FDA proposes rule change to improve nutrition

The US Food and Drug Administration (FDA) has 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 provide flexibility to facilitate industry innovation in the production of standardised foods to reduce sodium content in the same manner that is already possible for non-standardised foods.

FDA Commissioner Robert M Califf said the proposed rule is a step forward in the FDA’s efforts to improve nutrition and reduce chronic disease. Reduced sodium intake could lower the risk of hypertension, a leading cause of heart disease and stroke. This may overall lead to the creation of a healthier food supply, a key priority in the FDA’s nutrition work.

The proposed rule, ‘Use of Salt Substitutes to Reduce the Sodium Content in Standardised Foods’, is part of the National Strategy on Hunger, Nutrition, and Health. Released in conjunction with the first White House Conference on Hunger, Nutrition, and Health on 28 September 2022, the strategy provides a roadmap of actions the US Government will take to end hunger and reduce diet-related diseases by 2030, while reducing disparities. The proposed rule change calls on stakeholders to make commitments to advance the strategy’s goals while building on the success of the $8 billion package of private and public sector commitments announced at the conference.

The proposed rule change also supports the goals of the FDA’s voluntary sodium reduction targets for processed, packaged and prepared foods. The FDA has several initiatives to help accelerate efforts to create an overall healthier food supply, such as developing an updated definition and a voluntary symbol for the ‘healthy’ nutrient content claim, front-of-package labelling, and Dietary Guidance Statements on food labels, as well as establishing recommendations for nutrition labelling for online grocery shopping.

Susan Mayne, Director of the FDA’s Centre for Food Safety and Applied Nutrition (CFSAN), said most people in the US consume too much sodium which comes from processed, packaged and prepared foods.

SOIs typically describe which ingredients certain foods must contain and which ingredients are optional. Some SOIs also prescribe production and formulation methods. There are over 250 SOIs, including products like milk, milk chocolate, breads, cheeses and ketchup. Foods with SOIs are often referred to as standardised foods.

Most SOIs do not currently permit the use of salt substitutes. The proposed rule uses a ‘horizontal’ approach, affecting most SOIs across various foods and categories of foods. It would amend the 80 SOIs that specify salt as a required or 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 defines salt substitutes as safe and suitable, but does not list permitted substitutes. 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 labelling requirements as other ingredients and are currently used in non-standardised foods.

In October 2021, the FDA issued guidance for industry that finalised short-term voluntary sodium reduction targets in over 160 categories of food. The proposed rule change, if finalised, may help manufacturers reach those targets. The FDA will be accepting comments to the proposed rule 120 days after publication in the Federal Register.

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