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BIG WIN: FDA Announces New Action On Fluoride Products (Not Toothpaste)
The U.S. Food and Drug Administration (FDA) announced it is “initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market.”
“Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers. They have also never been approved by the FDA,” the FDA stated in a press release.
“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. Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ,” it added.
“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,” said FDA Commissioner Dr. Marty Makary.
“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,” he added.
Today, FDA announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers.… pic.twitter.com/bvBxfdjky1
— U.S. FDA (@US_FDA) May 13, 2025
Per CNN:
US Health and Human Services Secretary Robert F. Kennedy Jr. has pledged to roll back CDC recommendations that fluoride be added to municipal drinking water and has promised that a panel of experts will review the guidelines and make new recommendations.
Kennedy can’t formally prevent communities from adding fluoride to their drinking water, but some states and cities have already followed his lead. Utah recently banned the use of fluoride in drinking water, and Florida lawmakers passed a similar ban. Other states are considering similar moves.
“Ending the use of ingestible fluoride is long overdue,” Kennedy said in Tuesday’s news release. “I’m grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children. This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”
“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,” Makary said.
“This is especially concerning with young children where the microbiome is in a critical state of development. When it comes to children, this FDA will always err on the side of safety,” he added.
WATCH:
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
NBC News reports:
The FDA said the evaluation should be completed by Oct. 31.
The new action goes after tablets and drops that contain fluoride. According to the American Dental Association, pediatric dentists can prescribe fluoride supplements to kids living in areas with low fluoride levels in drinking water.
Dr. Meg Lochary, a pediatric dentist in Union County, North Carolina, said she’s been prescribing more of the drops and tablets since county commissioners voted to stop adding fluoride to its water supply last year.