Ingestible fluoride products used to prevent dental caries have a long and twisted regulatory history relative to their permitted marketing status.  After searching the web for an explanation, I found an interesting article (here) published by the Fluoride Action Network.  I provide this article as it gives a reasonable historical account of the avenues along which the FDA permits marketing of fluoride as an unapproved prescription drug product.  While the article might be biased in some regards, it does provide a good overview of the historical information that clarifies the (somewhat ambiguous) regulatory saga that surrounds these products.

But, today, the FDA has indicated its intention to remove these ingestible products from the marketplace as described in the Agency’s posting (here) titled FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market.  The FDA says, “Unlike toothpaste with fluoride or fluoride rinses [which, by the way, fall under the OTC monograph M021 for their marketing authorization], these products are swallowed and ingested by infants and toddlers.  They have also never been approved by the FDA.  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.  Other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ.”

The notice goes on to say that “[t]he agency has set a goal date of October 31 for completing a safety review and public comment period and for taking appropriate action regarding removal of these products from the market.  In conjunction with this evaluation, the U.S. Department of Health and Human Services plans to disseminate best practices for dental hygiene in children that are feasible, effective and do not alter gut health.”

The FDA notice also provides additional information on ingestible fluoride products, along with links to the following topics:

  • Does fluoride exposure impact on the human microbiome? – PubMed
  • Effect of Fluoride on Gut Microbiota: A Systematic Review | Nutrition Reviews | Oxford Academic
  • Fluoride Exposure and Children’s IQ Scores: A Systematic Review and Meta-Analysis
  • Does fluoride exposure affect thyroid function? A systematic review and dose-response meta-analysis
  • Water fluoridation for the prevention of dental caries – Iheozor-Ejiofor, Z – 2024 | Cochrane Library

With several states already taking action to halt the addition of fluoride to their public drinking water, the FDA notice adds a new twist to the fluoride story.  To be continued??  We will keep you posted!