Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population

Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population

Hybrid Public Meeting
July 23, 2025 | 9:30am-4pm (eastern)

The Reagan-Udall Foundation for the FDA, in cooperation with the Food and Drug Administration, will convene a hybrid public meeting to gather input on the clinical use and safety concerns associated with orally ingestible unapproved prescription drug products containing fluoride for use in children.

The public — including consumers/patients, healthcare providers, researchers, and industry — can request to provide brief public comment on four key topics related to the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population.

1. Clinical Use and Prescribing Considerations for Pediatric Tooth Decay Prevention
    
2. Safety Concerns
    
3. Appropriateness of Pediatric Use Considering Additional Sources of Exposure
    
4. 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.

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.

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