On Monday, the Food and Drug Administration — under the auspices of Robert Kennedy’s Department of Health and Human Services (HHS) — issued a statement that the agency was initiating steps to remove ingestible fluoride supplements, though not fluoridated products like toothpaste or mouthwash, from the market.
The move runs counter to recommendations not only from other HHS agencies, such as the Centers for Disease Control and Prevention (CDC) but governing medical bodies such as the American Dental Association (ADA), the American Academy of Pediatrics (AAP), and the American Academy of Pediatric Dentistry (AAPD).
Fluoride has been added to U.S. public water supplies since the 1940s in an attempt to reduce tooth decay and cavities, especially in children, by remineralizing tooth enamel. Currently, fluoridated water is supplied to nearly 75% of Americans through public water systems. While fluoride is naturally present in virtually all water, it often falls below levels that would be beneficial to dental health. As such, supplements are often recommended for children between six months and 16 years if fluoride levels in water falls below recommended levels to prevent cavities, the most prevalent chronic disease in both children and adults.
Kennedy has been critical of fluoridation efforts, and vowed that the Trump administration would take aim at the removal of fluoride as early as November of 2024.
The FDA announcement makes frightening but largely unsubstantiated claims about fluoride, linking it to alteration of the gut microbiome, thyroid disorders, weight gain, and “possibly decreased IQ.” It also notes that fluoride supplements have “never been approved by the FDA,” which is true simply because supplements — from fluoride to Vitamin A tablets to herbal compounds — do not fall under the purview of FDA approval.
“The FDA does NOT have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before the supplements are sold to the public,” the agency notes on its own website.
As for claims of gut, thyroid, and cognitive health, while data exist that support further study, nothing definitively links fluoride ingestion to any of these health outcomes. Literature regarding the effect of fluoride on gut health was inconclusive, particularly at the low levels children will typically get from water or supplements. A new study on fluoride and thyroid function was based on highly fluoridated water, not supplements or levels equivalent to that in fluoridated water in the U.S., and results “are not consistent with previously published literature” per the American Thyroid Association.
The January 2025 study regarding fluoride and cognition in children specifically noted that while researchers could assert “with moderate confidence” that drinking water containing more than 1.5 milligrams of fluoride per liter was associated with lower IQ in children, it was “important to note that there were insufficient data to determine if the low fluoride level of 0.7 mg/L currently recommended for U.S. community water supplies has a negative effect on children’s IQ.” Fluoride supplements typically have between .25 and .5 mg for infants and toddlers and 1 mg for older children. The NTP found no evidence that fluoride exposure had adverse effects on adult cognition.
The agency has set a goal date of October 31 — Halloween — for taking action regarding the removal of such products, perhaps ironically given its associations with sugar and cavities.
