The Food and Drug Administration moved to limit the use of unapproved fluoride products for children, taking action to restrict their sale.
Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement that the agency is “driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride. 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.”
The action fulfills a plan announced in May, when the FDA took steps to remove ingestible fluoride prescription drug products from the market. These products were never approved by the FDA.
FDA Commissioner Marty Makary explained that there are “better ways” to protect children’s dental health than “taking unapproved ingestible fluoride,” which can affect the gut microbiome.
The FDA has also published a scientific evaluation of the use of unapproved ingestible fluoride products, explaining that they appear to “reduce tooth decay
in permanent teeth but not primary teeth.”
“An effective method to prevent tooth decay in all children is through good dental hygiene, including the topical application of fluoride via tooth brushing with fluoridated toothpaste,” the evaluation explains. “For children who do not receive adequate fluoride through water and other dietary sources, however, it may be beneficial to supplement their dietary intake with ingestible fluoride drug products based on patient specific factors.”
Similar actions to protect children from fluoride products were taken by Texas Attorney General Ken Paxton, who asserted that companies have engaged in deceptive advertising in targeting children in their marketing.
