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2023 FDLI Update 4 (2023)
MoCRA Is Here - Now What? Unpacking Litigation and Regulatory Risk for Cosmetics Brands following MoCRA's Enactment

handle is hein.journals/fdliup2023 and id is 6 raw text is: '0r .,0 MoCRA Is Here-Now What? Unpacking Litigation and Regulatory Risk for Cosmetics Brands Following MoCRA's Enactment by Frederick R. Ball, Alyson Walker Lotman & Kelly A. Bonner On December 23, 2022, Congress enacted the first major statutory change to the Food and Drug Ad- ministration (FDA)'s ability to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act (FDCA). Passed with bipartisan and industry support, the Modern- ization of Cosmetics Regulation Act (MoCRA) significant- ly expands FDA's rulemaking and enforcement authority over cosmetics and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States. Although MoCRA establishes several new requirements concerning product safety, it provides comparatively little guidance on the kinds of marketing or promotional claims brands can now make about the safety of their products. This article explores MoCRAs impact on cosmetics companies, what questions remain unresolved following MoCRA's passage, and what companies can do to protect themselves from regulatory scrutiny and litigation risk while continuing to educate consumers. Background Before MoCRA, the United States had not substantially changed or updated federal regulations governing cosmetics since the passage of the FDCA in 1938 and the passage of the Fair Packaging and Labeling Act (FPLA) in 1966. The FDCA required finished cosmetic products to be safe when used by customers in accordance with product labeling or custom- ary usage and to not be misbranded or adulterated,2 while the FPLA required cosmetics marketed on a retail basis to consumers in interstate commerce to be honestly and informatively labeled.3 The FDCA and the FPLA constituted the basis of federal cosmetics regulation for over 50 years, even as the cosmetics industry grew exponentially during that time, and required more comprehensive guidance. Although consumer advocacy groups and industry groups, like the Personal Care Products Council, called for updated regulation, several recent attempts to update the existing regulatory scheme failed to progress in Congress.4 What's New Following MoCRA? It is difficult to understate the impact that MoCRA will have on the cosmetics industry with respect to federal regu- latory oversight. MoCRA contains a number of significant federal obliga- tions regarding product safety. For example, MoCRA now: . requires any facility that manufactures or processes cosmetic products intended for sale in the United States-irrespective of whether the facility is located in the United States-to register with FDA; 4 UPDATE Spring 2023 w ww . fd li. or g

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