This proposed rule, if finalized, would amend FDA standard of identity (SOI) regulations that specify salt (sodium chloride) as a required or optional ingredient to permit the use of salt substitutes in standardized foods, to reduce the sodium content.  Reducing sodium may help reduce the risk of hypertension, a leading cause of heart disease and stroke.  The proposed rule, if finalized, would help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods lower in sodium while maintaining the basic nature and essential characteristics of the foods.

This proposed rule would amend SOI that specify salt as a required or optional ingredient, to permit the use of salt substitutes.  The proposed rule would give manufacturers the flexibility to use salt substitutes in standardized foods, to reduce sodium content.  If finalized, the proposed rule would not result in regulatory costs for firms.  The proposal would not require manufacturers to replace salt with salt substitutes.  Instead, manufacturers would have the option of using salt substitutes to replace salt in standardized foods.  Should manufacturers choose to use this flexibility to reformulate some products by substituting some salt with salt substitutes, the primary benefits realized would result from lower sodium consumption by U.S. consumers who choose to purchase and consume the reformulated versions of such products, and increased profit (producer surplus) for manufacturers (or at least no decrease in profits). The primary cost of such voluntary market behavior would include reformulation and relabeling costs for the manufacturers.

Regulatory Impact Analysis

Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods (Proposed Rule). Preliminary Regulatory Impact Analysis (PDF - 181KB) 

Federal Register: 88 FR 21148 

Docket: FDA-2022-N-2226