The FDA will hold a public meeting on July 23, 2025, to review the potential removal of ingestible fluoride supplements, a move the ADA warns could harm at-risk pediatric patients.
The U.S. Food and Drug Administration (FDA) is preparing to evaluate the continued availability of ingestible fluoride supplements, including tablets and drops commonly prescribed to children in areas lacking fluoridated water. The ADA describes these supplements as “vital” for children in communities without access to fluoridated water or where topical applications are insufficient, adding that “the prohibition of these products would particularly harm at-risk pediatric patients.”
A public meeting is scheduled for Wednesday, July 23, 2025, from 9:30 AM to 4 PM at the FDA White Oak Campus in Silver Spring, Md. The meeting will be hosted by the Reagan-Udall Foundation, which will compile a report based on research and testimony presented during the event.
The ADA calls the decision to use the congressionally created Reagan-Udall Foundation “unorthodox,” as it does not participate in regulatory decision-making or offer advice to the FDA on policy matters. Typically, the FDA’s Human Drug Advisory Committee makes such recommendations.
The FDA first announced its intention to remove ingestible fluoride supplements from the U.S. market in May.
The ADA has submitted its official comments for consideration by the panel. They emphasize the safety and efficacy of ingestible fluoride supplements when used as directed, particularly for children in areas without access to fluoridated water. The six-part letter addresses scientific evidence on fluoride’s benefits and responds to concerns about potential health risks, including neurodevelopmental and thyroid effects. Citing peer-reviewed research, the ADA argues that current guidelines are based on sound science and that removing these products could negatively impact pediatric oral health. The organization also urged the FDA to rely on high-quality studies and offered to collaborate on further scientific review.
ADA President Brett Kessler, DDS, and other experts will participate in the July 23 event to advocate for the continued availability of fluoride supplements for children. The meeting is open to the public in a hybrid format. Registration is required.
Photo: ID 184916248 © Jhvephotos | Dreamstime.com
