PRIA Logo™
Title 21 — Food and DrugsRelease 119-73not60

§364h Small Businesses

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter VI— COSMETICS › § 364h

Last updated Apr 5, 2026|Official source

Summary

If a person or business in charge of cosmetics, or the owner/operator of a facility, had average U.S. gross sales of those cosmetics under $1,000,000 for the past three years (adjusted for inflation) and they do not make or process the products, they are treated as small businesses and are not subject to the rules in sections 364b or 364c. The exemption does not apply if they manufacture or process products that regularly touch the eye’s mucous membrane, are injected, are for internal use, or are meant to change appearance for more than 24 hours in normal use when consumers do not remove them.

Full Legal Text

Title 21, §364h

Food and Drugs — Source: USLM XML via OLRC

(a)Responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of the cosmetic products described in subsection (b), shall be considered small businesses and not subject to the requirements of section 364b or 364c of this title.
(b)The exemptions under subsection (a) shall not apply to any responsible person or facility engaged in the manufacturing or processing of any of the following products:
(1)Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
(2)Cosmetic products that are injected.
(3)Cosmetic products that are intended for internal use.
(4)Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 364h

Title 21 — Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60