WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) announced new enforcement actions on Thursday to restrict the sale of unapproved ingestible fluoride prescription products marketed for children. The agency issued notices to four companies, outlining its intent to take action against products labeled for children under three years old or those at low or moderate risk of tooth decay.

According to the FDA, these unapproved products have been available since the 1940s without formal evaluation for safety, effectiveness, or quality. A recent scientific review concluded that ingestible fluoride should not be used in very young children or those who are not at high risk for cavities, citing potential impacts on the gut microbiome and broader health concerns.

Health and Human Services Secretary Robert F. Kennedy Jr. stated that the move is part of ongoing efforts to improve child health and end the use of outdated science in medical products. “This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” Kennedy said.

FDA Commissioner Marty Makary added that while topical fluoride has proven benefits for dental health, ingestible forms may present unnecessary risks. The agency’s review referenced findings suggesting fluoride exposure may not significantly reduce cavities in baby teeth and could be linked to other developmental concerns, including lower IQ levels in some studies.

To guide the medical community, the FDA has also issued a letter to healthcare professionals warning of the potential risks associated with these products. Additionally, the agency, in coordination with the National Institutes of Health and the Department of Health and Human Services, plans to launch a national oral health strategy focused on research and prevention of childhood dental disease.

The FDA’s full scientific evaluation and related materials are available at www.fda.gov.