-CITE-

21 USC Sec. 342 01/19/04

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 342. Adulterated food

-STATUTE-

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.

-SOURCE-

(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.)

-MISC1-

AMENDMENTS

2002 - Subsec. (h). Pub. L. 107-188 added subsec. (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\'.\"

-TRANS-

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.

-MISC2-

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.\"

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 333, 334, 346, 346a,

346b, 347b, 348, 350a, 350b, 360b, 379e of this title.

-FOOTNOTE-

(!1) So in original. The period probably should be \"; or\".

(!2) So in original. Probably should be \"subparagraph\".

-End-