FDA Publishes Final Guidance on Voluntary Sodium Reduction Goals for Processed, Packaged, and Prepared Foods

On October 13, 2021, FDA issued final guidance on voluntary targets for reducing sodium in commercially processed, packaged and prepared food over the next 2.5 years. This builds on FDA’s earlier June 2016 draft guidance on this topic. The final guidance supports industry’s ongoing sodium reduction efforts, enumerates common targets to define and measure progress, and affords companies flexibility and time to meet these targets.

This client alert summarizes the key provisions of the Final Guidance that may warrant industry attention.

FDA Final Guidance

High levels of sodium consumption have long been of concern to the FDA. This final guidance aims to support industry efforts to reduce the average sodium intake. In particular, FDA proposes to reduce average sodium intake from over 3,400 mg/day to 3,000 mg/day.[1] FDA notes this target remains above the 2,300 mg/day sodium limit recommended by scientific consensus groups and the Dietary Guidelines for Americans[2] to reduce the risk of hypertension and heart disease. However, the agency believes that a gradual and voluntary approach to reducing sodium in the food supply will afford industry members more flexibility in supporting the public health goals of this guidance.[3] FDA hopes that market leaders in each category will participate to create a public health impact and minimize the impact of low-market share products that do not participate.

The proposed sodium targets, although voluntary, cover a significant portion of the food industry. The Guidance outlines sodium reduction targets for 16 overarching food categories, with individual sodium targets for 163 subcategories. These categories include a mix of packaged food, processed food, and food served at restaurants. The agency chose specific foods based on their contribution to sodium intake, the total amount of sodium added to the food, similar functional roles for sodium-containing ingredients, similar sodium concentrations, similar technical potential for reduction in sodium content, compatibility with existing industry and regulatory categories, and comments received to the draft guidance docket.[4]

Appendix Table 1 of the final guidance contains the entire list of food categories and voluntary targets. The table includes four key elements: food categories, baseline sodium concentrations, target mean sodium concentrations, and upper bound sodium concentrations.

• Food Categories. Examples of the overarching food categories include: “dairy,” “fats, oils, and dressings,” “fruits, vegetables and legumes,” “cereals,” “bakery products,” and “snacks,” among others.
• 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.
• Target mean concentrations. The target mean concentrations, in milligrams per 100 grams of food, are the goals for each sodium level per category.
• 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.

In sum, the guidance enumerates short-term goals that include both a target mean concentration and an upper bound concentration of sodium for various specified categories of food. FDA has set the target mean sodium concentration as the agency’s goal for each food category as a whole rather than for every product in that category.

Of note, FDA has based the target mean and upper bound sodium concentrations on the agency’s previously released 2009-2010 What We Eat in America (WWEIA) survey. With this data, the agency estimates that the mean population’s sodium intake could decrease to around 3,000 mg/day if the food industry were able to achieve the short-term goals presented in the guidance.[5] The target mean and upper bound limits for each category have remained similar between the final and draft versions. For example, for Pretzels, the target mean concentration moved from 1020 mg to 1040 mg per 100 g and the upper bound sodium concentration moved from 1460 mg to 1480 mg per 100 g from the draft to the final guidance.

FDA recognizes that any change in the food supply’s sodium content will take time and the goal’s extended timeframe is intended to balance the need for reductions in sodium, as well as technical and market constraints relating to sodium reduction and reformulation. FDA anticipates that these sodium goals will be achievable for all companies (and have already been achieved by some manufacturers), even for smaller businesses with fewer resources compared to larger companies.[6]

FDA does not provide detailed guidance on the technical details on how to reduce sodium. The agency is relying on experts from the food industry to innovate new food reformulations that maintain the same level of food safety. However, while the industry has discretion over how to reduce their product’s sodium levels, FDA cautions that any solution must be consistent with public health goals. For example, it would be inappropriate for manufacturers to use a sodium reduction strategy that relies on increases in added sugar.[7]

Long-Term Sodium Reduction Goals

Notably, FDA did not finalize the long-term (10-year) targets for sodium reduction as described in the June 2016 draft guidance. FDA plans to continue its dialogue with industry and evaluate progress in achieving the short-term goals before revisiting future targets. However, various health-advocacy groups have taken issue with FDA for not pressing ahead with long-term targets at this time. We foresee continued pressure from these stakeholders in advocating for FDA to finalize the long-term sodium reduction goals.

Looking Ahead

Sodium reduction has been a key public health issue across administrations. FDA hopes this final guidance will foment change to industry practices which, in turn, will lead to reduced consumer demand for added sodium products.[8] Many food companies are actively working to reduce their products’ sodium levels by offering a variety of foods to meet differing consumer tastes, and this final guidance will serve to facilitate heightened attention to sodium reduction across the food industry.[9]

Covington will closely monitor developments on this issue, particularly any final guidance on long-term sodium targets, and would be pleased to answer questions regarding the likely impact of FDA’s voluntary sodium reduction targets on industry interests.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.