FDA limits access to fluoride supplements

The FDA on Oct. 31 announced efforts to restrict the availability of ingestible fluoride drug products to children under 3 years old or to those at low or moderate risk for tooth decay. Specifically, the agency issued notices to four companies, stating its intent to take enforcement action against those marketing unapproved ingestible fluoride-containing drugs labeled for use in this patient population. The FDA also sent a letter to healthcare professionals highlighting its recommendation against using these products in such patients. Earlier this year, the agency had announced plans to withdraw fluoride supplements from the market by October 2025 but has since decided to implement a new warning label rather than an outright ban. The ADA issued a statement calling for the use of clinical judgment – rather than a warning label – in determining appropriate fluoride levels for children.