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FDA Mulls Ban on Fluoride Supplements, Sparking Concern Among Dental Professionals

The United States Food and Drug Administration is weighing the removal of all ingestible fluoride supplements from the US market, prompting outcry from oral health leaders. A July 23 public meeting will review emerging research, but the ADA warns the move could jeopardize access to proven caries prevention for at-risk children.

The United States Food and Drug Administration (FDA) is considering a sweeping action that could eliminate all ingestible fluoride supplements (ie, tablets and drops used primarily by young children to prevent tooth decay) in a move that has sparked alarm across the dental community.

A public meeting hosted by the Reagan-Udall Foundation will take place July 23 at the FDA’s White Oak Campus in Silver Spring, Maryland. The meeting will explore the safety of prescription fluoride supplements, with discussions focused on neurodevelopment, IQ, gut microbiome impact, and thyroid health. While the foundation will issue a report based on the testimony, the FDA is not obligated to act on the conclusions.

The American Dental Association (ADA) has submitted comprehensive comments in response to the FDA’s Federal Register notice, emphasizing that the majority of high-quality scientific evidence does not support claims of harm from fluoride at recommended levels. Supplements are a vital public health tool, particularly for children living in areas without fluoridated water or access to consistent topical fluoride applications.

The proposed prohibition could disproportionately harm pediatric patients in rural or underserved communities, many of whom rely on these supplements to prevent early childhood caries. According to the ADA, these products are most effective when integrated with other fluoride sources such as toothpaste, varnishes, and community water fluoridation.

The ADA has offered to partner with the FDA to provide peer-reviewed literature and expert input to ensure policy decisions reflect the best available science. Until then, oral health professionals are urged to stay informed and advocate for evidence-based policies that protect access to essential preventive care. Click here to read more.

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