FDA Moves to Withdraw Children’s Prescription Fluoride Products

Washington, D.C. – The Food and Drug Administration (FDA) announced on May 13, 2025, that it will begin pulling prescription fluoride drops and tablets for children off the market. The decision comes amid rising concerns over the potential health risks associated with fluoride, a mineral commonly found in drinking water, toothpaste, and mouth rinses intended to prevent tooth decay.

Some state legislatures and health experts argue that fluoride poses risks that overshadow its benefits. However, dentists contest this viewpoint. Margherita Fontana, a professor at the University of Michigan, stated, “The only side effect that we know of from using fluoride is dental fluorosis,” which causes cosmetic alterations such as white or brown marks on teeth.

FDA Commissioner Dr. Marty Makary has directed the agency’s Center for Drug Evaluation and Research to evaluate evidence related to systemic fluoride exposure from pediatric products. He highlighted the need for this inquiry to better inform parents about potential risks. Concerns noted in the FDA’s announcement include the possibility that fluoride could alter a child’s gut microbiome and lead to weight gain, thyroid disorders, and decreased IQ.

“The best way to prevent cavities in children is by avoiding excessive sugar intake and practicing good dental hygiene,” Makary added. Experts share an urgent concern over the U.S. diet, which contains excessive sugar linked to chronic diseases. Fontana remarked, “If we start removing fluoride products, we’re going to regress to a time when dentures were common among young people.”

The FDA plans to complete its evaluation by October 31. The withdrawal primarily targets pediatric drops and tablets prescribed to children in areas with low fluoride in drinking water. Dr. Meg Lochary, a pediatric dentist from Union County, North Carolina, expressed frustration, stating, “This really hampers our goal of providing kids with fluoride. It takes away parental choice for better dental health.”

The FDA press release referenced multiple studies regarding fluoride; however, none specifically addressed the effects of oral tablets or drops. Previous studies indicated that while extremely high fluoride levels could negatively impact microbiomes, optimal water fluoridation levels in the U.S. are considered safe.

Additionally, a study published in JAMA Pediatrics this year identified a correlation between high fluoride exposure and lower IQ scores in children, though these studies were largely conducted in regions with much higher fluoride levels than those typically found in the U.S.

Fontana concluded that current evidence linking fluoride to health issues is insufficient, stating, “Rigorous studies on this don’t exist.” In parallel, health activist Robert F. Kennedy Jr. criticized fluoride as “industrial waste,” expressing support for the FDA’s decision, which he believes is long overdue. Recently, Utah and Florida took steps to ban fluoride in public water systems.