On August 7, 2023, the U.S. Food and Drug Administration (FDA) published draft guidance to help cosmetic companies submit cosmetic product facility registrations and cosmetic product listings to the FDA. “Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products” describes new MoCRA requirements for facility registration and product listing and exemptions under MoCRA for certain small businesses.

The guide contains information on the following topics:

  • Legal requirements for submitting cosmetic product facility registrations and product listings;
  • New definitions
  • Responsible Person obligations;
  • Information to be presented in registrations;
  • How to make records and submissions and
  • Timeline

FDA is accepting comments on the draft guidance until September 7.FDA Newsroom, FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products