FDA Backs Off Required Talc Testing for Asbestos Contamination

Agency claims the proposed testing regimen may have “unintended consequences” on other products, such as medications.

Federal regulators are withdrawing a proposed rule that would have required talcum powder–based cosmetics to be tested for asbestos, a contaminant linked to mesothelioma, lung cancer and other serious diseases.

The U.S. Food and Drug Administration (FDA) announced a proposed asbestos testing rule in late December 2024, which would have made it mandatory that talc-containing cosmetic products be tested for asbestos using both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TRM)/Energy Dispersive Spectroscopy (EDS)/Selected Area Electron Diffraction (SAED). 

At the time, the agency identified these methods as the most reliable techniques for detecting asbestos in talc and ensuring the safety of cosmetic products. Under the proposal, any product that failed to undergo the required testing would have been deemed adulterated and therefore illegal to sell under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

However, the FDA issued a Federal Register notice on November 28, announcing it was withdrawing the proposed talc testing rule, indicating it could have “unintended consequences” for some cosmetic products that are also drugs.

Asbestos Exposure Risks

For decades, asbestos exposure has been known to cause a number of serious health conditions, including mesothelioma, lung cancer and asbestosis. Mesothelioma is a rare but deadly form of cancer, which is only known to occur as a result of exposure to toxic asbestos particles. 

Concerns about talc contamination grew substantially after Johnson & Johnson issued a Baby Powder recall in October 2019, after testing determined that some bottles of their popular talcum powder products contained levels of chrysotile asbestos. Then, in 2020, a study directly linked talcum powder asbestos contamination to mesothelioma risks.

As a result, Johnson & Johnson currently faces more than 90,000 Baby Powder lawsuits and Shower-to-Shower lawsuits in state and federal courts, most involving similar claims that women developed ovarian cancer or other reproductive malignancies after applying the powder to their genitals. The company has already spent billions resolving most additional claims that asbestos in the products also caused mesothelioma.

Last week’s Federal Register notice indicates the FDA received comments questioning how the rule would apply to talc-based cosmetics that also function as drugs or medical treatments. The agency also noted that several commenters warned the proposal’s definition of asbestos conflicted with definitions already used by other federal agencies.

“FDA received comments regarding the Agency’s statutory authority under law to add a specific adulteration provision relating to talc testing and regarding its authority to consider a cosmetic containing any amount of asbestos to be adulterated.”

– Federal Register Doc. 2025-21407

The FDA received some comments from trade associations warning that talc used in over-the-counter medications and other consumer products could be adversely affected by the rule.

According to a November 26 New York Times report, FDA officials claim the agency plans to submit a new proposed rule that will offer a more comprehensive approach to addressing asbestos in cosmetics and drugs, but did not say when.

Talcum Powder Lawsuits

Most talcum powder lawsuits have been filed in federal courts, where claims brought by women throughout the U.S. have been consolidated into a talcum powder cancer lawsuit MDL, or multidistrict litigation, in the District of New Jersey under U.S. District Judge Michael Shipp, who is overseeing coordinated discovery and pretrial proceedings. However, hundreds of claims have also been filed in California state court.

The first of three California talcum powder trials is currently underway, involving two claims that have been combined for one trial. The first federal bellwether trial is expected to begin late this year or early 2026, and will involve a talcum powder ovarian cancer lawsuit brought by Carter Judkins, who was diagnosed with ovarian cancer in December 2016, after using Johnson’s Baby Powder as part of her daily routine for more than 30 years.

There are also other trials scheduled for next year in New Jersey and Pennsylvania state courts.

While the outcome of these trials will have no binding effect on other claims, they will be used to gauge how juries may respond to evidence and testimony that will be repeated throughout the litigation. What those juries decide could help determine the potential size of any talcum powder cancer settlement payouts Johnson & Johnson ultimately agrees to pay to resolve future claims.

If the parties do not reach a talcum powder cancer lawsuit settlement agreement after the trials have concluded, judges may have to begin planning individual trial dates for a mass of lengthy and expensive litigation that would heavily burden state and federal court systems.

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