Are Hair Products Regulated by the FDA?
This guide covers exactly how FDA classifies each type of hair product, what MoCRA requires for cosmetic hair brands, what OTC drug compliance looks like for anti-dandruff and hair loss products, and the specific hair product categories that have unique FDA considerations.
Which FDA Category Does Your Hair Product Fall Into?
The determining factor is intended use — what the product claims to do on its label and in its marketing. A product's physical form (liquid, cream, spray) does not determine its classification. A shampoo bottle can be a cosmetic or an OTC drug depending entirely on what claims appear on the label.
| Product | Classification | FDA Framework | Key Requirements |
|---|---|---|---|
| Shampoo (cleansing only) | Cosmetic | MoCRA / 21 CFR Part 701 | Facility registration, product listing, INCI labeling, safety substantiation |
| Conditioner, hair mask, hair oil | Cosmetic | MoCRA / 21 CFR Part 701 | Facility registration, product listing, INCI labeling, safety substantiation |
| Styling products (gel, mousse, spray, wax) | Cosmetic | MoCRA / 21 CFR Part 701 | Facility registration, product listing, INCI labeling |
| Hair color / hair dye | Cosmetic | MoCRA / 21 CFR Part 701 | Facility registration, product listing; coal tar dyes require caution statement + patch test directions |
| Chemical relaxers, keratin treatments | Cosmetic | MoCRA / 21 CFR Part 701 | Facility registration, product listing; formaldehyde-releasing products subject to FDA safety alerts |
| Dry shampoo, leave-in conditioner | Cosmetic | MoCRA / 21 CFR Part 701 | Facility registration, product listing, INCI labeling |
| Anti-dandruff shampoo | OTC Drug | 21 CFR Part 358 Subpart H | Drug Establishment Registration, drug listing (SPL), Drug Facts label, monograph compliance |
| Minoxidil hair loss treatment | OTC Drug | OTC Monograph / 21 CFR Part 172 | Drug Establishment Registration, drug listing (SPL), Drug Facts label, monograph compliance |
| Scalp psoriasis / seborrheic dermatitis treatment | OTC Drug | 21 CFR Part 358 Subpart H | Drug Establishment Registration, drug listing (SPL), Drug Facts label, monograph compliance |
| Lice treatment (pediculicide) | OTC Drug | OTC Monograph | Drug Establishment Registration, drug listing, Drug Facts label |
| Anti-dandruff + conditioning shampoo | Both | MoCRA + 21 CFR Part 358 | Both cosmetic and drug requirements apply simultaneously |
What MoCRA Requires for Cosmetic Hair Product Brands
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded FDA's authority over cosmetics — including hair care products. Most hair brands entering the U.S. market will primarily need to address these MoCRA requirements:
OTC Drug Requirements for Anti-Dandruff and Hair Loss Products
Hair products that make drug claims require a completely separate set of FDA compliance steps beyond MoCRA. The OTC drug pathway for hair products is governed primarily by FDA's monograph system — particularly the Dandruff, Seborrheic Dermatitis, and Psoriasis monograph at 21 CFR Part 358 Subpart H.
Permitted Active Ingredients for Anti-Dandruff Products
Only the following active ingredients at the specified concentrations are permitted in OTC anti-dandruff shampoos under the FDA monograph:
Zinc Pyrithione
0.3–2% in a shampoo formulation. The most common active ingredient in OTC anti-dandruff shampoos. Also permitted in non-rinse-off products.
Selenium Sulfide
1% in a shampoo formulation. Effective for dandruff and seborrheic dermatitis. Higher concentrations (2.5%) require a prescription.
Salicylic Acid
1.8–3% in a shampoo formulation. Works by loosening and removing dandruff flakes. Also permitted in scalp treatments.
Coal Tar
0.5–5% in a shampoo formulation. Effective for dandruff, seborrheic dermatitis, and scalp psoriasis. Subject to the coal tar hair dye caution statement provision if also used as a colorant.
OTC Drug Registration Requirements for Hair Products
Manufacturers of anti-dandruff shampoos, minoxidil products, and other OTC drug hair care items must complete:
Drug Establishment Registration
All facilities that manufacture, pack, or relabel OTC drug hair products must register with FDA as drug establishments. Foreign facilities must designate a U.S. Agent for drug purposes — separate from any MoCRA cosmetic U.S. Agent. Annual renewal between October 1 and December 31.
