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

# §364h. Small businesses

- (a) **In general—** [Responsible persons](/usc/21/364.md?p=4), and owners and operators of [facilities](/usc/21/364.md?p=3-A), whose average gross annual sales in the United States of [cosmetic products](/usc/21/364.md?p=2) 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](/usc/21/364.md?p=2) described in [subsection (b)](#b), shall be considered small businesses and not subject to the requirements of section [364b](/usc/21/364b.md) or [364c](/usc/21/364c.md) of this title.
- (b) **Requirements applicable to all manufacturers and processors of cosmetics—** The exemptions under [subsection (a)](#a) shall not apply to any [responsible person](/usc/21/364.md?p=4) or [facility](/usc/21/364.md?p=3-A) engaged in the manufacturing or processing of any of the following [products](/usc/21/360eee.md?p=13):
  - (1) [Cosmetic products](/usc/21/364.md?p=2) that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual.
  - (2) [Cosmetic products](/usc/21/364.md?p=2) that are injected.
  - (3) [Cosmetic products](/usc/21/364.md?p=2) that are intended for internal use.
  - (4) [Cosmetic products](/usc/21/364.md?p=2) 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.

## Source credit

(June 25, 1938, ch. 675, § 612, as added Pub. L. 117–328, div. FF, title III, § 3502, Dec. 29, 2022, 136 Stat. 5857.)

## Notes

### Statutory Notes and Related Subsidiaries

### 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.