21 Usc 342

From the U.S. Code Online via GPO Access
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[Laws in effect as of January 3, 2005]
[Document not affected by Public Laws enacted between
January 3, 2005 and August 11, 2006]
[CITE: 21USC342]

TITLE 21--FOOD AND DRUGS

CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV--FOOD

Sec. 342. Adulterated food

A food shall be deemed to be adulterated--

(a) Poisonous, insanitary, etc., ingredients

(1) If it bears or contains any poisonous or deleterious substance
which may render it injurious to health; but in case the substance is
not an added substance such food shall not be considered adulterated
under this clause if the quantity of such substance in such food does
not ordinarily render it injurious to health.\1\ (2)(A) if it bears or
contains any added poisonous or added deleterious substance (other than
a substance that is a pesticide chemical residue in or on a raw
agricultural commodity or processed food, a food additive, a color
additive, or a new animal drug) that is unsafe within the meaning of
section 346 of this title; or (B) if it bears or contains a pesticide
chemical residue that is unsafe within the meaning of section 346a(a) of
this title; or (C) if it is or if it bears or contains (i) any food
additive that is unsafe within the meaning of section 348 of this title;
or (ii) a new animal drug (or conversion product thereof) that is unsafe
within the meaning of section 360b of this title; or (3) if it consists
in whole or in part of any filthy, putrid, or decomposed substance, or
if it is otherwise unfit for food; or (4) if it has been prepared,
packed, or held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious
to health; or (5) if it is, in whole or in part, the product of a
diseased animal or of an animal which has died otherwise than by
slaughter; or (6) if its container is composed, in whole or in part, of
any poisonous or deleterious substance which may render the contents
injurious to health; or (7) if it has been intentionally subjected to
radiation, unless the use of the radiation was in conformity with a
regulation or exemption in effect pursuant to section 348 of this title.
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\1\ So in original. The period probably should be ``; or''.
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(b) Absence, substitution, or addition of constituents

(1) If any valuable constituent has been in whole or in part omitted
or abstracted therefrom; or (2) if any substance has been substituted
wholly or in part therefor; or (3) if damage or inferiority has been
concealed in any manner; or (4) if any substance has been added thereto
or mixed or packed therewith so as to increase its bulk or weight, or
reduce its quality or strength, or make it appear better or of greater
value than it is.

(c) Color additives

If it is, or it bears or contains, a color additive which is unsafe
within the meaning of section 379e(a) of this title.

(d) Confectionery containing alcohol or nonnutritive substance

If it is confectionery, and--
(1) has partially or completely imbedded therein any
nonnutritive object, except that this subparagraph shall not apply
in the case of any nonnutritive object if, in the judgment of the
Secretary as provided by regulations, such object is of practical
functional value to the confectionery product and would not render
the product injurious or hazardous to health;
(2) bears or contains any alcohol other than alcohol not in
excess of one-half of 1 per centum by volume derived solely from the
use of flavoring extracts, except that this clause shall not apply
to confectionery which is introduced or delivered for introduction
into, or received or held for sale in, interstate commerce if the
sale of such confectionery is permitted under the laws of the State
in which such confectionery is intended to be offered for sale;
(3) bears or contains any nonnutritive substance, except that
this subparagraph shall not apply to a safe nonnutritive substance
which is in or on confectionery by reason of its use for some
practical functional purpose in the manufacture, packaging, or
storage of such confectionery if the use of the substance does not
promote deception of the consumer or otherwise result in
adulteration or misbranding in violation of any provision of this
chapter, except that the Secretary may, for the purpose of avoiding
or resolving uncertainty as to the application of this subparagraph,
issue regulations allowing or prohibiting the use of particular
nonnutritive substances.

(e) Oleomargarine containing filthy, putrid, etc., matter

If it is oleomargarine or margarine or butter and any of the raw
material used therein consisted in whole or in part of any filthy,
putrid, or decomposed substance, or such oleomargarine or margarine or
butter is otherwise unfit for food.

