Beauty, Health & Wellness

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mocra white paper blog

Just over a month after the Food and Drug Administration (FDA) announced its intent to delay enforcement of facility registration and product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the Government Accountability Office (GAO) issued a report, “COSMETIC SAFETY: Better Planning Would Enhance FDA Efforts to Implement New Law,” with seven recommendations to strengthen FDA efforts to implement its new cosmetic oversight responsibilities.Continue Reading GAO Report Concludes that the FDA Needs to Strengthen its Efforts to Implement MoCRA

mocra white paper blog

On October 13, 2023 The FDA announced that two of the requirements set forth in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)— facility registration and product listing—will be included as part of the Structured Product Labeling (SPL) framework. SPL is a document formatting standard adopted by FDA for exchanging product-related information. Continue Reading FDA Publishes SPL Guide for MoCRA Facility Registration and Product Listings

mocra white paper blog

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) establishes a number of new requirements for the cosmetics industry. Among other things, facilities that manufacture and process cosmetics in the U.S. will need to be registered with the FDA, and companies that manufacture cosmetics will need to submit a list of all cosmetics (and their ingredients) to the FDA.Continue Reading FDA Seeks Comments on COSMETICS Direct for MoCRA Facility Registration and Product Listing

white paper

In December 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”)—the most significant expansion of the U.S. Food and Drug Administration’s authority to regulate cosmetics in nearly 85 years—was signed into law. Among other things, MoCRA gives the FDA authority to require facility registration and reporting of serious adverse events, impose certain record-keeping obligations, recall cosmetic products, and establish good manufacturing practices. With many of MoCRA’s provisions going into effect at the end of this year, cosmetics companies need to prepare to address these requirements and regulations, which may also have a considerable impact on the litigation landscape.

Crowell’s Product Risk Management team has written two publications to help cosmetics companies prepare for the big changes ahead.Continue Reading Modernization of Cosmetics Regulation Act (“MoCRA”) White Paper