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Title 21, Food and DrugsRelease 119-110

§364h Small Businesses

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

Last updated Sep 22, 2026|Official source

Summary

If a cosmetic seller’s average U.S. sales were less than $1,000,000 over the previous 3-year period (adjusted for inflation), and they do not make or process the products, they are treated as a small business and do not have to follow the rules in sections 364b or 364c. But if an owner, operator, or other responsible person makes or processes cosmetics that touch the eye’s mucous membrane, are injected, are for internal use, or are meant to change appearance for more than 24 hours without the consumer removing them, those exemptions do not apply and the rules must be followed.

Full Legal Text

Title 21, §364h

Food and Drugs, Source: USLM XML via OLRC

(a)In general
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)Requirements applicable to all manufacturers and processors of cosmetics
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

Sep 22, 2026

Release point: 119-110