FDA Action on Ingestible Fluoride Drugs for Children (2025)

Table of Contents

1. 1. What the FDA Did
2. 2. What the Products Are, and What “Unapproved” Means
3. 3. The May 2025 Announcement and the Reasons Given
4. 4. The Public Meeting and the Questions Asked
5. 5. The October 2025 Conclusion
6. 6. The Notices to Four Companies
7. 7. The Letter to Health Care Professionals
8. 8. The Safety Concerns and How Firm the FDA Calls Them
9. 9. What the Action Does Not Do
10. 10. Dates and Legal Status (as of 11 October 2026)
11. 11. How the Action Fits Earlier Policy
12. 12. Primary Documents
13. Key Research Papers
14. Connections

1. What the FDA Did

The action came in three public steps:

• 13 May 2025 — announcement. An FDA news release, “FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market,” said the agency was “initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market” and set a goal date of 31 October 2025 for completing a safety review and public comment period and for “taking appropriate action regarding removal of these products from the market.”
• 16 June 2025 — Federal Register notice. A notice titled “Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishment of a Public Docket; Request for Comments” (90 FR 25329, FR Doc. 2025-10943, Docket No. FDA-2025-N-1557) announced a public meeting for 23 July 2025 and opened a docket for comments. The Federal Register is the U.S. government’s daily journal of rules and notices; a docket is the public file in which the documents and the comments on one matter are collected.
• 31 October 2025 — conclusion and enforcement notice. A second news release, “FDA Acts to Protect Children from Unapproved Fluoride Drug Products,” announced “actions to restrict the sale of unapproved ingestible fluoride prescription drug products for children.” The FDA published its scientific evaluation, sent notices to four companies, sent a letter to health care professionals and posted a program page, “Ingestible Fluoride Drug Products,” gathering the documents.

The program page sums up the outcome in one line: “FDA recommends that ingestible fluoride drug products be limited to children aged three years and older who are at high risk for tooth decay.”

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2. What the Products Are, and What “Unapproved” Means

The products are prescription fluoride drops and tablets meant to be swallowed. The Federal Register notice states that they “were first marketed in the United States in the 1940s to prevent dental caries, particularly in children who lived in areas with low or no water fluoridation.” Dental caries is the medical term for tooth decay. The FDA’s letter to health care professionals describes the current market as “ingestible single-ingredient unapproved prescription sodium fluoride products” sold “as oral chewable tablets and oral drops with products dosed in the range of 0.25 mg to 1.0 mg per day.”

The May release draws the line between these products and the fluoride most people know: “Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers.” Toothpaste and rinses deliver fluoride to the tooth surface (topical use); the drops and tablets deliver it into the body (systemic use).

“Unapproved” has a specific meaning. A new drug normally reaches the U.S. market only after the FDA reviews an application showing that it is safe and effective and that it is made to consistent quality standards. Some older drugs never went through that review. The Federal Register notice states that although these fluoride products “are still prescribed today, none have been reviewed and approved by FDA for safety, effectiveness, or quality,” and that “FDA has previously not taken action to remove such unapproved drug products from the market.” The October release repeats the point: the products “have been used since the 1940s” without FDA review or approval.

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3. The May 2025 Announcement and the Reasons Given

The 13 May release gave the agency’s reasons for opening the review. It states that “ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in childhood,” and that “other studies have suggested an association between fluoride and thyroid disorders, weight gain and possibly decreased IQ.” The gut microbiome is the community of bacteria and other microbes that lives in the intestine.

The release quotes FDA Commissioner Marty Makary, M.D., M.P.H.: “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. For the same reason that fluoride may kill bacteria on teeth, it may also kill intestinal bacteria important for a child’s health.” The Commissioner said he was instructing the Center for Drug Evaluation and Research (CDER, the FDA office that oversees medicines) “to evaluate the evidence regarding the risks of systemic fluoride exposure from FDA-regulated pediatric ingestible fluoride prescription drug products,” and added, “When it comes to children, we should err on the side of safety.”

