WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has announced actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children. The agency sent notices to four companies outlining the agency's intention to take enforcement action against those marketing unapproved fluoride-containing ingestible drugs labeled for use in children under age 3 or older children at low or moderate risk for tooth decay.
'This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,' said Health and Human Services Secretary Robert F. Kennedy Jr. 'It's scary that these products have been used for decades without approval.'
Based on the scientific evaluation published, FDA concluded that such products should not be used in children under age 3 or by older children who are not at high risk of tooth decay. 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.
While evidence indicates fluoride reduces the risk of dental caries in older children, a Cochrane review - an independent analysis that combines results from multiple scientific studies - of the medical literature concluded that fluoride did not reduce dental caries in baby teeth. The FDA also recognizes other preliminary but potentially concerning data on risks, such as a recent meta-analysis suggesting increased fluoride exposure is associated with decreases in IQ.
To help channel this recommendation into clinical practice, the FDA also sent a letter to health care professionals warning about the risks associated with these products.
Copyright(c) 2025 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2025 AFX News