Cosmetic or drug in the US: how FDA decides
FDA classifies a product by intended use: cleanse and beautify is a cosmetic; treat, prevent disease, or affect body structure or function is a drug (FD&C Act §201). The claims you make decide the category.
Short answer: FDA decides between cosmetic and drug by intended use — what the product claims to do. Cleanse, beautify, promote attractiveness: cosmetic (FD&C Act §201(i)). Treat or prevent disease, or affect the structure or function of the body: drug (FD&C Act §201(g)). Some products are both, and must satisfy both sets of rules.
The decision table
| Claim on the product | Category |
|---|---|
| Moisturizes, cleanses, perfumes | Cosmetic |
| Makes skin look smoother | Cosmetic |
| “Treats acne” | Drug |
| “Protects against sunburn” (SPF) | Drug (OTC sunscreen) |
| “Controls dandruff” | Drug (OTC anti-dandruff) |
| “Boosts collagen production” | Risky — a structure/function style claim |
| Shampoo that cleans, with drug claims on the dandruff version | Both, as separate products |
How intent is established
Intended use comes from what the product says and implies — the label, website copy, social posts, and even the product's name. The ingredient list does not decide it: the same salicylic acid is a cosmetic exfoliant in one bottle and an OTC acne drug ingredient in another. A product can also be a cosmetic and a drug at the same time (a moisturizing shampoo marketed to control dandruff), in which case it must comply with both regimes.
One edge case: a product meeting FDA's definition of true soap (the bulk of it made of alkali-salt fatty material, labeled only as soap) may be regulated as a consumer product rather than as either category — the FDA page linked below spells out that test.
Common mistakes
- Reviewing the label but not the Amazon listing, where drug-claim language often creeps in.
- Assuming “clinically proven” is safe. “Clinically proven to reduce the appearance of fine lines” is a cosmetic appearance claim; “clinically proven to boost collagen” is a structure/function claim.
- Treating SPF as a claim flavor. An SPF number makes the product an OTC drug in the US.
- Importing EU wording. The EU has no cosmetic/drug split in the same form — EU-compliant claims can still be US drug claims.
Sources
- FD&C Act §201(g) (drug) and §201(i) (cosmetic), intended-use definitions — fda.gov, “Is It a Cosmetic, a Drug, or Both?”
- FDA, MoCRA overview (what being a cosmetic still requires) — fda.gov
- 21 CFR 701.3, ingredient designation — eCFR, issue 2026-11-06
Last verified: 2026-11-10.
Not legal advice, and not a guarantee of compliance or of acceptance by any authority.
Want this checked against your own formula? Run the free label check. Type your marketing claims into the optional field and the check flags the ones that flip the category. It returns an issue list, not a print-ready label.
Related: “Treats acne” makes it a drug · SPF claims and Drug Facts