Feds Admit Fluoride May Harm Children—Prescription Products Yanked [WATCH]

The U.S. Food and Drug Administration (FDA) announced this week that it will withdraw approval for pediatric prescription drugs that contain concentrated, ingestible fluoride.

The decision follows growing scientific evidence linking fluoride ingestion in children to potential health risks, including thyroid dysfunction, reduced IQ, and microbiome disruption.

BREAKING: Robert F. Kennedy Jr.’s FDA to phase out fluoride supplements for children. pic.twitter.com/IsHm3jmxpz

— Leading Report (@LeadingReport) May 14, 2025

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In a statement released Monday, the FDA emphasized that while fluoride in toothpaste and mouth rinses is used topically and then spit out, these prescription drug formulations are swallowed and absorbed into the body.

The agency noted that none of the affected products had ever received formal FDA approval.

“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 FDA said.

“Other studies have suggested an association between fluoride and thyroid disorders, weight gain, and possibly decreased IQ.”

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FDA Commissioner Dr. Marty Makary said the agency is taking a precautionary approach based on new findings and a focus on child safety.

“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,” 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.”

Makary has directed the FDA’s Center for Drug Evaluation and Research to further assess the risks associated with systemic fluoride exposure in children.

“When it comes to children, we should err on the side of safety,” he added.

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 Secretary Robert F. Kennedy Jr. endorsed the FDA’s decision, referencing a recent systematic review published in JAMA Pediatrics.

That review examined 74 peer-reviewed studies and found a consistent association between fluoride exposure and reduced cognitive function in children.

“This isn’t fringe science—this is mainstream, peer-reviewed data,” Kennedy said in a post on X.

“Yes, when it comes to children, we should always err on the side of safety.”

Kennedy has also been a vocal critic of fluoride use in public water systems.

Earlier this month, Utah and Florida became the first states in the country to implement statewide bans on public water fluoridation, moves supported by Kennedy and health policy advocates who argue that fluoride’s risks now outweigh its benefits.

The FDA’s decision represents a significant shift in federal policy on fluoride and comes amid mounting calls from medical professionals and public health advocates to reevaluate long-standing fluoride recommendations.

While fluoride has historically been promoted as a tool to prevent tooth decay, especially in children, emerging research has led to renewed scrutiny of its systemic use—particularly among young populations whose bodies are still developing.

The agency has not yet specified a timeline for the complete removal of affected prescription products from the market but stated it will provide guidance to manufacturers and health care providers in the coming weeks.

Parents currently using fluoride supplements for their children are encouraged to consult with pediatricians and dental professionals to discuss alternatives.

The FDA’s review of fluoride safety is ongoing, and additional regulatory actions may follow as more data becomes available.

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