FDA update on registration of cosmetic products intended for import into the U.S. market

Today, the U.S. Food and Drug Administration (FDA) released an update on ongoing activities related to the new registration of cosmetic product structures and listing cosmetic products, as required by the Cosmetic Regulatory Modernization Act of 2022 (MoCRA).

August 2023
The FDA issued draft guidance on registering cosmetic product structures and product listings. The FDA received more than 40 comments on that draft and is currently evaluating those comments. Once finalized, the guidance will provide recommendations and instructions to help companies submit cosmetic product facility registrations and listings to the FDA.

September 2023
The FDA announced the opportunity to comment on its new electronic data submission portal in the draft (Cosmetics Direct). The FDA must now obtain Office of Management and Budget (OMB) review and approval from the Executive Office of the President under the Paperwork Reduction Act for the proposed collection of registration and listing information.

October 2023
The FDA announced the publication of the Implementation Guide for Structuring Product Labeling (SPL) with Validation Procedures. The Implementation Guide can be used to develop SPL authorization tools. In the future, once the FDA begins accepting data, users will be able to submit SPL submissions via the FDA's Electronic Submissions Gateway (ESG) or SPL authorization software, including Xforms, for registrations and structure listings of cosmetic products.

With today’s update, November 01, 2023, the FDA will provide further information on the launch date for electronic submission of registration data for cosmetic products intended for sale in the U.S. market in the coming weeks.

The industry can continue to prepare for registration and listing by reviewing documents provided by the FDA and being proactive in gathering the information needed to complete facility registrations and product listings.