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The Food and Drug Administration (FDA) is proposing to amend its regulations to permit the use of salt substitutes in standardized foods in which salt (sodium chloride) is a required or optional ingredient.  The proposed rule, if finalized, would support industry efforts to reduce sodium content in standardized foods and improve dietary patterns by helping to reduce consumer sodium consumption.

Statement of Need:

FDA seeks to improve dietary patterns in the United States to help reduce the burden of diet-related chronic diseases and advance health equity. We are committed to accomplishing this by, in part, creating a healthier food supply for all. One way FDA is working towards this goal is by helping to reduce sodium across the food supply.

FDA is proposing to amend 80 standards of identity (SOI) that include salt as a required or optional ingredient to allow the use of salt substitutes. Salt substitutes are ingredients that can help to reduce sodium in the food supply. FDA is proposing to permit the use of salt substitutes to reduce the sodium content in standardized foods. Most SOI regulations that include salt as a required or optional ingredient do not allow the use of salt substitutes. Therefore, food manufacturers are currently precluded from using salt substitutes in the production of these standardized foods. The proposed rule does not identify specific salt substitutes, but rather, proposes a broad definition to provide flexibility and facilitate industry innovation.

The proposed rule would permit the use of salt substitutes across 80 SOI that require salt as an ingredient or provide for salt as an optional ingredient. In addition, the proposed rule would update the incorporation by reference (IBR) information of several SOI to refer to the most recent versions of the IBR materials and to provide up-to-date contact information for obtaining the IBR materials. The proposed rule would also make technical amendments to correct typographical errors in some SOI regulations.

Summary of the Legal Basis:

FDA is issuing this proposed rule under sections 201, 401, 402, 409, and 701 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 341, 342, 348, 371). These sections authorize FDA to issue regulations establishing a reasonable definition and standard of identity to promote honesty and fair dealing in the interest of consumers; define food additives, provide authorizations and exemptions from regulation as a food additive, and allow the agency to issue regulations for the efficient enforcement of the FD&C Act.

Alternatives:

The rule is a voluntary or permitting rule with no regulatory costs. Therefore, we did not consider alternatives designed to reduce the regulatory impact.

Anticipated Costs and Benefits:

Voluntary or permitting rules generate potential for social benefits that depend on voluntary behavior for their realization. Being voluntary, they do not generate regulatory costs. Net social costs are possible if the newly allowed voluntary behavior generates net social costs, in which case we should not have permitted that behavior. In this case, we can identify only a potential social benefit. However, the size of any actually occurring benefit is unknown. Because we cannot rule out economic significance, we set the primary estimated annualized benefits at the minimum that would make the rule economically significant, which is $165 M. That social benefit is calculated net of the cost of the voluntary activity that generates those benefits. We set the uncertainty range to give that figure as the mean, so it runs from $0 to $330 M.

Risks:

There are no known risks.