May 13, 2025 – Today, the U.S. Food and Drug Administration (FDA) announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. The rationale provided was that “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.”
The FDA will be completing a safety review including inviting public comment by October 31, 2025. The AADOCR plans to submit comments as part of this process.
Although unrelated to the proposed regulatory action against fluoride supplements, community water fluoridation was mentioned in the FDA press release. AADOCR reiterates its strong support for community water fluoridation as a safe, effective, and evidence-based intervention for the prevention of dental caries as stated in our policy statement adopted in March 2025.
