Scientists pleading fluoride’s case at a public meeting hosted by the Food and Drug Administration last Wednesday were given a cold reception by the agency’s new drug czar.
George Tidmarsh, who became director of the Center for Drug Evaluation and Research, or CDER, last Monday, didn’t seem convinced of the benefits of ingestible fluoride supplements for children who live in areas with low or no water fluoridation.
This story first appeared in NOTUS, a publication from the nonprofit, nonpartisan Allbritton Journalism Institute.
“We’ve got to look at a risk-benefit analysis. And since this isn’t approved, it’s never been through the rigorous FDA process of saying there’s a benefit that outweighs the risk,” Tidmarsh told NOTUS about the fluoride supplements. “And if there’s not, then, you know, we should probably act.”
When asked if the FDA would reanalyze the data on fluoride supplements, Tidmarsh said, “That’s what we’ll do.”
But many of the meeting’s attendees disagreed with the new CDER director.
“We do know what the safe dosage of fluoride is,” said James Bekker, a dentist and associate dean of the University of Utah School of Dentistry. “Any data that refutes the benefit of fluoride is either something taken out of context or flawed data with some kind of extreme level of fluoride that’s being tested.”
“We’ve got to look at a risk-benefit analysis. And since this isn’t approved, it’s never been through the rigorous FDA process of saying there’s a benefit that outweighs the risk.”
Ingestible fluoride supplements are prescribed by pediatricians and dentists to children who drink non-fluoridated water. While these products have not been approved by the FDA, the agency has turned a blind eye to them for decades, and they are recommended by medical organizations like the American Academy of Pediatric Dentistry.
In May, the FDA announced that it would act to remove ingestible fluoride products from the market. The agency cited studies that show that ingesting fluoride alters the gut microbiome, though the scientists who conducted this research called it inconclusive.
“Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ,” the FDA said in the statement announcing the new policy. Research has shown that the low levels of fluoride used to supplement drinking water are generally safe. In a press release, the president of the American Dental Association said removing ingestible fluoride products from the market would “stand to hurt rural America, not make them healthier.”
But Health and Human Services Secretary Robert F. Kennedy Jr. has said that he will direct the Centers for Disease Control and Prevention to stop recommending water fluoridation nationwide. Utah and Florida passed laws earlier this year removing fluoride from drinking water.
“We do know what the safe dosage of fluoride is.”
At times, last Wednesday’s meeting was a reminder of how contentiousfluoride remains within the scientific community and the FDA.
Susan Winckler, chief executive officer of the Reagan-Udall Foundation, was given the unenviable role of moderating panels that included both advocates for fluoride supplementation and its detractors.
“Sir, let’s illustrate versus interrogate,” Winckler told panelist Bill Osmunson, a retired dentist who has advocated for the removal of fluoride from water supplies nationwide, during a heated exchange between Osmunson and Bekker.
Original article online at: https://undark.org/2025/07/28/fda-fluoride-supplements/