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
- What the FDA Announced
- What the Rule Does and Does Not Do
- Which Foods Are Covered
- Labeling: What Existing Rules Already Require
- The Potassium and Kidney Question
- The Evidence on Salt Substitutes
- How It Fits the FDA’s Sodium-Reduction Work
- The Rulemaking Record: Proposal, Comments and Changes
- Legal Authority and the FDA’s Cost Analysis
- Dates: Effective Date and Dairy Objections
- Primary Documents
- Key Research Papers
- Connections
- 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.”
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:
- No list of approved substitutes. “The final rule does not list specific salt substitutes,” so ingredients developed later are covered without another rulemaking.
- No new ingredients. It “does not permit the use of any ingredients or substances that are not already permitted in non-standardized foods” and gives no food-additive authorization or exemption. Each substitute must be an approved food additive or exempt from that definition, for example as generally recognized as safe (GRAS) for its use; potassium chloride, for example, is affirmed as GRAS in 21 CFR 184.1622 at levels not exceeding current good manufacturing practice.
- No minimum sodium cut. The definition “does not require a minimum replacement level of salt or prescribe the sodium content” of the food.
- No obligation. “Compliance with the final rule is voluntary.”
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.
3. Which Foods Are Covered
Table 1 of the rule lists the 80 standards it edits directly, including:
- Milk and cream products: acidified milk, cultured milk, sour cream, acidified sour cream and eggnog.
- Cheeses from asiago and blue to swiss and emmentaler, among them cheddar, colby, cream cheese, dry curd cottage cheese, mozzarella, parmesan, provolone, romano, and pasteurized process cheese, cheese food and cheese spread.
- Bakery, flour and pasta: bread, rolls and buns; self-rising flour; self-rising white corn meal; macaroni and noodle products.
- Fruit and vegetables: canned applesauce, canned figs, fruit butter, canned green and wax beans, canned corn, canned peas, canned tomatoes, tomato concentrates, catsup, canned mushrooms, tomato juice and frozen peas.
- Fish: canned oysters, canned Pacific salmon, canned wet pack shrimp and canned tuna.
- Cacao products: chocolate liquor, breakfast cocoa, and sweet, white and milk chocolate.
- Other foods: margarine; cane, maple, sorghum and table sirup; mayonnaise and salad dressing.
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.”
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:
- Ingredient list. Every substitute is declared by its common or usual name (21 CFR 101.4(a)(1); section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act). Ingredients take specific, not collective, names (21 CFR 101.4(b)), and the rule does not make “salt substitute” a collective name.
- Potassium chloride is declared as “potassium chloride” or “potassium salt.” The second name comes from an FDA guidance of 18 December 2020 (85 FR 82332) announcing enforcement discretion for “potassium salt”; the 2019 draft had proposed “potassium chloride salt.”
- Nutrition Facts. The rule states that a food containing two or more percent of the recommended daily intake for potassium per serving must declare its potassium content (21 CFR 101.9(c)(8)(ii) and (iii)). The reference daily intake for potassium is 4,700 mg for adults and children aged 4 and over (21 CFR 101.9(c)(8)(iv)).
- Monosodium glutamate used as a substitute must be declared as “monosodium glutamate” (21 CFR 101.22(h)(5)); a substitute that is or contains a major food allergen must be declared under section 403(w).
- “Low sodium” claims must still meet the claim’s limit (21 CFR 101.61(b)(4)): 140 mg of sodium or less per reference amount customarily consumed, with separate criteria for meals and main dishes.
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.”
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.
- It said it “recognize[s] the need for certain individuals to monitor potassium intake” and pointed to the Nutrition Facts label and ingredient list, as for non-standardized foods “permitted to contain potassium chloride for decades.”
- It declined to require a hyperkalemia warning, for three stated reasons: potassium facts are already required on the label, and people who limit potassium “are already on notice to monitor the potassium content of foods they consume”; so many foods contain potassium that a requirement “could result in a large quantity of products in the food supply bearing a warning statement, which would undermine the utility of such a statement”; and widespread warnings “could also deter people who need to consume more potassium from consuming potassium-containing foods.”
