Find out whether your cosmetic brand or factory must register with FDA, list products, or qualifies for the small business exemption — and what every brand selling in the U.S. still has to do.
Start the Free Checker → See the RulesThe Modernization of Cosmetics Regulation Act of 2022 (MoCRA) gave FDA new powers over cosmetics sold in the United States. Facility registration and product listing have been enforced since July 1, 2024, and the rules continue through 2027.
| Requirement | Who | How often | Small business exempt? |
|---|---|---|---|
| Facility registration | Factories that manufacture or process cosmetics for the U.S. (foreign ones need a U.S. Agent) | Renew every 2 years | Yes, unless higher-risk products |
| Product listing | The Responsible Person (the brand on the label) | Update every year | Yes, unless higher-risk products |
| Label: U.S. contact for adverse events | Every cosmetic sold in the U.S. | On every label | No |
| Serious adverse event reports | The Responsible Person | Within 15 business days of learning of one | No |
| Safety substantiation records | The Responsible Person | Kept for each product | No |
"Higher-risk" products remove the small business exemption: products that regularly contact the eye area, injected products, products for internal use, and products meant to change appearance for more than 24 hours that the consumer does not remove.
If your average yearly U.S. sales of cosmetic products over the last three years are under $1 million, you do not have to register a facility or list products with FDA — as long as you do not make any of the higher-risk products above. The exemption does not cover labeling, adverse event reporting or safety records, so every brand still needs a compliant label.
More detail: Is your cosmetics business exempt from MoCRA?
$300 for 1 year or $450 for 2 years. Includes the registration and U.S. Agent service for foreign factories.
$150 per product, filed under the Responsible Person.
$250. Ingredient list, net quantity, warnings, claims and the U.S. adverse event contact.
$100. The FDA facility identifier needed for registration, if you don't have one.
FDA charges no fee for cosmetic registration or listing.
If you manufacture or process cosmetics sold in the U.S., your facility must be registered with FDA and the registration renewed every two years. If your name is on the label (the Responsible Person), each product must be listed with FDA and the listing updated every year. These rules continue in 2027. Small businesses with under $1 million in average yearly U.S. cosmetic sales are exempt from registration and listing unless they make certain higher-risk products.
Businesses whose average gross annual U.S. sales of cosmetic products over the previous three years are under $1,000,000 (adjusted for inflation) do not have to register facilities or list products. The exemption does not apply if they make products that regularly contact the eye area, injected products, products for internal use, or products meant to change appearance for more than 24 hours that the consumer does not remove.
Yes. Small businesses still need a compliant label, including a U.S. address, phone number or website for adverse event reports, must report serious adverse events to FDA, and must keep records showing their products are safe.
The Responsible Person is the manufacturer, packer or distributor whose name appears on the cosmetic product label. The Responsible Person lists products with FDA, handles adverse event reports and keeps safety records.
Yes. Foreign facilities that manufacture or process cosmetics for the U.S. must name a U.S. Agent when registering with FDA.
Products such as sunscreen, anti-dandruff shampoo and acne treatments are regulated as over-the-counter drugs in the U.S. They follow FDA's drug establishment registration and drug listing rules instead of MoCRA registration.
FDA charges no fee. Orionex charges $300 for cosmetic facility registration with one year of U.S. Agent service, or $450 for two years; $150 per product listing; $100 for an FEI number request; and $250 for a cosmetic label review.
Send us your product list and we will tell you exactly what MoCRA requires — free, within one business day.
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