The FDA just dropped a bombshell announcement that will have parents scrambling to check their medicine cabinets.
Federal health officials have finally admitted what many have suspected for years about fluoride.
And the FDA has suddenly yanked prescription fluoride products for children after acknowledging serious health concerns most Americans never knew existed.
FDA reverses course on fluoride safety claims
The U.S. Food and Drug Administration made a stunning reversal on May 13 when it announced it would initiate action to remove prescription drugs containing concentrated, ingestible fluoride for children from the market.
For decades, parents were told fluoride was perfectly safe and essential for their children’s dental health. Now, federal officials are singing a different tune after reviewing mounting scientific evidence linking fluoride consumption to disturbing health outcomes.
The FDA’s announcement came after studies revealed potential dangers that include thyroid dysfunction, reduced IQ in children, and harmful disruption of the gut microbiome.
“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 stated in its official press release. “Other studies have suggested an association between fluoride and thyroid disorders, weight gain, and possibly decreased IQ.”
Most alarming for parents is the FDA’s revelation that none of these prescription fluoride products had ever received formal FDA approval in the first place.
FDA commissioner makes shocking statement about fluoride safety
FDA Commissioner Marty Makary, M.D., M.P.H. didn’t mince words when explaining the reasoning behind this dramatic action.
“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 in the announcement. “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 went even further, instructing the Center for Drug Evaluation and Research to conduct a thorough evaluation of the evidence regarding systemic fluoride exposure risks.
“When it comes to children, we should err on the side of safety,” Makary stated, setting a clear October 31 deadline for completing a safety review and public comment period before taking final action to remove these products from the market.
This stark reversal represents a major shift in federal health policy that has promoted fluoride for generations.
Fluoride supplements vs. topical products
The FDA’s decision specifically targets pediatric prescription fluoride products that are swallowed rather than used topically and spit out.
Health officials made a clear distinction between the withdrawn products and fluoride-containing items like toothpaste and mouth rinses that remain on the market.
“Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers,” the FDA explained in their statement.
The key difference is that topical fluoride products applied to teeth and then expectorated pose significantly less risk than concentrated fluoride supplements designed to be ingested.
This differentiation raises troubling questions about why it took so long for federal health authorities to acknowledge the risks of ingested fluoride products, especially for developing children.
Growing scientific concern over fluoride’s health impacts
The FDA’s action follows years of increasing scientific scrutiny regarding fluoride’s effects on human health beyond its cavity-prevention benefits.
Beyond the concerns explicitly cited by the FDA, some researchers have raised additional questions about fluoride’s potential role in behavioral issues, hormone disruption, and even connections to certain developmental disorders.
The gut microbiome disruption mentioned by the FDA is particularly concerning given recent scientific understanding of how crucial gut health is to overall immune function, brain development, and long-term wellness.
Thyroid dysfunction linked to fluoride exposure could impact children’s growth, metabolism, and energy levels. The potential IQ impacts mentioned by the FDA may be even more alarming for parents concerned about their children’s cognitive development.
HHS Secretary Kennedy champions the fluoride decision
Health and Human Services Secretary Robert F. Kennedy, Jr. praised the FDA’s decision, calling it “long overdue.”
“I’m grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children,” Kennedy said. “This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”
The move aligns perfectly with the Trump Administration’s health initiatives, particularly Kennedy’s stated mission to ensure children grow up in a healthy environment.
According to the FDA’s announcement, HHS plans to develop and disseminate best practices for dental hygiene in children that are “feasible, effective and do not alter gut health” — a dramatic shift away from decades of promoting fluoride consumption.