The release also quotes Health and Human Services Secretary Robert F. Kennedy, Jr.: “Ending the use of ingestible fluoride is long overdue.” It states that the Department of Health and Human Services (HHS) “plans to disseminate best practices for dental hygiene in children that are feasible, effective and do not alter gut health.”

Under “Related Information” the release linked five published papers: a review on fluoride and the human microbiome, a systematic review on fluoride and gut microbiota, a systematic review and meta-analysis on fluoride and children’s IQ, a dose-response meta-analysis on fluoride and thyroid function, and the 2024 Cochrane review of water fluoridation. All five are listed under Key Research Papers below.

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4. The Public Meeting and the Questions Asked

The Federal Register notice, signed on 11 June 2025 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs, set a hybrid (in-person and online) public meeting for 23 July 2025, 9:30 a.m. to 4:00 p.m. Eastern Time, at the FDA White Oak Campus in Silver Spring, Maryland. The meeting was facilitated by the Reagan-Udall Foundation for the FDA, which the notice describes as “an independent 501(c)(3) not-for-profit organization created by Congress to advance the mission of FDA.” Written and electronic comments to the docket were due by 16 July 2025.

The notice explains why the review was opened. FDA “is aware of recent scientific research on the safety of ingestible fluoride.” It adds a qualification: “While the safety concerns presented in the scientific literature have generally focused on fluoride levels greater than those found in prescription drug products marketed in the United States, given that these products are predominantly used in young children, FDA is undertaking a review of their safety.” It also records the other side of the history: “numerous medical and dental organizations in the United States have recommended the use of ingestible fluoride products for individuals for whom regular topical treatment is difficult to achieve and those for whom topical fluoride only is insufficient to avoid dental decay.”

The FDA asked the clinical, patient, public health and research communities to comment on four topics:

1. The evidence supporting current clinical uses of these products for tooth decay prevention in children, and the factors clinicians weigh when prescribing them.
2. The safety concerns, “taking into account the amount of fluoride they provide when used as directed.”
3. Their continued use, “considering the additional sources of fluoride available.”
4. The potential impact on patients and clinicians of removing the products from the market, and whether alternatives exist.

A footnote limits the scope: “Although the Agency is aware that there are other fluoride-containing products on the market, including dietary supplements, this public meeting is focused only on orally ingestible unapproved prescription drug products containing fluoride.” The FDA program page states that a summary of the meeting and the comments, the presentations and a recording were made available through the Reagan-Udall Foundation.

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5. The October 2025 Conclusion

On 31 October 2025, the goal date set in May, the FDA published its scientific evaluation. The program page describes it as “an analysis of utilization trends, a high-level examination of the benefits and risks of ingestible fluoride drug products, and a recommendation to restrict use of ingestible fluoride drug products to children aged three years and older who are at high risk for tooth decay.” (The evaluation itself is a separate PDF; this page reports its conclusion only as the FDA’s release and program page summarize it.)

The October release states: “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.” The program page gives the reasoning in one sentence: the recommendation “addresses the lack of proven benefit of ingestible fluoride drug products on primary teeth, as well as emerging safety concerns when fluoride overexposure occurs.” Primary teeth are the baby teeth.

On benefit, the release reports both sides of the evidence the FDA weighed: “While evidence indicates fluoride reduces the risk of dental caries in older children, a Cochrane review — an independent analysis that combines results from multiple scientific studies — of the medical literature concluded that fluoride did not reduce dental caries in baby teeth.” The release does not name which Cochrane review it means. On risk, it states that fluoride “may also alter the gut microbiome, which may have broader health implications,” and that the FDA “recognizes other preliminary but potentially concerning data on risks, such as a recent meta-analysis suggesting increased fluoride exposure is associated with decreases in IQ.”

