FDA recommends that ingestible fluoride drug products be limited to children aged three years and older who are at high risk for tooth decay.
Read FDA's assessment of the benefit/risk considerations regarding the use of ingestible fluoride drug products in children.
View the meeting summary, download presentations and watch the meeting recording.
FDA intends to take compliance action against certain unapproved fluoride-containing prescription drug products. View an example letter.
Background
In May 2025, FDA initiated a review of the evidence regarding the risks of orally ingestible fluoride prescription drug products in pediatric populations. FDA subsequently held a public meeting in July 2025 to gather scientific input on this topic, as well as collected public comments through a Federal Register Notice. FDA also conducted a scientific evaluation that provided an analysis of utilization trends, a high-level examination of the benefits and risks of ingestible fluoride drug products, and a recommendation to restrict use of ingestible fluoride drug products to children aged three years and older who are at high risk for tooth decay. This recommendation addresses the lack of proven benefit of ingestible fluoride drug products on primary teeth, as well as emerging safety concerns when fluoride overexposure occurs.
FDA’s Intent to Take Compliance Action
Consistent with our general risk-based enforcement approach and to address potential safety concerns, FDA is providing notice that we intend to take compliance action against companies that market unapproved fluoride-containing ingestible drug products with labeling:
- for children under three years of age; or
- that does not limit use to children at high risk for dental caries, such as those who have a history of tooth decay and lack access to fluoridated drinking water.
FDA continues to review information regarding the use of ingestible fluoride drug products and may consider additional regulatory action to address emerging, serious health risks. Furthermore, FDA will continue to enforce the new drug approval requirements of the Federal Food, Drug, and Cosmetic Act, applying our risk-based enforcement approach to individual unapproved ingestible fluoride drug products.
