The short answer
A hair serum, scalp tonic or hair oil is a cosmetic if it only makes hair look thicker, fuller or shinier. It becomes a drug as soon as it claims to grow hair, regrow hair or stop hair loss — because that affects the structure or function of the body.
And the drug route is narrow. FDA’s 1989 final rule (21 CFR 310.527) says no ingredient in an OTC external hair grower or hair loss product is generally recognized as safe and effective — including biotin, amino acids, jojoba oil and topical hormones. Outside FDA-approved products such as minoxidil, there is no monograph to follow.
Claims: cosmetic or drug?
| Claim | Usually |
|---|---|
| “Thicker-looking, fuller-looking hair” | Cosmetic |
| “Reduces breakage”, “strengthens hair against damage” | Cosmetic (appearance and condition of the hair shaft) |
| “Nourishes and conditions the scalp” | Cosmetic |
| “Promotes hair growth”, “regrows hair”, “new hair in 8 weeks” | Drug |
| “Stops hair loss”, “prevents thinning”, “anti-hair fall” (meaning fewer hairs shed from the scalp) | Drug |
| “Activates hair follicles”, “blocks DHT” | Drug |
| “Treats dandruff” | OTC drug (dandruff monograph) |
What 21 CFR 310.527 means for brands
- The rule covers OTC drug products for external use as hair growers or for hair loss prevention.
- It lists ingredients that had been marketed for these uses — among them amino acids, biotin, estradiol and other topical hormones, jojoba oil, lanolin, nucleic acids, sulfur and urea — and finds that none can be considered generally recognized as safe and effective for that use.
- Products initially introduced after January 8, 1990 that make these claims without FDA approval are subject to regulatory action.
- So a hair growth product needs an approved new drug application (or an approved generic, as with minoxidil) — not just drug registration.
Two routes
- 1Stay a cosmeticUse appearance claims only. Register the facility and list the product under MoCRA, keep safety records, and add a U.S. contact to the label. Review every claim on every channel.
- 2Sell an approved drugA minoxidil product made under an approved application needs drug establishment registration, an NDC, drug listing and a Drug Facts label that matches the approved labeling. See NDC numbers for OTC drugs.
Example: a scalp serum brand from Japan
A Japanese brand sells a rice-protein scalp serum that is marketed at home for hair loss. For the U.S. it changes the name to “Volumizing Scalp Serum”, uses “for fuller-looking hair” and “helps reduce breakage from brushing”, and removes before-and-after photos from its U.S. store. The serum is then a cosmetic: the factory is registered under MoCRA, the product is listed and the label has a U.S. contact. Its separate minoxidil foam, made under an approved application by a partner, goes through drug registration and listing instead.
Cosmetics label review with drug-claims check $250. Cosmetic facility registration with U.S. Agent from $300 (1 year) or $450 (2 years). Product listing $150 per product.
Frequently asked questions
Can a cosmetic hair serum claim to grow hair?
No. Hair growth and hair loss prevention claims make the product a drug, and FDA has found no OTC ingredient generally recognized as safe and effective for those uses.
Is biotin hair serum a drug?
If it claims to grow hair or stop hair loss, yes — and biotin is one of the ingredients listed in 21 CFR 310.527. If it only claims fuller-looking or stronger-feeling hair, it can be a cosmetic.
Is “anti-hair fall” a drug claim?
If it means less hair shed from the scalp, it is a hair loss claim and so a drug claim. “Reduces breakage” of the hair shaft is usually a cosmetic claim.
What about minoxidil?
Minoxidil products sold over the counter are FDA-approved drugs. They need drug establishment registration, an NDC, drug listing and Drug Facts labeling that matches the approval.
Sources
- 21 CFR 310.527 — OTC hair growers and hair loss prevention products
- FDA — Rulemaking history: OTC hair growth and loss drug products (54 FR 28772, July 7, 1989)
- FDA — Is it a cosmetic, a drug, or both? (Or is it soap?)
Requirements checked on November 11, 2026. This article is general information, not legal advice.