FDA Restricts Unapproved Ingestible Fluoride Products for Children

The US Food and Drug Administration (FDA) has announced new actions to halt the sale of unapproved ingestible fluoride prescription drugs for children. Notices were issued to four companies marketing such products for kids under age 3 or for older children at low or moderate risk of tooth decay.

The FDA determined that these fluoride products—used for decades without approval—pose potential risks to children’s gut microbiome and offer limited benefits for baby teeth. The agency concluded that ingestible fluoride should not be used in young children or those not at high risk of cavities.

This action aligns with the Make Our Children Healthy Again Strategy, launched in 2025 under President Trump’s health initiative. The FDA also plans to develop a national fluoride research agenda with federal partners to guide safer oral health practices and address gaps in understanding fluoride’s long-term effects.

03-11-2025