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21 U.S.C. § 607 — Labeling, marking, and container require-
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Page 748
TITLE 21—FOOD AND DRUGS
§ 607
PRIOR PROVISIONS
A prior section 606, acts Mar. 4, 1907, ch. 2907, title I,
§ 6, formerly 4th par., 34 Stat. 1261; renumbered § 6 and
amended Pub. L. 90–201, §§ 1, 3, 12(e), Dec. 15, 1967, 81
Stat. 584, 588, 592; Pub. L. 99–641, title IV, § 403(a), Nov.
10, 1986, 100 Stat. 3567, was formerly classified to section
74 of this title and was repealed by Pub. L. 110–234, title
XI, § 11016(b)(1)(B), May 22, 2008, 122 Stat. 1369, and Pub.
L. 110–246, § 4(a), title XI, § 11016(b)(1)(B), June 18, 2008,
122 Stat. 1664, 2131. Prior to repeal, section read as fol-
lows: ‘‘For the purposes hereinbefore set forth the Sec-
retary shall cause to be made, by inspectors appointed
for that purpose, an examination and inspection of all
meat food products prepared for commerce in any
slaughtering, meat-canning, salting, packing, ren-
dering, or similar establishment, and for the purposes
of any examination and inspection and inspectors shall
have access at all times, by day or night, whether the
establishment be operated or not, to every part of said
establishment; and said inspectors shall mark, stamp,
tag, or label as ‘Inspected and passed’ all such products
found to be not adulterated; and said inspectors shall
label, mark, stamp, or tag as ‘Inspected and con-
demned’ all such products found adulterated, and all
such condemned meat food products shall be destroyed
for food purposes, as hereinbefore provided, and the
Secretary may remove inspectors from any establish-
ment which fails to so destroy such condemned meat
food products: Provided, That subject to the rules and
regulations of the Secretary the provisions of this sec-
tion in regard to preservatives shall not apply to meat
food products for export to any foreign cou
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Page 748
TITLE 21—FOOD AND DRUGS
§ 607
PRIOR PROVISIONS
A prior section 606, acts Mar. 4, 1907, ch. 2907, title I,
§ 6, formerly 4th par., 34 Stat. 1261; renumbered § 6 and
amended Pub. L. 90–201, §§ 1, 3, 12(e), Dec. 15, 1967, 81
Stat. 584, 588, 592; Pub. L. 99–641, title IV, § 403(a), Nov.
10, 1986, 100 Stat. 3567, was formerly classified to section
74 of this title and was repealed by Pub. L. 110–234, title
XI, § 11016(b)(1)(B), May 22, 2008, 122 Stat. 1369, and Pub.
L. 110–246, § 4(a), title XI, § 11016(b)(1)(B), June 18, 2008,
122 Stat. 1664, 2131. Prior to repeal, section read as fol-
lows: ‘‘For the purposes hereinbefore set forth the Sec-
retary shall cause to be made, by inspectors appointed
for that purpose, an examination and inspection of all
meat food products prepared for commerce in any
slaughtering, meat-canning, salting, packing, ren-
dering, or similar establishment, and for the purposes
of any examination and inspection and inspectors shall
have access at all times, by day or night, whether the
establishment be operated or not, to every part of said
establishment; and said inspectors shall mark, stamp,
tag, or label as ‘Inspected and passed’ all such products
found to be not adulterated; and said inspectors shall
label, mark, stamp, or tag as ‘Inspected and con-
demned’ all such products found adulterated, and all
such condemned meat food products shall be destroyed
for food purposes, as hereinbefore provided, and the
Secretary may remove inspectors from any establish-
ment which fails to so destroy such condemned meat
food products: Provided, That subject to the rules and
regulations of the Secretary the provisions of this sec-
tion in regard to preservatives shall not apply to meat
food products for export to any foreign country and
which are prepared or packed according to the speci-
fications or directions of the foreign purchaser, when
no substance is used in the preparation or packing
thereof in conflict with the laws of the foreign country
to which said article is to be exported; but if said arti-
cle shall be in fact sold or offered for sale for domestic
use or consumption then this proviso shall not exempt
said article from the operation of all the other provi-
sions of this chapter.’’
AMENDMENTS
2014—Subsec. (b). Pub. L. 113–79 added subsec. (b) and
struck out former subsec. (b). Prior to amendment, text
read as follows: ‘‘In the case of an examination and in-
spection under subsection (a) of a meat food product de-
rived from catfish, the Secretary shall take into ac-
count the conditions under which the catfish is raised
and transported to a processing establishment.’’
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 2014 AMENDMENT
Amendment by Pub. L. 113–79 effective as if enacted
as part of section 11016(b) of Pub. L. 110–246, see section
12106(c) of Pub. L. 113–79, set out as a note under section
601 of this title.
EFFECTIVE DATE
Enactment of this section and repeal of former sec-
tion 6 of act Mar. 4, 1907, and Pub. L. 110–234 by Pub. L.
110–246 effective May 22, 2008, the date of enactment of
Pub. L. 110–234, except as otherwise provided, see sec-
tion 4 of Pub. L. 110–246, set out as a note under section
8701 of Title 7, Agriculture.
