On May 20, 2025, as announced, FDA Commissioner Martin Makary held his panel discussion on talc in food and medications.[1] The discussion lasted just under two hours, and is available on YouTube for your viewing and perhaps your amusement. Makary opened and closed the event with what could have been the plaintiffs’ opening and closing statements from one of the many talc trials that have clouded courtrooms across the land. He asked rhetorically: “Why don’t we talk about at our oncology meetings the 1993 National Toxicology Program results that found clear evidence of carcinogenic activity of talc in animal studies?’” Perhaps because the talc findings were questionable at best, and the asbestos findings with respect to gastrointestinal cancers were exculpatory for talc.
Makary’s introductory remarks were followed by the panelists’ introducing themselves by their training and involvement with talc issues. Other than Makary, the participants were FDA Deputy Commissioner Sara Brenner, George Tidmarsh, John Joseph Godleski, Sandra McDonald, Daniel Cramer, Joellen Schildkraut, Malcolm Sim, Steven Pfeiffer, Nicolas Wentzensen, and Nicole C. Kleinstreuer. Godleski and Cramer have served as plaintiffs’ expert witnesses in ovarian cancer litigation, which was not particularly germane to the panel discussion. In their initial discussions of qualifications and background, neither Godleski nor Cramer disclosed his potential conflicts of interest, or the amount of fees earned. Sandra McDonald described her experience in assisting Godleski, but she did not declare whether she earned any money for consulting services to the lawsuit industry. Later in the panel discussion, when George Tidmarsh stated that no one should be vilified for past practices in using talc, Daniel Cramer jumped in to vilify Johnson & Johnson with the suggestion that somehow that company had surreptitiously arranged for the National Cancer Institute to remove a statement about how talc “may be associated with talc use” from its website just before he was about to testify in his first talc trial for plaintiffs.
None of the panelists had served as a defense expert witness. Steven Pfeiffer works for a pharmaceutical company, but not one that had any experience with the safety or efficacy of talc as an ingredient in medications.
None of the panelists had participated in any toxicologic or epidemiologic study of talc on cancers or diseases of the digestive organs. None of the panelists made it his or her business to become familiar with the extensive studies of the asbestos and talc on gastrointestinal cancers. The lack of experience, or specific citations to any study, did not stop Daniel Cramer from suggesting that talc was responsible for inflammatory bowel disease, autoimmune diseases, and gastrointestinal cancers. Like Cramer, epidemiologist Joellen Schildkraut, focused on ovarian cancer, and made the false assertion that the relationship between talc and gastrointestinal cancers is understudied. Schildkraut held back from asserting that talc causes ovarian cancer, but she heartily endorsed banning talc on the precautionary principle. All the panelists concurred with the suggestion that talc be eliminated from food and drugs, without waiting for “the epidemiologists to catch up.”
Two issues were grossly misrepresented by the panelists. None of them, however, was well informed enough for the misrepresentations to have been overt lies. The first whopper was that National Toxicology Program (NTP) testing had shown carcinogenicity of talc in its inhalational studies for the lung and other organs. The second whopper was that rice on talc was used prevalently in the United States, and that it was responsible for digestive organ cancers. Nicole C. Kleinstreuer, who has worked at the NTP, and accurately described its activities gave a description of its animal talc studies, perhaps a bit slanted, but not too inaccurate. When George Tidmarsh later misrepresented NTP talc findings, however, Kleinsteuer was silent.
