WASHINGTON, D.C. — May 13, 2025 — The U.S. Food and Drug Administration (FDA) announced today that it is taking steps to remove ingestible fluoride prescription drug products for children from the market, citing concerns over safety and lack of prior approval. These concentrated fluoride supplements, unlike topical fluoride in toothpaste or rinses, are swallowed by infants and toddlers and have never been formally approved by the agency.
The FDA highlighted growing evidence that systemic fluoride exposure in early childhood may pose health risks. Research has suggested that ingestible fluoride could disrupt the developing gut microbiome, potentially contributing to thyroid disorders, weight gain, and decreased IQ in children.
“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. When it comes to children, we should err on the side of safety.”
The FDA is launching a formal review of the safety of pediatric ingestible fluoride products, with a public comment period and a final decision expected by October 31, 2025. The agency also plans to work with the U.S. Department of Health and Human Services (HHS) to provide parents with alternative, gut-safe dental hygiene recommendations for children.
HHS Secretary Robert F. Kennedy, Jr., voiced strong support for the FDA’s move, calling it “long overdue.”
“This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again,” said Kennedy.
This marks a significant policy shift in the U.S., as concerns about fluoride have increasingly influenced public health decisions. Several U.S. states have already reduced or ended fluoridation of public water supplies. Meanwhile, most European countries do not fluoridate drinking water, reflecting global skepticism around systemic fluoride use.
The FDA’s action aligns with broader efforts under the “Make America Healthy Again” initiative to ensure children are raised in environments that prioritize safety, transparency, and science-backed wellness practices.
