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.
See our Law360 article, “MoCRA Will Give Cosmetics Litigation A Makeover,” to learn more about the potential litigation impacts of MoCRA’s requirements and steps companies can take now to manage their risk.
More extensive information on MoCRA can be found in our Modernization of Cosmetics Regulation Act White Paper. This white paper serves as a comprehensive overview of the history of cosmetics regulation in the United States, MoCRA’s new requirements and FDA’s new enforcement powers, potential litigation impacts, and specific action items companies can take now to best prepare themselves for MoCRA’s changes.
For further information, please contact:
Rachel Raphael, Partner, Crowell & Moring
rraphael@crowell.com