The release ties the timing to the Make Our Children Healthy Again Strategy, released by the President’s Make America Healthy Again Commission on 9 September 2025, which “directed the FDA to evaluate fluoride products.” It quotes Commissioner Makary: “There are better ways to protect children’s teeth than taking unapproved ingestible fluoride, which is now recognized to alter the gut microbiome.” Secretary Kennedy is quoted: “It’s scary that these products have been used for decades without approval. Today’s action raises public awareness, informs medical professionals, and builds on President Trump’s commitment to Make Our Children Healthy Again.”

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6. The Notices to Four Companies

The October release states that the FDA “sent notices to four companies outlining the agency’s intention to take enforcement action.” The companies are not named in the FDA documents. The agency published an example of the notice, dated 31 October 2025 and signed by the Director of CDER, with the firm’s name and product names left blank.

The notice tells each firm that FDA intends “to pursue compliance action against certain unapproved fluoride-containing prescription drug products.” “Compliance action” is the FDA’s term for enforcement against products that do not meet federal drug law. The notice names two kinds of labeling as the target — 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, such as those who have a history of tooth decay and lack access to fluoridated drinking water.”

Each firm was asked, “within thirty (30) days of receipt of this letter,” to notify the FDA in writing “of the specific steps you intend to take to ensure your products address the safety concerns described above,” or to say so if it no longer makes or sells the products. The notice states that the FDA “continues to review information regarding the use of ingestible fluoride drug products and may consider additional regulatory action to address emerging, serious health risks,” and that it “will continue to enforce the new drug approval requirements of the Federal Food, Drug, and Cosmetic Act, applying our risk-based enforcement approach to individual unapproved ingestible fluoride drug products.”

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7. The Letter to Health Care Professionals

The same day, Commissioner Makary sent a letter titled “Ingestible fluoride drug products: What health care professionals should know.” It restates the FDA’s recommendation that the tablets and drops “should not be given to children under age three or any child at low or moderate risk for tooth decay.”

The letter adds detail on one well-documented effect, dental fluorosis — changes in tooth enamel caused by too much fluoride while teeth are forming. It states that “minimal to mild dental fluorosis is a well-established adverse effect of fluoride exposure documented in the literature and the FDA Adverse Event Reporting System,” that very mild fluorosis (“barely perceptible white spots or lines on the teeth”) is most common, and that in rare cases moderate to severe fluorosis can cause defects ranging from “barely discernable markings to brown stains and surface pitting.” According to the letter, the age-3 cut-off “avoids the highest risk window for moderate to severe dental fluorosis at age two for permanent incisors and molar teeth.”

On alternatives, the letter states that “deficiencies in diet and dental hygiene should be addressed with families as a first step,” that “topical application is an effective fluoride delivery system,” and that “daily tooth brushing with an appropriate amount of fluoride toothpaste should be recommended.” These are the FDA’s words to clinicians, reported here as such.

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8. The Safety Concerns and How Firm the FDA Calls Them

Across the documents the FDA names five areas of concern, and it describes their strength differently:

• Gut microbiome. The May release says ingested fluoride “has been shown to alter the gut microbiome”; the October release says it “may also alter the gut microbiome, which may have broader health implications”; the clinician letter says research “has also shown that fluoride alters gut microbiome development.”
• Thyroid function. Described as an association suggested by “other studies” (May release) and by “some epidemiological studies” (clinician letter).
• Weight gain. Listed in the same terms, as a suggested association.
• IQ. “Possibly decreased IQ” (May release); “preliminary but potentially concerning data … such as a recent meta-analysis suggesting increased fluoride exposure is associated with decreases in IQ” (October release).
• Dental fluorosis. Called “well-established” in the clinician letter.

The Federal Register notice gives the agency’s most careful wording: some studies suggest an association between ingestible fluoride and effects on “thyroid hormones, changes to the microbiome, and possibly decreased IQ. These safety findings are not conclusive, but they warrant continued research and discussion.” The same notice notes that the literature’s safety concerns “have generally focused on fluoride levels greater than those found in prescription drug products marketed in the United States.” The site’s Fluoride Toxicity pages describe the underlying studies in more detail.

