The U.S. Food and Drug Administration (FDA) has announced plans to remove concentrated ingestible fluoride prescription drug products for children from the market, citing potential health risks. These supplements, which have never received FDA approval, are typically prescribed to children in areas lacking fluoridated water. Unlike topical fluoride applications, these products are swallowed, raising concerns about their systemic effects on young children.
FDA Commissioner Dr. Marty Makary emphasized the importance of erring on the side of safety when it comes to children’s health. He noted that ingesting fluoride has been shown to alter the gut microbiome, which is particularly concerning given its critical role in early childhood development. Additionally, studies have suggested associations between fluoride ingestion and thyroid disorders, weight gain, and possibly decreased IQ in children.
Health and Human Services Secretary Robert F. Kennedy Jr. supported the FDA’s decision, referencing a systematic review published in JAMA Pediatrics that analyzed 74 high-quality studies. The review found a clear association between fluoride exposure and reduced IQ in children, reinforcing the need for caution.
The FDA has set a goal date of October 31, 2025, to complete a safety review and public comment period regarding the removal of these products. In the interim, the agency recommends that parents and healthcare providers focus on proven methods for preventing cavities, such as reducing sugar intake and maintaining good dental hygiene practices.
The American Dental Association (ADA) has expressed concern over the FDA’s move, particularly regarding its potential impact on children in rural areas where fluoridated water is not available. ADA President Dr. Brett Kessler stated that fluoride supplements have been effective in reducing tooth decay and that their removal could disproportionately affect underserved communities.
This development aligns with a broader trend of reevaluating fluoride use in public health. Recently, states like Florida and Utah have enacted bans on adding fluoride to public water systems, reflecting growing skepticism about the practice. As the FDA moves forward with its review, the debate over fluoride’s role in children’s health is likely to continue.
