# 2025-10943: FDA Opens Debate on Unapproved Fluoride Prescriptions for Children

2025-10943, Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishment of a Public Docket; Request for Comments, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16, effective 2025-07-23; PRIA reads it as touching household money (as of 2026-11-02).

- Canonical: https://policyrisk.com/federal-register/2025-10943
- As of: 2026-11-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-10943
- Title: Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishment of a Public Docket; Request for Comments
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 25329
- Published: 2025-06-16
- Effective: 2025-07-23
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-02

## In one line

FDA Opens Debate on Unapproved Fluoride Prescriptions for Children

## 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.

## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population." The purpose of the hybrid public meeting is to seek public input on the clinical use and safety concerns associated with the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population. The public meeting will be facilitated by the Reagan-Udall Foundation for the FDA. FDA is establishing a docket for public comment on this topic.

## Effects PRIA read

- Public meeting on pediatric fluoride: benefit, low. 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 t…
- Unapproved pediatric fluoride safety review: cost, high. 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…

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## Sources
- [2025-10943 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/16/2025-10943/use-of-orally-ingestible-unapproved-prescription-drug-products-containing-fluoride-in-the-pediatric)
- [2025-10943 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-16/pdf/2025-10943.pdf)

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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-10943 (as of 2026-11-02).