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9. What the Action Does Not Do

• It is not a ban or a regulation. No rule was published. The October step is a stated intent to take compliance action against products whose labeling falls outside the FDA’s limits, delivered through notices to manufacturers, under the agency’s “risk-based enforcement approach.”
• It does not end all use. The FDA’s stated limits leave room for use in children aged 3 and older who are at high risk of tooth decay, such as those with a history of decay and no access to fluoridated drinking water.
• It does not cover toothpaste or rinses. The May release distinguishes the swallowed products from “toothpaste with fluoride or fluoride rinses,” and the clinician letter describes topical fluoride as “an effective fluoride delivery system.”
• It does not regulate community water fluoridation. The FDA documents concern prescription drug products only. The May release mentions water fluoridation only as background, noting that “several states have taken action to stop fluoridation of drinking water.”
• It does not address dietary supplements containing fluoride. The Federal Register notice states that the meeting was “focused only on orally ingestible unapproved prescription drug products containing fluoride.”
• It does not approve any fluoride product. The products remain unapproved drugs; the FDA states it will keep enforcing the new-drug approval requirements against individual products.

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10. Dates and Legal Status (as of 11 October 2026)

• 13 May 2025 — FDA announces it is initiating action and sets a 31 October goal date.
• 11 June 2025 — Federal Register notice signed.
• 16 June 2025 — notice published (90 FR 25329); Docket FDA-2025-N-1557 opens.
• 16 July 2025 — comment deadline for the public meeting.
• 23 July 2025 — public meeting, facilitated by the Reagan-Udall Foundation.
• 9 September 2025 — Make Our Children Healthy Again Strategy directs the FDA to evaluate fluoride products.
• 31 October 2025 — scientific evaluation published; notices sent to four companies; letter to health care professionals; firms given 30 days to respond.

Status as of 11 October 2026: the October 2025 recommendation and the stated enforcement intent stand as published. No rule was proposed or finalized. No 2026 Federal Register document or FDA press release on ingestible fluoride drug products was found, so there is no later FDA step to report, and the FDA documents do not say what each of the four companies did in response to its notice.

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11. How the Action Fits Earlier Policy

For about eight decades these products were sold and prescribed without FDA approval and without FDA action against them; the Federal Register notice says so directly, and it records that medical and dental organizations had recommended them for children for whom topical fluoride alone was not enough. Against that record, the 2025 action is the first FDA step to limit their use that the agency’s documents describe.

The action sits inside the Make America Healthy Again program. The May release calls it “consistent with Secretary Kennedy’s Make American Healthy Again effort,” and the October release cites the September 2025 Make Our Children Healthy Again Strategy as directing the review. In the same October release the FDA announced that, “in partnership with the National Institutes of Health and the U.S. Department of Health and Human Services,” it is “launching development of a fluoride research agenda and the first national oral health strategy,” with the stated goal to “close critical research gaps and guide efforts to better combat the most common childhood chronic disease in America.”

The same year the FDA took several other actions aimed at children’s exposures and medicines, among them the lead action levels for baby food in January and the label change for extended-release ADHD stimulants under age 6 in July. The broader debate over fluoride in public water, which the FDA documents mention only in passing, is covered on the site’s Water Fluoridation and Informed Consent page.

