Legal Lens: MoCRA in motion – Unpacking the biggest regulatory shift in US cosmetics law



Welcome back to another edition of the Legal Lens, where we navigate all things legal and regulatory in the world of personal care products.

For those of you who are new, my name is Kelly, your friendly neighborhood lawyer—a title that probably won’t get me a tryout with the Avengers any time soon—and I’m here to demystify the legal side of the beauty world. Anything said here is intended to be entertaining and educational, and not intended as formal legal advice.

So where did we leave off?

Why do I keep hearing about MoCRA?

On December 23, 2022, Congress enacted the Modernization of Cosmetics Regulation Act (MoCRA)​—the most significant statutory change to the U.S. federal government’s ability to regulate cosmetics since the federal Food, Drug, and Cosmetic Act in 1938.

Passed as part of the $1.7 trillion omnibus Consolidated Appropriations Act of 2023 and the Food and Drug Omnibus Reform Act, MoCRA significantly expands FDA rulemaking and enforcement over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics in the United States.

How so?

MoCRA contains a number of significant new or enhanced federal obligations with respect to cosmetics. For example, MoCRA now:

  • Requires any facility that manufactures or processes cosmetic products intended for sale in the United States—whether or not the facility is located in the U.S.—to register with the FDA;
  • Requires manufacturers, packers, and distributors of cosmetics intended for sale in the U.S. to list products and ingredient information;
  • Imposes greater recordkeeping obligations for product safety and increased reporting obligations for serious adverse events—with an expanded definition of what constitutes a .serious adverse event; and
  • Imposes new labeling requirements, including providing contact information for adverse event reporting, and notifications for products intended for professional use.



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