Background

The new sodium reduction targets, referred to as Phase II targets, are part of FDA’s ongoing efforts to address the public health issue of excess sodium consumption by encouraging industry to voluntarily undertake sodium reductions in foods. FDA states that the average sodium intake for Americans 1 year and older is approximately 3,400 mg/day.  The daily value for sodium established by FDA in 2016 is 2,300 mg/day. The 3,400 mg/day intake exceeds the daily value and is the same intake amount that FDA reported when it issued Phase I target guidance in 2021.  FDA did not address the impact, if any, of the Phase I guidance that became effective in April of this year on sodium intake but did provide a separate progress report evaluating sodium reductions across 16 food categories. The Phase I targets intended to reduce sodium intake to 3,000 mg/day and the Phase II targets aim to further reduce average sodium intake in the U.S. to 2,750 mg/day, which would represent a 19% reduction from 3,400 mg/day. FDA explains that, while a reduction to 2,750 mg/day is still higher than the recommended 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.” The new goals also align with the Healthy People 2030 goal of reducing average sodium intake to approximately 2,750 mg/day in the U.S. by 2030.²

Preliminary Assessment on Phase I Progress

The Phase II goals build on an initial set of short-term (2.5 year) targets issued by FDA in October 2021.³ These initial targets, referred to as Phase I, aimed to reduce average sodium intake from 3,400 to 3,000 mg/day (a 12% reduction), with a targeted completion date of April 2024.

Together with the draft guidance, FDA on August 15, 2024 issued a preliminary assessment showing the progress being made toward achieving the Phase I targets. According to the assessment, about 40% of food categories have already achieved or are within 10% of meeting the Phase I targets. This is based on data comparing 2010, the baseline year used for the Phase I targets, and 2022, the most recent year for which data were available.

Of note, the preliminary assessment shows that 100% of toddler and baby food categories, and 67% of both the dairy and cereals categories, saw sodium reductions. The assessment also shows that, as between the two broad categories – packaged food and restaurant food – the former had greater sodium reductions. More than 60% of packaged food categories decreased in sodium (compared to 35% for restaurant food), while 25% of packaged food categories increased in sodium (compared to 49% for restaurant food), though FDA does not identify which categories these are. Importantly, the report does not provide a further breakdown of the specific packaged food and restaurant food subcategories, though this information could be gathered by comparing the 2010 baseline data from the October 2021 guidance to the 2022 baseline.⁴

The Table, below, contains the agency data on the food categories evaluated and the percentage of products that had decreased, no change, or increased sodium levels.  Food product categories with a lower percentage of overall sodium reduction could receive increased scrutiny from food industry critics that may be incentivized to highlight categories or products that are not making significant sodium reductions under the voluntary program. 

FDA has yet to analyze data from 2023 or the first few months of 2024 (Phase I ended in April 2024), so the preliminary assessment does not fully capture progress against the Phase I targets. FDA intends to conduct a more formal evaluation of the Phase I targets when data from 2024 becomes available. Going forward, FDA also intends to conduct an assessment of progress on sodium reduction relative to the targets about every three years.

Summary of Phase II Targets

FDA has updated the baseline sodium concentrations in Table 1 and now is using 2022 information, as opposed to 2010 data.  FDA explains that these data are derived from publicly available food labels and menus, as opposed to analytical testing.  Based on this methodology, it is unclear the extent to which FDA’s figures reflect newly reformulated products that are still working their way into distribution. In the event that updated labeling information that reflects actual sodium reductions may not have been available to FDA, the agency’s figures may not fully reflect the industry reformulations that have occurred to date.

As seen in the Phase I final guidance, the Phase II draft guidance identifies target mean (average) and upper bound sodium concentrations for each of the target food categories.  As noted above, the Phase II targets would represent roughly a 19% reduction in sodium compared to current intake, as compared to the 12% reduction recommended in the Phase I targets.  FDA explains that the 3-year goals are intended to gradually reduce sodium across the foods supply, and that these goals were developed with a particular emphasis on maintaining concentrations needed for food safety, such as for food preservation. Further, FDA views the 3-year targets as feasible using existing technology because they are within the range of currently available products.

FDA is encouraging companies to compare their products’ sodium content to the Phase II targets when considering additional sodium reductions in products or menu items.

Table A, below, provides a few examples of the food categories, baseline levels, target mean concentrations, and upper bound concentrations found in Table 1 of the draft guidance. We have also included in Table A the 2.5-year sales weighted means and upper bound levels outlined in the 2021 Phase I final guidance.

Why it Matters and Next Steps

While the targets are voluntary, they may be a source of media attention and public scrutiny.   Additionally, consumer groups and the class action bar will likely use the draft guidance to put additional pressure on industry to work towards lowering sodium content in foods.

FDA stated that it does not intend to finalize the draft long-term (10 year) sodium reduction goals that were included in the 2016 draft guidance.⁵ The agency instead plans to announce any future sodium reduction goals via draft guidance.  This means that FDA will not go straight to a final long-term  (10-year) guidance, but instead will issue further draft guidance.

Comments on the draft guidance are due November 14, 2024. Please reach out to us with any questions or for assistance in developing comments.

Authored by Martin Hahn, Veronica Colas, and Rebecca Popkin.

References

1  Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Guidance for Industry (August 2024), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-voluntary-sodium-reduction-goals-edition-2.

2 See Healthy People 2030 objective, Reduce consumption of sodium by people aged 2 years and over — NWS‑12, https://health.gov/healthypeople/objectives-and-data/browse-objectives/nutrition-and-healthy-eating/reduce-consumption-sodium-people-aged-2-years-and-over-nws-12.

3 86 Fed. Reg. 57156 (Oct. 14, 2021).

4 Note that some subcategories were added or removed between 2010 and 2022 (because of available data), and only comparable subcategories were analyzed. For example, “six packaged food categories in 2022 do not have a 2010 counterpart and 15 restaurant food categories in 2022 did not have a 2010 counterpart.” See Sodium Reduction in the U.S. Food Supply 2010-2022: A Preliminary Assessment of Progress (August 2024), https://www.fda.gov/food/food-labeling-nutrition/sodium-reduction-us-food-supply-2010-2022-preliminary-assessment-progress.

5 81 Fed. Reg. 35363 (June 2, 2016).