FDA Moves to Remove Ingestible Fluoride Prescription Products for Children
June 11, 2025
The U.S. Food and Drug Administration (FDA) has announced plans to remove ingestible fluoride prescription drug products for children from the market. This decision marks a significant shift in how fluoride is regulated, particularly in its systemic use for dental health.
Why Is the FDA Taking Action?
Unlike fluoride toothpaste and rinses, which are applied topically, ingestible fluoride supplements are swallowed and absorbed into the body. These products have been prescribed to children in areas where drinking water lacks fluoridation, aiming to strengthen developing teeth.
However, the FDA has raised concerns about potential health risks, including:
Alteration of the gut microbiome, which is particularly sensitive in early childhood development.
Possible links to thyroid disorders, weight gain, and cognitive effects, though further research is needed.
Lack of FDA approval—these products were never formally evaluated for safety and efficacy.
FDA Commissioner Marty Makary emphasized that good dental hygiene and reduced sugar intake are more effective strategies for cavity prevention than systemic fluoride exposure.
Impact on Public Health & Dental Care
The FDA’s decision has sparked debate among dentists, health officials, and policymakers. While fluoride has long been recognized for its cavity-preventing properties, critics argue that systemic ingestion may pose unintended health risks.
Some experts warn that removing fluoride supplements could create challenges for children in underserved areas, where access to fluoridated water is limited. The American Dental Association (ADA) continues to support community water fluoridation as a safe and effective method for preventing tooth decay.
What Happens Next?
The FDA has set a deadline of October 31 to complete its safety review and public comment period before finalizing the removal of these products. In the meantime, the Department of Health and Human Services (HHS) plans to release best practices for children's dental hygiene that do not involve altering gut health.
This move aligns with broader efforts to reevaluate fluoride use in public health, with some states already banning fluoridation in drinking water.
Final Thoughts
The FDA’s action reflects a growing focus on child health and safety, balancing the benefits of fluoride with potential risks. As research continues, policymakers and health professionals will need to navigate the evolving landscape of dental care and public health regulations.