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FDA announces draft guidance for industry on reduction of sodium

The FDA draft guidance provides target short- and long-term mean and upper bound sodium concentrations for food categories and is particularly aimed at national and regional restaurant chains and food manufacturers whose products make up a significant proportion of national sales.


The FDA released draft guidance last week on voluntary sodium reductions for the food industry.

Focusing on commercially processed, packaged, or prepared food, the draft guidance looks at both long-term and short-term targets (defined as 2-year and 10-year time frames, respectively) to help U.S. consumers reduce sodium intake gradually to 2,300 mg/d. Current average sodium intake in the U.S. is approximately 3,400 mg/d, the FDA said in a press release.

The FDA said its draft guidance is particularly aimed at national and regional restaurant chains and food manufacturers whose products make up a significant proportion of national sales in 1 or more food categories. In addition, the agency noted that its sodium goals are in line with those recommended by the 2015 Dietary Guidelines Advisory Committee, Healthy People 2020, and the Institute of Medicine.

The FDA draft guidance provides target short- and long-term mean and upper bound sodium concentrations for food categories including cheese; fats, oils, and dressings; fruits, vegetables, and legumes; nuts and seeds; soups; sauces, gravies, dips, condiments, and seasonings; cereals; bakery products; meat and poultry; fish and other seafood; snacks; sandwiches; and salads. The guidance, which includes detailed tables, was published online June 2 and is available for public comment.

Also on the topic of sodium, a study published last month in The Lancet looked at the association between urinary sodium excretion and cardiovascular events. The pooled analysis examined data on 113,118 patients, 63,559 with hypertension and 69,559 without, and found that increased sodium intake was associated with greater increases in systolic blood pressure in the former group versus the latter. In patients with hypertension, high sodium excretion (defined as 7 g/d or more) and low sodium excretion (defined as less than 3 g/d) were both associated with higher risk for death and major cardiovascular events than a sodium excretion of 4 to 5 g/d. In patients without hypertension, increased risk was associated with low sodium excretion but not high sodium excretion. The study authors speculated that the association between sodium intake and cardiovascular disease might be related to mechanisms other than blood pressure and called for additional studies in this area. “Our data suggest that although a persuasive case can be made to reduce sodium intake in individuals with hypertension and high sodium intake, it is unclear whether the remaining more than 90% of the population will benefit from dietary sodium reduction,” they wrote.

The author of an accompanying comment called the study results “provocative” and noted several possible criticisms of its methods, including study design and the method used to estimate urinary sodium excretion. However, he concluded that “it should come as no surprise that a low-salt-for-all policy would benefit some and disadvantage others.” He wrote that “rather than allowing contrary evidence to dispel the positive efforts that have been made to reduce the salt content of foods,” efforts should be directed toward creating policy that would benefit the majority without compromising the minority.