Drug Listing (SPL Format)
Each OTC drug hair product must be individually listed with FDA in Structured Product Labeling (SPL) format. The listing includes the product's active ingredients, concentrations, labeling, and packaging information. Drug listings must be updated when formulations or labeling change.
Drug Facts Labeling
OTC drug hair products must carry a Drug Facts panel under 21 CFR Part 201.66. Required sections include: active ingredient and purpose; uses; warnings (including "when not to use," stop use instructions); directions; other information; and inactive ingredients. A cosmetic ingredient list is not a substitute for a Drug Facts panel.
OTC Monograph Compliance
The product's formulation, active ingredient(s), and labeling claims must conform to the applicable OTC monograph. Using an active ingredient not listed in the monograph, or using a listed ingredient outside its permitted concentration range, requires either a New Drug Application (NDA) or a petition to amend the monograph.
Hair Product Categories With Unique FDA Considerations
Coal Tar Hair Dyes — Unique Statutory Exemption
Coal tar hair dyes occupy a unique regulatory position. Under 21 U.S.C. § 361(a), coal tar hair dyes are exempt from FDA's cosmetic adulteration provisions — meaning FDA cannot declare them adulterated solely on the basis of their coal tar content — provided the label bears a caution statement warning users about potential skin irritation and includes adequate directions for conducting a preliminary patch test. This exemption does not remove coal tar hair dyes from MoCRA registration, product listing, or other labeling requirements. It only provides a specific carve-out from one provision of the adulteration rules. Manufacturers of coal tar hair dyes must include the required caution statement and patch test directions on every product label.
Chemical Relaxers and Formaldehyde-Releasing Treatments
Chemical relaxers (both lye/sodium hydroxide and no-lye/guanidine formulations) and keratin smoothing treatments are regulated as cosmetics. However, FDA has issued specific safety alerts regarding formaldehyde in keratin hair smoothing products. Products that release formaldehyde during application — including products labeled as "formaldehyde-free" that contain formaldehyde-releasing ingredients like methylene glycol — have been the subject of FDA warnings due to inhalation and contact exposure risks.
Manufacturers of keratin treatments and hair smoothing products should review FDA's guidance on formaldehyde in cosmetics and ensure their safety substantiation addresses formaldehyde release during intended use conditions. Hair straightening products marketed to or used by minors have also received heightened attention from FDA in recent years.
Minoxidil — The OTC Hair Regrowth Drug
Minoxidil is the only active ingredient for hair regrowth that FDA has approved under the OTC monograph framework for consumer use. Minoxidil 2% is approved for both men and women; minoxidil 5% solution and foam is approved for men. Products marketed for hair regrowth with minoxidil at these concentrations must comply with Drug Establishment Registration, drug listing, and the applicable OTC monograph — including the Drug Facts label with specific use instructions and the required warning about discontinuation. Minoxidil at concentrations outside the monograph range, or combined with other claimed active ingredients for hair growth, may not qualify for the OTC monograph pathway and could require an NDA.
Hair Products With Drug Claims — Even If Cosmetic Ingredients
A product that contains only cosmetic ingredients can still be regulated as a drug if its labeling makes drug claims. "Treats dandruff," "stimulates hair follicles," "clinically proven to regrow hair" — these are drug claims that trigger drug registration requirements regardless of what ingredients are actually in the product. Claims language must be reviewed before label artwork is finalized.
Strengthening / Repairing Claims — Cosmetic or Drug?
"Strengthens hair," "repairs damage," "rebuilds hair structure" — these are generally cosmetic claims about appearance. But "regenerates hair follicles," "stimulates scalp cell growth," or "reverses hair loss" cross into drug claim territory because they describe an effect on the body's physiological processes. The line between cosmetic and drug claims is judgment-intensive and should be reviewed by a regulatory specialist before launch.
Get Your Hair Product Fully FDA-Compliant
FDA Registration Assistance handles MoCRA cosmetic facility registration and product listing, Drug Establishment Registration, OTC drug listing, U.S. Agent services, INCI labeling review, Drug Facts panel review, and claims classification — for hair care brands worldwide.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. 1,000+ clients. 135+ countries. 15+ years of FDA regulatory experience.
Frequently Asked Questions — FDA Regulation of Hair Products
1. Are hair products regulated by the FDA?
Yes. All hair products sold in the United States are FDA-regulated. Most — shampoos, conditioners, styling products, hair color — are regulated as cosmetics under MoCRA. Hair products with drug claims (anti-dandruff, hair regrowth) are regulated as OTC drugs with additional Drug Establishment Registration requirements.
