FDA Regulatory Framework for Cosmetics Gets Major Overhaul via Cooley

27 January 2023

Enacted on December 29, 2022, as part of the 2023 omnibus bill, the Modernization of Cosmetics Regulation Act (MoCRA) is a major overhaul of the Food and Drug Administration’s current regulatory framework for cosmetics.

MoCRA amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FDCA) to include new provisions for cosmetic products.

These provisions create significant new authorities for the FDA and, for the first time since the FDCA was enacted in 1938, enhance the FDA’s regulatory oversight of cosmetics.

While MoCRA does not include a premarket approval requirement for cosmetics, it does create new obligations for the cosmetics industry. Some of the key provisions are outlined below.

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