As we have previously blogged, last month FDA indicated that it would publish a proposed rule amending the standards of identity (SOIs) of foods in which salt (i.e., sodium chloride) is a mandatory or optional ingredient to allow for the use of salt substitutes. Yesterday, FDA published the proposed rule in the Federal Register with comments due by August 8, 2023 (120 days from publication).

The proposal allows for the use of salt substitutes in standardized foods and rather than specifically list salt substitutes, it defines “salt substitute” broadly to include any safe and suitable ingredient or combination of ingredients which is used to replace salt and which does not alter the essential characteristics of the food. This approach is intended to cover both ingredients that are currently used as salt substitutes (e.g., potassium chloride), as well as ingredients that in future will be used as salt substitutes (without the need for additional rulemaking). We note that the rule does not propose to amend the SOI for oysters in 21 CFR 161.130 since FDA’s understanding is that industry uses readily available seawater during the shucking process and does not add salt. FDA is requesting comment on its understanding of this process.

Currently, the only option for most manufacturers who would like to lower the salt content of standardized foods which reference salt is to make a nutrient content claim, but this requires a very significant reduction in salt content which is often difficult to achieve (e.g., a “reduced sodium” claim requires a 25% reduction). We note that there are a few SOIs for low sodium foods which already allow for the use salt substitutes (e.g., 21 CFR 133.116 (“low sodium cheddar cheese”)).

The proposed rule is part of FDA’s continuing efforts to improve nutrition and reduce intake of sodium, which increases risk of high blood pressure, a leading cause of heart disease and stroke. Americans consume an average of 3,400 mg of sodium per day, which is almost 50% more than the 2,300 mg/day recommendation adopted by the Dietary Guidelines for Americans, 2020-2025. 70% of this consumption comes from sodium added during manufacturing and commercial food preparation.