SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a draft guidance for industry entitled “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2).” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.

Sodium is widely present in the American diet (most commonly, but not exclusively, as a result of eating or drinking foods to which sodium chloride, commonly referred to as “salt,” has been added). More than 70 percent of total sodium intake is from sodium added during food manufacturing and commercial food preparation (Ref. 1). The average sodium intake for those 1 year and older in the United States is approximately 3,400 milligrams/day (mg/day) (Ref 2). The “Dietary Guidelines for Americans, 2020-2025” (Ref. 2) advises individuals 14 years and older to limit their consumption to 2,300 mg/day; this aligns with recommendations from the National Academies of Sciences, Engineering, and Medicine, which set the chronic disease risk reduction intake for sodium at 2,300 mg/day for those 14 years and older (Ref. 3). The guidance aims to help Americans reduce average sodium intake to 2,750 mg/day (Phase II) by encouraging food manufacturers, restaurants, and food service operations to gradually reduce sodium in a wide variety of food categories over time. Although we recognize that a reduction even to 2,750 mg/day still would be higher than the recommended sodium limit of 2,300 mg/day, the Phase II goals are 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.

In the Federal Register of October 14, 2021, we announced the availability of the final guidance for industry, “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods” (86 FR 57156). The ( print page 66729) draft guidance builds on the voluntary Phase I (2.5-year) sodium reduction goals issued in October 2021. When finalized, the draft guidance will describe our views on the next voluntary goals (Phase II (3-year)) for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or prepared. The 3-year goals are 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. The distribution of sodium concentrations in currently available products in each category was a significant factor in developing these quantitative sodium concentration goals. We developed the goals with a particular emphasis on maintaining concentrations needed for food safety, given the function of salt as a food preservative. The Phase II goals are within the range of concentrations found in currently marketed foods and are feasible using existing technical strategies.

We note that we do not intend to finalize the draft long-term (10-year) sodium reduction goals that were included in the 2016 draft of the first edition of the guidance that we announced in the Federal Register of June 2, 2016 (81 FR 35363). We plan to announce any future sodium reduction goals via draft guidance.

II. Paperwork Reduction Act of 1995

While the guidance contains no collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 101 have been approved under OMB control number 0910-0381. The collections of information in 21 CFR 101.11 have been approved under OMB control number 0910-0782.

III. Electronic Access

Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/​FoodGuidances, https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance.

IV. References

The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

1. Harnack L.J., M.E. Cogswell, J.M. Shikany, et al. “Sources of Sodium in U.S. Adults From 3 Geographic Regions.” Circulation, 135 (May 9, 2017): pp. 1775-1783. Available at: https://www.ahajournals.org/​doi/​10.1161/​CIRCULATIONAHA.116.024446 (accessed December 26, 2023).

2. U.S. Department of Agriculture and U.S. Department of Health and Human Services. “Dietary Guidelines for Americans, 2020-2025.” 9th Edition. December 2020. Available at: https://www.dietaryguidelines.gov/​ (accessed December 26, 2023).

3. National Academies of Sciences, Engineering, and Medicine. “Dietary Reference Intakes for Sodium and Potassium” (March 2019). Washington, DC: The National Academies Press. Available at: http://www.nationalacademies.org/​hmd/​Reports/​2019/​dietary-reference-intakes-sodium-potassium.aspx (accessed December 26, 2023).