The U.S. Food and Drug Administration (FDA) has taken decisive action to restrict the sale of unapproved ingestible fluoride prescription drugs marketed for children, marking a significant step in protecting child health. In notices sent to four companies, the agency outlined plans to enforce regulations against products labelled for use in children under age three or in older children who are at low or moderate risk for tooth decay.
For decades, ingestible fluoride products have been promoted as preventive treatments for dental cavities. However, the FDA emphasized that these products were never reviewed or approved for safety, effectiveness, or quality, even though they have been in use since the 1940s. Based on a new scientific evaluation, the agency concluded that such products should not be used in children under age three or in older children who are not at high risk of tooth…
