FDA Proposes Rule for Mandatory Asbestos Testing of Talc-Containing Cosmetics

SG 050/25

The US Food and Drug Administration (FDA) is proposing a requirement for standardized testing methods to detect and identify asbestos contamination in talc-containing cosmetic products.

The FDA proposal would mandate testing of talc-containing products by manufacturers in alignment with the Modernization of Cosmetics Regulation Act (MoCRA) to enhance consumer safety. Manufacturers would be required to utilize both polarized light microscopy (PLM) and transmission electron microscopy (TEM), combined with energy dispersive spectroscopy (EDS) and selected area electron diffraction (SAED), to detect asbestos in talc-containing cosmetic products. These methods are expected to provide a comprehensive approach to asbestos detection.

Testing would be required on representative samples from each batch or lot of the final talc-containing cosmetic products or the talc ingredient itself. Alternatively, manufacturers could rely on certificates of analysis (COA) from their suppliers, provided they verify the reliability of these certificates.

The proposed rule would also require manufacturers to maintain detailed records of asbestos testing methods (i.e. raw data and descriptions of testing methods/protocol). If manufacturers rely on supplier COAs, they must document verification of supplier testing. Records must be retained for at least three years and made available to the FDA within one business day upon request.

Failure to comply with testing or recordkeeping requirements would render the cosmetic product adulterated under the Federal Food, Drug and Cosmetic Act (FD&C Act). Additionally, any presence of asbestos in a cosmetic product or its talc ingredient would also deem the product adulterated, prohibiting its sale and distribution within the US market.

The comment period is open to industry stakeholders and the public until March 27, 2025.

Key terms under FDA-2023-N-4225 (RIN 0910–AI82)

Timeline summary:

Compliance provisions:

• Failure to test a talc ingredient or a talc-containing product in compliance with the proposed act renders the product adulterated under section 601(c) of the FD&C Act
• Failure to comply with recordkeeping requirements renders the cosmetic product adulterated under section 601(c) of the FD&C Act
• If asbestos is present in a talc-containing cosmetic product or talc ingredient, the product is adulterated under section 601(a) of the FD&C Act

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