The U.S. Food and Drug Administration announced Tuesday it is taking steps to remove concentrated ingestible fluoride prescription drug products for children from the market, citing potential health risks and a lack of FDA approval.
Unlike fluoride toothpaste or rinses, these swallowed products, used by infants and toddlers, may disrupt the gut microbiome and pose other health concerns.
“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,” said FDA Commissioner Marty Makary, M.D., M.P.H. “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 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.”
The FDA has set a goal of October 31, 2025, to complete a safety review, hold a public comment period, and decide on removing these products. Studies have linked ingested fluoride to changes in the gut microbiome, critical during early childhood development, as well as potential associations with thyroid disorders, weight gain, and decreased IQ.
The move aligns with broader efforts by the U.S. Department of Health and Human Services to promote safer dental hygiene practices for children that avoid gut health risks.
“Ending the use of ingestible fluoride is long overdue,” said HHS Secretary Robert F. Kennedy Jr. “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.”
The action follows steps by several U.S. states to halt water fluoridation, a practice not adopted in most of Europe and many other countries. The FDA’s initiative supports Kennedy’s “Make America Healthy Again” campaign to foster healthier environments for children. The agency and HHS plan to share evidence-based dental hygiene guidelines to replace reliance on ingestible fluoride products.