2025-10943Notice

FDA Hosts Meeting on Safety of Kids Swallowing Fluoride Prescriptions

Published Date: 6/16/2025

Notice

Summary

The FDA is hosting a public meeting to talk about the safety and use of unapproved fluoride medicines kids might take by mouth. They want parents, doctors, and everyone to share their thoughts to help decide what’s best. This is a chance to shape future rules and make sure kids stay safe, with comments open soon and no costs yet.

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

FDA Seeks Public Input on Oral Fluoride Drugs

The FDA will hold a hybrid public meeting titled "Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population" to get input on clinical use and safety concerns for children. The meeting is being facilitated by the Reagan‑Udall Foundation, and the FDA is establishing a public docket so parents, clinicians, and other stakeholders can submit comments.

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Key Dates

Published Date
6/16/2025

Department and Agencies

Department
Independent Agency
Agency
Health and Human Services Department
Food and Drug Administration
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