FDA Final Rule on Salt Substitutes in Standardized Foods (2026)

On Friday 9 October 2026 the U.S. Food and Drug Administration announced a final rule that lets makers of 139 “standardized” foods — foods whose recipes are fixed by federal regulation, such as bread, cheddar cheese, canned peas, canned tuna and mayonnaise — replace some or all of the added salt with a “safe and suitable” salt substitute and still sell the food under its standard name. The rule, “Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods,” was filed for public inspection at 8:45 a.m. that day and printed in the Federal Register on Tuesday 13 October 2026 at 91 FR 65040–65070 (FR Doc. 2026-20848; Docket No. FDA-2022-N-2226; RIN 0910-AI72). It takes effect on Monday 14 December 2026; objections to its dairy provisions are due by Thursday 12 November 2026.

This page reports what the documents say: the announcement, the new definition and the standards it amends, the labelling rules it relies on, the FDA’s answers on potassium and kidney disease, the evidence on salt substitutes, the sodium-reduction context, the rulemaking record, the legal basis and costs, and the dates. The rule permits a change; it requires none. Figures come from the rule, FDA and WHO documents, a trial registry record or the abstracts of the cited papers. The site’s news report on the same rule is FDA Lets Salt Substitutes Into 139 Standard Foods.

Table of Contents

  1. What the FDA Announced
  2. What the Rule Does and Does Not Do
  3. Which Foods Are Covered
  4. Labeling: What Existing Rules Already Require
  5. The Potassium and Kidney Question
  6. The Evidence on Salt Substitutes
  7. How It Fits the FDA’s Sodium-Reduction Work
  8. The Rulemaking Record: Proposal, Comments and Changes
  9. Legal Authority and the FDA’s Cost Analysis
  10. Dates: Effective Date and Dairy Objections
  11. Primary Documents
  12. Key Research Papers
  13. Connections
  14. Featured Videos

1. What the FDA Announced

The FDA’s Human Foods Program announced the rule in a constituent update dated 9 October 2026, “FDA Issues Final Rule on Salt Substitutes in Standardized Foods.” It states: “Before today’s final rule, 139 SOIs allowed or required the addition of salt, but did not permit the use of salt substitutes in these foods. This meant manufacturers had few options to lower the sodium content in these standardized foods.” (SOI stands for standard of identity.)

The update gives the health rationale in two sentences — “Americans consume too much sodium. Excess sodium increases the risk of high blood pressure, a leading cause of heart disease and stroke” — and says the rule supports the Make America Healthy Again initiative and the FDA’s voluntary sodium reduction goals. It adds that “later this year, the agency will issue a report evaluating progress against the Phase I targets.” No official is quoted by name.

The Federal Register document is a 31-page final rule amending the food-standards parts of Title 21 of the Code of Federal Regulations (21 CFR parts 130, 131, 133 and others). It is signed by Robert F. Kennedy, Jr., Secretary of Health and Human Services. Its summary says the rule provides “flexibility to facilitate industry innovation in the production of standardized foods lower in sodium while maintaining the basic nature and essential characteristics of the foods,” and that “reducing sodium may help reduce the risk of hypertension, a major risk factor for heart disease and stroke.”

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2. What the Rule Does and Does Not Do

The problem. A standard of identity defines what a food sold under a common name must contain; in the FDA’s words, standards “often describe in detail what a food must contain and what is optional.” Makers could use less salt, or none where it was optional, but as the 2023 proposal put it they “cannot replace salt with another ingredient unless the standard permits the use of another ingredient.” Only three standards did: low sodium cheddar cheese, low sodium colby cheese, and margarine, which allows potassium chloride in dietary margarine. The other route, 21 CFR 130.10, requires a food to meet a defined nutrient content claim such as “low sodium,” and the FDA says reducing sodium to those amounts “may be impracticable.”

The new definition. The rule adds a subpart C, “Flexibility in Standardized Foods,” with one section, 21 CFR 130.30. It requires that “the ingredients used as substitutes must not change the basic nature and essential characteristics of the food,” and defines the term: “Salt substitute means a safe and suitable ingredient (or combination of safe and suitable ingredients) that is used to replace some or all of the added salt (sodium chloride), to reduce sodium in the food, and that serves the functions of salt in the food.”

The FDA calls this a “horizontal approach”: one definition applies across the standards, and 80 individual standards are edited to allow it, in one of three ways: an ingredient line changes from “Salt” to “Salt or salt substitute,” “Salt substitute” is added to a list of optional ingredients, or, in several cheese standards, a sentence is added that “where the curd is salted, salt substitute may be used.” Because 59 more standards borrow their ingredients from those 80 by cross-reference, “the final rule permits the use of salt substitutes in 139 SOI.”