(f) Dietary supplement or ingredient: safety

(1) If it is a dietary supplement or contains a dietary ingredient
that--
(A) presents a significant or unreasonable risk of illness or
injury under--
(i) conditions of use recommended or suggested in labeling,
or
(ii) if no conditions of use are suggested or recommended in
the labeling, under ordinary conditions of use;

(B) is a new dietary ingredient for which there is inadequate
information to provide reasonable assurance that such ingredient
does not present a significant or unreasonable risk of illness or
injury;
(C) the Secretary declares to pose an imminent hazard to public
health or safety, except that the authority to make such declaration
shall not be delegated and the Secretary shall promptly after such a
declaration initiate a proceeding in accordance with sections 554
and 556 of title 5 to affirm or withdraw the declaration; or
(D) is or contains a dietary ingredient that renders it
adulterated under paragraph (a)(1) under the conditions of use
recommended or suggested in the labeling of such dietary supplement.

In any proceeding under this subparagraph, the United States shall bear
the burden of proof on each element to show that a dietary supplement is
adulterated. The court shall decide any issue under this paragraph on a
de novo basis.
(2) Before the Secretary may report to a United States attorney a
violation of paragraph \2\ (1)(A) for a civil proceeding, the person
against whom such proceeding would be initiated shall be given
appropriate notice and the opportunity to present views, orally and in
writing, at least 10 days before such notice, with regard to such
proceeding.
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\2\ So in original. Probably should be ``subparagraph''.
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(g) Dietary supplement: manufacturing practices

(1) If it is a dietary supplement and it has been prepared, packed,
or held under conditions that do not meet current good manufacturing
practice regulations, including regulations requiring, when necessary,
expiration date labeling, issued by the Secretary under subparagraph
(2).
(2) The Secretary may by regulation prescribe good manufacturing
practices for dietary supplements. Such regulations shall be modeled
after current good manufacturing practice regulations for food and may
not impose standards for which there is no current and generally
available analytical methodology. No standard of current good
manufacturing practice may be imposed unless such standard is included
in a regulation promulgated after notice and opportunity for comment in
accordance with chapter 5 of title 5.

(h) Reoffer of food previously denied admission

If it is an article of food imported or offered for import into the
United States and the article of food has previously been refused
admission under section 381(a) of this title, unless the person
reoffering the article affirmatively establishes, at the expense of the
owner or consignee of the article, that the article complies with the
applicable requirements of this chapter, as determined by the Secretary.

(June 25, 1938, ch. 675, Sec. 402, 52 Stat. 1046; Mar. 16, 1950, ch. 61,
Sec. 3(d), 64 Stat. 21; July 22, 1954, ch. 559, Sec. 2, 68 Stat. 511;
July 9, 1956, ch. 530, 70 Stat. 512; Pub. L. 85-929, Sec. 3(a), (b),
Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86-2, Mar. 17, 1959, 73 Stat. 3;
Pub. L. 86-618, title I, Secs. 102(a)(1), (2), 105(c), July 12, 1960, 74
Stat. 397, 398, 404; Pub. L. 89-477, June 29, 1966, 80 Stat. 231; Pub.
L. 90-399, Sec. 104, July 13, 1968, 82 Stat. 352; Pub. L. 99-252,
Sec. 10, Feb. 27, 1986, 100 Stat. 35; Pub. L. 102-571, title I,
Sec. 107(4), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(i),
Aug. 13, 1993, 107 Stat. 776; Pub. L. 103-417, Secs. 4, 9, Oct. 25,
1994, 108 Stat. 4328, 4332; Pub. L. 104-170, title IV, Sec. 404, Aug. 3,
1996, 110 Stat. 1514; Pub. L. 107-188, title III, Sec. 309, June 12,
2002, 116 Stat. 673.)

