WASHINGTON, D.C. (WOWO) — The Food and Drug Administration is limiting the use of fluoride supplements for children, citing potential safety concerns. The agency said the products should no longer be used for children under 3 or for older children who are not at high risk of tooth decay.

Previously, fluoride tablets, lozenges, and drops were prescribed for children as young as six months, especially in areas with low fluoride levels in drinking water. The FDA also warned companies not to market their products outside the new guidelines.

A new FDA analysis concluded that fluoride supplements provide limited benefits for most children and may be linked to gut changes, weight gain, and cognitive effects. The agency sent guidance letters to healthcare providers and dentists outlining the risks.

The American Dental Association disputes the claims, noting that fluoride at recommended levels has not been linked to major health problems, aside from possible tooth discoloration. Dentists have expressed concerns that restricting supplements could lead to increased cavities, particularly in rural communities without fluoridated water.

Fluoride is widely used to strengthen teeth by replacing minerals lost during normal wear, and it is also added to drinking water in many U.S. communities. The FDA’s action does not affect fluoride toothpaste, mouthwash, or treatments provided in dental offices.