Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VI — COSMETICS › § 361
A cosmetic is treated as unsafe and cannot be sold if it could harm people when used as the label says or in normal ways. It is unsafe if it contains poisonous stuff, is filthy or rotten, was made or packed in dirty conditions, or is stored in a poisonous container. It is also unsafe if it uses a color additive that one of the laws calls unsafe, or if it was made without following the required good manufacturing rules in section 364b. Coal‑tar hair dyes are allowed only if their label clearly warns about possible skin irritation, tells users to do a small test first, says not to use on eyelashes or eyebrows because of blindness risk, and gives test instructions. For rule purposes, “hair dye” does not include eyelash or eyebrow dyes. Finally, a cosmetic is unsafe if the product or any ingredient lacks the required proof of safety under section 364d(c).
Full Legal Text
Food and Drugs, Source: USLM XML via OLRC
Legislative History
Reference
Citation
21 U.S.C. § 361
Title 21, Food and Drugs
Last Updated
Sep 23, 2026
Release point: 119-110