Amendments

2002--Par. (h). Pub. L. 107-188 added par. (h).
1996--Par. (a). Pub. L. 104-170 added subpar. (2) and struck out
former subpar. (2) which read as follows: ``(2)(A) if it bears or
contains any added poisonous or added deleterious substance (other than
one which is (i) a pesticide chemical in or on a raw agricultural
commodity; (ii) a food additive; (iii) a color additive; or (iv) a new
animal drug) which is unsafe within the meaning of section 346 of this
title, or (B) if it is a raw agricultural commodity and it bears or
contains a pesticide chemical which is unsafe within the meaning of
section 346a(a) of this title, or (C) if it is, or if it bears or
contains, any food additive which is unsafe within the meaning of
section 348 of this title: Provided, That where a pesticide chemical has
been used in or on a raw agricultural commodity in conformity with an
exemption granted or a tolerance prescribed under section 346a of this
title and such raw agricultural commodity has been subjected to
processing such as canning, cooking, freezing, dehydrating, or milling,
the residue of such pesticide chemical remaining in or on such processed
food shall, notwithstanding the provisions of sections 346 and 348 of
this title, not be deemed unsafe if such residue in or on the raw
agricultural commodity has been removed to the extent possible in good
manufacturing practice and the concentration of such residue in the
processed food when ready to eat is not greater than the tolerance
prescribed for the raw agricultural commodity, or (D) if it is, or it
bears or contains, a new animal drug (or conversion product thereof)
which is unsafe within the meaning of section 360b of this title;''.
That part of Pub. L. 104-170 which directed the substitution of ``or (3)
if it consists'' for ``(3) if it consists'' was executed by making the
substitution for ``(3) If it consists'' to reflect the probable intent
of Congress.
1994--Par. (f). Pub. L. 103-417, Sec. 4, added par. (f).
Par. (g). Pub. L. 103-417, Sec. 9, added par. (g).
1993--Par. (a). Pub. L. 103-80, Sec. 3(i)(1), substituted a period
for ``; or'' at end of subpar. (1) and ``If it'' for ``if it'' at
beginning of par. (3). That part of Pub. L. 103-80, Sec. 3(i)(1), which
directed the substitution of a period for ``; or'' at end of subpar. (2)
could not be executed because ``; or'' did not appear.
Par. (d)(1). Pub. L. 103-80, Sec. 3(i)(2), substituted ``, except
that this subparagraph'' for ``: Provided, That this clause''.
Par. (d)(3). Pub. L. 103-80, Sec. 3(i)(3), substituted ``, except
that this subparagraph shall not apply'' for ``: Provided, That this
clause shall not apply'' and ``, except that the Secretary may, for the
purpose of avoiding or resolving uncertainty as to the application of
this subparagraph'' for ``: And provided further, That the Secretary
may, for the purpose of avoiding or resolving uncertainty as to the
application of this clause''.
1992--Par. (c). Pub. L. 102-571 substituted ``379e(a)'' for
``376(a)''.
1986--Par. (d)(2). Pub. L. 99-252 inserted provision that this
clause not apply to confectionery introduced or delivered for
introduction into or received or held for sale in, interstate commerce
if the sale is permitted under the laws of the State in which the
confectionery is intended to be offered for sale.
1968--Par. (a)(2). Pub. L. 90-399 added cls. (A)(iv) and (D).
1966--Par. (d). Pub. L. 89-477 permitted the imbedding of
nonnutritive objects in confectionery foods if in the judgment of the
Secretary of Health, Education, and Welfare, as provided by regulation,
the imbedding of the object is of practical functional value to the
confectionery product and would not render it injurious or hazardous to
health, raised to one-half of 1 per centum by volume the upper limit for
the allowable use of alcohol derived solely from the use of flavoring
extracts, allowed the use of safe nonnutritive substances in and on
confectionery foods by reason of their use for some practical and
functional purpose in the manufacture, packaging, or storage of the
confectionery foods if the use of the substances does not promote
deception of the consumer or otherwise result in adulteration or
misbranding, authorized the Secretary to issue regulations on the use of
particular nonnutritive substances, and removed reference to
nonnutritive masticatory substances added to chewing gum and harmless
flavoring, harmless resinous glaze not in excess of four-tenths of 1 per
centum, natural gum, authorized coloring, and pectin.
1960--Par. (a). Pub. L. 86-618, Sec. 102(a)(1), substituted ``other
than one which is (i) a pesticide chemical in or on a raw agricultural
commodity; (ii) a food additive; or (iii) a color additive'' for
``(except a pesticide chemical in or on a raw agricultural commodity and
except a food additive)'' in cl. (2)(A).
Par. (c). Pub. L. 86-618, Sec. 102(a)(2), amended par. (c)
generally, substituting provisions deeming a food adulterated if it is,
or it bears or contains, a color additive which is unsafe within the
meaning of section 376 of this title for provisions which related to
food that bears or contains a coal-tar color other than one from a batch
that has been certified in accordance with regulations as provided by
section 346 of this title, and struck out provisos which related to the
use of color on oranges.
Par. (d). Pub. L. 86-618, Sec. 105(c), substituted ``authorized
coloring'' for ``harmless coloring''.
1959--Par. (c). Pub. L. 86-2 extended from Mar. 1, 1959, to May 1,
1959, the period during which subsection is inapplicable to oranges
which have been colored with F.D. & C. Red 32, and inserted proviso
requiring Secretary to establish regulations prescribing the conditions
under which Citrus Red No. 2 may be safely used in coloring certain
mature oranges, and providing for separately listing and for
certification of batches of such color.
1958--Par. (a). Pub. L. 85-929, among other changes, inserted cl.
(2)(C) relating to food additive unsafe within the meaning of section
348 of this title, and to pesticide chemical, and added cl. (7) relating
to radiated food.
1956--Par. (c). Act July 9, 1956, inserted second proviso relating
to coloring of oranges.
1954--Par. (a)(2). Act July 22, 1954, provided in the case of any
raw agricultural commodity bearing or containing a pesticide chemical,
that such commodity shall be deemed to be adulterated if such pesticide
chemical is unsafe within the meaning of section 346a of this title.
1950--Par. (e). Act Mar. 16, 1950, added par. (e).

