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Title 21 — Food and Drugs

Chapter 9 — Federal Food, Drug, and Cosmetic Act

§ 362. Misbranded cosmetics

Statutory text

A cosmetic shall be deemed to be misbranded—

(a)

If its labeling is false or misleading in any particular.

(b)

If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and (3) the information required under section 364e of this title: Provided, That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.

(c)

If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(d)

If its container is so made, formed, or filled as to be misleading.

(e)

If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 379e of this title. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 361(a) of this title).

(f)

If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of title 15.

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. Pub. L. 75–675 § 602 · 52 Stat. 1040

    Enacted · 21 U.S.C. § 362

    June 25, 1938, ch. 675, § 602, 52 Stat. 1054

    Source evidence

    Code source credit
    June 25, 1938, ch. 675, § 602, 52 Stat. 1054

    Enacted provision · exact public law section
    Sec. 602. misbranded cosmetics A cosmetic shall be deemed to be misbranded— (a) If its labeling is false or misleading in any particular. (b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, Proviso. Variations and exemptions. That under clause (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary. (c) If any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. (d) If its container is so made, formed, or filled as to be misleading.

  2. Color Additive Amendments of 1960

    Pub. L. 86–618 title I § 102(c)(2) · 74 Stat. 397

    Added · 21 U.S.C. § 362(e)

    Pub. L. 86–618 added par. (e)

    Source evidence

    Code amendment note
    Par. (e). Pub. L. 86–618 added par. (e).

    Enacted provision · exact public law section
    (2) Section 602 of such Act (relating to the circumstances under which cosmetics shall be deemed to be misbranded) is amended by adding at the end thereof the following new paragraph: “(e) If it is a color additive, unless its packaging and labeling are in conformity with such packaging and labeling requirements, applicable to such color additive, as may be contained in regulations issued under section 706. This paragraph shall not apply to packages of color additives which, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of section 601(a)).”

  3. Poison Prevention Packaging Act of 1070

    Pub. L. 91–601 § 6(f) · 84 Stat. 1670

    Added · 21 U.S.C. § 362(f)

    Pub. L. 91–601 added par. (f)

    Source evidence

    Code amendment note
    Par. (f). Pub. L. 91–601 added par. (f).

    Enacted provision · exact public law section
    Sec. 6. (a) For the purpose of assisting in carrying out the purposes of this Act, the Secretary shall appoint a technical advisory committee, designating a member thereof to be chairman, composed of not more than eighteen members who are representative of (1) the Department of Health, Education, and Welfare, (2) the Department of Commerce, (3) manufacturers of household substances subject to this Act, (4) scientists with expertise related to this Act and licensed practitioners in the medical field, (5) consumers, and (6) manufacturers of packages and closures for household substances. The Secretary shall consult with the technical advisory committee in making findings and in establishing standards pursuant to this Act. (b) Members of the technical advisory committee who are not Compensation and travel expenses. regular full-time employees of the United States shall, while attending meetings of such committee, be entitled to receive compensation at a rate fixed by the Secretary, but not exceeding $100 per diem, including traveltime, and while so serving away from their homes or regular places of business, they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 of the United States Code for persons in the Government service employed 80 Stat. 499; 83 Stat. 190. intermittently.

  4. Prescription Drug User Fee Act of 1992

    Pub. L. 102–571 title I § 107(12) · 106 Stat. 4491

    Substituted · 21 U.S.C. § 362(e)

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

    Source evidence

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

    Enacted provision · exact public law section
    (12) Section 602(e) (21 U.S.C. 362(e)) is amended by striking out “706” and inserting in lieu thereof “721”.

  5. Modernization of Cosmetics Regulation Act of 2022

    Pub. L. 117–328 div. FF title III § 3503(a)(3) · 136 Stat. 4459

    Added · 21 U.S.C. § 362(b)(3)

    Pub. L. 117–328 added par. (3) before proviso

    Source evidence

    Code amendment note
    Subsec. (b)(3). Pub. L. 117–328 added par. (3) before proviso.

    Enacted provision · exact public law section
    (3) Misbranded cosmetics.— Section 602(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 362(b)) is amended— (A) by striking “and (2)” and inserting “(2)”; and (B) by inserting after “numerical count” the following: “; and (3) the information required under section 609”.

    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

Editorial Notes

Amendments1960–2022 · 4 rounds

2022

Subsec. (b)(3). Pub. L. 117–328 added par. (3) before proviso.

1992

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

1970

Par. (f). Pub. L. 91–601 added par. (f).

1960

Par. (e). Pub. L. 86–618 added par. (e).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

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

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–601 effective , and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 8 of Pub. L. 91–601, set out as an Effective Date note under section 1471 of Title 15, Commerce and Trade.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective , 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; Postponement

Par. (b) effective , and such subsection effective , as provided by regulations for certain lithographed labeling and containers bearing certain labeling, 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.

Construction; Confidentiality

Nothing in amendment made by Pub. L. 117–328, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.

Executive Documents

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 notes set out under section 321 of this title.

Credits

1938–2022 · 5 acts
  1. 1938June 25, 1938, ch. 675, § 602, 52 Stat. 1054
  2. 1960Pub. L. 86–618, title I, § 102(c)(2), , 74 Stat. 398
  3. 1970Pub. L. 91–601, § 6(f), formerly § 7(f), , 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, § 1205(c), , 95 Stat. 716
  4. 1992Pub. L. 102–571, title I, § 107(12), , 106 Stat. 4499
  5. 2022Pub. L. 117–328, div. FF, title III, § 3503(a)(3), , 136 Stat. 5858.
Show as published

(June 25, 1938, ch. 675, § 602, 52 Stat. 1054; Pub. L. 86–618, title I, § 102(c)(2), , 74 Stat. 398; Pub. L. 91–601, § 6(f), formerly § 7(f), , 84 Stat. 1673, renumbered Pub. L. 97–35, title XII, § 1205(c), , 95 Stat. 716; Pub. L. 102–571, title I, § 107(12), , 106 Stat. 4499; Pub. L. 117–328, div. FF, title III, § 3503(a)(3), , 136 Stat. 5858.)

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USLM identifier /us/usc/t21/s362