FDA Clarifies Certificates & Facility Registration

The US Food and Drug Administration is informing cosmetic product facilities, retailers, and industry responsible persons that the agency does not provide certificates or other documents to verify compliance for cosmetic product facility registration. 

Under section 607 of the FD&C Act, as amended by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), owners or operators of facilities manufacturing or processing cosmetic products are generally required to register their facilities with the FDA and renew their registration every two years. Additionally, the responsible person for each marketed cosmetic product must list each product with the FDA, including product ingredients, and provide any updates annually.

Cosmetic product facility registration and cosmetic product listing is neither a cosmetic approval program nor a promotional tool. The assignment of a facility registration number or product listing number does not indicate FDA approval of the facility or its cosmetic products.

The FDA has received an increased number of inquiries from individuals seeking to obtain certificates or other documents to verify compliance for cosmetic product facility registration or confirm that a person or facility is not required to register with the FDA.

The FDA is aware that e-commerce platforms, such as TikTok Shop, may ask those wanting to sell their products on these platforms to provide proof of FDA registration or if they are not required to register with the FDA, a letter or email from the FDA confirming such a registration exemption.

The FDA does not provide certificates or other documents to verify compliance for cosmetic product facility registration or cosmetic product listing, including but not limited to:

• a certificate as proof of cosmetic product facility registration or cosmetic product listing, 
• a verification document, such as a letter or email, stating a facility is registered or a cosmetic product is listed, or
• a document (e.g., certificate, letter, or email) confirming a facility or responsible person is not required to register or list cosmetic products with the FDA. 

More information can be found here.