.MoCRA Toolkit (PRINT ONLY)

Enacted in December 2022. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress and other stakeholders to modernize the U.S. cosmetic regulatory framework.  Prepared together with counsel at Covington & Burling, this tool kit is designed to provide an overview of new requirements and authorities that MoCRA established.  Although this Toolkit provides PCPC’s current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. Compliance with MoCRA requires independent judgement based upon facts of a particular situation, and this Toolkit is not intended to replace regulatory counsel to ensure compliance.  This Toolkit covers Adverse Events, Facility Registration, Facility Suspension, Product Listing, Safety Substantiation, Labeling, Recalls, Fragrance Provisions, Cosmetics Records Access, Good Manufacturing Practices Rule, Talc Rule and PFAS report.    Quantities are limited.