NTP Ingestion Studies
Makary did not identify the NTP studies to which he referred, but Kleinsteuer described a talc inhalation study that has only one referent. The NTP conducted long-term rodent inhalation and ingestion assays for both talc and different kinds of asbestos, in the 1980s and 1990s. For talc, the NTP published, in 1993, only one long-term inhalational study in rats and mice.[2] In mice, exposed to talc by inhalation for up to two years, there was no evidence of any “neoplastic” effects. The results in rats were more difficult to interpret. In male rats, exposed for over two years, there was weak evidence of neoplastic effects based upon an increased incidence of benign or malignant adrenal gland pheochromocytomas. In female rats, the NTP reported “clear evidence” of excess alveolar/bronchiolar (lung) adenomas and carcinomas and benign or malignant adrenal gland pheochromocytomas of the adrenal gland. The meaning of these rodent studies obviously varies depending upon whether you are a rat or a mouse of a certain breed; the meaning for humans is even murkier, even for humans that are rodent-like. The multiple comparisons across exposure levels for dozens if not hundreds of outcomes, and the lumping of benign and malignant effects together, certainly makes the NTP statistical analyses suspect. This report was marked by significant controversy, and some scientists refused to endorse its finding because adrenal gland pheochromocytomas were not treatment-related; the maximum-tolerated dose was exceeded for female rats at the higher exposure level, thus violating the study’s protocol; and talc is thus not expected to cause tumors in rats (and mice) exposed at levels that do not cause “marked chronic lung toxicity.”[3]
One of the lawsuit industry’s, and Makary’s, theories about the harmfulness of ingested talc is based upon the supposition that talc has asbestos contaminants. This theory is as vague as is the term asbestos, which has no mineralogical meaning; instead, the term asbestos was historically used to refer to six different minerals: actinolite, anthophyllite, amosite (cummingtonite-grunerite), chrysotile, crocidolite, and tremolite. All of these minerals, except for chrysotile, are amphibole minerals. Some of the amphibole minerals occur in both fibrous and non-fibrous form, and the ill health effects of the amphibole fibers are generally attributed to their resistance to biological degradation and their high aspect ratio. Things get a bit crazy because the federal government, for purposes of standardizing aerosol measurements, set the aspect ratio for counting “fibers,” at 3:1. The pathogenicity of “federal fibers,” which are not really fibers, is highly disputed.
The NTP never conducted long-term talc ingestion studies; it did something much better. The NTP tested dietary high-dose, long-term ingestion of various asbestos types in multiple species. The NTP did not leave the exposure issue vague with “asbestos” as the dietary source. Instead, the NTP was more precise when testing whether ingesting “asbestos” was harmful to rodents. The NTP ran separate ingestion experiments on chrysotile, amosite, and crocidolite, with the different form of asbestos making up one percent of the animals’ lifetime diet. Overall, these experiments were “null”; that is, they provided no support for the carcinogenicity of ingested asbestos of the types tested.
The NTP conducted lifetime ingestion studies in male and female rats with a diet of one percent crocidolite asbestos, the most toxic and carcinogenic form of asbestos in human beings. The NTP experiments showed that under these conditions, long-term ingestion of crocidolite asbestos was neither overtly toxic nor carcinogenic in male or in female rats.[4] After crocidolite, amosite asbestos, fibrous cummingtonite-grunerite, named for “asbestos mines of South Africa, is the most toxic and carcinogenic of the asbestos fibers. The NTP showed that feeding male and female rats amosite asbestos for one percent of their diet, for their lifetimes, was not overtly toxic, did not affect their survival, and was not carcinogenic.[5] The NTP repeated its life-time one percent amosite diet in Syrian Golden hamsters, again without toxic or carcinogenic response in either the male or female hamsters.[6]
Looking at the least toxic and carcinogenic asbestos mineral, chrysotile, the NTP’s conducted long-term one percent feed studies of both “short range” and “long range” (chrysotile fiber length) in Syrian Golden hamsters. Again the results were “null”; that is, there was no treatment-related toxicity or carcinogenicity.[7] There were no increases in adrenal cortical adenomas (benign growths) when compared with concurrent controls, but there was an increase of these benign tumors when compared with pooled control groups from other experiments. Ultimately, the NTP concluded that the biological importance of these benign adrenal growths in the absence of cancers or tumors of the gastrointestinal tract (which was the target organ) was questionable, at best.
