MAHA: FDA in hand of Health Secretary Kennedy Jr. announces recall of children's ingestible fluoride products

The U.S. Food and Drug Administration (FDA) announced its decision Tuesday to withdraw from the market ingestible fluoride products prescribed for children because of evidence suggesting they alter the gut microbiome during infancy.

In a press release, the agency noted that ingestible products, unlike topicals such as toothpaste and mouthwash, pose risks to the early development of the gut microbiome, which it called a "magnified concern."

The FDA has set an Oct. 31 deadline to complete a safety review and public comment period before final removal of these products.

Ingestible fluoride products are primarily prescribed for children at high risk for tooth decay, especially in areas where drinking water has low concentrations of fluoride. This naturally occurring mineral strengthens teeth by becoming incorporated into their structure, making them more resistant to decay, although its benefits are best known in topical applications.

The FDA commissioner, Marty Makary, emphasized the importance of prioritizing child safety. "The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome,” he said.

Makary added that he has instructed the FDA's Center for Drug Evaluation and Research to assess the risks of systemic exposure to fluoride in pediatric drugs, with the goal of providing clearer information to parents and medical professionals.

The decision has the backing of Health and Human Services Secretary Robert F. Kennedy Jr. who called the elimination of ingestible fluoride "long overdue."

In addition, the secretary noted, "Ending the use of ingestible fluoride is long overdue.” “I’m grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children. This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.” 

Kennedy, a longtime critic of fluoride use in public health, previously announced he would order the Center for Disease Control and Prevention (CDC) to cease recommending fluoridation of drinking water.

The FDA's decision

The FDA cited several studies to support its decision. A 2023 analysis noted that "acute fluoride toxicity” can negatively disrupt the normal microbiome, although it stressed that more research is needed on long-term consequences.

The same study highlighted that fluoride-containing oral hygiene products may have beneficial effects on the oral microbiome to prevent cavities. Another analysis, published this year, indicated that fluoride at low levels (less than 2 mg/L NaF in humans) does not affect the gut microbiota. In the United States, water fluoridation levels are maintained at 0.7 mg/L.

The withdrawal of these products marks a significant change in public health policy in the United States.