MoCRA Update: FDA’s Product Listing and Facility Registration Portal is Open for Business!
Just before the original Dec. 29, 2023, deadline for cosmetic product listings and facility registration, FDA released the new and improved FDA CDER Direct & Cosmetics Direct portal. The portal is accessible at https://direct.fda.gov/.
A couple of things to note about the portal and product submissions:
- Cosmetic manufacturers and processors must register their Facilities with the FDA before a cosmetic product listing that identifies a particular Facility can be accepted. Accordingly, we encourage companies using third-party manufacturers and processors to contact those third parties and request that their facility registration be completed sooner rather than later. Note — even if a Facility has not yet registered, a draft cosmetic product listing can be created and saved until all its Facilities have completed their registration.
- Ingredient lists may be uploaded into the portal as a single Excel document per product. Once in the portal, an option to download the Excel template is available.
In addition, although FDA announced it is exercising its discretion to delay enforcement of the product listing and facility registration requirements until July 1, 2024, all other Dec. 29, 2023, effective MoCRA requirements (e.g., adverse event record keeping, serious adverse event reporting, safety substantiation documentation) are now in effect and enforceable.
We are here to help.
If you need assistance preparing for and submitting product listings or facility registration or have any questions regarding MoCRA, please do not hesitate to contact us.
- Angela Diesch
- Ashish Talati
- Rend Al-Mondhiry
- Lauren Aronson
- Abhishek Gurnani
- Ivan Wasserman
- Jennifer Adams
- Karmina Fefferman
- Natascia Taken