The two MoCRA requirements
- Facility registration: every facility, in the U.S. or abroad, that manufactures or processes cosmetics for U.S. distribution must register with FDA and renew every two years. Facilities outside the U.S. must name a U.S. Agent.
- Product listing: the Responsible Person, the company whose name is on the label, must list each cosmetic product with FDA, including its ingredients, and update the listing every year. See our product listing guide.
The facility and the Responsible Person can be different companies. A brand owner that uses a contract manufacturer lists the products; the manufacturer registers its facility.
Who does not need to register
| You only label, relabel, pack, repack, store or distribute cosmetics | Facility registration is generally not required. |
|---|---|
| Beauty salons, spas and retailers that do not make cosmetics | Generally exempt from registration and listing. Making your own branded products changes this. |
| Qualifying small businesses | Exempt from registration and listing, unless they make the higher-risk products listed below. |
| Products regulated as drugs, such as sunscreens | Follow FDA drug rules instead. See cosmetic or drug? |
The small-business exemption
A business generally qualifies if its average gross annual sales of cosmetic products in the U.S. over the previous three years are less than $1 million, adjusted for inflation. No application is needed, but keep sales records that show you qualify.
The exemption does not apply if you make or process any of these products:
- Products that regularly come into contact with the mucous membrane of the eye, such as mascara and eyeliner
- Injected products
- Products intended for internal use
- Products meant to change appearance for more than 24 hours where removal by the consumer is not part of normal use, such as some hair and lash dyes
Deadlines
- New facilities register within 60 days of starting to make or process cosmetics for the U.S.
- Registration is updated within 60 days of a change, such as a new address or U.S. Agent.
- New products are listed within 120 days of going on the U.S. market.
Questions
Does FDA charge a fee for cosmetic registration?
No. FDA does not charge for MoCRA facility registration or product listing.
Does FDA approve cosmetics?
No. FDA does not approve cosmetics (other than color additives) before they are sold. Registration and listing do not mean FDA approval.
Does FDA issue a registration certificate for cosmetics?
No. FDA does not issue certificates. Regovant gives you a certificate of registration for your records, which buyers can verify online.
How Regovant can help
Regovant LLC registers cosmetic facilities under MoCRA, lists your products and acts as your U.S. Agent. Facility registration with U.S. Agent service is $369 per year, product listing is $269 per product and a cosmetic label review is $369 per product. See the cosmetics service, all guides or prices.