Talc Safety To Be Subject of New Independent Scientific Expert Panel Led by FDA

Panelists urged shift to non-talc alternatives in food, drugs and cosmetics, after thousands of lawsuits have been filed in recent years against manufacturers of talc-based products over cancer risks.

A panel of scientific experts met this week at the request of federal regulators to discuss the potential side effects of talc and cancer risks consumers may face, and determined that alternative sources should be used wherever possible.

On Tuesday, the U.S. Food and Drug Administration (FDA) held a roundtable discussion (video) with an independent panel of experts on the safety of talc in food, drug and cosmetics products. The event, led by FDA Commissioner Dr. Martin Makary, marked the start of a broader agency effort to publicly evaluate controversial ingredients tied to serious health risks.

Talc, hydrated magnesium silicate, is a soft mineral used in baby powder, cosmetics and pharmaceutical tablets. The concern stems from the fact that talc is often mined near asbestos, a known carcinogen. Without rigorous purification, talc products can become contaminated with asbestos fibers.

In addition to these contamination risks, some researchers have raised concerns that even asbestos-free talc may pose health hazards. Studies have suggested that talc particles, when applied to the genital area, can migrate into the body and may increase the risk of ovarian cancer through chronic inflammation or other mechanisms.

These concerns were amplified in June 2024, when the World Health Organization’s International Agency for Research on Cancer (IARC) classified talc as “probably carcinogenic” to humans, even when it is asbestos-free.

WHO’s classification added weight to the ongoing litigation against Johnson & Johnson, which now faces thousands of Baby Powder lawsuits and Shower-to-Shower lawsuits, each raising similar allegations that the company’s talc-based products were often contaminated with asbestos, causing women to develop ovarian cancer and other injuries after applying the powder to their genitals.

Experts Promote Shift Away From Talc Use

During the roundtable discussion, the panel of researchers, pathologists and toxicologists reached a consensus that manufacturers should move away from using talc due to its risks vs. benefits. The panelists determined that there are safer, reasonably priced alternatives to talcum powder that should be used instead.

“Despite the potential carcinogenic harm with topical talc, it continues to be ingested by children and adults through food and some medications. We are bringing together a group of leading independent experts to assess the available evidence around talc and consider whether its continued use is necessary given modern alternatives,” Makary said in a press release announcing the meetings. “This is a critical step toward ensuring that ingredients in products used every day by Americans meet the highest standards for safety.”

The panel reached a consensus that talc use should be phased out due to the unfavorable risk-benefit profile. Experts emphasized that cost-effective, safer alternatives are widely available and should be adopted by manufacturers.

Still, the panel underscored the need for continued research on the potential side effects of talc, not only on the cancer risks but also on the broader biological impact of exposure.

“I think even if we removed all the exposure tomorrow, it would still be a good idea to continue to study the pathological effects of talc in the GI tract, because there’s a lot that’s not known, as well as the other body systems as well,” Dr. Sandra A. McDonald, a talc expert and pathologist on the American Board of Pathology, said at the meeting. “And the reason for that is that even if we remove exposure today…we still have all the past or legacy exposures that have occurred that we need to know what’s going to happen or what might happen.”

Panelists also urged more effective communication of risks to both the public and healthcare professionals, citing a disconnect between scientific findings and clinical awareness. Makary echoed that concern, questioning whether chronic talc exposure could contribute to rising rates of inflammatory conditions.

“I’m amazed that there is a disconnect between the clinical community and the scientific community on so many of these issues,” Makary said. “We talked about talc as a pro- inflammatory agent. Is it a total coincidence that we are seeing a rise in inflammatory conditions, inflammatory bowel disease, ulcerative colitis, Crohn’s disease, irritable bowel syndrome, a whole host of conditions?”

While the panel does not have the authority to implement regulatory changes itself, its expert findings are expected to carry significant weight in shaping future FDA policy decisions. The agency often relies on such independent scientific input to guide risk assessments and determine whether new regulations or warnings are warranted. 

May 2025 Talcum Powder Lawsuits Update

The panel’s recommendations echo concerns that have been central to a growing number of lawsuits filed over the past decade by women who developed ovarian cancer and other serious injuries after using talc-based products. These lawsuits allege that manufacturers failed to warn consumers about the risks associated with talc, including potential asbestos contamination and long-term inflammatory effects.

Johnson & Johnson, one of the primary defendants in the talcum powder litigation, has faced mounting pressure from more than 90,000 lawsuits filed by individuals who developed ovarian cancer and side effects after using the company’s talc-based products. 

Earlier this year, a U.S. Bankruptcy Judge in Texas rejected the company’s latest attempt to resolve the litigation through a controversial $9 billion settlement plan, which would have transferred liability to a subsidiary that then filed for bankruptcy protection. The court found the maneuver lacked good faith, echoing arguments raised by plaintiffs and the U.S. government that the strategy was designed to sidestep accountability. 

As a result, active litigation is still underway in the civil court system. All talcum powder cancer lawsuits filed in federal court have been centralized in the U.S. District Court for the District of New Jersey since 2016, where they will continue to be litigated under U.S. District Judge Michael Shipp.

Johnson & Johnson has indicated that it does not intend to appeal the dismissal of this latest bankruptcy filing and has suggested that it now intends to defend the claims in court.

The company has already resolved 95% of claims alleging talcum powder exposure led to cases of mesothelioma. The remaining cases are primarily gynecological cancer claims, mainly dealing with cases of ovarian cancer. 

Since the litigation emerged, Johnson & Johnson has pledged to remove talc from its Baby Powder products, although the company has denied that use of the talc-based products poses health risks.

In the coming weeks, Judge Shipp is expected to schedule a case management conference with the parties, and reschedule the first federal talcum powder MDL trial, which will be closely watched by the parties to gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.