Do I need to register cosmetics with the FDA?
The short answer, with the official forms and the agencies' own links.
The short answer
Under MoCRA, the facility that makes or processes the cosmetics registers it (Form FDA 5066, every two years), and the brand on the label lists each product (Form FDA 5067, updated every year). Both are free and filed in Cosmetics Direct.
The forms involved
Cosmetic product facility registration (MoCRA)
U.S. Food and Drug AdministrationUS federal
Filed online in Cosmetics Direct by the facility that makes or processes the cosmetics.
- Fee
- Free
- Filed
- Filed online
- Renews
- Every two years.
Cosmetic product listing (MoCRA)
U.S. Food and Drug AdministrationUS federal
Filed online in Cosmetics Direct by the brand (the responsible person on the label), one listing per product.
- Fee
- Free
- Filed
- Filed online
- Renews
- Update every year.
General information, not legal or tax advice. Agency requirements change; check the agency's page before you file.
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