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15 U.S.C. § 1455 — Procedure for promulgation of regula-

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

15 U.S.C. § 1455 — Procedure for promulgation of regula-

Page 1413 TITLE 15—COMMERCE AND TRADE § 1455 affixed to such commodity, of any printed matter stating or representing by implication that such commodity is offered for retail sale at a price lower than the ordinary and cus- tomary retail sale price or that a retail sale price advantage is accorded to purchasers thereof by reason of the size of that package or the quantity of its contents; (3) require that the label on each package of a consumer commodity (other than one which is a food within the meaning of section 321(f) of title 21) bear (A) the common or usual name of such consumer commodity, if any, and (B) in case such consumer commodity consists of two or more ingredients, the common or usual name of each such ingredient listed in order of decreasing predominance, but nothing in this paragraph shall be deemed to require that any trade secret be divulged; or (4) prevent the nonfunctional-slack-fill of packages containing consumer commodities. For purposes of paragraph (4) of this subsection, a package shall be deemed to be nonfunctionally slack-filled if it is filled to substantially less than its capacity for reasons other than (A) pro- tection of the contents of such package or (B) the requirements of machines used for enclosing the contents in such package. (d) Development by manufacturers, packers, and distributors of voluntary product standards Whenever the Secretary of Commerce deter- mines that there is undue proliferation of the weights or masses, measures, or quantities in which any consumer commodity or reasonably comparable consumer commodities are being distributed in packages for sale at retail and such undue proliferation impairs the reasonable ability of consumers to make value comparisons with respect to such consum

