FDA moves to take prescription fluoride supplements off the market
- On Tuesday, May 20, 2025, the FDA announced plans to phase out prescription fluoride supplements used for children in the US.
- The move follows mounting legal challenges and Health Secretary Robert F. Kennedy Jr.'s campaign citing health risks from ingestible fluoride products never formally approved by the FDA.
- FDA Commissioner Marty Makary said these supplements pose swallowing risks, including potential harm to gut bacteria and links to decreased IQ and other health concerns from recent studies.
- The FDA will complete a scientific review of these children's supplements by late October and request manufacturers voluntarily remove them before a lengthy formal rulemaking process begins.
- This announcement intensifies the federal effort against ingestible fluoride as some states ban fluoridation, raising questions about the future role of systemic fluoride in dental care.
180 Articles
180 Articles
FDA removing from market concentrated ingestible fluoride prescription drug products for children
"Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood," according to the FDA.
FDA Targets Children's Fluoride Supplements
The U.S. Food and Drug Administration (FDA) has announced plans to remove concentrated ingestible fluoride prescription drug products for children from the market, citing potential health risks. These supplements, which have never received FDA approval, are typically prescribed to children in areas lacking fluoridated water. Unlike topical fluoride applications, these products are swallowed, raising concerns about their systemic effects on young…
FDA fluoride ban proposal stuns dentists and scientists amid health concerns
A long-standing dental treatment aimed at preventing cavities in children may soon disappear from the US market, as the Food and Drug Administration (FDA) moves to eliminate fluoride supplements over safety concerns. The agency announced on May 13 that it intends to remove prescription fluoride tablets and drops, citing potential links to altered gut bacteria, thyroid disorders, and lowered IQ. The decision does not affect fluoride in toothpaste…
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