FDA Starts Next Phase of Sodium Reduction Efforts

Constituent Update

August 15, 2024

Today, the FDA took another important step in its sodium reduction efforts. The agency has issued new, voluntary targets for sodium reduction in foods in a draft guidance that serves as Phase II of the agency’s ongoing work. The new targets build on the final, voluntary sodium reduction goals issued in 2021, now referred to as Phase I, to further reduce diet-related diseases associated with consuming high levels of sodium.

The draft guidance, “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2)” contains three-year sodium reduction targets for 163 food categories that are commercially processed and packaged, or prepared in food service establishments such as restaurants. Industry has been working to meet the 2021, or Phase I, targets by April 2024. The Phase II targets would provide new goals for industry to work toward by three years after the guidance is finalized. The targets are intended to help address the excess intake of sodium in the U.S.—which is currently almost 50 percent more on average than the recommended limit.

Too much sodium in the diet can raise blood pressure—a major risk factor for heart disease and stroke—which disproportionately impacts racial and ethnic minority groups in this country. Strong scientific evidence supports lowering sodium intake from current levels. Reducing sodium intake has the potential to prevent hundreds of thousands of premature deaths and illnesses in the coming years.

The draft targets issued today focus on commercially processed, packaged and prepared foods in the marketplace, because more than 70 percent of sodium intake in the U.S. population is from sodium added during food manufacturing and commercial food preparation. The voluntary targets, when finalized, would support reducing sodium intake to about 2,750 milligrams/day (mg/day), approximately 20% lower than intake prior to the Phase 1 targets outlined in the FDA’s 2021 final guidance. While still higher than the recommended 2,300 mg/day for those 14 years and older, the new targets are part of an iterative approach that balances the public health objective with the practicality of shifting industry practices and consumer preferences to advance public health. Even modest improvements across the population could produce a large public health benefit.

Preliminary data from 2022 Sodium Reduction in the U.S. Food Supply 2010-2022: A Preliminary Assessment of Progress show that about 40% of food categories had already reached the targets set in the 2021 guidance, or were very close. This is based on data comparing 2010, the baseline year used for the Phase I targets, and 2022, the most recent date for which data were available. More data will become available later to assess the full time covered by the Phase I targets (through April 2024). Going forward, the FDA intends to conduct an assessment of progress on sodium reduction relative to the targets about every three years.

Comments on the draft guidance can be submitted electronically to http://www.regulations.gov. To ensure that the FDA has the opportunity to consider comments on this draft guidance before work on the final version of the guidance begins, comments should be submitted by November 14, 2024.

The FDA will host a webinar for interested parties to provide an overview of the voluntary sodium reduction goals draft guidance (Edition 2) and address questions. More information on the webinar will be released shortly.

The agency’s new draft voluntary sodium reduction guidance is part of the White House National Strategy on Hunger, Nutrition and Health to help reduce diet-related diseases by 2030 and aligns with the Healthy People 2030 goal of reducing average sodium intake to approximately 2,750 mg/day in the U.S.

U.S. Food and Drug Administration

FDA Starts Next Phase of Sodium Reduction Efforts

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