Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                CFSAN Constituent Updates

CFSAN Constituent Updates Home
          Food
          News & Events from CFSAN
          CFSAN Constituent Updates
          FDA To Propose to Permit Salt Substitutes to Reduce Sodium in Standardized FoodsCFSAN Constituent Updates FDA To Propose to Permit Salt Substitutes to Reduce Sodium in Standardized Foods
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintWhat's New

April 7, 2023

The proposed rule to amend the standards of identity (SOIs) to permit the use of salt substitutes in foods for which salt is a required or optional ingredient is on display today in the *Federal Register* and will publish on April 10, 2023. The comment due date is August 8, 2023. Electronic comments can be sent to Regulations.gov. Submit written comments to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.


Original Constituent Update

March 24, 2023

The U.S. Food and Drug Administration (FDA) will soon propose to amend the standards of identity (SOIs) to permit the use of salt substitutes in foods for which salt is a required or optional ingredient. The proposed rule would provide manufacturers with flexibility and facilitate industry innovation to reduce sodium in standardized foods. The FDA is making available the pre-publication text of the *Federal Register*notice.

The upcoming proposed rule is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health. The National Strategy provides a roadmap of actions the federal government will take to end hunger and reduce diet-related diseases by 2030 – all while reducing disparities. The National Strategy was released in conjunction with the first White House Conference on Hunger, Nutrition, and Health in over 50 years, hosted by President Biden on September 28, 2022. The upcoming proposed rule also complements the goals of the FDA’s voluntary sodium reduction targets for processed, packaged and prepared foods.

SOIs typically describe what ingredients a food must contain and what is optional.  They may describe the amount or proportion of ingredients or components.  Some SOIs also prescribe a method of production or formulation. There are more than 250 SOIs, and they include products like milk, milk chocolate, various breads, various cheeses and ketchup.  Foods with SOIs are often referred to as standardized foods.

Salt substitutes are currently used in many non-standardized foods in the U.S., but most FDA SOIs do not permit the use of salt substitutes. The proposed rule would use a “horizontal” approach for SOIs, under which a single rule would apply to multiple SOIs across several categories of standardized foods. Specifically, the proposed rule would amend the 80 SOIs that specify salt as a required or an optional ingredient.  Because these 80 SOIs are referenced in other SOIs, 140 of the 250 SOIs currently established for a wide variety of foods could be affected. The proposed rule does not list permitted salt substitutes but defines them as safe and suitable ingredients used to replace some or all of the added sodium chloride and that serve the functions of salt in food.  The extent to which salt can be replaced depends on the ability of a salt substitute to replace the functions of salt in food without compromising food safety and the characteristics of the food.

The FDA is requesting comments on potential salt substitutes that may be used as a result of the new flexibility provided in this proposed rule.

Most people in the U.S. consume too much sodium. Reducing sodium may help reduce the risk of high blood pressure, a leading cause of heart disease and stroke. The majority of sodium comes from processed, packaged and prepared foods, not from table salt added to food when cooking or eating.  In October 2021, the FDA issued guidance for industry that finalized short-term voluntary sodium reduction targets in over 160 categories of packaged and restaurant prepared food. If finalized, the proposed rule issued today may help manufacturers to meet these voluntary targets because a number of foods for which targets were established are covered by SOIs.

Comments can be submitted until 120 days after the date of publication in the *Federal Register*. Electronic comments can be sent to Regulations.gov. Submit written comments to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Additional Information

Proposed Rule: Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods
	Standards of Identity for Food
	Press Release: FDA Takes Additional Steps to Improve Nutrition, Reduce Disease with Expanded Use of Salt Substitutes to Help Lower Sodium Intake

                                                                                  Content current as of:
      04/07/2023
              
              
Regulated Product(s)
		 Food & BeveragesCFSAN Constituent Updates
 Subscribe to CFSAN Constituent Updates
                        Get email updates delivered to your inbox.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop