SILVER SPRING, Md. — The U.S. Food and Drug Administration announced on May 14, 2025, plans to remove concentrated ingestible fluoride prescription drug products for children from the market, citing potential health risks. Unlike fluoride toothpaste or rinses, these unapproved products, swallowed by infants and toddlers, may disrupt the gut microbiome and are linked to thyroid disorders, weight gain, and possible IQ reduction.
“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.” Makary directed the Center for Drug Evaluation and Research to assess risks of systemic fluoride exposure in these products to inform parents and medical professionals.
The FDA aims to complete a safety review and public comment period by October 31, 2025, before taking action to remove the products. The U.S. Department of Health and Human Services will share dental hygiene best 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.”
The decision aligns with efforts to reduce fluoride exposure. Several states have halted water fluoridation, and most European countries do not add fluoride to drinking water. Kennedy noted the action supports the Make America Healthy Again initiative to foster healthier environments for children.
Studies have raised concerns about ingested fluoride’s impact on early gut microbiome development, critical for childhood health. Research also suggests associations with thyroid issues, weight gain, and cognitive effects. The FDA’s move targets prescription fluoride products, which lack agency approval, unlike topical fluoride applications like toothpaste.
The review process will evaluate scientific evidence to guide the products’ market removal. The FDA encourages public input during the comment period to shape its final decision. HHS’s forthcoming dental hygiene guidelines will emphasize practical, safe methods to prevent cavities, such as reducing sugar consumption and regular brushing.
The announcement follows growing scrutiny of fluoride’s safety. While fluoride in toothpaste and water has long been used to prevent tooth decay, ingested forms pose unique risks, particularly for young children. The FDA’s action reflects a precautionary approach, prioritizing pediatric safety amid emerging research.
