FDA Withdraws Cosmetics Proposed Rule: Let Us (Not) Talk About Talc

As we explained here, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires the FDA to issue proposed regulations establishing standardized testing methods to detect and identify asbestos in talc-containing cosmetic products.

In December 2024, the FDA published a proposed rule that, if finalized, would have required manufacturers of talc-containing cosmetic and cosmetic-drug combination products to test for asbestos using specified methods and to maintain related records.

Now, almost exactly one year later, the FDA has announced that it is withdrawing the proposed rule as of November 28.

FDA’s Rationale for Withdrawal

The FDA reported that it received 49 comments on the proposed rule, noting that commenters raised concerns in three principal areas.

• The potential for “unintended consequences” for talc-containing products if the proposal were finalized.
• Alignment on the proposed definition of “asbestos” with established approaches used by other federal agencies, including the US Department of Labor (Occupational Safety and Health Administration (OSHA) and Mine Safety and Health Administration (MSHA)) and the Environmental Protection Agency (EPA).
• The FDA’s statutory authority to add a specific adulteration provision to the Food, Drug, and Cosmetic Act regarding talc testing, and deem any cosmetic product containing any amount of asbestos adulterated.

The FDA concluded that there was “good cause” to withdraw the proposed rule in light of broader policy priorities (i.e., Make America Healthy Again priorities), scientific and technical issues raised in the comments, and legal considerations under the Administrative Procedure Act. The agency also explained it is taking action “to reconsider best means of addressing the issues covered by the proposed rule and broader principles to reduce exposure to asbestos, and to ensure that any standardized testing method requirements for detecting asbestos in talc-containing cosmetic products help protect users of talc-containing cosmetic products from harmful exposure to asbestos.”

What This Means for Industry Now

Continued Obligations Under MoCRA

The statutory requirement for the FDA to establish standardized testing methods for talc-containing cosmetics remains in place. Withdrawal of this proposal does not eliminate the FDA’s mandate; it simply signals that the FDA will reassess and may re-propose a revised approach.

Expect Re-Engagement on Definitions and Methods

Given the comments, the FDA may revisit the scope of “asbestos,” method selection and sensitivity, and harmonization with OSHA, MSHA, and EPA frameworks.

Maintain Robust, Fit-for-Purpose Controls

Manufacturers and distributors of talc-containing cosmetic and cosmetic-drug combination products should continue to do the following.

• Qualify and monitor talc suppliers, including specifications that address asbestos contamination risk.

• Use scientifically sound, validated methods, appropriate to assess asbestos risk.

• Preserve records that demonstrate method suitability, results, and supplier controls as part of MoCRA’s broader compliance expectations.

Prepare for a Future Proposal

Companies may be required to provide substantive data on method performance (e.g., detection limits, false positive or negative rates, or inter-laboratory reproducibility), feasibility, and supply chain impacts when the FDA re-engages.

ArentFox Schiff will continue to closely monitor additional updates on MoCRA compliance.

If you are interested in more information about MoCRA or are seeking guidance on any cosmetic-related requirements, please contact the authors.