
The US Food and Drug Administration appears poised to continue with a plan to ban prescription fluoride supplements at a time when many experts say that access to the products has become especially important.
Most US residents live in a community where fluoride is added to the public drinking water, according to federal data from 2022. But this year, Utah and Florida became the first states to ban the practice, and similar legislation has been introduced in several other states.
Fluoride is a mineral that can be found naturally in some foods and groundwater. It can help prevent tooth decay by strengthening the protective outer layer of enamel that can be worn away by acids formed by bacteria, plaque and sugars in the mouth. Adding fluoride to public water systems started in the US in 1945, and is considered by many public health experts – including the US Centers for Disease Control and Prevention – to be one of the top public health success stories of the last century.
In places where fluoride is not in the drinking water, fluoride tablets or drops may be prescribed for babies and children to reduce the risk of tooth decay.
Fluoride prescriptions spiked in Utah this spring amid changes to the public drinking water. An analysis of electronic health records conducted for CNN by Epic Research showed that the share of the population with a prescription for fluoride supplements jumped 30% in a matter of months, from about 1% at the start of the year to 1.3% by May.
However, the FDA announced in May that it plans to remove ingestible fluoride prescription drug products for children from the market by the end of October – marking clear intentions before conducting the necessary safety review or public comment period.
On Wednesday, the Regan-Udall Foundation, an independent nonprofit organization created by Congress to advance the FDA’s mission, hosted a public meeting to discuss the risks and benefits of the prescription fluoride supplements.
Dozens of dentists, researchers, public health experts and other members of the public spoke at the meeting, and thousands of others shared their thoughts in the federal register ahead of time. Among those expressing support for prescription fluoride were the American Dental Association, the American Academy of Pediatrics, the American Academy of Pediatric Dentistry and the American Association of Public Health Dentistry.
Dr. George Tidmarsh, who was announced as the new director of the FDA’s Center for Drug Evaluation and Research on Monday, was present at the meeting and shared his thoughts early on.
“Our job at FDA is to balance risk and benefit, and every day we have to make that balance,” Tidmarsh said. “It’s frequently a challenge, not always, but nothing is without risk, and you have to make sure that if there is risk, there’s a clear benefit. And that analysis needs to be done with data.”
He critiqued the first two presenters who were in favor of fluoride supplements largely for their lack of data. However, one presenter was tasked with sharing a “lived patient experience.” The other, Dr. James Bekker, a pediatric dentist from Utah, agreed on the importance of data but said that his goal was not to overwhelm the audience with numbers-heavy slides using information that is “readily available all across the country.”
Just 30 minutes into an hours-long meeting that was meant to offer robust discussion on a much broader set of research on the topic of fluoride supplements, Tidmarsh also chose to single out two studies that highlight risks.
One was a lengthy federal review published in August by the National Institutes of Health’s toxicology program, which concluded that higher levels of fluoride exposure are linked to lowered IQ in children. This has become a key argument for proponents of banning fluoride, but others have said the work lacks key context. Fluoridated water is the most common exposure noted in this analysis and the focus of most research on the topic, and the potential risks are identified with exposure at much higher levels than what is used in the US. Prescription fluoride supplements that are available to children in the US in tablet and drop form are not formally FDA-approved, but are also well below recommended levels.
Experts on both sides of the issue on Wednesday agreed in large part that more research is needed to better understand the risks and benefits of fluoride supplements in general.
Dr. Susan Fisher-Owens, a pediatrician and clinical professor at the University of California San Francisco, shared a presentation on Wednesday about the links between fluoride and neurocognitive development.
“In general, I am an optimist, who believes good science can change people’s minds and lives for the better. It would be easy to believe this is a foregone conclusion, given the announcement of removing supplements from market came before the science was presented, and Tidmarsh stated his opinion after only the first round,” she said. “Still, I hope, for my patients’ sake, that the presentations emphasizing safety at levels as seen in the US will convince the FDA.”
As the national conversation around fluoride has ramped up in recent months, dentists and doctors say that they’re getting more questions about fluoride from patients and parents who want to better understand the risks and benefits – but evidence suggests that most still remain largely in favor of fluoride.
“There’s a changing political conversation, but it’s not necessarily changing where the average American perception of fluoride is yet,” said Melissa Burroughs, senior director of public policy at CareQuest Institute for Oral Health, a nonprofit focused on equitable access to dental care. A poll conducted by the organization in July found that most US adults support community water fluoridation.
“Removing fluoride without a plan to try to support those communities will only keep it an already serious oral health crisis,” Burroughs said.
An analysis of electronic health records conducted for CNN by Truveta found that fluoride prescription rates among children in the US have been declining for the past few years – but rates are consistently about 20 times higher in states where community fluoridation is least common compared to rates in states where it is most common. As in Florida and Utah, decisions to add – or remove – fluoride to public water are determined at the local level. The question is sometimes put to public vote, and community members almost always vote in favor of adding fluoride.
Similar data showing a decline in fluoride prescription rates among children was presented at the meeting on Wednesday.
Dr. David Krol, a pediatrician representing the American Academy of Pediatrics, said that the trend was “really hypothesis-generating.” He theorized that it could be evidence of more thorough conversations between providers and their patients about all of the different ways they might already be getting fluoride and their individual risk assessments for cavities and tooth decay.
“After that conversation, there’s still a need for the provision of supplementation for some patients,” Krol said.
Others have suggested that there may be a link to more widespread hesitancy around government intervention on individual health that ramped up during the Covid-19 pandemic.
But as community water fluoridation starts to roll back, experts say that protecting the option to use prescription fluoride supplements is key. In fact, the legislation in Utah that banned the addition of fluoride to the public drinking water included provisions to expand access to prescription fluoride – emphasizing the desire for choice.
“We’re talking about supplements here today, and we’re talking about a choice, and giving people a choice if they want to have that benefit of fluoride. In a non-fluoridated area or where it doesn’t occur naturally, supplement is the only tool they have,” Bekker said at the meeting Wednesday. “So as we consider supplements, the opportunity to have them available is a matter of people’s choice. We’re not forcing anyone to take them, we’re allowing them to have an option and to have a choice.”