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On December 23, 2022, Congress enacted the first major change to the FDA’s ability to regulate cosmetics since the Food Drug & Cosmetic Act. The Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rule making and enforcement authority over cosmetics, introducing new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United Sates. It also provides FDA access to cosmetic products records, under certain conditions. 

ECI regulatory experts are monitoring the FDA’s communications related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and can provide support to the cosmetic industry. Beginning in December 2023, the following new requirements come into effect:

  • Facility Registration and Product Listing
  • Safety Substantiation
  • Serious Adverse Event Reporting
  • Mandatory Recall Authority
  • Standardized Test methods for Talc-Containing Cosmetics

The implementation of MoCRA may sound challenging to cosmetic manufacturers. Taking proactive steps toward MoCRA compliance ensures compliance and safe products. Consider whether you have the regulatory expertise to support an assessment of your products, processes, and procedures. With proper planning, any size business can identify an appropriate solution to meet these new requirements.

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