On December 18, 2023, the U.S. FDA officially launched the Cosmetics Direct portal* for the submission of cosmetic product listings and facility registrations. As the SRC team has begun submitting filings in the new portal, we have found it to be working well and to be a user-friendly platform. FDA has also issued a final Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, which includes frequently asked questions about the facility registration and product listing requirements, such as “What if my product is both a drug and a cosmetic product?” and “What information is submitted as part of facility registration and product listing under section 607 of the FD&C Act?”.

Though the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) states a deadline of 12/29/2023 for product listings and registrations to be complete, due to the delays in rolling out the Cosmetics Direct portal, FDA has announced that it will not enforce this part of the law until 07/01/2024 to allow stakeholders additional time to file their listings in the portal. The requirements for safety substantiation and adverse event reporting are still effective beginning 12/29/2023 and SRC is readily available to provide assistance in these areas.

While enforcement does not begin until July 1st, SRC recommends completing your facility registrations and product listings in the Cosmetics Direct portal as soon as possible to ensure you have plenty of time to address any questions or issues that may arise. Our team is fully trained and ready to assist you with all your compliance needs for cosmetic products, including submitting product listings, facility registrations, and managing their renewals.

Contact your SRC Consultant for more information on how we may help you and your firm comply with these new cosmetic regulations.

*Though there are paper processes available to complete these listings and registrations, FDA and the SRC team strongly recommend using the online portal to avoid unnecessary delays.

 

Crystal Maira

Senior Consultant

Posted on: 12/27/23