The US Food and Drug Administration proposed establishing and requiring standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

The proposed rule, entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,” if finalized, requires manufacturers of talc-containing cosmetic products to test their products for asbestos using specific testing methods. The proposed rule also contains corresponding adulteration provisions. Asbestos, a known human carcinogen, is a potential contaminant in talc, which is an ingredient used in certain cosmetic products. This proposed rule, if finalized, would help protect consumers by, to the extent it reduces exposure to asbestos, resulting in fewer asbestos-related illnesses.

FDA does not currently require any specific method or approach to test for asbestos in talc-containing cosmetic products. The proposal requires manufacturers of talc-containing cosmetic products use both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED) to test talc-containing cosmetic products for potential asbestos contamination. 

According to FDA, the proposal to require manufacturers of talc-containing cosmetic products to test for asbestos using PLM and TEM/EDS/SAED is aligned with scientific opinions from an Interagency Working Group on Asbestos in Consumer Products (IWGACP) formed in the fall of 2018. FDA held a public meeting entitled “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc” in February 2020, where preliminary scientific opinions of the IWGACP were presented. Subsequently, FDA released the IWGACP’s final scientific opinions in a White Paper (IWGACP White Paper) and related Technical Appendices, in January 2022, both of which were peer-reviewed.

The proposed rule requires manufacturers to test representative samples of each batch or lot of talc-containing cosmetic product or on representative samples of each batch or lot of the talc ingredient used in the manufacture of cosmetic products. Further, manufacturers of talc-containing cosmetic products may rely on a certificate of analysis from the talc supplier if they qualify the supplier by establishing and maintaining the reliability of the supplier’s certificate of analysis by performing verification testing.

The proposed rule also contains enforcement provisions. Failure to operate in compliance with the testing or recordkeeping provisions of the rule would render the talc-containing cosmetic product adulterated under 601(c) for the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 361(c)]. In addition, the proposed rule states if asbestos is present in a cosmetic product, or in talc used in a cosmetic product, that cosmetic product would be deemed adulterated under 601(a) of the FD&C Act [21 U.S.C. 361(a)]; and if asbestos is present in talc intended for use in a cosmetic, that talc is adulterated under 601(a) of the FD&C Act [21 U.S.C. 361(a)]. 

This proposed rule, if finalized, would protect consumers by, to the extent it reduces exposure to asbestos, resulting in fewer asbestos-related illnesses, maintains FDA. Manufacturers would also benefit from fewer recalls of talc-containing cosmetics.

Comments on the proposed rule should be submitted within 90 days after publication of the Notice of Availability in the Federal Register. You may submit electronic comments to Regulations.gov. All written comments should be identified with the docket number FDA-2023-N-4225 and title “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products” of the proposed rule.