CareQuest Institute for Oral Health has responded to new US Food and Drug Administration (FDA) enforcement actions that limit the use of fluoride supplements in children, emphasizing that the decision could reduce access to an important preventive measure for families without fluoridated water.
“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.”
In a press release, CareQuest Institute stated that it appreciates the FDA’s engagement with pediatric and dental experts and encourages ongoing collaboration with health professionals to ensure decisions about fluoride remain based on scientific evidence. However, the organization noted that the new actions diverge from recommendations made by the American Academy of Pediatrics and the American Dental Association. These groups advise that fluoride supplements can benefit children from six months through age three — a period important for tooth formation — when community water lacks fluoride.
The FDA’s new enforcement actions advise against using fluoride supplements for children under three years old, or for older children who are not at high risk for cavities. Under the new guidance, manufacturers are no longer permitted to market ingestible fluoride products for children under three or for older children not considered high risk. The company stated that this could leave younger children without protection against cavities, particularly as several states have reduced access to fluoride by eliminating water-fluoridation mandates. Utah and Florida have enacted statewide bans, and other states are considering similar measures.
According to the company, children’s oral health outcomes are already worsening. CareQuest Institute analysis found that emergency department visits among children 14 and under for preventable dental problems rose nearly 60 percent from 2019 to 2022, marking the only age group 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.”
CareQuest Institute for Oral Health is a national nonprofit focused on advancing a more accessible, equitable, and integrated oral health system through research, philanthropy, health transformation, and policy advocacy.