Can Your Scalp Serum
Say It Grows Hair?
No. In the US, the claim decides whether a scalp product is a cosmetic or a drug. “Grows hair,” “stops hair loss,” “anti-dandruff” and “relieves itching” are drug claims. “Cleanses,” “conditions,” “exfoliates buildup,” “cooling feel” and “hair looks fuller” are cosmetic claims. Below: why, with a word-by-word table and sources.
By LuxeFormula Labs · October 1, 2026 · 7 min read
Why the claim, not the ingredient, decides
The Federal Food, Drug, and Cosmetic Act defines products by their intended use. A cosmetic is meant to cleanse, beautify or change appearance. A drug is meant to treat or prevent disease, or to affect the structure or function of the body. FDA judges intended use mostly by what you say — on the label, on your website, in your Amazon listing and on social media.
That's why the same rosemary scalp oil can be a cosmetic for one brand and an unapproved drug for another. One says “a nourishing pre-wash massage oil.” The other says “rosemary oil regrows hair.”
Hair growth and hair loss: always a drug claim
FDA's regulation at 21 CFR 310.527 says there is a lack of data to establish that any ingredient is generally recognized as safe and effective for over-the-counter use as a hair grower or for hair-loss prevention. In practice, an OTC product claiming either needs FDA approval as a new drug — topical minoxidil is the familiar example. Words that trigger this include “grows,” “regrows,” “thickens hair density,” “boosts follicles,” “prevents shedding,” and “blocks DHT.”
Dandruff: an OTC drug with its own rulebook
Anti-dandruff products are over-the-counter drugs covered by FDA's monograph for dandruff, seborrheic dermatitis and psoriasis (M032). They must use listed active ingredients — such as pyrithione zinc, salicylic acid, selenium sulfide, coal tar or sulfur — at set concentrations, carry a Drug Facts panel, and be made in a drug-registered facility. A cosmetic scrub can contain an exfoliant, but it cannot promise to control dandruff.
Itch, inflammation and microbes
“Relieves itchy scalp,” “calms inflammation,” “antifungal” and “antibacterial” all describe treating a condition or killing microbes on the body, which are drug uses. Describe the experience instead: a cooling, refreshing feel, or a scalp that feels clean.
The wording table
| Claim | Category | |
|---|---|---|
| “Cleanses, purifies the feel, removes buildup” | ✓ | Cosmetic |
| “Hydrates, conditions, nourishes the scalp” | ✓ | Cosmetic |
| “Exfoliates; lifts away flakes of product residue” | ✓ | Cosmetic — avoid tying “flakes” to dandruff |
| “Cooling, tingling, refreshing feel” | ✓ | Cosmetic |
| “Hair looks thicker, fuller, shinier” | ✓ | Cosmetic — describes appearance |
| “Strengthens hair against breakage from brushing” | ✓ | Cosmetic if about the hair fiber, not growth |
| “Promotes hair growth; regrows hair; boosts follicles” | ✕ | Drug — 21 CFR 310.527 |
| “Stops, prevents or reduces hair loss; blocks DHT” | ✕ | Drug — 21 CFR 310.527 |
| “Anti-dandruff; controls seborrheic dermatitis or psoriasis” | ✕ | OTC drug — monograph M032 |
| “Relieves itching; soothes irritation; anti-inflammatory” | ✕ | Drug — treats a condition |
| “Antibacterial; antifungal; kills microbes on the scalp” | ✕ | Drug |
| “Works like minoxidil; clinically proven to grow hair” | ✕ | Drug claim, and comparative claims need evidence |
Trending ingredients are fine — trending claims often aren't
Rosemary, caffeine, peptides, biotin, niacinamide and peppermint all appear in cosmetic scalp products. Use them, name them, and describe what the product does cosmetically. Keep fragrance components such as essential oils within IFRA limits, and remember that marketplaces apply their own policies to drug-style claims too.
Scrubs: no plastic microbeads
The Microbead-Free Waters Act bans plastic microbeads in rinse-off cosmetics in the US. Scalp scrubs use sea salt, sugar, jojoba esters or other non-plastic exfoliants.
MoCRA basics for scalp care brands
Under the Modernization of Cosmetics Regulation Act, the responsible person — usually the brand named on the label — lists each product with FDA, keeps records that support its safety, reports serious adverse events, and puts US contact information on the label. The facility that makes it must be registered. For more, see our MoCRA guide and FDA requirements overview.
A five-point check before you approve a label
- Does any word promise growth, less shedding or thicker density? Rewrite to appearance.
- Does it mention dandruff, seborrheic dermatitis or psoriasis? Remove, unless you're making an OTC drug.
- Does it treat itch, irritation, inflammation, bacteria or fungus? Describe feel instead.
- Do the product page, Amazon listing and social posts say the same thing as the label?
- Can you back up every performance claim with evidence?
Scalp Claims
Questions
Sources
- FDA — Is it a cosmetic, a drug, or both? (or is it soap?)
- 21 CFR 310.527 — OTC hair grower and hair-loss prevention drug products
- FDA OTC Monograph M032 — dandruff, seborrheic dermatitis and psoriasis
- FDA — Microbead-Free Waters Act FAQs
- FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
General information, not legal advice. Have your final label and marketing reviewed for your markets.