View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AI72 Publication ID: Fall 2022 
Title: Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods 

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.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 130    21 CFR 131    21 CFR 133    21 CFR 136    21 CFR 155    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 336    21 U.S.C. 346    21 U.S.C. 343    21 U.S.C. 348    21 U.S.C. 371    21 U.S.C. 379e   
Legal Deadline:  None

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.


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.


There are no known risks.

Action Date FR Cite
NPRM  03/00/2023 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Jeanmaire Hryshko
Lead Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition, 5001 Campus Drive, HFS-265,
College Park, MD 20740
Phone:240 402-2371