The FDA has issued a final rule to permit the use of salt substitutes in foods with standards of identity (SOI) that specify salt (sodium chloride) as a required or optional ingredient. Today’s final rule gives manufacturers of foods subject to a SOI regulation the flexibility to reduce sodium, enabling innovation and the production of healthier standardized foods.
SOIs were developed to help protect consumers and promote honesty and fair dealing. SOIs often describe in detail what a food must contain and what is optional and sometimes describe the amount or proportion of ingredients or components. Many SOIs also prescribe a method of production or formulation.
Before today’s final rule, 139 SOIs allowed or required the addition of salt, but did not permit the use of salt substitutes in these foods. This meant manufacturers had few options to lower the sodium content in these standardized foods.
Americans consume too much sodium. Excess sodium increases the risk of high blood pressure, a leading cause of heart disease and stroke. The final rule supports the Make America Healthy Again initiative and the FDA’s broader sodium reduction efforts, including the multi-phase Voluntary Sodium Reduction Goals which encourage industry to gradually reduce the sodium content of their products across the U.S. food supply. Later this year, the agency will issue a report evaluating progress against the Phase I targets; a preliminary assessment issued in 2024 showed encouraging signs of progress.
This final regulation showcases how the FDA provides manufacturers of standardized foods the flexibility to innovate to reduce sodium and make more healthful foods, which may help lower chronic disease rates.