As the U.S. regulatory framework is strengthened under the Cosmetic Regulatory Modernization Act (MoCRA), the U.S. Food and Drug Administration (FDA) has published proposed rulemaking that could significantly impact cosmetics containing talc.
On December 26, 2024, the FDA proposed introducing standardized test methods to detect the presence of asbestos in cosmetic products containing talc. Asbestos is a known human carcinogen and, although not intentionally added to cosmetics, can be a naturally occurring contaminant in talc, which is commonly used in powders and makeup products.
The proposed rule would require manufacturers to test their products using validated techniques such as:
PLM (polarized light microscopy)
TEM/EDS/SAED (transmission electron microscopy/energy dispersive spectroscopy/selected area electron diffraction)
These methods were reviewed and supported by the Interagency Working Group on Asbestos in Consumer Products (IWGACP) in a peer-reviewed scientific report published in 2022.
To date, no specific method has been formally mandated in the United States for testing for asbestos in cosmetics. The goal of this proposal is to harmonize testing practices and enhance consumer safety.
Products that do not comply with this rule would be considered adulterated under the FD&C Act.
Products found to contain asbestos would be removed from the market, and violating manufacturers would face potential fines.
Beyond critical health concerns, these regulations provide transparency and an opportunity for responsible brands to demonstrate the accuracy of their product safety. Fewer recalls, simpler compliance, and greater consumer confidence are all direct benefits. The proposed rule is now open for public comment for 90 days via Regulations.gov under the reference number FDA-2023-N-4225.
More information:https://ecomundo.eu/en/blog/fda-projet-regle-talc-amiante-cosmetiques
