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15 U.S.C. § 1459 — Definitions
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-
Page 1415
TITLE 15—COMMERCE AND TRADE
§ 1460
1 See References in Text note below.
metic (as those terms are defined by the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 301 et
seq.]), and any other article, product, or com-
modity of any kind or class which is custom-
arily produced or distributed for sale through
retail sales agencies or instrumentalities for
consumption by individuals, or use by individ-
uals for purposes of personal care or in the per-
formance of services ordinarily rendered within
the household, and which usually is consumed or
expended in the course of such consumption or
use. Such term does not include—
(1) any meat or meat product, poultry or
poultry product, or tobacco or tobacco prod-
uct;
(2) any commodity subject to packaging or
labeling requirements imposed by the Sec-
retary of Agriculture pursuant to the Federal
Insecticide, Fungicide, and Rodenticide Act [7
U.S.C. 136 et seq.], or the provisions of the
eighth paragraph under the heading ‘‘Bureau
of Animal Industry’’ of the Act of March 4,
1913 (37 Stat. 832–833; 21 U.S.C. 151–157),1 com-
monly known as the Virus-Serum-Toxin Act;
(3) any drug subject to the provisions of sec-
tion 503(b)(1) or 506 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(b)(1) and 356);
(4) any beverage subject to or complying
with packaging or labeling requirements im-
posed under the Federal Alcohol Administra-
tion Act (27 U.S.C. 201 et seq.); or
(5) any commodity subject to the provisions
of the Federal Seed Act (7 U.S.C. 1551–1610).1
(b) The term ‘‘package’’ means any container
or wrapping in which any consumer commodity
is enclosed for use in the delivery or display of
that consumer commodity to retail purchasers,
but does not include—
(1) shipping containers or wrappings used
solely for the transportation of any consumer
commodity in bulk or in quantity to manufac-
turers, packers, or processors, or to wholesale
or retail distributors thereof;
(2) shipping containers or outer wrappings
used by retailers to ship or deliver any com-
modity to retail customers if such containers
and wrappings bear no printed matter per-
taining to any particular commodity; or
(3) containers subject to the provisions of
the Act of August 3, 1912 (37 Stat. 250, as
amended; 15 U.S.C. 231–233), or the Act of
March 4, 1915 (38 Stat. 1186, as amended; 15
U.S.C. 234–236).
(c) The term ‘‘label’’ means any written, print-
ed, or graphic matter affixed to any consumer
commodity or affixed to or appearing upon a
package containing any consumer commodity.
(d) The term ‘‘person’’ includes any firm, cor-
poration, or association.
(e) The term ‘‘commerce’’ means (1) commerce
between any State, the District of Columbia, the
Commonwealth of Puerto Rico, or any territory
or possession of the United States, and any place
outside thereof, and (2) commerce within the
District of Columbia or within any territory or
possession of the United States not organized
with a legislative body, but shall not include ex-
ports to foreign countries.
(f) The term ‘‘principal display panel’’ means
that part of a label that is most likely to be dis-
played, presented, shown, or examined under
normal and customary conditions of display for
retail sale.
(Pub. L. 89–755, § 10, Nov. 3, 1966, 80 Stat. 1301;
Pub. L. 90–628, § 2, Oct. 22, 1968, 82 Stat. 1320.)
Editorial Notes
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to subsec. (a), is act June 25, 1938, ch. 675, 52 Stat. 1040,
which is classified generally to chapter 9 (§ 301 et seq.)
of Title 21, Food and Drugs. For complete classification
of this Act to the Code, see section 301 of Title 21 and
Tables.
The Federal Insecticide, Fungicide, and Rodenticide
Act, referred to in subsec. (a)(2), 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 sub-
chapter II (§ 136 et seq.) 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 Virus-Serum-Toxin Act, referred to in subsec.
(a)(2), is the eighth paragraph under the heading ‘‘Bu-
reau of Animal Industry’’ of act Mar. 4, 1913, ch. 145, 37
Stat. 832, which is classified generally to chapter 5 (§ 151
et seq.) of Title 21, Food and Drugs. For complete clas-
sification of this Act to the Code, see Short Title note
set out under section 151 of Title 21 and Tables.
The Federal Alcohol Administration Act, referred to
in subsec. (a)(4), is act Aug. 29, 1935, ch. 814, 49 Stat. 977,
which is classified generally to chapter 8 (§ 201 et seq.)
of Title 27, Intoxicating Liquors. For complete classi-
fication of this Act to the Code, see section 201 of Title
27 and Tables.
The Federal Seed Act, referred to in subsec. (a)(5), is
act Aug. 9, 1939, ch. 615, 53 Stat. 1275, which is classified
generally to chapter 37 (§ 1551 et seq.) of Title 7, Agri-
culture. For complete classification of this Act to the
Code, see section 1551 of Title 7 and Tables.
AMENDMENTS
1968—Subsec. (b)(3). Pub. L. 90–628 struck out ref-
erence to the Act of August 31, 1916, and the Act of May
21, 1928.
