FDA clears salt substitutes in 80 standardised foods to cut sodium

The Food and Drug Administration has issued a final rule allowing manufacturers to use salt substitutes in foods governed by federal "standards of identity," a change the agency says is meant to make it easier to produce lower-sodium versions of staple products. The rule was published in the Federal Register on 13 October 2026 and takes effect on 14 December 2026 [s1].

Standards of identity are the recipes the government fixes for named foods, specifying which ingredients a product must or may contain to be sold under a particular name. Most of the standards that list salt — sodium chloride — as a required or optional ingredient did not previously permit substitutes, so manufacturers could not reduce sodium by swapping in another ingredient and still call the product by its standardised name [s1]. The final rule changes that across 80 standards at once [s1].

What the rule does

Rather than approve a list of specific substitutes, the FDA took what it calls a "horizontal approach": it amended its general food-standards regulation to create a new subpart C, "Flexibility in Standardized Foods," and added a definition of "salt substitute" that applies across every standard that permits salt [s1]. The agency says the single definition "allows ingredients or combinations of ingredients to be used as salt substitutes in standardized foods by manufacturers currently or in the future" [s1]. The change is permissive, not mandatory: a manufacturer may reformulate, or may leave a product unchanged.

The FDA framed the action around diet and chronic disease. According to the Dietary Guidelines for Americans, it notes, the general population aged 14 and above should consume less than 2,300 milligrams of sodium per day [s1]. "Reducing sodium consumption may help reduce the risk of hypertension, a major risk factor for heart disease and stroke," the agency wrote [s1]. The rule, it said, is intended to give manufacturers "flexibility to innovate and make more healthful, lower-sodium foods" [s1].

Limits built into the change

The rule does not loosen food-safety review. The FDA was explicit that permitting salt substitutes in a standard "does not provide either an authorization or an exemption from regulation as a food additive" [s1]. Any ingredient used as a substitute must still either be generally recognised as safe or be an approved food additive; a food containing an unapproved additive remains adulterated under the law [s1]. In other words, the rule opens a door in the recipe standards but leaves the separate safety gate in place.

Because reformulation is voluntary, the FDA concluded there are no regulatory costs to the rule itself [s1]. It nonetheless classified the action as "significant" under Executive Order 12866 — the threshold for which includes an annual effect on the economy of 100 million dollars or more — while noting that the voluntary nature of the change meant benefits and costs could not be quantified [s1].

How it was reached

The FDA first proposed the change on 10 April 2023 [s2]. It received more than 120 comments from consumers, consumer groups, trade organisations, manufacturers and health bodies before issuing the final version [s1]. The agency described the step as part of a broader effort to modernise ageing standards of identity so they do not "impede innovation, including the ability to produce healthier foods" [s1]. Alongside the salt-substitute provision, the rule updates technical references within the affected standards, including pointing to the 22nd edition of the "Official Methods of Analysis of AOAC INTERNATIONAL" [s1].

One procedural wrinkle remains open. Objections and requests for a hearing on the amendments to the dairy standards in parts 131 and 133 of the regulations may be filed through 12 November 2026, a window specific to those dairy provisions rather than the rule as a whole [s1].

What is settled and what is not

What is fixed are the dates and the mechanism: an effective date of 14 December 2026, 80 standards amended, and a single cross-cutting definition of "salt substitute" added to the food-standards regulation [s1]. The health rationale the agency cites — the link between sodium intake, hypertension and cardiovascular risk — is stated as the reason for the change, not as a projected outcome of it [s1].

What is not settled is how much sodium, if any, will actually come out of the food supply. The rule compels no reformulation, and the FDA itself declined to estimate the effect, saying the voluntary design makes any change in consumption impossible to quantify in advance [s1]. Whether the new flexibility translates into lower-sodium products will depend on decisions individual manufacturers make in the months after the rule takes effect.