Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population

Hybrid Public Meeting
July 23, 2025 | 9:30am-4pm (eastern)

KidsThe Reagan-Udall Foundation for the FDA, in cooperation with the Food and Drug Administration, will convene a hybrid public workshop to gather input on the clinical use and safety concerns associated with orally ingestible unapproved prescription drug products containing fluoride for use in children.

The public — including consumers/patients, healthcare providers, researchers, and industry — are invited to provide brief public comment on four key topics related to the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population.

  1. Clinical Use and Prescribing Considerations for Pediatric Tooth Decay Prevention
     
  2. Safety Concerns
     
  3. Appropriateness of Pediatric Use Considering Additional Sources of Exposure
     
  4. Impact of Removal of Orally Ingestible Unapproved Prescription Drug Products/Potential Alternatives

The deadline to request to present public comment is Wednesday, July 9, 2025. Comments can be made by in-person and virtual attendees.

To view the Federal Register Notice, please click here.

Register to Attend In-Person
Register to Attend Virtually