FDA Announces and Seeks Comments on Cosmetics Direct — Portal for Cosmetic Facility Registration and Product Listing

As we reported previously, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States — one of which was a requirement for annual cosmetic product facility registration and product listing, which goes into effect later this year. The agency has now rolled out drafts of Cosmetics Direct and paper forms for use in this process:

• Draft Cosmetics Direct Electronic Submissions Portal
• Draft FDA Form 5066 - Registration of Product Facility
• Draft FDA Form 5067 - Cosmetic Product Listing

Per FDA:

Cosmetics Direct includes the required registration and listing submission information from the paper forms in a standard electronic format. This will help the respondent organize their registration and listing submission to include the information needed for FDA and will give the respondent access to their previous Cosmetics Direct registrations and listing submissions.

The FDA is now seeking feedback on the drafts of Cosmetics Direct and FDA Forms 5066 and 5067, with comments due by October 18, 2023.

ArentFox Schiff will continue to closely monitor additional updates on MoCRA compliance.

If you are interested in more information about MoCRA, would like guidance on complying with these new requirements, or would like assistance preparing a comment on the draft items noted above, please contact ArentFox Schiff’s FDA practice group.