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Talc-Testing Rule Withdrawal: Are the Wheels Coming Off at the FDA?

Published December 2, 2025
Published December 2, 2025
Marcelo Moreira via Pexels

Key Takeaways:

  • The FDA withdrew its proposed rule, despite scientific consensus on the potential presence of asbestos in talc.
  • MAHA priorities and “highly scientific and technical issues” in public comments drove the agency to withdraw the rule.
  • The FDA’s lack of urgency undercuts its own “expert roundtable on talc,” held earlier this year.

In a regressive regulatory pivot, the U.S. Food and Drug Administration (FDA) withdrew its proposed rule requiring standardized methods for detecting asbestos in talc-containing cosmetic products, published in the Federal Register on November 28.

The proposed rule, initially published in December 2024 under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), was expected to set the first federally enforceable testing standards for asbestos contamination in cosmetic talc, a long-standing, controversial ingredient at the center of litigation, consumer concern, and industry scrutiny.

As stated in the notice, the FDA claimed it had good cause to withdraw the proposed rule, on “the basis of the Make America Healthy Again (MAHA) priorities to ensure safe additives in the American food and drug supply ….” Robert F. Kennedy Jr., Secretary of Health and Human Services (HHS), signed the withdrawal, underscoring the administration's growing role in shaping cosmetic safety policy under the MAHA public health umbrella. The agency also said that the decision to withdraw the proposed rule was in response to public comments it received.

If you can look past the lengthy run-on sentences and vague language in the notice, you will see evidence of a flailing agency plagued by MAHA and mass job reductions. The notice reads like it was put together by FDA interns who panicked upon reading the “highly scientific and technical issues” raised in the public comments.

But these “highly scientific and technical issues” are not new to the FDA. On May 20, 2025, FDA Commissioner Dr. Martin Makary hosted an “FDA Expert Roundtable on Talc.” Dr. Makary’s opening remarks at the expert roundtable highlighted the urgency of talc testing and the potential dangers of asbestos in cosmetics and food.

After quoting a large body of research around talc and asbestos, Dr. Makary looked up from his notes and said in earnest to the panelists, “Are we ignoring these results because we’re concerned about what it means for our lives?”

After a meaningful pause, Dr. Makary continued, “Are we ignoring these results because we’re worried about the potential [that] we would have to change the way medications, candy, and food are made? Are we putting our heads in the sand?”

With hands crossed, Dr. Makary then addressed the panelists as if he were lecturing to his students, raising his eyebrows in an almost scolding way, “Well, today is one of those opportunities for us to learn [eyebrow raise] about the different opinions and the scientific evidence on this topic.”

Panelist Dr. George Tidmarsh, who recently resigned as the Director of the Center for Drug Evaluation and Research (CDER) pending an ethics investigation (he’s accused of using his authority to carry out a personal vendetta), stated that due to the scientific evidence showing the potential dangers of talc, the question shouldn’t be if talc should be removed from the US market, but when.

Dr. Nicolas Wentzensen, Deputy Director and Head of the Clinical Genetics Branch at the National Institute of Health’s (NIH) National Cancer Institute (NCI), pointed out the “flawed” industry standards for assessing asbestos in talc. “It’s really very hard to assess what is a pure talc association versus what is contaminated,” Wentzensen said.

In an email to BeautyMatter, Rachael Burden, Communications Advisor for the FDA, said that the agency remains committed to assessing the safety and necessity of talc use in the American food, drug, and cosmetics supply.

The expert panelists agreed that the scientific evidence indicates that talc is a potential carcinogen. In 2024, the European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) recommended a classification of talc as a carcinogen and intends to ban all talc products by 2027.


"Cosmetic users deserve a rule that produces accurate results and that protects critical manufacturing investments.”
By Chris Phalen, Vice President of Domestic Policy, National Association of Manufacturers

Follow. The. Money.

The FDA’s notice of withdrawal stated that its decision was based on 49 public comments. What the agency didn’t specify is that many of the comments were submitted by organizations or individuals who could potentially lose significant revenue if the FDA had finalized the 2024 proposed rule.

It’s not surprising that multiple mineral miners and manufacturers would chime in on the withdrawn proposed rule. Vanderbilt Minerals, LLC, notorious for paying out millions in litigation for its asbestos-contaminated talc, demanded more than recommended changes in its comment to the FDA, using the word “must” in its comments 32 times. The company cited  a need for the FDA to change definitions and testing methods and to institute a risk-based de minimis testing method.

While the National Association of Manufacturers (NAM) attempted to appeal to the MAHA-led HHS by conjuring President Trump's Executive Order from January 2025, “Unleashing Prosperity Through Deregulation,” the trade organization asked the FDA to "reconsider and repropose a rule that better aligns with both the congressional intent of MoCRA and the administration’s efforts to reduce the regulatory burden on manufacturers."

Chris Phalen, Vice President of Domestic Policy, National Association of Manufacturers, told BeautyMatter in a statement, “Manufacturers need a rule that aligns with congressional intent and Gold Standard Science, utilizing scientifically sound testing methods. This means relying on validated testing methods along with their appropriate detection limits and allowing for ambiguous results to be clarified through additional testing. Cosmetic users deserve a rule that produces accurate results and that protects critical manufacturing investments.”

Mixing talc with politics is nothing new. David Rosner, Ronald H. Lauterstein Professor Emeritus of Sociomedical Sciences and Professor of History at Columbia University, and author, co-wrote a paper, “‘Nondetected’: The Politics of Measurement of Asbestos in Talc, 1971-1976,” published in the March 2019 issue of the American Journal of Public Health. In the journal, Rosner laid out all the ways the FDA has dodged stricter talc regulation since 1971 and how little has changed as a result. “The consequences of industry’s actions and inactions—and of its knowledge or lack thereof—that were identified a half century ago are still with us.”

Waiting Game

The FDA said it needs additional time to evaluate the issues raised in the comments, reconsider its legal footing under the Administrative Procedure Act, and align with MAHA priorities; withdrawal of the proposed rule does not mean abandonment.

Section 3505 of MoCRA requires the FDA to develop standardized testing methods for asbestos in talc-containing cosmetics. With the 2024 proposed ruling now off the table, the agency said it will issue a new proposed rule after reassessing its approach.

The decision to withdraw comes as asbestos in talc remains a top consumer-safety flashpoint:

  • Litigation exposure continues to widen, with thousands of lawsuits involving billions of dollars alleging links between talc and cancer, targeting brands across beauty, personal care, and OTC categories, including Johnson & Johnson, which has previously come under fire. 
  • Consumer trust in talc products remains fragile, with many brands proactively pivoting towards talc-free formulations. 
  • Industry standards remain fragmented, with varied analytical methodologies and inconsistent detection thresholds leaving companies navigating a regulatory gray zone.

The now-withdrawn rule would have required manufacturers to test either finished cosmetic products containing talc or the talc ingredient itself before use and maintain compliant records. Any presence of asbestos or failure to conduct required testing would have rendered a product adulterated. Note that many cosmetic brands that use talc conduct their own voluntary asbestos testing.

Burden reiterated that the FDA will submit a new proposed rule that “offers a more comprehensive approach to reducing exposure to asbestos and reducing asbestos-related illness, including identifying safer additives and ingredients as alternatives, especially when they are less costly.”

A spokesperson for the Personal Care Products Council (PCPC) said the organization is aware of the withdrawal, but that the FDA has also stated it intends to meet its statutory obligations under MoCRA.

Testing talc-containing products for asbestos remains voluntary for the cosmetics industry. The good news is that the majority of cosmetic brands and manufacturers believe testing talc products is a basic requirement.

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