FDA

FDA limits pediatric fluoride supplements to high-risk children ages 3 and up

November 5, 2025

FDA now requires manufacturers of ingestible fluoride prescription products to update labeling, limiting use to children aged 3 and older who are at high risk for dental caries. These products have never been FDA approved, and a recent agency review found limited benefit for primary teeth along with emerging safety concerns. Potential risks include gut microbiome alterations, thyroid dysfunction, weight gain, and possible neurodevelopmental effects such as reduced IQ.

While fluoride can help prevent cavities in older children, FDA cited an analysis of studies that showed no benefit for baby teeth. In a letter to clinicians, the agency advised prioritizing diet and oral hygiene interventions first. Recommended strategies include daily brushing with fluoride toothpaste and topical fluoride applications, which remain effective and safe for caries prevention.

Source:

(2025, October 31). FDA. FDA Acts to Protect Children from Unapproved Fluoride Drug Products. [News Release]. https://www.fda.gov/news-events/press-announcements/fda-acts-protect-children-unapproved-fluoride-drug-products