On November 28, 2025, while most cosmetic companies were promoting their “Black Friday” deals for this year, the FDA quietly issued a Federal Register notice withdrawing the Agency’s previously proposed regulation for standardized testing methods to detect and identify asbestos in talc-containing cosmetic products, also known as the “Talc Rule.” The Talc Rule was proposed just under a year prior, on December 26, 2024, in accordance with a Congressional mandate under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), described further in our April 2025 publication, available here. The FDA confirmed that it will propose a new Talc Rule to fulfill its MoCRA obligations but did not indicate how, or to what extent, the new Talc Rule will differ from the original or which major federal holiday the Agency’s proposal will follow this time.
Why Did FDA Withdraw the Proposed Talc Rule?
The FDA’s announcement attributed the withdrawal to “Make America Healthy Again (MAHA) priorities to ensure safe additives in the American food and drug supply, the highly scientific and technical issues addressed in public comments the Agency has received [in response to the proposed Talc Rule], and the complexity of asbestos testing and legal considerations under the Administrative Procedure Act” (APA).
In particular, FDA briefly noted commenters’ concerns about the effect the proposed Rule would have on talc-containing products regulated as both cosmetics and drugs and other broader unintended consequences for many other consumer products made with talc. The Agency also referred to requests for revised definitions of “asbestos” and other terms to align with the definitions or approaches used by other federal agencies, such as the Occupational Safety and Health Administration, Mine Safety and Health Administration, and the Environmental Protection Agency.
Regarding the cited APA considerations, the Agency pointed to comments questioning the FDA’s statutory authority to deem cosmetic products containing any amount of asbestos to be adulterated under the federal Food, Drug & Cosmetic Act.
What Now?
This action adds yet another layer of uncertainty for cosmetic companies grappling with how to remain compliant with existing regulations while making the necessary preparations to comply with new laws and rules on the horizon. International brands are faced with unique challenges, as countries’ respective regulatory approaches to cosmetics, generally, and to asbestos and talc, in particular, continue to vary. For example, asbestos is already banned in the European Union, and many stakeholders are expecting talc to be similarly prohibited within the next two years in light of the recent European Chemicals Agency recommendation to classify talc as a Category 1B carcinogen.
Visit HB At The Counter to stay up to date on any future updates from FDA on the Talc Rule or the Agency’s plans to implement any of the other Congressional directives set forth in MoCRA.
