The U.S. Food and Drug Administration (FDA) has now reportedly announced the removal of prescription drug products containing concentrated ingestible fluoride intended for children, a decision prompted by growing concerns over the potential health risks associated with these substances.
This announcement marks a significant shift in regulatory policy regarding fluoride, particularly in pediatric medicine.
The FDA’s decision is based on recent studies that suggest a correlation between ingested fluoride and adverse health outcomes in children, including lower IQ, weight gain, and thyroid dysfunction.
Unlike topical fluoride products, such as toothpaste and rinses, which are not ingested, these prescription drugs are designed to be swallowed by infants and toddlers.
Notably, the FDA indicated that these products had never received formal approval for safety or efficacy.
Commissioner Marty Makary emphasized the importance of prioritizing children’s health, stating, “When it comes to children, we should err on the side of safety.”
He pointed out that while fluoride can effectively reduce cavities, excessive consumption may disrupt the delicate balance of the gut microbiome, crucial for early childhood development. “The best way to prevent cavities is through good dental hygiene and a balanced diet, not by altering a child’s microbiome,” he said.
Research has increasingly highlighted how ingested fluoride can impact gut health, raising alarms among health professionals.
The FDA’s action aims to protect children from potential systemic exposure to fluoride, which may have unforeseen consequences.
Makary announced that the FDA’s Center for Drug Evaluation and Research would evaluate the evidence surrounding the risks of fluoride exposure in pediatric patients.
Health and Human Services Secretary Robert F. Kennedy Jr. praised the FDA’s initiative, referencing a systematic review published in JAMA Pediatrics that analyzed 74 studies and found a clear link between fluoride exposure and reduced cognitive function in children.
Kennedy, a long-time critic of fluoride in drinking water, has supported efforts in several states, including Utah and Florida, to ban fluoride from public water supplies.
This FDA decision signals a growing recognition of the need for caution in pediatric healthcare, particularly regarding substances that could impact child development.
As the debate over fluoride continues, the FDA’s actions may lead to further scrutiny of its use in various products and its safety for young populations.
With increasing public awareness of health issues related to fluoride, parents and healthcare providers will likely seek clearer guidance on the implications of fluoride exposure, particularly in the context of children’s health.
The FDA’s commitment to ensuring safety in pediatric medicine reflects a broader trend toward prioritizing child health over conventional practices.
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