In a pivotal step, the US Food and Drug Administration (FDA) has proposed a plan to create uniform methods for detecting asbestos in cosmetics containing talc.
Concerns About Asbestos
Asbestos, a mineral notorious for its links to cancer, often occurs alongside talc in the same geological formations. This proximity complicates the extraction process, making it difficult to ensure the purity of talc products.
Talc is a popular ingredient in cosmetics, valued for its moisture-absorbing qualities that help prevent clumping and contribute to the silky texture of face makeup.
FDA’s Testing Proposal
Linda Katz, head of the FDA’s Office of Cosmetics and Colors, noted that the agency has been diligently testing and sampling talc-containing cosmetics for asbestos over the years. In addition, the FDA has partnered with other federal agencies to reduce the risks associated with asbestos exposure from potentially contaminated talc products.
The FDA’s assessment includes a thorough review of scientific research and the complex policy issues surrounding asbestos detection in talc. With confidence, the agency believes the proposed testing methods will effectively ensure the safety of products that contain talc.
If this proposal gains approval, it would require manufacturers of talc-based cosmetics to conduct asbestos testing using specific methods. These methods would include Polarized Light Microscopy (PLM) with dispersion staining, along with options such as Transmission Electron Microscopy (TEM), Energy Dispersive Spectroscopy (EDS), or Selected Area Electron Diffraction (SAED) for precise asbestos identification.
Regulatory Implications
Manufacturers would also have the alternative option of using a certificate of analysis from their talc suppliers. The proposal calls for companies to keep detailed records that demonstrate compliance with the new testing requirements.
This regulatory effort aligns with the FDA’s commitment to adhere to section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
Once finalized, the regulations would classify any talc-based cosmetics from manufacturers that do not comply with the testing and record-keeping requirements as adulterated products. Furthermore, cosmetics found to contain asbestos, whether in the product itself or in the talc, would also fall under this adulteration classification. This means any talc intended for cosmetic use that contains asbestos would be considered non-compliant.
Currently, there is a public comment period open for 90 days, following the rule’s publication in the Federal Register on December 27, 2024. After this period, the FDA will take into account the feedback received as it develops the final rule.
Several notable companies in the beauty sector, including Estée Lauder Companies, Avon, and Johnson & Johnson, continue to navigate legal challenges related to talc exposure.
Source: Cosmeticsbusiness