The U.S. Food and Drug Administration (FDA) announced on May 13 that it is taking steps to remove concentrated ingestible fluoride prescription drops and tablets for infants and toddlers from the market following a safety review and public comment.
FDA Commissioner Dr. Marty Makary, MPH, has instructed the U.S. Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products. The agency hopes to conclude this evaluation by October 31, according to a FDA news release dated May 13.
The FDA suggests that these ingestible fluoride products, which often are given to children at high risk of tooth decay, may alter the gut microbiome and possibly are associated with weight gain, thyroid disorders, and a decrease in IQ.
“The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome,” Makary said in the release. “For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health.”
Along with this evaluation, the U.S. Department of Health and Human Services plans to release best practices for dental hygiene in children that are “feasible, effective and do not alter gut health,” according to the release.
“Ending the use of ingestible fluoride is long overdue,” U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said in the news release.
Kennedy has promised to recommend ending water fluoridation since before President Donald Trump was reelected. Kennedy has claimed that the cavity-fighter fluoride is an "industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease."
In April, the U.S. Environmental Protection Agency (EPA) announced it would swiftly review new scientific data on the potential health risks associated with adding fluoride to public drinking water. The announcement was made during an event with Kennedy in which he also said he plans to direct the U.S. Centers for Disease Control and Prevention to stop recommending fluoride's addition to public water systems while putting together a task force to discuss and act on the issue.
These aren’t the only movements against fluoride. Some states have already stepped up efforts to end community water fluoridation.
In March, Utah signed a law banning fluoride in public drinking water, becoming the first state to take such a drastic measure. The law took effect on May 7. Florida appears to be on a similar trajectory.
In September 2024, a U.S. judge in California issued a milestone decision that adding fluoride to public drinking water to help prevent tooth decay is risky to individuals, including children, who may face lowered IQs. Therefore, the practice requires government intervention.
