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21 USC § 361 - Adulterated cosmetics

---
identifier: "/us/usc/t21/s361"
source: "usc"
legal_status: "official_prima_facie"
title: "21 USC § 361 - Adulterated cosmetics"
title_number: 21
title_name: "FOOD AND DRUGS"
section_number: "361"
section_name: "Adulterated cosmetics"
chapter_number: 9
chapter_name: "FEDERAL FOOD, DRUG, AND COSMETIC ACT"
subchapter_number: "VI"
subchapter_name: "COSMETICS"
positive_law: false
currency: "119-84"
last_updated: "2026-04-17"
format_version: "1.1.0"
generator: "[email protected]"
source_credit: "(June 25, 1938, ch. 675, § 601, 52 Stat. 1054; Pub. L. 86–618, title I, § 102(c)(1), July 12, 1960, 74 Stat. 398; Pub. L. 102–571, title I, § 107(11), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(x), Aug. 13, 1993, 107 Stat. 778; Pub. L. 117–328, div. FF, title III, § 3503(a)(2), Dec. 29, 2022, 136 Stat. 5858.)"
---

# § 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)** 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 section 379e(a) of this title.

**(f)** If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of section 364b of this title.

**1** If it is a cosmetic product, and the cosmetic product, including each ingredient in the cosmetic product, does not have adequate substantiation for [^1] safety, as defined in section 364d(c) of this title.

So in original. Probably should be “of”.

---

**Source Credit**: (June 25, 1938, ch. 675, § 601, 52 Stat. 1054; Pub. L. 86–618, title I, § 102(c)(1), July 12, 1960, 74 Stat. 398; Pub. L. 102–571, title I, § 107(11), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(x), Aug. 13, 1993, 107 Stat. 778; Pub. L. 117–328, div. FF, title III, § 3503(a)(2), Dec. 29, 2022, 136 Stat. 5858.)

## Editorial Notes

### Amendments

2022—Subsecs. (f), (g).  added subsecs. (f) and (g).

1993—Subsec. (a).  substituted “usual, except that this” for “usual: , That this”.

1992—Par. (e).  substituted “379e(a)” for “376(a)”.

1960—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

Amendment by  effective on the date that is 1 year after , see , set out as a note under .

### Effective Date of 1960 Amendment

Amendment by  effective , subject to the provisions of , see , set out as a note under .

### Effective Date; Postponement

Par. (e) effective , see , , set out as an Effective Date; Postponement in Certain Cases note under .

### Effective Date

Section 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

Nothing 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 .