The Food and Drug Administration (FDA) announced last week that the agency will be taking action to remove prescription drug products with ingestible fluoride for children from the market.
In a Department of Health and Human Services press release last Tuesday, President Donald Trump’s administration confirmed that the FDA would be taking action after studies have shown that ingestible fluoride can “alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood.” The press release also noted that studies have indicated that there may be a connection between fluoride and weight gain, thyroid disorders, and a decreased IQ.
The FDA explained that unlike fluoride’s inclusion in toothpaste and mouth rinses, child drug products with ingestible fluoride, which have not been approved by the agency, are “swallowed and ingested by infants and toddlers.”
In a video statement highlighting the FDA’s action against ingestible fluoride in children’s prescription drugs, Makary warned that drugs containing fluoride are currently “prescribed to infants as young as six months of age.”
“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,” FDA Commissioner Marty Makary said. “For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health.”
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“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,” Makary added. “When it comes to children, we should err on the side of safety.”
In last week’s press release, the FDA announced that it would complete a safety review and public comment period by October 31 and that the agency would take “appropriate action” regarding the removal of ingestible fluoride prescription drug products for children from the market.
In a statement on X, formerly Twitter, Health and Human Services Secretary Robert F. Kennedy Jr. expressed his support for the FDA’s action against ingestible fluoride in children’s drugs. He explained that a recent review of 74 “high-quality studies” discovered a “clear association between fluoride exposure and reduced IQ in children.”
“This isn’t fringe science—this is mainstream, peer-reviewed data,” Kennedy tweeted. “Yes, when it comes to children, we should always err on the side of safety.”
