The U.S. Food and Drug Administration (FDA) has announced a nationwide crackdown on unapproved and potentially risky prescription fluoride products being sold for children, warning that many have been in circulation for decades without proper review or authorization.
In a notice issued to manufacturers, the agency told companies selling ingestible fluoride drugs that it plans to remove unapproved products from the market.
“We are providing this notice to allow your company time to assess your products and take appropriate corrective actions,” regulators wrote.
Decades of Unapproved Use
According to a new FDA analysis, ingestible fluoride products, such as pills and drops prescribed to prevent cavities, have been used in the U.S. since the 1940s but were never formally approved.
While the analysis found the products may help reduce tooth decay in permanent teeth, it also determined there is no proven benefit for younger children.
The agency also highlighted several health risks, including tooth discoloration and potential harm to the gut microbiome.
“Overall, out of an abundance of caution, it would be prudent to limit use of ingestible fluoride drug products to children aged three years and older who are at high risk of tooth decay,” the FDA stated.
That includes children with a history of cavities or limited access to fluoridated water, the agency said.
Trump Administration Targets “Outdated Science”
The move comes as part of President Donald Trump’s “Make America Healthy Again” initiative, which seeks to reevaluate long-standing public health practices.
“This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” said Health Secretary Robert F. Kennedy Jr., who oversees the FDA.
“It’s scary that these products have been used for decades without approval.
“Today’s action raises public awareness, informs medical professionals, and builds on President Trump’s commitment to Make Our Children Healthy Again.”
FDA Commissioner Dr. Marty Makary said newer science shows the products can interfere with healthy gut bacteria.
“There are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome,” Makary said.
“The microbiome is increasingly recognized to be central to a child’s health and development.”
Products Under Scrutiny
The crackdown targets chewable tablets and drops made by Method Pharmaceuticals, Bryant Ranch Prepack, and Winder Laboratories.
Method manufactures drops marketed for children as young as six months old, while the tablets are sold for children ages three to sixteen.
None of the companies has publicly responded to the FDA’s notice.
Fluoride Debate Intensifies
The FDA first announced plans in May to phase out ingestible fluoride drugs, citing new evidence linking fluoride consumption to disruption of gut microbiota.
“Ending the use of ingestible fluoride is long overdue,” Kennedy said at the time.
Fluoride remains a common additive in water and toothpaste.
However, health officials under the Trump administration have questioned the long-standing assumption that systemic fluoride is universally beneficial.
Kennedy has also said that the Centers for Disease Control and Prevention (CDC) will stop recommending the addition of fluoride to drinking water.
Although the agency has not yet updated its guidance.
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