“Safe and suitable” already has a meaning (21 CFR 130.3(d)): the ingredient performs an appropriate function, is used at a level no higher than necessary, and is not an unapproved food or color additive. The substitute must also do salt’s job. The FDA refused to let it serve only “one or more” of salt’s functions, because manufacturers could then “arbitrarily choose which functions of salt are replaced.” Its example: salt does not prevent spoilage in dry self-rising flour or heat-sterilized canned corn, so a flavor ingredient may replace lost flavor there, but an ingredient that only preserves would not qualify.

What the rule does not do:

The rule also updates cited laboratory methods to the 22nd edition (2023) of the Official Methods of Analysis and fixes typographical errors, such as “mapel” for “maple” in the maple sirup standard.

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3. Which Foods Are Covered

Table 1 of the rule lists the 80 standards it edits directly, including:

The other 59 follow by cross-reference; the 2023 proposal’s example is the bread standard, which the standards for enriched, milk, raisin and whole wheat bread, rolls and buns refer to. The amended text can be a single line, such as the bread standard’s “(4) Salt or salt substitute,” or a phrase in a description: catsup “may contain salt or salt substitute (sodium chloride formed during acid neutralization shall be considered added salt).”

Left unchanged. The oyster standard (21 CFR 161.130) allows shucking in saltwater of less than 0.75 percent salt for no more than 30 minutes; salt is not an added ingredient there, and the FDA said a substitute “could affect the amount of shrinkage or water absorption of the oysters.” The frozen raw breaded shrimp standards already allow safe and suitable batter and breading ingredients other than artificial flavorings, sweeteners, colors and chemical preservatives, so they needed no change.

Which products will change is unknown. The FDA wrote that it does not know “how many foods will be voluntarily reformulated because of the final rule or which ingredients will be used to reformulate standardized foods.”

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4. Labeling: What Existing Rules Already Require

“The final rule does not prescribe any new labeling requirements for ingredients used to replace salt in standardized foods.” It relies on existing rules:

The FDA declined requests for extra labelling, such as a flag for ingredients new to standardized foods or a temporary front-of-package notice of added potassium. Makers may add truthful, non-misleading statements voluntarily, including about reformulation. The rule also mentions the FDA’s January 2025 proposal (90 FR 5426) for a front-of-package “Nutrition Info box” showing sodium among the nutrients to limit, a measure that applies only “if finalized.”

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5. The Potassium and Kidney Question

What commenters said. As the rule summarizes them, some comments said potassium-based substitutes could affect people who monitor potassium because of chronic kidney disease, heart failure or medicines, “because of an increased risk of hyperkalemia” — “a condition where there is too much potassium in the blood.” Some said many people do not know they have kidney disease or may not read labels, making added potassium a “hidden” source; others said the evidence may not show that substitutes lead to hyperkalemia, or that more research is needed.

How the FDA answered.

The 2023 proposal’s economic analysis had already noted that consumers who need to limit their potassium intake “may see negative health effects” if makers use potassium chloride, and asked for evidence to quantify such costs.

What the evidence base reports.

See Hyperkalemia (High Potassium), Hyperkalemia and Heart Rhythm and Kidney Disease. Decisions about potassium intake in kidney disease belong with a clinician.

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6. The Evidence on Salt Substitutes

What the rule cites. The rule’s health rationale rests on evidence about sodium, not on trials of substitutes. For the link between sodium and hypertension it cites a 2013 modelling study projecting 280,000 to 500,000 deaths averted over 10 years from a gradual 40% cut in US sodium intake; the National Academies’ 2019 Dietary Reference Intakes for sodium and potassium; and a 2020 Cochrane review in which sodium reduction lowered systolic pressure by 5.71 mmHg (95% CI 4.74 to 6.67) in white participants with high blood pressure and by 1.14 mmHg in those with normal blood pressure, while renin, aldosterone, noradrenaline, cholesterol and triglyceride rose.

For sodium sources it cites a 2017 study of 450 US adults: sodium added to food outside the home made up 70.9% of intake, salt added in home cooking 5.6% and at the table 4.9%. For taste, a 2012 study found that mixing potassium chloride with sodium chloride reduced its bitter, chemical and metallic side tastes. For potassium intake, a 2016 modelling study by researchers at a food manufacturer, using Dutch data from 2,106 people, estimated that replacing 20% of the sodium chloride in each food with potassium chloride would raise median potassium intake by 453 mg a day from 3,334 mg (674 mg at 50% and 733 mg at 100% replacement).

