FDA pulls approval of ingestible fluoride drugs for children, citing health concerns

The Food and Drug Administration (FDA) announced it will remove from the market prescription drugs for children that contain concentrated, ingestible fluoride.

In its decision, the FDA cited multiple studies linking ingested fluoride in children to adverse health effects, including reduced IQ, thyroid dysfunction, and weight gain. The agency emphasized that, unlike fluoride in toothpaste or mouth rinses, these products are swallowed and absorbed into the body, and have never been approved by the FDA.

“Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood,” the agency said in a press release. “Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ.”

FDA Commissioner Marty Makary said the agency is prioritizing children, saying it is best to “err on the side of safety.”

“The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” Makary said in a statement. “I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”

Health and Human Services Secretary Robert F. Kennedy Jr. backed the move, pointing to a recent systematic review in JAMA Pediatrics that analyzed 74 high-quality studies and found a clear link between fluoride exposure and lowered IQ in children. 

“This isn’t fringe science—this is mainstream, peer-reviewed data,” Kennedy wrote in a post on X. “Yes, when it comes to children, we should always err on the side of safety.”

Kennedy has also criticized fluoride in public water supplies and supported recent decisions by Utah and Florida to ban the practice. Both states became the first to implement statewide fluoride bans this month.