CareQuest Institute Reacts to New FDA Action on Children’s Fluoride Supplements and Urges Continued Focus on Prevention and Access

New actions could limit fluoride access for children most at risk of tooth decay 

November 3, 2025 (Boston, MA) – The US Food and Drug Administration (FDA) has announced new enforcement actions addressing fluoride supplements for children. The agency advises that these supplements should not be used in children under three years old, or in older children who are not at high risk for cavities. 

CareQuest Institute for Oral Health appreciates the FDA’s engagement with pediatric and dental experts and encourages continued collaboration with health professionals to ensure that decisions around fluoride are guided by the best available science and evidence. However, the agency’s new enforcement actions diverge from long-standing recommendations from the American Academy of Pediatrics and the American Dental Association, who in addition to older children, advise that children from six months through age three — a period critical for tooth formation and lifelong oral health — benefit from fluoride supplements when their water lacks fluoride.  

“While this action is not nearly as restrictive as the FDA’s early proposals, we remain concerned that these recommendations would reduce access to an important preventive tool — especially for families in communities without fluoridated drinking water,” said Melissa Burroughs, Senior Director of Policy and Advocacy for CareQuest Institute. “Decades of research show that fluoride — when used appropriately — is a safe and effective tool for preventing tooth decay and strengthening developing teeth. This conflicts with decades of guidance from pediatric and dental experts and risks deepening a growing oral health crisis for children.”

Under the new enforcement action, manufacturers can no longer market ingestible fluoride products for children under three or for older children not deemed “high risk.” This leaves the youngest children without basic protection against cavities at a time when several states are also scaling back access by ending water-fluoridation mandates. Utah and Florida have already enacted statewide bans, and other states are considering similar measures. 

Overall, children’s oral health is already worsening. CareQuest Institute analysis shows emergency department visits among children 14 and under for preventable dental problems rose nearly 60 percent from 2019 to 2022 — the only age group now above pre-pandemic levels. 

“We’re already seeing the consequences of limited access to oral health care, and this decision will only make them worse,” Burroughs said. “Every child deserves the chance to grow up free from preventable dental disease, no matter where they live.”