FDA Cracks Down on Unapproved Fluoride Supplements for Kids

The U.S. Food and Drug Administration (FDA) warned four companies last week that it may take action against them for selling unapproved prescription fluoride supplements for use by children under age 3 or older children at low or moderate risk of tooth decay.

The move is part of a broader push by the agency to remove unapproved fluoride products from the market. The FDA did not name the four companies.

“The FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” U.S. Health Secretary Robert F. Kennedy Jr. said in a press release. “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.”

Stuart Cooper, executive director for the Fluoride Action Network (FAN), told The Defender:

“FAN petitioned the FDA a decade ago to end the sale of fluoride supplements for use in children, and we were part of the FDA’s latest review, which led to this decision. While not the full prohibition we had hoped for, this is still a major victory and a significant step in the right direction.”

The FDA never approved fluoride supplements, which come in tablet or lozenge form. However, doctors have routinely prescribed them for decades — even to babies as young as 6 months old — to prevent cavities.