In the United States, ingestible fluoride products once prescribed to children in areas without fluoridated tap water are now facing removal from the market. The Food and Drug Administration (FDA) has launched a scientific review of children's fluoride supplements sold as tablets and drops, and plans to ask manufacturers to voluntarily withdraw them.
According to The Associated Press, the FDA announced the plan last May, saying it aimed to complete its review by October of that year. Because formally withdrawing an approved medical product requires a rulemaking process that can take years, the FDA reportedly chose instead to encourage manufacturers to withdraw their products voluntarily.
What These Dentist-Prescribed Tablets Are
Ingestible fluoride products come as tablets, drops or lozenges, and dentists and pediatricians have prescribed them for children and teens at higher risk of cavities because the tap water in their area has low fluoride levels. The Centers for Disease Control and Prevention (CDC) has set guidelines for how much fluoride should be added to tap water since 1962, and the basic idea behind these products is to make up in tablet form for what the water lacks. In a paper published in 2010, the American Dental Association (ADA) recommended the supplements for children age 16 and under who are at high risk of cavities.
The Dispute Over the FDA's Rationale and the Situation in Korea
The FDA's Rationale and the ADA's Rebuttal
FDA Commissioner Marty Makary explained that swallowed fluoride may affect the gut bacteria involved in digestion and immunity, and that some studies have linked excess intake to lower IQ. However, the National Toxicology Program report he cited was based on data gathered in Canada, China, India, Iran, Pakistan and Mexico, and found a tendency toward lower IQ in children only when fluoride intake exceeded twice the CDC's recommended level, a different condition from the doses actually prescribed.
The ADA countered that the evidence falls short. "Proposals like this stand to hurt rural America, not make them healthier," said Dr. Brett Kessler, president of the ADA. "More than ever, at this critical time in American health care policy, it is vital that we slow down to properly study the full implications of actions like this on the health of the nation."
Utah's Easing of Fluoride Supplement Rules
Coincidentally, Utah, the first U.S. state to ban fluoride from tap water entirely, eased its rules around the same time to let people buy fluoride supplements without a prescription. As more areas remove fluoride from their water, demand for supplements is bound to grow, yet the FDA is now trying to push those very supplements off the market too. We've previously covered a Michigan county that ran into opposition from dentists when it tried to end water fluoridation, but this time the fight is over tablets rather than water. Earlier this year we also looked separately at how the Middle East war has even shaken fluoride levels in tap water in parts of the United States.
Korea's Halt to Water Fluoridation and Its Cavity Prevention
In Korea, there isn't much room for this kind of fight to begin with. The water fluoridation program that began in Jinhae, South Gyeongsang Province in 1981 was wound down nationwide by 2019, as local governments withdrew one by one, citing public complaints and the burden of facility safety inspections required under the Chemicals Control Act. Today, cavity prevention in Korea centers on fluoride varnish applied at the dentist's office, fluoride toothpaste, and elementary school fluoride rinse programs, while ingestible fluoride tablets and drops are rarely used in clinical practice. The debate over "fluoride to swallow or not" playing out in the United States turns, in Korea, into a different question altogether.