FDA Lowers the Fluoride Limit for Fluoridated Bottled Water (2022)

Table of Contents

1. What the FDA Did on April 20, 2022
2. What the Rule Changes
3. The Terms in Plain Language
4. The Basis the FDA Gave
5. From the 2019 Proposal to the 2022 Final Rule
6. What the Public Docket Holds
7. What the Rule Does Not Do
8. Dates and Legal Status as of October 18, 2026
9. How It Fits Later FDA Fluoride Actions
10. Primary Documents
11. Key Research Papers
12. Connections
13. Featured Videos

1. What the FDA Did on April 20, 2022

The FDA, part of the Department of Health and Human Services, published a final rule titled “Beverages: Bottled Water” in the Federal Register on April 20, 2022. Its citation is 87 FR 23434 (pages 23434–23441, eight pages), and it is filed under Docket No. FDA-2018-N-1815 and Regulation Identifier Number (RIN) 0910-AI03. The rule amends Title 21 of the Code of Federal Regulations, part 165.

The rule’s summary states that the FDA is “revising the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter (mg/L).”

The Federal Register record marks the rule as significant, and the government’s regulatory agenda entry for RIN 0910-AI03 lists its priority as “Other Significant.” The record files it under the topics Beverages, Bottled water, and Food grades and standards.

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2. What the Rule Changes

• A single ceiling of 0.7 mg/L. Bottled water to which the manufacturer adds fluoride may not contain more than 0.7 mg/L of fluoride.
• It replaces a range. In the FDA’s words, the final rule “revises the current allowable levels, which range from 0.8 to 1.7 mg/L, for fluoride in domestically packaged and imported bottled water to which fluoride is added.”
• It covers domestic and imported water alike. The limit applies both to bottled water packaged in the United States and to imported bottled water, as long as fluoride was added by the manufacturer.
• It applies from fixed dates. The rule was effective June 21, 2022; the compliance date, by which products had to meet the new limit, was October 17, 2022.

The change is a reduction at the top of the range: the lowest earlier allowable level, 0.8 mg/L, was already above the new 0.7 mg/L ceiling, so every earlier allowable level for added fluoride was lowered.

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3. The Terms in Plain Language

• Milligrams per liter (mg/L). The weight of fluoride, in thousandths of a gram, in one liter of water. A limit of 0.7 mg/L means no more than 0.7 milligrams of fluoride in each liter.
• Quality standard. The regulation that sets allowable levels of certain substances in bottled water. The rule changes the fluoride entry in the FDA’s quality standard for bottled water.
• Fluoride “added by the manufacturer.” Fluoride that a bottler puts into the water on purpose, as opposed to fluoride already present in the source water. The rule’s limit covers only the first kind (section 7).
• Dental caries. The medical term for tooth decay, described on the site’s Tooth Decay page.
• Dental fluorosis. A change in the appearance of tooth enamel linked to fluoride intake, described on the site’s Dental Fluorosis page.
• Federal Register and docket. The Federal Register is the U.S. government’s daily publication of rules and official notices. A docket is the public file for an action, kept on regulations.gov, where the documents and public comments are stored.
• Effective date and compliance date. The effective date is when the rule becomes part of the regulations; the compliance date is when products must actually meet it.

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4. The Basis the FDA Gave

The FDA gave two reasons in the rule’s summary.

First, it described 0.7 mg/L as the level “which available data suggests provides an optimal balance between the prevention of dental caries and the risk of dental fluorosis.” This is the FDA’s own statement of its basis.

Second, it tied the change to drinking-water policy: “We are taking this action to make the quality standard regulation for fluoride added to bottled water consistent with the 2015 recommendation by the U.S. Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries.” Community water systems are public water suppliers; the rule brings the ceiling for fluoridated bottled water to the level the PHS recommendation names for fluoridated tap water. The 2015 PHS recommendation itself is listed among the papers below.

