Modernization of Cosmetics Regulations Act (MoCRA)
BY: Elisabeth Kotsalidis
The Modernization of Cosmetics Regulation Act (MoCRA) was signed into law on December 29, 2022. MoCRA is the first major update to the Food and Drug Administration’s (FDA) rulemaking and enforcement authority over the cosmetics industry since 1938. It was crafted with support and input from the Food and Drug Administration, consumer groups, and the cosmetics industry.
MoCRA’s provisions create a variety of new compliance obligations for cosmetic companies. For instance, MoCRA stipulates that cosmetic companies must register both their domestic and foreign facilities with the FDA. MoCRA requires that companies list each cosmetic product offered for distribution in the United States with the FDA. MoCRA also compels companies to report serious adverse events associated with the use of cosmetic products to the FDA. In an effort to increase the safety of cosmetic products, MoCRA requires safety substantiation of the products marketed and distributed in the United States through tests and research that support a reasonable certainty that the cosmetic products are safe.
MoCRA has significantly increased the FDA’s authority, allowing the agency to inspect the cosmetics manufacturing and processing facilities, as well as their records. MoCRA grants the FDA the authority to request a recall of a product if it determines that there is probability that the product is adulterated or misbranded, and its use will cause serious adverse health consequences or death. The FDA has also been instructed to develop regulations that establish and require standardized testing methods for identifying asbestos in talc-containing cosmetic products and assess the use of perfluoroalkyl and polyfluoroalkyl substances in cosmetics. However, MoCRA does recognize that the cosmetics industry is known for its many successful small businesses and therefore offers some flexibility through exemptions from many requirements for small businesses.
As of the Winter of 2024, the FDA is in the process of issuing draft guidance and requesting public comments. Small and large businesses and trade associations from all over the world have been sharing suggestions, expressing concerns, and requesting clarification. Cosmetics companies should keep an eye on the FDA’s website, where the agency releases frequent updates to ensure they do not miss new draft guidance or the period for public comments.
Although the full effect of MoCRA and the FDA’s ensuing regulations is still unknown, lawyers have expressed concerns over the potential for increased litigation, incoming discovery requests on their adverse event reporting data, and the threat of negligence allegations if they fail to comply with the new manufacturing practices rules. There are also concerns about the increased costs businesses will face associated with the creation and maintenance of adverse event reporting recording systems, employment of more regulatory affairs and compliance employees, and annual product listing updates. Even though MoCRA introduces new burdens on cosmetics companies, it was a long overdue overhaul of the FDA’s authority over cosmetics, brings cosmetics regulation more into line with the agency’s authority over food, drugs, and devices, and ultimately provides greater safety to users of cosmetics.
Key Sources
Modernization of Cosmetic Regulation Act of 2022, Pub. L. No. 117-328, sec. 2, § 3502, Stat. 1389 (codified at 21 USC 361).
Food and Drug Admin., Modernization of Cosmetics Regulation Act of 2022, COSMETICS LAWS & REGULATIONS (Sept. 18, 2023), https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022.
Kristen R. Klesh, MoCRA Increases FDA Oversight of the Cosmetics Industry, Loeb & Loeb LLP Client Alerts/Reports (March 2023), https://www.loeb.com/en/insights/publications/2023/03/mocra-increases-fda-oversight-of-the-cosmetics-industry.
Wade Ackerman, Jessica O’Connell & James Holloway, MoCRA: 6 Key Takeaways From The New Cosmetics Law, Covington & Burling LLP News and Insights, 4 (Jan. 20, 2023), https://www.cov.com/-/media/files/corporate/publications/2023/01/mocra-6-key-takeaways-from-the-new-cosmetics-law.pdf.
Frederick R. Ball, Alyson Walker Lotman & Kelly A. Bonner, MoCRA[1] Is Here—Now What? Unpacking Litigation and Regulatory Risk for Cosmetics Brands Following MoCRA’s Enactment, Food and Drug Law Institute (2023), https://www.fdli.org/2023/02/mocra-is-here-now-what-unpacking-litigation-and-regulatory-risk-for-cosmetics-brands-following-mocras-enactment/.
U.S. Food and Drug Administration, Modernization of Cosmetics Regulation Act of 2022 – Key Terms and Provisions, YouTube (Apr. 12, 2023), https://www.youtube.com/watch?v=p4UsMzXKyck&t=282s.