The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics in nearly 85 years. FDA is now enforcing MoCRA’s product listing and facility registration requirements (as of July 1, 2024) along with MoCRA’s adverse event reporting, safety substantiation, recall authority, and records access requirements. But how is FDA actually effectuating its new enforcement powers regarding cosmetics? Below we explore two significant emerging trends that shed light on this question. These trends reveal that at present, FDA is most focused on regulating products that exist at the nexus of the definition of “drugs” and “cosmetic products.” In other words, FDA continues to focus on companies and products already on its radar as part of its authority over drugs.
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