US FDA salt substitute rule expands sodium reduction options for manufacturers

The US FDA has finalized a rule permitting salt substitutes in foods covered by 139 standards of identity, expanding manufacturers’ options to reduce sodium in standardized products. 

The rule was published in the Federal Register on October 13 and is scheduled to take effect on December 14, 2026. The affected categories include cheese, bread, canned vegetables, mayonnaise, and salad dressing.

Michael Dykes, president and CEO of the International Dairy Foods Association, welcomes the rule. 

“This update provides dairy manufacturers with additional flexibility to reduce sodium while maintaining product quality, safety, and consumer expectations,” he says. 

The FDA says the change gives manufacturers “the flexibility to reduce sodium, enabling innovation and the production of healthier standardized foods.” 

Standards of identity specify what a food must contain, which ingredients are optional, and, in some cases, how it must be made. Many standards had restricted the use of substitutes where salt was listed as a required or optional ingredient. 

The FDA also recently revised the standard of identity for pasteurized orange juice, giving manufacturers greater formulation flexibility. 

The rule directly amends 80 standards, with another 59 covered through existing cross-references. Salt substitutes can already be used in non-standardized foods. 

More formulation flexibility 

Manufacturers may replace some or all added sodium chloride with safe and suitable ingredients or ingredient combinations. The rule sets no minimum replacement level. 

The definition accommodates current and future salt substitutes rather than listing specific ingredients. Flavors, flavor enhancers, and mineral salts may qualify if they meet the criteria. Potassium chloride is one example, but the rule is not limited to potassium-based ingredients. The FDA notes that its bitter and metallic taste can constrain its use. 

Substitutes must serve the functions of the salt being replaced and preserve the food’s essential characteristics. Existing food additive and GRAS requirements continue to apply. 

Reformulation remains voluntary. Dairy provisions may be stayed following properly filed objections, which are due November 12. 

The Center for Science in the Public Interest welcomes the change and urges manufacturers to act. 

“It’s now up to the food industry to change product formulations and make our food supply healthier,” says Eva Greenthal, senior policy scientist at the nonprofit consumer advocacy organization. 

Supporting sodium reduction 

More than 70% of sodium consumed in the US comes from processed, packaged, and prepared foods, according to the FDA. Excess sodium can raise blood pressure, a major risk factor for heart disease and stroke. 

The agency supports gradual sodium reductions to allow time for reformulation and for consumer tastes to adjust. Salt also performs technical functions, including controlling microbial growth. 

The final rule supports the FDA’s broader sodium reduction efforts, including voluntary goals for commercially processed, packaged, and prepared foods. The agency also links the measure to the Make America Healthy Again initiative. 

In March 2023, the FDA proposed allowing safe and suitable salt substitutes in standardized foods to give manufacturers more flexibility to reduce sodium while preserving food safety and essential product characteristics. The proposal formed part of broader efforts to improve nutrition and food labeling. 

The FDA plans to issue a report later this year assessing progress against its Phase I sodium reduction targets. A preliminary assessment published in 2024 showed encouraging progress, according to the agency.