Effective Date of 1968 Amendment

Amendment by Pub. L. 90-399 effective on first day of thirteenth
calendar month after July 13, 1968, see section 108(a) of Pub. L. 90-
399, set out as an Effective Date and Transitional Provisions note under
section 360b of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to the
provisions of section 203 of Pub. L. 86-618, see section 202 of Pub. L.
86-618, set out as a note under section 379e of this title.

Effective Date of Nematocide, Plant Regulator, Defoliant, and Desiccant
Amendment of 1959

Effective date of par. (a)(2) as in force prior to July 22, 1954,
with respect to particular commercial use of a nematocide, plant
regulator, defoliant, or desiccant in or on a raw agricultural commodity
made before Jan. 1, 1958, see section 3(b) of Pub. L. 86-139, Aug. 7,
1959, 73 Stat. 288.

Effective Date of 1958 Amendment

Section 6 of Pub. L. 85-929, as amended by Pub. L. 87-19, Sec. 2,
Apr. 7, 1961, 75 Stat. 42; Pub. L. 88-625, Sec. 2, Oct. 3, 1964, 78
Stat. 1002, provided that:
``(a) Except as provided in subsections (b) and (c) of this section,
this Act [amending this section, sections 321, 331, 346, and 348 of this
title, and section 210 of Title 42, The Public Health and Welfare, and
enacting provisions set out as notes under sections 321 and 451 of this
title] shall take effect on the date of its enactment [Sept. 6, 1958].
``(b) Except as provided in subsection (c) of this section, section
3 of this Act [amending this section and section 346 of this title]
shall take effect on the one hundred and eightieth day after the date of
enactment of this Act [Sept. 6, 1958].
``(c) With respect to any particular commercial use of a food
additive, if such use was made of such additive before January 1, 1958,
section 3 of this Act [amending this section and section 346 of this
title] shall take effect--
``(1) Either (A) one year after the effective date established
in subsection (b) of this section, or (B) at the end of such
additional period (but not later than two years from such effective
date established in subsection (b)) as the Secretary of Health,
Education, and Welfare [now Health and Human Services] may prescribe
on the basis of a finding that such extension involves no undue risk
to the public health and that conditions exist which necessitate the
prescribing of such an additional period, or
``(2) on the date on which an order with respect to such use
under section 409 of the Federal Food, Drug, and Cosmetic Act
[section 348 of this title] becomes effective,
whichever date first occurs. Whenever the Secretary has, pursuant to
clause (1)(B) of this subsection, extended the effective date of section
3 of this Act [amending this section] to March 5, 1961, or has on that
date a request for such extension pending before him, with respect to
any such particular use of a food additive, he may, notwithstanding the
parenthetical time limitation in that clause, further extend such
effective date, not beyond June 30, 1964, under the authority of that
clause (but subject to clause (2)) with respect to such use of the
additive (or a more limited specified use or uses thereof) if, in
addition to making the findings required by clause (1)(B), he finds (i)
that bona fide action to determine the applicability of such section 409
[section 348 of this title] to such use or uses, or to develop the
scientific data necessary for action under such section, was commenced
by an interested person before March 6, 1960, and was thereafter pursued
with reasonable diligence, and (ii) that in the Secretary's judgment
such extension is consistent with the objective of carrying to
completion in good faith, as soon as reasonably practicable, the
scientific investigations necessary as a basis for action under such
section 409 [section 348 of this title]: Provided, That if the Secretary
has, pursuant to this sentence, granted an extension to June 30, 1964,
he may, upon making the findings required by clause (1)(B) of this
subsection and clauses (i) and (ii) of this sentence, further extend
such effective date, but not beyond December 31, 1965. The Secretary may
at any time terminate an extension so granted if he finds that it should
not have been granted, or that by reason of a change in circumstances
the basis for such extension no longer exists, or that there has been a
failure to comply with a requirement for submission of progress reports
or with other conditions attached to such extension.''

