FDA moves to standardize asbestos testing in talc cosmetics

The US Food and Drug Administration (FDA) has announced a proposed rule that would require manufacturers of talc-containing cosmetic products to use standardized testing methods to detect asbestos contamination. This regulatory move, part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), aims to enhance consumer safety by reducing the risk of exposure to asbestos, a known carcinogen.

If finalized, the rule would represent a significant change for cosmetics manufacturers and suppliers, imposing stricter testing and recordkeeping requirements.

Proposed rule: New testing requirements for asbestos

The FDA’s proposed rule, titled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,” mandates that manufacturers use both Polarized Light Microscopy (PLM) with dispersion staining and Transmission Electron Microscopy (TEM) to test for asbestos.

Currently, there are no FDA-mandated methods for asbestos testing in talc-based products. “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,” said Linda Katz, M.D., M.P.H., director of the FDA’s Office of Cosmetics and Colors in a media statement.

The agency believes the proposed techniques are the most appropriate for detecting asbestos in cosmetic products.

Why this rule matters to the cosmetics industry

Talc, a naturally occurring mineral, is widely used in personal care products for its moisture-absorbing and texture-enhancing properties. However, talc deposits often occur alongside asbestos-containing rocks, creating a contamination risk.

“Asbestos is a known human carcinogen,” the FDA stated in its Constituent Update. “If finalized, [the rule] would result in fewer asbestos-related illnesses by reducing exposure to this harmful contaminant.”

The proposed rule is particularly relevant for manufacturers because failure to comply would have legal and financial consequences. If a product is found to contain asbestos, or if a manufacturer fails to meet the testing and recordkeeping requirements, the product would be considered adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This designation could trigger regulatory enforcement actions and product recalls, causing reputational damage and financial loss to businesses.

Testing methods: What manufacturers need to know

Manufacturers may also rely on a certificate of analysis from their talc suppliers, but they must verify the accuracy of these certificates through their own periodic testing.

The rule would require manufacturers to test representative samples from each batch of finished cosmetic products containing talc or from each lot of talc used as an ingredient. Manufacturers must maintain records to demonstrate compliance with these requirements.

Consumer and Industry Impact

The FDA emphasized that the proposed rule is designed to protect consumers from asbestos exposure and reduce asbestos-related illnesses. “We believe that the proposed testing techniques are appropriate methods to detect asbestos to help ensure the safety of talc-containing cosmetic products,” said Dr. Katz in a media statement.

For manufacturers, adhering to the rule would minimize the risk of costly recalls and improve consumer confidence in talc-containing products. However, it would also introduce additional compliance and operational challenges, particularly for companies that source talc from multiple suppliers.

The rule is based on recommendations from the Interagency Working Group on Asbestos in Consumer Products (IWGACP), a group formed in 2018 to address concerns about asbestos contamination in consumer products.

Next steps: Public comments and final rule development

The FDA is encouraging public comments on the proposed rule. The comment period will remain open for 90 days after the rule is published in the Federal Register.

After the comment period closes, the FDA will review the feedback before issuing a final rule. Manufacturers and industry stakeholders are urged to participate in the public commenting process to provide insights on the practical implementation of the rule.

Comments can be submitted electronically through Regulations.gov, using docket number FDA-2023-N-4225.

For cosmetics manufacturers and suppliers, the proposed rule presents both a challenge and an opportunity to enhance product safety and consumer trust. Industry stakeholders should take an active role in shaping the final rule by participating in the public comment process.