The U.S. Food and Drug Administration (FDA) has issued a final rule permitting the use of salt substitutes in standardized foods governed by FDA standards of identity (SOIs) that specify salt as a required or optional ingredient. The rule applies to 139 SOIs and takes effect 60 days after it publishes in the Federal Register.
Until now, manufacturers of these foods had few options to lower sodium without leaving the standard. The rule gives you flexibility to reformulate while keeping the product within its SOI. It also gives food companies a clearer basis to respond to public health guidance on sodium.
What the Final Rule Changes
Standards of identity define what a food must contain to be sold under a particular name. Cheese, bread, and mayonnaise are among the foods they cover. Before this rule, none of the 139 affected SOIs allowed a salt substitute in place of sodium chloride.
Now, you may replace some or all of the added salt with a substitute that reduces sodium and performs salt’s functions in the food. The product must still keep its basic nature and essential characteristics, and the ingredient must meet existing food additive and GRAS requirements. The rule gives flexibility, not a mandate.
Alignment with Broader FDA Sodium Reduction Policy
The rule supports the FDA’s multi-phase Voluntary Sodium Reduction Goals, which encourage industry to gradually reduce sodium across the U.S. food supply. It also supports the Make America Healthy Again initiative. Excess sodium raises the risk of high blood pressure, a leading cause of heart disease and stroke.
The FDA plans to release a report on progress against the Phase I targets later this year. A preliminary assessment issued in 2024 showed encouraging signs.
Which Foods Are Affected
The 139 SOIs span dairy products, bread and baked goods, canned and frozen vegetables, tomato products, canned seafood, margarine, mayonnaise, and salad dressing, among others. Foods regulated by USDA, such as meat and poultry, are not part of this rule.
If you make a product covered by one of these SOIs and salt is part of the formula, you can now consider a substitute. Review the specific standard first, since each SOI has its own requirements.
What This Means for Your Business
You now have a regulatory pathway to reformulate a standardized food with a salt substitute. The rule adds no new labelling requirements, but existing ones still apply. A salt substitute must appear in the ingredient statement under its common or usual name, and potassium chloride must be declared as such. Potassium also appears on the Nutrition Facts panel when a serving contains 2% or more of the Daily Value.
Reformulation can also affect taste, texture, and shelf stability, so it helps to review your options early. At QSS, our team supports food manufacturers with U.S. food regulatory compliance, including SOI interpretation, reformulation review, and labelling strategy.
Frequently Asked Questions
Do I have to replace salt in my standardized food?
No. The rule grants permission, not a mandate. You can continue using salt as you currently formulate.
Does using a salt substitute qualify my product for a sodium claim?
Not automatically. The rule does not change what a nutrient content claim requires. A product labelled “low sodium,” for example, still has to meet the sodium requirements for that claim.
Can I call the ingredient “salt substitute” on my label?
No. “Salt substitute” is not an acceptable collective name. Each ingredient is declared in the ingredient statement by its common or usual name.
Talk With Our Team About Your Reformulation
Changes to a standard of identity can open new options for your products, and they also raise questions about formulation, labelling, and compliance. Our team can help you review the affected SOI, assess a salt substitute, and plan your label updates. If you are considering a sodium reduction project, contact us and we will walk through how this rule applies to your products.
