Overview
- The FDA told four manufacturers to stop marketing ingestible fluoride drug products for children age 3 or younger and for patients at low or moderate risk of tooth decay.
- The agency said the products have never been approved for safety, effectiveness or quality and warned it will pursue compliance action if concerns are not addressed.
- Officials cited evidence of potential gut microbiome disruption and a lack of demonstrated cavity prevention in infants, while noting strong benefits for older children remain well supported.
- FDA Commissioner Marty Makary advised clinicians to use topical fluoride applications and supervise daily brushing with an appropriate amount of fluoride toothpaste.
- The American Dental Association objected on access grounds for non‑fluoridated and rural communities, while HHS Secretary Robert F. Kennedy Jr. backed the move and the FDA said it is developing a fluoride research agenda and a national oral health strategy with HHS and NIH.