Two years ago, Congress greatly expanded the authority of the U.S. Food and Drug Administration (FDA) by enacting the Modernization of Cosmetics Regulation Act (MoCRA). This Act requires companies to register each facility with the FDA where they manufacture or process cosmetics and list those products with the FDA, too. Then, late last year, FDA issued two MoCRA-related guidances: one that delays MoCRA’s enforcement dates for registering cosmetics manufacturing and processing facilities and listing cosmetic products, and a second that provides specific details on registration and listing amendments and renewals – including when a product is also a drug. This last item is one indication that MoCRA has narrowed the gap between how the FDA regulates cosmetics and drugs.
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