• On August 16, 2024, FDA issued Edition 2 of the Draft Guidance for Industry: Voluntary Sodium Reduction Goals covering target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods. The Guidance builds on Phase 1, which set initial targets to encourage the food industry to voluntarily reduce sodium levels in various processed, packaged, and prepared foods.
  • The Guidance is intended to provide voluntary goals to “reduce excess population sodium intake, while recognizing and supporting the important roles sodium plays in food technology and food safety.” More than 70% of total sodium intake is from sodium added during food manufacturing and commercial food preparation, with the average daily sodium intake at approximately 3,400 mg/day. The 2020-2025 Dietary Guidelines for Americans, however, advises individuals 14 and older to limit their consumption to 2,300 mg/day. The Guidance sets a goal to help reduce sodium intake to 2,750 mg/day, which, while higher than the Dietary Guidelines recommends, is “intended to balance the need for broad and gradual reductions in sodium and what is publicly known about technical and market constraints on sodium reduction and reformulation.”
  • Excess sodium consumption has been shown to be a contributing factor in the development of hypertension, which is a leading cause of heart disease and stroke. Decreasing population sodium intake is expected to reduce the rate of hypertension and lower blood pressure. Researchers estimate that broadly reducing sodium intake could prevent between 280,000 and 500,000 premature deaths over 10 years.
  • The Guidance sets voluntary goals for baseline, target mean, and upper bound sodium concentrations for several foods and food categories. The baseline is the “state of the market” for each category in 2022 based on information gathered from food labels and menus. The target mean concentration is the “desired average sodium concentration” and the voluntary upper bound is a standard that can be applied to every product in a category.
  • The initiative to reduce sodium is one of many nutrition initiatives FDA is working on to reduce diet-related chronic diseases, including an updated definition of “healthy” and a proposed rule for front-of-pack nutrition labeling.
  • Keller and Heckman will continue to monitor and provide updates on FDA’s sodium reduction goals and other nutrition initiatives.