FDA Warns Against Fluoride Pills for Children Under 3

Unapproved Supplements Pose Risks Like Gut Issues and IQ Drops; Only for High-Risk Older Kids

Muhammad Kamran Akhtar
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Web Desk — November 2, 2025

Washington: The U.S. Food and Drug Administration (FDA) has issued a strong alert to parents and dentists: Do not give fluoride tablets or lozenges to children under age 3, as they can harm young kids’ health.

The FDA’s review found these ingestible supplements—never fully approved by the agency—offer limited dental benefits but carry emerging risks like gut microbiome changes, weight gain, cognitive effects, and tooth discoloration. Extra fluoride intake is especially dangerous for toddlers, whose bodies absorb it differently than topical products like toothpaste.

These pills are typically prescribed in areas with low-fluoride water to prevent cavities, but the FDA now limits them to children aged 3 and older at high risk of tooth decay. The agency sent notices to four manufacturers, warning of enforcement if they market to younger or low-risk kids. A letter to healthcare providers urges caution.

Health Secretary Robert F. Kennedy Jr. called it a “historic step” to shield children from fluoride dangers, aligning with the “Make Our Children Healthy Again” initiative. The American Dental Association agrees on restrictions but stresses dentists’ judgment for safe use.

Parents: Always consult a pediatrician or dentist before any fluoride supplement for young children.

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