FDA Convenes Panel Evaluating the Role of Talc as a Food Additive

On May 20, 2025, the U.S. Food and Drug Administration (“FDA”) held a panel to discuss the “safety and necessity” of talc as an additive in food and drugs.¹ Talc, a naturally occurring hydrated magnesium silicate known for its softness and absorption capabilities, has historically been used in numerous consumer goods, including food, cosmetics and medical products.

According to FDA Commissioner Dr. Martin Makary, “[d]espite the potential carcinogenic harm with topical talc, it continues to be ingested by children and adults through food and some medications,” raising an apparent question regarding the use of talc as an additive in food and certain pharmaceutical drugs.² Additionally, in his opening remarks to the Panel, Commissioner Makary commented further, “I’m not suggesting that talc is the driver of our chronic disease epidemic, but if we generally believe it’s pro-inflammatory and kids are ingesting it, aside from the potential cancer-causing effects, shouldn’t there be reason for concern? . . . Is it a total coincidence that we are seeing a rise in inflammatory conditions? . . . I’m just floating that question.” According to the Commissioner, an estimated “20 million people” in the United States consume talc on a regular basis as an additive in foods and pharmaceutical drugs.

FDA has pointed to certain recent publications as driving its decision to convene a panel on talc’s use in food and drugs. For example, in a press release announcing the Panel, FDA referenced the International Agency for Research on Cancer’s (“IARC’s”) 2024 finding that talc is a Group 2A carcinogen, i.e. “probably carcinogenic” based on animal data, and included a link to a recent article in the Journal of the Academy of Public Health written by one of the experts on the Panel, Dr. George Tidmarsh.³ The article references lawsuits brought against manufacturers of cosmetic talcum-powder products, touting a jury verdict in Missouri as claimed evidence “underscor[ing] the urgency with which federal health agencies must reevaluate talc’s status as a safe additive.”⁴

In addition to Dr. Tidmarsh, the Panel consisted of members from a variety of disciplines, including pediatrics, pathology, obstetrics and gynecology, and epidemiology. This included Dr. Daniel Cramer, a professor of obstetrics and gynecology who has served as an expert witness on behalf of plaintiffs in talc litigation on multiple occasions. The Panel did not include representatives from the food industry but did include Dr. Steven Pfeiffer, a scientist working in drug development at Mirador Therapeutics.

Panelists reportedly considered the risks of talc as well as the relative safety and availability of alternatives. While certain experts acknowledged study limitations and noted insufficient evidence of causation in the body of scientific evidence studying the relationship between talc and cancer, Panel members generally supported removing talc as an additive in food and drugs in favor of what they apparently may perceive as safer alternatives. Dr. Pfeiffer, for example, told the Panel that alternatives to talc in pharmaceutical drugs “have been shown to be safe” and are “cheap and readily available.” And Dr. Nicole Kleinstreuer, acting NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives, emphasized magnesium stearate as an example of a safer alternative to talc for use in drugs and food. Dr. Tidmarsh noted that while it is easy to identify talc in the use of pharmaceutical drugs given pharmaceutical labeling requirements, citing “seven of the ten most common” brand-name pharmaceutical drugs as containing talc, it is “difficult” to identify talc in foods because talc is not required to be disclosed in food labeling. Nonetheless, he identified rice, cheese, flour, gum and candy as potential sources of talc in foods.

The Panel has received criticism, including in an opinion piece published by the Wall Street Journal Editorial Board, characterizing the Panel as touting “dubious evidence” and “helping plaintiff attorneys broaden their attacks against food and drug makers.”⁵

The Panel comes on the heels of increased FDA scrutiny of the use of talcum powder in consumer products such as cosmetics in recent years. Late last year, for example, FDA proposed a rule seeking to standardize the test methods that manufacturers of talc-containing cosmetic products and/or their talc suppliers should use in assessing their products for the presence of asbestos.⁶ Prior to that proposal, FDA commissioned an Interagency Working Group on Asbestos in Consumer Products, which consisted of subject matter experts from eight U.S. federal agencies, to evaluate the efficacy of the available testing methods.

In sum, though talc has been ubiquitous in food and consumer goods for decades, in recent years, FDA has been increasingly focused on the use of talc across a variety of industries. This heightened focused comes in the wake of nearly 60,000 pending lawsuits alleging harm from the use of talcum powder.⁷ Given these pending claims and the timing of FDA’s renewed focus on talc, some have argued that FDA seems to be letting pending litigation influence its public health initiatives, rather than the other way around.