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

The Associated Press
October 31, 2025, 7:06 PM

WASHINGTON (AP) — The Food and Drug Administration on Friday moved to limit the use of fluoride supplements used to strengthen children’s teeth, the latest action by Health Secretary Robert F. Kennedy Jr. and his deputies against a chemical that is a mainstay of dental care. … 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. … Fluoride tablets and lozenges are sometimes recommended for children and teens at increased risk of tooth decay or cavities because of low fluoride in their local drinking water. Companies also sell drops for babies.

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 agency also sent a form letter to dentists and other health providers warning about the risks of the products.

Those claims have been disputed by the American Dental Association, which has said there are no significant health problems associated with fluoride when used at the levels prescribed by dentists. The supplements can cause spotting or discoloration of teeth due to the extra fluoride, a downside the FDA also noted.

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