (ii) on a quarterly basis. Amounts required to be reimbursed under clause (ii), shall be made on the basis of estimates made by the Secretary of the expenses described in clause (ii) that are incurred by the Secretary in the 3-month period immediately preceding such reimbursement.

(iv) Adjustments

Adjustments of reimbursements made under clause (ii) shall be made to the extent necessary to correct prior estimates that were in excess of, or less than, the amount required to be reimbursed under clause (iii).

(v) Authorization of appropriations

There are authorized to be appropriated each fiscal year amounts in the Fund 1 for use for quarantine or inspection services.

(4) Adjustment in fee amounts

Subject to the limits set forth in paragraph (1), the Secretary shall adjust the amount of the fees to be assessed under this subsection to reflect the cost to the Secretary in administering such subsection, in carrying out the activities at ports in customs territory of the United States and preclearance and preinspection sites outside the customs territory of the United States in connection with the provision of agricultural quarantine inspection services, and in maintaining a reasonable balance in the Account.

(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) Omitted

(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 2

(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 3 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 (19 U.S.C. 1306);

(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).

(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.

(Pub. L. 101–624, title XXV, §2509, Nov. 28, 1990, 104 Stat. 4069; Pub. L. 101–508, title I, §1203, Nov. 5, 1990, 104 Stat. 1388–11; Pub. L. 102–237, title X, §1015, Dec. 13, 1991, 105 Stat. 1902.)

References in Text

Section 101 of Public Law 92–73, referred to in subsec. (f)(1)(L), is listed in a Similar Provisions note set out under section 129 of this title.

Codification

Section is comprised of section 2509 of Pub. L. 101–624. Subsecs. (b) and (c)(2) of section 2509 of Pub. L. 101–624 amended section 147a(f) of Title 7, Agriculture, and section 114a of this title, respectively.

Amendments

1991—Subsec. (a)(1). Pub. L. 102–237, §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, §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, §1015(3), substituted “Subject to the limits set forth in paragraph (1), the” for “The”.

1990—Subsec. (a)(1). Pub. L. 101–508, §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, §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, §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 a note under section 511r of Title 7, Agriculture.

Report on Agricultural Quarantine Inspection Fund

Pub. L. 104–66, title I, §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.”

1 So in original. Probably should be “Account”.

2 So in original. Probably should be “Liens”.

3 So in original. Probably should be “makes”.

SUBCHAPTER IV—IMPORTATION OF MILK AND CREAM

Federal Food, Drug, and Cosmetic Act

By virtue of act June 25, 1938, ch. 675, §902(c), 52 Stat. 1059 [section 392(b) of this title], nothing contained in section 301 et seq. of this title shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of this subchapter.

Subchapter Referred to in Other Sections

This subchapter is referred to in section 392 of this title.

§141. Prohibition of importation without permit

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.

(Feb. 15, 1927, ch. 155, §1, 44 Stat. 1101; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695.)

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.

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”.

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 note set out under section 41 of this title.

Cross References

Federal Food, Drug, and Cosmetic Act as not affecting, modifying, repealing, or superseding this subchapter, see section 392 of this title.

§142. Milk or cream when unfit for importation

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.

(Feb. 15, 1927, ch. 155, §2, 44 Stat. 1101.)

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.

Section Referred to in Other Sections

This section is referred to in section 143 of this title.

§143. Inspection; certified statement in lieu thereof; waiver of requirements of section 142; regulations; suspension and revocation of permits

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.

(Feb. 15, 1927, ch. 155, §3, 44 Stat. 1102; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695.)

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.

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 note set out under section 41 of this title.

§144. Unlawful receiving of imported milk or cream

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.

(Feb. 15, 1927, ch. 155, §4, 44 Stat. 1103.)

§145. Penalties

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.

(Feb. 15, 1927, ch. 155, §5, 44 Stat. 1103.)

§146. Authorization of appropriations

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.

(Feb. 15, 1927, ch. 155, §6, 44 Stat. 1103; 1940 Reorg. Plan No. IV, §12, eff. June 30, 1940, 5 F.R. 2421, 54 Stat. 1237; 1953 Reorg. Plan No. 1, §5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Oct. 17, 1979, Pub. L. 96–88, title V, §509(b), 93 Stat. 695.)

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.

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 note set out under section 41 of this title.

§147. Repeal of inconsistent laws

Any laws or parts of laws inconsistent with this subchapter are repealed.

(Feb. 15, 1927, ch. 155, §7, 44 Stat. 1103.)

Cross References

Federal Food, Drug, and Cosmetic Act as not affecting, modifying, repealing, or superseding this subchapter, see section 392 of this title.

§148. Powers of State with respect to milk or cream lawfully imported

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.

(Feb. 15, 1927, ch. 155, §8, 44 Stat. 1103.)

§149. Definitions

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.

(Feb. 15, 1927, ch. 155, §9, 44 Stat. 1103; June 25, 1959, Pub. L. 86–70, §19, 73 Stat. 145; July 12, 1960, Pub. L. 86–624, §15, 74 Stat. 415.)

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”.

CHAPTER 5—VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS

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

By virtue of act June 25, 1938, ch. 675, §902(c), 52 Stat. 1059 [section 392(b) of this title], nothing contained in section 301 et seq. of this title shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of this chapter.

Cross References

Biological products, regulation, see section 262 of Title 42, The Public Health and Welfare.

Chapter Referred to in Other Sections

This chapter is referred to in sections 382, 392 of this title; title 15 section 1459; title 35 sections 156, 271.

§151. Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments

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.

(Mar. 4, 1913, ch. 145, §1 [part], 37 Stat. 832; Dec. 23, 1985, Pub. L. 99–198, title XVII, §1768(a), 99 Stat. 1654.)

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.

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, §1 [part], 37 Stat. 832, which is classified to this chapter, is popularly known as the “Virus-Serum-Toxin Act”.

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.

§152. Importation regulated and prohibited

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.

(Mar. 4, 1913, ch. 145, §1 [part], 37 Stat. 832; Sept. 28, 1988, Pub. L. 100–449, title III, §301(d), 102 Stat. 1868.)

Codification

See note set out under section 151 of this title.

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.

§153. Inspection of imports; denial of entry and destruction

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.

(Mar. 4, 1913, ch. 145, §1 [part], 37 Stat. 832.)

Codification

See note set out under section 151 of this title.

§154. Regulations for preparation and sale; licenses

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.

(Mar. 4, 1913, ch. 145, §1 [part], 37 Stat. 832; Dec. 23, 1985, Pub. L. 99–198, title XVII, §1768(b), 99 Stat. 1654.)

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.

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.

§154a. Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria

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.

(Mar. 4, 1913, ch. 145, §1 [part], as added Dec. 23, 1985, Pub. L. 99–198, title XVII, §1768(c), 99 Stat. 1654.)

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.

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.

§155. Permits for importation

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.

(Mar. 4, 1913, ch. 145, §1 [part], 37 Stat. 833.)

Codification

See note set out under section 151 of this title.

§156. Licenses conditioned on permitting inspection; suspension of licenses

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.

(Mar. 4, 1913, ch. 145, §1 [part], 37 Stat. 833.)

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, §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.

Codification

See note set out under section 151 of this title.

§157. Inspection

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.

(Mar. 4, 1913, ch. 145, §1 [part], 37 Stat. 833; Dec. 23, 1985, Pub. L. 99–198, title XVII, §1768(d), 99 Stat. 1655.)

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.

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.

Cross References

Overtime of employees working at establishments which prepare virus, serum, toxin and analogous products, see section 394a of Title 7, Agriculture.

Section Referred to in Other Sections

This section is referred to in title 7 section 394a.

§158. Offenses; punishment

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.

(Mar. 4, 1913, ch. 145, §1 [part], 37 Stat. 833.)

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.

Codification

See note set out under section 151 of this title.

§159. Enforcement; penalties applicable; Congressional findings

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.

(Mar. 4, 1913, ch. 145, §1 [part], as added Dec. 23, 1985, Pub. L. 99–198, title XVII, §1768(e), 99 Stat. 1655.)

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.

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.

CHAPTER 5A—BUREAU OF NARCOTICS

§§161 to 165. Omitted

Codification

Section 161, acts June 14, 1930, ch. 488, §1, 46 Stat. 585; Oct. 15, 1949, ch. 695, §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, §2, 46 Stat. 585; June 26, 1930, ch. 623, §1, 46 Stat. 819; Oct. 27, 1970, Pub. L. 91–513, title III, §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, §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, §3, 46 Stat. 586; June 26, 1930, ch. 623, §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, §5, 46 Stat. 587, provided for review of decisions of Commissioner of Narcotics by the Secretary of the Treasury.

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.

CHAPTER 6—NARCOTIC DRUGS

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.

IMPORTATION OR EXPORTATION

§§171 to 174. Repealed. Pub. L. 91–513, title III, §1101(a)(2), (4), Oct. 27, 1970, 84 Stat. 1291

Section 171, acts Feb. 9, 1909, ch. 100, §1, 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 14, 1930, ch. 488, §3, 46 Stat. 586; July 1, 1944, ch. 377, §8, 58 Stat. 721; Mar. 8, 1946, ch. 81, §7, 60 Stat. 39; Aug. 8, 1953, ch. 394, §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, §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, §1, 42 Stat. 596, also classified to this section, was repealed by Pub. L. 89–554, §8(a), Sept. 6, 1966, 80 Stat. 645.

Section 173, acts Feb. 9, 1909, ch. 100, §2(b), (d), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; June 14, 1930, ch. 488, §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, §6, 46 Stat. 587, provided for importation of additional amounts of coca leaves.

Section 174, acts Feb. 9, 1909, ch. 100, §2(c), (f), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §1, 42 Stat. 596; June 7, 1924, ch. 352, 43 Stat. 657; Nov. 2, 1951, ch. 666, §§1, 5(1), 65 Stat. 767; July 18, 1956, ch. 629, title I, §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 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.”

§175. Repealed. June 27, 1952, ch. 477, title IV, §403(a)(10), 66 Stat. 279

Section, acts Feb. 9, 1909, ch. 100, §2(e), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §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.

§§176 to 185. Repealed. Pub. L. 91–513, title III, §1101(a)(2), (9), Oct. 27, 1970, 84 Stat. 1291, 1292

Section 176, acts Feb. 9, 1909, ch. 100, §2(g), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202 §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, §2(h), as added July 18, 1956, ch. 629, title I, §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, §2(i), as added July 18, 1956, ch. 629, title I, §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, §2(a), 35 Stat. 614; Jan. 17, 1914, ch. 9, 38 Stat. 275; May 26, 1922, ch. 202, §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, §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, §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, §5, as added Jan. 17, 1914, ch. 9, 38 Stat. 275; amended May 26, 1922, ch. 202, §2, 42 Stat. 597; June 14, 1930, ch. 488, §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, §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, §6, as added Jan. 17, 1914, ch. 9, 348 Stat. 275; amended May 26, 1922, ch. 202, §2, 42 Stat. 597; June 14, 1930, ch. 488, §3, 46 Stat. 586; Apr. 22, 1960, Pub. L. 86–429, §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, §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, §8, as added Jan. 17, 1914, ch. 9, 38 Stat. 277; amended May 26, 1922, ch. 202, §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, §1, 55 Stat. 584; July 18, 1956, ch. 629, title I, §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, §9, as added May 26, 1922, ch. 202, §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.

MARIHUANA AND HEALTH REPORTING

§§186, 187. Transferred

Codification

Section 186, Pub. L. 91–296, title V, §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, §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.

DOMESTIC CONTROL OF PRODUCTION AND DISTRIBUTION OF THE OPIUM POPPY

§§188 to 188n. Repealed. Pub. L. 91–513, title III, §1101(a)(7), Oct. 27, 1970, 84 Stat. 1292

Sections, acts Dec. 11, 1942, ch. 720, 56 Stat. 1045; June 25, 1959, Pub. 86–70, §20, 73 Stat. 145; July 12, 1960, Pub. L. 86–624, §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.

IMPORTATION BY CHINESE SUBJECTS OR TRAFFICKING IN, IN CHINA, BY UNITED STATES CITIZENS

§§191 to 193. Repealed. Pub. L. 91–513, title III, §1101(a)(1), Oct. 27, 1970, 84 Stat. 1291

Sections, acts Feb. 23, 1887, ch. 210, 24 Stat. 409; June 25, 1948, ch. 646, §§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.

