The FDA plans to remove fluoride supplements from the U.S. market by October 2025 following a safety review citing potential health risks—an action the ADA warns could undermine access to proven cavity prevention.

The U.S. Food and Drug Administration (FDA) announced that it intends to remove ingestible fluoride supplements—such as tablets and drops—from the U.S. market by October 2025, pending the outcome of a safety review.

The agency noted that these products have never been formally approved by the FDA. It also cited research that it says raises concerns about potential health effects, including the impact of ingested fluoride on the developing gut microbiome in children. The agency also claims that additional studies have suggested possible associations between fluoride and thyroid disorders, weight gain, and decreased IQ.

The proposed action does not apply to topical fluoride products such as toothpaste or mouth rinses.

ADA Challenges Validity of Referenced Research

The American Dental Association (ADA) responded with strong concerns, warning that the studies referenced by the U.S. Department of Health and Human Services (HHS) do not provide conclusive evidence of harm at the fluoride levels currently prescribed by dental professionals.

“There is limited research on the studies of microbiome composition and fluoride association,” the ADA stated.

Brett Kessler, DDS, ADA president added, “Proposals like this stand to hurt rural America, not make them healthier. More than ever, at this critical time in American health care policy, it is vital that we slow down to properly study the full implications of actions like this on the health of the nation.”

READ MORE: ADA Pushes Back on Fluoride Misinformation Following EPA Announcement

Fluoride Supplements Support Cavity Prevention in Underserved Communities

Fluoride supplements have long been used to prevent tooth decay in areas without access to fluoridated water. These supplements provide systemic fluoride exposure, which supports enamel health and reduces cavity risk when used in accordance with prescribed dosing.

“In non-fluoridated communities, especially rural areas, fluoride supplements are the only chance for individuals to get the appropriate amount of fluoride to prevent tooth decay,” Kessler noted. “This is true even when other sources of fluoride are available, like fluoride-containing toothpastes and mouth rinses.”

Water Fluoridation Proven to Reduce Tooth Decay

Currently, about 70% of the U.S. population receives fluoridated community water, which public health studies have shown reduces tooth decay by about 25% in both children and adults. However, some municipalities and states have recently rolled back fluoridation programs, putting more reliance on fluoride supplements to maintain cavity prevention.

Kessler pointed to Utah as an example, where a recent ban on community water fluoridation left fluoride supplements as one of the few remaining tools for cavity prevention—an approach even the state’s own health department had recommended as an effective alternative.

ADA Warns of Reduced Prevention Options

“If prescription and over-the-counter fluoride supplements are also banned, then there are fewer prevention methods of tooth decay available,” said Kessler. “This is not ideal for our patients, but it will be particularly harmful to the most vulnerable and those who lack access to care.”

According to the ADA, in communities that have eliminated water fluoridation—such as Calgary, Canada; Juneau, Alaska; and Israel—health officials have documented increases in tooth decay rates and treatment costs, even when tooth brushing habits remained unchanged.

Final FDA Decision Expected by October 2025

The FDA’s safety review is ongoing, with a final decision on the future of fluoride supplements expected by October 2025.

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