FDA moves to take prescription fluoride drops and tablets for kids off the market

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FDA moves to take prescription fluoride drops and tablets for kids off the market

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The Food and Drug Administration on Tuesday announced it will begin the process of pulling prescription fluoride drops and tablets for children off the market. The supplements are usually given to 

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The federal government and some state legislatures are increasingly drawing attention to what they claim are the risks associated with fluoride, a mineral that’s been used for decades in community water systems, toothpastes and mouth rinses to prevent tooth decay.

Dentists fiercely contest that the harms of fluoride outweigh the benefits.

FDA Commissioner Dr. Marty Makary said in a news release that he’s instructing the agency’s 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.”

The news release suggested that ingested fluoride can alter a child’s gut microbiome and cause weight gain, thyroid disorders and “possibly decreased IQ.”

U.S. Food and Drug Administration Commissioner Martin Makary attends a press conference in the Roosevelt Room at the White House in Washington, D.C., U.S., May 12, 2025. REUTERS/Nathan Howard

Nathan Howard | Reuters

“The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene,” Makary said.

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 

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, 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 

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 to its water supply last year.

“This is really going to hamper our goal of providing kids with fluoride,” Lochary said. “It’s ridiculous, and it takes away the choice of parents to allow their children to have better dental health. It doesn’t make scientific sense.”

“Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers,” the news release said.

Health Secretary Robert F. Kennedy Jr. has previously referred to fluoride as “industrial waste” on the 

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 and 

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 that the faster the mineral goes away, the better.

“Ending the use of ingestible fluoride is long overdue,” Kennedy said in Tuesday’s announcement.

Utah and Florida recently banned the addition of fluoride to public water systems. 

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