The United States Food and Drug Administration (FDA) has announced plans to remove oral fluoride supplements for children from the market, including tablets, drops, and lozenges.

The agency cited concerns over potential effects on gut microbiota and confirmed that these products were never formally approved for sale in the U.S.

These fluoride supplements are primarily prescribed to children in areas with low levels of fluoride in drinking water and are intended to prevent tooth decay.

According to the FDA, emerging research suggests that ingested fluoride may disrupt intestinal bacterial balance, which plays a role in digestion and immune function.

The agency plans to initiate voluntary removal by manufacturers, followed by formal regulatory action if necessary.

A scientific review and public comment period will continue until October thirty-first, twenty twenty-five.

The initiative is part of a broader public health direction led by Health Secretary Robert F. Kennedy Jr., who has voiced longstanding opposition to fluoride use in public water systems and oral products.

Kennedy has described fluoride as a 'dangerous neurotoxin' and linked its use to various health conditions, including thyroid disease and neurological disorders.

These associations have been widely contested by major medical and dental organizations.

The American Dental Association (ADA) and the American Dental Hygienists’ Association (ADHA) have criticized the FDA’s decision, stating that fluoride at recommended levels is safe and effective in reducing tooth decay.

ADA President Dr. Brett Kessler warned that removing supplements may disproportionately harm vulnerable populations, particularly children from low-income households without regular access to dental care.

Erin Haley-Heitz, president of the ADHA, echoed concerns about widening disparities in oral health.

The U.S. Centers for Disease Control and Prevention (CDC) continues to endorse fluoride use in dental care, citing studies that show water fluoridation reduces tooth decay by over twenty-five percent even in areas with widespread use of fluoride toothpaste and mouthwash.

While the FDA’s move does not affect over-the-counter fluoride toothpaste, mouth rinses, or professional fluoride treatments provided by dental practitioners, it adds to a growing national trend.

The state of Utah recently passed legislation banning the addition of fluoride to public water supplies.

To compensate, fluoride supplements are now available there without prescription.

Outside the U.S., the issue remains contentious.

The FDA emphasized that public input will be considered before finalizing any mandatory withdrawal.

Stakeholders have until the end of October twenty twenty-five to submit comments through the agency’s open review process.