The U.S. Food and Drug Administration (FDA) has announced measures to limit the sale of unapproved ingestible fluoride prescription drug products intended for children. The agency has sent notices to four companies, stating its intention to take enforcement action against those marketing these unapproved products for children under age 3 or for older children who are at low or moderate risk for tooth decay.
"This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride," said Health and Human Services Secretary Robert F. Kennedy Jr.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. Today's action raises public awareness, informs medical professionals, and builds on President Trump's commitment to Make Our Children Healthy Again."
This move aligns with the Make Our Children Healthy Again Strategy, released by President Trump's Make American Healthy Again Commission in September 2025, which instructed the FDA to assess fluoride products.
"There are better ways to protect children's teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome. The microbiome is increasingly recognized to be central to a child's health and development," said FDA Commissioner Marty Makary, M.D., M.P.H.
The FDA's decision comes after months of scientific review and consultation with parents, clinicians, advocates, and federal partners through a public meeting and comment period. The agency published an evaluation of current use and potential risks associated with unapproved ingestible fluoride drug products. A summary of these discussions is available online.
Although ingestible fluoride drug products have been in use since the 1940s, they have not undergone FDA review or approval for safety or effectiveness. According to the agency's recent evaluation, such products should not be given to children under age 3 or older children unless they are at high risk for tooth decay. The same antibacterial properties that allow fluoride to reduce bacteria on teeth may also impact the gut microbiome in ways that could affect broader health outcomes.
Research indicates that while fluoride can help prevent dental caries in older children, an independent Cochrane review found no evidence it reduces cavities in baby teeth. The FDA also notes emerging data suggesting potential risks; a recent meta-analysis reported an association between increased fluoride exposure and lower IQ scores.
To support this new guidance in clinical settings, the FDA has sent letters warning healthcare professionals about potential risks linked with these products. Additionally, working alongside the National Institutes of Health and U.S. Department of Health & Human Services, the FDA will begin developing a research agenda on fluoride as well as launch a national oral health strategy aimed at closing research gaps and improving efforts against childhood dental disease.