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12. Primary Documents

1. U.S. Food and Drug Administration (2025). FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market. FDA News Release, 13 May 2025 — fda.gov news release
2. Food and Drug Administration, HHS (2025). Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population; Public Meeting; Establishment of a Public Docket; Request for Comments. Federal Register 90:25329–25331, 16 June 2025. Docket No. FDA-2025-N-1557 — FR Doc. 2025-10943
3. U.S. Food and Drug Administration (2025). FDA Acts to Protect Children from Unapproved Fluoride Drug Products. FDA News Release, 31 October 2025 — fda.gov news release
4. U.S. Food and Drug Administration (2025). Ingestible Fluoride Drug Products. FDA program page, content current as of 31 October 2025 — fda.gov program page
5. U.S. Food and Drug Administration, Center for Drug Evaluation and Research (2025). Example notice to industry on unapproved fluoride-containing prescription drug products, 31 October 2025 — fda.gov PDF (example letter)
6. U.S. Food and Drug Administration (2025). Ingestible fluoride drug products: What health care professionals should know. Letter from the Commissioner of Food and Drugs, 31 October 2025 — fda.gov PDF (letter)
7. U.S. Food and Drug Administration (2025). Scientific evaluation of the current use of unapproved ingestible fluoride drug products, 31 October 2025 — fda.gov PDF (scientific evaluation)

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Key Research Papers

1. Moran GP, Zgaga L, Daly B, Harding M, Montgomery T (2023). Does fluoride exposure impact on the human microbiome? Toxicology Letters 379:11-19 — PubMed PMID: 36871794
2. Yasin M, Zohoori FV, Kumah EA, Subramanian M, Dean P, Orr CH (2025). Effect of fluoride on gut microbiota: a systematic review. Nutrition Reviews 83(7):e1853-e1880 — PubMed PMID: 40063073
3. Taylor KW, Eftim SE, Sibrizzi CA, Blain RB, Magnuson K, Hartman PA, Rooney AA, Bucher JR (2025). Fluoride exposure and children’s IQ scores: a systematic review and meta-analysis. JAMA Pediatrics 179(3):282-292 — PubMed PMID: 39761023
4. Iamandii I, De Pasquale L, Giannone ME, Veneri F, Generali L, Consolo U, Birnbaum LS, Castenmiller J, Halldorsson TI, Filippini T, Vinceti M (2024). Does fluoride exposure affect thyroid function? A systematic review and dose-response meta-analysis. Environmental Research 242:117759 — PubMed PMID: 38029816
5. Iheozor-Ejiofor Z, Walsh T, Lewis SR, Riley P, Boyers D, Clarkson JE, Worthington HV, Glenny AM, O’Malley L (2024). Water fluoridation for the prevention of dental caries. Cochrane Database of Systematic Reviews 10(10):CD010856 — PubMed PMID: 39362658
6. Tubert-Jeannin S, Auclair C, Amsallem E, Tramini P, Gerbaud L, Ruffieux C, Schulte AG, Koch MJ, Rège-Walther M, Ismail A (2011). Fluoride supplements (tablets, drops, lozenges or chewing gums) for preventing dental caries in children. Cochrane Database of Systematic Reviews 2011(12):CD007592 — PubMed PMID: 22161414

Papers 1–5 are the five studies linked under “Related Information” in the FDA’s 13 May 2025 news release. Paper 6 is the Cochrane review of fluoride supplements of the kind the action concerns; it is listed here for context and is not cited in the FDA documents above.

PubMed Topic Searches

1. PubMed: fluoride supplements, children and dental caries
2. PubMed: fluoride and gut microbiota
3. PubMed: fluoride, dental fluorosis and primary teeth
4. PubMed: fluoride exposure and children’s IQ

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Connections

• FDA Actions of 2025
• FDA and Regulation
• Fluoride in Water
• Fluoride Toxicity
• Fluoride, Brain Development and IQ
• Fluoride and Thyroid Function
• Dental Fluorosis
• Water Fluoridation and Informed Consent
• Tooth Decay (Dental Caries)
• The Oral Microbiome
• Hydroxyapatite vs Fluoride Toothpaste
• Fluoride Without Consent: The Push to End Mass Medication
• FDA Action Levels for Lead in Baby Food (2025)
• FDA Label Change for Extended-Release ADHD Stimulants Under Age 6 (2025)
• FDA Ends the Semaglutide Shortage and Compounded Copies (2025)

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