Cosmetics & The Law

On December 26, 2024, the U.S. Food and Drug Administration (FDA) announced a proposed rule to to establish required 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). 

If finalized, the proposed rule, entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,” would require manufacturers of talc-containing cosmetic products to test their products for asbestos using specific testing methods.

The proposed rule would require manufacturers to 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.  Testing of a representative sample would be required on either each batch of talc-containing cosmetic product or on each batch or lot of the talc ingredient. Alternatively, the manufacturer could rely on a certificate of analysis (COA) 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.

Enforcement provisions in the proposed rule provide that failure to perform the testing or to comply with the 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, if asbestos is present in a cosmetic, or in talc used in a cosmetic, that cosmetic 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)]. 

FDA had previously held a public meeting on this topic in 2020 and in 2022 the INTERAGENCY WORKING GROUP ON ASBESTOS IN CONSUMER PRODUCTS (IWGACP) released a White Paper wherein it provided IWGACP’s Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc. For information on the prior public meeting and the supporting documentation, you can check out the 2020 docket here.

Comments on the new proposed rule may be submitted electronically through Regulations.gov until March 27, 2025 to docket number FDA-2023-N-4225 and title “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.”

Please reach out if you would like assistance with submitting comments or have questions about how this new rule may impact your business.