FDA Moves to Eliminate Fluoride-Based Prescription Drugs for Children from Market
On May 13, 2025, the U.S. Food and Drug Administration (FDA) announced plans to remove ingestible fluoride prescription drug products for children from the market. These supplements, which have been widely used to help prevent tooth decay in non-fluoridated areas, will undergo a final safety review before the FDA takes action. The agency raised concerns about fluoride’s potential effects on gut microbiome development, thyroid disorders, weight gain, and lower IQ. A decision is expected by October 31, following a public comment period. The FDA also signaled that the Department of Health and Human Services (HHS) intends to publish best practices for children’s dental hygiene that are “feasible, effective and do not alter gut health.”
Impact on General Dentistry: AGD continues to monitor federal regulatory developments and remains committed to advocating for the use of fluoride as a preventative measure against cavities and tooth decay. The FDA’s announcement can be found here.
Impact on General Dentistry: AGD continues to monitor federal regulatory developments and remains committed to advocating for the use of fluoride as a preventative measure against cavities and tooth decay. The FDA’s announcement can be found here.