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YOUR SOURCE ON FOOD LITIGATION AND REGULATION

FDA issued a Voluntary Sodium Reduction guidance in October 2021, aimed to help Americans reduce average daily sodium intake over the next two and a half years. The guidance suggests voluntary sodium reduction targets for food manufacturers, restaurants, and food service operators for 163 categories of processed, packaged, and prepared foods.

Overall, the goal of the guidance is to support a gradual reduction of average sodium intake from around 3,400 mg/day to 3,000 mg/day, despite FDA's recognition that the recommended sodium limit is 2,300 mg/day. FDA specifically encourages attention by "food manufacturers whose products make up a significant proportion of national sales in one or more categories" to use the guidance for product reformulation to achieve voluntary sodium reduction.

FDA's Approach to Voluntary Sodium Reduction in the Food Supply

In a table format, FDA summarizes the results of its analysis of the sodium content of the food supply and identifies both the target mean (average) and upper bound sodium concentrations for various food categories, including cheeses, sauces, meat and poultry, frozen meals, and baby food. The table contains four key elements: (1) Foods and food categories; (2) Baseline sodium concentrations; (3) Target mean sodium concentrations; and (4) Upper bound sodium concentrations.

Food industry manufacturers may consider using the voluntary goals to inform their decision about the current content of sodium in their products. The baseline concentrations included in the table provide context and are FDA's assessment of the "state of the market" regarding sodium concentrations in each food category based on publicly available food labels and menus. The target mean concentration is set as FDA's goal for the food category as a whole, rather than for every product in that category. The upper bound concentration is FDA's goal for the highest level of sodium for an individual product in a particular food category.

Implications for Food Industry Stakeholders

In the guidance, FDA explicitly recognizes that more than 70% of Americans' sodium intake comes from foods where sodium was added during the food manufacturing and commercial food preparation process. The guidance notes average US sodium intake statistics and describes public health consequences, including the "the broad consensus among experts" regarding the relationship between blood pressure and cardiovascular diseases. FDA clearly states that the agency, in conjunction with other regulatory agencies, intends to monitor the prevalence of sodium in the food supply over time. Since FDA does not want sodium reductions to lead to product reformulations that negatively affect the nutritional quality of food, FDA plans to monitor other nutrients (e.g., added sugars and saturated fat) by reviewing product nutrition information and ingredient lists.

Given these clear indications in the guidance, food manufacturers can expect additional guidance surrounding sodium content in commercially processed foods. Though this guidance is voluntary and supports targeted reduction over the next two and a half years, manufacturers may want to assess their current or future food manufacturing operations, especially since FDA intends to "continue the dialogue on sodium reduction." Additionally, manufacturers should review their food labels and ensure that no nutrients potentially raise a red flag for FDA.

We will continue to monitor sodium-related developments and additional guidance from FDA. Should anyone have questions or need assistance with food labeling or manufacturing strategies to voluntarily follow the guidance, please feel free to contact us.