Because of prior research suggesting that carcinogencity was a function of fiber rigidity and length, the NTP tested ingested chrysotile in rats, at two different fiber lengths. For its experiments, the NTP defined “short-range chrysotile (SR)” as short fibers with a median length of 0.66 microns, and a range of 0.088 to 51.1 microns. “Intermediate-range (IR) chrysotile fibers had a median length of 0.82 microns, with a range from 0.104 to 783.4 microns. The NTP did not use long-range chrysotile fibers, which are generally greater than 5 microns in length. Male and female F344/N rats ingested an NTP one percent diet of chrysotile, in the two lengths of chrysotile, SR and IR, for a lifetime. There were no neoplastic or non-neoplastic diseases, overt toxicity, or decrease in survival associated with SR chrysotile ingestion, in either the male or the female rats.[8] In the female rats, there was no effect on fertility or litter, overt toxicity, or carcinogenicity from IR chrysotile ingestion. The male rats also did not show any adverse clinical signs, but they experienced a statistically insignificant increase in benign colonic polyps, which the NTP stretched to characterize as “some” (but not clear) evidence of carcinogenicity.
Rice is Nice, With or Without Talc
The FDA panelists’ inaccurate claims about talc on rice also cry out for rebuttal, which no panelist seemed able or willing to give. Given that the panel was convened with only four days notice, and without public comment, it operated in a fact-free zone, and operated mostly as a propaganda exercise. The history of the ingested asbestos and talc controversy goes back over half a century. Some background is needed to understand exactly how outlandish the rice-on-talc claim is.
The causal association between asbestosis and lung cancer was well established by the early 1960s,[9] as was the causal association between crocidolite asbestos exposure and mesothelioma.[10] Some sources carelessly credit Irving Selikoff with these discoveries, but he was not so much of a discoverer, as he was a zealous spokesman for the safety of asbestos-exposed workers. Selikoff worked hand-in-hand with various labor unions to publicize and politicize asbestos risks that had been shown by other workers. Credit for the lung cancer connection properly goes to earlier work done by Sir Richard Doll and others, and the crocidolite-mesothelioma connection was shown by J. Christopher Wagner, in 1960. Where Selikoff deserves credit is in tireless efforts to expand the scope of asbestos-related diseases beyond lung cancer and mesothelioma, with or without sufficient evidence, and thus to expand the compensability of other diseases of ordinary life in asbestos workers.
In his efforts to extend the scope of compensation, Selikoff did not limit himself to risks that had been scientifically established; he sought to expand the list of asbestos-related diseases. He advanced the unsubstantiated notions that all six kinds of asbestos minerals carried the same risks, that asbestos caused virtually every kind of cancer in humans, that any asbestos in the environment required extreme remedial action, and that asbestos was responsible for a very high percentage of all human cancers.
No doubt Selikoff wanted credit for scientific discoveries, but he also wanted science that would support compensation. Selikoff understood that if the asbestos workers stopped smoking, their risks of lung cancer would fall, and their cancer morbidity and mortality would be more influenced by gastrointestinal cancers, given that colorectal cancer was the leading cause of cancer-related death in non-smoking men, in the 1960s.
