The U.S. Food and Drug Administration (FDA) has announced plans to withdraw prescription fluoride supplements commonly used in children to prevent tooth decay. The decision has sparked debate among medical professionals and could affect global dental health recommendations.
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The FDA plans to remove prescription fluoride supplements (tablets, drops, lozenges) from the market.
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These products are used primarily in children without access to fluoridated drinking water.
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The agency cites concerns about the potential impact of fluoride on the gut microbiome, despite inconclusive evidence.
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New guidelines for children’s oral health are expected by October 31, 2025.
A controversial move by the FDA: what's changing?
In April 2025, the U.S. Food and Drug Administration (FDA) announced its intention to withdraw fluoride supplements prescribed for children, including tablets, drops, and lozenges. These supplements have been used primarily in children living in areas without fluoridated drinking water to prevent dental caries.
This decision has alarmed medical and dental professionals, as it contradicts decades of evidence-based recommendations and established public health policies supporting fluoride use in caries prevention.
Gut microbiome under scrutiny: is fluoride to blame?
The FDA’s rationale centers on possible negative effects of systemic fluoride on the gut microbiome in children. However, experts have pointed out that even the studies referenced by the agency fail to provide definitive evidence of harm at currently recommended doses.
– The best way to prevent tooth decay in children is to avoid excessive sugar and ensure proper oral hygiene, said FDA Commissioner Dr. Marty Makary. – We should not interfere with a child’s microbiome unless there’s a clear reason to do so. When it comes to children, safety should be our top priority, he added.
New oral health guidelines expected by October 2025
The FDA has stated that by October 31, 2025, it will complete a safety review of fluoride supplements and take appropriate regulatory action, including their possible removal from the U.S. market. Alongside this, the agency plans to release updated pediatric oral health guidelines that are described as “effective, realistic, and without adverse effects on gut health.”
Is fluoride still safe and effective in dentistry?
Fluoride remains a cornerstone of dental caries prevention, most commonly as an ingredient in toothpaste, varnishes, gels, and mouth rinses. Its antibacterial and remineralizing properties are well-documented and supported by decades of clinical research.
In recent years, scientists have begun exploring fluoride’s potential systemic effects, including its influence on the gut microbiota. Preliminary studies suggest that even low doses may alter bacterial composition, which could affect immune function, metabolism, and general health – though conclusive evidence is lacking.
What dental professionals need to know
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This decision does not affect topical fluoride, which remains standard in preventive and restorative care.
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Pediatric dentists and GPs may need to reassess preventive fluoride protocols, especially in underserved populations.
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Dental professionals should stay updated on the forthcoming FDA guidelines.
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Ongoing communication with parents will be key to maintaining public trust in fluoride safety and effectiveness.
