📰 Is Fluoride on the Way Out? FDA Sparks Debate Over Child Safety

On May 13, the U.S. Food and Drug Administration (FDA) surprised the medical community by announcing its intent to remove prescription ingestible fluoride supplements—such as tablets and drops—for children from the market. This move, which has ignited intense scientific and public discussion, is part of an ongoing safety review set to conclude by October 31, 2025.

For decades, pediatricians and dentists have prescribed fluoride to children living in areas without fluoridated water, as a preventive measure against cavities. However, the FDA states that these products were never formally approved by the agency, and that new research raises concerns about potential risks during childhood development.

One of the key arguments supporting this decision is based on recent studies suggesting that ingested fluoride may disrupt the developing gut microbiome—a vital ecosystem of bacteria involved in digestion, immunity, and neurological development. Additional research cited by the FDA links excessive fluoride exposure to possible thyroid dysfunction, delayed cognitive development, and neurotoxic effects, although the reliability of this evidence at common clinical doses remains under debate.

Robert F. Kennedy Jr., current Secretary of Health and Human Services, strongly backed the move, calling fluoride a “dangerous neurotoxin” that must be eliminated from children's environments. “We are keeping our promise to make America healthy again,” he stated at a press briefing.

However, the American Dental Association (ADA) has expressed serious concerns, arguing that the fluoride levels used in clinical practice have not been proven harmful. The organization warns that eliminating these supplements could increase oral health disparities, especially in low-income and rural communities.

Importantly, the FDA clarified that this action does not affect topical fluoride products like toothpaste or mouth rinses, which remain recommended for cavity prevention.

As this regulatory review unfolds, the future of prescription fluoride remains at the center of a complex conversation involving public health, scientific evidence, and pediatric prevention strategies.