By 1950, Selikoff had already become an advocate, who testified and wrote reports as a claimants’ expert witness in many asbestos cases. In the early 1950s, New Jersey lawyer Carl Gelman retained Selikoff to examine 17 workers from the Paterson plant of Union Asbestos and Rubber Company (UNARCO). Gelman filed workers’ compensation claims on behalf of these UNARCO workers, and Selikoff supported Gelman’s claims with reports and testimony. In the early 1950s, Anton Szczesniak, one of the UNARCO claimants, with Selikoff’s support as an expert witness, sought compensation for “intestinal cancer.” In 1965, Selikoff testified to support an asbestos insulator’s claim that asbestos exposure caused his colorectal cancer.[11] In 1974, Selikoff wrote a review article on asbestos exposure and gastrointestinal cancers, without any disclosure of his pro-plaintiff testimonial adventures.[12] Serious epidemiologists such as Sir Richard Doll and Sir Richard Peto pushed back on Selikoff’s exaggerated projections of asbestos-related mortality,[13] and his assertion that asbestos caused digestive system cancers.[14] Forty years after Selikoff testified for the claimant in an asbestos colorectal cancer case, the Institute of Medicine published a systematic review of the evidence available to Selikoff and later evidence, which showed that the evidence was insufficient “to infer a causal relationship between asbestos exposure and pharyngeal, stomach, and colorectal cancers.”[15]
Selikoff’s rent-seeking and fear-mongering spawned many asbestos scares. Some scientists accepted Selikoff’s dogma that a single asbestos fiber, of any variety, could cause any human cancer. The Mt. Sinai jihad against “asbestos” extended to any exposures involving asbestos, or even other minerals that contained “elongated mineral particles,” that nominally met the crude definition of asbestos. This jihad led to a prolonged litigation against the Reserve Mining Company, which had permits to dump taconite tailings in Lake Superior, since the late 1940s. Using Selikoff’s claim that “asbestiform” mineral particles had entered the water supply, the U.S. Environmental Protection Agency was able to obtain an injunction against the mining company.[16]
Regulatory overreach, Selikoff’s exaggerated testimony, and the trial judge’s partiality and bias marred the litigation.[17] After decades of research on asbestos in drinking water, there remains no substantial evidence that supports a conclusion that ingested asbestos in drinking water causes gastrointestinal or any other cancer.[18]
Selikoff was the head of an anti-asbestos lobby that promoted the fiction that asbestos was responsible for all manners of human ailments, regardless of dose or route of administration.[19] One of the panics he helped initiate involved the claim that talc-dusted rice was responsible for the high rate of stomach cancer among Japanese in Japan.
Reuben Merliss published an article in Science, in 1971, in which he attempted to attribute the high rate of stomach cancer in Japan to the Japanese custom of dusting rice with talc. Merliss relied upon overall population rates and trends to draw an ecologic inference that the Japanese rice (with talc and any asbestos contaminants) was responsible for the Japanese higher incidence of stomach cancer.[20]
The Merliss hypothesis, inspired by Selikoff, was sunk by a much more careful analysis (which got less media coverage). Two epidemiologists analyzed data about use of talc-coated rice in Japan and Hawaii, and found no support for the claim that talc-coated rice increased the risk of developing stomach cancer.[21]
Their more careful dietary assessment found high rates of stomach cancer among Japanese in Japan who did not consume talc-coated rice, while Japanese in Hawaii, who consumed considerable quantities of talc-coated rice had intermediate rates of stomach cancer (lower than in Japan). Filipinos in Hawai had very low rates of gastric cancer, even though they consumed the greatest amounts of talc-coated rice of any of the observed groups. The secular incidence trend of stomach cancer decreased more substantially among the talc-exposed Japanese living in Hawaii than among the non-exposed Japanese living in Japan.
Although the asbestos perpetual motion litigation machine continues to churn, the lawsuit industry has been hampered by the bankruptcy of virtually every company that made an asbestos-containing product, and the reduction of asbestos use and exposures over the last 50 years. The lawsuit industry’s shift to demonize and monetize talc as the next mineral target was predictable. What was not predictable was that we would have a Secretary of Health & Human Services whose sole experience in medicine has been in suing pharmaceutical and other manufacturing industries, perpetuating medieval beliefs in the miasma theory of disease causation,[22] and spreading conspiracies, misinformation, and disinformation. FDA Commissioner Makary has shown himself to be a willing accomplice in advancing the Secretary’s agenda. In his closing remarks, Makary made unsupported assertions, then retreated to the dodge that he was just asking questions. Makary strongly suggested that the recent increase in colorectal cancer among young people has been caused by the use of talc in food and medications. He failed to reference any evidence for his suggestion, which is, in any event, hard to square with the history of use of talc in medications for centuries, and the steady overall decline in the incidence of colorectal cancer in men and women.[23]
The Center for Truth in Science has sponsored rigorous systematic reviews of the evidence on cosmetic talc use and female reproductive cancers,[24] and respiratory cancers.[25] The systematic review of talc on reproductive organ cancers integrated evidence across toxicologic and epidemiologic studies, and found suggestive evidence of no association between the use of perineal talc and ovarian and endometrial cancers. The systematic review of talc use and respiratory cancers similarly integrated the available toxicologic and epistemiologic evidence, and rejected a causal association. The review reached a conclusion of suggestive evidence in the opposite direction – of no association between inhaled talc and mesothelioma or lung cancer.
