FDA Issues Warnings on Fluoride Medications for Children

The Food and Drug Administration (FDA) has issued warnings to four companies concerning their sale of “unapproved fluoride-containing oral medications” intended for children under three, as well as for those at low or moderate risk of tooth decay.

“This Halloween, the FDA is putting an end to outdated science in order to protect children from the risks posed by ingestible fluoride,” stated Health and Human Services Secretary Robert F. Kennedy Jr. in a press release about the FDA’s enforcement action.

The specific names of the four companies that received warnings from the FDA last Friday were not disclosed. The FDA mentioned it would take “compliance action” if the companies did not address the agency’s “safety concerns.”

According to the FDA, this enforcement action stems from public feedback and scientific assessments conducted over the summer, which led to revisions in their guidelines for ingestible fluoride medications.

“It’s shocking that these products have been used without proper authorization for so long,” Kennedy remarked in the announcement. “Today’s action is part of President Trump’s initiative to enhance public awareness, educate health professionals, and improve children’s health.”

Kennedy has previously voiced concerns about fluoride use, suggesting it should be viewed as “industrial waste” linked to various health issues like arthritis, bone fractures, and neurodevelopmental disorders.

He has also taken measures to discourage the addition of fluoride in drinking water, a move that has alarmed public health experts. While fluoride naturally occurs in water, many states and local governments enhance its levels to help prevent tooth decay.

Common fluoride products include various toothpastes and mouthwashes, which employ minerals to minimize bacteria in the mouth and reduce cavity risks. Some brands of bottled water, along with beverages like tea and coffee, also contain fluoride.

The FDA also sent a letter on Friday, notifying healthcare professionals about the new recommendations concerning ingestible fluoride medications.

Additionally, the release detailing the FDA’s enforcement efforts mentioned that the agency is collaborating with the Department of Health and Human Services and the National Institutes of Health to establish a fluoride research agenda and a national oral health strategy.

“The objective is to address significant research gaps and guide the fight against one of America’s most prevalent chronic childhood illnesses,” the release indicated.