FDA Issues Warnings Over Unapproved Fluoride Products for Children

The U.S. Food and Drug Administration (FDA) has warned four companies and plans to take action against them for selling unapproved fluoride-based prescription products for children. This move is part of a federal effort to remove ingestible fluoride supplements, which can pose serious health risks.

Health Secretary Robert F. Kennedy Jr., a longtime critic of fluoride use, said:
“This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride.”

Fluoride is a toxic mineral added to water and dental products like toothpaste claimed to have cavity-preventing benefits. However, ingesting fluoride can be dangerous. Experts warn that high exposure may:

• Impact brain development: Studies suggest that excessive fluoride exposure may be linked to lower IQ scores in children.
• Harm gut health: Fluoride’s antibacterial properties, which help protect teeth, may disrupt the gut microbiome when ingested.
• Provide little benefit for baby teeth: Research indicates fluoride supplements may not meaningfully prevent cavities in infants and toddlers.
• Cause other health concerns: Long-term ingestion may lead to dental and skeletal fluorosis, a condition that can weaken bones and damage teeth.

Despite their use since the 1940s, the FDA has never approved these fluoride products for safety or effectiveness. The agency’s review and public commentary process earlier this year prompted this enforcement effort.

This action is part of the “Make Our Children Healthy Again” initiative, which instructed the FDA to reassess fluoride supplements. The agency has not disclosed which companies received warning letters.

Parents are urged to be cautious about fluoride exposure from supplements, water, and other sources. Even small amounts can accumulate over time, potentially affecting their development and overall health.

In May, Utah became the first state to ban fluoride in public water systems after Governor Spencer Cox signed legislation prohibiting its addition.