THE WHAT? The U.S. Food and Drug Administration (FDA) released draft guidelines on cosmetic product facility registrations and product listings as part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
THE DETAILS The draft explains the process for stakeholders to register cosmetic product facilities and submit product listings to the FDA. Cosmetic product manufacturers and processors must register their facilities with the FDA, update details within 60 days of changes, and renew every two years. Each marketed cosmetic product must be listed with the FDA annually, detailing its ingredients. Some small businesses are exempt unless their products meet specific criteria, such as being intended for eye contact, injections, internal use, or extended appearance alteration. Exemptions are also available for certain products already regulated as drugs and devices.
THE WHY? The FDA plans to introduce an electronic registration and submission portal in October 2023, with a paper form option also being developed. Facilities must obtain an FDA Establishment Identifier (FEI) before registering, and product listings need the respective facility’s registration number. If a facility is exempt from registration, the facility’s name and address are required. Stakeholders should complete registrations and listings by December 29, 2023. The FDA also invites industry members for a voluntary pilot program to test the new electronic portal.