U.S. FDA Issues Draft Guidance on Cosmetic Facility Registration and Product Listing

Aug. 9 2023

On August 7, the U.S. Food and Drug Administration (FDA) released the draft guidance, Registration and Listing of Cosmetic Product Facilities and Products, detailing the proposed submission process. In a Constituent Update announcing the draft guidance, the FDA stated that they intend “to make the new electronic submission portal available October 2023” and that “stakeholders should plan to register and list well in advance of the December 29, 2023, statutory deadline.”

The Registration and Listing of Cosmetic Product Facilities and Products draft guidance provides definitions and clarification on who needs to register and list their cosmetic products. It also indicates what information must be submitted and what optional information may be submitted as part of the facility registration and product listing process.

The FDA explains that they intend to use the FDA Establishment Identifier (FEI) as the facility registration number. Noting that the owner or operator of a facility will need to obtain a FEI number before submitting the facility registration. The facility registration (FEI) number will be required as part of the product listing as well.

Additionally, the draft guidance states what information will and will not be publicly accessible – noting that as per MoCRA, the product listing number and information on what brands a facility manufacturers will not be available for public disclosure.

The FDA reminds companies that information submitted to the voluntary cosmetic registration program will not be transferred over to the new database.

Background

As part of the Modernization of Cosmetics Regulation Act, or MoCRA for short, manufacturers and processers of cosmetic products shall register each establishment facility with the FDA and the responsible person (the person whose name appears on the label) shall submit a cosmetic product listing. However, under certain circumstances companies may be exempt from the facility registration and product listing requirements.

Link to the Constituent Update: https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-draft-guidance-registration-and-listing-cosmetic-product-facilities-and-products

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