Ingestible Fluoride for Children Faces FDA Scrutiny
The FDA is taking steps to remove prescription fluoride drops and tablets for children over concerns about gut health and unproven safety.
By
Lana Pine
| Published on May 13, 2025
2 min read
Credit: Adobe Stock/hedgehog94
The U.S. Food and Drug Administration has announced that it is beginning the process of removing certain fluoride-containing prescription drugs for children from the market — specifically ingestible forms meant to be swallowed.
According to the American Dental Association, systemic fluorides are swallowed and become part of developing tooth structures, while also offering topical protection through their presence in saliva. This differs from topical fluorides, such as toothpaste and rinses, which work by strengthening teeth already present in the mouth.
Ingestible fluoride supplements may be prescribed for children between 6 months and 16 years old who are considered at high risk for tooth decay. However, these products have never been officially approved by the FDA.
Now, growing concerns about their safety — especially in young children — are prompting action.
Recent research has shown that ingested fluoride can disrupt the gut microbiome, the delicate balance of bacteria in the digestive system. This is especially concerning in infants and toddlers, whose microbiome is still developing and plays a major role in long-term immune and metabolic health. Some studies have also linked fluoride to thyroid problems, weight gain and possible effects on IQ.
FDA Commissioner Marty Makary, M.D., MPH, emphasized that good dental health in children can be achieved without risking gut health. “The best way to prevent cavities in children is by avoiding excessive sugar and practicing good dental hygiene, not by altering a child’s microbiome,” he said.
The FDA plans to complete a safety review and open public comments by October 31, with the potential to remove these products from the market permanently.
At the same time, the U.S. Department of Health and Human Services will release new recommendations for dental care in kids that don’t involve altering gut bacteria.
While many countries, including most of Europe, do not fluoridate drinking water, the U.S. has continued to do so. However, several states have recently taken action to reduce or eliminate water fluoridation.
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