- It declined to publish a list of foods likely to be reformulated with potassium, as one “would be too speculative to be useful.”
- It “cannot determine the extent to which the final rule may affect the amount of potassium in the food supply,” expects potassium chloride use to be “self-limiting because of its inherent bitter and metallic taste characteristics,” and plans “to monitor relevant data and scientific publications for changes in U.S. consumption patterns in potassium intake.”
- It stated that standards of identity “do not address dietary restrictions related to individuals’ specific disease conditions or their use of certain medications.”
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.
- The trials excluded the people at risk. WHO reports that all 26 trials in its review “specifically excluded participants in whom an increased intake of potassium could cause harm – for example, people with kidney disease, impaired renal function or those using potassium-sparing medications or potassium supplements.” The registry record of the largest, SSaSS, excluded people if they or a family member used a potassium-sparing diuretic or a potassium supplement or had serious renal impairment.
- The guideline leaves them out. WHO’s recommendation excludes “individuals with kidney impairments or with other circumstances or conditions that might compromise potassium excretion,” and it calls the trials’ hyperkalaemia data unreliable: “Very few studies reported on hyperkalaemia and studies that did report on hyperkalaemia also used variable, in some cases unclear, criteria to define the condition.” The Cochrane review behind it says the lack of evidence in such people limits “conclusions on the safety of LSSS [low-sodium salt substitutes] in the general population.”
- Blood potassium rises slightly. On average it rose by 0.12 mmol/L (95% CI 0.07 to 0.18), with little to no difference in hyperkalaemia (moderate certainty). In the DECIDE-Salt care-home trial, biochemical hyperkalemia was more frequent with the substitute but, the authors report, not associated with adverse clinical outcomes.
- A review names the risk. A 2020 review in Hypertension lists “a possible increased risk of hyperkalemia and its principal adverse consequences: arrhythmias and sudden cardiac death, especially in people with conditions that impair potassium excretion such as chronic kidney disease,” with “insufficient evidence regarding the effects of potassium-enriched salt substitutes on the occurrence of hyperkalemia.”
- A model weighs the trade-off. For replacing table and cooking salt across China, a 2020 BMJ study estimated about 11,000 (6,422 to 16,562) additional hyperkalaemia-related deaths among people with chronic kidney disease, against a net of about 21,000 (1,928 to 42,926) fewer deaths in that group — projections for another country and another use of salt.
- Medicines. Two case reports describe severe hyperkalaemia in people taking ACE inhibitors for high blood pressure who also used a salt substitute; potassium returned to normal after the substitute was stopped.
See Hyperkalemia (High Potassium), Hyperkalemia and Heart Rhythm and Kidney Disease. Decisions about potassium intake in kidney disease belong with a clinician.
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:
- SSaSS (2021). 600 villages in rural China were randomized to a substitute of 75% sodium chloride and 25% potassium chloride or to regular salt; 20,995 people with prior stroke, or aged 60 or over with high blood pressure, were followed for a mean of 4.74 years. Stroke (rate ratio 0.86, 95% CI 0.77 to 0.96), major cardiovascular events (0.87, 0.80 to 0.94) and death (0.88, 0.82 to 0.95) were less frequent with the substitute; serious adverse events attributed to hyperkalemia did not differ significantly (rate ratio 1.04, 0.80 to 1.37).
- DECIDE-Salt (2023). In 48 Chinese care homes with 1,612 residents aged 55 or older, a substitute of 62.5% sodium chloride and 25% potassium chloride lowered systolic pressure by 7.1 mmHg (95% CI 3.8 to 10.5) over two years and reduced cardiovascular events (hazard ratio 0.60, 0.38 to 0.96), with no effect on total mortality (0.84, 0.63 to 1.13).
- A 2022 meta-analysis of 21 trials and 31,949 participants: systolic pressure 4.61 mmHg lower, total mortality risk ratio 0.89 (0.85 to 0.94), cardiovascular events 0.89 (0.85 to 0.94).
- The WHO guideline (27 January 2025), based on 26 trials in 34,961 adults, reports reductions of 4.76 mmHg systolic and 2.43 mmHg diastolic (moderate certainty) and makes a conditional recommendation: “If choosing to use table salt, WHO suggests replacing regular table salt with lower-sodium salt substitutes that contain potassium.” It rates overall certainty low.
