The US Food and Drug Administration (FDA) has finalized a rule that lets manufacturers replace some or all of the salt in 139 federally standardized foods with salt substitutes, a change the agency says is meant to help lower sodium across the food supply. The FDA announced the rule on October 9; it was published in the Federal Register on October 13 and takes effect December 14, 2026. Reformulation is voluntary.
Standards of identity are federal regulations that define what a food must contain to be sold under a given name, and many of them list salt as a required or optional ingredient without allowing anything in its place. According to the final rule, 80 standards are amended directly and a further 59 are covered through existing cross-references, for a total of 139. Trade publication FoodNavigator lists the affected categories as including many cheeses, bread and rolls, self-rising flour and cornmeal, macaroni and noodle products, canned vegetables, fruits and some canned fish, tomato products, chocolate and cocoa products, margarine, mayonnaise and certain syrups.
The rule does not name approved substitutes. Instead it adds a definition to the regulations: a salt substitute is “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.” Substitutes must not change what the rule calls the basic nature and essential characteristics of the food, must comply with existing food-additive and GRAS requirements, and may be used only at levels no higher than necessary. The agency wrote that defining the term broadly was intended to allow innovation without further rulemaking.
The FDA first proposed the change on April 10, 2023, and received more than 120 comments from consumers, trade groups, manufacturers, public health organizations and others, according to the rule. The agency cites the Dietary Guidelines for Americans, which advise people aged 14 and older to consume less than 2,300 milligrams of sodium a day, and says reducing sodium may help lower the risk of hypertension, a major risk factor for heart disease and stroke. In its announcement the agency said the rule supports the Make America Healthy Again initiative and its Voluntary Sodium Reduction Goals, and that it will publish a report later this year on progress against the first phase of those targets.
Why it matters
FoodNavigator reports that more than 70% of Americans’ sodium intake comes from foods where sodium is added during manufacturing or commercial preparation, and that the FDA’s voluntary goals aim to cut average intake by about 20%, with a proposed second-phase target of roughly 2,750 milligrams a day. For manufacturers of standardized foods, the rule removes a barrier that the FDA acknowledged had left them with few options for cutting sodium. Whether products actually change will depend on companies choosing to reformulate, since the rule sets no minimum sodium reduction and requires nothing of them.
The most contested question in the comments was potassium. The rule notes that potassium chloride is already permitted as a salt substitute in non-standardized foods, and the FDA says it expects its use to be self-limiting because of its bitter, metallic taste at higher levels. Several commenters warned that more potassium in staple foods could raise the risk of hyperkalemia, or excess potassium in the blood, for people with chronic kidney disease or heart failure and for those on certain medications, and some asked for a warning statement. The FDA declined, writing that ingredient lists must already declare “potassium chloride” or “potassium salt” and that potassium content is already required elsewhere on the label, so the information is available to consumers who need it. Commenters also raised concerns that kidney disease is more common in some minority and lower-income communities.
What to watch
Most of the amendments take effect on December 14, 2026. Changes to the dairy standards in parts 131 and 133, which cover milk products and cheeses, fall under a provision of the Food, Drug, and Cosmetic Act that allows formal objections and hearing requests; those are due by November 12, 2026, according to the Federal Register notice. The FDA’s draft second-phase sodium targets, published in August 2024 and covering 163 food categories according to FoodNavigator, remain to be finalized, and the agency’s promised progress report on the October 2021 first-phase goals is due before the end of the year. As the law firm Keller and Heckman notes, the rule names no specific ingredients, so any substitute must independently qualify as safe and suitable; the FDA writes that the same food-additive and GRAS requirements that apply to non-standardized foods apply here.
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