CHICAGO, October 31, 2025 — Today, the U.S. Food and Drug Administration (FDA) announced its recommendation that ingestible fluoride drug products should not be given to children under age three or any child at low or moderate risk for tooth decay. Earlier this year, the FDA announced its intent to remove fluoride supplements from the market effective October 2025 but determined a new warning would be utilized instead of a full ban on fluoride supplements.
“The research shows that daily use of fluoride tablets or drops at home are a safe and effective way to strengthen teeth and prevent cavities in children who are at high risk for tooth decay and whose water is deficient in fluoride,” said Richard J. Rosato, D.M.D., president of the American Dental Association. “A doctor’s clinical judgment, not a new warning label, should remain the guiding factor in determining appropriate fluoride use for children, ensuring both safety and access to essential oral health care.”
Fluoride supplements have been shown to be effective at reducing tooth decay and are one method for maintaining oral health when utilized daily in compliance with the proper dose. The first step before taking supplements is to determine the fluoride content in the drinking water (well or water system). The American Dental Association’s guidelines for fluoride supplements by age:
- Birth–6 months: No fluoride supplements recommended (minimal risk of deficiency at this age).
- 6 months–3 years: If the local water supply has <0.3 ppm fluoride, prescribe 0.25 mg fluoride per day typically as liquid drops for infants. No supplement is needed if water fluoride ≥0.3 ppm.
- 3–6 years: If water fluoride is <0.3 ppm, give 0.50 mg/day; if water fluoride is moderate (0.3–0.6 ppm), give 0.25 mg/day. No supplement is needed if water fluoride ≥0.6 ppm.
- 6–16 years: If water fluoride is <0.3 ppm, give 1.0 mg/day; if water is 0.3–0.6 ppm, give 0.50 mg/day. No supplement is needed if water fluoride ≥0.6 ppm.
In places with fluoride bans in community water systems, like Utah and Florida, where the recommended level of fluoride of 0.7 mg/L has been reduced or terminated, health experts need to look to other public prevention programs like fluoride supplements and sealant and fluoride varnish programs to offset tooth decay and mitigate factors impeding dental care treatment options in these communities.
“Prescription-strength fluoride supplements are safe, but they are not prescribed for everyone; their use should remain a thoughtful decision made between a dentist and the patient,” said Dr. Rosato. “Appropriate fluoride supplementation is based on each child's unique needs. Determining patients’ needs for a fluoride supplement must include individual discussions between parents and guardians with their children’s dentists and pediatricians.”
For more information on community water fluoridation and ADA advocacy, visit ADA.org/fluoride.