FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium intake in Americans. Consistent with its intention to “continue the dialogue on sodium reduction,” FDA recently issued a proposed rule that would amend certain standards of identity (SOIs) to allow the use of salt substitutes in foods that list salt as a required or optional ingredient.
The goal of the proposed rule would be to help improve dietary patterns by reducing sodium consumption, which may help reduce the risk of hypertension, a leading cause of heart disease and stroke.
An SOI is a set of mandatory requirements established by FDA to define what a specific food product is, its name, and the ingredients that must or may be used in its production. SOIs specify both the required and optional ingredients in a food and sometimes describe the amount of each ingredient and the method of production or formulation.
There are more than 250 established SOIs for a variety of products including milk, chocolate, bread, cheese, and ketchup. Foods for which FDA has established an SOI are referred to as “standardized” foods.
Currently, most SOIs that include salt as an ingredient do not allow the use of salt substitutes. The proposed rule uses a “horizontal approach” for updating SOIs, meaning the proposed rule would affect multiple SOIs and apply across various categories of food. Salt is currently listed as a required or optional ingredient in 80 SOIs. Since some SOIs cross-reference others, the proposed rule would amend the 80 SOIs and potentially affect 140 of the 250 currently established SOIs.
Although the proposed rule does not list permitted salt substitutes, it defines them as a “safe and suitable ingredient (or combination of ingredients)” used to replace some or all of the salt in a standardized food. FDA notes that the extent to which the amount of salt can be replaced depends on the salt substitute’s ability to substitute for salt without compromising food safety or changing the essential characteristics of the standardized food.
Implications for Food Industry Stakeholders
As mentioned in FDA’s Voluntary Sodium Reduction guidance, and reiterated in the proposed rule, more than 70% of sodium intake in the United States comes from foods where sodium was added during the food manufacturing and commercial food preparation process. However, FDA recognizes that salt serves various important functions in foods and that the industry must balance sodium reduction efforts with manufacturing food products that maintain high nutritional standards and meet consumer preferences.
In an effort to balance FDA’s sodium reduction efforts and consumer preferences, the proposed rule defines salt substitutes broadly to “allow food manufacturers the flexibility to use salt substitutes and allow for innovation in producing healthier standardized foods” while not requiring manufacturers to replace salt with salt substitutes.
Though this proposed rule provides flexibility for food manufacturers to use salt substitutes, manufacturers should assess their current or future food manufacturing operations to consider offering lower-sodium food options to accommodate consumer preferences.
While there is no proposed implementation date for the rule, manufacturers should monitor the rule’s developments to ensure there is sufficient time for implementing their food labeling or manufacturing strategies if they choose to use salt substitutes in their foods. The proposed rule is open for public comments until August 8, 2023.