Cosmetics Constituent Update
Today the U.S. Food and Drug Administration (FDA) announced the release of the following enhancements to help industry keep their registration and listing submissions up to date:
- the availability of two new features in Cosmetics Direct, the electronic submission portal for the new registration and listing of cosmetic product facilities and products requirements established by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The new Cosmetics Direct features allow for the discontinuation and relisting of cosmetic product listing.
- The discontinuation of cosmetic product listing feature provides responsible persons the option to discontinue cosmetic products previously listed in Cosmetics Direct that are no longer on the market.
- The relisting feature provides responsible persons the option to relist cosmetic products that were previously discontinued in Cosmetics Direct and are being brought back to the market.
Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the Federal Food, Drug, and Cosmetic Act or section 4(a) of the Fair Packaging and Labeling Act.
In Cosmetics Direct, discontinuing a product differs from deleting a product. When a product is discontinued, it remains in the Structured Product Labeling (SPL) file and can be relisted. However, once a product is deleted, it is permanently removed from the SPL file and cannot be retrieved for relisting.
For instructions on how to discontinue and/or relist cosmetic products, see the updated User’s Guide to Cosmetics Direct.
For More Information
- Deadline for Registration and Listing of Cosmetic Product Facilities and Products: What Does the Deadline Mean to You, and How is FDA Helping You Comply?
- Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing
- Final Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
- Registration & Listing of Cosmetic Product Facilities and Products
Related Resources
- Cosmetics Direct
- Download the User’s Guide
- Cosmetics Direct – Facility Registration Tutorial (April 2024)
- Cosmetics Direct – Product Listing Tutorial (April 2024)
Email Contacts for Inquiries
- For general questions regarding electronic registration and listing of cosmetic product facilities, contact eRLC@fda.hhs.gov
- For assistance with accounts activation and validation errors in Cosmetics Direct, contact cosmeticsdirect@fda.hhs.gov
- For assistance with CDER Direct and Combination accounts in FDA Direct, contact CDERDirect@fda.hhs.gov
- FEI Search Portal
- For general questions regarding FEI numbers and requesting an FEI number, contact feiportal@fda.hhs.gov
- FDA’s Global Substance Registration System (GSRS) UNII Search Service
- If you would like to request a Unique Ingredient Identifier (UNII) for ingredients that are not in the GSRS database, contact FDA-SRS@fda.hhs.gov
Posted in Cosmetics, FDA and USDA Regulatory Update.