Copyright Interesting Engineering
The U.S. Food and Drug Administration has moved to end a decades-old dental habit, restricting the sale of unapproved ingestible fluoride drugs for children. The decision targets products that have long slipped through regulatory cracks, marketed to parents as preventive solutions for tooth decay. In a sweeping announcement, the FDA said it sent enforcement notices to four companies selling unapproved fluoride-containing drugs for children under age 3, and for older kids at low or moderate risk of cavities. The move marks the first major federal reassessment of fluoride safety since the 1940s. “This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” said Health and Human Services Secretary Robert F. Kennedy Jr. “It’s scary that these products have been used for decades without approval.” The announcement follows directives from President Donald Trump’s ‘Make Our Children Healthy Again Strategy’, launched in September 2025 to review long-standing pediatric health practices under the Make America Healthy Again Commission. Rethinking dental science FDA Commissioner Marty Makary said fluoride’s benefits for dental health are now weighed against emerging evidence about its effect on the gut microbiome — the complex ecosystem of bacteria that influences immunity, growth, and brain development. “There are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome,” Makary said. “The microbiome is increasingly recognized to be central to a child’s health and development.” The agency’s scientific review found that ingestible fluoride products have never been reviewed or approved for safety or effectiveness, despite decades of use. It concluded these drugs should not be used in children under 3, or in older children who aren’t at high risk of cavities. For the same antibacterial reason fluoride helps on teeth, the FDA warned, it could disrupt microbial balance in the gut, with broader health implications still being studied. Data, doubt, and next steps A Cochrane review, which pooled data from multiple studies, found fluoride offered little benefit for baby teeth. The FDA also cited recent research linking increased fluoride exposure with lower IQ scores, prompting greater caution around early exposure. The new policy comes after months of public consultation and scientific debate involving clinicians, parents, and researchers. The agency also released a full evaluation report and a summary of public comments online. To guide future policy, the FDA is partnering with the National Institutes of Health and the Department of Health and Human Services to launch a national fluoride research agenda and the first U.S. oral health strategy. The initiative aims to fill key data gaps and reshape prevention methods for dental disease, the most common chronic childhood condition in America. By turning the page on unapproved fluoride drugs, the FDA signals a broader shift toward evidence-based pediatric care, one that places modern science, not habit, at the center of children’s health policy.
