Insights

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.

On October 25, 2024, FDA issued final guidance to the tattoo industry on the preparation, packing and holding of tattoo inks aimed at preventing the risk of microbial contamination. FDA is getting involved because tattoo ink is considered a cosmetic product regulated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

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.