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Page 1413 TITLE 15—COMMERCE AND TRADE § 1455 affixed to such commodity, of any printed matter stating or representing by implication that such commodity is offered for retail sale at a price lower than the ordinary and cus- tomary retail sale price or that a retail sale price advantage is accorded to purchasers thereof by reason of the size of that package or the quantity of its contents; (3) require that the label on each package of a consumer commodity (other than one which is a food within the meaning of section 321(f) of title 21) bear (A) the common or usual name of such consumer commodity, if any, and (B) in case such consumer commodity consists of two or more ingredients, the common or usual name of each such ingredient listed in order of decreasing predominance, but nothing in this paragraph shall be deemed to require that any trade secret be divulged; or (4) prevent the nonfunctional-slack-fill of packages containing consumer commodities. For purposes of paragraph (4) of this subsection, a package shall be deemed to be nonfunctionally slack-filled if it is filled to substantially less than its capacity for reasons other than (A) pro- tection of the contents of such package or (B) the requirements of machines used for enclosing the contents in such package. (d) Development by manufacturers, packers, and distributors of voluntary product standards Whenever the Secretary of Commerce deter- mines that there is undue proliferation of the weights or masses, measures, or quantities in which any consumer commodity or reasonably comparable consumer commodities are being distributed in packages for sale at retail and such undue proliferation impairs the reasonable ability of consumers to make value comparisons with respect to such consumer commodity or commodities, he shall request manufacturers, packers, and distributors of the commodity or commodities to participate in the development of a voluntary product standard for such com- modity or commodities under the procedures for the development of voluntary products stand- ards established by the Secretary pursuant to section 272 of this title. Such procedures shall provide adequate manufacturer, packer, dis- tributor, and consumer representation. (e) Report and recommendations to Congress upon industry failure to develop or abide by voluntary product standards If (1) after one year after the date on which the Secretary of Commerce first makes the re- quest of manufacturers, packers, and distribu- tors to participate in the development of a vol- untary product standard as provided in sub- section (d) of this section, he determines that such a standard will not be published pursuant to the provisions of such subsection (d), or (2) if such a standard is published and the Secretary of Commerce determines that it has not been ob- served, he shall promptly report such deter- mination to the Congress with a statement of the efforts that have been made under the vol- untary standards program and his recommenda- tion as to whether Congress should enact legis- lation providing regulatory authority to deal with the situation in question. (Pub. L. 89–755, § 5, Nov. 3, 1966, 80 Stat. 1298; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–245, title I, § 107(a)(1), (2), Feb. 14, 1992, 106 Stat. 13; Pub. L. 102–329, §§ 1(1), (2), 3, Aug. 3, 1992, 106 Stat. 847, 848.) Editorial Notes AMENDMENTS 1992—Pub. L. 102–245, § 107(a)(1), (2), (b), which di- rected amendment of section, effective two years after Feb. 14, 1992, by substituting ‘‘weight or mass’’ for ‘‘weight’’ in subsec. (c)(1) and ‘‘weights or masses’’ for ‘‘weights’’ in subsec. (d), was repealed by Pub. L. 102–329, § 3. Subsec. (c)(1). Pub. L. 102–329, § 1(1), substituted ‘‘weight or mass’’ for ‘‘weight’’. Subsec. (d). Pub. L. 102–329, § 1(2), substituted ‘‘weights or masses’’ for ‘‘weights’’. Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted for ‘‘Secretary of Health, Education, and Wel- fare’’ in subsec. (a) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education. EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102–329 effective Feb. 14, 1994, but with such amendment to have no effect on the sale or distribution of products whose labels have been printed before such date, no application to unit pricing, advertising, recipe programs, nutrition labeling, or other general pricing information, and no construction requiring changes in package size or affecting in any way the size of packages, see section 2 of Pub. L. 102–329, set out as a note under section 1453 of this title. § 1455. Procedure for promulgation of regula- tions (a) Hearings by Secretary of Health and Human Services Regulations promulgated by the Secretary under section 1453 or 1454 of this title shall be promulgated, and shall be subject to judicial re- view, pursuant to the provisions of subsections (e), (f), and (g) of section 371 of title 21. Hearings authorized or required for the promulgation of any such regulations by the Secretary shall be conducted by the Secretary or by such officer or employees of the Department of Health and Human Services as he may designate for that purpose. (b) Judicial review; hearings by Federal Trade Commission Regulations promulgated by the Commission under section 1453 or 1454 of this title shall be promulgated, and shall be subject to judicial re- view, by proceedings taken in conformity with the provisions of subsections (e), (f), and (g) of section 371 of title 21 in the same manner, and with the same effect, as if such proceedings were taken by the Secretary pursuant to subsection (a) of this section. Hearings authorized or re- quired for the promulgation of any such regula- tions by the Commission shall be conducted by the Commission or by such officer or employee of the Commission as the Commission may des- ignate for that purpose. 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), and which is introduced or delivered for introduction into commerce in violation of any of the provisions of this chapter, or the regulations issued pursu- ant to this chapter, shall be deemed to be mis- branded within the meaning of chapter III of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 331 et seq.], but the provisions of section 303 of that Act (21 U.S.C. 333) shall have no application to any violation of section 1452 of this title. (b) Unfair or deceptive acts or practices in com- merce Any violation of any of the provisions of this chapter, or the regulations issued pursuant to this chapter, with respect to any consumer com- modity which is not a food, drug, device, or cos- metic, shall constitute an unfair or deceptive act or practice in commerce in violation of sec- tion 45(a) of this title and shall be subject to en- forcement under section 45(b) of this title. (c) Imports In the case of any imports into the United States of any consumer commodity covered by this chapter, the provisions of sections 1453 and 1454 of this title shall be enforced by the Sec- retary of the Treasury pursuant to section 801(a) and (b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381). (Pub. L. 89–755, § 7, Nov. 3, 1966, 80 Stat. 1300.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a) and (c), is act June 25, 1938, ch. 675, 52 Stat. 1040. Chapter III of the Act is classified generally to subchapter III (§ 331 et seq.) of chapter 9 of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables. § 1457. Omitted Editorial Notes CODIFICATION Section, Pub. L. 89–755, § 8, Nov. 3, 1966, 80 Stat. 1300; Pub. L. 93–608, § 3(2), Jan. 2, 1975, 88 Stat. 1972; Pub. L. 97–375, title II, §§ 202(d), 206(b), Dec. 21, 1982, 96 Stat. 1822, 1823, which required officers and agencies required or authorized by this chapter to promulgate regula- tions, to transmit an annual report to Congress de- scribing activities carried out for the administration and enforcement of this chapter, terminated, effective May 15, 2000, pursuant to section 3003 of Pub. L. 104–66, as amended, set out as a note under section 1113 of Title 31, Money and Finance. See, also, pages 54, 92, and 172 of House Document No. 103–7. § 1458. Cooperation with State authorities; trans- mittal of regulations to States; noninter- ference with existing programs (a) A copy of each regulation promulgated under this chapter shall be transmitted prompt- ly to the Secretary of Commerce, who shall (1) transmit copies thereof to all appropriate State officers and agencies, and (2) furnish to such State officers and agencies information and as- sistance to promote to the greatest practicable extent uniformity in State and Federal regula- tion of the labeling of consumer commodities. (b) Nothing contained in this section shall be construed to impair or otherwise interfere with any program carried into effect by the Secretary of Health and Human Services under other pro- visions of law in cooperation with State govern- ments or agencies, instrumentalities, or polit- ical subdivisions thereof. (Pub. L. 89–755, § 9, Nov. 3, 1966, 80 Stat. 1301; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695.) Statutory Notes and Related Subsidiaries CHANGE OF NAME ‘‘Secretary of Health and Human Services’’ sub- stituted for ‘‘Secretary of Health, Education, and Wel- fare’’ in subsec. (b) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education. § 1459. Definitions For the purpose of this chapter— (a) The term ‘‘consumer commodity’’, except as otherwise specifically provided by this sub- section, means any food, drug, device, or cos-

