Source - Dietary Supplement & Cosmetics Legal Bulletin | September 2023

FDA Issues Draft Guidance on Cosmetic Product Facility Registrations and Product Listings

The U.S. Food and Drug Administration (FDA) has issued draft guidance on cosmetic product facility registrations and product listings, which are required by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Under MoCRA, cosmetic product manufacturers and processes are required to register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years. Additionally, a responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide annual updates. Certain small businesses are exempted from these requirements, and exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

When the draft guidance is finalized, it will help stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit and when to submit, as well as certain exemptions to the registration and listing requirements.

The draft guidance includes information about an electronic registration and listing submission portal. FDA said it intends to make the portal available in October 2023. The draft guidance also discusses FDA’s intention to use the FDA Establishment Identifier (FEI) as the required facility registration number.

FDA said in an August 7 Constituent Update that stakeholders should plan to register and list well in advance of the December 29, 2023, statutory deadline. 

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