2023 U.S. Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter VI - Cosmetics
Sec. 364e - Labeling

Each cosmetic product shall bear a label that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product.

The responsible person shall identify on the label of a cosmetic product each fragrance allergen included in such cosmetic product. Substances that are fragrance allergens for purposes of this subsection shall be determined by the Secretary by regulation. The Secretary shall issue a notice of proposed rulemaking promulgating the regulation implementing this requirement not later than 18 months after December 29, 2022, and not later than 180 days after the date on which the public comment period on the proposed rulemaking closes, shall issue a final rulemaking. In promulgating regulations implementing this subsection, the Secretary shall consider international, State, and local requirements for allergen disclosure, including the substance and format of requirements in the European Union, and may establish threshold levels of amounts of substances subject to disclosure pursuant to such regulations.

(June 25, 1938, ch. 675, §609, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5854.)

For delayed effective date of subsection (a) of this section, see Effective Date of 2022 Amendment note below.

Pub. L. 117–328, div. FF, title III, §3503(b)(2), Dec. 29, 2022, 136 Stat. 5859, provided that: "Section 609(a) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 364e(a)], as added by section 802 [probably should be "section 3502"], shall take effect on the date that is 2 years after the date of enactment of this Act [Dec. 29, 2022]."

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.