MISCELLANEOUS

§196. Repealed. July 1, 1944, ch. 373, title XIII, §1313, 58 Stat. 714

Section, act June 14, 1930, ch. 488, §4(b), (c), 46 Stat. 587; 1939 Reorg. Plan No. I, §§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, §5, 60 Stat. 1049, 713 by act Feb. 28, 1948, ch. 83, §9(b), 62 Stat. 47, 813 by act July 30, 1956, ch. 779, §3(b), 70 Stat. 720, 913 by Pub. L. 88–581, §4(b), Sept. 4, 1964, 78 Stat. 919, 1013 by Pub. L. 89–239, §3(b), Oct. 6, 1965, 79 Stat. 931, 1113 by Pub. L. 91–572, §6(b), Dec. 24, 1970, 84 Stat. 1506, 1213 by Pub. L. 92–294, §3(b), May 16, 1972, 86 Stat. 137, 1313 by Pub. L. 93–154, §2(b)(2), Nov. 16, 1973, 87 Stat. 604, and was repealed by Pub. L. 93–222, §7(b), Dec. 29, 1973, 87 Stat. 936.

§§197, 198. Repealed. Pub. L. 91–513, title III, §1101(a)(4), Oct. 27, 1970, 84 Stat. 1291

Section 197, act June 14, 1930, ch. 488, §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, §8, 46 Stat. 587; July 18, 1956, ch. 629, title III, §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.

§§198a to 198c. Transferred

Codification

Section 198a, act Aug. 11, 1955, ch. 800, §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, §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, §3, 69 Stat. 685, which related to contempt proceedings, was transferred to section 969 of this title.

§199. Repealed. Pub. L. 91–513, title III, §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.

§§200 to 200b. Repealed. Nov. 2, 1951, ch. 666, §5(2), 65 Stat. 769

Sections, acts Aug. 12, 1937, ch. 598, §§1–3, 50 Stat. 627; July 1, 1944, ch. 377, §9, 58 Stat. 721; Mar. 8, 1946, ch. 81, §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.

CHAPTER 7—PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA

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.

        

§201. Doing business without a license unlawful; employment of Chinese subjects

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.

(Mar. 3, 1915, ch. 74, §1, 38 Stat. 817.)

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.

Section Referred to in Other Sections

This section is referred to in section 202 of this title.

§202. Certain classes of persons and corporations excepted; insecticides

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.

(Mar. 3, 1915, ch. 74, §1, 38 Stat. 818.)

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.

§203. Application for license; requirements; qualifications for license

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.

(Mar. 3, 1915, ch. 74, §2, 38 Stat. 818.)

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.

Section Referred to in Other Sections

This section is referred to in section 204 of this title.

§204. Issuance of license

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.

(Mar. 3, 1915, ch. 74, §3, 38 Stat. 819.)

§205. Display of license in pharmacy

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.

(Mar. 3, 1915, ch. 74, §5, 38 Stat. 819.)

§206. Revocation of license

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.

(Mar. 3, 1915, ch. 74, §4, 38 Stat. 819.)

§207. Restrictions on sales; written orders or prescriptions

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.

(Mar. 3, 1915, ch. 74, §6, 38 Stat. 819.)

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.

Section Referred to in Other Sections

This section is referred to in sections 208, 211 of this title.

§208. Certain preparations and sales excepted

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.

(Mar. 3, 1915, ch. 74, §6, 38 Stat. 819.)

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.

Section Referred to in Other Sections

This section is referred to in section 211 of this title.

§209. Poisons; book entry of sale; labels

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.

(Mar. 3, 1915, ch. 74, §7, 38 Stat. 820.)

§210. Pharmacist; unauthorized use of title

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.

(Mar. 3, 1915, ch. 74, §10, 38 Stat. 821.)

§211. Preservation of originals of prescriptions compounded and copies thereof; inspection of prescriptions by consular officers; marking containers of drugs

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.

(Mar. 3, 1915, ch. 74, §9, 38 Stat. 821.)

§212. Offenses; punishment; duty to enforce provisions

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.

(Mar. 3, 1915, ch. 74, §11, 38 Stat. 821.)

§213. Fraudulent representations to evade or defeat restrictions

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.

(Mar. 3, 1915, ch. 74, §8, 38 Stat. 821.)

§214. Previous laws unaffected

Nothing in this chapter shall be construed as modifying or revoking any of the provisions of sections 191 to 193 1 of this title.

(Mar. 3, 1915, ch. 74, §13, 38 Stat. 822.)

References in Text

Sections 191 to 193 of this title, referred to in text, were repealed by Pub. L. 91–513, title III, §1101(a)(1), Oct. 27, 1970, 84 Stat. 1291. See section 801 et seq. of this title.

1 See References in Text note below.

§215. “Consul” defined

The word “consul” as used in this chapter shall mean the consular officer in charge of the district concerned.

(Mar. 3, 1915, ch. 74, §12, 38 Stat. 822.)

CHAPTER 8—NARCOTIC FARMS

§§221 to 237. Repealed. July 1, 1944, ch. 373, title XIII, §1313, 58 Stat. 714

Section 221, act Jan. 19, 1929, ch. 82, §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, §2, 45 Stat. 1085, provided for narcotic farms. See section 257 of Title 42.

Section 222a, act June 23, 1935, ch. 725, §1, 49 Stat. 1840, provided name for narcotic farm at Lexington, Ky.

Section 222b, act Mar. 28, 1938, ch. 55, §1, 52 Stat. 134, provided name for narcotic farm at Fort Worth, Texas.

Section 223, act Jan. 19, 1929, ch. 82, §3, 45 Stat. 1085; 1939 Reorg. Plan No. I, §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, §4, 45 Stat. 1086, provided for construction of buildings for two of the narcotic farms.

Section 225, act Jan. 19, 1929, ch. 82, §5, 45 Stat. 1086; June 14, 1930, ch. 488, §4(a), 46 Stat. 586; 1939 Reorg. Plan No. I, §§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, §6, 45 Stat. 1086; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for care and treatment of addicts. See section 257 of Title 42.

Section 227, act Jan. 19, 1929, ch. 82, §7, 45 Stat. 1086, provided for transfer to and from farms of addicts who are prisoners. See section 259 of Title 42.

Section 228, act Jan. 19, 1929, ch. 82, §8, 45 Stat. 1087, provided that it was the duty of prosecuting officers to report convicted persons believed to be addicts. See section 259 of Title 42.

Section 229, act Jan. 19, 1929, ch. 82, §9, 45 Stat. 1087; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for employment of addicts. See section 258 of Title 42.

Section 230, act Jan. 19, 1929, ch. 82, §10, 45 Stat. 1087, provided for parole of inmates. See section 259 of Title 42.

Section 231, act Jan. 19, 1929, ch. 82, §11, 45 Stat. 1087; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for discharge of addicts. See section 259 of Title 42.

Section 232, act Jan. 19, 1929, ch. 82, §12, 45 Stat. 1088; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for admission of voluntary patients. See section 260 of Title 42.

Section 233, act Jan. 19, 1929, ch. 82, §13, 45 Stat. 1088; 1939 Reorg. Plan No. I, §§201, 205, eff. July 1, 1939, 4 F.R. 2728, 53 Stat. 1424, 1425, provided for furnishing of gratuities and transportation to discharged convicts. See section 259 of Title 42.

Section 234, act. Jan. 19, 1929, ch. 82, §14, 45 Stat. 1089; 1939 Reorg. Plan No. I, §§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. See section 261 of Title 42.

Section 235, act Jan. 19, 1929, ch. 82, §15, 45 Stat. 1089, provided penalties for escape of inmates. See section 261 of Title 42.

Section 236, act Jan. 19, 1929, ch. 82, §16, 45 Stat. 1089, provided penalties for procuring of escape by inmates. See section 261 of Title 42.

Section 237, act Jan. 19, 1929, ch. 82, §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 §711 by act Aug. 13, 1946, ch. 958, §5, 60 Stat. 1049, §713 by act Feb. 28, 1948, ch. 83, §9(b), 62 Stat. 47, §813 by act July 30, 1956, ch. 779, §3(b), 70 Stat. 720, §913 by Pub. L. 88–581, §4(b), Sept. 4, 1964, 78 Stat. 919, §1013 by Pub. L. 89–239, §3(b), Oct. 6, 1965, 79 Stat. 931, §1113 by Pub. L. 91–572, §6(b), Dec. 24, 1970, 84 Stat. 1506, §1213 by Pub. L. 92–294, §3(b), May 16, 1972, 86 Stat. 137, §1313 by Pub. L. 93–154, §2(b)(2), Nov. 16, 1973, 87 Stat. 604, and was repealed by Pub. L. 93–222, §7(b), Dec. 29, 1973, 87 Stat. 936.

 10

CHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACT

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.

        

SUBCHAPTER III—PROHIBITED ACTS AND PENALTIES

331.
Prohibited acts.
332.
Injunction proceedings.
(a)
Jurisdiction of courts.
(b)
Violation of injunction.
333.
Penalties.
(a)
Violation of section 331 of this title; second violation; intent to defraud or mislead.
(b)
Prescription drug marketing violations.
(c)
Exceptions in certain cases of good faith, etc.
(d)
Exceptions involving misbranded food.
(e)
Prohibited distribution of human growth hormone.
(f)
Violations related to devices.
333a.
Repealed.
334.
Seizure.
(a)
Grounds and jurisdiction.
(b)
Procedure; multiplicity of pending proceedings.
(c)
Availability of samples of seized goods prior to trial.
(d)
Disposition of goods after decree of condemnation; claims for remission or mitigation of forfeitures.
(e)
Costs.
(f)
Removal of case for trial.
(g)
Administrative restraint; detention orders.
335.
Hearing before report of criminal violation.
335a.
Debarment, temporary denial of approval, and suspension.
(a)
Mandatory debarment.
(b)
Permissive debarment.
(c)
Debarment period and considerations.
(d)
Termination of debarment.
(e)
Publication and list of debarred persons.
(f)
Temporary denial of approval.
(g)
Suspension authority.
(h)
Termination of suspension.
(i)
Procedure.
(j)
Judicial review.
(k)
Certification.
(l)
Applicability.
335b.
Civil penalties.
(a)
In general.
(b)
Procedure.
(c)
Judicial review.
(d)
Recovery of penalties.
(e)
Informants.
335c.
Authority to withdraw approval of abbreviated drug applications.
(a)
In general.
(b)
Procedure.
(c)
Applicability.
(d)
Judicial review.
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.
(a)
Poisonous, insanitary, etc., ingredients.
(b)
Absence, substitution, or addition of constituents.
(c)
Color additives.
(d)
Confectionery containing alcohol or nonnutritive substance.
(e)
Oleomargarine containing filthy, putrid, etc., matter.
(f)
Dietary supplement or ingredient: safety.
(g)
Dietary supplement: manufacturing practices.
343.
Misbranded food.
(a)
False or misleading label.
(b)
Offer for sale under another name.
(c)
Imitation of another food.
(d)
Misleading container.
(e)
Package form.
(f)
Prominence of information on label.
(g)
Representation as to definition and standard of identity.
(h)
Representation as to standards of quality and fill of container.
(i)
Label where no representation as to definition and standard of identity.
(j)
Representation for special dietary use.
(k)
Artificial flavoring, artificial coloring, or chemical preservatives.
(l)
Pesticide chemicals on raw agricultural commodities.
(m)
Color additives.
(n)
Packaging or labeling of drugs in violation of regulations.
(o)
Saccharin for immediate consumption.
(p)
Saccharin not for immediate consumption.
(q)
Nutrition information.
(r)
Nutrition levels and health-related claims.
(s)
Dietary supplements.
343–1.
National uniform nutrition labeling.
343–2.
Dietary supplement labeling exemptions.
(a)
In general.
(b)
Application.
(c)
Burden of proof.
343a.
Health risks presented by use of saccharin.
(a)
Statement on vending machines dispensing food containing saccharin respecting health risk; regulations.
(b)
Availability and distribution of information; review and revision.
344.
Emergency permit control.
(a)
Conditions on manufacturing, processing, etc., as health measure.
(b)
Violation of permit; suspension and reinstatement.
(c)
Inspection of permit-holding establishments.
345.
Regulations making exemptions.
346.
Tolerances for poisonous or deleterious substances in food; regulations.
346a.
Tolerances for pesticide chemicals in or on raw agricultural commodities.
(a)
Conditions of safety.
(b)
Establishment of tolerances.
(c)
Exemptions.
(d)
Regulations pursuant to petition; publication of notice; time for issuance; referral to advisory committees; effective date; hearings.
(e)
Regulations pursuant to Administrator's proposals.
(f)
Data submitted as confidential.
(g)
Advisory committees; appointment; composition; compensation; clerical assistance.
(h)
Right of consultation.
(i)
Judicial review.
(j)
Temporary tolerances.
(k)
Regulations based on public hearings before January 1, 1953.
(l)
Pesticides under Federal Insecticide, Fungicide, and Rodenticide Act; functions of Administrator of the Environmental Protection Agency; certifications; hearing; time limitation; opinion; regulations.
(m)
Amendment of regulations.
(n)
Guaranties.
(o)
Payment of fees; services or functions as conditioned on; waiver or refund of fees.
346b.
Authorization of appropriations.
347.
Intrastate sales of colored oleomargarine.
(a)
Law governing.
(b)
Labeling and packaging requirements.
(c)
Sales in public eating places.
(d)
Exemption from labeling requirements.
(e)
Color content of oleomargarine.
347a.
Congressional declaration of policy regarding oleomargarine sales.
347b.
Contravention of State laws.
348.
Food additives.
(a)
Unsafe food additives; exception for conformity with exemption or regulation.
(b)
Petition for regulation prescribing conditions of safe use; contents; description of production methods and controls; samples; notice of regulation.
(c)
Approval or denial of petition; time for issuance of order; evaluation of data; factors.
(d)
Regulation issued on Secretary's initiative.
(e)
Publication and effective date of orders.
(f)
Objections and public hearing; basis and contents of order; statement.
(g)
Judicial review.
(h)
Amendment or repeal of regulations.
(i)
Exemptions for investigational use.
349.
Bottled drinking water standards; publication in Federal Register.
350.
Vitamins and minerals.
(a)
Authority and limitations of Secretary; applicability.
(b)
Labeling and advertising requirements for foods.
(c)
Definitions.
350a.
Infant formulas.
(a)
Adulteration.
(b)
Requirements for quality factors, good manufacturing practices, and retention of records.
(c)
Registration of persons distributing new infant formula.
(d)
Submission of information about new infant formula required.
(e)
Additional notice requirements for manufacturer.
(f)
Procedures applicable to recalls by manufacturer; regulatory oversight.
(g)
Recordkeeping requirements for manufacturer; regulatory oversight and enforcement.
(h)
Exemptions; regulatory oversight.
(i)
Nutrient requirements.
350b.
New dietary ingredients.
(a)
In general.
(b)
Petition.
(c)
“New dietary ingredient” defined.

        

SUBCHAPTER V—DRUGS AND DEVICES

Part A—Drugs and Devices

351.
Adulterated drugs and devices.
(a)
Poisonous, insanitary, etc., ingredients; adequate controls in manufacture.
(b)
Strength, quality, or purity differing from official compendium.
(c)
Misrepresentation of strength, etc., where drug is unrecognized in compendium.
(d)
Mixture with or substitution of another substance.
(e)
Devices not in conformity with performance standards.
(f)
Certain class III devices.
(g)
Banned devices.
(h)
Manufacture, packing, storage, or installation of device not in conformity with applicable requirements or conditions.
(i)
Failure to comply with requirements under which device was exempted for investigational use.
352.
Misbranded drugs and devices.
(a)
False or misleading label.
(b)
Package form; contents of label.
(c)
Prominence of information on label.
(d)
Habit forming substances.
(e)
Designation of drugs or devices by established names.
(f)
Directions for use and warnings on label.
(g)
Representations as recognized drug; packing and labeling; inconsistent requirements for designation of drug.
(h)
Deteriorative drugs; packing and labeling.
(i)
Drug; misleading container; imitation; offer for sale under another name.
(j)
Health-endangering when used as prescribed.
(k)
Insulin not properly certified.
(l)
Antibiotic drugs improperly certified.
(m)
Color additives; packing and labeling.
(n)
Prescription drug advertisements: established name; quantitative formula; side effects, contraindications, and effectiveness; prior approval; false advertising; labeling; construction of the Convention on Psychotropic Substances.
(o)
Drugs or devices from nonregistered establishments.
(p)
Packaging or labeling of drugs in violation of regulations.
(q)
Restricted devices using false or misleading advertising or used in violation of regulations.
(r)
Restricted devices not carrying requisite accompanying statements in advertisements and other descriptive printed matter.
(s)
Devices subject to performance standards not bearing requisite labeling.
(t)
Devices for which there has been a failure or refusal to give required notification or to furnish required material or information.
353.
Exemptions and consideration for certain drugs, devices, and biological products.
(a)
Regulations for goods to be processed, labeled, or repacked elsewhere.
(b)
Prescription by physician; exemption from labeling and prescription requirements; misbranded drugs; compliance with narcotic and marihuana laws.
(c)
Sales restrictions.
(d)
Distribution of drug samples.
(e)
Wholesale distributors; guidelines for licensing; definitions.
(f)
Veterinary prescription drugs.
(g)
Regulation of combination products.
354.
Repealed.
355.
New drugs.
(a)
Necessity of effective approval of application.
(b)
Filing application; contents.
(c)
Period for approval of application; period for, notice, and expedition of hearing; period for issuance of order.
(d)
Grounds for refusing application; approval of application; “substantial evidence” defined.
(e)
Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to public health.
(f)
Revocation of order refusing, withdrawing or suspending approval of application.
(g)
Service of orders.
(h)
Appeal from order.
(i)
Exemptions of drugs for research; discretionary and mandatory conditions; direct reports to Secretary.
(j)
Abbreviated new drug applications.
(k)
Records and reports; required information; regulations and orders; access to records.
(l)
Public disclosure of safety and effectiveness data.
(m)
“Patent” defined.
356.
Certification of drugs containing insulin.
(a)
Standards for certification.
(b)
Regulations.
(c)
Tests or methods of assay; revision.
357.
Certification of drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug.
(a)
Regulations prescribed by Secretary; release prior to certification; “antibiotic drug” defined.
(b)
Provisions of regulations.
(c)
Exemption of drugs not involving safety and efficacy of use; considerations; certification after exemption; labeling and advertising claims.
(d)
Exemption of drugs stored, processed, and labeled at plants other than manufacturer's, used in manufacture of other drugs or for investigational purposes; discretionary and mandatory conditions; direct reports to Secretary.
(e)
Exempted new drugs subject to section 355 of this title; request for certification of exempted drug; determination of compliance with sections 351(b) and 352(g) of this title.
(f)
Filing of petitions; contents; notice; answer; public hearing; orders.
(g)
Records and reports; professional ethics and interests of patients; examination of data; access to records.
(h)
Issuance of regulations; conditions; amendment or repeal of regulations; effective date; procedure; lack of substantial evidence.
358.
Authority to designate official names.
(a)
Necessity or desirability; use in official compendiums; infringement of trademarks.
(b)
Review of names in official compendiums.
(c)
Determinations of complexity, usefulness, multiplicity, or lack of name; designation by Secretary.
(d)
Revised official names; compilation, publication, and public distribution of listings.
(e)
Request by compiler of official compendium for designation of name.
359.
Nonapplicability of subchapter to cosmetics.
360.
Registration of producers of drugs or devices.
(a)
Definitions.
(b)
Annual registration.
(c)
New producers.
(d)
Additional establishments.
(e)
Registration number; uniform system for identification of devices intended for human use.
(f)
Availability of registrations for inspection.
(g)
Exclusions from application of section.
(h)
Inspection of premises.
(i)
Foreign establishments.
(j)
Filing of lists of drugs and devices manufactured, prepared, propagated and compounded by registrants; statements; accompanying disclosures.
(k)
Report preceding introduction of devices into interstate commerce.
360a.
Repealed.
360b.
New animal drugs.
(a)
Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research.
(b)
Filing application for uses of new animal drug; contents; patent information; abbreviated application.
(c)
Period for approval of application; period for, notice, and expedition of hearing; period for issuance of order; abbreviated applications; withdrawal periods; effective date of approval; relationship to other applications; withdrawal or suspension of approval; bioequivalence; filing of additional patent information.
(d)
Grounds for refusing application; approval of application; factors; “substantial evidence” defined.
(e)
Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to health of man or animals.
(f)
Revocation of order refusing, withdrawing or suspending approval of application.
(g)
Service of orders.
(h)
Appeal from order.
(i)
Publication in Federal Register; effective date and revocation or suspension of regulation.
(j)
Exemption of drugs for research; discretionary and mandatory conditions.
(k)
Food containing new animal drug considered unadulterated while approval of application for such drug is effective.
(l)
Records and reports; required information; regulations and orders; examination of data; access to records.
(m)(1)
Filing application for uses of animal feed containing new animal drug; contents.
(2)
Period for approval of application; period for, notice, and expedition of hearing; period for issuance of order.
(3)
Grounds for refusing application; approval of application; approval effective during existence of subsection (i) regulation.
(4)
Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to health of man or animals.
(5)
Records and reports; regulations and orders; access to records.
(n)
Abbreviated applications for new animal drugs; contents, filing, etc.; lists of approved drugs.
(o)
“Patent” defined.
(p)
Safety and effectiveness data.
360c.
Classification of devices intended for human use.
(a)
Classes of devices.
(b)
Classification panels.
(c)
Classification panel organization and operation.
(d)
Panel recommendation; publication; priorities.
(e)
Classification changes.
(f)
Initial classification and reclassification of certain devices.
(g)
Information.
(h)
Definitions.
(i)
Substantial equivalence.
360d.
Performance standards.
(a)
Reasonable assurance of safe and effective performance; periodic evaluation.
(b)
Establishment of a standard.
360e.
Premarket approval.
(a)
General requirement.
(b)
Regulation to require premarket approval.
(c)
Application for premarket approval.
(d)
Action on application for premarket approval.
(e)
Withdrawal and temporary suspension of approval of application.
(f)
Product development protocol.
(g)
Review.
(h)
Service of orders.
(i)
Revision.
360f.
Banned devices.
(a)
General rule.
(b)
Special effective date.
360g.
Judicial review.
(a)
Petition; record.
(b)
Additional data, views, and arguments.
(c)
Standard for review.
(d)
Finality of judgments.
(e)
Remedies.
(f)
Statement of reasons.
360h.
Notification and other remedies.
(a)
Notification.
(b)
Repair, replacement, or refund.
(c)
Reimbursement.
(d)
Effect on other liability.
(e)
Recall authority.
360i.
Records and reports on devices.
(a)
General rule.
(b)
User reports.
(c)
Persons exempt.
(d)
Certification.
(e)
Device tracking.
(f)
Reports of removals and corrections.
360j.
General provisions respecting control of devices intended for human use.
(a)
General rule.
(b)
Custom devices.
(c)
Trade secrets.
(d)
Notices and findings.
(e)
Restricted devices.
(f)
Good manufacturing practice requirements.
(g)
Exemption for devices for investigational use.
(h)
Release of information respecting safety and effectiveness.
(i)
Proceedings of advisory panels and committees.
(j)
Traceability.
(k)
Research and development.
(l)
Transitional provisions for devices considered as new drugs or antibiotic drugs.
(m)
Humanitarian device exemption.
360k.
State and local requirements respecting devices.
(a)
General rule.
(b)
Exempt requirements.
360l.
Postmarket surveillance.
(a)
In general.
(b)
Surveillance approval.

        

Part B—Drugs for Rare Diseases or Conditions

360aa.
Recommendations for investigations of drugs for rare diseases or conditions.
(a)
Request by sponsor; response by Secretary.
(b)
Regulations.
360bb.
Designation of drugs for rare diseases or conditions.
(a)
Request by sponsor; preconditions; “rare disease or condition” defined.
(b)
Notification of discontinuance of drug or application as condition.
(c)
Notice to public.
(d)
Regulations.
360cc.
Protection for drugs for rare diseases or conditions.
(a)
Exclusive approval, certification, or license.
(b)
Exceptions.
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.
(a)
Authority of Secretary.
(b)
Definitions.
(c)
Authorization of appropriations.

        

Part C—Electronic Product Radiation Control

360hh.
Definitions.
360ii.
Program of control.
(a)
Establishment.
(b)
Powers of Secretary.
(c)
Record keeping.
360jj.
Studies by the Secretary.
(a)
Report to Congress.
(b)
Participation of other Federal agencies.
(c)
Organization of studies and participation.
360kk.
Performance standards for electronic products.
(a)
Promulgation of regulations.
(b)
Administrative procedure.
(c)
Publication in Federal Register.
(d)
Judicial review.
(e)
Availability of record.
(f)
Technical Electronic Product Radiation Safety Standards Committee.
(g)
Review and evaluation.
(h)
Product certification.
360ll.
Notification of defects in and repair or replacement of electronic products.
(a)
Notification; exemption.
(b)
Method of notification.
(c)
Requisite elements of notification.
(d)
Copies to Secretary of communications by manufacturers to dealers or distributors regarding defects.
(e)
Notice from Secretary to manufacturer of defects or failure to comply with standards.
(f)
Correction of defects.
(g)
Effective date.
360mm.
Imports.
(a)
Refusal of admission to noncomplying electronic products.
(b)
Bond.
(c)
Liability of owner or consignee for expenses connected with refusal of admission.
(d)
Designation of agent for purposes of service.
360nn.
Inspection, records, and reports.
(a)
Inspection of premises.
(b)
Record keeping.
(c)
Disclosure of technical data.
(d)
Public nature of reports.
(e)
Trade secrets.
(f)
Information required to identify and locate first purchasers of electronic products.
360oo.
Prohibited acts.
360pp.
Enforcement.
(a)
Jurisdiction of courts.
(b)
Penalties.
(c)
Venue; process.
(d)
Warnings.
(e)
Compliance with regulations.
(f)
Additional remedies.
360qq.
Annual report.
360rr.
Federal-State cooperation.
360ss.
State standards.

