FDA Proposes New Testing Rules to Detect Asbestos in Cosmetics

The agency said the rule will protect people who use talc-containing products from possible exposure to the known carcinogen.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) proposed a federal rule on Dec. 26 aimed at protecting people who use talc-containing cosmetic products from potential asbestos exposure.

If finalized, the rule would require cosmetic products containing talc to be tested using standardized methods to detect if asbestos, a known carcinogen, is present.

Under the agency’s proposed rule, manufacturers of talc-containing cosmetic products would be required to test for asbestos using methods such as Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM), to detect and identify whether or not asbestos is present in the products.

Alternatively, manufacturers may rely on a certificate of analysis from the talc supplier, according to the FDA.

Research on possible links between cancer and talc has been mixed, with some studies reporting a slightly increased risk and some reporting no increase, according to the American Cancer Society.

“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,” FDA Office of Cosmetics and Colors Director Linda Katz said in a Dec. 26 statement.

Katz said the agency has “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,” she said.

The proposed rule contains provisions that would require manufacturers to keep records to demonstrate compliance with the rule. If manufacturers fail to comply with the testing and record-keeping requirements, the FDA would be allowed to declare their products “adulterated” under the Federal Food, Drug, and Cosmetic Act.

The term “adulterated” means the product or products are “defective, unsafe, not shown to be safe, filthy, or produced under insanitary conditions,” or made under procedures and controls that “do not comply with Current Good Manufacturing Practice regulations,” according to the FDA.

The proposal comes as pharmaceutical giant Johnson & Johnson grapples with ongoing litigation alleging links between its branded talc products, including baby powder, and ovarian cancer. Cosmetics firm Avon also faces lawsuits over claims its talc-based products were contaminated with asbestos.

Both companies say the claims are without merit and are seeking to resolve the lawsuits.

Talc is a naturally occurring mineral used in a variety of cosmetics and personal care products, in part due to its ability to absorb moisture, prevent caking, and improve the overall feel of the product.

Asbestos, a mineral fiber mined from underground deposits, is found in the same types of rock as talc deposits, leading to a risk of cross-contamination. Due to this risk, it is important to test for the presence of asbestos in talc-containing cosmetic products, according to the FDA.

The FDA is seeking public comments on the proposed rule for the next 90 days, after which, the agency said it will review and consider comments as it develops the final rule.

Erik Haas, worldwide vice president of litigation at Johnson & Johnson, said the FDA’s proposed rule requires testing by Transmission Electron Microscopy (TEM), something he said the company has “utilized for approximately 50 years and which has consistently demonstrated our talc did not contain asbestos.”

“This is just one piece of the robust body of science that proves that our talc does not cause cancer of any type,” Haas told The Epoch Times via email.

The Epoch Times reached out to Avon for comment but did not receive a response by publication time.

Reuters and the Associated Press contributed to this report.