---
kind: "section"
citation: "21 U.S.C. § 364e"
title: "21"
title_heading: "Food and Drugs"
number: "364e"
heading: "Labeling"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/364e"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter VI — Cosmetics"
---

# §364e. Labeling

- (a) **General requirement—** Each [cosmetic product](/usc/21/364.md?p=2) shall bear a [label](/usc/21/321.md?p=k) that includes a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the [responsible person](/usc/21/364.md?p=4) can receive [adverse event](/usc/21/364.md?p=1) reports with respect to such [cosmetic product](/usc/21/364.md?p=2).
- (b) **Fragrance allergens—** The [responsible person](/usc/21/364.md?p=4) shall identify on the [label](/usc/21/321.md?p=k) of a [cosmetic product](/usc/21/364.md?p=2) each fragrance allergen included in such [cosmetic product](/usc/21/364.md?p=2). Substances that are fragrance allergens for purposes of this subsection shall be determined by the [Secretary](/usc/21/321.md?p=d) by regulation. The [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=d) shall consider international, [State](/usc/21/321.md?p=a-1), 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](/usc/21/360eee.md?p=9) by an official [State](/usc/21/321.md?p=a-1) authority to practice in the field of cosmetology, nail care, barbering, or esthetics.
  - (2) **Professional use labeling—** A [cosmetic product](/usc/21/364.md?p=2) introduced into [interstate commerce](/usc/21/321.md?p=b) and intended to be used only by a professional shall bear a [label](/usc/21/321.md?p=k) that—
    - (A) contains a clear and prominent statement that the [product](/usc/21/360eee.md?p=13) shall be administered or used only by [licensed](/usc/21/360eee.md?p=9) professionals; and
    - (B) is in conformity with the requirements of the [Secretary](/usc/21/321.md?p=d) for [cosmetics](/usc/21/321.md?p=i) [labeling](/usc/21/321.md?p=m) under this chapter and [section 1453(a) of title 15](/usc/15/1453.md?p=a).

## Source credit

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

## 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.