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.”
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.
- Phase I. Final guidance of 14 October 2021 (86 FR 57156; Docket No. FDA-2014-D-0055) set voluntary 2.5-year goals “intended to support an average sodium intake reduction to 3,000 milligrams/day.” The FDA reports that 2022 data show about 40% of the Phase I targets reached or within 10%, against the 2010 baseline; its full progress report was still pending when the rule was announced.
- Phase II. Draft guidance issued 15 August 2024 (notice 89 FR 66727) proposes 3-year targets for 163 food categories that, if achieved, would bring average intake to about 2,750 mg a day; the FDA says the two phases together would cut average intake by about 20% from previous levels. Comments were extended to 13 January 2025 (89 FR 87589), and the rule still describes Phase II as a draft.
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).
8. The Rulemaking Record: Proposal, Comments and Changes
- 2019. At an FDA public meeting on “horizontal approaches” to modernizing food standards (27 September 2019; notice 84 FR 45497), some parties discussed allowing salt substitutes across standards at once.
- 10 April 2023. The FDA proposed the rule (88 FR 21148–21171), with comments due 8 August 2023. The proposal counted salt as a required or optional ingredient in 80 standards and, through cross-references, in 140; the final rule gives 139 without discussing the earlier figure. The proposal suggested an effective date 30 days after publication.
- Comments. The FDA received “more than 120 comments” (the regulations.gov docket lists 121) from consumers, consumer and public health groups, trade organizations, manufacturers, local government agencies and others.
- What changed. The definition now reads “combination of safe and suitable ingredients” instead of “combination of ingredients,” so every ingredient in a blend must be safe and suitable; the laboratory methods moved to the 2023 edition rather than the 2019 edition first proposed.
- What the FDA declined. A list of permitted substitutes with its own approval process; excluding substitutes “self-certified” as GRAS; adding “at present or in the future” to the definition; letting a substitute serve only “one or more” of salt’s functions; amending the oyster and breaded-shrimp standards; and the labelling and warning requests in sections 4 and 5.
- Out of scope. Unanswered comments included requests for enforcement discretion before the final rule, “and/or” ingredient labelling, the safety of specific ingredients, and sodium-reduction strategies such as taxation.
9. Legal Authority and the FDA’s Cost Analysis
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.
10. Dates: Effective Date and Dairy Objections
- Effective Monday 14 December 2026, “except as to any provisions in the SOI for dairy products that may be stayed by the filing of proper objections.”
- Dairy objections by Thursday 12 November 2026. Anyone adversely affected by the dairy provisions (parts 131 and 133) may file objections or request a hearing: electronically through regulations.gov, Docket No. FDA-2022-N-2226, until 11:59 p.m. Eastern Time, or on paper received by that date at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. “Late, untimely filed objections will not be considered.”
- Form. Each objection must be separately numbered, specify the provision and grounds with particularity, and state whether a hearing is requested; a hearing request needs a detailed description and analysis of the factual information to be presented, or that right is waived. The FDA will publish notice of the objections received, or of their absence, in the Federal Register.
- No compliance date. The rule sets none; using a substitute is voluntary.
11. Primary Documents
- 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
- 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)
- Public docket FDA-2022-N-2226 (proposal, references, comments, final rule) — regulations.gov docket
- 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
- 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
- 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
- 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
- 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
- Salt Substitute and Stroke Study (SSaSS), registry record and eligibility criteria — ClinicalTrials.gov NCT02092090
Key Research Papers
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Connections
- FDA and Regulation
- News, 9 October 2026: Salt Substitutes in 139 Standard Foods
- Sodium
- Potassium
- Chloride
- Hyperkalemia (High Potassium)
- Hyperkalemia and Heart Rhythm
- Salt Excess and High Blood Pressure
- Potassium for Blood Pressure
- Hypertension
- Stroke
- Kidney Disease (including Chronic Kidney Disease)
- Heart Failure
- FDA Proposal for Front-of-Package Nutrition Labels (2025)
- FDA Proposal to Make GRAS Notices Mandatory (2026)