On July 23, 2025, the Food and Drug Administration (FDA), in collaboration with the Reagan-Udall Foundation, held a meeting to consider the clinical use and safety concerns associated with orally ingestible unapproved prescription drug products containing fluoride for the pediatric population. The public meeting focused on four key areas: clinical use and prescribing considerations for pediatric tooth decay prevention; safety concerns associated with ingestible fluoride products; appropriateness of pediatric use in light of other fluoride exposures; and potential impacts and alternatives if these products are removed from the market. 

During the meeting, dentists, physicians, researchers, public health experts, and other members of the public discussed viewpoints both for and against fluoride usage. Dr. George Tidmarsh, the newly appointed Director of FDA’s Center for Drug Evaluation and Research (CDER), stated that fluoride tablets have not undergone FDA’s formal drug approval process and that removing them from the market would not constitute revoking an approved drug. Many dentists and physicians emphasized that fluoride, including in tablet form, is supported by substantial evidence for its effectiveness in preventing cavities and that taking the products off the market could lead to an increase in tooth decay, particularly in states considering an end to community water fluoridation.

A recording of the meeting can be found here. 

Impact on General Dentistry: The AGD continues to monitor federal developments and remains committed to advocating for the use of fluoride as a preventive measure against cavities and tooth decay. The FDA’s evaluation of these products could significantly influence future access to fluoride for children. 

The AGD submitted comments for the hearing that can be found here.

The AGD previously issued action alerts encouraging members to submit comments ahead of the July 16 deadline—thank you to all who participated.