FDA Proposes Changes Encouraging Inclusion of Salt Substitutes to Combat Chronic Illness

In a historic move, the US Food and Drug Administration (FDA) has announced proposed changes to the standards of identity for foods that include salt.

The changes, which permit the use of safe and suitable salt substitutes, are aimed at supporting healthier food supply by providing further flexibility to promote production of standardized foods to reduce sodium content and comes less than 2 years after the landmark Salt Substitute and Stroke Study.¹

“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 Robert M. Califf, MD, commissioner of the FDA and cardiologist.^1,2 “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.”

Titled “Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods”, the proposed rule, which complements the goals of the FDA’s voluntary sodium reduction targets for processed, packaged, and prepared foods, is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health.¹ The proposed rule contains several notable changes to current regulations. The proposed rule would not list specific salt substitutes but would cover ingredients or combinations of ingredients used as salt substitutes by food manufacturers currently or in the future.

In their release, the FDA noted the rule would also introduce a voluntary symbol for “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.¹

In their release, the FDA pointed out most standards of identity (SOIs) do not currently permit use of salt substitutes. With the proposed rule implementing a horizontal approach to updating these SOIs, it would amend 80 preexisting SOIs specifying salt as a required or an optional ingredient and, 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.¹

Although not among the references cited in the proposed rule, many in the healthcare community point to the Salt Substitute and Stroke Study (SSaSS) as a major turning point in the recognition of the value of salt substitutes in reducing chronic illness. Hailed by the George Institute, which was the trial’s sponsor, as one of the largest dietary intervention studies ever conducted³, SSaSS not only provided insight into the effects of sodium reduction for reducing risk of mortality, but demonstrated feasibility of large-scale implementation of sodium reduction through salt substitutes.

A 20,995-person study with a mean duration of follow-up of 4.74 years, the trial enrolled a population of older adults in 600 villages in rural China and randomized them in a 1:1 to regular salt or a salt substitute with 25% potassium chloride. Among this study population, which had a high prevalence of histories of hypertension and stroke (88.4% and 72.6%, respectively), use of the salt substitute was associated with a 14% reduction in rate of stroke (Rate ratio [RR], 0.86 [95% confidence interval [CI], 0.77-0.96]; P=.006), a 13% reduction in rate of major adverse cardiovascular events (RR, 0.87 [95% CI, 0.80-0.94]; P <.001), and a 12% reduction in rate of death (HR, 0.88 [95% CI, 0.82-0.95]; P <.001).⁴

“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, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition.¹ “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.”

The FDA pointed out the agency would be accepting comments to the prosed rule 120 days after publication in the Federal Register.¹

References

1. Office of the Commissioner. FDA takes additional steps to improve nutrition, reduce disease with expanded use of salt substitutes to help lower sodium intake. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-steps-improve-nutrition-reduce-disease-expanded-use-salt-substitutes-help-lower. Published March 24, 2023. Accessed March 24, 2023.
2. Office of the Commissioner. Robert Califf. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/fda-organization/robert-califf. Accessed March 24, 2023.
3. China Salt Substitute and stroke study (ssass). The George Institute for Global Health. https://www.georgeinstitute.org/projects/china-salt-substitute-and-stroke-study-ssass. Accessed March 24, 2023.
4. Neal B, Wu Y, Feng X, et al. Effect of salt substitution on cardiovascular events and death. New England Journal of Medicine. 2021;385(12):1067-1077. doi:10.1056/nejmoa2105675