What the rule does not discuss. The final rule does not mention the randomized trials of salt substitutes or the 2025 WHO guideline, and the 2023 proposal does not mention the trials:

The scope gap. The trials mostly tested salt added in cooking or at the table; the FDA rule concerns salt added by manufacturers. WHO notes that “most trials assessed discretionary use”; the Cochrane review “cannot draw firm conclusions about effects of non-discretionary LSSS implementations”; and SSaSS excluded people who eat most meals outside the home. Based on that evidence, WHO’s recommendation “does not apply to … non-discretionary salt already present in manufactured foods,” and WHO adds that as substitutes enter manufactured foods, “such changes must be monitored at the population level to estimate total sodium and potassium intake from both discretionary and non-discretionary sources.”

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7. How It Fits the FDA’s Sodium-Reduction Work

The intake gap. The FDA’s 2024 Phase II notice puts average US sodium intake at about 3,400 mg a day and states that “more than 70 percent of total sodium intake is from sodium added during food manufacturing and commercial food preparation.” The final rule cites the Dietary Guidelines for Americans, 2025–2030, for a limit of less than 2,300 mg a day for people aged 14 and over.

Why substitutes as well as cuts. The FDA agreed with commenters that taste preferences “may adapt and adjust over time,” but wrote that “the amount of sodium that can be removed without substitution may be limited, particularly in standardized foods for which salt is a required ingredient,” because salt may matter for “taste, microbial safety, or other functions.”

Related actions. The rule builds on the 2020 potassium chloride naming guidance and refers to the 2025 front-of-package label proposal. It treated the safety of particular substitutes, and requirements for GRAS conclusions, as outside its scope, noting that the FDA has “instituted a post-market review process to review substances more systematically for continued safety.” A separate proposal of 11 August 2026 (91 FR 51834) would make GRAS notification mandatory; see FDA Proposal to Make GRAS Notices Mandatory (2026).

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8. The Rulemaking Record: Proposal, Comments and Changes

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Authority. The rule is issued under sections 201, 401, 402 and 701 of the Federal Food, Drug, and Cosmetic Act. Section 401 provides for standards of identity that “will promote honesty and fair dealing in the interest of consumers”; the FDA concludes that permitting substitutes does so because “many consumers desire more nutritious and healthy food options, such as lower-sodium versions of foods.” The dairy amendments (parts 131 and 133) are issued under section 701(e), and they are the provisions open to objections (section 10).

Costs and benefits. “There are no regulatory costs of the final rule as there are no regulatory requirements or regulatory penalties if manufacturers of a standardized food choose not to take advantage of the flexibility to use salt substitutes.” Annualized monetized benefits and costs are recorded as $0 in every estimate; benefits (“potential health benefits of reduced sodium consumption” among them) and costs (voluntary reformulation, re-labelling, possible consumer dissatisfaction) are described only in words, because “due to the voluntary nature of the rule, no changes in costs of production or increase in consumer satisfaction can be quantified.”

Regulatory status. The Office of Information and Regulatory Affairs found the rule significant under section 3(f)(1) of Executive Order 12866, and within 5 U.S.C. 804(2), the Congressional Review Act’s definition of a major rule, because it “is likely to result in an annual effect on the economy of $100 million or more or to meet other criteria specified in” that Act. The FDA calls it “an Executive Order 14192 deregulatory action,” certifies no significant impact on a substantial number of small entities, and found no need for an environmental assessment (21 CFR 25.32(a)) or a new collection of information.

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10. Dates: Effective Date and Dairy Objections

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11. Primary Documents

  1. U.S. Food and Drug Administration, Human Foods Program (2026). FDA Issues Final Rule on Salt Substitutes in Standardized Foods. Constituent Update, 9 October 2026 — fda.gov constituent update
  2. Food and Drug Administration, HHS (2026). Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods. Final rule. Federal Register 91:65040–65070, 13 October 2026 — FR Doc. 2026-20848 (official PDF)
  3. Public docket FDA-2022-N-2226 (proposal, references, comments, final rule) — regulations.gov docket
  4. Food and Drug Administration, HHS (2023). Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods. Proposed rule. Federal Register 88:21148–21171, 10 April 2023 — FR Doc. 2023-06456
  5. Food and Drug Administration, HHS (2020). The Use of an Alternate Name for Potassium Chloride in Food Labeling; Guidance for Industry; Availability. Federal Register 85:82332, 18 December 2020 — FR Doc. 2020-27750
  6. Food and Drug Administration, HHS (2021). Voluntary Sodium Reduction Goals; Guidance for Industry; Availability. Federal Register 86:57156, 14 October 2021 — FR Doc. 2021-22453
  7. Food and Drug Administration, HHS (2024). Voluntary Sodium Reduction Goals; Draft Guidance for Industry (Edition 2); Availability. Federal Register 89:66727, 16 August 2024 — FR Doc. 2024-18261; FDA page Sodium Reduction in the Food Supply
  8. World Health Organization (2025). Use of lower-sodium salt substitutes: WHO guideline. Geneva: WHO, 27 January 2025. ISBN 978-92-4-010559-1 — WHO guideline page
  9. Salt Substitute and Stroke Study (SSaSS), registry record and eligibility criteria — ClinicalTrials.gov NCT02092090