2. What makes a hair product a cosmetic vs. an OTC drug?
Intended use as stated in labeling and marketing. A hair product is a cosmetic when it cleanses, conditions, styles, colors, or beautifies hair. It is an OTC drug when it treats or prevents a disease or condition (dandruff, hair loss, scalp psoriasis) or affects the body's structure or function. The same shampoo formula becomes an OTC drug when "treats dandruff" appears on the label.
3. Do hair product companies need to register with FDA under MoCRA?
Yes. Under MoCRA, all facilities manufacturing or processing cosmetic hair products for U.S. distribution must register with FDA annually through the Cosmetics Direct portal. Each product must also be individually listed. Foreign facilities must designate a U.S. Agent.
4. Do anti-dandruff shampoos require OTC drug registration?
Yes. Anti-dandruff shampoos are OTC drugs under 21 CFR Part 358 Subpart H. Permitted active ingredients include zinc pyrithione (0.3–2%), selenium sulfide (1%), salicylic acid (1.8–3%), coal tar (0.5–5%), and pyrithione zinc (1–2%). Manufacturers must complete Drug Establishment Registration, drug listing in SPL format, OTC monograph compliance, and Drug Facts labeling.
5. Is minoxidil-based hair loss treatment an OTC drug?
Yes. Minoxidil topical products for hair regrowth are OTC drugs. Minoxidil 2% is permitted for men and women; 5% solution and foam for men. Manufacturers need Drug Establishment Registration, drug listing, OTC monograph compliance, and Drug Facts labeling. Minoxidil outside the monograph concentration range requires an NDA.
6. What FDA labeling is required for cosmetic hair products?
Under 21 CFR Part 701: product identity on the Principal Display Panel; net quantity; manufacturer/distributor name and address; complete ingredient list in descending order using INCI nomenclature; and required warnings. Labels must be in English. Non-INCI ingredient names are a labeling violation.
7. What is INCI and why does it matter for hair products?
INCI — International Nomenclature of Cosmetic Ingredients — is the standardized naming system required for cosmetic ingredient declarations under 21 CFR Part 701.3. All ingredients must use their INCI name, not trade names or brand names. Using non-INCI names makes the label non-compliant and the product potentially misbranded.
8. What are the MoCRA requirements for hair product companies?
MoCRA requires: (1) annual facility registration through Cosmetics Direct; (2) individual product listing for each hair product; (3) safety substantiation for each product; (4) serious adverse event reporting within 15 business days; and (5) FDA-compliant labeling with INCI ingredient names. Records must be maintained for FDA inspection.
9. What is the MoCRA adverse event reporting requirement for hair products?
Under MoCRA, serious adverse events associated with cosmetic hair products must be reported to FDA within 15 business days of receiving the report. Serious adverse events include death, life-threatening experiences, inpatient hospitalization, disability, or significant disfigurement. For hair products, chemical burns, severe allergic reactions, or injuries meeting this threshold must be reported. Annual aggregate safety reports are also required.
10. Are hair dyes and hair color products FDA-regulated?
Yes — as cosmetics subject to MoCRA. Coal tar hair dyes have a unique exemption under 21 U.S.C. § 361(a) from FDA's adulteration provisions, provided the label includes a caution statement and patch test directions. This exemption does not remove coal tar hair dyes from MoCRA registration, product listing, or INCI labeling requirements.
11. Do chemical relaxers and keratin treatments have special FDA requirements?
They are regulated as cosmetics under MoCRA. However, formaldehyde-releasing keratin treatments have been the subject of FDA safety alerts. Products releasing formaldehyde — even those labeled "formaldehyde-free" that contain methylene glycol — may pose health risks. Manufacturers should review FDA's formaldehyde guidance and address formaldehyde release in their safety substantiation.
12. What is the Drug Facts label and when is it required?
The Drug Facts label is required on all OTC drug hair products under 21 CFR Part 201.66. It must include active ingredients and purpose; uses; warnings; directions; other information; and inactive ingredients. Cosmetic hair products use an INCI ingredient list — not a Drug Facts panel. Products needing both cosmetic and drug labeling must satisfy requirements for both formats.
13. Do foreign hair product manufacturers need a U.S. Agent?
Yes — in potentially two separate ways. For cosmetic hair products under MoCRA, a U.S. Agent is required for facility registration. For OTC drug hair products, a separate U.S. Agent for Drug Establishment Registration is also required. A company making both cosmetic and OTC drug hair products may need U.S. Agent designations under both systems.
