The Food and Drug Administration (FDA) has put four companies on notice for marketing “unapproved fluoride-containing ingestible drugs” for use by children under the age of 3 or children at low or moderate risk of tooth decay.
“This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” Secretary of Health and Human Services Robert F. Kennedy Jr. said in a release announcing the FDA’s crackdown.
The release did not specify which four companies had received notices, which the FDA sent out Friday. The FDA warned the companies that it would pursue “compliance action” unless they addressed the organization’s “safety concerns.”
The agency wrote that it was pursuing this compliance action based on public input and scientific evaluation conducted over the summer, which resulted in the FDA modifying its guidelines around the use of ingestible fluoride drug products.
“It’s scary that these products have been used for decades without approval,” Kennedy said in the release. “Today’s action raises public awareness, informs medical professionals, and builds on President Trump’s commitment to Make Our Children Healthy Again.”
Kennedy has long expressed skepticism over the use of fluoride in water and products, believing the naturally occurring mineral to be “an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease.”
He has taken steps to discourage the use of fluoride in drinking water, a move that has alarmed public health experts. Fluoride can be found naturally in water, but state and local governments typically add larger amounts of the mineral due to its ability to prevent cavities in teeth.
Popular products that use fluoride include toothpaste and mouthwash, which incorporate the mineral to reduce bacteria in the mouth and reduce chances of cavities. Tea, coffee and certain brands of fluoridated water also contain the mineral.
The FDA also sent a letter Friday to health care professionals informing them of its changed recommendations for the use of ingestible fluoride drug products.
The release announcing the FDA’s crackdown also indicated the agency is launching “development of a fluoride research agenda and the first national oral health strategy” alongside the Health and Human Services Department and the National Institutes of Health.
“The goal is to close critical research gaps and guide efforts to better combat the most common childhood chronic disease in America,” the release states.