        

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.
(a)
Authority to promulgate regulations.
(b)
Regulations for imports and exports.
(c)
Conduct of hearings.
(d)
Effectiveness of definitions and standards of identity.
(e)
Procedure for establishment.
(f)
Review of order.
(g)
Copies of records of hearings.
372.
Examinations and investigations.
(a)
Authority to conduct.
(b)
Availability to owner of part of analysis samples.
(c)
Records of other departments and agencies.
(d)
Information on patents for drugs.
(e)
Powers of enforcement personnel.
372a.
Transferred.
373.
Records of interstate shipment.
374.
Inspection.
(a)
Right of agents to enter; scope of inspection; notice; promptness; exclusions.
(b)
Written report to owner; copy to Secretary.
(c)
Receipt for samples taken.
(d)
Analysis of samples furnished owner.
(e)
Accessibility of records.
375.
Publicity.
(a)
Reports.
(b)
Information regarding certain goods.
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.
(a)
Determination of misbranding; notification of Federal Trade Commission by Secretary; contents.
(b)
Action by Federal Trade Commission precluding action by Secretary; exception.
(c)
Secretary's determination of imminent hazard to health as suspending applicability of provisions.
(d)
Coordination of action by Secretary with Federal Trade Commission.
379.
Confidential information.
379a.
Presumption of existence of jurisdiction.
379b.
Consolidated administrative and laboratory facility.
(a)
Authority.
(b)
Awarding of contract.
(c)
Donations.
(d)
Authorization of appropriations.
379c.
Transferred.
379d.
Automation of Food and Drug Administration.
(a)
In general.
(b)
Authorization of appropriations.

        

Part B—Colors

379e.
Listing and certification of color additives for foods, drugs, devices, and cosmetics.
(a)
Unsafe color additives.
(b)
Listing of colors; regulations; issuance, amendment or repeal; referral to advisory committee; report and recommendations; appointment and compensation of advisory committee.
(c)
Certification of colors.
(d)
Procedure for issuance, amendment, or repeal of regulations.
(e)
Fees.
(f)
Exemptions.

        

Part C—Fees

subpart 1—freedom of information fees

379f.
Recovery and retention of fees for freedom of information requests.
(a)
In general.
(b)
Use of fees.
(c)
Waiver of fees.

        

subpart 2—fees relating to drugs

379g.
Definitions.
379h.
Authority to assess and use drug fees.
(a)
Types of fees.
(b)
Fee amounts.
(c)
Increases and adjustments.
(d)
Fee waiver or reduction.
(e)
Effect of failure to pay fees.
(f)
Assessment of fees.
(g)
Crediting and availability of fees.
(h)
Collection of unpaid fees.
(i)
Construction.

        

SUBCHAPTER VIII—IMPORTS AND EXPORTS

381.
Imports and exports.
(a)
Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission.
(b)
Disposition of refused articles.
(c)
Charges concerning refused articles.
(d)
Reimportation.
(e)
Exports.
382.
Exports of certain unapproved products.
(a)
Drugs intended for human or animal use which require approval or licensing.
(b)
Conditions for export; active pursuit of drug approval or licensing; application for export, contents, approval or disapproval; list of eligible countries for export; criteria for list change.
(c)
Report to Secretary by holder of approved application; events requiring report; annual report to Secretary on pursuit of approval of drug.
(d)
Export of drug under approved application prohibited.
(e)
Determination by Secretary of noncompliance, failure of active pursuit of drug approval, imminent hazard of drug to public health, or exportation of drug to noneligible country; notices and hearings; prohibition on exportation of drug.
(f)
Drugs used in prevention or treatment of tropical disease.
(g)
Reference to Secretary and holder of application.
383.
Office of International Relations.

        

SUBCHAPTER IX—MISCELLANEOUS

391.
Separability clause.
392.
Exemption of meats and meat food products.
(a)
Law determinative of exemption.
(b)
Laws unaffected.
393.
Food and Drug Administration.
(a)
In general.
(b)
Commissioner.
(c)
Technical and scientific review groups.
394.
Scientific review groups.
395.
Loan repayment program.
(a)
In general.
(b)
Applicability of certain provisions.
(c)
Authorization of appropriations.

        

Chapter Referred to in Other Sections

This chapter is referred to in sections 453, 457, 466, 467, 467f, 601, 607, 620, 679, 802, 811, 829, 902, 1033, 1049, 1052, 1401, 1402, 1403 of this title; title 7 sections 136v, 138i, 1431c, 5341, 6519; title 15 sections 70j, 1261, 1263, 1277, 1457, 1459, 1460, 2057a, 2057b, 2079; title 18 section 42; title 19 section 2578a; title 26 sections 170, 4817; title 35 sections 155, 156, 271; title 42 sections 262, 300aa–22, 300aa–23, 1396r–8, 1786, 3512, 7671.

SUBCHAPTER I—SHORT TITLE

§301. Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

(June 25, 1938, ch. 675, §1, 52 Stat. 1040.)

Effective Date; Postponement in Certain Cases

Act June 23, 1939, ch. 242, §§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

Section 902(a) of act June 25, 1938, 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.”

Hazardous Substances

Federal Hazardous Substances Act as not modifying this chapter, see Pub. L. 86–613, §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.

Short Title of 1994 Amendments

Pub. L. 103–417, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §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, §1, Oct. 18, 1968, 82 Stat. 1173, provided that: “This Act [enacting provisions now comprising part C (§§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, §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, §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, §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, §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, §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’.”

SUBCHAPTER II—DEFINITIONS

§321. Definitions; generally

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 drugs” 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 Homeopathic 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) 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 [7 U.S.C. 136 et seq.] as now in force or as hereafter amended, and which is used in the production, storage, or transportation of raw agricultural commodities.

(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 as 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 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

(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, 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.


(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) or 357 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, 357, 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, certified as an antibiotic under section 357 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.


Except for purposes of paragraph (g), a dietary supplement shall be deemed to be a food within the meaning of this chapter.

(June 25, 1938, ch. 675, §201, 52 Stat. 1040; July 22, 1954, ch. 559, §1, 68 Stat. 511; Sept. 6, 1958, Pub. L. 85–929, §2, 72 Stat. 1784; July 12, 1960, Pub. L. 86–618, title I, §101, 74 Stat. 397; Oct. 10, 1962, Pub. L. 87–781, title I, §102(a), title III, §307(a), 76 Stat. 781, 796; July 15, 1965, Pub. L. 89–74, §§3(a), 9(b), 79 Stat. 227, 234; July 13, 1968, Pub. L. 90–399, §102, 82 Stat. 351; Oct. 24, 1968, Pub. L. 90–639, §§1, 4(a), 82 Stat. 1361, 1362; Oct. 27, 1970, Pub. L. 91–513, title II, §701(a), (g), 84 Stat. 1281, 1282; Oct. 21, 1972, Pub. L. 92–516, §3(3), 86 Stat. 998; Apr. 22, 1976, Pub. L. 94–278, title V, §502(a)(2)(A), 90 Stat. 411; May 28, 1976, Pub. L. 94–295, §3(a)(1)(A), (2), 90 Stat. 575; Nov. 23, 1977, Pub. L. 95–203, §4(b)(3), 91 Stat. 1453; Sept. 26, 1980, Pub. L. 96–359, §3, 94 Stat. 1193; Nov. 16, 1988, Pub. L. 100–670, title I, §107(a)(1), 102 Stat. 3984; Nov. 8, 1990, Pub. L. 101–535, §5(b), 104 Stat. 2362; Nov. 28, 1990, Pub. L. 101–629, §16(b), 104 Stat. 4526; May 13, 1992, Pub. L. 102–282, §6, 106 Stat. 161; June 16, 1992, Pub. L. 102–300, §6(a), (b), 106 Stat. 240; Oct. 29, 1992, Pub. L. 102–571, title I, §107(1), 106 Stat. 4499; Aug. 13, 1993, Pub. L. 103–80, §§3(b), (dd)(1), 4(b), 107 Stat. 775, 779; Oct. 25, 1994, Pub. L. 103–417, §§3(a), (b), 10(a), 108 Stat. 4327, 4332.)

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, as amended, which was classified to subchapter I (§1 et seq.) of chapter 1 of this title, was repealed (except for section 14a which was transferred to section 372a of this title) by act June 25, 1938, ch. 675, §902(a), 52 Stat. 1059, and is covered by this chapter.

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in par. (q), 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 (§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 (§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 (§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.

Amendments

1994—Par. (g)(1). Pub. L. 103–417, §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, §3(b), added subpar. (6).

Par. (ff). Pub. L. 103–417, §3(a), added par. (ff).

1993—Pars. (c), (d). Pub. L. 103–80, §3(dd)(1), substituted “Health and Human Services” for “Agriculture”.

Par. (h). Pub. L. 103–80, §4(b), amended directory language of Pub. L. 102–300, §6(a)(1). See 1992 amendment note below.

Pars. (v) to (ff). Pub. L. 103–80, §3(b), redesignated pars. (w) to (ff) as (v) to (ee), respectively.

1992—Pars. (c), (d). Pub. L. 102–300, §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, §6(a)(1), as amended by Pub. L. 103–80, §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, §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, §6(a)(2), added par. (ff).

1990—Par. (g)(1). Pub. L. 101–629, §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, §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, §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, §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, §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, §701(a), struck out par. (v) which defined “depressant or stimulant drug”.

1968—Par. (a)(2). Pub. L. 90–639, §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, §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, §102(c), added subpar. (5).

Par. (u). Pub. L. 90–399, §102(d), inserted reference to section 360b of this title.

Par. (v)(3). Pub. L. 90–639, §1, inserted reference to lysergic acid diethylamide.

Pars. (w), (x). Pub. L. 90–399, §102(e), added pars. (w) and (x).

1965—Par. (g). Pub. L. 89–74, §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, §3(a), added par. (v).

1962—Par. (a). Pub. L. 87–781, §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, §102(a)(1), inserted “and effectiveness” after “to evaluate the safety”, and “and effective” after “as safe”.

Par. (p)(2). Pub. L. 87–781, §102(a)(2), inserted “and effectiveness” after “safety”.

1960—Par. (s). Pub. L. 86–618, §101(a), excluded color additives from definition of “food additive”.

Par. (t). Pub. L. 86–618, §101(c), added par. (t). Former par. (t) redesignated (u).

Par. (u). Pub. L. 86–618, §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 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. (w) 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, 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, §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.”

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, §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.

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 note set out under section 41 of this title.

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 References

Appropriations for purpose and administration of pars. (q) and (r) of this section, see section 346b of this title.

Section Referred to in Other Sections

This section is referred to in sections 343, 346b, 350, 352, 355, 360b, 379e, 802, 825 of this title; title 7 section 136; title 15 sections 1454, 1456, 1471, 2052, 2602; title 18 sections 842, 1365; title 35 section 156; title 42 sections 274e, 287c–11, 289g–2, 300cc–12, 1396r–8; title 49 section 5702.

1 So in original. Probably should be paragraph “(v)”.

§321a. “Butter” defined

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.

(Mar. 4, 1923, ch. 268, 42 Stat. 1500.)

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, as amended, which was classified to subchapter I (§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, §902(a), 52 Stat. 1059, and is covered by this chapter.

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 902(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.

§321b. “Package” defined

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.

(July 24, 1919, ch. 26, 41 Stat. 271.)

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 (§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, §902(a), 52 Stat. 1059, and is covered by this chapter.

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 902(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.

§321c. Nonfat dry milk; “milk” defined

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 11/2 per centum by weight unless otherwise indicated.

The term “milk”, when used herein, means sweet milk of cows.

(Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70 Stat. 486.)

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 (§301 et seq.). For complete classification of this Act to the Code, see section 301 of this title and Tables.

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.

Amendments

1956—Act July 2, 1956, substituted “nonfat dry milk” for “nonfat dry milk solids or defatted milk solids”.

SUBCHAPTER III—PROHIBITED ACTS AND PENALTIES

Subchapter Referred to in Other Sections

This subchapter is referred to in section 378 of this title; title 15 section 1456.

§331. Prohibited acts

The following acts and the causing thereof are prohibited:

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.

(c) The receipt in interstate commerce of any food, drug, device, 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 or 355 of this title.

