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21 U.S.C. § 321a — ‘‘Butter’’ defined
Federal law — U.S. Code and appendices · legal_authorities
Page 46
TITLE 21—FOOD AND DRUGS
§ 321a
‘‘(a) Nothing in this Act [enacting section 360a of this
title, amending sections 321, 331, 333, 334, 360, and 372 of
this title and section 1114 of Title 18, Crimes and Crimi-
nal Procedure, and enacting provisions set out as notes
under sections 321, 352, and 360a of this title] shall be
construed
as
authorizing
the
manufacture,
compounding, processing, possession, sale, delivery, or
other disposal of any drug in any State in contraven-
tion of the laws of such State.
‘‘(b) No provision of this Act nor any amendment
made by it shall be construed as indicating an intent
on the part of the Congress to occupy the field in which
such provision or amendment operates to the exclusion
of any State law on the same subject matter, unless
there is a direct and positive conflict between such pro-
vision or amendment and such State law so that the
two cannot be reconciled or consistently stand to-
gether.
‘‘(c) No amendment made by this Act shall be con-
strued to prevent the enforcement in the courts of any
State of any statute of such State prescribing any
criminal penalty for any act made criminal by any
such amendment.’’
EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS
Pub. L. 87–781, title II, § 202, Oct. 10, 1962, 76 Stat. 793,
provided that: ‘‘Nothing in the amendments made by
this Act [enacting sections 358 to 360, amending sec-
tions 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e,
and 381 of this title, and enacting provisions set out as
notes under sections 321, 331, 332, 352, 355, 360, and 374 of
this title] to the Federal Food, Drug, and Cosmetic Act
[this chapter] shall be construed as invalidating any
provision of State law which would be valid in the ab-
sence of such amendments unless th
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Page 46
TITLE 21—FOOD AND DRUGS
§ 321a
‘‘(a) Nothing in this Act [enacting section 360a of this
title, amending sections 321, 331, 333, 334, 360, and 372 of
this title and section 1114 of Title 18, Crimes and Crimi-
nal Procedure, and enacting provisions set out as notes
under sections 321, 352, and 360a of this title] shall be
construed
as
authorizing
the
manufacture,
compounding, processing, possession, sale, delivery, or
other disposal of any drug in any State in contraven-
tion of the laws of such State.
‘‘(b) No provision of this Act nor any amendment
made by it shall be construed as indicating an intent
on the part of the Congress to occupy the field in which
such provision or amendment operates to the exclusion
of any State law on the same subject matter, unless
there is a direct and positive conflict between such pro-
vision or amendment and such State law so that the
two cannot be reconciled or consistently stand to-
gether.
‘‘(c) No amendment made by this Act shall be con-
strued to prevent the enforcement in the courts of any
State of any statute of such State prescribing any
criminal penalty for any act made criminal by any
such amendment.’’
EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS
Pub. L. 87–781, title II, § 202, Oct. 10, 1962, 76 Stat. 793,
provided that: ‘‘Nothing in the amendments made by
this Act [enacting sections 358 to 360, amending sec-
tions 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e,
and 381 of this title, and enacting provisions set out as
notes under sections 321, 331, 332, 352, 355, 360, and 374 of
this title] to the Federal Food, Drug, and Cosmetic Act
[this chapter] shall be construed as invalidating any
provision of State law which would be valid in the ab-
sence of such amendments unless there is a direct and
positive conflict between such amendments and such
provision of State law.’’
DEFINITIONS
Pub. L. 105–115, § 2, Nov. 21, 1997, 111 Stat. 2297, pro-
vided that: ‘‘In this Act [see Short Title of 1997 Amend-
ment note set out under section 301 of this title], the
terms ‘drug’, ‘device’, ‘food’, and ‘dietary supplement’
have the meaning given such terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).’’
Executive Documents
TRANSFER OF FUNCTIONS
Functions of Secretary of Health, Education, and
Welfare [now Health and Human Services] under Drug
Abuse Control Amendments of 1965 [see Short Title of
1965 Amendment note set out under section 301 of this
title] transferred to Attorney General except function
of regulating counterfeiting of those drugs which are
not ‘‘depressant or stimulant’’ drugs, see section 2 of
Reorg. Plan No. 1 of 1968, set out in the Appendix to
Title 5, Government Organization and Employees.
