The short answer
Nail polish, top coats, gels, artificial nails, removers and glues are cosmetics — so the MoCRA steps apply. Products that treat nail problems, such as fungus, are drugs. The US-specific points are colors, warnings and how salon-only products are labeled.
| Requirement | What it means | Who |
|---|---|---|
| Facility registration (MoCRA) | Facilities that manufacture or process cosmetics for the US register with FDA and renew every two years | The manufacturing facility |
| Product listing | Each product is listed with its ingredients, and updated every year | The Responsible Person |
| Label | English label: identity, net quantity, ingredients in descending order, name and place of business, warnings, and a contact for adverse event reports | The brand |
| Colors + warnings | Approved colors; warnings needed for safe use; retail ingredient lists | The brand |
| Safety substantiation | Records showing the product is safe as used | The Responsible Person |
| Adverse event reporting | Serious adverse events reported to FDA within 15 business days | The Responsible Person |
Colors in nail products
All colors in cosmetics must be FDA-approved for the intended use, and certifiable colors must come from FDA-certified batches. Nail brands often have dozens of shades — check each one. See our guide to color additives.
Ingredients of concern
- Formaldehyde (formalin, methylene glycol) in some hardeners and polishes can cause irritation and allergic reactions; tosylamide/formaldehyde resin is linked to possible allergies.
- Toluene and dibutyl phthalate (DBP) have been used as solvent and plasticizer; many brands have moved away from them.
- Methyl methacrylate (MMA) monomer in artificial nails led to FDA action in the 1970s; FDA notes it is still occasionally used.
- Artificial nail removers with acetonitrile can be subject to child-resistant packaging rules (a CPSC requirement).
Salon-only vs retail
| Product | Ingredient list on the label? |
|---|---|
| Used only in salons | Not required under FDA labeling rules |
| Free samples | Not required |
| Sold at retail or online — even if marked “For professional use only” | Required |
State and local authorities license salons and nail technicians; OSHA covers worker safety in salons. FDA regulates the products themselves.
Example
A gel polish maker in China registers its factory under MoCRA and lists each product. It checks all 80 shades against FDA's color list, adds flammability and skin-contact warnings, and gives its salon kits full ingredient lists because they are also sold online.
What FDA does — and does not do — for cosmetics
FDA does not approve cosmetic products or their labels before they are sold (color additives are the exception). Registration and listing are not an approval, so never write “FDA approved” or “FDA certified” on a cosmetic label or website. Under MoCRA, the brand carries the responsibility: it must be able to show the product is safe as used, and FDA can inspect records, ask for safety information and, in serious cases, suspend a facility's registration or order a recall.
At the US border, FDA reviews imported cosmetics and can detain a shipment that appears adulterated or misbranded — for example a wrong or missing English label, an unapproved color, a prohibited ingredient or drug claims. Detained goods must be brought into compliance, exported or destroyed, so it pays to fix problems before the first shipment.
Small businesses: what MoCRA exempts
MoCRA exempts certain small businesses from facility registration, product listing and GMP. The exemption does not cover products that regularly touch the eye's mucous membrane, injected products, products for internal use, or products meant to change appearance for more than 24 hours. Labeling, safety substantiation and adverse event reporting are not on the exempt list — and many US retailers and marketplaces ask for registration and listing anyway.
Step by step: selling your nail products in the US
- 1Decide: cosmetic, drug or bothYour claims and ingredients decide it. A drug needs drug registration, listing and Drug Facts labeling.
- 2Register the manufacturing facilityUnder MoCRA, and renew every two years. Foreign facilities name a U.S. Agent.
- 3List every productThe Responsible Person lists each product with its ingredients and updates the listing every year.
- 4Make the label US-readyEnglish text, ingredient list, warnings, contact for adverse events — and the product-specific points above.
- 5Keep safety records and an adverse event processSafety substantiation on file; serious adverse events reported within 15 business days.
Checklist
- Every shade uses colors approved for that use; certified batches where required
- Needed warnings on the label (flammability, skin contact)
- Ingredient list on anything sold at retail or online
- No fungus or other treatment claims unless it is a compliant drug
- MoCRA facility registration, product listing, safety records and adverse event process
Tell us your products — we send your MoCRA and FDA requirements in writing, free.
Frequently asked questions
Are nail products cosmetics?
Most are. FDA regulates nail products for home and salon use as cosmetics. Products intended to treat medical problems such as nail fungus are drugs.
Do salon-only products need an ingredient list?
Products used only in salons and free samples do not need an ingredient list under FDA’s labeling rules. But products sold at retail — including online — need one, even if they say “For professional use only”.
Which colors can I use in nail polish?
Only color additives approved for that use. Check every shade against FDA’s list of color additives permitted in cosmetics, and buy certifiable colors from FDA-certified batches.
Is formaldehyde allowed in nail products?
FDA lists formaldehyde (also called formalin or methylene glycol) among nail product ingredients of concern because it can cause irritation and allergic reactions. Products must be safe as used, carry any warnings needed, and declare ingredients.
Who is the Responsible Person under MoCRA?
The manufacturer, packer or distributor whose name appears on the label. The Responsible Person lists the products, keeps safety records and reports serious adverse events to FDA within 15 business days.
Are small cosmetic businesses exempt from MoCRA?
Certain small businesses are exempt from facility registration, product listing and GMP — but not for products that touch the eye’s mucous membrane, injected products, products for internal use or products that change appearance for more than 24 hours. Labeling, safety records and adverse event reporting still apply.
Sources
- FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA) (content current as of Oct 29, 2026)
- FDA — Summary of Cosmetics Labeling Requirements
- FDA — Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
- FDA — Nail Care Products
- FDA — Color Additives and Cosmetics: Fact Sheet
- FDA — Color Additives Permitted for Use in Cosmetics
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.