14. Is a hair product a drug if it says it "strengthens" or "repairs" hair?
Generally no — strengthening and repairing claims typically refer to cosmetic effects on appearance. But claims suggesting the product affects living scalp cells, permanently alters hair biology, or treats hair loss cross into drug territory. The distinction is between affecting the appearance of hair (cosmetic) and affecting the body's physiological processes (drug).
15. What hair products are classified as OTC drugs?
OTC drug hair products include: anti-dandruff shampoos with zinc pyrithione, selenium sulfide, salicylic acid, or coal tar at monograph concentrations; minoxidil topical products for hair regrowth; scalp seborrheic dermatitis and psoriasis treatments; and pediculicide (lice treatment) products. The classification is determined by the active ingredient and the claims on the label.
16. What is safety substantiation and is it required for hair products?
Safety substantiation is MoCRA's requirement to maintain adequate evidence of safety for each cosmetic product under reasonably foreseeable conditions of use. For hair products, this means ingredient safety documentation, formulation testing results, and any relevant clinical or consumer safety testing. Records must be available to FDA upon request during inspections.
17. Do hair products need to be tested before going to market?
FDA does not require pre-market approval or specific mandated testing for cosmetic hair products. However, MoCRA's safety substantiation requirement means manufacturers must have adequate safety evidence before distributing. For OTC drug hair products, the applicable OTC monograph specifies ingredient, concentration, and labeling requirements that must be met before marketing — without a separate pre-market submission for monograph-compliant products.
18. What happens if a hair product is sold without MoCRA registration?
Selling without completing MoCRA facility registration or product listing is a prohibited act under the FDCA. FDA can issue warning letters, refuse imported products at the port, and seek injunctions. Imported hair products from unregistered facilities may be detained or refused at U.S. ports of entry.
19. Are hair care tools and devices regulated by FDA?
Standard hair tools — straightening irons, dryers, curling irons — are regulated by CPSC, not FDA. They are not FDA products unless they make therapeutic claims (e.g., treating scalp conditions or stimulating hair growth), which could classify them as medical devices subject to FDA Device Establishment Registration and 510(k) review.
20. Do professional-use-only hair products have different FDA requirements?
No. FDA does not have a separate regulatory pathway for professional salon products. The same MoCRA registration, product listing, labeling, and safety requirements apply to professional hair products. Professional formulations may have different ingredient concentrations that in some cases affect the cosmetic vs. drug classification.
21. What is the Cosmetics Direct portal?
Cosmetics Direct is FDA's online portal for MoCRA cosmetic facility registration and product listing. All facilities manufacturing or processing cosmetic hair products for U.S. distribution must register through this portal, and each product must be individually listed.
22. Are hair products that are both cosmetics and drugs subject to both sets of requirements?
Yes. A product that is both cosmetic and drug — like an anti-dandruff plus conditioning shampoo — must comply with MoCRA facility registration and product listing and Drug Establishment Registration and drug listing. Both cosmetic ingredient labeling and Drug Facts labeling requirements must be satisfied. FDA does not provide a combined pathway for dual-category products.
23. What is the coal tar hair dye exemption?
Under 21 U.S.C. § 361(a), coal tar hair dyes are exempt from FDA's cosmetic adulteration provisions if the label includes a caution statement about skin irritation and adequate directions for a patch test. This does not remove them from MoCRA, ingredient listing, or other labeling requirements — it only exempts them from one specific adulteration provision. The caution statement and patch test directions must appear on every coal tar hair dye label.
24. Can FDA Registration Assistance handle both MoCRA and OTC drug compliance for hair brands?
Yes. FDA Registration Assistance provides complete compliance for hair care brands across both categories — MoCRA facility registration and product listing, U.S. Agent services, INCI labeling review, Drug Establishment Registration, SPL drug listing, OTC monograph compliance review, and Drug Facts panel review. 1,000+ clients. 135+ countries.
25. What are the most common FDA compliance mistakes for hair product brands?
Most common mistakes: failing to complete MoCRA facility registration and product listing before distribution; using non-INCI ingredient names on cosmetic labels; making drug claims on cosmetic products without completing drug registration; omitting a Drug Facts panel on anti-dandruff shampoos; using active ingredient concentrations outside the monograph-permitted range; failing to report serious adverse events within 15 business days; and not updating product listings when formulations change.