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

15 U.S.C. § 1455 — Procedure for promulgation of regulations

**(a) Hearings by Secretary of Health and Human Services** Regulations promulgated by the Secretary under section 1453 or 1454 of this title shall be promulgated, and shall be subject to judicial review, pursuant to the provisions of subsections (e), (f), and (g) of [section 371 of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section371&num=0&edition=prelim). Hearings authorized or required for the promulgation of any such regulations by the Secretary shall be conducted by the Secretary or by such officer or employees of the Department of Health and Human Services as he may designate for that purpose. **(b) Judicial review; hearings by Federal Trade Commission** Regulations promulgated by the Commission under section 1453 or 1454 of this title shall be promulgated, and shall be subject to judicial review, by proceedings taken in conformity with the provisions of subsections (e), (f), and (g) of [section 371 of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section371&num=0&edition=prelim) in the same manner, and with the same effect, as if such proceedings were taken by the Secretary pursuant to subsection (a) of this section. Hearings authorized or required for the promulgation of any such regulations by the Commission shall be conducted by the Commission or by such officer or employee of the Commission as the Commission may designate for that purpose. **(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 political subdivision of any

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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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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

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

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

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

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

21 U.S.C. § 381 — Imports and exports

Page 636 TITLE 21—FOOD AND DRUGS § 379dd–2 1 So in original. Probably should be preceded by a comma. (June 25, 1938, ch. 675, § 771, as added Pub. L. 110–85, title VI, § 601(b), Sept. 27, 2007, 121 Stat. 897.) § 379dd–2. Activities of the Food and Drug Ad- ministration (a) In general The Commissioner shall receive and assess the report submitted to the Commissioner by the Executive Director of the Foundation under sec- tion 379dd(l)(2) of this title. (b) Report to Congress Beginning with fiscal year 2009, the Commis- sioner shall submit to Congress an annual report summarizing the incorporation of the informa- tion provided by the Foundation in the report described under section 379dd(l)(2) of this title and by other recipients of grants, contracts, memoranda of understanding, or cooperative agreements into regulatory and product review activities of the Food and Drug Administration. (c) Extramural grants The provisions of this part and section 360bbb–5 of this title shall have no effect on any grant, contract, memorandum of understanding, or cooperative agreement between the Food and Drug Administration and any other entity en- tered into before, on, or after September 27, 2007. (June 25, 1938, ch. 675, § 772, as added Pub. L. 110–85, title VI, § 601(b), Sept. 27, 2007, 121 Stat. 897.) SUBCHAPTER VIII—IMPORTS AND EXPORTS § 381. Imports and exports (a) Imports; list of registered foreign establish- ments; samples from unregistered foreign es- tablishments; examination and refusal of ad- mission 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, g

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 381

Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 381. This identifies an authority to review, not proof of applicability.