The FDA talc panel was fool’s gold, and not the promised “gold standard” science. Rather than engaging with the systematic reviews sponsored by the Center, or for that matter with any systematic reviews, Commissioner Makary and his panel wallowed in anecdotes, stories, and isolated study results, without trying to identify and synthesize all the available evidence.
[1] FDA Expert Panel on Talc, “Independent Expert Panel to Evaluate Safety and Necessity of Talc in Food, Drug, and Cosmetic Products,” FDA (May 20, 2025).
[2] NTP Technical Report on the Toxicology and Carcinogenesis Studies of Talc (CAS No. 14807-96-6) in F344/N Rats and B6C3F Mice (Sept. 1993).
[3] Jay I. Goodman, “An Analysis of the National Toxicology Program’s (NTP) Technical Report (NTP TR 421) on the Toxicology and Carcinogenesis Studies of Talc,” 21 Regulatory Toxicol. & Pharmacology 244 (1995). See also Robyn L. Prueitt, Nicholas L. Drury, Ross A. Shore, Denali N. Boon & Julie E. Goodman, “Talc and human cancer: a systematic review of the experimental animal and mechanistic evidence,” 54 Critical Reviews in Toxicology 359 (2024).
[4] NTP TR-280 Toxicology and Carcinogenesis Studies of Crocidolite Asbestos (CASRN 12001-28-4) In F344/N Rats (Feed Studies) (1988).
[5] NTP TR-279 Toxicology and Carcinogenesis Studies of Amosite Asbestos (CASRN 12172-73-5) in F344/N Rats (Feed Studies) (1990).
[6] NTP TR-249 Lifetime Carcinogenesis Studies of Amosite Asbestos (CASRN 12172-73-5) in Syrian Golden Hamsters (Feed Studies) (1983).
[7] NTP TR-246 Lifetime Carcinogenesis Studies of Chrysotile Asbestos (CASRN 12001-29-5) in Syrian Golden Hamsters (Feed Studies) (1990).
[8] NTP – TR-295 Toxicology and Carcinogenesis Studies of Chrysotile Asbestos (CASRN 12001-29-5) in F344/N Rats (Feed Studies) (1985).
[9] See Richard Doll, “Mortality from Lung Cancer in Asbestos Workers,” 12 Br. J. Indus. Med. 81 (1955).
[10] See J. Christopher Wagner, C.A. Sleggs, and Paul Marchand, “Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province,” 17 Br. J. Indus. Med. 260 (1960); J. Christopher Wagner, “The discovery of the association between blue asbestos and mesotheliomas and the aftermath,” 48 Br. J. Indus. Med. 399 (1991).
[11] See “Health Hazard Progress Notes,”16 The Asbestos Worker 13 (May 1966) (“A recent decision has widened the range of compensable diseases for insulation workers even further. A member of Local No. 12. Unfortunately died of a cancer of the colon. Dr. Selikoff reported to the compensation court that his research showed that these cancers of the intestine were at least three times as common among the insulation workers as in men of the same age in the general population. Based upon Dr. Selikoff’s testimony, the Referee gave the family a compensation award, holding that the exposure to many dusts during employment was responsible for the cancer. The insurance company appealed this decision. A special panel of the Workman’s Compensation Board reviewed the matter and agreed with the Referee’s judgment and affirmed the compensation award. This was the first case in which a cancer of the colon was established as compensable and it is likely that this case will become an historical precedent.”).
