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15 U.S.C. § 1456 — Enforcement
Federal law — U.S. Code and appendices · legal_authorities
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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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-
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
**(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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Federal law — U.S. Code and appendices · legal_authorities
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
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
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
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
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;
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 331
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 333
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Federal law — U.S. Code and appendices · legal_authorities
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
**(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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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
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