FDA moves to take fluoride supplements for children off the market

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17-05-2025

U.S. health regulators announced they are beginning to remove ingestible fluoride supplements for children from the market, the latest move by Health and Human Services Secretary Robert F. Kennedy Jr. to target the tooth-strengthening mineral.
Fluoride – a naturally occurring mineral found in water, soil, air, and various foods – helps prevent dental cavities and tooth decay. The mineral has been added to public water supplies for decades in the United States and to dental products, such as toothpaste, as a dental cavities prevention measure.
In a news release on May 13, the U.S. Department of Health and Human Services said the Food and Drug Administration is starting to phase out "concentrated ingestible fluoride prescription drug products" from the market. Fluoride supplements are typically prescribed to children at high risk of dental cavities and tooth decay, or who live in areas where their drinking water is not fluoridated.
The agency noted that the supplements, taken orally with tablets or drops, are not approved by the FDA. FDA Commissioner Marty Makary also suggested the supplements may alter a child's gut microbiome, and cited studies that show a possible link between ingested fluoride and "thyroid disorders, weight gain, and possibly decreased IQ."
"Ending the use of ingestible fluoride is long overdue," Kennedy said in a statement. "This decision brings us one step closer to delivering on President Trump's promise to Make America Healthy Again."
Kennedy's push against fluoride is part of his controversial Make America Healthy Again movement, which is centered on ending what he calls the "chronic disease epidemic." Scientists and dental health organizations have repeatedly warned that the HHS secretary's recommendations against fluoride are disastrous for public health.
"Rationales for limiting use should be based on evidence, and there is no scientific evidence that fluoride at low levels affects gut microbiota," American Dental Hygienists' Association President Erin Haley-Hitz said in a statement following the FDA's announcement.
Removing fluoride resources will create "unprecedented challenges for oral disease prevention" in underserved areas, Haley-Hitz added. The American Dental Association has also reiterated its support for community water fluoridation to help prevent tooth decay, according to Reuters.
The FDA has set a goal date of Oct. 31 for completing a safety review and public comment period on the measure.
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Fluoride works by strengthening the tooth's enamel, its hard outer surface, making it more resistant to the acid produced by bacteria in the mouth that causes tooth decay, the Centers for Disease Control and Prevention said. Fluoride also reverses early tooth decay by replacing and preventing the loss of minerals.
Before the start of community water fluoridation, dental decay and cavities were widespread and impacted the entire population of the United States, according to Johns Hopkins Bloomberg School of Public Health. Public health officials later recommended water fluoridation after research showed fluoride could reduce tooth decay.
The CDC has called the fluoridation of drinking water one of the 10 greatest public health achievements of the 20th century, during which Americans' life expectancies rose by 30 years.
More than 100 health organizations, including the CDC, American Medical Association, World Health Organization, American Academy of Pediatrics, and American Dental Association, maintain that water fluoridation is safe and effective. Studies show that community water fluoridation reduces tooth decay by more than 25% in children and adults, even in an era with widespread availability of fluoride from dental products, according to the American Dental Association.
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Kennedy has endorsed claims that fluoride is behind a host of health conditions, from ADHD and hypothyroidism to lowering IQ. Dentists and epidemiologists have hit back at those accusations as scientifically unproven, and have warned that removing fluoride from water systems could take a serious toll on public health.
In April, the Kennedy said he would tell the CDC to stop recommending that cities and states add fluoride to public water systems. Adding fluoride to water is not required by law.
Utah became the first state in the United States to ban fluoride in public water systems after Gov. Spencer Cox signed legislation in March. The law went into effect May 7.
Florida is set to become the second state to ban fluoride from being added to public water supplies after Gov. Ron DeSantis announced on May 6 that he planned to sign the bill into law. The new law is expected to take effect July 1.
Contributing: Swapna Venugopal Ramaswamy, Cybele Mayes-Osterman, and Hannah Yasharoff, USA TODAY; Reuters
This article originally appeared on USA TODAY: FDA to remove fluoride supplements for children off the market