The Food and Drug Administration (FDA) announced Tuesday it is taking a step toward “ending outdated practices” related to children’s health and will begin removing ingestible fluoride prescription drug products for kids from the market.
Health and Human Services and the FDA are “taking bold action to protect America’s children by initiating the removal of unapproved, ingestible fluoride prescription drug products from the market,” Department of Health and Human Services spokesman Andrew Nixon told Fox News Digital Tuesday. “These fluoride prescription drug products, given to infants and toddlers, have never been approved by the FDA and pose real risks to developing children — including harm to the gut microbiome, potential thyroid dysfunction, weight gain, and even reduced IQ. This is not just a public health issue — it’s a moral issue.”
“This marks another step toward delivering on our Make America Healthy Again promise — by ending outdated practices and putting Gold Standard Science at the center of children’s health,” he added.
The FDA announced earlier Tuesday it had begun the initial steps of removing “concentrated ingestible fluoride prescription drug products for children from the market.”
Fluoride is frequently used to protect teeth from decay and cavities.
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Ingestible fluoride, such as tablets prescribed to kids at high-risk for cavities, was never approved by the FDA, according to its chief, Marty Makary, and have been “shown to alter the gut microbiome,” as well as possible association “between fluoride and thyroid disorders, weight gain and possibly decreased IQ.”
Ingestible fluoride is swallowed, and differs from other fluoride products, such as toothpaste bolstered with fluoride.
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Makary said in a Tuesday press release that children can avoid heavy sugar intake to dodge cavities instead of “altering a child’s microbiome.” The gut microbiome is the ecosystem of microorganisms that live in a person’s intestines.
“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 press release. “For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health.”
“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.”
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Nixon told Fox News Digital that HHS and the FDA will launch a full safety review, including with public input, as health leaders work to finalize details of the plan by Oct. 31.
“The American people deserve transparency and accountability,” Nixon said. “The Department will issue new guidelines promoting safe, effective dental hygiene without compromising gut health.”
HHS Secretary Robert F. Kennedy Jr. added in the press release that “ending the use of ingestible fluoride is long overdue.”
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“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.”
Kennedy posted to X following President Donald Trump’s election win in November 2024 that the Trump administration “will advise all U.S. water systems to remove fluoride from public water” upon Inauguration Day.
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“Fluoride is an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease. President @realDonaldTrump and First Lady @MELANIATRUMP want to Make America Healthy Again,” he continued.
Trump told the media shortly after Kennedy’s X post that such a plan to remove fluoride from water systems “sounds OK to me.”
FIRST STATE TO BAN FLUORIDE IN DRINKING WATER WILL HEED MAHA MOVEMENT’S CALL TO ACTION
Utah became the first state in the nation to ban fluoride from public water systems in May, while Republican Florida Gov. Ron DeSantis signed a bill May 6 banning fluoride additives to the state’s public water supply. That law will take effect July 1.
“Jamming fluoride in the water supply … is essentially a forced medication,” DeSantis said during a news conference May 6 in Tallahassee, Florida. “At the end of the day, we should all agree that people deserve informed consent.”
Amid states moving to ban fluoride from water systems specifically, local dentists and critics of the move claim it will hurt residents who rely on the fluoride to bolster dental health.
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