On December 14, 2023, the U.S. Food and Drug Administration provided an update related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). With this new update, an industry “responsible person” is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days. For information on how to report a cosmetic related complaint use the link below.
How to Report a Cosmetic Related Complaint | FDA
The FDA also published an Updated Structured Product Labeling Implementation Guide with Validation Procedures on December 14, 2023. Cosmetics product facility registrations and product listings are now included within the SPL framework. To see more information on the updated guide use the link below.