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FDA Warns Against Fluoride Tablets for Young Children
- November 3, 2025
- I. Edwards HealthDay Reporter
The U.S. Food and Drug Administration (FDA) is moving to limit the use of prescription fluoride for children, warning that most kids should not be given fluoride tablets or drops unless they are at high risk for tooth decay.
These products are often prescribed in areas where tap water does not contain enough fluoride, a mineral that helps prevent cavities.
Local water providers can tell consumers how much flouride is in their tap water, while well water households would need test their water privately through a water testing company, notes the U.S. Centers for Disease Control and Prevention (CDC).
The FDA sent warning letters to companies that make fluoride tablets and drops, telling them not to promote the products for use in young kids.
The announcement follows a push from U.S. Health Secretary Robert F. Kennedy Jr., who has questioned the safety of fluoride and is now re-evaluating current CDC recommendations that support water fluoridation.
"The FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” Kennedy said in a statement.
In a new scientific review, the FDA said fluoride should not be routinely prescribed because:
It can stain developing teeth.
There is emerging evidence of possible neurocognitive and gastrointestinal effects.
The benefits for baby teeth are limited.
However, the agency did note that fluoride may still help children who have very little exposure to it through water or diet.
The American Dental Association (ADA) still recommends prescription fluoride for children 6 months and older who are at high risk for tooth decay and do not get enough fluoride in their drinking water.
Scott Tomar, a dentist and ADA spokesperson on community water fluoridation, told The Washington Post that the FDA's recommendations were not too different from existing ADA guidance.
Earlier this year, the FDA had considered pulling all prescription fluoride for children, but decided not to go that far.
“Ultimately the report that came out from the FDA, I think was certainly a far more measured and thoughtful approach than what was suggested in that initial press release,” Tomar explained.
FDA Commissioner Dr. Martin Makary said “there are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome."
He added that "the microbiome is increasingly recognized to be central to a child’s health and development."
But the FDA’s own scientific report noted that the evidence on fluoride and gut health remains unclear.
As of 2022, more than 70% of Americans on public water systems receive fluoridated water, The Post reported.
But that number is shrinking as some states push back. For example, Utah and Florida both passed laws this year banning water fluoridation.
More information
The Cleveland Clinic has more on fluoride.
SOURCE: The Washington Post, Oct. 31, 2025
