MoCRA & Cosmetic Compliance
The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant reform to federal cosmetic regulation in over 85 years. Anthony Girand advises cosmetic brands, manufacturers, importers, and distributors in navigating MoCRA obligations and building robust compliance programs.
Schedule a ConsultationWhat is MoCRA?
Enacted December 29, 2022 as part of the Consolidated Appropriations Act, MoCRA is the first major expansion of federal cosmetic authority since the Federal Food, Drug, and Cosmetic Act of 1938. Before MoCRA, cosmetics were largely self-regulated — the FDA could only act after a product caused harm.
MoCRA grants the FDA substantial new authority: mandatory facility registration and product listing, safety documentation requirements, serious adverse event reporting, records access, Good Manufacturing Practice standards (in development), and mandatory recall authority. It applies to domestic and foreign brands, contract manufacturers, importers, and distributors.
FDA continues to issue guidance and rulemaking under MoCRA — including pending rules on GMP requirements, fragrance allergen disclosure, and asbestos testing in talc. Cosmetic businesses must actively monitor these developments.
MoCRA Compliance Services
Facility Registration & Product Listing
MoCRA requires every facility that manufactures or processes cosmetics for U.S. distribution to register with FDA and renew biennially. Each marketed product must be listed in FDA's Cosmetics Direct portal within 120 days of launch, with annual updates. Anthony advises brands, contract manufacturers, and importers on meeting these obligations accurately and on time.
Adverse Event Reporting & Recordkeeping
Responsible persons must report serious adverse events to FDA within 15 business days of becoming aware. Records must be maintained for six years. Anthony helps clients establish complaint-handling systems, draft adverse event reporting procedures, and prepare for FDA inspection of those records.
Safety Substantiation & GMP Compliance
Companies must maintain records supporting adequate safety substantiation for every cosmetic product. FDA is also finalizing Good Manufacturing Practice (GMP) regulations for cosmetic facilities. Anthony advises clients on building defensible safety files, reviewing ingredient data, and preparing for upcoming GMP requirements.
Labeling, Fragrance Allergens & PFAS
MoCRA mandates updated labeling including adverse event contact information and professional-use designations. Pending FDA rulemaking will require fragrance allergen disclosure. FDA also published a December 2025 report on PFAS in cosmetics. Anthony counsels clients on current labeling compliance and positioning for upcoming rulemaking.
Who Needs MoCRA Counsel?
MoCRA applies to any business that manufactures, packages, distributes, or markets cosmetics in the United States — regardless of size or location.
Anthony Girand Law advises brand owners, Responsible Persons, manufacturers, and importers on MoCRA and FDA cosmetics compliance. Share a few details to help the firm evaluate and route your inquiry.
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