Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population
Hybrid Public Meeting
July 23, 2025 | 9:30am-4pm (eastern)
On July 23, 2025, the Reagan-Udall Foundation for the FDA, in collaboration with the FDA, convened a public meeting on “Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population.” The meeting brought together clinicians, researchers, state and local health representatives, parents, and patient advocates to discuss the use, benefits, risks, and evidence gaps related to these products.
Across the discussion, two central perspectives emerged. Some viewed the role of ingestible fluoride drug products as a vital preventive tool to reduce pediatric dental caries, particularly in communities without consistent access to fluoridated water. Parental and some clinical experiences underscored how these products can help bridge gaps in oral health, particularly for children in underserved areas. In contrast, other clinicians highlighted concerns about potential systemic risks, including neurocognitive and endocrine effects, and pointed to uncertainties in the evidence base. These views underscored the lack of randomized controlled trials, the limited scope of existing research, and uncertainties about safe exposure thresholds. Public input demonstrated a wide range of views, including both support for these products as a preventive option and concerns regarding their safety, regulatory status, and necessity given available topical alternatives.
Prior to the meeting, the public was invited to register to provide brief public comment on four key topics.
- Clinical Use and Prescribing Considerations for Pediatric Tooth Decay Prevention
- Safety Concerns
- Appropriateness of Pediatric Use Considering Additional Sources of Exposure
- Impact of Removal of Orally Ingestible Unapproved Prescription Drug Products/Potential Alternatives
Note the deadline to request to present public comment was Wednesday, July 9, 2025. Everyone who expressed interest in presenting public comment was offered a spot to do so.
Watch the Full Meeting and Public Comment
Background Information
Prescription fluoride drops and tablets for ingestion were first marketed in the United States in the 1940s to prevent dental caries, particularly in children who lived in areas with low or no water fluoridation. Although these products are still prescribed today, none have been reviewed and approved by FDA for safety, effectiveness, or quality. FDA has previously not taken action to remove such unapproved drug products from the market. Over the years, numerous medical and dental organizations in the United States have recommended the use of ingestible fluoride products for individuals for whom regular topical treatment is difficult to achieve and those for whom topical fluoride only is insufficient to avoid dental decay.
However, FDA continuously monitors the safety of drug products sold in the United States, including marketed unapproved prescription drug products, and is aware of recent scientific research on the safety of ingestible fluoride. While the safety concerns presented in the scientific literature have generally focused on fluoride levels greater than those found in prescription drug products marketed in the United States, given that these products are predominantly used in young children, FDA is undertaking a review of their safety.
To view the Federal Register Notice, please click here.