The U.S. Food and Drug Administration’s new drug director said the agency will reassess whether ingestible fluoride supplements provide enough benefit to justify their use in children without fluoridated water.
Margaret Manto reports for NOTUS.
In short:
- George Tidmarsh, the new head of the FDA’s Center for Drug Evaluation and Research, said fluoride supplements have never undergone a formal approval process and called for a fresh risk-benefit review.
- Fluoride advocates, including dentists and pediatric experts, argued that low-dose supplements remain safe and critical for children in areas without water fluoridation.
- The FDA has proposed removing these supplements from the market, citing research on gut microbiome disruption and possible links to thyroid issues and reduced IQ, though some studies remain inconclusive.
Key quote:
“We’ve got to look at a risk-benefit analysis. And since this isn’t approved, it’s never been through the rigorous FDA process of saying there’s a benefit that outweighs the risk.”
— George Tidmarsh, director of the FDA's Center for Drug Evaluation and Research
Why this matters:
Fluoride has long been added to public water supplies to reduce tooth decay, but its use in supplements for children without access to fluoridated water has drawn scrutiny. Health advocates argue the mineral prevents cavities, especially in low-income communities, while critics cite studies linking high exposure to potential developmental and neurological risks.
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