The FDA has notified manufacturers that it intends to pursue compliance actions against unapproved ingestible fluoride prescription drugs for children. In a Halloween press release, the agency said it was tightening a long-standing regulatory gap for products that have been sold for decades without new-drug approval. In it, Human Services Secretary Robert F. Kennedy Jr. said the agency is “driving a stake through the heart of outdated science” adding that it is “protecting our kids from the risks associated with ingestible fluoride.”
The action targets ingestible prescription fluoride products: drops, tablets and lozenges. It does not apply to topical products such as toothpaste, mouth rinses or dental office varnishes, nor does it affect community water fluoridation.
The letters target products labeled for children under 3 or for older children without limiting use to those at high risk for tooth decay; companies have 30 days to describe corrective steps.
Such products have been marketed since the 1940s without ever receiving new drug approval, a regulatory gap FDA is now closing under risk-based enforcement priorities outlined in the administration’s Make Our Children Healthy Again strategy.
FDA’s action follows a May–October review that included a Federal Register notice and public meeting organized with the Reagan-Udall Foundation and a docket to gather data on safety, clinical use and alternatives. The agency has also published a scientific evaluation summary indicating a plan to limit ingestible fluoride to children 3 years and older who are high risk, a shift from common pediatric practice in some regions. Current American Academy of Pediatric Dentistry guidelines recommend fluoride supplements for children 6 months and older in non-fluoridated areas. In 2023, it noted: “supplements for children under age six due to their continued dental development and consumption of fluoride from a variety of sources.”
New research on IQ and microbiome contributing to FDA re-evaluation
While major dental and medical organizations including the American Dental Association and American Academy of Pediatrics have long recommended fluoride supplements for high-risk children, two strands of recent evidence are driving FDA’s re-evaluation: emerging neurodevelopmental and microbiome literature. A 2025 JAMA Pediatrics meta-analysis across 74 studies reports an overall inverse association between fluoride exposure and children’s IQ, with approximately 1.63 IQ points lower per 1 mg/L increase in urinary fluoride; but when exposure is estimated by water concentrations below approximately 1.5 mg/L, above U.S. water fluoridation levels of 0.7 mg/L, the dose-response is uncertain owing to limited data. The authors call for more prospective cohorts at lower exposures typical of U.S. practice.
Cross-sectional studies dominated the JAMA analysis. These designs can show associations but are less capable of establishing cause-and-effect than longitudinal cohort studies.
FDA’s review was informed by the National Toxicology Program’s August 2024 monograph on fluoride neurotoxicity.
Separately, a 2025 systematic review of fluoride’s gut microbiome effects found disruptions at high doses in animals and no adverse effects at ≤2 mg/L NaF in limited human studies, with potentially beneficial effects at very low doses typical of water fluoridation. Overall certainty is low.
While a 2024 Cochrane review found fluoride prevents cavities in permanent teeth, evidence for baby teeth was inconclusive, with contemporary studies showing far smaller effects than pre-1975 research, when fluoride toothpaste became widely available.
ADA had pushed back on FDA’s proposed restrictions
In May 2025, the American Dental Association opposes removing supplements, stating: “Fluoride supplements have been shown to be effective at reducing tooth decay and are one method for maintaining oral health when utilized daily in compliance with the proper dose.” The U.S. Preventive Services Task Force continues to recommend oral fluoride supplementation starting at 6 months when water contains less than 0.6 ppm fluoride (Grade B recommendation).
Filed Under: Regulatory affairs
