FDA Seeks Removal of Ingestible Fluoride Prescriptions for Children

The U.S. Food and Drug Administration (FDA) announced plans to remove ingestible prescription fluoride products for children from the market, citing concerns that these products alter the gut microbiome during a crucial phase of childhood development. Unlike topical fluoride treatments such as toothpaste and mouthwash, these ingestible fluoride supplements, often prescribed to children in areas with low fluoride water, may pose risks including potential impacts on thyroid function, weight gain, and intelligence, though they have not been formally FDA approved. The FDA aims to complete a scientific safety review and public comment period by October 31, with initial steps including requests for voluntary product removal from manufacturers. Health and Human Services Secretary Robert F. Kennedy Jr., a longtime critic of fluoride use, praised the move as "long overdue" and has also advocated ending water fluoridation programs. FDA Commissioner Marty Makary emphasized that preventing cavities should focus on reducing sugar intake and maintaining good dental hygiene rather than systemic fluoride exposure, highlighting concerns about disrupting beneficial intestinal bacteria. The decision marks a significant shift in federal policy regarding fluoride use in pediatric care, aligning with recent efforts to reevaluate fluoride's role in public health.