10/11 October 2023
The FDA is currently working on approaches to strengthen its oversight in regard to the safety of cosmetic products. Therefore, the agency issued a draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products. According to the FDA, the guidance will help to accomplish several objectives, such as
In March 2023, the agency has stopped accepting submissions to the voluntary cosmetic registration program (VCRP) as a result of the facility registration and product listing mandated by the Modernization of Cosmetics Regulation Act (MoCRA). Therefore, the agency is developing a new system for receiving the required registration and listing information.
When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing
In addition, the MoCRA provided new authorities to FDA including:
The Responsible Person will need to obtain the relevant FDA Establishment Identifier (FEI) (the FDA intends to use the FEI as the required facility registration number) for each facility where the cosmetic product is manufactured or processed, because the facility registration number is required for the product listing submission. If the facility is a small business that is exempt from registration and has no facility registration number, then facility name/address can be provided instead for the product listing.
Submission of information about existing cosmetic product facilities and products is required no later than 29 December 2023.
For more information please see FDA's draft guidance Registration and Listing of Cosmetic Product Facilities and Products.