FDA to review prescription fluoride supplements for kids at risk for tooth decay

NBC News

5 days ago

The Trump administration is inching closer to banning fluoride tablets and drops often prescribed to kids who don't have access to fluoridated drinking water and are at high risk for mouths full of decayed teeth.
On Wednesday, the Food and Drug Administration will host a public meeting featuring both supporters and opponents of fluoride supplements. While dentists overwhelmingly say the tablets have been used safely for decades, more than half of the meeting will be spent 'identifying safety concerns and potential risk' associated with the supplements.
A final decision about whether to pull fluoride supplements off the market isn't expected until the end of October. In May, the FDA commissioner, Dr. Marty Makary, announced the agency's intention to get rid of them.
Wednesday's meeting includes 18 speakers, including well-known fluoride skeptics like Dr. Bill Osmonsun, a retired dentist now with the Fluoride Action Network, and Dr. Bruce Lanphear, a professor of health sciences at Simon Fraser University in Canada. Lanphear published a controversial 2019 study suggesting that IQ levels were slightly lower in kids whose mothers had ingested more fluoride while pregnant, research that's frequently cited by Health Secretary Robert F. Kennedy Jr.
Dr. Charlotte Lewis, a professor of pediatrics at the University of Washington School of Medicine, and Dr. Jayanth Kumar, who previously was dental director for California, will counter those presentations.
Dr. James Bekker, a pediatric dentist and a member of the Utah Dental Association who is scheduled to speak at Wednesday's meeting, said: 'Say we take supplements off the market. What's the alternative? There is none.'
Utah and Florida have banned fluoride from public water systems. Similar legislation is under consideration in Kentucky, Massachusetts and Nebraska.
Critics say the risks from fluoride during a child's early years override the benefit of protecting against tooth decay, a disease that can cause pain, infection and other possible health problems.
In an interview with Fox News, Kennedy acknowledged that areas without fluoride in their water are likely to have 'slightly more cavities.'
Bekker was more blunt. 'Buckle up,' he said. 'We're going to have an onslaught of cavities.'
What are fluoride supplements?
Nearly two-thirds of dentists in the United States prescribe fluoride supplements to their patients, especially in areas without community water fluoridation, according to a American Dental Association report this year.
Sodium fluoride tablets and drops are prescription only, and they have been used for decades to prevent tooth decay. A 2011 analysis of 11 studies, including some randomized controlled trials, by French researchers found that 0.25 mg up to 1 mg a day of the supplements reduced rates of cavities in kids by nearly a quarter.
The chewable tablets come in several doses and are particularly important for families who live in areas without fluoride in drinking water and who don't have dental insurance or can't afford regular visits to dentists. Even though Medicaid covers oral health for children, fewer than half went to the dentist at least once a year.
Cavities that erupt in those kids get worse if they're left untreated, and they can cause widespread damage. The decay 'eats away at the bone' around the tooth and sometimes gets into the bloodstream, said Dr. Steven Levy, a professor of preventive and community dentistry at the University of Iowa.
'This is more than just a garden-variety, middle-class person's experience with a cavity,' he said.
Major public health groups, including the American Academy of Pediatrics and the U.S. Preventive Services Task Force, recommend prescribing supplements for children starting at 6 months if the water supply isn't fluoridated.
Fluoride supplements are often given to kids from age 5 until they have their permanent teeth, around age 13 or 14, Bekker said. Babies get drops until they're old enough to chew tablets. They're generally inexpensive.
Over-the-counter vitamins and supplements don't contain fluoride. Fluoride is available over the counter only in toothpaste and mouthwashes.
Limited research on fluoride supplements
According to Makary, the FDA commissioner, ingested fluoride alters the gut microbiome. That assertion appears to hinge on a 2023 review of research on the matter. Scientists in Ireland noted that animal studies suggested ingesting fluoride affected the microbiome but that none of the studies examined fluoride and the human microbiome. They concluded that any possible effect of fluoride on the microbiome is 'still in its early days, and studies investigating the impact of fluoride on the human microbiome have only begun to appear in the literature.'
Makary also objects to the fluoride supplements because they aren't approved by the FDA. Because the supplements had been in use for decades before Congress mandated that drug manufacturers show that their products were not only safe but also effective, they were never required to go through the approval process. For almost as long as the supplements have been prescribed, critics have been concerned about the lack of rigorous data showing their potential health effects and how they protect kids' teeth.
'I think we really need to understand the benefits,' said Linda Birnbaum, a toxicologist and former director of the National Institute of Environmental Health Sciences and the National Toxicology Program. Birnbaum is listed as a speaker at the FDA meeting Wednesday.
'Why is this even a question? This is the biggest no-brainer since sliced bread,' he said.