FDA targets talc in food and medicine

The US Food and Drug Administration is seeking information about the health risks of talc, or hydrous magnesium silicate, in food and drugs. Manufacturers voluntarily removed the common mineral, known for its anticaking and moisture absorption properties, from most body powders and cosmetics sold in the US several years ago because of concerns over a possible link to ovarian cancer. But talc is still prevalent in food and drugs, FDA officials said during a panel discussion on May 20.


“Talc is in candy that children eat. It’s in food,” FDA commissioner Marty Makary said. It is also in 4 of the 10 most-common medications in the US, he noted. Those drugs—Lipitor, Synthroid, Prilosec, and Neurontin—are taken by nearly 20 million people in the country, according to data reported in April by George Tidmarsh, adjunct professor of pediatrics and neonatology at Stanford University School of Medicine, and his colleague Arman Sharma (DOI: 10.70542/rcj-japh-art-16avrw).


Tidmarsh was one of several expert scientists who spoke during the FDA’s panel discussion. “If you've ever unwrapped a piece of gum, that white powder that keeps it from sticking to the wrapper—that's talc that you're putting in your mouth that we now know is carcinogenic,” he said.


Last year, the International Agency for Research on Cancer (IARC) concluded that talc is probably a human carcinogen on the basis of limited evidence for ovarian cancer in humans, sufficient evidence for lung and adrenal gland cancer in experimental animals, and strong mechanistic evidence of chronic inflammation and altered cell proliferation in human cell–based systems.


Several scientists who served on IARC’s talc working group spoke during the panel discussion. All of them expressed support for removing talc from food and drugs. The health concerns of talc go beyond cancer. Several of the panel members, including pathologists, epidemiologists, and physicians, highlighted growing evidence that talc is associated with chronic inflammation.


“Talc gets into our tissues and stays there a long time,” said John Joseph Godleski, professor emeritus of pathology at Harvard School of Public Health. Since 2017, Godleski has used polarized light microscopy and scanning electron microscopy to study gynecologic tissues from over 300 ovarian cancer patients with genital exposure to talc. “We found talc in 90% of the cases,” he said at the FDA meeting, noting that they found asbestos fibers in just under 10%.


It is difficult to tease apart the carcinogenic effects of asbestos, a common impurity in some talc, from the health effects of talc itself, several panel members said.
I think there's just been a general lack of awareness about the use of talc in our food and drug supply.
George Tidmarsh, adjunct professor of pediatrics and neonatology, Stanford University School of Medicine


Malcolm Sim, professor emeritus in the School of Public Health and Preventive Medicine at Monash University, served as cochair of the human studies subgroup of the IARC working group on talc. He joined others on the FDA panel in calling for the agency to eliminate talc from food and medicine. He also referred to occupational studies of workers who mine talc and of those who use it to make rubber, ceramics, paper, and other products that show a link to respiratory and gastrointestinal cancers.


The panel did not include representatives from the food industry. The National Confectioners Association did not respond to a request for comment on the prevalence of talc in candy and gum and whether candymakers are looking for alternatives.


But Steven Pfeiffer, an organic chemist who works on drug development at Mirador Therapeutics, spoke about the pharmaceutical industry’s use of talc.


Drugmakers use talc primarily as a glidant to improve the flowability of ingredients into machinery that forms tablets and capsules and as a lubricant to keep tablet and capsule shells from sticking to machinery, Pfeiffer said. In some cases, he added, drug companies also add talc as filler to achieve a desired weight.



Alternatives to talc, including magnesium stearate, calcium stearate, and colloidal silicon dioxide, can be used in solid, oral tablet formulations, Pfeiffer told FDA officials. Such alternatives have “been shown to be safe,” he said. “They're cheap and readily available.” The pharmaceutical industry has moved away from talc, but drugs that contain the substance are still on the market, he said.


Branded drugs, including Synthroid, Lipitor, and Nexium, had a legacy use of talc, and they still contain it, Tidmarsh said at the FDA meeting. But manufacturers replaced talc with magnesium stearate in the generic versions, he said.

Unclear what foods have talc


Consumers can easily identify which drugs, including over-the-counter medicines, contain talc because the ingredient is listed on the label, Tidmarsh said. But that is not the case with food, he added.


It is unclear what foods contain talc because companies do not have to include processing aids in the list of ingredients on the label, says Michael Hansen, senior scientist in the advocacy division of Consumer Reports.


The FDA considers talc generally recognized as safe (GRAS) for use in food, so manufacturers do not have to notify the agency when they add it to food. Tidmarsh reiterated that it is commonly found in chewing gum and candy, but said it could be added to hundreds of foods, including cheese and flour. He referred FDA officials to the Codex Alimentarius, published by the Food and Agriculture Organization and the World Health Organization, for a list of foods that talc can be added to.


According to the codex, talc is approved for use in food as an anticaking agent, glazing agent, and thickener, Hansen says. A huge number of items could contain the mineral, including milk and cream powders, cheese, salt, and breakfast cereals like rolled oats, he says. Studies conducted in China and other countries have reported talc in flour and rice, he adds.


“Wheat flour is one of the most common things in the food supply,” Makary noted during the panel discussion. “It seems like there's a suggestion there that there could be talc in one of the most common foods that is consumed.”


“I think there's just been a general lack of awareness about the use of talc in our food and drug supply,” Tidmarsh said. “Most of the focus has been, appropriately, on the perineal use of talc, and now that's been replaced with corn starch.” When people are made aware that talc is in the food and drug supply, he said, “they're pretty horrified by it.”


Panel members at the meeting generally agreed that the scientific evidence linking talc to inflammation and cancer supports removing the substance from the food and drug supply.


Talc has been recognized as a carcinogen for 40 years, “and yet we're feeding it to our nation's children,” Makary said. “I'm amazed that we scratch our heads asking, why are we seeing GI cancers go up in young people, and we never stop to think about the existing body of scientific evidence that has been there.”


Talc may not be the driver of the chronic disease epidemic affecting 40% of kids in the US, Makary said. It may not be the cause of the increase in GI cancer in young people, he added. “But it may be contributing.”

Makary did not elaborate on any next steps the FDA might take to address the risks of talc in food and medicine. But he made a point of asking the panel whether it would be ethical to conduct a randomized controlled clinical trial to study whether consuming talc during childhood causes cancer. No one on the panel thought that would be a good idea.

https://cen.acs.org/safety/consumer-safety/FDA-targets-talc-food-medicine/103/web/2025/05