Electronic Submission Portal for Cosmetics

Recommendation

10/11 October 2023

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Development, Manufacture & Control of Dermatopharmaceutics and Cosmetics

The U.S. FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). According to the agency, Cosmetics Direct includes the required registration and listing submission information from the paper forms in a standard electronic format. This will help the applicant organize their registration and listing submission to include the information needed for FDA and will give access to the previous Cosmetic Direct registrations and listing submissions.

FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. However, applicants that prefer to submit paper registrations and listings will still have the option to do so. Draft screenshots of the electronic system are available below for review and comments:

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

For more information please see the Registration and Listing of Cosmetic Product Facilities and Products View on the FDA Website.