MoCRA Update: FDA opens Cosmetics Direct portal and issues Final Guidance document

On December 18, 2023, FDA finally opened the Cosmetics Direct electronic submission portal for facility registration and cosmetic product listing, as required according to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) . The Cosmetics Direct portal shall be used exclusively for electronic submissions of facility registrations and cosmetic product listings to FDA.

FDA is also developing paper forms for facility registration and cosmetic product listing as an alternative submission tool, announced to be available soon.

As previously reported, on November 8, 2023, FDA announced that it “does not intend to enforce the requirements related to facility registration and cosmetic product listing for an additional six months after December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.”

FDA will however remain “ready to accept registration and listing information” by the statutory deadline of December 29, 2023, and encourages companies to meet that deadline if they are able to do so.

Additionally, on December 18, FDA issued another version of the Final Guidance document . As those documents released before, the guidance provides recommendations and instructions to assist persons submitting facility registrations and product listings and includes definitions and clarifications on legal responsibilities, information to be included in portal submissions, when and how to conduct those submissions, etc.

FDA further declares that the guidance however does “not establish legally enforceable responsibilities” and describes FDAs “current thinking on a topic and should be viewed only as recommendations.”