FDA Restricts Sale of Ingestible Fluoride for Children

Agency claims fluoride products do not prevent cavities in baby teeth, amid studies that raise concerns it could actually cause developmental problems.

Federal regulators say they intend to ban the sale of ingestible fluoride prescription products for young children, indicating no such products have ever been approved, though they have been sold in the U.S. for decades.

As part of the Trump Administration’s Make America Healthy Again strategy, the U.S. Food and Drug Administration (FDA) announced the ingestible fluoride restrictions on October 31, saying the products were no longer recommended for children under the age of 3 years old.

In addition, the FDA announced plans to take enforcement action against four companies accused of marketing unapproved fluoride products to children, following warning notices issued to each firm.

Fluoride is a naturally occurring mineral that helps protect teeth by fighting bacteria and strengthening enamel. It has long been added to toothpaste and public water supplies to reduce cavities, and is widely regarded as safe when used properly.

However, the FDA has never reviewed or approved ingestible fluoride supplements for safety or effectiveness, even though they have been sold in the United States since the 1940s.

Under the new plan, the FDA would restrict the sale of unapproved ingestible fluoride prescription products for children under the age of 3, recommending they not be used for children who do not face high risk of tooth decay. The products include fluoride-containing supplements that come in chewable tablets, lozenges and liquid form.

According to the agency, FDA investigators conducted a months-long review of recent scientific evidence and determined fluoride alters the gut microbiome in children, which can have long-term health effects.

Additionally, the FDA announced the evidence indicates fluoride does not reduce cavities in baby teeth, and indicated there was preliminary data pointing to other risks, including decreases in IQ.

The agency said it spent months reviewing scientific data and receiving feedback from the scientific community, federal partners, medical professionals and parents before making the decision.

“There are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome. The microbiome is increasingly recognized to be central to a child’s health and development.”

– FDA Commissioner Dr. Marty Makary

Companies that received warning letters have 30 days to respond, outlining steps for compliance. The FDA did not indicate which companies were issued the letters.

There was no timeline regarding how soon the ban would take effect.

Fluoride Health Concerns

Earlier this year, data published by researchers from Bangladesh indicated exposure to fluoride during pregnancy and early childhood may cause cognitive impairment and learning disabilities among children.

Another study published by a team of international researchers concluded exposure to fluoride from community drinking water was linked to lower IQ scores among children. The higher the exposure level, the lower the child’s IQ dropped.

This is the latest move against fluoride by Health and Human Services Secretary Robert F. Kennedy, Jr. Last month Kennedy called on other federal regulatory agencies to stop recommending community water fluoridation.

In April, the U.S. Environmental Protection Agency (EPA) announced plans to review the safety and effectiveness of adding fluoride to drinking water.

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