Read My Lipstick: FDA Will Not Certify Cosmetic Facility Registration or Product Listing

As we have reported on extensively, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded the FDA’s requirements for cosmetic products, introducing facility registration, product listing, adverse event reporting, and numerous other compliance obligations.

In a statement issued last week, the FDA noted that the agency has received “an increased number of inquiries” from entities seeking official documentation confirming that their facilities are properly registered or, alternatively, that their facilities are exempt from the registration requirement. The agency further noted that certain ecommerce platforms may ask for proof of FDA facility registration or registration exemption from companies seeking to sell their products on such platforms.

As any entity that has registered a cosmetic facility or listed a cosmetic product with the FDA has already discovered, no such official documentation exists. And now, the FDA has explicitly acknowledged that it does not issue certificates, letters of good standing, verification emails, or any similar documentation confirming that an entity has complied with cosmetic product facility registration or cosmetic product listing requirements.

Companies operating in the cosmetic industry should keep in mind the following:

• Do not rely on third-party “compliance certificates.” If a supplier, contract manufacturer, or business partner presents a document purporting to be an FDA-issued certificate of compliance for cosmetic facility registration or cosmetic product listing, that document is not genuine.

• Maintain your own records. Because the FDA will not issue confirmatory documents, companies should retain their own records of facility registration submissions, including confirmation numbers, screenshots, or other evidence of successful registration through the FDA’s Cosmetics Direct portal.

• International trade considerations. Companies exporting cosmetic products may face requests from foreign regulators or trading partners for FDA-issued compliance documentation. Companies should be prepared to explain that the FDA does not issue such documents and to provide alternative evidence of registration status, such as a screenshot from the Cosmetics Direct portal.

We are continuing to closely monitor developments related to MoCRA compliance and all things cosmetics and will provide more updates as they come. If you are interested in more information about MoCRA or are seeking guidance on any cosmetic-related requirements, please contact the authors.