(e) The refusal to permit access to or copying of any record as required by section 350a or 373 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 355(i) or (k), 357(d) or (g), 360b(a)(4)(C), 360b(j), (l), or (m), 360e(f), or 360i of this title, or the refusal to permit access to or verification or copying of any such required record.

(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, 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, 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, 356, 357, 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, 355, 356, 357, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 374, 379, or 379e of this title concerning any method or process which as a trade secret is entitled to protection. 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, 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) 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.

(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 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.

(q)(1) 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.

(2) With respect to any device, 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 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 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.

(u) 1 The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under section 350b of this title.

(June 25, 1938, ch. 675, §301, 52 Stat. 1042; Dec. 22, 1941, ch. 613, §1, 55 Stat. 851; July 6, 1945, ch. 281, §1, 59 Stat. 463; Mar. 10, 1947, ch. 16, §1, 61 Stat. 11; June 24, 1948, ch. 613, §1, 62 Stat. 582; Mar. 16, 1950, ch. 61, §3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, §2, 67 Stat. 477; Sept. 6, 1958, Pub. L. 85–929, §5, 72 Stat. 1788; July 12, 1960, Pub. L. 86–618, title I, §§104, 105(a), 74 Stat. 403; Oct. 10, 1962, Pub. L. 87–781, title I, §§103(c), 104(e)(1), 106(c), 114(a), title III, §304, 76 Stat. 784, 785, 788, 791, 795; July 15, 1965, Pub. L. 89–74, §§5, 9(c), 79 Stat. 232, 235; July 13, 1968, Pub. L. 90–399, §103, 82 Stat. 352; Oct. 24, 1968, Pub. L. 90–639, §2(b), 82 Stat. 1361; Oct. 27, 1970, Pub. L. 91–513, title II, §701(a), 84 Stat. 1281; Aug. 16, 1972, Pub. L. 92–387, §4(e), 86 Stat. 562; May 28, 1976, Pub. L. 94–295, §§3(b), 4(b)(1), 7(b), 90 Stat. 576, 580, 582; Sept. 26, 1980, Pub. L. 96–359, §5, 94 Stat. 1193; Oct. 27, 1986, Pub. L. 99–570, title IV, §4014(b)(2), 100 Stat. 3207–120; Apr. 22, 1988, Pub. L. 100–293, §7(a), 102 Stat. 99; Nov. 3, 1990, Pub. L. 101–502, §5(j), 104 Stat. 1289; Nov. 5, 1990, Pub. L. 101–508, title IV, §4755(c)(2), 104 Stat. 1388–210; June 16, 1992, Pub. L. 102–300, §3(a)(1), 106 Stat. 238; Oct. 29, 1992, Pub. L. 102–571, title I, §107(2), (3), 106 Stat. 4499; Aug. 13, 1993, Pub. L. 103–80, §3(c), 107 Stat. 775; Oct. 22, 1994, Pub. L. 103–396, §2(b)(1), 108 Stat. 4154; Oct. 25, 1994, Pub. L. 103–417, §10(b), 108 Stat. 4332.)

Amendments

1994—Par. (e). Pub. L. 103–396, §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, §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, §3(c)(1), substituted “379, or 379e” for “379e, or 379”.

Par. (s). Pub. L. 103–80, §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, §5(b), inserted reference to section 350a of this title in two places.

Par. (j). Pub. L. 96–359, §5(c), inserted reference to section 350a of this title.

Par. (s). Pub. L. 96–359, §5(a), added par. (s).

1976—Par. (e). Pub. L. 94–295, §3(b)(2), inserted references to sections 360e(f) and 360i of this title.

Par. (j). Pub. L. 94–295, §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, §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, §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, §3(b)(1), added par. (q).

Par. (r). Pub. L. 94–295, §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, §103(1), inserted reference to section 360b(j), (l), and (m) of this title.

Par. (j). Pub. L. 90–399, §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, §9(c), designated existing provisions as subpar. (1) and added subpars. (2) and (3).

Par. (q). Pub. L. 89–74, §5, added par. (q).

1962—Par. (e). Pub. L. 87–781, §§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, §104(e)(1), inserted “approval of” before “an application”, and substituted “in effect” for “effective”.

Par. (o). Pub. L. 87–781, §114(a), added par. (o).

Par. (p). Pub. L. 87–781, §304, added par. (p).

1960—Par. (i). Pub. L. 86–618, §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, §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 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, §§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.

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.

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 note set out under section 41 of this title.

Section Referred to in Other Sections

This section is referred to in sections 321, 332, 333, 347b, 360i, 360j of this title; title 42 section 1396r–8.

1 So in original. Probably should be “(v)”.

§332. Injunction proceedings

(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.

(June 25, 1938, ch. 675, §302, 52 Stat. 1043; Oct. 10, 1962, Pub. L. 87–781, title I, §103(d), title II, §201(c), 76 Stat. 784, 793; Aug. 13, 1993, Pub. L. 103–80, §3(d), 107 Stat. 775.)

Amendments

1993—Subsec. (a). Pub. L. 103–80, §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, §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, §103(d), struck out “(e),” after “paragraphs”.

Pub. L. 87–781, §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].”

Section Referred to in Other Sections

This section is referred to in sections 334, 360j of this title; title 42 section 1396r–8.

1 So in original. Probably should be followed by a comma.

§333. Penalties

(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.

(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.

(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(f) 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) A civil penalty under paragraph (1) shall be assessed 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 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, 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.

(C) 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 agreed upon in compromise, may be deducted from any sums owing by the United States to the person charged.

(3) Any person who requested, in accordance with paragraph (2)(A), a hearing respecting the assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty 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.

(4) 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 (3), or

(B) after a court in an action brought under paragraph (3) 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 (3) 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.

(June 25, 1938, ch. 675, §303, 52 Stat. 1043; Oct. 26, 1951, ch. 578, §2, 65 Stat. 649; July 12, 1960, Pub. L. 86–618, title I, §105(b), 74 Stat. 403; July 15, 1965, Pub. L. 89–74, §§7, 9(d), 79 Stat. 233, 235; Oct. 24, 1968, Pub. L. 90–639, §3, 82 Stat. 1361; Oct. 27, 1970, Pub. L. 91–513, title II, §701(b), 84 Stat. 1281; Apr. 22, 1976, Pub. L. 94–278, title V, §502(a)(2)(B), 90 Stat. 411; Apr. 22, 1988, Pub. L. 100–293, §7(b), 102 Stat. 99; Nov. 18, 1988, Pub. L. 100–690, title II, §2403, 102 Stat. 4230; Nov. 28, 1990, Pub. L. 101–629, §17(a), 104 Stat. 4526; Nov. 29, 1990, Pub. L. 101–647, title XIX, §1904, 104 Stat. 4853; Aug. 26, 1992, Pub. L. 102–353, §3, 106 Stat. 941; Aug. 13, 1993, Pub. L. 103–80, §3(e), 107 Stat. 775; Sept. 13, 1994, Pub. L. 103–322, title XXXIII, §330015, 108 Stat. 2146.)

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, as amended, which is classified principally to subchapter I (§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.

Amendments

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 not be executed 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, §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, §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, §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, §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, §3(b)(4), substituted “subsection (a)(1) of this section” for “subsection (a) of this section”.

Subsec. (d). Pub. L. 102–353, §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, §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, §7(b), inserted parenthetical exception provision.

Subsec. (c)(5). Pub. L. 89–74, §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 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.

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 note set out under section 41 of this title.

Enforcement

Pub. L. 99–660, title I, §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].”

Cross References

Furnishing of guaranties, applicability to raw agricultural commodities, see section 346a of this title.

Section Referred to in Other Sections

This section is referred to in sections 331, 346a, 360j, 859 of this title; title 15 section 1456.

1 So in original. Words “of this section” probably should not appear.

§333a. Repealed. Pub. L. 101–647, title XIX, §1905, Nov. 29, 1990, 104 Stat. 4853

Section, Pub. L. 100–690, title II, §2401, Nov. 18, 1988, 102 Stat. 4230, related to forfeiture and illegal trafficking in steroids or human growth hormones.

§334. Seizure

(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 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, and (D) Any adulterated or misbranded device.

(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, 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 paragraphs (1) and (2) of section 381(e) 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 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 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 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 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 during the period of its detention for the purpose of identifying the device as detained. Any person who would be entitled to claim a device if it were seized under subsection (a) of this section may appeal to the Secretary a detention of such device 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 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.

(June 25, 1938, ch. 675, §304, 52 Stat. 1044; June 24, 1948, ch. 613, §2, 62 Stat. 582; Aug. 7, 1953, ch. 350, §3, 67 Stat. 477; Aug. 31, 1957, Pub. L. 85–250, 71 Stat. 567; July 15, 1965, Pub. L. 89–74, §6, 79 Stat. 232; Oct. 24, 1968, Pub. L. 90–639, §4(b), 82 Stat. 1362; Oct. 27, 1970, Pub. L. 91–513, title II, §701(c), (d), 84 Stat. 1281, 1282; Apr. 22, 1976, Pub. L. 94–278, title V, §502(a)(2)(C), 90 Stat. 411; May 28, 1976, Pub. L. 94–295, §§3(c), 7(a), 90 Stat. 576, 582; June 16, 1992, Pub. L. 102–300, §6(c), 106 Stat. 240; Aug. 13, 1993, Pub. L. 103–80, §3(f), 107 Stat. 775.)

Amendments

1993—Subsec. (a)(1). Pub. L. 103–80, §3(f)(1), substituted “found. No libel” for “found: Provided, however, That no libel”.

Subsec. (d)(1). Pub. L. 103–80, §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, §3(c)(1), struck out “device,” after “Any article of food, drug,”.

Subsec. (a)(2). Pub. L. 94–295, §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, §7(a), added subsec. (g).

1970—Subsec. (a)(2). Pub. L. 91–513, §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, §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, §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, §6(b)(1), inserted “equipment, or other thing proceeded against” after “article” in first sentence.

Subsec. (d). Pub. L. 89–74, §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 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.

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.

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 note set out under section 41 of this title.

Federal Rules of Civil Procedure

Admiralty and maritime rules of practice (which included libel procedures) were superseded, and civil and admiralty procedures in United States district courts were unified, effective July 1, 1966, see rule 1 and Supplemental Rules for Certain Admiralty and Maritime Claims, Title 28, Appendix, Judiciary and Judicial Procedure.

Section Referred to in Other Sections

This section is referred to in sections 331, 360j, 372 of this title; title 42 section 1396r–8.

§335. Hearing before report of criminal violation

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.

(June 25, 1938, ch. 675, §305, 52 Stat. 1045.)

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 note set out under section 41 of this title.

§335a. Debarment, temporary denial of approval, and suspension

(a) Mandatory debarment

(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

(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, or

(B) an individual from providing services in any capacity to a person that has an approved or pending drug product application.

(2) Persons subject to permissive debarment

The following persons are subject to debarment under 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) 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 subsection (b)(2) 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) or (b)(2)(A) 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) 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) 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) of this section if such termination serves the interests of justice and adequately protects the integrity of the drug approval process.

(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 355 or 357 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, and clauses (i) and (ii) of subsection (b)(2)(B) 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 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.

(June 25, 1938, ch. 675, §306, as added May 13, 1992, Pub. L. 102–282, §2, 106 Stat. 150.)

Prior Provisions

A prior section 306 of act June 25, 1938, was renumbered section 309 and is classified to section 336 of this title.

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.”

Section Referred to in Other Sections

This section is referred to in sections 321, 335b of this title.

§335b. Civil penalties

(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.

(June 25, 1938, ch. 675, §307, as added May 13, 1992, Pub. L. 102–282, §3, 106 Stat. 159; amended Aug. 13, 1993, Pub. L. 103–80, §3(g), 107 Stat. 776.)

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.

Section Referred to in Other Sections

This section is referred to in sections 321, 335a of this title.

§335c. Authority to withdraw approval of abbreviated drug applications

(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.

(June 25, 1938, ch. 675, §308, as added May 13, 1992, Pub. L. 102–282, §4, 106 Stat. 160.)

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.

Section Referred to in Other Sections

This section is referred to in section 321 of this title.

§336. Report of minor violations

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.

(June 25, 1938, ch. 675, §309, formerly §306, 52 Stat. 1045; renumbered §309, May 13, 1992, Pub. L. 102–282, §2, 106 Stat. 150.)

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 note set out under section 41 of this title.

Federal Rules of Civil Procedure

Admiralty and maritime rules of practice (which included libel procedures) were superseded, and civil and admiralty procedures in United States district courts were unified, effective July 1, 1966, see rule 1 and Supplemental Rules for Certain Admiralty and Maritime Claims, Title 28, Appendix, Judiciary and Judicial Procedure.

§337. Proceedings in name of United States; provision as to subpoenas

(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.

(June 25, 1938, ch. 675, §310, formerly §307, 52 Stat. 1046; Sept. 3, 1954, ch. 1263, §37, 68 Stat. 1239; Nov. 8, 1990, Pub. L. 101–535, §4, 104 Stat. 2362; renumbered §310, May 13, 1992, Pub. L. 102–282, §2, 106 Stat. 150.)

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.

SUBCHAPTER IV—FOOD

§341. Definitions and standards for food

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.

(June 25, 1938, ch. 675, §401, 52 Stat. 1046; Apr. 15, 1954, ch. 143, §1, 68 Stat. 54; Aug. 1, 1956, ch. 861, §1, 70 Stat. 919; Aug. 13, 1993, Pub. L. 103–80, §3(h), 107 Stat. 776.)

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.”

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 note set out under section 41 of this title.

Section Referred to in Other Sections

This section is referred to in sections 337, 343, 343–1, 350, 371 of this title.

§342. Adulterated food

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 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; (3) If 2 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 3 (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.

(June 25, 1938, ch. 675, §402, 52 Stat. 1046; Mar. 16, 1950, ch. 61, §3(d), 64 Stat. 21; July 22, 1954, ch. 559, §2, 68 Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Sept. 6, 1958, Pub. L. 85–929, §3(a), (b), 72 Stat. 1784; Mar. 17, 1959, Pub. L. 86–2, 73 Stat. 3; July 12, 1960, Pub. L. 86–618, title I, §§102(a)(1), (2), 105(c), 74 Stat. 397, 398, 404; June 29, 1966, Pub. L. 89–477, 80 Stat. 231; July 13, 1968, Pub. L. 90–399, §104, 82 Stat. 352; Feb. 27, 1986, Pub. L. 99–252, §10, 100 Stat. 35; Oct. 29, 1992, Pub. L. 102–571, title I, §107(4), 106 Stat. 4499; Aug. 13, 1993, Pub. L. 103–80, §3(i), 107 Stat. 776; Oct. 25, 1994, Pub. L. 103–417, §§4, 9, 108 Stat. 4328, 4332.)

Amendments

1994—Par. (f). Pub. L. 103–417, §4, added par. (f).

Par. (g). Pub. L. 103–417, §9, added par. (g).

1993—Par. (a). Pub. L. 103–80, §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, §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, §3(i)(2), substituted “, except that this subparagraph” for “: Provided, That this clause”.

Par. (d)(3). Pub. L. 103–80, §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, §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, §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, §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 subsection 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 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, §2, Apr. 7, 1961, 75 Stat. 42; Pub. L. 88–625, §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, §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’.”

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 note set out under section 41 of this title.

Cross References

Appropriations for establishing tolerances for pesticide chemicals, see section 346b of this title.

Section Referred to in Other Sections

This section is referred to in sections 321, 334, 346, 346a, 346b, 347b, 348, 350a, 350b, 360b, 379e of this title.

1 So in original. The period probably should be “; or”.

2 So in original. Probably should be “or (3) if”.

3 So in original. Probably should be “subparagraph”.

§343. Misbranded food

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; or

(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.

(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) Saccharin for immediate consumption

(1) If it contains saccharin, unless, except as provided in subparagraph (2), its label and labeling bear the following statement: “USE OF THIS PRODUCT MAY BE HAZARDOUS TO YOUR HEALTH. THIS PRODUCT CONTAINS SACCHARIN WHICH HAS BEEN DETERMINED TO CAUSE CANCER IN LABORATORY ANIMALS”. Such statement shall be located in a conspicuous place on such label and labeling as proximate as possible to the name of such food and shall appear in conspicuous and legible type in contrast by typography, layout, and color with other printed matter on such label and labeling.

(2) The Secretary may by regulation review and revise or remove the requirement of subparagraph (1) if the Secretary determines such action is necessary to reflect the current state of knowledge concerning saccharin.

(p) Saccharin not for immediate consumption

(1) If it contains saccharin and is offered for sale, but not for immediate consumption, at a retail establishment, unless such retail establishment displays prominently, where such food is held for sale, notice (provided by the manufacturer of such food pursuant to subparagraph (2) for consumers respecting the information required by paragraph (o) to be on food labels and labeling.

(2) Each manufacturer of food which contains saccharin and which is offered for sale by retail establishments but not for immediate consumption shall, in accordance with regulations promulgated by the Secretary pursuant to subparagraph (4), take such action as may be necessary to provide such retail establishments with the notice required by subparagraph (1).

(3) The Secretary may by regulation review and revise or remove the requirement of subparagraph (1) if he determines such action is necessary to reflect the current state of knowledge concerning saccharin.

(4) The Secretary shall by regulation prescribe the form, text, and manner of display of the notice required by subparagraph (1) and such other matters as may be required for the implementation of the requirements of that subparagraph and subparagraph (2). Regulations of the Secretary under this subparagraph shall be promulgated after an oral hearing but without regard to the National Environmental Policy Act of 1969 [42 U.S.C. 4321 et seq.] and chapter 5 of title 5. In any action brought for judicial review of any such regulation, the reviewing court may not postpone the effective date of such regulation.

(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) 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) 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.

(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, 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.


(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.

(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.

(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 denies the petition, 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.

(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.

(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.

(June 25, 1938, ch. 675, §403, 52 Stat. 1047; June 29, 1960, Pub. L. 86–537, §1, 74 Stat. 251; July 12, 1960, Pub. L. 86–618, title I, §102(a)(3), 74 Stat. 398; Dec. 30, 1970, Pub. L. 91–601, §6(c), formerly §7(c), 84 Stat. 1673, renumbered Aug. 13, 1981, Pub. L. 97–35, title XII, §1205(c), 95 Stat. 716; Apr. 22, 1976, Pub. L. 94–278, title V, §502(a)(1), 90 Stat. 411; Nov. 23, 1977, Pub. L. 95–203, §4(a)(1), (b)(1), 91 Stat. 1452, 1453; Nov. 8, 1990, Pub. L. 101–535, §§2(a), 3(a), 7, 104 Stat. 2353, 2357, 2364; Aug. 17, 1991, Pub. L. 102–108, §2(a), (c), 105 Stat. 549; Oct. 29, 1992, Pub. L. 102–571, title I, §107(5), (6), 106 Stat. 4499; Aug. 13, 1993, Pub. L. 103–80, §§2(b), 3(j), 107 Stat. 773, 776; Oct. 25, 1994, Pub. L. 103–417, §§6, 7(a)–(c), 10(c), 108 Stat. 4329, 4330, 4332.)

References in Text

The National Environmental Policy Act of 1969, referred to in par. (p)(4), is Pub. L. 91–190, Jan. 1, 1970, 83 Stat. 852, as amended, which is classified generally to chapter 55 (§4321 et seq.) 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 4321 of Title 42 and Tables.

Amendments

1994—Par. (q)(5)(F). Pub. L. 103–417, §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, §7(c), added cl. (F).

Par. (r)(6). Pub. L. 103–417, §6, added subpar. (6).

Par. (s). Pub. L. 103–417, §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, §7(a), added par. (s).

1993—Par. (e). Pub. L. 103–80, §3(j)(1), substituted “count, except that” for “count: Provided, That”.

Par. (i). Pub. L. 103–80, §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, §3(j)(3), substituted “, except that” for “: Provided, That”.

Par. (l). Pub. L. 103–80, §3(j)(4), substituted “chemical, except that” for “chemical: Provided, however, That”.

Par. (q)(5)(E) to (G). Pub. L. 103–80, §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, §3(j)(5), substituted “(5)(D)” for “5(D)”.

Par. (r)(4)(B). Pub. L. 103–80, §3(j)(6), substituted “paragraph” for “subsection”.

1992—Par. (i). Pub. L. 102–571, §107(5), substituted “379e(c)” for “376(c)”.

Par. (m). Pub. L. 102–571, §107(6), substituted “379e” for “376”.

1991—Par. (i). Pub. L. 102–108, §2(c), amended directory language of Pub. L. 101–535, §7(1), (3). See 1990 Amendment note below.

Par. (q)(4)(A). Pub. L. 102–108, §2(a), substituted “(D)” for “(C)”.

1990—Par. (i). Pub. L. 101–535, §7, as amended by Pub. L. 102–108, §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, §2(a), added par. (q).

Par. (r). Pub. L. 101–535, §3(a), added par. (r).

1977—Par. (o). Pub. L. 95–203, §4(a)(1), added par. (o).

Par. (p). Pub. L. 95–203, §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, §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, §1(2), added par. (l).

Par. (m). Pub. L. 86–618 added par. (m).

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, §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, §1, Aug. 17, 1991, 105 Stat. 549; Pub. L. 102–571, title I, §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 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.].”

Regulations

Section 2(b) of Pub. L. 101–535, as amended by Pub. L. 102–571, title II, §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, §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.]

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 note set out under section 41 of this title.

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 Subsec. (o)(2)

Section 4(a)(3) of Pub. L. 95–203 provided that: “The Secretary shall report to the Committee on Human Resources of the Senate [now the Committee on Labor and Human Resources of the Senate] and the Committee on Interstate and Foreign Commerce [now the Committee on Commerce] of the House of Representatives any action taken under section 403(o)(2) of the Federal Food, Drug, and Cosmetic Act [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.”

Section Referred to in Other Sections

This section is referred to in sections 321, 333, 334, 337, 343–1, 345, 347, 350, 371 of this title.

1 So in original. Probably should be followed by a comma.

§343–1. National uniform nutrition labeling

(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), or 343(i)(2) 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 a requirement for nutrition labeling of food which is exempt under subclause (i) or (ii) of section 343(q)(5)(A) 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.

(June 25, 1938, ch. 675, §403A, as added Nov. 8, 1990, Pub. L. 101–535, §6(a), 104 Stat. 2362; amended Aug. 17, 1991, Pub. L. 102–108, §2(b), 105 Stat. 549; Oct. 22, 1994, Pub. L. 103–396, §3(a), 108 Stat. 4154.)

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.

Amendments

1994—Subsec. (a)(1). Pub. L. 103–396, §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, §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, §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

Section 10(b) of Pub. L. 101–535, as amended by Pub. L. 102–571, title I, §107(16), title II, §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, §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.”

§343–2. Dietary supplement labeling exemptions

(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.

(June 25, 1938, ch. 675, §403B, as added Oct. 25, 1994, Pub. L. 103–417, §5, 108 Stat. 4328.)

§343a. Health risks presented by use of saccharin

(a) Statement on vending machines dispensing food containing saccharin respecting health risk; regulations

The Secretary may by regulation require vending machines through which food containing saccharin is sold to bear a statement of the risks to health which may be presented by the use of saccharin. A regulation under this subsection shall require such statement to be located in a conspicuous place on such vending machine and as proximate as possible to the name of each food containing saccharin which is sold through such machine. Any food containing saccharin which is sold in a vending machine which does not meet any applicable requirement promulgated under this subsection shall, for purposes of this chapter, be considered a misbranded food.

(b) Availability and distribution of information; review and revision

The Secretary shall (1) prepare information respecting the nature of the controversy surrounding the use of food containing saccharin, and (2) provide for the distribution of such information for display by retail establishments where such food is sold but not for immediate consumption. The Secretary may review and revise such information if he determines such action is necessary to reflect the current state of knowledge concerning the risks to health presented by the use of saccharin.

(Pub. L. 95–203, §4(c), (d), Nov. 23, 1977, 91 Stat. 1453, 1454.)

Codification

Subsecs. (a) and (b) of this section were, in the original, designated as “(c)” and “(d)” and have been editorially changed for codification purposes.

Section was enacted as part of Pub. L. 95–203, known as the Saccharin Study and Labeling Act and not as part of act June 25, 1938, ch. 675, 52 Stat. 1040, known as the Federal Food, Drug, and Cosmetic Act, which comprises this chapter.

§344. Emergency permit control

(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.

(June 25, 1938, ch. 675, §404, 52 Stat. 1048.)

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 note set out under section 41 of this title.

Section Referred to in Other Sections

This section is referred to in sections 331, 333, 334, 371 of this title.

§345. Regulations making exemptions

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.

(June 25, 1938, ch. 675, §405, 52 Stat. 1049; Nov. 8, 1990, Pub. L. 101–535, §5(a), 104 Stat. 2362.)

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.

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 note set out under section 41 of this title.

Section Referred to in Other Sections

This section is referred to in section 343 of this title.

§346. Tolerances for poisonous or deleterious substances in food; regulations

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.

(June 25, 1938, ch. 675, §406, 52 Stat. 1049; Sept. 6, 1958, Pub. L. 85–929, §3(c), 72 Stat. 1785; July 12, 1960, Pub. L. 86–618, title I, §103(a)(1), 74 Stat. 398.)

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.

