The U.S. FDA has replaced the former Quality System regulation with the new Quality Management System Regulation (QMSR), effective 2 February 2026. By incorporating ISO 13485:2016 into 21 CFR 820, the FDA aligns U.S. medical device quality requirements with internationally recognised standards.
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Selling cosmetics in California: applicable regulatory framework
Selling cosmetics in California means navigating both federal rules under MoCRA and some of the strictest state-level regulations in the US. Beyond MoCRA, brands must comply with California-specific measures such as Proposition 65, the Safe Cosmetics Program, CARB VOC limits, the Toxic-Free Cosmetics Act, and the PFAS-Free Cosmetics Act.
FDA launches real-time adverse event reporting system for cosmetic products
On 12 September 2025, the US Food and Drug Administration (FDA) announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. FAERS is an interactive tool that provides the public with real-time access to adverse events reports associated with cosmetic products.