US Code

Public Law 119-73 (01/23/2026)

21 U.S.C. § 361

Adulterated cosmetics

A cosmetic shall be deemed to be adulterated—
(a)
If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual, except that this provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: “Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”, and the labeling of which bears adequate directions for such preliminary testing. For the purposes of this paragraph and paragraph (e) the term “hair dye” shall not include eyelash dyes or eyebrow dyes.
(b)
If it consists in whole or in part of any filthy, putrid, or decomposed substance.
(c)
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.
(d)
If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.
(e)
section 379e(a) of this title If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe within the meaning of .
(f)
section 364b of this title If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of .
(g)
1
1 So in original. Probably should be “of”.
section 364d(c) of this title If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for  safety, as defined in .

June 25, 1938, ch. 675, § 60152 Stat. 1054Pub. L. 86–618, title I, § 102(c)(1)74 Stat. 398Pub. L. 102–571, title I, § 107(11)106 Stat. 4499Pub. L. 103–80, § 3(x)107 Stat. 778Pub. L. 117–328, div. FF, title III, § 3503(a)(2)136 Stat. 5858(, ; , , ; , , ; , , ; , , .)

Editorial Notes

Amendments

Pub. L. 117–3282022—Subsecs. (f), (g). added subsecs. (f) and (g).

Pub. L. 103–80Provided1993—Subsec. (a). substituted “usual, except that this” for “usual: , That this”.

Pub. L. 102–5711992—Par. (e). substituted “379e(a)” for “376(a)”.

Pub. L. 86–618section 376(a) of this titlesection 364 of this title1960—Par. (e). substituted “and it is, or it bears or contains, a color additive which is unsafe within the meaning of ” for “and it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by ”.

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328section 3503(b)(1) of Pub. L. 117–328section 331 of this titleAmendment by effective on the date that is 1 year after , see , set out as a note under .

Effective Date of 1960 Amendment

Pub. L. 86–618section 203 of Pub. L. 86–618section 202 of Pub. L. 86–618section 379e of this titleAmendment by effective , subject to the provisions of , see , set out as a note under .

Effective Date; Postponement

act June 23, 1939, ch. 24253 Stat. 853section 301 of this titlePar. (e) effective , see , , set out as an Effective Date; Postponement in Certain Cases note under .

Effective Date

section 301 of this titleSection effective twelve months after , except par. (a), which, with certain exceptions, became effective on , see section 1002(a) of act , set out as a note under .

Construction; Confidentiality

Pub. L. 117–328section 331(j) of this titlesection 1905 of title 18section 552(b)(4) of title 5section 3503(c)(2) of Pub. L. 117–328section 364 of this titleNothing in amendment made by , to be construed to authorize the disclosure of information that is prohibited from disclosure under or or that is subject to withholding under , see , set out as a note under .