The Food and Drug Administration will work to pull fluoride supplements for children from the market, the agency announced Tuesday.
The move comes at the same time as a wave of bills aiming to restrict use of the mineral, which has long been added to public water supplies because it strengthens teeth and can prevent cavities. In March, Utah became the first state to ban the addition of fluoride to public water. Legislation restricting fluoridated drinking water has also been introduced in Florida, Louisiana, North Dakota, Tennessee and Montana. Health Secretary Robert F. Kennedy Jr. has said he will tell the Centers for Disease Control and Prevention to stop recommending fluoride in water altogether.
The F.D.A. said it will review the safety of ingestible fluoride products for children by Oct. 31, citing a range of potential health risks that are not based in rigorous research.
“The evidence is incredibly weak to make this kind of move,” said Dr. Scott Tomar, a public health dentist and oral epidemiologist at the University of Illinois Chicago. He added: “You don’t make public health policy based on one or two pretty weak review articles.”
Why do dentists recommend fluoride supplements?
Dentists prescribe fluoride tablets, lozenges and drops to children who live in areas without fluoridated water or who are at high risk of developing cavities, which could be because they have high amounts of plaque, do not regularly go to the dentist or have family members with dental disease.
These supplements are designed to provide a similar amount of fluoride to what people typically get from drinking water.
Fluoride drops and tablets provide an extra level of exposure that prevents tooth decay, beyond the amounts of fluoride children get from toothpastes and mouth washes, said Dr. F. Perry Wilson, a physician and chronic disease epidemiologist at the Yale School of Medicine. That’s because supplements, like fluoridated water, get into the bloodstream and then into saliva.
“You really do need a bit of a constant level bathing your teeth,” Dr. Wilson said. His own children took fluoride supplements growing up, he said, at the recommendation of their dentist.
Do they carry health risks?
The F.D.A. pointed to a range of health concerns about fluoride supplements. In a news release, the agency said that fluoride can alter the gut microbiome in children and cited a review of studies on the subject.
That review noted that high levels of fluoride may disrupt rats’ microbiome, but also called the issue “under researched” in humans.
“Myself and my co-authors were quite clear in our article that there is little evidence to suspend fluoride use and that further research is needed,” Dr. Gary Moran, a professor at Trinity College Dublin and the lead author of the paper, wrote in an email. Dr. Moran added that while there is only limited evidence on fluoride and microbiome disturbance, there is “extensive” research on fluoride products and preventing tooth decay.
The F.D.A. pointed to another paper that reviewed studies on fluoride and the gut microbiome. Every study in that review concluded that consuming fluoride at or under the level the World Health Organization has recommended — which is higher than the amount of fluoride typically found in drinking water in the United States — increases the growth of good bacteria in the gut. Too much fluoride discouraged the growth of that bacteria.
“Fluoride has many proven health benefits, particularly with regard to dental health, and the research we have done should not discourage people from ingesting small amounts of fluoride,” Caroline Orr, a researcher at Teesside University in England and an author of that study, wrote in an email.
The amount of fluoride people get from supplements isn’t enough to kill bacteria in the gut, said Dr. Steven Levy, a public health dentist at the University of Iowa.
Dr. Wilson added that untreated cavities can cause infections that require antibiotics — which have been shown to significantly affect the microbiome.
The F.D.A. also cited concerns about the link between high levels of fluoride exposure and lower I.Q. in children. A federal analysis of 74 studies, published this year, did find an association between higher levels of exposure and lower scores. But outside researchers have noted that the studies included came from outside of the United States, and have criticized the paper for having methodological flaws. And even an author of that study has said that the paper was not intended to assess “the broader public health implications of water fluoridation in the United States.”
The F.D.A. release warned, too, about an unproven connection between fluoride exposure and thyroid issues. The agency linked to a review of studies on thyroid function and fluoride exposure, which found a possible association between high levels of fluoride exposure and thyroid diseases, although the evidence was inconsistent and “too limited to draw conclusions,” the paper authors wrote.
Many of the studies in that review “come from places like India, where the levels of fluoride that are consumed are nothing like we’d ever see here in the United States,” said Dr. Patricia Braun, a professor of pediatrics at the University of Colorado Anschutz Medical Campus and a member of an American Academy of Pediatrics committee on oral health.
The F.D.A. also suggested a connection between fluoride supplements and weight gain.
“There just isn’t,” Dr. Tomar said. He added: “I’ve never seen a credible study that showed that fluoride exposure increased weight gain.”
Dr. Wilson said that while there are many studies suggesting potential risks to fluoride, “none of them are very high-quality, all of them have methodological issues.”
That’s not to say there is no risk, he added. “That’s the nuance of it. We just don’t know. And so it’s easy enough, rhetorically, to say, ‘Oh, well, if you don’t know, shouldn’t we err on the side of caution?’ But then you lose the benefit,” Dr. Wilson said.
“Everyone forgets that any choice you make here has a cost.”
What other options exist to protect children’s teeth?
If children are not able to access fluoride supplements — and if they are not in an area with fluoridated drinking water — they could use fluoridated toothpaste and mouth rinses. However, those are not always sufficient to protect against cavities, Dr. Wilson said, because they do not provide a consistent level of fluoride in the mouth. Dentists also offer fluoride treatments at their offices, although that relies on children regularly going to appointments.
Dr. Marty Makary, the commissioner of the F.D.A., wrote in a statement that limiting sugar and practicing good dental hygiene was the optimal way to prevent cavities.
Doctors and researchers said that was not always realistic.
“If you are able to control the public’s excessive sugar intake and get them all to have good dental hygiene, then you should get more than one Nobel Prize,” Dr. Levy said.
Dani Blum is a health reporter for The Times.
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