Regulatory Action: Withdrawal of Prescription Fluoride Supplements for Children from Market Announced by FDA
The U.S. Food and Drug Administration (FDA) announced plans on Tuesday to withdraw prescription fluoride supplements for children from the market, effective from October 2025. The move follows a safety review completed by the regulatory body. This decision does not affect topical fluoride products such as toothpaste and mouth rinses.
Dentists and pediatricians contend that the ban would eliminate a valuable tool in preventing tooth decay. They argue that the decision could impact rural communities and low-income populations, where community water fluoridation may not be readily available.
The American Dental Association asserts that a review of the safety record of prescribed fluoride levels has not revealed any harmful effects, suggesting a cautious approach to any changes. Meanwhile, the American Academy of Pediatrics reiterates its support for fluoride as an essential tool in preventing dental decay, affirming the importance of maintaining children's oral health.
Both medical professionals may express concerns about the impact of removing a proven preventive measure, particularly where other fluoride sources are limited. Dentists emphasize the effectiveness of fluoride supplements, especially in regions devoid of community water fluoridation.
Despite the FDA's safety concerns, dentists and pediatricians advocate for the continued use of fluoride as a crucial preventative measure.
Engaging in robust discussions, dentists and pediatricians advocate that the continued use of fluoride supplements in children's health regimens is essential, given their role in promoting dental health-and-wellness. In areas with minimal access to community water fluoridation, they argue that the ban on prescription fluoride supplements may exacerbate dental health issues, ultimately pushing back against the FDA's decision.
