The U.S. Food and Drug Administration appears to be poised to continue its plans to ban prescription fluoride supplements when many experts say access to products has become particularly important.
Federal data for 2022 shows that most U.S. residents live in communities where fluoride is added to public drinking water. However, this year, Utah and Florida became the first states to ban practices, with similar laws being introduced in several other states.
Fluorides are minerals that can be found naturally in some foods and groundwater. It helps to prevent tooth decay by strengthening the protective outer layer of enamel, which can be worn by acids formed by bacteria, plaques and sugars in the mouth. Adding fluoride to public water systems has been launched in the United States in 1945 and is considered one of the best public health practices of the last century, with many public health experts, including the Centers for Disease Control and Prevention.
Where fluoride is not present in drinking water, fluoride or drops can be prescribed to reduce the risk of tooth decay and children.
A fluoride formula spiked in Utah this spring amidst the transformation into public drinking water. An analysis of electronic health records conducted for CNN by a grand study showed that the proportion of the population containing prescriptions of fluoride supplements increased from about 1% at the beginning of the year to 1.3% by May.
However, the FDA announced in May that it plans to remove ingestible fluoride prescription drugs for children from the market by the end of October.
On Wednesday, the Regan-All Foundation, an independent nonprofit created by Congress to advance the FDA mission, held a public meeting to discuss the formulations and benefits of fluoride supplements.
Dozens of dentists, researchers, public health experts and other members of the public spoke at the meeting, while thousands of other people shared their thoughts in advance on the federal register. Among those who expressed support for prescribing fluoride were the American Dental Association, the American Academy of Pediatrics, the American Academy of Pediatrics, and the American Association of Public Health.
Announced Monday as the new director of the FDA’s Drug Evaluation and Research Center, Dr. George Tidmarsh attended the meeting and shared his thoughts early.
“Our job at the FDA is to balance risk and profits, and we have to balance that every day,” says Tidmarsh. “It’s a challenge often, but not always, but there’s nothing without risk. If there’s risk, you need to make sure there’s a clear advantage, and you need to do that analysis with the data.”
He criticized the first two presenters who supported fluoride supplements, primarily due to lack of data. However, one presenter was tasked with sharing “the experiences that the patient experiences lived.” Another, Dr. James Becker, a pediatric dentist in Utah, agreed on the importance of the data, but said his goal was not to overwhelm the audience with numbers-heavy slides using information that is “easy to get across the nation.”
After just 30 minutes of a few hours’ meeting aimed at providing a robust discussion of a much broader study on the topic of fluoride supplements, Tidmarsh also chose to select two studies highlighting the risk.
One concluded that a lengthy federal review issued in August by the National Institutes of Health’s Toxicology Program concluded that levels of fluoride exposure were high. This has become an important argument for supporters of banning fluoride, but others have stated that the work lacks important context. Fluorinated water is the most common exposure in this analysis and is the focus of most research on topics, with potential risks identified at much higher levels of exposure than those used in the US. Fluoride supplements available to children in the US in the form of tablets and drops are not officially FDA approved, but are well below the recommended level.
Experts on both sides of Wednesday’s issue largely agreed that more research is needed to better understand the risks and benefits of fluoride supplements in general.
Dr. Susan Fisher Wens, a pediatrician and clinical professor at the University of California, San Francisco, shared a presentation Wednesday on the link between fluoride and neurocognitive development.
“In general, I am an optimist and believe that good science can change people’s minds for the better. Given the announcement that supplements will be removed from the market before science was presented, it’s easy to believe this is a natural conclusion, and Tidmarsh gave his opinion after the first round,” she said. “Even so, I hope that for my patients a presentation that emphasizes safety at the level seen in the US will convince the FDA.”
With the rise of national conversations about fluoride over the past few months, dentists and doctors say they are getting more questions about fluoride from patients and parents who want to better understand the risks and benefits, but the evidence suggests that most still support fluoride.
“There’s a shift in political conversation, but it’s not necessarily where the average American perception of fluoride is still there,” said Melissa Burrougs, 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 water fluorination in their communities.
“Removing fluoride without a plan to support these communities only maintains an already serious oral health crisis,” Burrows said.
An analysis of electronic health records conducted by Truveta on CNN shows that fluoride prescription rates in children in the United States have declined over the past few years, but they are consistently about 20 times higher in states where community fluorination is low compared to the proportion of states where the most common. Like Florida and Utah, decisions to add or remove fluoride from public water are determined at the local level. Questions are sometimes voted on the public vote, and community members almost always vote in favor of adding fluoride.
Similar data showing a decline in fluoride prescription rates in children was released at a meeting Wednesday.
Dr. David Chroll, a leading pediatrician at the American Academy of Pediatrics, said the trend is “truly hypothesized.” He theorized that various methods that may already be taking fluoride, and all methods that may have undergone individual risk assessments for cavity and tooth decay, are evidence of a more thorough conversation between the provider and its patients.
“After that conversation, we still need to provide supplemental supplies for some patients,” Khlor said.
Others have suggested that there may be links to more broadly hesitating government interventions on individual health that have increased during the Covid-19 pandemic to wider hesitation.
However, as community water fluorination begins to roll back, experts say it’s important to protect your options to use fluoride supplements. In fact, Utah’s law that prohibited the addition of fluoride to public drinking water contained provisions to expand access to fluoride formulations.
“We’re talking about supplements here today. We’re talking about options. We’re giving people choices if they want to have the benefits of fluoride. Supplements are the only tool in areas that aren’t fluorinated or where they don’t occur naturally,” Bekker said Wednesday. “So the opportunity to make supplements available is a matter of people’s choice. We don’t force anyone to take them with them. We allow them to have options and have options.”
