Potential Consumer Litigation Impacts from FDA’s Proposed Rule on Standardized Testing for Talc-Containing Cosmetics

For years, consumers have initiated legal actions against cosmetic companies alleging a causal relationship between the use of certain cosmetic products containing talc (such as baby powder) and the development of various cancers, commonly mesothelioma and ovarian cancer, with varied results. Below, we discuss a recent proposed rule from FDA proposing asbestos testing for cosmetics containing talc and potential impacts on ongoing and new consumer litigation.

On December 27, 2024, the Food and Drug Administration (FDA) published a proposed rule in the Federal Register, requiring certain standardized testing methods to detect and identify asbestos in talc-containing cosmetic products pursuant to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), along with an enforcement mechanism.

On January 20, 2025, President Donald Trump signed an Executive Order requiring departments and agencies to (1) submit any upcoming proposed rule for approval by an agency head appointed by the President and (2) withdraw any rule submitted but not yet published in the Federal Register. Because this proposed rule was already published in the Federal Register in December 2024, this proposed rule does not need to be approved or withdrawn. This proposed rule does not yet have an effective date, but the Executive Order also encourages agencies to postpone any effective date by 60 days. Given this suggested postponement and that this administration may be more amenable to industry comments, the final rule may be further delayed. That said, a standardized testing rule for talc-containing cosmetics is required under the MoCRA statute, and therefore FDA is legally required to follow through with a final rulemaking.

The proposed rule indicates that talc is a mineral ingredient used in many popular cosmetics such as body powders, face powders, blush, foundation, and eyeshadow. Talc can be impacted by asbestos, which is a known carcinogen found in the same rock types as talc deposits. FDA cited research showing that asbestos may be inseparable from talc in the mining process, prompting a concern that talc-containing cosmetic products may be contaminated with asbestos.

Who Must Comply?

If the proposed rule becomes final in substantially similar form, manufacturers of any talc-containing cosmetic product, including cosmetics that are also classified as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act), would be subject to the requirements in FDA’s proposed rule.  

Testing Requirements

FDA’s proposed rule would require manufacturers to test a representative sample of each batch or lot of a talc-containing cosmetic product or test the talc ingredient for the presence of asbestos. This testing would need to be done using both Polarized Light Microscopy (PLM) (with dispersion staining) and Transmission Electron Microscopy (TEM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED). Under the rule, any amount of asbestos detected by either approach would render the sample positive for asbestos.

In lieu of testing the product batch or talc ingredient, the proposed rule would also allow manufacturers to rely on a certificate of analysis from a talc supplier prior to using the talc ingredient in manufacturing a cosmetic product. If a manufacturer relies on a certificate of analysis, they would also need to verify that the supplier’s asbestos testing includes both PLM and TEM/EDS/SAED approaches and that the testing is performed on the specific talc purchased by the manufacturer on an annual basis.

Recordkeeping and Retention Requirements

The proposed rule would also mandate that manufacturers keep records of asbestos test data, including raw data, and detailed descriptions of how samples were tested. Manufacturers who rely on a talc supplier’s certificate of analysis would need to retain the certificates and documentation of how the manufacturer verified the supplier’s test results.

Manufacturers would be required to retain these records for a period of 3 years and make the documents available for inspection and copying, including electronic delivery, within 1 business day of a request from FDA.

Enforcement

Under the proposed rule, a cosmetic product will be considered adulterated if (1) any asbestos is present in any finished cosmetic product or the talc used in the product, or (2) if the manufacturer fails to comply with either the testing or recordkeeping requirements. The significance of deeming a cosmetic product adulterated would be at least twofold. First, both the FD&C Act and MoCRA prohibit the sale or delivery of an adulterated cosmetic product. In addition, under MoCRA, FDA has authority to recall any cosmetic product the agency determines is adulterated.

Public Comment Period

FDA seeks comments on the proposed rule, which may be submitted electronically at https://www.regulations.gov/, or by mail, by March 27, 2025, 11:59 p.m. Eastern Time. FDA specifically invites comments on the proposed rule definitions, existing industry practices on testing talc, the timeline for maintaining and submitting testing records, and the cost to industry in implementing the new requirements. Interested companies with a stake in these potential new requirements should strongly consider submitting comments for FDA’s consideration.

We will be following the comments and will provide updates with industry insights or concerns.

Potential Litigation Impacts

Assuming FDA’s proposed rule goes into effect in substantially the same form as the proposed rule, a variety of potential impacts on consumer litigation are possible.

First, FDA’s proposed rule sets forth specific testing standards, requiring use of PLM (with dispersion staining) and TEM/ EDS/ SAED. This may set a new industry standard for accepted testing regarding the presence of asbestos in cosmetic products. This means that a consumer’s claims regarding the presence of asbestos in cosmetic products that are premised on testing different from that required in FDA’s proposed rule may be called into question. Similarly, expert methodology based on different types of testing may be easier to challenge under Daubert or other state standards for exclusion of expert testimony. On the flip side, however, companies subject to FDA’s eventual final rule may face arguments that any noncompliance with FDA’s testing requirements makes a cosmetic product adulterated under federal law.

Second, the recordkeeping requirement under this proposed rule would likely become a basis for plaintiffs to request testing and certificate documentation in discovery. Companies subject to FDA’s final rule should implement practices to ensure both compliance with any recordkeeping requirements and the ability to produce historical records to the agency and/or plaintiffs in the event of litigation.

Third, FDA’s proposed new requirements may form the basis of a compliance defense under certain state laws. In other words, where this defense exists under state law, a company faced with consumer litigation may be able to demonstrate its compliance with FDA’s requirements under the final rule to avoid liability. At a minimum, compliant companies will have created documentation supporting a finding there was no asbestos in their products—and this could go a long way to undermining a causation argument in consumer litigation.

We will continue to follow developments in FDA’s proposed rule as it undergoes the process to become final and watch for and report on real world litigation impacts.