Functions of Federal Security Administrator trans-
ferred to Secretary of Health, Education, and Welfare
and all agencies of Federal Security Agency transferred
to Department of Health, Education, and Welfare by
section 5 of Reorg. Plan No. 1 of 1953, set out in the Ap-
pendix to Title 5, Government Organization and Em-
ployees. Federal Security Agency and office of Admin-
istrator abolished by section 8 of Reorg. Plan No. 1 of
1953.
Food and Drug Administration in Department of Ag-
riculture and its functions, except those functions re-
lating to administration of Insecticide Act of 1910 and
Naval Stores Act, transferred to Federal Security
Agency, to be administered under direction and super-
vision of Federal Security Administrator, by Reorg.
Plan No. IV of 1940, set out in the Appendix to Title 5.
§ 321a. ‘‘Butter’’ defined
For the purposes of the Food and Drug Act of
June 30, 1906 (Thirty-fourth Statutes at Large,
page 768) ‘‘butter’’ shall be understood to mean
the food product usually known as butter, and
which is made exclusively from milk or cream,
or both, with or without common salt, and with
or without additional coloring matter, and con-
taining not less than 80 per centum by weight of
milk fat, all tolerances having been allowed for.
(Mar. 4, 1923, ch. 268, 42 Stat. 1500.)
Editorial Notes
REFERENCES IN TEXT
The Food and Drug Act of June 30, 1906, referred to in
text, is act June 30, 1906, ch. 3915, 34 Stat. 768, which
was classified to subchapter I (§ 1 et seq.) of chapter 1
of this title, was repealed (except for section 14a which
was transferred to section 376 of this title) by act June
25, 1938, ch. 675, § 1002(a), formerly § 902(a), 52 Stat. 1059;
renumbered § 1002(a), Pub. L. 111–31, div. A, title I,
§ 101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by
this chapter.
CODIFICATION
Section, which was not enacted as part of the Federal
Food, Drug, and Cosmetic Act which comprises this
chapter, was formerly classified to section 6 of this
title. Section 1002(a) of act June 25, 1938, set out as an
Effective Date note under section 301 of this title, pro-
vided that this section should remain in force and ef-
fect and be applicable to the provisions of this chapter.
§ 321b. ‘‘Package’’ defined
The word ‘‘package’’ where it occurs the sec-
ond and last time in the act entitled ‘‘An act to
amend section 8 of an act entitled, ‘An act for
preventing the manufacture, sale, or transpor-
tation of adulterated or misbranded or poi-
sonous deleterious foods, drugs, medicines, and
liquors, and for regulating traffic therein, and
for other purposes,’ ’’ approved March 3, 1913,
shall include and shall be construed to include
wrapped meats inclosed in papers or other mate-
rials as prepared by the manufacturers thereof
for sale.
(July 24, 1919, ch. 26, 41 Stat. 271.)
Editorial Notes
REFERENCES IN TEXT
An act approved March 3, 1913, referred to in text, is
act Mar. 3, 1913, ch. 117, 37 Stat. 732, which amended
section 10 of this title. For complete classification of
this Act to the Code, see Tables.
‘‘An act for preventing the manufacture, sale, or
transportation of adulterated or misbranded or poi-
sonous deleterious foods, drugs, medicines, and liquors,
and for regulating traffic therein, and for other pur-
poses’’, referred to in text, is act June 30, 1906, ch. 3915,
34 Stat. 768, which was classified to subchapter I (§ 1 et
seq.) of chapter 1 of this title, was repealed (except for
section 14a which was transferred to section 376 of this
title) by act June 25, 1938, ch. 675, § 1002(a), formerly
§ 902(a), 52 Stat. 1059; renumbered § 1002(a), Pub. L.
111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat.
1784, and is covered by this chapter.
CODIFICATION
Section, which was not enacted as part of the Federal
Food, Drug, and Cosmetic Act which comprises this
chapter, was formerly classified to the last sentence of
paragraph third of section 10 of this title. Section
1002(a) of act June 25, 1938, set out as an Effective Date
note under section 301 of this title, provided that this
section should remain in force and effect and be appli-
cable to the provisions of this chapter.
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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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
Stored review status: release_metadata_unconfirmed. The source passage cites 21 U.S.C. § 321. This identifies an authority to review, not proof of applicability.
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
Stored review status: historical_2024_not_currentness_verified. The source passage cites 21 U.S.C. § 321. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
For the purposes of the Food and Drug Act of June 30, 1906 (Thirty-fourth Statutes at Large, page 768) “butter” shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321a
Stored review status: release_metadata_unconfirmed. Same stored citation; legal effect and authority still require review.