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# FDA Moves to Ban Pediatric Ingestible Fluoride Drugs
- URL: https://www.fdaweb.com/fda-moves-to-ban-pediatric-ingestible-fluoride-drugs/
- Published: 2025-05-13T12:00:00.000Z
- Updated: 2026-09-14T15:11:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159168

FDA 5/13 announced plans to remove from the market concentrated ingestible fluoride prescription drug products for children, citing safety concerns and a lack of formal approval. The products, typically prescribed for infants and toddlers, differ from fluoride toothpaste or mouth rinses because they are meant to be swallowed, an [agency notice](https://content.govdelivery.com/accounts/USFDA/bulletins/3e036b3?ref=fdaweb.com) says. FDA revealed that these ingestible products have never been approved by the agency and are now under renewed scrutiny due to emerging health risks.

“Ingested fluoride has been shown to alter the gut microbiome, a particular concern during early childhood when this system is developing,” FDA commissioner **Marty Makary** is quoted in the notice as saying. “The best way to prevent cavities in children is by reducing sugar intake and maintaining good dental hygiene — not by disrupting a child’s internal health.”

FDA plans to complete a formal safety review and allow for public comment before taking action, with a target deadline of 10/31\. CDER has been tasked with assessing the risks associated with systemic fluoride exposure in pediatric populations.

The move is intended to align with broader HHS efforts to promote safer, more holistic approaches to child dental care. The announcement comes amid growing skepticism of fluoride use, with several states having already begun limiting fluoridation in drinking water, a move echoed by many countries in Europe and around the world.

Health officials say updated dental hygiene guidelines will be issued alongside the review, focusing on effective, non-invasive methods that avoid potential risks to gut health.