The Food and Drug Administration (FDA) rolled out measures to restrict the sales of fluoride-based drugs for children. The watchdog advised that children below the age of three and those at risk of tooth decay should avoid ingestible fluoride, as per an AP report. Commonly available off the shelf, the FDA also sent letters to manufacturers not to market such products to children.
This comes after the FDA’s announcement in May to completely remove prescription fluoride from the market. However, Friday’s decision fell short of the ban.
What are fluoride tablets?
Often considered to be dietary supplements, cavity-fighting fluoride tablets are prescribed to help prevent tooth decay. While they are not a substitute for oral care and hygiene, these tablets contain nearly 0.25 to 1 mg of fluoride, and the dose and duration depend on the child’s age. They are commonly prescribed to children in communities where water lacks its natural minerals.
Since such tablets do not replace oral hygiene, they work as a supplement to topical usage via toothpaste. In use since the 1940s, fluoride intake has often been dependent on the age and exposure of the person taking it.
Risks involved
A scientific evaluation conducted by the association on ‘Ingestible Fluoride Drug Products’ warned of the risks of fluorosis, a recognised clinical problem. Especially at risk were the children below the age of 6 and during the ages 1.5 to 3, the critical tooth development stage.
It can express itself through discolouration, brown stains, and even enamel pitting. As per the FDA’s evaluation, other emerging concerns include neurocognitive, thyroid, gut microbiome, and weight gain effects, but require further research to affirm the direct correlation. Some studies, published in the National Library of Medicine, also suggest that dosage should be dependent on weight, and not age, since it might lead to inaccurate assessment of needs. In some rare cases, fluoride ingestion might trigger allergic reactions such as rash and gastrointestinal symptoms.
Today, the FDA is taking action to restrict the sale of unapproved ingestible fluoride prescription products for young children. We’ve sent notices to 4 companies outlining the agency’s intention to take action against those that market unapproved fluoride-containing ingestible… pic.twitter.com/TG2DhsoWYW
— U.S. FDA (@US_FDA) October 31, 2025
The FDA study concluded that there are only limited benefits of these tablets and must be restricted for use in children under the age of 3. “Fluoride may work to kill bacteria on teeth; it may also alter the gut microbiome, which may have broader health implications,” the agency said in a statement.
The American Dental Association disagrees
Following the Trump administration‘s urging the FDA to evaluate the sale of such supplements, the American Dental Association disputed the findings and claims. They revealed that there was no significant health problem associated with fluoride use, as per the prescribed levels by the dentists. In fact, an AP report also mentioned that dentists have warned that restricting fluoride supplements may result in more cavities and dental problems in rural communities, which are less likely to have fluoridated water.
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