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Title 21, Food and DrugsRelease 119-110

§364d Safety Substantiation

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VI — COSMETICS › § 364d

Last updated Sep 22, 2026|Official source

Summary

A responsible person for a cosmetic must make sure the product has enough proof that it is safe and must keep records that show that proof. Coal-tar hair dye that meets the rules in section 361(a) does not have to meet that proof requirement, but the responsible person still must keep safety records. Adequate substantiation of safety: studies, tests, research, analyses, or other evidence that qualified experts judge enough to show, with reasonable certainty, that the product is safe. Safe: the product and its ingredients do not harm users when used as the label says or in the usual way; minor, short-lived reactions or mild skin irritation alone do not make it unsafe. The Secretary may consider total exposure when deciding safety.

Full Legal Text

Title 21, §364d

Food and Drugs, Source: USLM XML via OLRC

(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: (1) Adequate substantiation of safety
(2)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.

Legislative History

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

ConfidentialityNothing 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

.”

Reference

Citations & Metadata

Citation

21 U.S.C. § 364d

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110