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, §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 note set out under section 41 of this title.

Cross References

Pesticide chemical regulations, see section 346a of this title.

Section Referred to in Other Sections

This section is referred to in sections 342, 346a, 371 of this title.

§346a. Tolerances for pesticide chemicals in or on raw agricultural commodities

(a) Conditions of safety

Any poisonous or deleterious pesticide chemical, or any pesticide chemical which is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of pesticide chemicals, as safe for use, added to a raw agricultural commodity, shall be deemed unsafe for the purposes of the application of clause (2) of section 342(a) of this title unless—

(1) a tolerance for such pesticide chemical in or on the raw agricultural commodity has been prescribed by the Administrator of the Environmental Protection Agency (hereinafter in this section referred to as the “Administrator”) under this section and the quantity of such pesticide chemical in or on the raw agricultural commodity is within the limits of the tolerance so prescribed; or

(2) with respect to use in or on such raw agricultural commodity, the pesticide chemical has been exempted from the requirement of a tolerance by the Administrator under this section.


While a tolerance or exemption from tolerance is in effect for a pesticide chemical with respect to any raw agricultural commodity, such raw agricultural commodity shall not, by reason of bearing or containing any added amount of such pesticide chemical, be considered to be adulterated within the meaning of clause (1) of section 342(a) of this title.

(b) Establishment of tolerances

The Administrator shall promulgate regulations establishing tolerances with respect to the use in or on raw agricultural commodities of poisonous or deleterious pesticide chemicals and of pesticide chemicals which are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of pesticide chemicals, as safe for use, to the extent necessary to protect the public health. In establishing any such regulation, the Administrator shall give appropriate consideration, among other relevant factors, (1) to the necessity for the production of an adequate, wholesome, and economical food supply; (2) to the other ways in which the consumer may be affected by the same pesticide chemical or by other related substances that are poisonous or deleterious; and (3) to the opinion of the Secretary of Agriculture 1 as submitted with a certification of usefulness under subsection (l) of this section. Such regulations shall be promulgated in the manner prescribed in subsection (d) or (e) of this section. In carrying out the provisions of this section relating to the establishment of tolerances, the Administrator may establish the tolerance applicable with respect to the use of any pesticide chemical in or on any raw agricultural commodity at zero level if the scientific data before the Administrator does not justify the establishment of a greater tolerance.

(c) Exemptions

The Administrator shall promulgate regulations exempting any pesticide chemical from the necessity of a tolerance with respect to use in or on any or all raw agricultural commodities when such a tolerance is not necessary to protect the public health. Such regulations shall be promulgated in the manner prescribed in subsection (d) or (e) of this section.

(d) Regulations pursuant to petition; publication of notice; time for issuance; referral to advisory committees; effective date; hearings

(1) Any person who has registered, or who has submitted an application for the registration of, a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.] may file with the Administrator of Health and Human Services,2 a petition proposing the issuance of a regulation establishing a tolerance for a pesticide chemical which constitutes, or is an ingredient of, such pesticide, or exempting the pesticide chemical from the requirement of a tolerance. The petition shall contain data showing—

(A) the name, chemical identity, and composition of the pesticide chemical;

(B) the amount, frequency, and time of application of the pesticide chemical;

(C) full reports of investigations made with respect to the safety of the pesticide chemical;

(D) the results of tests on the amount of residue remaining, including a description of the analytical methods used;

(E) practicable methods for removing residue which exceeds any proposed tolerance;

(F) proposed tolerances for the pesticide chemical if tolerances are proposed; and

(G) reasonable grounds in support of the petition.


Samples of the pesticide chemical shall be furnished to the Administrator upon request. Notice of the filing of such petition shall be published in general terms by the Administrator within thirty days after filing. Such notice shall include the analytical methods available for the determination of the residue of the pesticide chemical for which a tolerance or exemption is proposed.

(2) Within ninety days after a certification of usefulness by the Secretary of Agriculture 3 under subsection (l) of this section with respect to the pesticide chemical named in the petition, the Administrator of Health and Human Services 4 shall, after giving due consideration to the data submitted in the petition or otherwise before him, by order make public a regulation—

(A) establishing a tolerance for the pesticide chemical named in the petition for the purposes for which it is so certified as useful, or

(B) exempting the pesticide chemical from the necessity of a tolerance for such purposes,


unless within such ninety-day period the person filing the petition requests that the petition be referred to an advisory committee or the Administrator within such period otherwise deems such referral necessary, in either of which events the provisions of paragraph (3) of this subsection shall apply in lieu hereof.

(3) In the event that the person filing the petition requests, within ninety days after a certification of usefulness by the Secretary of Agriculture 3 under subsection (l) of this section with respect to the pesticide chemical named in the petition, that the petition be referred to an advisory committee, or in the event the Administrator of Health and Human Services 4 within such period otherwise deems such referral necessary, the Administrator of Health and Human Services 4 shall forthwith submit the petition and other data before him to an advisory committee to be appointed in accordance with subsection (g) of this section. As soon as practicable after such referral, but not later than sixty days thereafter, unless extended as hereinafter provided, the committee shall, after independent study of the data submitted to it by the Administrator and other data before it, certify to the Administrator a report and recommendations on the proposal in the petition to the Administrator, together with all underlying data and a statement of the reasons or basis for the recommendations. The sixty-day period provided for herein may be extended by the advisory committee for an additional thirty days if the advisory committee deems this necessary. Within thirty days after such certification, the Administrator shall, after giving due consideration to all data then before him, including such report, recommendations, underlying data, and statement, by order make public a regulation—

(A) establishing a tolerance for the pesticide chemical named in the petition for the purposes for which it is so certified as useful; or

(B) exempting the pesticide chemical from the necessity of a tolerance for such purposes.


(4) The regulations published under paragraph (2) or (3) of this subsection will be effective upon publication.

(5) Within thirty days after publication, any person adversely affected by a regulation published pursuant to paragraph (2) or (3) of this subsection, or pursuant to subsection (e) of this section, may file objections thereto with the Administrator, specifying with particularity the provisions of the regulation deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections. A copy of the objections filed by a person other than the petitioner shall be served on the petitioner, if the regulation was issued pursuant to a petition. The petitioner shall have two weeks to make a written reply to the objections. The Administrator shall thereupon, after due notice, hold such public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. Any report, recommendations, underlying data, and reasons certified to the Administrator by an advisory committee shall be made a part of the record of the hearing, if relevant and material, subject to the provisions of section 556(c) 5 of title 5. The National Academy of Sciences shall designate a member of the advisory committee to appear and testify at any such hearing with respect to the report and recommendations of such committee upon request of the Administrator, the petitioner, or the officer conducting the hearing: Provided, That this shall not preclude any other member of the advisory committee from appearing and testifying at such hearing. As soon as practicable after completion of the hearing, the Administrator shall act upon such objections and by order make public a regulation. Such regulation shall be based only on substantial evidence of record at such hearing, including any report, recommendations, underlying data, and reasons certified to the Administrator by an advisory committee, and shall set forth detailed findings of fact upon which the regulation is based. No such order shall take effect prior to the ninetieth day after its publication, unless the Administrator finds that emergency conditions exist necessitating an earlier effective date, in which event the Administrator shall specify in the order his findings as to such conditions.

(e) Regulations pursuant to Administrator's proposals

The Administrator may at any time, upon his own initiative or upon the request of any interested person, propose the issuance of a regulation establishing a tolerance for a pesticide chemical or exempting it from the necessity of a tolerance. Thirty days after publication of such a proposal, the Administrator may by order publish a regulation based upon the proposal which shall become effective upon publication unless within such thirty-day period a person who has registered, or who has submitted an application for the registration of, a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.] containing the pesticide chemical named in the proposal, requests that the proposal be referred to an advisory committee. In the event of such a request, the Administrator shall forthwith submit the proposal and other relevant data before him to an advisory committee to be appointed in accordance with subsection (g) of this section. As soon as practicable after such referral, but not later than sixty days thereafter, unless extended as hereinafter provided, the committee shall, after independent study of the data submitted to it by the Administrator and other data before it, certify to the Administrator a report and recommendations on the proposal together with all underlying data and a statement of the reasons or basis for the recommendations. The sixty-day period provided for herein may be extended by the advisory committee for an additional thirty days if the advisory committee deems this necessary. Within thirty days after such certification, the Administrator may, after giving due consideration to all data before him, including such report, recommendations, underlying data and statement, by order publish a regulation establishing a tolerance for the pesticide chemical named in the proposal or exempting it from the necessity of a tolerance which shall become effective upon publication. Regulations issued under this subsection shall upon publication be subject to paragraph (5) of subsection (d) of this section.

(f) Data submitted as confidential

All data submitted to the Administrator or to an advisory committee in support of a petition under this section shall be considered confidential by the Administrator and by such advisory committee until publication of a regulation under paragraph (2) or (3) of subsection (d) of this section. Until such publication, such data shall not be revealed to any person other than those authorized by the Administrator or by an advisory committee in the carrying out of their official duties under this section.

(g) Advisory committees; appointment; composition; compensation; clerical assistance

Whenever the referral of a petition or proposal to an advisory committee is requested under this section, or the Administrator otherwise deems such referral necessary the Administrator shall forthwith appoint a committee of competent experts to review the petition or proposal and to make a report and recommendations thereon. Each such advisory committee shall be composed of experts, qualified in the subject matter of the petition and of adequately diversified professional background selected by the National Academy of Sciences and shall include one or more representatives from land-grant colleges. The size of the committee shall be determined by the Administrator. Members of an advisory committee shall receive compensation and travel expenses in accordance with subsection (b)(5)(D) of section 379e of this title. The members shall not be subject to any other provision of law regarding the appointment and compensation of employees of the United States. The Administrator shall furnish the Committee with adequate clerical and other assistance, and shall by rules and regulations prescribe the procedure to be followed by the committee.

(h) Right of consultation

A person who has filed a petition or who has requested the referral of a proposal to an advisory committee in accordance with the provisions of this section, as well as representatives of the Department of Health and Human Services, shall have the right to consult with any advisory committee provided for in subsection (g) of this section in connection with the petition or proposal.

(i) Judicial review

(1) In a case of actual controversy as to the validity of any order under subsection (d)(5), (e), or (l) of 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) In the case of a petition with respect to an order under subsection (d)(5) or (e) of this section, a copy of the petition shall be forthwith transmitted by the clerk of the court to the Administrator, or any officer designated by him for that purpose, and thereupon the Administrator 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 exclusive jurisdiction to affirm or set aside the order complained of in whole or in part. The findings of the Administrator with respect to questions of fact shall be sustained if supported by substantial evidence when considered on the record as a whole, including any report and recommendation of an advisory committee.

(3) In the case of a petition with respect to an order under subsection (l) of this section, a copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary of Agriculture,6 or any officer designated by him for that purpose, and thereupon the Administrator 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 exclusive jurisdiction to affirm or set aside the order complained of in whole or in part. The findings of the Administrator with respect to questions of fact shall be sustained if supported by substantial evidence when considered on the record as a whole.

(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 Administrator of Health and Human Services 7 or the Secretary of Agriculture,6 as the case may be, 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 Administrator of Health and Human Services 7 or the Secretary of Agriculture,6 as the case may be, 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.

(j) Temporary tolerances

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 his own initiative, establish a temporary tolerance for the pesticide chemical for the uses covered by the permit whenever in his judgment such action is deemed necessary to protect the public health, or may temporarily exempt such pesticide chemical from a tolerance. In establishing such a tolerance, the Administrator shall give due regard to the necessity for experimental work in developing an adequate, wholesome, and economical food supply and to the limited hazard to the public health involved in such work when conducted in accordance with applicable regulations under the Federal Insecticide, Fungicide, and Rodenticide Act.

(k) Regulations based on public hearings before January 1, 1953

Regulations affecting pesticide chemicals in or on raw agricultural commodities which are promulgated under the authority of section 346(a) of this title upon the basis of public hearings instituted before January 1, 1953, in accordance with section 371(a) of this title, shall be deemed to be regulations under this section and shall be subject to amendment or repeal as provided in subsection (m) of this section.

(l) Pesticides under Federal Insecticide, Fungicide, and Rodenticide Act; functions of Administrator of the Environmental Protection Agency; certifications; hearing; time limitation; opinion; regulations

The Secretary of Agriculture,8 upon request of any person who has registered, or who has submitted an application for the registration of, a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.], and whose request is accompanied by a copy of a petition filed by such person under subsection (d)(1) of this section with respect to a pesticide chemical which constitutes, or is an ingredient of, such pesticide, shall, within thirty days or within sixty days if upon notice prior to the termination of such thirty days the Administrator deems it necessary to postpone action for such period, on the basis of data before him, either—

(1) certify to the Administrator of Health and Human Services 9 that such pesticide chemical is useful for the purpose for which a tolerance or exemption is sought; or

(2) notify the person requesting the certification of his proposal to certify that the pesticide chemical does not appear to be useful for the purpose for which a tolerance or exemption is sought, or appears to be useful for only some of the purposes for which a tolerance or exemption is sought.


