FDA proposes Standardized Testing for Asbestos in Talc-Containing Cosmetic Products

The U.S. Food and Drug Administration (FDA) is proposing to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. When finalized, the rule would require manufacturers of talc-containing cosmetic products (TCCPs) to test their products for asbestos using specific testing methods. 

Background and Proposed FDA Rule

Asbestos, a known human carcinogen, is a potential contaminant in talc, which is an ingredient used in certain cosmetic products. The FDA does currently not require any specific method or approach to test for asbestos in TCCPs. Thus, the agency proposes to require that TCCP manufacturers use both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED) to test TCCPs for potential asbestos contamination. The proposal is aligned with scientific opinions from an Interagency Working Group on Asbestos in Consumer Products (IWGACP) formed in 2018.

Manufacturers will be required to test representative samples of each batch / lot of TCCPs or on representative samples of each batch / lot of the talc used in the manufacture of cosmetic products. However, TCCP manufacturers may also 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 CoA by performing verification testing.

The proposed rule also contains enforcement provisions. If the proposed rule is finalized, cosmetic products (or talc) would be considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act),

• if a manufacturer fails to operate in compliance with either the testing or recordkeeping requirements of the rule,
• if asbestos is present in a cosmetic product, or in talc used in a cosmetic product,
• if asbestos is present in talc intended for use in a cosmetic product.

When finalized, it would "protect consumers by, to the extent it reduces exposure to asbestos, resulting in fewer asbestos-related illnesses. Manufactures would also benefit from fewer recalls of talc-containing cosmetics", the agency says.

Comments on the proposed rule should be submitted to the FDA by 27 March 2025. All written comments should be identified with the docket number and the title of the proposed rule: "Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products".