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Registration & Listing of Cosmetic Product Facilities and Products

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily.

MoCRA provided new authorities to FDA including:


For Industry 

Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products 
(August 2023)
FDA issued this draft guidance on cosmetic product facility registrations and product listings, as mandated by the MoCRA.

FEI Search Portal
FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. To determine if an entity already has an FEI number, please refer to the FEI Search Portal. If your firm does not have an FEI number assigned by FDA, see How can I request an FEI? at FEI Search Portal.


Comment Request 

FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067).

Cosmetics Direct includes the required registration and listing submission information from the paper forms in a standard electronic format. This will help the respondent organize their registration and listing submission to include the information needed for FDA and will give the respondent access to their previous Cosmetic Direct registrations and listing submissions.

FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. Respondents that prefer to submit paper registrations and listings will still have the option to do so.

Draft screenshots of the electronic system are available below for review and comments. For more information, see the Federal Register Notice.

Draft Cosmetics Direct Electronic Submissions Portal

Draft FDA Form 5066 -Registration of Product Facility

Draft FDA Form 5067 - Cosmetic Product Listing

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