In the final days of its last session, Congress overhauled FDA’s regulatory framework for cosmetics as part of the year-end Consolidated Appropriations Act, 2023. Signed into law by President Biden on December 29, 2022, the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), as it has been titled, added significant new authorities to chapter VI of the Federal Food, Drug, and Cosmetic Act (“FDCA”)—the first major amendments to FDA’s cosmetics authorities since President Franklin D. Roosevelt signed the FDCA into law in 1938. Earlier this year, MoCRA passed the Senate HELP Committee with bipartisan support, led by HELP Chair Patty Murray (D-WA) and Ranking Member Richard Burr (R-NC) as part of the broader committee efforts to reauthorize FDA’s medical product user fee programs. MoCRA—considered a “super-rider” for the user fee reauthorization—did not advance when Congress enacted the user fee package in late September. But during the final weeks of the congressional session, Sens. Murray and Burr worked with E&C Chairman Frank Pallone (D-NJ) and Ranking Member Cathy McMorris Rodgers (R-WA) to settle on a suite of reforms to attach to the year-end omnibus appropriations package. Notably, while MoCRA will be included in that suite, certain other FDA-related “super-riders” did not advance, including: (i) the VALID Act, which would have established a regulatory framework specifically for diagnostics, and (ii) reforms to FDA’s regulatory framework for dietary supplements.
MoCRA represents over a decade of significant efforts by Congress and many stakeholders, including FDA, consumer and environmental groups, and the beauty and personal care industry (on behalf of which Covington is proud to have been deeply involved in MoCRA’s development).
This client alert summarizes the key provisions of MoCRA. Importantly, the new enforcement provisions of MoCRA do not require immediate compliance; instead, as outlined below, MoCRA includes specific compliance dates for certain of the requirements and directs FDA to undertake rulemaking or issue guidance to implement other of the requirements. We anticipate meaningful efforts by FDA this year to work towards implementing these new authorities.
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