In a landmark decision, the U.S. Food and Drug Administration (FDA) has announced plans to remove concentrated ingestible fluoride products prescribed to children—such as tablets, lozenges, and drops—from the U.S. market. These products, often used in areas with low levels of fluoride in drinking water, have come under scrutiny for potential health risks.
The FDA cited growing concerns that fluoride, when ingested, may alter the gut microbiome in young children, a critical stage of early development. Additionally, emerging research has suggested links between fluoride ingestion and a range of health issues, including thyroid dysfunction, weight gain, and lowered IQ levels in children.
What’s more, these products have never gone through the FDA’s formal approval process. Despite being widely prescribed, they remained unapproved and unreviewed—until now.
Dr. Marty Makary, the FDA Commissioner, emphasized that children’s dental health can be better protected through safer alternatives. “We should be focused on reducing sugar intake and promoting strong hygiene habits,” he said. “Altering a child’s microbiome is not the solution to cavity prevention.”
The FDA will now begin a formal safety review and public comment period, with final action expected by October 31, 2025. Until then, manufacturers and health professionals are being advised to prepare for the likely removal of these products from shelves.
Health and Human Services Secretary Robert F. Kennedy Jr. voiced his full support for the decision, pointing to a recent review published in a major medical journal that found a significant correlation between fluoride exposure and reduced IQ in children. Kennedy has long warned against the risks of adding fluoride to drinking water, and his stance has helped push policy changes in states like Utah and Florida, both of which have moved to ban fluoride from their municipal water systems.
Importantly, the FDA’s move does not affect topical fluoride products such as toothpaste, mouth rinses, or professional dental treatments. These remain widely endorsed for cavity prevention when used as directed.
The American Dental Association, however, has pushed back against the FDA’s move, arguing that the studies cited do not conclusively prove harm at the fluoride concentrations commonly prescribed. The group also warned that banning fluoride supplements could disproportionately affect children in rural or underserved communities with limited access to fluoridated water and dental care.
Still, the FDA’s action signals a major shift in public health policy and reignites the national debate over fluoride’s role in children’s health. As the agency moves forward with its safety review, officials say new guidelines will be issued to help parents and healthcare providers focus on safe and effective dental practices that don’t come with hidden risks.
This decision could mark the beginning of a broader re-evaluation of fluoride’s place in American healthcare.