FDA Launches Cosmetics Direct, Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products Under MoCRA, and Updates Instructions for Serious Adverse Event Reporting for Cosmetic Products

3 min

Last week, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, a new electronic submission portal for the registration and listing of cosmetic product facilities and products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), and published a user's guide for the portal. Cosmetics Direct contains user friendly data entry forms, performs initial validations, creates and saves the structured product labeling (SPL) submission, and submits the SPL to the FDA. As an alternative, users may satisfy the facility registration and product listing requirements by transmitting SPL-formatted submissions through the FDA's Electronic Submissions Gateway (ESG) or any SPL authoring software including Xforms. Any companies considering alternative methods for submitting registration and listing information should account for the time that using these alternatives could add to the process. For example, the FDA ESG system requires users to apply for a free account before submitting any data, which can take one to three weeks. Registration and listing information also may be submitted on paper (FDA Forms 5066 and 5067). However, the FDA strongly encourages electronic submissions.

Last week, the FDA also issued final guidance with recommendations and instructions on what information is needed for both cosmetic product facility registrations and product listings, who is responsible for making the submissions, and how and when to make the submissions. The guidance also includes a new draft section, Appendix B, for comment purposes only, that describes frequently asked questions and answers about cosmetic-product-facility registrations and product-listing submissions. Aside from the question-and-answer section, this guidance finalizes the draft guidance that was published in August 2023. To ensure that the FDA considers your comment on the new draft section, you should comment on the information in Appendix B by January 18, 2024.

While in the final guidance the agency reiterates that it has delayed enforcement of the registration and listing requirements until July 1, 2024, certain MoCRA requirements will still be going into full effect on December 29, 2023, including the requirement that a responsible person must report serious adverse events associated with the use of cosmetic products in the United States to the FDA within 15 business days after learning of the serious adverse event. In preparation for the approaching deadline, last week, the FDA recently updated the instructions for MedWatch Form 3500A to make it easier to complete the form for reporting serious adverse events for cosmetic products.

For a full list of MoCRA's requirements and their compliance deadlines, please refer to our November 16 article. For additional information concerning MoCRA, please refer to our July 20 article. Please contact the authors if you would like to discuss your regulatory compliance obligations.