FDA Opens Debate on Unapproved Fluoride Prescriptions for Children
Published Date: 6/16/2025
Notice
Summary
The FDA is hosting a public meeting on July 23, 2025, to talk about the safety and use of unapproved fluoride prescription drugs for kids. They want parents, doctors, and anyone interested to share their thoughts by July 16, 2025. This could lead to new rules to keep kids safer and make sure these medicines are properly reviewed.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Unapproved pediatric fluoride safety review
The FDA states that prescription fluoride drops and tablets marketed since the 1940s for children have not been reviewed or approved by FDA for safety, effectiveness, or quality, and that FDA is undertaking a review of their safety. The Agency notes recent scientific studies suggesting associations with effects on thyroid hormones, changes to the microbiome, and possibly decreased IQ, and says these findings warrant continued research and discussion.
Public meeting on pediatric fluoride
The FDA is holding a hybrid public meeting on July 23, 2025, from 9:30 a.m. to 4:00 p.m. Eastern Time to get input about orally ingestible unapproved prescription fluoride products used in children. You can submit electronic or written comments to docket FDA-2025-N-1557 by July 16, 2025; requests to give an oral presentation must be made by July 9, 2025, and in-person registration is required by July 22, 2025 at 5:00 p.m. Eastern Time.
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