The U.S. Food and Drug Administration is tightening guidance on prescription fluoride for youngsters. The agency says most children should not receive fluoride tablets or drops unless they are at high risk for tooth decay. The move targets products often prescribed in areas where tap water lacks sufficient fluoride, a mineral that helps prevent cavities.
Public guidance and testing
Local water providers can inform consumers about fluoride levels in tap water.
Households relying on well water should have their supply tested privately for fluoride.
FDA actions and responses
The FDA sent warning letters to manufacturers of fluoride tablets and drops, instructing them not to promote these products for use in young children.
The new stance follows a broader push by Health Secretary Robert F. Kennedy Jr., who questions fluoride safety and is reassessing CDC recommendations on water fluoridation.
What the FDA says
A recent scientific review concludes fluoride should not be routinely prescribed to children.
Potential concerns cited include tooth staining, possible neurocognitive and gastrointestinal effects, and limited benefits for baby teeth.
The agency notes fluoride may still help children with very low exposure to fluoride via water or diet.
Professional guidance and the ADA
The American Dental Association (ADA) maintains a targeted role for prescription fluoride: for children six months and older who are at high risk for tooth decay and do not receive adequate fluoride from drinking water.
Scott Tomar, a dentist and ADA spokesperson on community water fluoridation, told The Washington Post that the FDA’s recommendations align closely with existing ADA guidance.
Earlier in the year, the FDA weighed removing all prescription fluoride for children but opted for a more measured approach.
Official statements
FDA Commissioner Dr. Martin Makary emphasizes that protecting children’s teeth can be achieved through methods other than ingestible, unapproved fluoride, noting emerging concerns about the gut microbiome.
The FDA’s scientific report also states that evidence linking fluoride to gut health remains unclear.
Trends in fluoridation
As of 2022, over 70% of Americans on public water systems received fluoridated water.
Some states are moving away from fluoridation; Utah and Florida recently enacted laws to ban water fluoridation.
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