MoCRA update: Draft Guidance on Registration and Listing of Cosmetic Facilities and Products

The draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, and when to submit, as well as certain exemptions to the registration and listing requirements.

MoCRA provided new authorities to FDA including:

• Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.

• Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually. 

This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. This guidance document explains, among other things:

• The statutory requirement to submit cosmetic product facility registrations and product listings;
• Definitions;
• Who is responsible for making the submissions;
• What information to include in the submissions;
• How to make the submissions; and
• When to make the submissions

The draft guidance also contains information about a new electronic registration and listing submission portal. FDA intends to make the new electronic submission portal available in October 2023.

Stakeholders should plan to register and list well in advance of the December 29, 2023, statutory deadline.

Sources:

• Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
• Federal Register Notice: Registration and Listing of Cosmetic Product Facilities and Products; Draft Guidance for Industry 
• Federal Register Notice: Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing