FDA Makes Big Announcement On Fluoride

The U.S. Food and Drug Administration (FDA) is removing from the market prescription drug products for children that contain concentrated ingestible fluoride, the agency announced this past week.

The FDA cited studies that suggest a connection between ingested fluoride in children and lower IQ, weight gain, and thyroid issues.

“Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers,” a press release from the agency said. “They have also never been approved by the FDA.”

“Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood,” the press release added. “Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ.”

FDA Commissioner Marty Makary said it’s vital that the FDA “err on the side of safety” when it comes to our children.

“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. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” the commissioner said in a statement. “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.”

Today, the FDA is taking action to remove concentrated ingestible fluoride prescription drug products for children from the market. A growing body of research is demonstrating how ingested fluoride can alter the gut microbiome. This is especially concerning with young children… pic.twitter.com/pKTtkGyV3J

— Dr. Martin Makary (@DrMakaryFDA) May 13, 2025

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. applauded Makary for the action.

“Thank you, [Dr. Marty Makary] for your leadership on this issue,” he posted to X on Saturday. “A recent systematic review published in JAMA Pediatrics, analyzing 74 high-quality studies, found a clear association between fluoride exposure and reduced IQ in children. This isn’t fringe science—this is mainstream, peer-reviewed data. Yes, when it comes to children, we should always err on the side of safety.”

Thank you, @DrMakaryFDA for your leadership on this issue. A recent systematic review published in JAMA Pediatrics, analyzing 74 high-quality studies, found a clear association between fluoride exposure and reduced IQ in children. This isn’t fringe science—this is mainstream,… https://t.co/zLpV90d628

— Secretary Kennedy (@SecKennedy) May 17, 2025

Kennedy has been a long-time critic of the addition of fluoride to the public water supply. Since RFK Jr. took over as secretary of HHS, a number of states have taken steps to remove the chemical from public drinking water. So far, Utah and Florida have officially banned the chemical.

Related: ‘It Raises Larger Issues’: DeSantis Bans Fluoride In Florida Water