‘When it comes to children, we should err on the side of safety,’ the agency’s commissioner said.
The Food and Drug Administration (FDA) plans to remove ingestible prescription drugs for children that contain fluoride, the agency announced on May 13.
The ingestible products have been linked to issues such as a disrupted gut microbiome.
“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,” Dr. Marty Makary, commissioner of the FDA,
said in a statement.
Researchers
reported in a review article in March that multiple studies have found that the gut microbiota was negatively impacted in people who ingested high amounts of fluoride, a disruption that can lead to problems such as cancer.
The FDA said it plans to complete a safety review by Oct. 31 before “taking appropriate action regarding removal of these products from the market.” At the same time, its parent agency, the Department of Health and Human Services, is planning to provide the public with guidance on strong dental hygiene for children that does not alter gut health.
“Ending the use of ingestible fluoride is long overdue,” Health Secretary Robert F. Kennedy Jr. said in a statement. “I’m grateful to Commissioner Makary for his leadership on this vital issue—one that directly safeguards the health and development of our children.”
The action does not affect toothpaste with fluoride. The fluoride products in question are typically in tablet form or a lozenge, chewed or sucked and then swallowed, according to the the Centers for Disease Control and Prevention. The agency
says they’re a way to “maximize the topical effect of fluoride” for children deemed at high risk of cavities.
The American Dental Association
says that fluoride supplements such as tablets can be prescribed for children aged 6 months to 16 years who are “at high risk for tooth decay and whose primary drinking water has a low fluoride concentration.”
Fluoride is also added to drinking water across the United States, an action that has come into question since a federal judge
determined in 2024 that new research indicated water with fluoride could lower IQ in children. Kennedy, who has described fluoride as “industrial waste,”
said in April he was going to direct health officials to stop recommending the addition of fluoride to water, and was forming a task force to study fluoride.
The CDC still
recommends adding fluoride to water, describing the practice as safe and effective.
