Modernization of Cosmetics Regulation Act of 2022 Passes!December 28, 2022
On December 23, 2022, when many of us were distracted by the cold weather, Congress passed the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act of 2023. FDORA includes, as subtitle E, the Modernization of Cosmetics Regulation Act of 2022!
As discussed here, the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) originally was included in the Senate version of the FDA Safety and Landmark Advancements (FDASLA) Act (S.4348). However, the House’s version of this bill did not include cosmetics regulation reform, and the final version of the FDA user fee legislation, which was enacted and signed into law on September 30, did not include the cosmetics regulation language.
MOCRA amendments to the Federal Food, Drug, and Cosmetic Act constitute the first statutory change to FDA’s authorities over cosmetics since 1938. As described in our previous blog post, MOCRA focuses on safety of cosmetics. Among other things, FDA is to develop and issue good manufacturing practice regulations, develop tests for asbestos and address PFAs in cosmetics. Industry will become subject to registration and listing requirements (one year after enactment of MOCRA), must have records to substantiate safety of its products, and must report serious side effects to FDA. MOCRA gives FDA mandatory recall authority (when it determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use or exposure to the cosmetic will cause serious adverse health consequences or death) and expands FDA’s access to certain records.
MOCRA preempts state law requirements differing from, or in addition to, those relating to registration and product listing, good manufacturing practice, recordkeeping, recalls, adverse event reporting, and safety substantiation. However, other prohibitions and limitations on the use or amount of an ingredient in a cosmetic product, state tort laws, and state laws and referendums, such as California’s Proposition 65, are carved out from preemption. Although the preemption provision certainly is not as strong as industry would prefer, industry has generally supported modernization of cosmetic regulation as it will advance innovation, modernize oversight and (presumably) bolster consumer confidence. At least for now, industry has been successful in preventing user fees for cosmetic companies. Congress appropriated $14,200,000 for fiscal year 2023, $25,960,000 for fiscal year 2024, and $41,890,000 for each of fiscal years 2025 through 2027 to FDA for developing regulations and performing the other activities under MOCRA.
The passing of MOCRA does not change matters for industry overnight. The requirements for registration and listing and new enforcement provisions become effective one year after enactment of the legislation. A client memo prepared in early 2023 will address MOCRA and other major provisions of FDORA in further detail.