Prime Highlights
- The FDA has taken a step to ban ingestible fluoride supplements among children on grounds of safety.
- The action comes in the face of increasing evidence that ingesting fluoride has caused developmental and endocrine health risks.
Key Facts
- Fluoride lozenges, tablets, and drops were never formally approved by the FDA despite having been present in the market for more than four decades.
- The action does not include topically applied fluoride items such as toothpaste and mouthwash.
Key Background
The United States Food and Drug Administration (FDA) intends to pull unapproved prescription use fluoride products out of the market, specifically those for use by children in tablet, lozenge, and drop form. Supplements were initially developed to reverse child tooth decay from areas where community water is not fluoridated. Yet the FDA determined the ingestible products never went through the official approval process and are long-term health hazards.
Recent scientific studies contradicted the systemic impact of fluoride intake. Intake was said to interfere with gut microbiota, inhibit thyroid function, and even impair the developing brain of children. The FDA reacted to regulatory measures, public health, and the necessity for stringent drug approval processes.
The step was received to mixed reactions. For example, public health advocates such as U.S. Health Secretary Robert F. Kennedy Jr. welcomed the action, citing the neurotoxicity of fluoride in addition to protecting metabolic and neurological well-being of children. Kennedy has been vocal long enough on the need for thorough screening of environmental and pharma exposure to children.
Conversely, other dentists as well as the American Dental Association (ADA) doubted it. They believe that such supplements of fluoride are essential in preventing children who don’t drink fluoridated water from getting tooth caries. The ADA cautions that its removal will impact rural and underserved communities with limited dental care access negatively.
Notably, the FDA stated that the products with fluoride that are applied topically like toothpaste, mouth rinses, and professionally applied gels are not included in this action and are still approved and acceptable for cavity prevention. The agency will permit a public comment period up to October 31, 2025, before making the ultimate finding of safety and effectiveness.
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