The short answer
Hair dyes have a special place in US law. Most coal-tar hair dyes are exempt from color additive approval — but only if the label carries FDA's caution statement and patch-test directions. Plus the normal MoCRA steps:
| 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 |
| Caution statement + patch test | Required on coal-tar hair dyes for the exemption to apply | 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 |
The coal-tar hair dye exemption
Under the FD&C Act, coal-tar hair dyes — which include most permanent and many semi-permanent dyes — do not need FDA approval as color additives, if:
- 1The label carries the caution statement“Caution — This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”
- 2The package includes skin-test directionsDirections for a preliminary (patch) test before each use.
Without these, FDA can take action against the product. The exemption does not cover other harmful ingredients in the product.
Plant and mineral dyes
Dyes that are not coal-tar dyes must be approved color additives listed for hair use. FDA names henna and bismuth citrate as approved for hair dyeing. Henna is approved for hair only — not for direct skin use such as body art. Lead acetate is no longer approved for hair dyes.
Eyelash and eyebrow dyes
Coal-tar dyes must never be used on eyelashes or eyebrows. A color additive needs specific FDA approval for that use. FDA's color additive fact sheet lists silver nitrate as approved only for professional eyebrow and eyelash dyeing, at up to 4%. Kits sold to consumers for lash tinting are a frequent compliance problem.
Other label points
- Ingredient list in descending order, using US ingredient names.
- Directions for use and any other warnings needed for safe use.
- Name and place of business, net quantity, and a contact for adverse event reports.
Example
A hair color brand in Italy registers its factory under MoCRA, lists each shade, and prints the full caution statement on every box with a separate patch-test leaflet. Its henna line is labeled for hair only, and it does not sell its salon lash tint to consumers.
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 hair dye 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
- Caution statement printed exactly; patch-test directions included
- Non-coal-tar dyes are approved color additives for hair
- No consumer eyelash or eyebrow dye unless the color is approved for that use
- MoCRA facility registration and product listing done
- Safety records and adverse event process in place
Tell us your products — we send your MoCRA and FDA requirements in writing, free.
Frequently asked questions
Do hair dyes need FDA approval?
Coal-tar hair dyes (most permanent and many semi-permanent dyes) do not need FDA approval, but only if the label carries FDA’s caution statement and directions for a skin test. Dyes from plant or mineral sources, such as henna, must be approved color additives.
What is the required hair dye caution statement?
The label must say, in substance: “Caution — This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.” Copy the exact wording from FDA’s hair dye page.
Can I sell a dye for eyelashes or eyebrows?
Only with a color additive approved for that use. Coal-tar hair dyes must not be used on eyelashes or eyebrows. FDA’s color additive fact sheet lists silver nitrate as approved only for professional eyebrow and eyelash dyeing, at up to 4%.
Is henna allowed in the US?
Henna (from the Lawsonia plant) is approved only for coloring hair. It is not approved for direct application to the skin, such as body art. “Black henna” products are a known safety concern.
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 — Hair Dyes (content current as of Sept 25, 2025)
- FDA — Color Additives and Cosmetics: Fact Sheet
Dates, fees and regulation numbers checked against FDA and Federal Register sources on November 8, 2026. This article is general information, not legal advice.