21 U.S.C. § 364e — Labeling

FEDERAL · 21 U.S.C. · Chapter 9

Labeling

Current through Pub. L. 119-102

Title 21 — Food and Drugs·Ch. 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT·Subch. VI

(a)General requirement 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)Fragrance allergens 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 pu

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(a) General requirement
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) Fragrance allergens
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) Cosmetic products for professional use
(1) Definition of professional
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) Professional use labeling
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.

21 U.S.C. § 364e (Labeling) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

Source Credit

History

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

Editorial Notes

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; 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.