US FDA warns four firms over unapproved fluoride drugs for children
The U.S. Food and Drug Administration said on Friday it warned four companies that it plans to take enforcement action over their sale of unapproved fluoride-based prescription drugs for children, as part of a broader federal push to remove ingestible fluoride supplements from the market.
Health Secretary Robert F. Kennedy Jr., a longtime critic of fluoride use, said the decision marks a major step in protecting children’s health.
“This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” Kennedy said.
Fluoride — a mineral that occurs naturally in water, soil and air — has been demonstrated to prevent dental cavities and tooth decay. For decades, it has been added to community water supplies and dental products such as toothpaste.
The move follows a months-long safety review and public comment period that began earlier this year, when the agency first announced its intent to phase out fluoride supplements for children.
The FDA said these products may alter the gut microbiome and pose broader health risks, especially for young children.
The agency added that it has never approved these products for safety or effectiveness, despite their use since the 1940s. A recent meta-analysis cited by the agency suggested that increased fluoride exposure may be linked to lower IQ scores in children.
While fluoride is known to help prevent cavities in older children, the FDA cited a Cochrane review that found no clear benefit for baby teeth.
The FDA also said that for the same reason fluoride kills bacteria on teeth, it may disrupt gut health when ingested.
The crackdown is part of President Donald Trump’s “Make Our Children Healthy Again” initiative, which directed the FDA to re-evaluate fluoride products.
The FDA did not immediately respond to a request for comment on which companies received the warning letters.
In May, Utah became the first U.S. state to ban fluoride in public water systems, after Governor Spencer Cox said he would sign legislation to that effect.
