The Food and Drug Administration announced Friday that it had sent warning letters to four companies marketing what it called “unapproved fluoride-containing ingestible drugs” for children under the age of 3, marking a significant shift in the government’s approach to fluoride use and safety.
“This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement.
The FDA did not identify the companies involved but warned that it would pursue “compliance action” if they failed to address what the agency described as “safety concerns.” The announcement follows a summer-long review of scientific evidence and public comments that prompted the FDA to update its guidance on fluoride-containing drug products.
“It’s scary that these products have been used for decades without approval,” Kennedy said. “Today’s action raises public awareness, informs medical professionals, and builds on President Trump’s commitment to Make Our Children Healthy Again.”
The decision represents one of the most visible examples of the administration’s growing skepticism toward long-standing public health practices that officials say have been slow to adapt to emerging science. Kennedy, a longtime critic of fluoride use, has frequently questioned the safety of adding the mineral to drinking water and other consumer products. He has described fluoride as “an industrial waste associated with arthritis, bone fractures, bone cancer, IQ loss, neurodevelopmental disorders, and thyroid disease.”
For decades, public health agencies have endorsed water fluoridation and the use of fluoride toothpaste as proven tools for preventing cavities, especially among children. Many local governments add fluoride to public water systems, while it also appears naturally in some water sources and is present in popular products such as toothpaste, mouthwash, tea, coffee, and bottled water.
The FDA said it was acting to protect children, particularly those at low or moderate risk of tooth decay, from unnecessary exposure to ingestible forms of the mineral. The agency’s new guidance effectively calls into question the safety of oral fluoride supplements—products often marketed to parents of young children as a preventive dental aid.
In conjunction with Friday’s enforcement action, the FDA sent a letter to health care professionals notifying them of the agency’s updated recommendations and encouraging them to reassess their use of fluoride supplements in pediatric care.
The agency also announced the creation of a new “fluoride research agenda and the first national oral health strategy,” to be developed in partnership with the Department of Health and Human Services 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 stated.
While the administration’s decision has unsettled many in the public health community, Kennedy and his allies frame the move as part of a broader effort to challenge entrenched medical orthodoxy and ensure that policies affecting children’s health are guided by updated science, not decades-old assumptions.
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