§ 361. Adulterated cosmetics

Footnotes

1. 1 So in original. Probably should be “of”.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Pub. L. 75–675 § 601 · 52 Stat. 1040

   Enacted · 21 U.S.C. § 361

   June 25, 1938, ch. 675, § 601, 52 Stat. 1054

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 601, 52 Stat. 1054

   Enacted provision · exact public law section
   Sec. 601. 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 Proviso. Coal-tar hair dye bearing informative legend. are customary or usual: Provided, 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 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 604.

2. 1960

   Color Additive Amendments of 1960

   Pub. L. 86–618 title I § 102(c)(1) · 74 Stat. 397

   Substituted · 21 U.S.C. § 361(e)

   Pub. L. 86–618 substituted “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”

   Source evidence

   Code amendment note
   Par. (e). Pub. L. 86–618 substituted “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”.

   Enacted provision · exact public law section
   (1) Section 601(e) of such Act (relating to cosmetics, other than hair dyes, deemed adulterated by reason of uncertified coal tar color) is amended to read as follows: “(e) If it is not a hair dye and it is, or it bears or contains, a color 21 USC 376. 21 USC 362. additive which is unsafe within the meaning of section 706(a).”

3. 1992

   Prescription Drug User Fee Act of 1992

   Pub. L. 102–571 title I § 107(11) · 106 Stat. 4491

   Substituted · 21 U.S.C. § 361(e)

   Pub. L. 102–571 substituted “379e(a)” for “376(a)”

   Source evidence

   Code amendment note
   Par. (e). Pub. L. 102–571 substituted “379e(a)” for “376(a)”.

   Enacted provision · exact public law section
   (11) Section 601(e) (21 U.S.C. 361(e)) is amended by striking out “706” and inserting in lieu thereof “721”.

4. 1993

   Nutrition Labeling and Education Act Amendments of 1993

   Pub. L. 103–80 § 3(x) · 107 Stat. 773

   Substituted · 21 U.S.C. § 361(a)

   Pub. L. 103–80 substituted “usual, except that this” for “usual: Provided, That this”

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 103–80 substituted “usual, except that this” for “usual: Provided, That this”.

   Enacted provision · exact public law section
   (x) Section 601.— Section 601(a) (21 U.S.C. 361) is amended by striking out “: Provided, That this” and inserting in lieu thereof “, except that this”.

5. 2022

   Modernization of Cosmetics Regulation Act of 2022

   Pub. L. 117–328 div. FF title III § 3503(a)(2) · 136 Stat. 4459

   Added · 21 U.S.C. § 361(f); 21 U.S.C. § 361(g)

   Pub. L. 117–328 added subsecs. (f) and (g)

   Source evidence

   Code amendment note
   Subsecs. (f), (g). Pub. L. 117–328 added subsecs. (f) and (g).

   Enacted provision · exact public law section
   (2) Adulterated products.— Section 601 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 361) is amended by adding at the end the following: “(f) If it has been manufactured or processed under conditions that do not meet the good manufacturing practice requirements of section 606. “(g) 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 section 608(c).” .

   Effective date note
   Amendment by Pub. L. 117–328 effective on the date that is 1 year after Dec. 29, 2022, see section 3503(b)(1) of Pub. L. 117–328, set out as a note under section 331 of this title.

5 of 5 references resolved to an enrolled provision