FDA Issues Draft Guidance on New Voluntary Targets for Sodium Reduction in Foods

FDA Issues Draft Guidance on New Voluntary Targets for Sodium Reduction in Foods

August 21, 2024, Covington Alert

On August 15, 2024, the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) took another important step in its sodium reduction efforts by issuing a Draft Guidance that contains new voluntary targets for sodium reduction in foods. The Draft Guidance builds on FDA’s October 2021 Final Guidance on Voluntary Sodium Reduction Goals, which established short-term voluntary targets for reducing sodium in commercially processed, packaged and prepared food. The Draft Guidance proposes new three-year sodium reduction targets for 16 overarching food categories and 163 subcategories that are commercially processed and packaged, or prepared in food service establishments such as restaurants. 

Background

Average sodium intake in the United States is currently almost 50% more than the recommended limit.^[1]  To help reduce sodium across the food supply, FDA has taken an iterative, step-wise approach that includes establishing voluntary sodium targets for industry, monitoring and evaluating progress, and engaging with stakeholders.

FDA’s sodium reduction efforts began in 2016, when it released draft guidance on the agency’s short-term and long-term goals for sodium reduction in a variety of commercially processed, packaged, or prepared foods. FDA issued final guidance on this topic in October 2021 (Final Guidance), in which it set a goal of reducing average sodium intake from over 3,400 mg/day to 3,000 mg/day. As of 2022, about 40% of the targets set for foods in the Final Guidance had been reached.^[2]  FDA has deemed the Final Guidance “Phase I” of its sodium reduction efforts.

The Draft Guidance marks the beginning of “Phase II” of FDA’s sodium reduction efforts. The Draft Guidance proposes to reduce average sodium intake from 3,000 mg/day to 2,750 mg/day. This target aligns with the Healthy People 2030 goal of reducing average sodium intake to approximately 2,750 mg/day in the United States by 2030,^[3] although it remains above the 2,300 mg/day sodium limit scientific consensus groups and the Dietary Guidelines for Americans recommend to reduce the risk of hypertension and cardiovascular disease.^[4] FDA believes that its Phase II targets will “balance the need for broad and gradual reductions in sodium with what is publicly known about technical and market constraints on sodium reduction and reformulation.”^[5] Overall, the Phase I and Phase II targets would support reducing average sodium intake in the United States by about 20% from pre-2021 levels. 

Key Elements of Draft Guidance

The Draft Guidance establishes revised, quantitative target concentrations and upper bound concentrations for sodium levels in various identified food categories. The proposed sodium targets apply to 16 overarching food categories and 163 subcategories—including packaged food, processed food, and food served at restaurants. FDA intends for the revised quantitative target concentrations and upper bound concentrations for sodium levels to accomplish five goals:

• Support increased food choice for consumers by encouraging food reformulation and new product development; 
• Support the Dietary Guidelines recommendation of limiting sodium intake to 2,300 mg/day by encouraging sodium reduction over the medium term to achieve an average intake of 2,750 mg/day;
• Provide uniform metrics for voluntary sodium reduction for industry stakeholders;
• Focus on the total amount of sodium in a given food as opposed to individual sodium-containing ingredients; and
• Support and extend industry’s voluntary efforts to reduce sodium across the range of commercially processed, packaged, and prepared foods.^[6]

Appendix Table 1 of the Draft Guidance summarizes the results of FDA’s analysis of the sodium content of the food supply as of 2022. It also identifies the entire list of food categories and voluntary targets comprising Phase II of FDA’s sodium reduction efforts. This table includes four key elements: food categories, 2022 baseline sodium concentrations, Phase II (3-year) target mean sodium concentrations, and Phase II (3-year) upper bound sodium concentrations. 

• Food Categories: Phase II contains the same overarching food categories as Phase I. These categories, which are compatible with existing industry and regulatory categories, include “dairy;” “fats, oils, and dressings;” “fruits, vegetables, and legumes;” “cereals;” “bakery products;” and “snacks,” among others. FDA organized these food categories on the basis of contribution to sodium intake, the amount of sodium added to the food, similar functional roles for sodium-containing ingredients, similar technical potential for reduction in sodium content, and compatibility with existing industry and regulatory categories.
• Baseline Sodium Concentrations: FDA developed its baseline sodium concentrations using (1) label data for packaged foods sold directly to the consumer and menu nutrition data for foods sold in large restaurant chains, and (2) sales volume data for such foods and the total sales of each chain for restaurant food, to ensure that products consumers purchase more frequently count for more in the final average. Each baseline represents FDA’s assessment of the approximate state-of-the-market regarding sodium concentrations in each food category in 2022.
• Target Mean Sodium Concentrations: FDA has proposed target mean sodium concentrations, in milligrams per 100 grams of food, per food category. In setting these target concentrations, FDA has taken into account concentrations necessary to achieve important food safety functions and functionality roles.
• Upper Bound Sodium Concentrations: The upper bound sodium concentrations, in milligrams per 100 grams of food, are goals for the highest level of sodium for products in each food category. The upper bound for each food category is influenced by the corresponding target mean concentration and the current distribution of sodium concentrations for products in that food category. The Draft Guidance notes that, when establishing these concentrations, FDA placed an emphasis on maintaining concentrations needed for food safety (e.g., concentrations necessary to allow for the continued use of salt as a food preservative).

The Draft Guidance does not provide in depth recommendations on the technical details of reducing sodium, indicating that the agency will instead continue to rely on industry experts to reformulate products. FDA notes, however, that product reformulations should not negatively affect the nutritional quality of the foods by modifying other nutrient levels, and that reformulations should take into account all Dietary Guidelines recommendations and FDA policies.^[7]

Looking Ahead

Interested parties should submit comments on the Draft Guidance by November 14, 2024.