§364e — Title 21 Food and Drugs | U.S. Code

Summary

Labels must show a domestic address, a domestic phone number, or an electronic contact (like a website) where the company or person responsible for the cosmetic can get reports of bad reactions. The label must also list every fragrance allergen the product contains. Which chemicals count as fragrance allergens will be set by the Secretary by rule. The Secretary must issue a proposed rule not later than 18 months after December 29, 2022, and must issue a final rule not later than 180 days after the public comment period on that proposal ends. When making the rule, the Secretary must look at international, State, and local allergen rules (including the EU) and may set cutoffs for how much of a substance must be present before it must be listed. A “professional” means someone licensed by a State in cosmetology, nail care, barbering, or esthetics. Products sold across State lines that are meant only for licensed professionals must have a clear label saying they are for licensed professionals only and must meet the Secretary’s labeling requirements.

Title 21, §364e

Food and Drugs — Source: USLM XML via OLRC

(a)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.

(b)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.

(c)(1)For purposes of this subsection, the term “professional” means an individual who is licensed by an official State authority to practice in the field of cosmetology, nail care, barbering, or esthetics.

(2)A cosmetic product introduced into interstate commerce and intended to be used only by a professional shall bear a label that—

(A)contains a clear and prominent statement that the product shall be administered or used only by licensed professionals; and

(B)is in conformity with the requirements of the Secretary for cosmetics labeling under this chapter and section 1453(a) of title 15.

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Effective Date

of 2022 Amendment 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].”

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.

§364e Labeling