Safety substantiation

21 U.S.C. § 364d

• Title: 21 — Food and Drugs
• Chapter: SUBCHAPTER VI—COSMETICS

Text

(a) Substantiation of safety
A responsible person for a cosmetic product shall ensure, and maintain records supporting, that there is adequate substantiation of safety of such cosmetic product.
(b) Coal-tar hair dye
Subsection (a) shall not apply to coal-tar hair dye that otherwise complies with the requirements of section 361(a) of this title. A responsible person for a coal-tar hair dye shall maintain records related to the safety of such product.
(c) Definitions
For purposes of this section:
The term "adequate substantiation of safety" means tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.
The term "safe" means that the cosmetic product, including any ingredient thereof, is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual. The Secretary shall not consider a cosmetic ingredient or cosmetic product injurious to users solely because it can cause minor and transient reactions or minor and transient skin irritations in some users. In determining for purposes of this section whether a cosmetic product is safe, the Secretary may consider, as appropriate and available, the cumulative or other relevant exposure to the cosmetic product, including any ingredient thereof.

History

(June 25, 1938, ch. 675, §608, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5854.)

Editorial Notes

Statutory Notes and Related Subsidiaries

Construction; Confidentiality
Nothing in section 3502 of Pub. L. 117–328, which enacted this section, 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.

Talc-Containing Cosmetics
Pub. L. 117–328, div. FF, title III, §3505, Dec. 29, 2022, 136 Stat. 5859, provided that:
"The Secretary of Health and Human Services—
"(1) not later than one year after the date of enactment of this Act [Dec. 29, 2022], shall promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products; and
"(2) not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations."