FDA Seeks Comments on COSMETICS Direct for MoCRA Facility Registration and Product Listing

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) establishes a number of new requirements for the cosmetics industry. Among other things, facilities that manufacture and process cosmetics in the U.S. will need to be registered with the FDA, and companies that manufacture cosmetics will need to submit a list of all cosmetics (and their ingredients) to the FDA.

The FDA already announced that it would be discontinuing the Voluntary Cosmetic Registration Program (VCRP), and creating a new portal for submissions required under MoCRA.

On September 18, 2023, the FDA announced a newly developed draft electronic submission portal (“Cosmetics Direct”) and a set of paper forms (Forms FDA 5066 and 5067), which the agency will use for submission of facility registration and product listings:

1. 1. Draft Cosmetics Direct Electronic Submissions Portal
   2. Draft FDA Form 5066 - Registration of Product Facility
   3. Draft FDA Form 5067 - Cosmetic Product Listing

FDA has also developed guidance to assist companies with entering all of the information required for facility registration and product listing. The guidance outlines who is responsible for registering facilities and listing products, what information is required for electronic and paper submission, and when the submission should be completed. The draft electronic and paper submissions are meant to give industry members a framework to organize the information they will need to register their facilities and submit product listings.

For the next three weeks, until October 18, 2023, FDA seek comments on Cosmetics Direct and the paper form submissions. The public comments made to date focus on the additional cost and burden on the industry, privacy considerations, and whether there will be a grace period to complete either the electronic or paper submission.