(The Center Square) – The U.S. Food and Drug Administration announced Tuesday that it is going to remove fluoride prescription drug products for children from the market.
Dentists give the fluoride drops and tablets to kids at high risk of developing cavities.
The federal government and some state governments have been cracking down on fluoride use over concerns from dentists and the American Dental Association, who say the benefits of fluoride outweigh potential harms.
The FDA noted Tuesday that unlike toothpaste with fluoride or fluoride rinses, prescription products are meant to be ingested. The federal agency also said such products were never approved by the FDA. The FDA also said 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 FDA said.
“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,” FDA Commissioner Dr. Marty Makary said. “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 Oct. 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,” HHS Secretary Robert F. Kennedy Jr said. “I’m grateful to Commissioner Makary for his leadership on this vital issue – one that directly safeguards the health and development of our children.”
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. Most recently Utah’s legislature took fluoride out public drinking water, as did Florida. The American Dental Association said 80 years of community water fluoridation at optimal levels has proven safe and effective at reducing tooth decay and maximizing oral health.
“As a father and a dentist, it is disheartening to see that a proven, public health policy, which exists for the greater good of an entire community’s oral health, has been dismantled based on distorted pseudo-science,” Dentists and ADA President Brett Kessler said in March. “The most common chronic childhood disease is cavities. We know that when community water fluoridation stops, it’s the children and the most vulnerable of our communities who suffer. We urge legislators and voters across the country not to make Utah’s significant mistake, and, instead, to trust credible data and science which shows that optimally fluoridating community water is safe, effective and helps prevent dental disease.”
