FDA Proposes Standardized Testing of Talc Cosmetics to Identify Asbestos

The U.S. Food and Drug Administration (FDA) has unveiled a proposed rule to require standardized testing to detect asbestos in talc-containing cosmetic products.

The FDA says the proposed rule, if finalized, would help protect consumers who use talc-containing cosmetic products from harmful exposure to asbestos. This proposal is part of the agency’s work to fulfill the requirements of section 3505 of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

The proposed rule sets forth the approaches manufacturers should use to detect and identify the presence of asbestos. Manufacturers may alternatively rely on a certificate of analysis from the talc supplier. The rule also contains provisions that would require manufacturers to keep records to demonstrate compliance with the rule.

Johnson & Johnson has been sued by thousands of people who claim that the company’s baby powder and other talc products contain asbestos and have caused ovarian and other cancers. The healthcare company claims its products are safe and refutes the allegation. However it has sought to settle the claims with a $18.2 billion payout in bankruptcy.

Talc is a naturally occurring mineral that has many uses in cosmetics and other personal care products, Asbestos, a known carcinogen, is found in the same rock types as talc deposits. Because there is the potential for contamination of talc with asbestos, the FDA says it is important to test for the presence of asbestos.

“For many years the FDA has been sampling and testing talc-containing cosmetics for asbestos as well as working with our federal partners on efforts to reduce consumers’ risk of exposure to asbestos, a known human carcinogen, from contaminated talc-containing cosmetic products,” said Linda Katz, M.D., M.P.H., director of the FDA’s Office of Cosmetics and Colors. “We have carefully considered the scientific evidence and complex policy issues related to detecting and identifying asbestos in talc and talc-containing cosmetic products. We believe that the proposed testing techniques are appropriate methods to detect asbestos to help ensure the safety of talc-containing cosmetic products.”

The FDA encourages public comment on this proposed rule.