The US Food and Drug Administration (FDA) has announced plans to withdraw concentrated ingestible fluoride prescription drugs intended for children from the market.
Unlike fluoride toothpaste or rinses, these products are ingested by infants and toddlers but have never received FDA approval.
Concerns have been raised about ingested fluoride’s impact on the gut microbiome, particularly during early childhood development. Research has also indicated potential links between fluoride and thyroid issues, weight gain, and reduced IQ.
The FDA aims to conclude a safety review and public consultation by 31 October 2025, after which it will decide on the removal of these products.
Alongside this, the US Department of Health and Human Services will issue guidelines on effective dental hygiene practices for children that do not compromise gut health.
FDA commissioner Marty Makary said: “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.
“I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated paediatric 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.”
In response to fluoride-related concerns, several US states have ceased adding fluoride to drinking water.
Additionally, most European countries and many others worldwide do not fluoridate their water supplies.
The FDA’s initiative aligns with Secretary Kennedy’s Make American Healthy Again campaign, which promotes a healthy environment for children.
HHS Secretary Robert Kennedy, Jr said: “Ending the use of ingestible fluoride is long overdue. I’m grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children.
“This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”
