21 U.S. Code § 361 - Adulterated cosmetics

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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.

Source

(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.)
Amendments

1993—Subsec. (a). Pub. L. 103–80substituted “usual, except that this” for “usual: Provided, That this”.
1992—Par. (e). Pub. L. 102–571substituted “379e(a)” for “376(a)”.
1960—Par. (e). Pub. L. 86–618substituted “and it is, or it bears or contains, a color additive which is unsafe within the meaning of section 376 (a) of this title” 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 section 364 of this title”.
Effective Date of 1960 Amendment

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

Par. (e) 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.
Effective Date

Section effective twelve months after June 25, 1938, except par. (a), which, with certain exceptions, became effective on June 25, 1938, see section 1002(a) of act June 25, 1938, set out as a note under section 301 of this title.

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21 CFR - Food and Drugs

21 CFR Part 2 - GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR Part 70 - COLOR ADDITIVES

21 CFR Part 71 - COLOR ADDITIVE PETITIONS

21 CFR Part 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

21 CFR Part 74 - LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

21 CFR Part 250 - SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS

21 CFR Part 300 - GENERAL

21 CFR Part 310 - NEW DRUGS

21 CFR Part 505

21 CFR Part 700 - GENERAL

21 CFR Part 701 - COSMETIC LABELING

21 CFR Part 710 - VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS

21 CFR Part 730

21 CFR Part 740 - COSMETIC PRODUCT WARNING STATEMENTS

21 CFR Part 800 - GENERAL

 

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