FDA issues warning about fluoride to parents, dentists
In this DML Report…
The U.S. Food and Drug Administration (FDA) has issued a direct warning to dentists and parents: do not administer ingestible fluoride tablets to children under three years old. These prescription products, swallowed whole unlike toothpaste or mouthwash, target kids in non-fluoridated water areas to prevent cavities but remain unapproved by the FDA after decades of use. The agency sent notices to four manufacturers signaling enforcement action, building on its May 2025 initiation to remove them from the market. HHS Secretary Robert F. Kennedy Jr. stated: "This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride." FDA Commissioner Dr. Marty Makary added: "There are better ways to protect children's teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome."
Scientific evidence underscores the risks: a 2011 Cochrane Review, the gold standard for evidence, found no clear proof that these tablets reduce decay in primary teeth. Fluoride disrupts the gut microbiome, with potential broad health impacts; a recent federal report linked water fluoride exposure to IQ drops of up to five points. Kennedy has cited connections to arthritis, bone fractures, bone cancer, thyroid disease, and neurodevelopmental disorders. While community water fluoridation, since the 1950s, has cut cavities by 25% and saved $6.5 billion annually, according to CDC data, ingestible forms lack safety approval and show limited benefits.
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FDA recommends: zero use for kids under three or low-risk older children; limit to high-risk cases only, with updated labels required. Dentists should prioritize twice-daily brushing. The American Dental Association opposes, arguing the tablets prevent decay in rural, non-fluoridated areas: "Proposals like this stand to hurt rural America." Kennedy calls this "long overdue," aligning with his Make America Healthy Again agenda to reduce fluoride exposure.