WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) announced a major regulatory shift this week, initiating action to remove ingestible fluoride prescription drug products for children from the market due to growing concerns about their safety and lack of formal approval.
Unlike topical fluoride products such as toothpaste or rinses, these concentrated fluoride medications are swallowed and intended for infants and toddlers. The FDA revealed that these ingestible fluoride products have never been approved by the agency and may pose health risks during early childhood development.
Research has increasingly suggested that ingested fluoride may alter the gut microbiome, which is especially concerning given the microbiome’s crucial role in early childhood health. Additional studies have linked fluoride exposure to thyroid disorders, weight gain, and potential cognitive effects such as lowered IQ.
“The best way to prevent cavities in children is by avoiding excessive sugar intake and practicing 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.”
Dr. Makary has directed the Center for Drug Evaluation and Research to conduct a thorough review of systemic fluoride exposure risks, with a goal date of October 31, 2025 to complete its assessment and public comment period. The findings will inform the FDA’s final decision regarding removal of these products from the market.
In tandem with the FDA’s review, the U.S. Department of Health and Human Services (HHS) will release updated best practices for childhood dental hygiene that prioritize both effectiveness and gut health.
“Ending the use of ingestible fluoride is long overdue,” said HHS Secretary Robert F. Kennedy, Jr. “This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”
The move aligns with broader international trends, as most European nations and many others around the world do not fluoridate drinking water. Several U.S. states have also scaled back water fluoridation programs in response to ongoing safety debates.
The FDA’s announcement marks a significant milestone in the national conversation on fluoride exposure and reflects a growing emphasis on protecting early childhood development through cautious, evidence-based public health policy.