[12] Irving J. Selikoff, “Epidemiology of Gastrointestinal Cancer,” 9 Envt’l Health Persp. 299 (1974).
[13] Richard Doll & Richard Peto, “The causes of cancer: quantitative estimates of avoidable risks of cancer in the United States today,” 66 J. Nat’l Cancer Instit. 1191 (1981).
[14] Richard Doll and Julian Peto, Asbestos: Effects on Health of Exposure to Asbestos 8 (1985).
[15] Jonathan M. Samet, et al., Asbestos: Selected Cancers – Institute of Medicine (2006).
[16] See Wendy Wriston Adamson, Saving Lake Superior: A Story of environmental action (1974); Frank D. Schaumburg, Judgment Reserved: A Landmark Environmental Case (1976); Robert V. Bartlett, The Reserve Mining Controversy: Science, Technology, and Environmental Quality (1980); Thomas F. Bastow, This Vast Pollution: United States of America v. Reserve Mining Company (1986); Michael E. Berndt & William C. Brice, “The origins of public concern with taconite and human health: Reserve Mining and the asbestos case,” 52 Regulatory Toxicol. & Pharmacol. S31 (2008).
[17] Reserve Mining Co. v. Lord, 529 F.2d 181 (8th Cir. 1976) (removing Judge Lord from case).
[18] See World Health Organization, Asbestos in Drinking Water (4th ed. 2021) (“no causal association between asbestos exposure via drinking-water and cancer development has been reported for any asbestos fibre type”); Jennifer Go, Nawal Farhat, Karen Leingartner, Elvin Iscan Insel, Franco Momoli, Richard Carrier & Daniel Krewski, “Review of epidemiological and toxicological studies on health effects from ingestion of asbestos in drinking water,” 54 Critical Reviews in Toxicology 856 (2024) (“Based on high-quality animal studies, an increased risk for cancer or non-cancer endpoints was not supported, aligning with findings from human studies. Overall, the currently available body of evidence is insufficient to establish a clear link between asbestos contamination in drinking water and adverse health effects.”); Kenneth D. MacRae, “Asbestos in drinking water and cancer,” 22 J. Royal Coll. Physicians 7 (1988).
[19] Francis Douglas Kelly Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997) (“[A]n anti-asbestos lobby, based in the Mount Sinai School of Medicine of the City University of New York, promoted the fiction that asbestos was an all-pervading menace, and trumped up a number of asbestos myths for widespread dissemination, through media eager for bad news.”).
[20] Rueben R. Merliss, “Talc-Treated Rice and Japanese Stomach Cancer,” 173 Science 1141 (1971). The claim persists in the underworld of medical speculation. See E. Whitin Kiritani, “Asbestos and Stomach Cancer in Japan – A Connection?” 33 Medical Hypotheses 159 (1990).
[21] Grant N. Stemmermann & Lawrence N. Kolonel, “Talc-coated rice as a risk factor for stomach cancer,” 31 Am. J. Clin. Nutrition 2017 (1978).
[22] Paul Offit, “Understanding RFK Jr.,” Beyond the Noise (Feb. 11, 2025).
[23] American Cancer Society, “Key Statistics for Colorectal Cancer” (last revised April 28, 2025).
[24] Heather N. Lynch, Daniel J. Lauer, Olivia Messina Leleck, Rachel D. Freid, Justin Collins, Kathleen Chen, William J. Thompson, A. Michael Ierardi, Ania Urban, Paolo Boffetta & Kenneth A. Mundt, “Systematic review of the association between talc and female reproductive tract cancers,” 5 Front. Toxicol. 1157761 (2023).
[25] Heather N. Lynch, Daniel J. Lauer, William J. Thompson, Olivia Leleck, Rachel D. Freid, Justin Collins, Kathleen Chen, A. Michael Ierardi, Ania M. Urban, Michael A. Cappello, Paolo Boffetta & Kenneth A. Mundt, “Systematic review of the scientific evidence of the pulmonary carcinogenicity of talc,” 10 Front. Public Health 989111 (2022).
