iThe U.S. Food and Drug Administration (FDA) announced on April 5, 2024, the results of its 2023 sampling assignment, testing talc-containing cosmetic products for the presence of asbestos. The testing was conducted using Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM). FDA states that “[a]sbestos was not detected in any of the 50 samples tested in 2023.”
FDA states that it selected and purchased cosmetic products, and then it blinded and transferred the samples to AMA Analytical Services, Inc. (AMA) for analyses. According to FDA, it selected products “based on various factors including type of talc-containing cosmetic product, price range, popular products on social media and in advertisements, products marketed to children, products marketed to women of color, and, if any, third party reports of potential asbestos contamination.”
As reported in our January 18, 2023, memorandum, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. MoCRA significantly strengthens FDA’s authority over cosmetic products. MoCRA states that talc-containing products require the establishment of regulations and standards test methods for detection and identification of asbestos. MoCRA establishes a timeline of one year for the proposed regulation, and no later than 180 days after the comment period closes for the final regulations. In its April 5, 2024, announcement, FDA states that it “intends to promulgate proposed regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.”
Commentary
The testing of asbestos, in various talc-containing cosmetic products, and comments noted by the agency itself, does signify progress with the requirement for FDA to develop a standardized testing method and require testing under MoCRA. The results noted in this latest assessment are encouraging considering recent issues with talc and talc-containing products testing positive for asbestos. FDA reported in 2019 multiple issues with various products, including those marketed and sold to children. FDA states “[c]ompanies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.” The development of test methods, and a requirement to test for asbestos, specifically, continues to point to changes in FDA’s authority and its approach to cosmetics and to specific cosmetic ingredients under MoCRA. As noted, MoCRA is the most significant expansion in this space since the Food, Drug, and Cosmetic Act was passed in 1938.