In the event that the Secretary of Agriculture 8 takes the action described in clause (2) of the preceding sentence, the person requesting the certification, within one week after receiving the proposed certification, may either (A) request the Secretary of Agriculture 8 to certify to the Administrator of Health and Human Services 9 on the basis of the proposed certification; (B) request a hearing on the proposed certification or the parts thereof objected to; or (C) request both such certification and such hearing. If no such action is taken, the Administrator may by order make the certification as proposed. In the event that the action described in clause (A) or (C) is taken, the Administrator shall by order make the certification as proposed with respect to such parts thereof as are requested. In the event a hearing is requested, the Secretary of Agriculture 8 shall provide opportunity for a prompt hearing. The certification of the Secretary of Agriculture 8 as the result of such hearing shall be made by order and shall be based only on substantial evidence of record at the hearing and shall set forth detailed findings of fact. In no event shall the time elapsing between the making of a request for a certification under this subsection and final certification by the Secretary of Agriculture 8 exceed one hundred and sixty days. The Administrator shall submit to the Administrator of Health and Human Services 9 with any certification of usefulness under this subsection an opinion, based on the data before him, whether the tolerance or exemption proposed by the petitioner reasonably reflects the amount of residue likely to result when the pesticide chemical is used in the manner proposed for the purpose for which the certification is made. The Secretary of Agriculture,8 after due notice and opportunity for public hearing, is authorized to promulgate rules and regulations for carrying out the provisions of this subsection.

(m) Amendment of regulations

The Administrator of Health and Human Services 9 shall prescribe by regulations the procedure by which regulations under this section may be amended or repealed, and such procedure shall conform to the procedure provided in this section for the promulgation of regulations establishing tolerances, including the appointment of advisory committees and the procedure for referring petitions to such committees.

(n) Guaranties

The provisions of section 333(c) of this title with respect to the furnishing of guaranties shall be applicable to raw agricultural commodities covered by this section.

(o) Payment of fees; services or functions as conditioned on; waiver or refund of fees

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 Secretary's 10 functions under this section. Under such regulations, the performance of the Secretary's 10 services or other functions pursuant to this section, including any one or more of the following, may be conditioned upon the payment of such fees: (1) The acceptance of filing of a petition submitted under subsection (d) of this section; (2) the promulgation of a regulation establishing a tolerance, or an exemption from the necessity of a tolerance, under this section, or the amendment or repeal of such a regulation; (3) the referral of a petition or proposal under this section to an advisory committee; (4) the acceptance for filing of objections under subsection (d)(5) of this section; or (5) the certification and filing in court of a transcript of the proceedings and the record under subsection (i)(2) of this section. Such regulations may further provide for waiver or refund of fees in whole or in part when in the judgment of the Administrator such waiver or refund is equitable and not contrary to the purposes of this subsection.

(June 25, 1938, ch. 675, §408, as added July 22, 1954, ch. 559, §3, 68 Stat. 511; amended Aug. 28, 1958, Pub. L. 85–791, §20, 72 Stat. 947; Oct. 30, 1970, Pub. L. 91–515, title VI, §601(d)(1), 84 Stat. 1311; Nov. 18, 1971, Pub. L. 92–157, title III, §303(a), 85 Stat. 464; Oct. 21, 1972, Pub. L. 92–516, §3(3), 86 Stat. 998; Nov. 8, 1984, Pub. L. 98–620, title IV, §402(25)(A), 98 Stat. 3359; June 16, 1992, Pub. L. 102–300, §6(b)(1), 106 Stat. 240; Oct. 29, 1992, Pub. L. 102–571, title I, §107(7), 106 Stat. 4499; Aug. 13, 1993, Pub. L. 103–80, §3(k), 107 Stat. 776.)

References in Text

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in subsecs. (d)(1), (e), (j), and (l), 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 (§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.

Amendments

1993—Pub. L. 103–80, §3(k)(6), substituted “Administrator” for “Secretary” wherever appearing except when followed by “of Agriculture”.

Subsec. (a)(1). Pub. L. 103–80, §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, §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, §3(k)(3), substituted “In the event” for “It the event” before “a hearing is requested”.

Subsec. (n). Pub. L. 103–80, §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, §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, §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, §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 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.

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, and functions of Department of Agriculture and Secretary of Agriculture under subsec. (l) of this section transferred to Administrator of Environmental Protection Agency by Reorg. Plan No. 3 of 1970, §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.

Cross References

Federal Advisory Committee Act, see Appendix to Title 5, Government Organization and Employees.

Section Referred to in Other Sections

This section is referred to in sections 342, 346b, 453, 601, 1033 of this title; title 7 section 450i.

1 See Transfer of Functions note below.

2 So in original. The words “of Health and Human Services,” probably should not appear.

3 See Transfer of Functions note below.

4 So in original. The words “Health and Human Services” probably should not appear.

5 So in original. Probably should be section “556(d)”.

6 See Transfer of Functions note below.

7 So in original. The words “Health and Human Services” probably should not appear.

8 See Transfer of Functions note below.

9 So in original. The words “Health and Human Services” probably should not appear.

10 So in original. Probably should be “Administrator's”.

§346b. Authorization of appropriations

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.

(July 22, 1954, ch. 559, §4, 68 Stat. 517.)

Codification

Section was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

§347. Intrastate sales of colored oleomargarine

(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.

(June 25, 1938, ch. 675, §407, as added Mar. 16, 1950, ch. 61, §3(c), 64 Stat. 20.)

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., §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].”

Section Referred to in Other Sections

This section is referred to in sections 331, 347b of this title.

§347a. Congressional declaration of policy regarding oleomargarine sales

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.

(Mar. 16, 1950, ch. 61, §3(a), 64 Stat. 20.)

Codification

Section was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

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.

Section Referred to in Other Sections

This section is referred to in section 347b of this title.

§347b. Contravention of State laws

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.

(Mar. 16, 1950, ch. 61, §6, 64 Stat. 22.)

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.

Codification

Section was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

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.

§348. Food additives

(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 (i) of this section; or

(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.


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.

(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) 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.

(i) Exemptions for investigational use

Without regard to subsections (b) to (h), 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.

(June 25, 1938, ch. 675, §409, as added Sept. 6, 1958, Pub. L. 85–929, §4, 72 Stat. 1785; amended June 29, 1960, Pub. L. 86–546, §2, 74 Stat. 255; Oct. 10, 1962, Pub. L. 87–781, title I, §104(f)(1), 76 Stat. 785; Nov. 8, 1984, Pub. L. 98–620, title IV, §402(25)(B), 98 Stat. 3359.)

Amendments

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.

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.

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, §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.

Moratorium on Authority of Secretary With Respect to Saccharin

Pub. L. 95–203, §3, Nov. 23, 1977, 91 Stat. 1452, as amended by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96–273, June 17, 1980, 94 Stat. 536; Pub. L. 97–42, §2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98–22, §2, Apr. 22, 1983, 97 Stat. 173; Pub. L. 99–46, May 24, 1985, 99 Stat. 81; Pub. L. 100–71, title I, §101, July 11, 1987, 101 Stat. 431; Pub. L. 102–142, title VI, Oct. 28, 1991, 105 Stat. 910, provided that: “During the period ending May 1, 1997, 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.

Section Referred to in Other Sections

This section is referred to in sections 321, 331, 342, 379e, 453, 601, 1033 of this title; title 7 section 450i; title 15 section 1262; title 35 section 155.

§349. Bottled drinking water standards; publication in Federal Register

Whenever the Administrator of the Environmental Protection Agency prescribes interim or revised national primary drinking water regulations under section 300g–1 of title 42, 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.

(June 25, 1938, ch. 675, §410, as added Dec. 16, 1974, Pub. L. 93–523, §4, 88 Stat. 1694.)

§350. Vitamins and minerals

(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.

(June 25, 1938, ch. 675, §411, as added Apr. 22, 1976, Pub. L. 94–278, title V, §501(a), 90 Stat. 410; amended Oct. 25, 1994, Pub. L. 103–417, §§3(c), 7(d), 108 Stat. 4328, 4331.)

Amendments

1994—Subsec. (b)(2). Pub. L. 103–417, §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, §3(c)(1), inserted “powder, softgel, gelcap,” after “capsule,”.

Subsec. (c)(1)(B)(ii). Pub. L. 103–417, §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, §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.”

Section Referred to in Other Sections

This section is referred to in sections 321, 343 of this title.

1 So in original. Probably should be “paragraph”.

§350a. Infant formulas

(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 aMaximum a
Protein (gm) 1.8 b  4.5.
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 g)c 750.0 (225 g).c
D (IU) 40.0 100.0.
K (g) 4.0
E (IU) 0.7 (with 0.7 IU/gm linoleic acid)
C (ascorbic acid) (mg) 8.0
B1 (thiamine) (g) 40.0
B2 (riboflavin) (g) 60.0
B6 (pyridoxine) (g) 35.0 (with 15 g/gm of protein in formula)
B12 (g) 0.15
Niacin (g) 250.0
Folic acid (g) 4.0
Pantothenic acid (g) 300.0
Biotin (g) 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 (g) 5.0
Zinc (mg) 0.5
Copper (g) 60.0
Manganese (g) 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.

(June 25, 1938, ch. 675, §412, as added Sept. 26, 1980, Pub. L. 96–359, §2, 94 Stat. 1190; amended Oct. 27, 1986, Pub. L. 99–570, title IV, §4014(a), (b)(1), 100 Stat. 3207–116, 3207–120; Aug. 13, 1993, Pub. L. 103–80, §3(l), 107 Stat. 777.)

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, §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, §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, §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, §4014(a)(1), redesignated subsec. (f) as (h).

Subsec. (h)(1). Pub. L. 99–570, §4014(a)(3), (4), substituted “(a), (b), and (c)” for “(a) and (b)” and “(e)(1)” for “(c)(1)”.

Pub. L. 99–570, §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, §4014(a)(6), substituted “(a), (b), and (c)” for “(a) and (b)”.

Subsec. (i). Pub. L. 99–570, §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].”

Section Referred to in Other Sections

This section is referred to in sections 331, 343, 374 of this title.

§350b. New dietary ingredients

(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) “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.

(June 25, 1938, ch. 675, §413, as added Oct. 25, 1994, Pub. L. 103–417, §8, 108 Stat. 4331.)

Section Referred to in Other Sections

This section is referred to in section 331 of this title.

SUBCHAPTER V—DRUGS AND DEVICES

Part A—Drugs and Devices

§351. Adulterated drugs and devices

A drug or device shall be deemed to be adulterated—

(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture

(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or (3) 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 (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 379e(a) of this title, or (B) it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of section 379e(a) of this title; or (5) if it is a new animal drug which is unsafe within the meaning of section 360b of this title; or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 360b of this title.

(b) Strength, quality, or purity differing from official compendium

If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.

(c) Misrepresentation of strength, etc., where drug is unrecognized in compendium

If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

(d) Mixture with or substitution of another substance

If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefor.

(e) Devices not in conformity with performance standards

If it is, or purports to be or is represented as, a device which is subject to a performance standard established under section 360d of this title unless such device is in all respects in conformity with such standard.

(f) Certain class III devices

(1) If it is a class III device—

(A)(i) which is required by a regulation promulgated under subsection (b) of section 360e of this title to have an approval under such section of an application for premarket approval and which is not exempt from section 360e of this title under section 360j(g) of this title, and

(ii)(I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the Secretary within the ninety-day period beginning on the date of the promulgation of such regulation, or

(II) for which such an application was filed and approval of the application has been denied, suspended, or withdrawn, or such a notice was filed and has been declared not completed or the approval of the device under the protocol has been withdrawn;

(B)(i) which was classified under section 360c(f) of this title into class III, which under section 360e(a) of this title is required to have in effect an approved application for premarket approval, and which is not exempt from section 360e of this title under section 360j(g) of this title, and

(ii) which has an application which has been suspended or is otherwise not in effect; or

(C) which was classified under section 360j(l) of this title into class III, which under such section is required to have in effect an approved application under section 360e of this title, and which has an application which has been suspended or is otherwise not in effect.


(2)(A) In the case of a device classified under section 360c(f) of this title into class III and intended solely for investigational use, paragraph 1 (1)(B) shall not apply with respect to such device during the period ending on the ninetieth day after the date of the promulgation of the regulations prescribing the procedures and conditions required by section 360j(g)(2) of this title.

(B) In the case of a device subject to a regulation promulgated under subsection (b) of section 360e of this title, paragraph