The FDA has initiated steps to remove ingestible fluoride supplements—such as tablets, lozenges, and drops—from the market for children. Unlike topical fluoride products, these supplements have never received formal FDA approval and are now under scrutiny due to potential health risks, including concerns related to thyroid function, gut health, and cognitive development.
A scientific review is expected to conclude by October 31, 2025. Following the review, manufacturers may be required to discontinue these products, prompting a shift toward alternatives like fluoride toothpaste, mouthwash, and water fluoridation for cavity prevention.
Major dental associations have voiced concerns that removing fluoride supplements could worsen dental health disparities, particularly in rural and underserved communities that lack access to fluoridated water.
The FDA is encouraging better oral hygiene and reduced sugar consumption as safer and more effective long-term strategies for preventing tooth decay. The decision reflects a growing trend toward greater precaution in pediatric healthcare policy.
