FDA Issues Final Guidance on Registration and Listing of Cosmetic Facilities and Products And Opens Registration Portal

Dec. 18, 2023

FDA has issued the long-awaited final guidance on registration and listing of cosmetic facilities and products.  As expected, the electronic portal, Cosmetics Direct, uses the Structured Product Listing (SPL) format for both, similar to drugs.  The registration deadline is July 1, 2024.

The guidance is located here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products

Instructions for submitting facility and product registration and a link to the portal are here: https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products/cosmetics-direct

Note that facilities must be registered before products as the FDA Establishment Identifier Number (FEIN) which is assigned upon facility registration is used when registering products.




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