The site’s Fluoride in Water and Fluoride Toxicity pages report research that raises concerns about fluoride intake. This page reports the FDA’s basis as the FDA stated it, without weighing it.

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5. From the 2019 Proposal to the 2022 Final Rule

The rule began as a proposed rule with the same title, “Beverages: Bottled Water,” published on April 3, 2019 (84 FR 12975, pages 12975–12979), under the same docket and RIN. Its summary stated that the FDA was “proposing to revise the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter (mg/L).”

The proposal gave the same reason as the final rule, consistency with the PHS recommendation for community water systems that add fluoride, and the same limit on its scope: it “will not affect the allowable levels for fluoride in bottled water to which fluoride is not added by the manufacturer.” Comments were due by June 3, 2019. The Federal Register record of the proposal reports 92 public comments on regulations.gov.

Comparing the two summaries, the 0.7 mg/L limit and its scope were finalized as proposed. The final rule’s summary adds two points the proposal’s summary did not state: the “optimal balance” wording, and the earlier allowable range of 0.8 to 1.7 mg/L. About three years passed between the proposal and the final rule.

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6. What the Public Docket Holds

The Federal Register record of the final rule lists 16 supporting documents in Docket No. FDA-2018-N-1815. Among those it names are:

• the final rule and its Final Regulatory Impact Analysis (an estimate of a rule’s costs and benefits) in the versions submitted to and cleared by the Office of Management and Budget, with comparison copies showing the changes between the two;
• a memorandum to the FDA’s Division of Dockets Management on the bottled water final rule;
• reference documents, including a Centers for Disease Control and Prevention (CDC) Division of Oral Health page on community water fluoridation and a 2020 fact sheet from the New Hampshire Department of Environmental Services.

The docket can be read on regulations.gov (Primary Documents, below). This page does not report the contents of those supporting documents, which were not read for it.

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7. What the Rule Does Not Do

• It does not cover fluoride from the source. The FDA states that the action “will not affect the allowable levels for fluoride in bottled water to which fluoride is not added by the manufacturer (such bottled water may contain fluoride from its source water).”
• It sets a ceiling, not a requirement to add fluoride. The rule limits fluoride in water to which fluoride is added; the Federal Register summary describes no requirement for any bottler to add it.
• It does not change tap water. The rule revises the quality standard for bottled water. The PHS recommendation it cites is addressed to community water systems; the rule borrows its level for bottled water and does not itself apply to those systems.
• It is not a drug action. Fluoride products taken as medicines are a separate matter, outside this beverage rule; the FDA’s 2025 steps on ingestible fluoride drugs for children are reported on their own page.

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8. Dates and Legal Status as of October 18, 2026

• April 3, 2019: the FDA publishes the proposed rule (84 FR 12975; Docket No. FDA-2018-N-1815).
• June 3, 2019: the comment period on the proposal closes.
• April 20, 2022: the FDA publishes the final rule (87 FR 23434).
• June 21, 2022: the rule takes effect.
• October 17, 2022: the compliance date; fluoridated bottled water must meet the 0.7 mg/L limit.

Status as of October 18, 2026: final and in force. A check of the Federal Register for FDA documents on fluoride and on bottled water published after the final rule, through October 18, 2026, found no later document that amends, delays or withdraws the bottled-water fluoride limit. The Federal Register record of the final rule lists no corrections.

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9. How It Fits Later FDA Fluoride Actions

The 2022 rule is the FDA’s food-side fluoride step of the period. The Federal Register shows a later and separate drug-side step: on June 16, 2025, the FDA announced a public meeting, held July 23, 2025, on “Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population” (90 FR 25329; Docket No. FDA-2025-N-1557), to seek public input on “the clinical use and safety concerns associated with” those products in children. That action and what followed are reported on the 2025 ingestible fluoride page.

Among the FDA’s 2022 food actions, two others also set or changed limits on substances in what people eat and drink: the draft action levels for lead in juice and the revocation of phthalate authorizations for food-contact use. Later contaminant limits are reported on the 2025 lead action levels for baby food page.

