Fluoride supplements have never been approved by the FDA to treat cavities.
Fluoride supplements were launched in the 1940s and later effectively grandfathered into the regulatory process. They never underwent the testing for safety and effectiveness typically required by FDA-regulated drugs, and the agency never granted them formal approval.
In 2016, FAN filed a Citizen Petition with FDA asking the Agency to remove fluoride drops/lozenges (“fluoride supplements”) from the market due to their lack of efficacy and dangers.
Our petition cited a letter the FDA sent to Kirkman Labs, a fluoride supplement manufacturer, informing the company that it couldn’t sell its products because they were unapproved drugs and didn’t meet the “generally recognized as safe” classification. The petition pointed out that FDA’s decision on Kirkman should apply to all supplement manufacturers.
The FDA didn’t disagree, but said it made decisions on a case-by-case basis, largely dependent on whether the U.S. attorney decided to file a lawsuit.
FAN is happy to see that FDA is now going to take action nationally to remove fluoride tablets from the market. Click here to read FAN’s In-depth newsletter on the FDA’s fluoride drug announcement.
FDA PRESS RELEASE
The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers. They have also never been approved by the FDA. Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood. Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased 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. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health,” said FDA Commissioner Marty Makary, M.D., M.P.H. “I am instructing our 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 to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”
The agency has set a goal date of October 31 for completing a safety review and public comment period and for taking appropriate action regarding removal of these products from the market. In conjunction with this evaluation, the U.S. Department of Health and Human Services plans to disseminate best practices for dental hygiene in children that are feasible, effective and do not alter gut health.
“Ending the use of ingestible fluoride is long overdue,” said HHS Secretary Robert F. Kennedy, Jr. “I’m grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children. This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”
Several states have taken action to stop fluoridation of drinking water, and fluoride is not added to drinking water in most of Europe or other countries of the world. This action by the FDA is consistent with Secretary Kennedy’s Make American Healthy Again effort to ensure children grow up in a healthy environment.
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