FDA Announces Availability of Cosmetics Direct Portal and Publication of Final Guidance on Cosmetic Facility Registration and Product Listing

On December 18, the US Food and Drug Administration (FDA) announced the availability of the Cosmetics Direct electronic submission portal and publication of final guidance for industry on cosmetic facility registration and cosmetic product listing.

As we reported last year, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposed extensive new requirements related to cosmetic products marketed in the United States. Among its many provisions, MoCRA imposes requirements for annual cosmetic product facility registration and cosmetic product listing.

We provided an overview of the facility registration and product listing requirements here and here, and additionally covered the draft version of the Cosmetics Direct portal here. As explained previously, Cosmetics Direct serves as the electronic submission portal to facilitate submissions of facility registrations and product listings.

While the electronic submission forms are available now, the FDA is also developing paper forms – Form FDA 5066 and Form FDA 5067 – for facility registration and product listing. The agency anticipates that the paper forms will soon be available on the FDA’s Registration & Listing of Cosmetic Product Facilities and Products page. As a reminder, companies will need to obtain an FDA Establishment Identifier (FEI) prior to submitting a cosmetic facility registration, as the agency will be using the FEI as the required facility registration number.

The FDA previously issued draft guidance regarding cosmetic facility registration and product listing requirements on August 8, 2023, which we covered here. Last month, the FDA issued the final version of this guidance.

Among other things, the final guidance provides further information regarding which entity is responsible for submitting the registration and listing, what information must be included, how to submit the registration and listing, and certain exemptions to these requirements. As explained here, the FDA previously announced its intent to delay enforcement of the registration and listing provisions until July 1, 2024, to provide the industry additional time to comply with these requirements.

Notably, the final guidance also includes a new draft guidance section in Appendix B, which covers frequently asked questions and answers about cosmetic facility registrations and cosmetic product listing submissions. The draft guidance section in Appendix B is included for comment purposes only. Comments should be submitted by January 18, 2024, to ensure that the FDA considers them before the agency begins work on the final version of this section.

ArentFox Schiff will continue to closely monitor additional updates on MoCRA compliance.

If you are interested in more information about MoCRA, would like guidance on complying with these new requirements or would like assistance preparing a comment on Appendix B, please contact ArentFox Schiff’s FDA Practice group.


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