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FDA Clarifies It Does Not Provide Certificates or Other Documents to Verify Compliance for Cosmetic Product Facility Registration

The U.S. 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 ecommerce 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.

For additional information on cosmetic product facility registration and cosmetic product listing, visit:

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I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
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