FDA Tightens Rules on Fluoride Supplements for Children

The United States Food and Drug Administration (FDA) is moving to restrict the sale of unapproved ingestible fluoride prescription products for children, signaling a major regulatory shift in preventive dental care. The agency intends to take enforcement action against manufacturers marketing these supplements for children younger than age 3 and those labeled for older children at low or moderate risk for dental caries. The agency sent notices to four companies apprising them of legal action should they continue to sell the fluoride supplements.

The decision follows months of debate about the safety and necessity of ingestible fluoride. While fluoride remains a cornerstone of caries prevention, the FDA has cited concerns about overexposure and the potential health risks associated with ingestive forms, including disruption of the gut microbiome. Fluoride supplements are typically recommended for children living in areas without sufficient levels of fluoride in the community water supply. While they have been prescribed and used since the 1940s, fluoride supplements are not FDA approved.

Fluoride tablets and drops are prescribed based on local water fluoride concentration and the child’s age, with no supplements recommended when fluoride levels meet or exceed 0.6 ppm. The restriction may disproportionately affect families in regions where community water fluoridation has been reduced or discontinued. Click here to read more.