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Key Research Papers

  1. Neal B, Wu Y, Feng X, Zhang R, Zhang Y, Shi J, et al. (2021). Effect of Salt Substitution on Cardiovascular Events and Death. New England Journal of Medicine 385(12):1067-1077 — PubMed PMID: 34459569
  2. Yuan Y, Jin A, Neal B, Feng X, Qiao Q, Wang H, et al. (2023). Salt substitution and salt-supply restriction for lowering blood pressure in elderly care facilities: a cluster-randomized trial. Nature Medicine 29(4):973-981 — PubMed PMID: 37055566
  3. Yin X, Rodgers A, Perkovic A, Huang L, Li KC, Yu J, et al. (2022). Effects of salt substitutes on clinical outcomes: a systematic review and meta-analysis. Heart 108(20):1608-1615 — PubMed PMID: 35945000
  4. Brand A, Visser ME, Schoonees A, Naude CE (2022). Replacing salt with low-sodium salt substitutes (LSSS) for cardiovascular health in adults, children and pregnant women. Cochrane Database of Systematic Reviews 8(8):CD015207 — PubMed PMID: 35944931
  5. Greer RC, Marklund M, Anderson CAM, Cobb LK, Dalcin AT, Henry M, Appel LJ (2020). Potassium-Enriched Salt Substitutes as a Means to Lower Blood Pressure: Benefits and Risks. Hypertension 75(2):266-274 — PubMed PMID: 31838902
  6. Marklund M, Singh G, Greer R, Cudhea F, Matsushita K, Micha R, et al. (2020). Estimated population wide benefits and risks in China of lowering sodium through potassium enriched salt substitution: modelling study. BMJ 369:m824 — PubMed PMID: 32321724
  7. Ray K, Dorman S, Watson R (1999). Severe hyperkalaemia due to the concomitant use of salt substitutes and ACE inhibitors in hypertension: a potentially life threatening interaction. Journal of Human Hypertension 13(10):717-720 — PubMed PMID: 10516744
  8. Graudal NA, Hubeck-Graudal T, Jurgens G (2020). Effects of low sodium diet versus high sodium diet on blood pressure, renin, aldosterone, catecholamines, cholesterol, and triglyceride. Cochrane Database of Systematic Reviews 12(12):CD004022 — PubMed PMID: 33314019
  9. Coxson PG, Cook NR, Joffres M, Hong Y, Orenstein D, Schmidt SM, Bibbins-Domingo K (2013). Mortality benefits from US population-wide reduction in sodium consumption: projections from 3 modeling approaches. Hypertension 61(3):564-570 — PubMed PMID: 23399718
  10. Harnack LJ, Cogswell ME, Shikany JM, Gardner CD, Gillespie C, Loria CM, et al. (2017). Sources of Sodium in US Adults From 3 Geographic Regions. Circulation 135(19):1775-1783 — PubMed PMID: 28483828
  11. van Buren L, Dötsch-Klerk M, Seewi G, Newson RS (2016). Dietary Impact of Adding Potassium Chloride to Foods as a Sodium Reduction Technique. Nutrients 8(4):235 — PubMed PMID: 27110818
  12. Sinopoli DA, Lawless HT (2012). Taste properties of potassium chloride alone and in mixtures with sodium chloride using a check-all-that-apply method. Journal of Food Science 77(9):S319-S322 — PubMed PMID: 22901084

Papers 8 to 12 are in the final rule’s own reference list; papers 1 to 7 are not. Each entry was checked against its PubMed record, and the figures on this page come from the abstracts.

PubMed Topic Searches

  1. PubMed: salt substitutes and cardiovascular events
  2. PubMed: potassium-enriched salt substitutes and hyperkalemia
  3. PubMed: salt substitutes and chronic kidney disease
  4. PubMed: potassium chloride in food reformulation

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Connections

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