FDA: Talc Cosmetics Will Mandate Asbestos Testing

On December 26, the U.S. Food and Drug Administration (FDA) released a statement recommending mandatory asbestos testing for cosmetics containing talc and proposed rules for testing and identifying asbestos in talc-containing cosmetics. Once implemented, this rule will require manufacturers to use specific testing methods to ensure their products are free from asbestos.

The FDA noted that this move aims to protect consumers from potential harm posed by asbestos, a known carcinogen. Previously, Johnson & Johnson reached a $700 million settlement with several U.S. states due to asbestos found in their talcum powder, with the company spending over $5 billion on similar cases in the past decade.

Talc is a natural mineral widely used in cosmetics and personal care products for purposes such as moisture absorption, preventing clumping, providing opacity to cosmetics, and improving product texture. However, since talc and asbestos can coexist in the same rock types and may contaminate each other during mining, testing for asbestos in cosmetics is crucial.

The 2022 Cosmetic Regulatory Modernization Act requires the FDA to establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics. Linda Katz, Director of the FDA’s Office of Cosmetics and Colors, stated that the FDA has long been sampling and testing talc-containing cosmetics for asbestos and collaborating with federal partners to reduce consumer exposure to asbestos risks. After considering scientific evidence and complex policy issues related to testing and identifying talc and asbestos in talc-containing cosmetics, the FDA believes the proposed testing techniques are appropriate for detecting asbestos and will help ensure the safety of talc-containing cosmetics.

The FDA proposed requiring manufacturers to use methods such as polarized light microscopy (PLM) and transmission electron microscopy/energy dispersive X-ray spectroscopy/selective area electron diffraction (TEM/EDS/SAED) for asbestos testing. The proposed rule mandates manufacturers to test representative samples from each batch of talc-containing cosmetics or representative samples from each batch of talc ingredients used in cosmetics. Moreover, if manufacturers can establish and maintain the reliability of supplier analytical certificates through validation testing and determine the qualifications of suppliers, they may rely on the supplier's analytical certificate for talc.

If manufacturers fail to comply with the testing or record-keeping requirements in the rule, their talc-containing cosmetics will be considered adulterated under Section 601(c) of the Federal Food, Drug, and Cosmetic Act. Additionally, if the cosmetics contain asbestos, or if the talc used in cosmetics contains asbestos, the cosmetics will be deemed adulterated under Section 601(a) of the Federal Food, Drug, and Cosmetic Act. Similarly, if the talc used in cosmetics contains asbestos, that talc will also be considered adulterated under Section 601(a) of the Federal Food, Drug, and Cosmetic Act.

The implementation of the proposed rule will help protect consumers to some extent and reduce the chances of asbestos exposure, thereby lowering the risk of asbestos-related diseases. The FDA stated that there will be a 90-day public comment period before the implementation of the proposed mandatory asbestos testing regulations.