On October 31, 2025, the Food and Drug Administration (FDA) announced new actions to limit the sale of unapproved ingestible fluoride prescription drug products for children under three years of age and for children at low or moderate risk for tooth decay. In a press release, FDA also noted that it plans to launch a fluoride research agenda and the first national oral health strategy.

As part of these actions, the agency sent notices to four companies warning that it would pursue “compliance action” against certain unapproved fluoride-containing prescription drug products unless they take “corrective actions.” The notice instructs the companies to notify FDA of specific steps they will take to address safety concerns regarding their products. FDA also issued a letter to health care professionals outlining its updated recommendation for the use of ingestible fluoride drug products.

FDA previously announced plans to remove ingestible fluoride prescription drug products for children from the market, citing concerns about potential effects on gut microbiome development, thyroid disorders, weight gain, and lower IQ. On July 23, 2025, FDA, in collaboration with the Reagan-Udall Foundation, held a meeting to consider the clinical use and safety concerns associated with these products for the pediatric population. AGD submitted comments to FDA ahead of the meeting and issued an action alert encouraging its members to submit comments.

Impact on General Dentistry: AGD continues to monitor federal regulatory developments and provide comments in favor of fluoride and remains committed to advocating for the use of fluoride as a safe and effective preventative measure against cavities and tooth decay. FDA’s recommendations could limit access to fluoride products and may have significant implications for oral health outcomes among children.