The US Food and Drug Administration proposed changes to the standards of identity (SOIs) for foods that include salt to permit the use of safe and suitable salt substitutes. The proposed rule would help support a healthier food supply by providing flexibility to facilitate industry innovation in the production of standardized foods to reduce sodium content, in the same manner that is already possible for non-standardized foods. This has the potential to contribute to better health outcomes by helping consumers to gradually reduce their sodium intake.

"Today's action is another step forward in our efforts to improve nutrition and reduce chronic disease by providing manufacturers another tool to lower the use of sodium in food production. This approach may help reduce Americans' sodium intake and lower their risk of hypertension, a leading cause of heart disease and stroke," said FDA commissioner Robert M. Califf, M.D. "Creating a healthier food supply, a key priority in the FDA's nutrition work, has the potential to improve Americans' health and reduce preventable diet-related diseases and deaths. Reducing sodium in the food supply may also advance health equity—unfortunately, hypertension and other diet-related diseases disproportionally impact underserved communities."

The proposed rule, "Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods," 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 Sept. 28, 2022. The announcement further supports the Administration's White House Challenge to End Hunger and Build Healthy Communities, a nationwide call-to-action to stakeholders across all of society to make bold commitments to advance the Strategy's goals. The Challenge builds on the success of the $8 billion package of private and public sector commitments that the Administration announced as part of the historic conference.

The proposed rule also complements the goals of the FDA's voluntary sodium reduction targets for processed, packaged and prepared foods. As part of the Administration's whole-of-government approach, the FDA has several initiatives to help accelerate efforts to empower consumers with information and create a healthier food supply, such as: developing an updated definition and a voluntary symbol for the "healthy" nutrient content claim, front-of-package labeling, and Dietary Guidance Statements on food labels, as well as establishing recommendations for nutrition labeling for online grocery shopping.

"Most people in the US consume too much sodium. The majority of sodium consumed comes from processed, packaged and prepared foods, not from salt people add to their food when cooking or eating," said Susan Mayne, Ph.D., director of the FDA's Center for Food Safety and Applied Nutrition. "This effort, combined with the FDA's voluntary sodium reduction targets, is part of the agency's overall nutrition strategy to create a healthier food supply, provide consumers with information to choose healthier foods and improve the health and wellness of our nation." 

SOIs typically describe what ingredients a certain food must contain and what ingredients are 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.

Most SOIs do not currently permit the use of salt substitutes. The proposed rule uses a "horizontal" approach to updating the SOIs. This means that the proposed rule would affect multiple SOIs and apply across various foods and categories of foods. Specifically, it 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 would be affected.

The proposed rule does not list permitted salt substitutes but defines them as safe and suitable ingredients (or a combination of ingredients) used to replace some or all of the salt in a standardized food. The extent to which salt can be replaced depends on the ability of salt substitutes to replace the functions of salt in food without compromising the food safety or other essential characteristics of the food. Salt substitutes are subject to the same labeling requirements as other ingredients and are currently used in non-standardized foods in the US

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. The FDA will be accepting comments to the proposed rule 120 days after publication in the Federal Register.