§ 607. Labeling, marking, and container require-
ments
(a) Labeling receptacles or coverings of meat or
meat food products inspected and passed; su-
pervision by inspectors
When any meat or meat food product prepared
for commerce which has been inspected as here-
inbefore provided and marked ‘‘Inspected and
passed’’ shall be placed or packed in any can,
pot, tin, canvas, or other receptacle or covering
in any establishment where inspection under the
provisions of this chapter is maintained, the
person, firm, or corporation preparing said prod-
uct shall cause a label to be attached to said
can, pot, tin, canvas, or other receptacle or cov-
ering, under the supervision of an inspector,
which label shall state that the contents thereof
have been ‘‘inspected and passed’’ under the pro-
visions of this chapter; and no inspection and
examination of meat or meat food products de-
posited or inclosed in cans, tins, pots, canvas, or
other receptacle or covering in any establish-
ment where inspection under the provisions of
this chapter is maintained shall be deemed to be
complete until such meat or meat food products
have been sealed or inclosed in said can, tin, pot,
canvas, or other receptacle or covering under
the supervision of an inspector.
(b) Information on articles or containers; legible
form
All carcasses, parts of carcasses, meat and
meat food products inspected at any establish-
ment under the authority of this subchapter and
found to be not adulterated, shall at the time
they leave the establishment bear, in distinctly
legible form, directly thereon or on their con-
tainers, as the Secretary may require, the infor-
mation required under paragraph (n) of section
601 of this title.
(c) Labeling: type styles and sizes; definitions
and standards of identity or composition;
standards of fill of container; consistency of
Federal and Federal-State standards
The Secretary, whenever he determines such
action is necessary for the protection of the pub-
lic, may prescribe: (1) the styles and sizes of
type to be used with respect to material re-
quired to be incorporated in labeling to avoid
false or misleading labeling in marketing and
labeling any articles or animals subject to this
subchapter or subchapter II of this chapter; (2)
definitions and standards of identity or composi-
tion for articles subject to this subchapter and
standards of fill of container for such articles
not inconsistent with any such standards estab-
lished under the Federal Food, Drug, and Cos-
metic Act [21 U.S.C. 301 et seq.], and there shall
be consultation between the Secretary and the
Secretary of Health and Human Services prior
to the issuance of such standards under either
Act relating to articles subject to this chapter
to avoid inconsistency in such standards and
possible impairment of the coordinated effective
administration of these Acts. There shall also be
consultation between the Secretary and an ap-
propriate advisory committee provided for in
section 661 of this title, prior to the issuance of
such standards under this chapter, to avoid, in-
sofar as feasible, inconsistency between Federal
and State standards.
(d) Sales under false or misleading name, other
marking or labeling or in containers of mis-
leading form or size; trade names, and other
marking, labeling, and containers approved
by Secretary
No article subject to this subchapter shall be
sold or offered for sale by any person, firm, or
corporation, in commerce, under any name or
Page 749
TITLE 21—FOOD AND DRUGS
§ 608
other marking or labeling which is false or mis-
leading, or in any container of a misleading
form or size, but established trade names and
other marking and labeling and containers
which are not false or misleading and which are
approved by the Secretary are permitted.
(e) Use withholding directive respecting false or
misleading marking, labeling, or container;
modification of false or misleading matter;
hearing;
withholding
use
pending
pro-
ceedings; finality of Secretary’s action; judi-
cial review; application of section 194 of title
7
If the Secretary has reason to believe that any
marking or labeling or the size or form of any
container in use or proposed for use with respect
to any article subject to this subchapter is false
or misleading in any particular, he may direct
that such use be withheld unless the marking,
labeling, or container is modified in such man-
ner as he may prescribe so that it will not be
false or misleading. If the person, firm, or cor-
poration using or proposing to use the marking,
labeling or container does not accept the deter-
mination of the Secretary, such person, firm, or
corporation may request a hearing, but the use
of the marking, labeling, or container shall, if
the Secretary so directs, be withheld pending
hearing and final determination by the Sec-
retary. Any such determination by the Sec-
retary shall be conclusive unless, within thirty
days after receipt of notice of such final deter-
mination, the person, firm, or corporation ad-
versely affected thereby appeals to the United
States court of appeals for the circuit in which
such person, firm, or corporation has its prin-
cipal place of business or to the United States
Court of Appeals for the District of Columbia
Circuit. The provisions of section 194 of title 7
shall be applicable to appeals taken under this
section.
(f) Lamb and mutton
The Secretary, consistent with United States
international obligations, shall establish stand-
ards for the labeling of sheep carcasses, parts of
sheep carcasses, sheepmeat, and sheepmeat food
products.
(Mar. 4, 1907, ch. 2907, title I, § 7, formerly 5th
par., 34 Stat. 1262; renumbered § 7 and amended
Pub. L. 90–201, §§ 1, 3(a), 6, Dec. 15, 1967, 81 Stat.
584, 588; Pub. L. 96–88, title V, § 509(b), Oct. 17,
1979, 93 Stat. 695; Pub. L. 104–127, title II, § 279,
Apr. 4, 1996, 110 Stat. 979.)
