The FDA Opened 139 Food Standards to Salt Substitutes. The Stroke Trial Behind the Idea Tested Home Cooking Salt.

High sodium intake increases the chance of hypertension, a leading contributor to heart disease and stroke. The Food and Drug Administration says more than 70 percent of the sodium Americans eat is added during manufacturing or commercial food preparation. On October 9, 2026, the agency issued a final rule on salt substitutes. It lets manufacturers replace some or all of the added salt in 139 federal food standards, among them bread, macaroni, canned applesauce and canned figs.

What the rule changes

A standard of identity is the FDA's recipe for a food sold under a familiar name. Before this rule, most standards that listed salt did not permit substitutes. A maker who wanted less sodium had to cut it by the amounts set for nutrient content claims, which the agency says may be impracticable. The final rule amends 80 standards directly. Another 59 are covered because they cross-reference the amended ones.

The rule names no approved substitute. It defines one broadly as a safe and suitable ingredient that replaces added salt and serves the functions of salt in the food. Potassium chloride is the best-known candidate, and Bloomberg Law reported that the change reaches foods including bread, canned peas and sour cream. The FDA first proposed it on April 10, 2023.

Nothing in it requires a recipe to change

The rule is voluntary. The FDA wrote that it received no information on how many foods will be reformulated or which ingredients will be used. Its economic analysis says the voluntary design means changes in production costs and consumer satisfaction cannot be quantified. Whatever happens to American sodium intake depends on decisions companies have not announced.

What the stroke evidence actually tested

The strongest evidence for potassium-enriched salt is the Salt Substitute and Stroke Study. It was presented in August 2021 and published in the New England Journal of Medicine. It enrolled 20,995 people from 600 villages in rural China, each with a history of stroke or aged 60 or older with high blood pressure. Participants used either regular salt or a substitute of about 75 percent sodium chloride and 25 percent potassium chloride.

Follow-up averaged 4.74 years. Stroke occurred at 29.14 events per 1,000 person-years in the substitute group and 33.65 in the regular salt group. Deaths ran 39.28 against 44.61. Serious adverse events attributed to hyperkalemia, meaning too much potassium in the blood, were nearly identical: 3.35 with the substitute and 3.30 with salt.

Those figures come from a single trial. It was open label, so participants knew which salt they were using. It excluded people with known kidney disease and people taking potassium supplements or potassium-sparing diuretics.

“This study provides strong evidence to take to the food industry.”

Neal, who presented the trial, said the results should apply in higher-income countries. He added that governments and food manufacturers would have to carry them out, because most salt there comes from processed food. Julie Ingelfinger, a Harvard Medical School pediatrics professor and deputy editor of the journal, raised two limits. The trial did not run serial potassium blood tests, so episodes of high potassium could have gone undetected. And the villagers added salt during household cooking, unlike typical Western diets, where commercial preservation adds much of it.

Where the rule and the trial part ways

The trial gave a substitute for home cooking, seasoning and food preservation to people at higher cardiovascular risk. The rule opens packaged staples to anyone who buys them. Commenters on the proposal pressed on that gap. Some said potassium-based ingredients could harm people with chronic kidney disease or heart failure, or people on certain medications. They added that many people with kidney disease may not know they have it. Others said the evidence does not show these ingredients cause hyperkalemia. Some said more research is needed.

The FDA's answer rests on labeling. A standardized food made with potassium chloride must list it in the ingredient statement as potassium chloride or potassium salt. Potassium appears on the Nutrition Facts label when a serving supplies 2 percent or more of the recommended daily intake. The agency also expects potassium chloride use to limit itself because of its bitter, metallic taste. It said it cannot determine how much the rule will change the amount of potassium in the food supply.

Dates to watch

Objections and hearing requests on the amended dairy standards are due November 12, 2026, and the rule takes effect December 14. The FDA says it will issue a report later this year on progress against its Phase I voluntary sodium targets. A 2024 preliminary assessment, in the agency's words, showed encouraging signs.