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15 U.S.C. § 1456 — Enforcement

Federal law — U.S. Code and appendices · legal_authorities

15 U.S.C. § 1456 — Enforcement

**(a) Misbranded consumer commodities** Any consumer commodity which is a food, drug, device, or cosmetic, as each such term is defined by section 201 of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 321](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321&num=0&edition=prelim)), and which is introduced or delivered for introduction into commerce in violation of any of the provisions of this chapter, or the regulations issued pursuant to this chapter, shall be deemed to be misbranded within the meaning of chapter III of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 331](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331&num=0&edition=prelim) et seq.], but the provisions of section 303 of that Act ([21 U.S.C. 333](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section333&num=0&edition=prelim)) shall have no application to any violation of [section 1452 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1452&num=0&edition=prelim). **(b) Unfair or deceptive acts or practices in commerce** Any violation of any of the provisions of this chapter, or the regulations issued pursuant to this chapter, with respect to any consumer commodity which is not a food, drug, device, or cosmetic, shall constitute an unfair or deceptive act or practice in commerce in violation of [section 45(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section45/a&num=0&edition=prelim) and shall be subject to enforcement under [section 45(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section45/b&num=0&edition=prelim). **(c) Imports** In the case of any imports into the United States of any con

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Source location: Title 15, Chapter 39, § 1456; chapter-039-fair-packaging-and-labeling-program.md

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21 U.S.C. § 301 — Short title

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

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21 U.S.C. § 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), 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,11 So in original. Probably should be “Pharmacopeia,”. 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 specif

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15 U.S.C. § 1452 — Unfair and deceptive packaging and labeling; scope of prohibition

**(a) Nonconforming labels** It shall be unlawful for any person engaged in the packaging or labeling of any consumer commodity (as defined in this chapter) for distribution in commerce, or for any person (other than a common carrier for hire, a contract carrier for hire, or a freight forwarder for hire) engaged in the distribution in commerce of any packaged or labeled consumer commodity, to distribute or to cause to be distributed in commerce any such commodity if such commodity is contained in a package, or if there is affixed to that commodity a label, which does not conform to the provisions of this chapter and of regulations promulgated under the authority of this chapter. **(b) Exemptions** The prohibition contained in subsection (a) shall not apply to persons engaged in business as wholesale or retail distributors of consumer commodities except to the extent that such persons (1) are engaged in the packaging or labeling of such commodities, or (2) prescribe or specify by any means the manner in which such commodities are packaged or labeled.

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21 U.S.C. § 381 — Imports and exports

**(a) Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission** The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or [section 387e(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/h&num=0&edition=prelim) and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of [section 360j(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim

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21 U.S.C. § 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, tobacco product, or cosmetic that is adulterated or misbranded. **(b)** The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce. **(c)** The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise. **(d)** The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,,11 So in original. 360bbb–3, or 364c of this title. **(e)** The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223 22 See References in Text note below. of this title (except when such violation is committed by a farm). **(f)** The refusal to permit entry or inspection as authorized by [section 374 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section374&num=0&edition=prelim). **(g)** The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded. *

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21 U.S.C. § 333 — Penalties

**(a) Violation of [section 331 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331&num=0&edition=prelim); second violation; intent to defraud or mislead** (1) Any person who violates a provision of [section 331 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331&num=0&edition=prelim) 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,11 So in original. Words “of this section” probably should not appear. 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), any person who violates [section 331(t) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section331/t&num=0&edition=prelim) by— (A) knowingly importing a drug in violation of [section 381(d)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/d/1&num=0&edition=prelim), (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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/c/1&num=0&edition=prelim), (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

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15 U.S.C. § 1456 — Enforcement

Page 1414 TITLE 15—COMMERCE AND TRADE § 1456 (c) Cooperation with other departments and agencies In carrying into effect the provisions of this chapter, the Secretary and the Commission are authorized to cooperate with any department or agency of the United States, with any State, Commonwealth, or possession of the United States, and with any department, agency, or po- litical subdivision of any such State, Common- wealth, or possession. (d) Returnable or reusable glass containers for beverages No regulation adopted under this chapter shall preclude the continued use of returnable or reus- able glass containers for beverages in inventory or with the trade as of the effective date of this Act, nor shall any regulation under this chapter preclude the orderly disposal of packages in in- ventory or with the trade as of the effective date of such regulation. (Pub. L. 89–755, § 6, Nov. 3, 1966, 80 Stat. 1299; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695.) Editorial Notes REFERENCES IN TEXT The effective date of this Act, referred to in subsec. (d), refers to the effective date of Pub. L. 89–755 which enacted this chapter to take effect July 1, 1967. See Ef- fective Date note set out under section 1451 of this title. Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Department of Health and Human Services’’ sub- stituted for ‘‘Department of Health, Education, and Welfare’’ in subsec. (a), pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education. § 1456. Enforcement (a) Misbranded consumer commodities Any consumer commodity which is a food, drug, device, or cosmetic, as each such term is defined by section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321),

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 321 — Definitions; generally

Page 36 TITLE 21—FOOD AND DRUGS § 321 1 So in original. Probably should be ‘‘Pharmacopeia,’’. of this title and section 210 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 321, 342, and 451 of this title] may be cited as the ‘Food Additives Amendment of 1958’.’’ SEVERABILITY Pub. L. 113–54, title I, § 106(b), Nov. 27, 2013, 127 Stat. 598, provided that: ‘‘If any provision of this Act [see Short Title of 2013 Amendment note above] (including the amendments made by this Act) is declared uncon- stitutional, or the applicability of this Act (including the amendments made by this Act) to any person or circumstance is held invalid, the constitutionality of the remainder of this Act (including the amendments made by this Act) and the applicability thereof to other persons and circumstances shall not be affected.’’ Pub. L. 110–85, title XI, § 1105, Sept. 27, 2007, 121 Stat. 975, provided that: ‘‘If any provision of this Act [see Short Title of 2007 Amendment note above], an amend- ment made [by] this Act, or the application of such pro- vision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions of such to any person or cir- cumstances shall not be affected thereby.’’ 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. 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 thi

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 331 — Prohibited acts

Page 47 TITLE 21—FOOD AND DRUGS § 331 1 So in original. 2 See References in Text note below. § 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 cen- tum by weight of moisture. The fat content is not over 11⁄2 per centum by weight unless other- wise 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.) Editorial Notes 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, 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’’. § 321d. Market names for catfish and ginseng (a) Catfish labeling (1) In general Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)— (A) the term ‘‘catfish’’ may only be consid- ered to be a common or usual name (or part thereof) for fish classified within the family Ictaluridae;

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21 U.S.C. § 333 — Penalties

Page 56 TITLE 21—FOOD AND DRUGS § 332 1 So in original. Probably should be followed by a comma. 1 So in original. Words ‘‘of this section’’ probably should not appear. restrictions under such section 301(ddd) that have begun to apply under subsection (b) [set out as a note above].’’ Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. § 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 re- straining order issued under this section, which also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the ac- cused, by a jury. (June 25, 1938, ch. 675, § 302, 52 Stat. 1043; Pub. L. 87–781, title I, § 103(d), title II, § 201(c), Oct. 10, 1962, 76 Stat. 784, 793; Pub. L. 103–80, § 3(d), Aug. 13, 1993, 107 Stat. 775.) Editorial Notes 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 Oc- tober 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

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