Regulators said an analysis showed only certain children age three years or older should take the products.
The Food and Drug Administration (FDA) warned companies selling prescription drugs containing fluoride for children on Oct. 31 that it intends to crack down on unapproved products containing fluoride.
“We are providing this notice to allow your company time to assess your products and take appropriate corrective actions,” regulators said in a notice to the companies.
An FDA analysis of ingestible fluoride products, which have been used since the 1940s but were never reviewed or approved, also released on Friday, said the products appear to reduce tooth decay in permanent teeth, but not in the teeth of younger children.
There are also risks to taking fluoride products, including tooth discoloration, the analysis said.
“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,” it stated.
That includes children with a history of tooth decay and a lack of access to fluoridated water, according to the FDA.
President Donald Trump’s Make America Healthy Again Commission said in a strategy document from September that the FDA should evaluate products with fluoride.
“This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” Health Secretary Robert F. Kennedy Jr., who oversees the FDA, said. “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 added, “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.”
The ingestible products include chewable tablets for children ages 3 to 16 made by three companies: Method Pharmaceuticals, Bryant Ranch Prepack, and Winder Laboratories. Method also makes drops marketed for children as young as 6 months of age. The companies did not respond to requests for comment.
