WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) announced today that it is taking steps to remove concentrated ingestible fluoride prescription drug products intended for children from the market. Unlike toothpaste or rinses, these swallowed fluoride products have never been FDA-approved.
The FDA cited concerns over studies showing that ingested fluoride can alter the gut microbiome, which is particularly worrisome during early childhood development. Additional research has suggested potential links between fluoride and thyroid disorders, weight gain, and possibly decreased IQ.
FDA Commissioner Marty Makary, M.D., M.P.H., stated that preventing children’s cavities is best achieved by limiting sugar intake and practicing good dental hygiene, rather than altering a child’s gut bacteria. He likened fluoride’s potential to kill beneficial intestinal bacteria to its effect on oral bacteria. The FDA has set a goal for October 31st to complete a safety review, gather public comments, and take action to remove these products.
In conjunction with the FDA’s evaluation, the U.S. Department of Health and Human Services (HHS) plans to disseminate best practices for children’s dental hygiene that are practical, feasible, and do not harm gut health.
HHS Secretary Robert F. Kennedy Jr. praised the FDA’s action as “long overdue” and consistent with the “Make America Healthy Again” effort. He noted that several states have already stopped water fluoridation, a practice uncommon in much of Europe and other parts of the world.
