FDA Proposed Rule: Testing Methods to Detect and Identify Asbestos in Talc-Containing Cosmetics

The U.S. Food and Drug Administration (FDA) has proposed requiring the use of standardized testing methods for talc-containing cosmetics, in order to detect and identify possible asbestos contaminants. The FDA has also proposed corresponding adulteration provisions. Asbestos is a potential contaminant in talc, which is used in certain cosmetics, and is a known human carcinogen. If finalized, this proposed rule would help protect users of talc-containing cosmetics from harmful exposure to asbestos, because these products may be contaminated. The FDA issued this proposed rule under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which requires the issuance of proposed and final regulations to establish and require standardized testing methods to detect and identify asbestos in talc-containing cosmetics. Summary of the main provisions of the proposed rule The proposed rule describes the testing methods that, if finalized, manufacturers of talc-containing cosmetics would need to use to detect and identify asbestos in these products. The proposed rule would require manufacturers to test a representative sample of each batch or lot of talc-containing cosmetic for asbestos using polarized light microscopy (PLM) (dispersion staining) and transmission electron microscopy (TEM)/energy dispersive spectroscopy (EDS)/selected area electron diffraction (SAED). The proposed rule also contains provisions allowing manufacturers the flexibility to test each batch or lot of the talc cosmetic ingredient, or to rely on a certificate of analysis for each batch or lot provided by a qualified talc supplier before using the talc to manufacture a talc-containing cosmetic, provided that the analytical methods used to test the talc include PLM and TEM/EDS/SAED. From discussions and meetings with industry representatives, the FDA understands that testing talc before adding it during cosmetic manufacturing is an industry practice to avoid manufacturing and selling talc cosmetics containing asbestos. We specifically invite comments on existing industry practices and the practicality of this approach. In addition, the proposed rule contains provisions requiring manufacturers to keep records demonstrating compliance with the rule. Finally, the proposed rule contains enforcement provisions. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a manufacturer's failure to operate in accordance with the testing and recordkeeping requirements would render the product adulterated. Furthermore, because no safe level below which asbestos would not have adverse health effects has been established, the FDA has determined that any amount of asbestos in a talc-containing cosmetic could harm users. Therefore, the proposed rule would provide in regulation that if asbestos is present in a talc-containing cosmetic, or in the talc used in the cosmetic, the cosmetic is adulterated under the FD&C Act. Likewise, if talc used in a cosmetic contains asbestos, the talc is adulterated under the FD&C Act. If finalized, the proposed rule would require the use of standardized testing methods to test talc-containing cosmetics to detect and identify asbestos that may be present as a talc contaminant. The benefits include potential public-health benefits for consumers from reduced asbestos exposure. If the proposed rule reduces exposure, the health benefits would include a reduction in diseases such as mesothelioma and lung, laryngeal and ovarian cancer.