FDA Begins Process to Remove Unapproved Fluoride Drugs for Children

The FDA has begun the process of removing “concentrated ingestible fluoride prescription drug products for children” from the market. The press release said these products are intended to be swallowed by infants and toddlers, but have never been approved by the FDA. The announcement also said ingesting fluoride alters the gut microbiome, “which is of magnified concern given the early development of the gut microbiome in childhood.”

The press release also mentions studies that have “suggested an association between fluoride and thyroid disorders, weight gain, and possibly decreased IQ.” The announcement comes on the heels of Florida becoming the second state in the nation to ban the practice of water fluoridation. The process includes a safety review, a public comment period, and potential action to remove the products from the market. The FDA hopes to complete the entire process by October 31.

“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, M.D., M.P.H. “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.”

The announcement links several studies, including a 2023 study published in Toxicology Letters. The study noted “extensive changes in cecum morphology” in mouse studies with high concentrations of fluoride (50-100 mg/L), which is substantially higher than the amount currently recommended in fluoridated water or fluoride supplements.

The authors note, “High concentrations of fluoride are likely to impact on the structure of the oral and gut microbiomes and further research is needed to determine if this impacts on overall health.” The authors state that extrapolating data from animal studies has limitations, but there are no studies examining the effects of fluoride on the human microbiome.

The authors of this study also found a connection between systemic fluoride exposure and obesity. The authors wrote, “A faecal microbiota transplantation from fluoride-treated mice was sufficient to induce obesity. The authors propose that the fluoride-induced bloom of Erysipelatoclostridium ramosum was responsible for exacerbation of obesity.”

Another study linked was published in March 2025 and found that high doses of sodium fluoride (NaF) are potentially detrimental to the microbiome. The study review included 42 animal studies, four human studies, and three in vitro studies. The authors wrote, “In humans, high doses potentially may be detrimental to the microbiome, whereas ≤ 2 mg L–1 NaF had positive effects. Similarly, ≥ 50 mg L–1 NaF in animals was unsafe, whereas ≤ 25 mg L–1 NaF had harmless effects.”

Fluoride tablets on the market come in three dosage levels. There are 1.0 mg fluoride tablets that are derived from 2.2 mg sodium fluoride; 0.5 mg fluoride derived from 1.1 mg sodium fluoride, and 0.25 mg fluoride derived from 0.55 mg sodium fluoride.

The HighWire reported in August about the National Toxicology Report that found water fluoridation at the rate of 1.5 mg per liter is associated with lower IQ in children. The recommended rate is 0.7 mg per liter for water systems, but the EPA cannot take action unless the fluoridation rate exceeds 4.0 mg per liter.

A study analyzing data from 2006-2011 found that 4.5% of US water systems (2.9 million residents) had levels exceeding 1.5 mg per liter, which is the recommended amount by the World Health Organization.

After the NTP report was released, a federal judge determined the EPA recommendation of 0.7 mg per liter is an “unreasonable risk to human health” and called upon the agency to take action. After that ruling in September, a wave of local municipalities and two states banned the practice of water fluoridation.

Fluoride supplements are often prescribed in the US to children who live in areas with low amounts of fluoride in the water. Michael Connett, who was the attorney for the Fluoride Action Network against the EPA, said in a The HighWire interview that any noticeable benefits from fluoride come from topical use on the teeth and not systemic exposure from consumption.

Countries with better dental health outcomes than the United States don’t fluoridate the water supply or widely prescribe fluoride tablets. Topical fluoride products are available with toothpaste and mouthwash, which are products that warn consumers not to swallow due to the high concentrations of fluoride.

A fluoride tablet manufactured by Method Pharmaceuticals, LLC has a label that states, “This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.”

The FDA website warns about prescription products that have not been approved by the agency. It states, “Unapproved prescription drugs pose significant risks to patients because they have not been reviewed by FDA for safety, effectiveness or quality. Without FDA review, there is no way to know if these drugs are safe and effective for their intended use, whether they are manufactured in a way that ensures consistent drug quality, or whether their label is complete and accurate. Unapproved drugs have resulted in patient harm, and the agency works to protect patients from the risks posed by these drugs.”

The FDA notes that all prescription products must be reviewed as a matter of law, but there are exceptions for those that are Generally Recognized as Safe and Effective (GRASE) and those that have been grandfathered in. Fluoride supplements are considered a grandfathered product on the claim that these supplements were marketed prior to 1938 when Congress passed the Food, Drug, and Cosmetic Act (FDCA).

The Fluoride Action Network said this claim by the FDA is “demonstrably false,” because there were no fluoride products marketed for human use before 1938. The FAN website states, “As Merck Indexes from the 1930s demonstrate, there was not a single fluoride product meant for human ingestion as a tooth decay preventative. In fact, prior to 1938, fluoride’s primary use was as a rodenticide (a chemical that kills rodents), while in Europe, some doctors were using it as a drug to reduce thyroid activity.

“Ending the use of ingestible fluoride is long overdue,” said HHS Secretary Robert F. Kennedy, Jr., “I’m grateful to Commissioner Makary for his leadership on this vital issue — one that directly safeguards the health and development of our children. This decision brings us one step closer to delivering on President Trump’s promise to Make America Healthy Again.”