Insights

On November 8, 2023, the U.S. Food and Drug Administration (FDA) issued guidance on its intent to delay enforcement of the facility registration and product listing requirements set forth in in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for an additional six months (until July 1, 2024) to allow cosmetics companies enough time to submit facility registration and product listing information.

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.