FDA Proposes Stricter Testing for Talc Products

The U.S. Food and Drug Administration (FDA) recently proposed a new rule to enhance the safety of cosmetic products containing asbestos. The rule, titled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,” seeks to mandate standardized testing procedures to identify the presence of asbestos, a known carcinogen, in these products.

Talc is a mineral commonly used in cosmetics for its moisture-absorbing properties and smooth texture. However, since talc deposits are often geologically close to asbestos, they can easily become contaminated with asbestos fibers. Asbestos exposure has been linked to severe health issues, including lung cancer, mesothelioma, and ovarian cancer. This is the rationale behind the FDA’s proposal to standardize testing methods to minimize the risk of asbestos contamination. The FDA requires manufacturers to implement two methods for testing:

• Polarized Light Microscopy (PLM)
• Transmission Electron Microscopy (TEM), including Energy Dispersive Spectroscopy (EDS) and Selected Area Electron Diffraction (SAED)

Since 2019, the agency’s contracted laboratory has analyzed over 200 talc-containing cosmetic product samples utilizing advanced techniques such as TEM, EDS, and SAED, which can reliably detect even a single asbestos fiber 0.1 microgram of talc. This gives confidence in the proposed testing methods, emphasizing the importance of adopting standardized testing to ensure product safety.

Manufacturers may also rely on a certificate of analysis from their talc suppliers, provided they verify the accuracy of these certificates through periodic testing. If finalized, this rule would impose new responsibilities on cosmetic product manufacturers, such as:

• Mandatory Testing: Each batch of talc-containing cosmetic products must be tested using the specified methods to ensure they are asbestos contamination-free.
• Recordkeeping: Manufacturers must maintain detailed records of their testing procedures and results, demonstrating compliance with the FDA’s standards.

Non-compliance with the rule’s testing and record-keeping provisions could result in the FDA deeming the cosmetic product adulterated under the Federal Food, Drug, and Cosmetic Act, leading to potential legal and financial repercussions. Additionally, if asbestos is present in a cosmetic product or talc used in a cosmetic product, the product and talc would be deemed adulterated, respectively.

This proposal comes in the wake of numerous lawsuits alleging that talc-based products, such as certain baby powders, were contaminated with asbestos, leading to health issues. Notably, Johnson & Johnson is facing over 62,000 claims asserting that their talc products caused cancer due to asbestos contamination. The company has proposed a settlement to resolve these claims, although it still maintains that its products are safe.

The FDA is currently seeking comments on the proposed rule from the public and industry stakeholders over 90 days ending March 27, 2025, after which the agency will review feedback before giving the final rule. If implemented, the rule will safeguard consumers of talc-based cosmetics by reducing the risk of asbestos exposure and addressing the potential for contamination. Additionally, it will help minimize product recalls and enhance consumer trust in talc-containing products.

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