FDA restricts sale of unapproved ingestible fluoride drugs for children

On October 31, 2025, the FDA announced actions to restrict and remove unapproved ingestible fluoride prescription drug products intended for children, citing concerns about systemic safety, including potential alterations to the gut microbiome and associations with thyroid disorders.¹

Previously, on May 13, 2025, the FDA and US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. stated that the federal agency would begin taking steps to remove these products from the market. According to the agency, the products “have never been approved by the FDA” and pose “magnified concern” because of the developing microbiome in early childhood.²

“The best way to prevent cavities in children is by avoiding excessive sugar intake and good dental hygiene, not by altering a child’s microbiome,” said FDA Commissioner Marty Makary, MD, MPH. “For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health. I am instructing our Center for Drug Evaluation and Research to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products to better inform parents and the medical community on this emerging area. When it comes to children, we should err on the side of safety.”

Federal enforcement and background

With this latest move, the FDA sent enforcement notices to 4 companies marketing unapproved fluoride-containing ingestible drugs labeled for use in children younger than 3 years or in older children at low or moderate risk for dental caries. The agency stated its intent to take enforcement action to stop the sale of these products.¹

“This Halloween, the FDA is driving a stake through the heart of outdated science and protecting our kids from the risks associated with ingestible fluoride,” said HHS Secretary Robert F. Kennedy Jr. “It’s scary that these products have been used for decades without approval. Today’s action raises public awareness, informs medical professionals, and builds on President Trump’s commitment to Make Our Children Healthy Again.”

The decision stems from the Make Our Children Healthy Again Strategy, issued by President Trump’s Make American Healthy Again Commission on September 9, 2025, which directed the FDA to reevaluate pediatric fluoride products.³ Commissioner 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 review and evidence base

The FDA’s latest scientific evaluation noted that ingestible fluoride drugs have not undergone agency review for safety, effectiveness, or quality since their introduction in the 1940s. The analysis concluded that these products should not be used in children younger than 3 years and should be limited to those at high risk for caries. For the same reason fluoride may kill bacteria on teeth, the agency warned, it may also disturb intestinal microbial balance with possible systemic consequences.¹

While topical fluoride use—such as in toothpaste or mouth rinses—has been proven effective and is regulated by the FDA, ingestible fluoride acts systemically and presents additional risks. An Associated Press report emphasized that “most products” containing topical fluoride fall under FDA oversight, while prescription ingestible formulations have not been approved.⁴

A Cochrane review of multiple studies found no evidence that fluoride supplementation prevents dental caries in primary teeth. The FDA also cited newer data suggesting potential neurologic and endocrine implications, including a meta-analysis linking higher fluoride exposure to lower IQ scores in children and observed associations with thyroid dysfunction.⁵

Systematic review: fluoride and the gut microbiome

Emerging mechanistic evidence further supports these safety concerns. A systematic review published March 10, 2025, in Nutrition Reviews examined 49 studies exploring the effects of systemic fluoride on gut microbiota composition, gene expression, and metabolic function. Of the studies, 42 were conducted in animals, 4 in humans, and 3 in vitro. Among human studies—including participants with dental fluorosis and patients with breast cancer—investigators observed shifts in microbial composition, with increased relative abundance of Acidobacteria and Proteobacteria and decreased Firmicutes and Bacteroidetes.⁶

“An ex vivo study of human feces indicated that ≤ 2 mg L–1 NaF might boost ‘health-associated’ taxa, but concentrations (≥ 10 mg L–1 NaF) could increase the ratio of some unhealthy microbes after 24 hours,” the authors wrote, concluding that higher exposures could be detrimental to the microbiome, whereas low-dose exposure might have neutral or beneficial effects.

Planned safety review and next steps

In its May announcement, the FDA set a goal date of October 31 for completing a comprehensive safety review and public comment period on the removal of ingestible fluoride products from the market. The HHS said it will publish guidance on best practices for pediatric dental hygiene that are “feasible, effective, and do not alter gut health.”²

While a formal market withdrawal process may take years, the Associated Press reported that the FDA will first ask manufacturers to voluntarily remove the unapproved drugs.⁷

In parallel, the FDA has begun drafting a Dear Healthcare Provider letter advising clinicians to avoid prescribing these products for children at low or moderate risk for caries. The agency is collaborating with the National Institutes of Health (NIH) and HHS to establish a national fluoride research agenda and the first US oral health strategy aimed at closing data gaps and developing safer preventive measures.¹

American Dental Association perspective

The American Dental Association (ADA) continues to support community water fluoridation and topical fluoride use as effective caries-prevention strategies. In an announcement on June 14, 2023, the ADA stated that fluoride supplements can be prescribed for children aged 6 months to 16 years who are at high risk of tooth decay and whose drinking water contains low fluoride concentrations. However, it also warns that “a potential risk of fluoride use is the development of fluorosis, which may occur when excess levels of fluoride are ingested during tooth development,” noting that fluorosis may present as white striations or stained pitting of enamel.⁸

Outlook

Dental caries remain the most common chronic disease of childhood in the United States. The FDA’s current initiative signals a shift toward evidence-based prevention strategies focused on safety and microbiome preservation. As Commissioner Makary stated, “When it comes to children, we should err on the side of safety.”

References

1. FDA Acts to Protect Children from Unapproved Fluoride Drug Products. FDA. October 31, 2025. Accessed October 31, 2025. https://www.fda.gov/news-events/press-announcements/fda-acts-protect-children-unapproved-fluoride-drug-products
2. FDA begins action to remove ingestible fluoride prescription drug products for children from the market. FDA. Press release. May 13, 2025. Accessed October 31, 2025. https://content.govdelivery.com/accounts/USFDA/bulletins/3e036b3
3. MAHA Commission Unveils Sweeping Strategy to Make Our Children Healthy Again. HHS. September 9, 2025. Accessed October 31, 2025. https://www.hhs.gov/press-room/maha-commission-report-childhood-disease-strategy.html
4. Yasin M, Zohoori FV, Kumah EA, Subramanian M, Dean P, Orr CH, Effect of Fluoride on Gut Microbiota: A Systematic Review, Nutrition Reviews, 2025;, nuae202, https://doi.org/10.1093/nutrit/nuae202
5. Perrone M. FDA and RFK Jr. aim to remove ingestible fluoride products used to protect kids' teeth. The Associated Press. October 31, 2025. Accessed May 13, 2025. https://apnews.com/article/fluoride-fda-kennedy-cavities-teeth-water
6. Ismail AI, Hasson H. Fluoride supplements, dental caries and fluorosis: a systematic review. J Am Dent Assoc. 2008;139(11):1457-1468. doi:10.14219/jada.archive.2008.0071
7. Yasin M, Zohoori FV, Kumah EA, Subramanian M, Dean P, Orr CH, Effect of Fluoride on Gut Microbiota: A Systematic Review, Nutrition Reviews, 2025;, nuae202, https://doi.org/10.1093/nutrit/nuae202
8. Fluoride: Topical and Systemic Supplements. American Dental Association. June 14, 2023. Accessed October 31, 2025. https://www.ada.org/resources/ada-library/oral-health-topics/fluoride-topical-and-systemic-supplements