FDA restricts use of kids' fluoride supplements citing emerging health risks

"The FDA released a new scientific analysis Friday, concluding that fluoride supplements have limited benefits for children's teeth and may be linked to emerging safety concerns, including gut issues, weight gain and cognition. "For the same reason fluoride may work to kill bacteria on teeth, it may also alter the gut microbiome, which may have broader health implications," the agency said in a statement."

"The FDA said that the products are no longer recommended for children younger than 3 and those who are older but don't face serious risks of tooth decay. Previously, the products have been prescribed for children as young as six months. The action stopped short of FDA statements in May suggesting regulators would seek the removal of the products from the market. Instead, the agency sent letters to four companies warning them not to market their products outside the new limits."

The Food and Drug Administration moved to limit fluoride supplement use for children, no longer recommending the products for children younger than three or for older children without serious tooth decay risk. Previously, supplements were prescribed for children as young as six months and available as tablets, lozenges and drops for babies. A new FDA scientific analysis concluded supplements offer limited dental benefits and may be linked to emerging safety concerns such as gut issues, weight gain and cognition, noting possible effects on the gut microbiome. The agency sent letters to four companies and alerts to health providers. The American Dental Association disputes significant health risks at prescribed levels.

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