The FDA Quietly Changes Ingestible Fluoride Policy for Children

By James Lyons‑Weiler, Science and Medicine Reporter, The MAHA Report

After a five-month review, the U.S. Food and Drug Administration (FDA) announced on October 31, 2025 that it would restrict ingestible fluoride tablets and drops prescribed to children.

Such tablets or drops have for years been prescribed for children to swallow; they are intended to prevent cavities from the inside (systemic fluoride), as opposed to topical forms like toothpaste or varnish.

The agency sent notices of intent to take enforcement action against four companies that produce these ingestibles and advised clinicians not to use such products in children under age three or in older children.

The policy narrows use to high‑risk children aged three and above and leaves topical fluoride and community‑water fluoridation outside the scope of the action, a move consistent with the administration’s use of risk-stratified policies that tailor preventive or therapeutic decisions to a patient’s specific risk level rather than applying uniform treatment to everyone.

“This Halloween, the FDA. is driving a stake through the heart of outdated science,” Health and Human Services Secretary Robert F. Kennedy Jr. said in the press announcement, framing the move within the Administration’s Make Our Children Healthy Again strategy. Commissioner Marty Makary added that “there are better ways to protect children’s teeth than taking unapproved ingestible fluoride.”

The FDA’s action targets unapproved, ingestible sodium‑fluoride drops and tablets historically given to infants and toddlers. It does not change the status of fluoride toothpaste or varnish, and it does not adjudicate community water fluoridation. The agency paired the action with a two‑page letter to health professionals and a 27‑page scientific evaluation that details utilization, benefit, and risk.

In its review, the FDA reported that 500,000 prescriptions for ingestible fluoride were filled in 2024, or 1.2 million when supplements are included. The report concluded that dental fluorosis, a cosmetic condition caused by excessive fluoride exposure during tooth development, leading to white or brown streaks on enamel, is a well‑established risk of systemic exposure, while evidence for neurocognitive, thyroid, microbiome, and weight‑gain effects is hypothesis‑generating and warrants further study. On balance, the FDA recommends limiting ingestible fluoride drugs to high‑risk children three years and older.

A review published by the Cochrane Collaboration in 2011found limited evidence that fluoride supplements prevent decay in primary teeth; results were uncertain and biased toward older studies. A 2024 update on community‑water fluoridation in the Cochrane Database reported small, uncertain benefits in modern cohorts, consistent with widespread fluoride toothpaste use.

A study published in JAMA Pediatrics in 2025 analyzed 74 studies and found a link between higher fluoride exposure and lower IQ scores across diverse populations. Another study conducted by researchers at the University of Toronto in 2019 found lower child IQ associated with higher maternal urinary fluoride levels, particularly in boys. A related Canadian study published in Environment International reported reduced non‑verbal intelligence in children exposed to higher tap‑water fluoride levels. In contrast, a study from the University of Otago in New Zealand found no association between childhood exposure to community water fluoridation and adult IQ. That study, however, adjusted for adult education—an outcome influenced by childhood intelligence—potentially masking any real effect of fluoride.

The FDA report did not mention the growing evidence from research on aluminum–fluoride combinations, which studies show can disrupt brain signaling and development. The potential of aluminofluoride complexes—where aluminium and fluoride act synergistically to influence neuronal function and development - is well-documented. Synergistic toxicity results when the combined toxic effect of two or more exposures is greater than the sum of individual effects.

Another study, in Neuroscience, showed that combined fluoride and aluminum exposures may exacerbate pathological neurobiological mechanisms linked to neurodegenerative or developmental injury. The October 31 action consists of enforcement notices to manufacturers, a scientific evaluation, the clinician letter, and the new research initiative. Organized dentistry supports risk‑based prescribing but disputes the FDAs weighting of emerging risks. The American Dental Association welcomed the focus on high‑risk children but maintained that fluoride supplements remain safe and effective when properly prescribed.

The FDAs decision refines, rather than reverses, policy on fluoride. It limits systemic ingestible fluoride use to children at high risk for cavities, aligning prevention with modern evidence and emphasizing transparency and a refined use of a precautionary principle in public health.