The U.S. Food and Drug Administration (FDA) announced on May 13, 2025, its intention to remove prescription ingestible fluoride supplements for children from the market. These supplements, including tablets, drops, and lozenges, have been commonly prescribed to children in areas lacking fluoridated water to help prevent cavities. However, the FDA noted that these products were never formally approved and have raised concerns due to potential health risks.

Reasons for the FDA’s Decision

The FDA’s action is based on emerging evidence suggesting that ingestible fluoride may:

• Disrupt the developing gut microbiome in children

• Be associated with thyroid dysfunction

• Potentially contribute to decreased IQ

FDA Commissioner Marty Makary emphasized the importance of prioritizing safety for children, stating that the best way to prevent cavities is through good dental hygiene and limiting sugar intake, rather than altering a child’s microbiome.

Timeline and Next Steps

• Public Comment Period: The FDA has set a deadline of October 31, 2025, to complete a safety review and gather public comments.

• Market Removal: Following the review, the FDA plans to take appropriate action to remove these products from the market.

• Guidance on Dental Hygiene: The U.S. Department of Health and Human Services intends to issue recommendations for dental hygiene practices that are effective and do not impact gut health.

Reactions and Implications

Health Secretary Robert F. Kennedy Jr., known for his critical stance on fluoride use, supports the FDA’s decision. He has previously advocated for removing fluoride from public water supplies, citing potential health risks.

However, the American Dental Association (ADA) opposes the move, warning that it could negatively affect underserved populations who rely on these supplements for dental health. The ADA maintains that current fluoride levels are safe and effective in preventing tooth decay.

It’s important to note that this action does not affect fluoride-containing toothpaste, mouthwashes, or professional dental treatments, which remain approved and widely recommended.