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 1968 AMENDMENT
Amendment by Pub. L. 90–628 effective 60 days after
Oct. 22, 1968, see section 3 of Pub. L. 90–628, set out as
a note under section 251 of this title.
§ 1460. Savings provisions
Nothing contained in this chapter shall be
construed to repeal, invalidate, or supersede—
(a) the Federal Trade Commission Act [15
U.S.C. 41 et seq.] or any statute defined there-
in as an antitrust Act;
(b) the Federal Food, Drug, and Cosmetic
Act [21 U.S.C. 301 et seq.]; or
(c) the Federal Hazardous Substances Label-
ing Act [15 U.S.C. 1261 et seq.].
(Pub. L. 89–755, § 11, Nov. 3, 1966, 80 Stat. 1302.)
Editorial Notes
REFERENCES IN TEXT
The Federal Trade Commission Act, referred to in
text, is act Sept. 26, 1914, ch. 311, 38 Stat. 717, which is
classified generally to subchapter I (§ 41 et seq.) of
Cross-references
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Federal law — U.S. Code and appendices · legal_authorities
For the purpose of this chapter—
**(a)** The term “consumer commodity”, except as otherwise specifically provided by this subsection, means any food, drug, device, or cosmetic (as those terms are defined by the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.]), and any other article, product, or commodity of any kind or class which is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or use by individuals for purposes of personal care or in the performance of services ordinarily rendered within the household, and which usually is consumed or expended in the course of such consumption or use. Such term does not include—
(1) any meat or meat product, poultry or poultry product, or tobacco or tobacco product;
(2) any commodity subject to packaging or labeling requirements imposed by the Secretary of Agriculture pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act [[7 U.S.C. 136](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section136&num=0&edition=prelim) et seq.], or the provisions of the eighth paragraph under the heading “Bureau of Animal Industry” of the Act of March 4, 1913 (37 Stat. 832–833; [21 U.S.C. 151–157](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section151–157&num=0&edition=prelim)),11 See References in Text note below. commonly known as the Virus-Serum-Toxin Act;
(3) any drug subject to the provisions of section 503(b)(1) or 506 of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 353(b)(1)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section353/b/1&num=0&edition=prelim) an
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Federal law — U.S. Code and appendices · legal_authorities
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.
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Federal law — U.S. Code and appendices · legal_authorities
Page 16
TITLE 21—FOOD AND DRUGS
§ 151
(b) The term ‘‘United States’’ means the fifty
States and the District of Columbia.
(Feb. 15, 1927, ch. 155, § 9, 44 Stat. 1103; Pub. L.
86–70, § 19, June 25, 1959, 73 Stat. 145; Pub. L.
86–624, § 15, July 12, 1960, 74 Stat. 415.)
Editorial Notes
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 de-
struction.
154.
Regulations for preparation and sale; li-
censes.
154a.
Special licenses for special circumstances; ex-
pedited procedure; conditions; exemptions;
criteria.
155.
Permits for importation.
156.
Licenses conditioned on permitting inspec-
tion; suspension of licenses.
157.
Inspection.
158.
Offenses; punishment.
159.
Enforcement; penalties applicable; Congres-
sional findings.
Statutory Notes and Related Subsidiaries
FEDERAL FOOD, DRUG, AND COSMETIC ACT
Nothing contained in chapter 9 (§ 301 et seq.) of this
title shall be construed as in any way affecting, modi-
fying, repealing, or superseding the provisions of this
chapter, see section 392(b) of this title.
§ 151. Preparation and sale of worthless or harm-
ful products for domestic animals prohibited;
preparation to be in compliance with rules at
licensed establishments
It shall be unlawful
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Federal law — U.S. Code and appendices · legal_authorities
This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
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Federal law — U.S. Code and appendices · legal_authorities
Page 30
TITLE 21—FOOD AND DRUGS
§ 301
Sec.
398.
Notices to States regarding imported food.
399.
Grants to enhance food safety.
399a.
Office of the Chief Scientist.
399b.
Office of Women’s Health.
399c.
Improving the training of State, local, terri-
torial, and tribal food safety officials.
399d.
Employee protections.
399e.
Nanotechnology.
399f.
Ensuring
adequate
information
regarding
pharmaceuticals for all populations, par-
ticularly underrepresented subpopulations,
including racial subgroups.
399g.
Food and Drug Administration Intercenter
Institutes.
399h.
National Centers of Excellence in Advanced
and Continuous Pharmaceutical Manufac-
turing.
399i.
Food and Drug Administration Working Cap-
ital Fund.
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.)
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES
Act June 23, 1939, ch. 242, §§ 1, 2, 53 Stat. 853, 854, pro-
vided that:
‘‘[SEC. 1] (a) The effective date of the following provi-
sions 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 ef-
fective 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), (
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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
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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.
*
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 331
Stored review status: release_metadata_unconfirmed. The source passage cites 21 U.S.C. § 331. This identifies an authority to review, not proof of applicability.
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
Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 331. This identifies an authority to review, not proof of applicability.
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
Stored review status: release_metadata_unconfirmed. The source passage cites 21 U.S.C. § 333. This identifies an authority to review, not proof of applicability.