Editorial Notes
REFERENCES IN TEXT
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (c)(2), is act June 25, 1938, ch. 675, 52 Stat.
1040, which is classified generally to chapter 9 (§ 301 et
seq.) of this title. For complete classification of this
Act to the Code, see section 301 of this title and Tables.
Either Act and these Acts, referred to in subsec.
(c)(2), mean the Federal Meat Inspection Act and the
Federal Food, Drug, and Cosmetic Act. The Federal
Meat Inspection Act is titles I to V of act Mar. 4, 1907,
ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat.
584, and Pub. L. 110–246, title XI, § 11015(a), June 18, 2008,
122 Stat. 2124, which are classified generally to sub-
chapters I to IV–A (§ 601 et seq.) of this chapter. For
complete classification of this Act to the Code, see
Short Title note under section 601 of this title and Ta-
bles.
CODIFICATION
Section was formerly classified to section 75 of this
title.
AMENDMENTS
1996—Subsec. (f). Pub. L. 104–127 added subsec. (f).
1967—Subsec. (a). Pub. L. 90–201, §§ 3(a), 6(a), (b),
struck out ‘‘interstate or foreign’’ before ‘‘commerce’’
and provisions prohibiting sales of meat or meat food
products in interstate or foreign commerce under any
false or deceptive names and permitting trade names or
names which are usual to such products and are not
false and deceptive and are approved by the Secretary
of Agriculture, now incorporated in subsec. (d), and des-
ignated remaining provisions as subsecs. (a), respec-
tively.
Subsecs. (b) to (e). Pub. L. 90–201, § 6(c), added subsecs.
(b) to (e).
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. (c)(2) pursuant to section 509(b) of Pub.
L. 96–88, which is classified to section 3508(b) of Title 20,
Education.
EFFECTIVE DATE OF 1967 AMENDMENT
Amendment by Pub. L. 90–201 effective Dec. 15, 1967,
except that with respect to equines (other than horses)
and their carcasses and parts thereof, meat, and meat
food products thereof, amendment effective upon expi-
ration of sixty days after Dec. 15, 1967, see section 20(b)
of Pub. L. 90–201, set out as an Effective Date note
under section 601 of this title.
§ 608. Sanitary inspection and regulation of
slaughtering and packing establishments; re-
jection of adulterated meat or meat food
products
The Secretary shall cause to be made, by ex-
perts in sanitation or by other competent in-
spectors, such inspection of all slaughtering,
meat canning, salting, packing, rendering, or
similar establishments in which amenable spe-
cies are slaughtered and the meat and meat food
products thereof are prepared for commerce as
may be necessary to inform himself concerning
the sanitary conditions of the same, and to pre-
scribe the rules and regulations of sanitation
under which such establishments shall be main-
tained; and where the sanitary conditions of any
such establishment are such that the meat or
meat food products are rendered adulterated, he
shall refuse to allow said meat or meat food
products to be labeled, marked, stamped or
tagged as ‘‘inspected and passed.’’
(Mar. 4, 1907, ch. 2907, title I, § 8, formerly 6th
par., 34 Stat. 1262; renumbered § 8 and amended
Pub. L. 90–201, §§ 1, 3, 12(a), (f), Dec. 15, 1967, 81
Stat. 584, 588, 592; Pub. L. 109–97, title VII,
§ 798[(a)](1), Nov. 10, 2005, 119 Stat. 2166.)
Editorial Notes
CODIFICATION
Section was formerly classified to section 76 of this
title.
AMENDMENTS
2005—Pub. L. 109–97 substituted ‘‘amenable species’’
for ‘‘cattle, sheep, swine, goats, horses, mules, and
other equines’’.
Cross-references
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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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 301
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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
**(a) Labeling receptacles or coverings of meat or meat food products inspected and passed; supervision by inspectors** When any meat or meat food product prepared for commerce which has been inspected as hereinbefore provided and marked “Inspected and passed” shall be placed or packed in any can, pot, tin, canvas, or other receptacle or covering in any establishment where inspection under the provisions of this chapter is maintained, the person, firm, or corporation preparing said product shall cause a label to be attached to said can, pot, tin, canvas, or other receptacle or covering, under the supervision of an inspector, which label shall state that the contents thereof have been “inspected and passed” under the provisions of this chapter; and no inspection and examination of meat or meat food products deposited or inclosed in cans, tins, pots, canvas, or other receptacle or covering in any establishment where inspection under the provisions of this chapter is maintained shall be deemed to be complete until such meat or meat food products have been sealed or inclosed in said can, tin, pot, canvas, or other receptacle or covering under the supervision of an inspector.
**(b) Information on articles or containers; legible form** All carcasses, parts of carcasses, meat and meat food products inspected at any establishment under the authority of this subchapter and found to be not adulterated, shall at the time they leave the establishment bear, in distinctly legible form, directly thereon or on their containers, as the Secretary may require, the information required under paragraph (n) of [section 601 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section601&num=0&edition=prelim).
**(c) Labeling: type styles and sizes; definitions
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