On December 26, 2024, the U.S. Food and Drug Administration took a major step toward better consumer protection with a proposed new rule under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Today’s proposed rule, “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,” proposes standardizing the methods by which asbestos contamination is detected and identified in cosmetic products containing talc.
Why This Rule Matters
Asbestos is a known human carcinogen and a potential contaminant in talc, an ingredient used in many cosmetic products. Current FDA regulations do not specify methods for testing asbestos contamination. This proposed rule closes that gap by requiring manufacturers to use standardized methods, ensuring consistency in testing practices and reducing the risk of asbestos exposure.
Overview of Proposed Rule
Test Methods: The manufacturer’s two accepted methods of testing for asbestos in talc-containing products are Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM/EDS/SAED).
Scope: Testing applies to representative samples of each batch or lot of talc-containing products and the raw talc ingredient.
Supplier Certification: Manufacturers may rely on certificates of analysis from talc suppliers but must verify their reliability through additional testing.
Enforcement Provisions: Failure to test or maintain records would render the product adulterated under sections 601(a) and 601(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Any product that contained asbestos would also be considered adulterated.
Background and Consistent with Scientific Opinions
FDA’s proposed rule is supported by scientific reviews led by the Interagency Working Group on Asbestos in Consumer Products, starting with an initial report in 2018. This rule is based on scientific opinions given at a public meeting in 2020 and included in the IWGACP White Paper published in 2022. These measures are designed to increase consumer protection and reduce health exposure associated with asbestos.
Benefits of the Proposed Rule
Consumer Safety: This will reduce asbestos exposure, thus reducing the number of asbestos-related illnesses.
Industry Confidence: Recalls are not initiated, and safety standards are always achieved.
Comment Period
All interested parties are encouraged to access the proposed rule and submit comments. Comments may be submitted 90 days after publication in the Federal Register via Regulations.gov, citing docket number FDA-2023-N-4225.
What’s Next?
As soon as this proposed rule is finalized, the cosmetic industry can expect a new safety paradigm. The manufacturers and the persons responsible shall make the necessary preparations to implement such a change and guarantee compliance.