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10. Primary Documents

1. Food and Drug Administration, HHS (2022). Beverages: Bottled Water. Final rule. Federal Register 87 FR 23434–23441, April 20, 2022. Docket No. FDA-2018-N-1815; RIN 0910-AI03; 21 CFR part 165. Effective June 21, 2022; compliance date October 17, 2022 — FR Doc. 2022-08273
2. Food and Drug Administration, HHS (2019). Beverages: Bottled Water. Proposed rule. Federal Register 84 FR 12975–12979, April 3, 2019. Docket No. FDA-2018-N-1815; RIN 0910-AI03. Comments due June 3, 2019 — FR Doc. 2019-06201
3. Regulatory agenda entry, RIN 0910-AI03, Beverages: Bottled Water — federalregister.gov RIN 0910-AI03
4. 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 FR 25329, June 16, 2025. Docket No. FDA-2025-N-1557 — FR Doc. 2025-10943
5. Public docket FDA-2018-N-1815 — regulations.gov FDA-2018-N-1815

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Key Research Papers

1. U.S. Department of Health and Human Services Federal Panel on Community Water Fluoridation (2015). U.S. Public Health Service Recommendation for Fluoride Concentration in Drinking Water for the Prevention of Dental Caries. Public Health Reports 130(4):318-331 — PubMed PMID: 26346489
2. Beltrán-Aguilar ED, Barker L, Sohn W, Wei L (2015). Water Intake by Outdoor Temperature Among Children Aged 1-10 Years: Implications for Community Water Fluoridation in the U.S. Public Health Reports 130(4):362-371 — PubMed PMID: 26346578
3. 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:CD010856 — PubMed PMID: 39362658
4. 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
5. Neurath C, Limeback H, Osmunson B, Connett M, Kanter V, Wells CR (2019). Dental Fluorosis Trends in US Oral Health Surveys: 1986 to 2012. JDR Clinical & Translational Research 4(4):298-308 — PubMed PMID: 30931722
6. Wiener RC, Shen C, Findley P, Tan X, Sambamoorthi U (2018). Dental Fluorosis over Time: A comparison of National Health and Nutrition Examination Survey data from 2001-2002 and 2011-2012. Journal of Dental Hygiene 92(1):23-29 — PubMed PMID: 29500282
7. Victory KR, Cabrera NL, Larson D, Reynolds KA, Latura J, Thomson CA, Beamer PI (2017). Comparison of Fluoride Levels in Tap and Bottled Water and Reported Use of Fluoride Supplementation in a United States-Mexico Border Community. Frontiers in Public Health 5:87 — PubMed PMID: 28497034

The first paper is the 2015 Public Health Service recommendation the FDA cites as the basis for the rule; the second, published in the same issue, studies children’s water intake by outdoor temperature in relation to community water fluoridation. The third is a systematic review of water fluoridation and tooth decay, and the fourth a federal systematic review and meta-analysis of fluoride exposure and children’s IQ scores. The fifth and sixth analyze dental fluorosis in U.S. national survey data over time. The last compares fluoride levels in tap and bottled water in one U.S. community.

PubMed Topic Searches

1. PubMed: bottled water fluoride
2. PubMed: dental fluorosis prevalence
3. PubMed: fluoride concentration in drinking water (0.7 mg/L)

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Connections

• FDA Actions of 2022
• FDA and Regulation
• Fluoride in Water
• Fluoride Toxicity
• Dental Fluorosis
• Fluoride and Thyroid Function
• Fluoride Chelation
• Toxic Minerals and Heavy Metals
• Tooth Decay (Dental Caries)
• Ingestible Fluoride Drugs for Children (2025)
• Lead in Juice Draft Action Levels (2022)
• Phthalates Food-Contact Revocation (2022)
• Lead Action Levels for Baby Food (2025)

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