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# FDA Moves to Restrict Unapproved Fluoride Drugs
- URL: https://www.fdaweb.com/fda-moves-to-restrict-unapproved-fluoride-drugs/
- Published: 2025-10-31T12:00:00.000Z
- Updated: 2026-09-14T15:25:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160144

FDA is announcing new actions aimed at protecting children from unapproved ingestible fluoride prescription drugs. The agency sent notices to four companies signaling its intent to take enforcement action against products marketed for children under age three, or for older children at low to moderate risk of tooth decay, according to an [FDA notice](https://www.fda.gov/news-events/press-announcements/fda-acts-protect-children-unapproved-fluoride-drug-products?ref=fdaweb.com).

The move comes as part of the administration’s Make Our Children Healthy Again Strategy, launched by president Trump’s Make American Healthy Again Commission in September. The FDA said its review was based on months of scientific evaluation, public meetings, and input from parents, clinicians, and federal partners.

FDA commissioner **Marty Makary** notes that ingestible fluoride can alter the gut microbiome, which plays a central role in child development. “There are better ways to protect children’s teeth than unapproved fluoride products,” he says.

An agency scientific evaluation concluded that fluoride drugs should not be used in children under three or in older children who are not at high risk for cavities. While fluoride is known to reduce dental caries in older children, the review found no benefit for baby teeth. FDA also cites preliminary research suggesting possible links between fluoride exposure and decreases in IQ.