Regulatory Update: Proposed rule for Detecting Asbestos in Talc-containing Products
On 26 December 2024, the Food and Drug Administration (FDA) proposed to establish and require standardised testing methods for detecting and identifying asbestos in talc-containing cosmetic products, as mandated by the Modernisation of Cosmetics Regulation Act (MoCRA).
The proposed rule, entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,” if finalized, would require manufacturers of talc-containing cosmetic products to test their products for asbestos using specific testing methods.
- FDA’s proposal to require manufacturers of talc-containing cosmetic products to test for asbestos using PLM and TEM/EDS/SAED (Proposed § 730.3(c)) 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)].
The proposed rule is now open for comments until 27 March 2025.
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