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U.S. Code as of:
01/19/04
Section 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.
(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.
(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.
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