FDA and ingestible fluoride for children: from a promised removal in May 2025 to a limit at age 3 and high caries risk

What it says#

FDA's May 13, 2025 news release said the agency "is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market." It drew the line at swallowing: "Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers. They have also never been approved by the FDA." It cited altered gut microbiome and "an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ," quoted Commissioner Marty Makary instructing the Center for Drug Evaluation and Research to evaluate the risks of systemic fluoride from these products, and set "a goal date of October 31 for completing a safety review and public comment period and for taking appropriate action regarding removal of these products from the market."

The comment period came through a Federal Register notice of June 16, 2025 (90 FR 25329, Docket FDA-2025-N-1557) announcing a hybrid public meeting on July 23, 2025 at FDA's White Oak campus, "to seek public input on the clinical use and safety concerns associated with the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population," with comments due July 16. ADA News reported that ADA president Brett Kessler spoke in the public comment session and that CDER director George Tidmarsh told the meeting that "nothing is without risk, and you have to make sure that if there is risk, there's a clear benefit. And that analysis needs to be done with data."

What FDA did on October 31, 2025 is narrower than what it announced in May. The release says the agency "sent notices to four companies outlining the agency's intention to take enforcement action against those marketing unapproved fluoride-containing ingestible drugs labeled for use in children under age 3 or older children at low or moderate risk for tooth decay." It states the conclusion: "Based on the scientific evaluation published today, the agency concluded that such products should not be used in children under age 3 or by older children who are not at high risk of tooth decay." It notes the products "have been used since the 1940s" without FDA review, that a Cochrane review "concluded that fluoride did not reduce dental caries in baby teeth," and that FDA "also sent a letter to health care professionals warning about the risks." The release attributes the timing to the Make Our Children Healthy Again Strategy of September 9, 2025, which "directed the FDA to evaluate fluoride products," and says FDA, NIH and HHS are "launching development of a fluoride research agenda and the first national oral health strategy."

The CDER evaluation is the substance. It reports "an estimated 500,000 prescriptions dispensed in 2024," down from 900,000 in 2020 and "an estimated 2.5 million prescriptions dispensed in 2000"; children aged 3 to 9 accounted for up to 70 percent of prescriptions and children under 3 up to 13 percent; pediatricians wrote about 43 percent and dentists about 29 percent in 2024. On benefit: "the use of ingestible fluoride drug products appears to reduce tooth decay in permanent teeth but not primary teeth." On risk: "dental fluorosis is a well-established adverse effect," while "the available evidence linking fluoride ingestion to other emerging safety concerns, neurocognitive, thyroid, gut microbiome, and weight gain effects, is hypothesis-generating and requires further investigation." Its recommendation: "out of an abundance of caution, it would be prudent to limit use of ingestible fluoride drug products to children aged three years and older who are at high risk of tooth decay," because "the highest risk window for moderate to severe dental fluorosis is age two for permanent incisors and molar teeth," and high risk means "those who have a history of tooth decay and lack access to fluoridated drinking water." It adds that "parents and clinicians would remain able to engage in shared decision making." The example industry letter, signed by Tidmarsh, gives each firm 30 days to say what it will do.

Who it applies to#

Manufacturers first: the notices went to four companies that list unapproved fluoride prescription products in FDA's registration system, and FDA's focus page says it "intends to take compliance action against companies that market unapproved fluoride-containing ingestible drug products with labeling: for children under three years of age; or that does not limit use to children at high risk for dental caries." Prescribers second: the letter to health care professionals carries the recommendation, and the evaluation names dentists as the second-largest prescriber group. Patients third: the children affected are those under 3, and those 3 and older without a history of decay or with fluoridated water.

The products' own labeling, as the evaluation quotes it, was written for children "living in areas where the drinking water fluoride contents does not exceed 0.6 ppm fluoride," with tablets for ages 3 to 16 and drops from 6 months. Topical fluoride is outside the action entirely; the ADA's statements stress that the review "applies to 'ingestible fluoride prescription drug products,' not toothpaste, mouth rinses or other topical products."

What changed#

The announced outcome changed between May and October. The May release promised a removal; the October release delivered a recommendation, a prescriber letter and enforcement notices keyed to labeling. The ADA's October 31 statement describes the shift plainly: FDA "announced its intent to remove fluoride supplements from the market effective October 2025 but determined a new warning would be utilized instead of a full ban."

For a dental office the practical change is the collision between two schedules. FDA now says no ingestible fluoride under age 3 and none for children at low or moderate risk. The ADA's statement of the same day restates its guideline: no supplement from birth to 6 months; from 6 months to 3 years, 0.25 mg per day if water is below 0.3 ppm; 0.5 mg from 3 to 6 years and 1.0 mg from 6 to 16 years where water is below 0.3 ppm, with lower doses at 0.3 to 0.6 ppm and none at or above 0.6 ppm. ADA president Richard Rosato's line: "A doctor's clinical judgment, not a new warning label, should remain the guiding factor in determining appropriate fluoride use for children." In May, then-president Kessler had said "proposals like this stand to hurt rural America, not make them healthier," and that in non-fluoridated communities "fluoride supplements are the only chance for individuals to get the appropriate amount of fluoride to prevent tooth decay."

Status as of September 13, 2026: FDA's Ingestible Fluoride Drug Products page, marked current as of October 31, 2025, still states the age-3, high-risk recommendation and the intent to take compliance action, and says FDA "may consider additional regulatory action to address emerging, serious health risks." No later FDA announcement on these products was found on fda.gov, and no removal order or approval action was found; whether the four companies changed their labeling could not be confirmed from FDA's pages.

Where the source is#

Both FDA news releases and the Ingestible Fluoride Drug Products focus page are on fda.gov and loaded normally; the CDER evaluation and the example industry letter are FDA media files that refused a plain download but served through the "download?attachment" address used in the downloads above. The letter to health care professionals (FDA media file 189422) could not be retrieved in either form and is described here only as the releases describe it. The June 16, 2025 Federal Register notice is on govinfo. The ADA's two statements and the ADA News accounts of the May announcement, the July 23 meeting and the October action are on ada.org.