Effective Date of 1954 Amendment

Section 5 of act July 22, 1954, provided that: ``This Act [amending
this section and section 321 of this title and enacting sections 346a
and 346b of this title] shall take effect upon the date of its enactment
[July 22, 1954], except that with respect to pesticide chemicals for
which tolerances or exemptions have not been established under section
408 of the Federal Food, Drug, and Cosmetic Act [section 346a of this
title], the amendment to section 402(a) of such Act [par. (a) of this
section] made by section 2 of this Act shall not be effective--
``(1) for the period of one year following the date of the
enactment of this Act [July 22, 1954]; or
``(2) for such additional period following such period of one
year, but not extending beyond two years after the date of the
enactment of this Act [July 22, 1954] as the Secretary of Health,
Education, and Welfare [now Health and Human Services] may prescribe
on the basis of a finding that conditions exist which necessitate
the prescribing of such additional period.''

Effective Date of 1950 Amendment

Amendment by act Mar. 16, 1950, effective July 1, 1950, see section
7 of act Mar. 16, 1950, set out as an Effective Date note under section
347 of this title.

Effective Date; Postponement

Par. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53
Stat. 853, set out as an Effective Date; Postponement in Certain Cases
note under section 301 of this title.

Short Title

Pub. L. 88-625, Sec. 1, Oct. 3, 1964, 78 Stat. 1002, provided:
``That this Act [amending provisions set out as a note under this
section and section 135 of Title 7, Agriculture] may be cited as the
`Food Additives Transitional Provisions Amendment of 1964'.''

Transfer of Functions

For transfer of functions of Federal Security Administrator 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 note set out under section
41 of this title.

Domestic Fish or Fish Product Compliance With Food Safety Standards or
Procedures Deemed To Have Met Requirements for Federal Commodity
Purchase Programs

Pub. L. 104-180, title VII, Sec. 733, Aug. 6, 1996, 110 Stat. 1601,
provided that: ``Hereafter, notwithstanding any other provision of law,
any domestic fish or fish product produced in compliance with food
safety standards or procedures accepted by the Food and Drug
Administration as satisfying the requirements of the `Procedures for the
Safe and Sanitary Processing and Importing of Fish and Fish Products'
(published by the Food and Drug Administration as a final regulation in
the Federal Register of December 18, 1995), shall be deemed to have met
any inspection requirements of the Department of Agriculture or other
Federal agency for any Federal commodity purchase program, including the
program authorized under section 32 of the Act of August 24, 1935 (7
U.S.C. 612c) except that the Department of Agriculture or other Federal
agency may utilize lot inspection to establish a reasonable degree of
certainty that fish or fish products purchased under a Federal commodity
purchase program, including the program authorized under section 32 of
the Act of August 24, 1935 (7 U.S.C. 612c), meet Federal product
specifications.''