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FDA Draft Guidance: Scaling Back Sodium

FDA issues draft guidance to encourage food industry to reduce sodium added to food.

  • According to FDA, average sodium intake in the U.S. is too high at approximately 3,400 mg/day.  Approximately 75% of total sodium intake comes from processed and commercially prepared foods.  For years, the Agency and the food industry have considered various approaches to encourage reduction of sodium intake to 2,300 mg/day, the level supported by leading experts and the overwhelming body of scientific literature.

  • On June 1, 2016, FDA issued a draft guidance document that provides voluntary sodium reduction targets for the food industry, specifically aimed at food manufacturers, restaurants, and food service operators.  To develop the guidelines, FDA began with baseline sodium concentrations for various identified food categories, with each baseline representing a tentative assessment of the approximate “state of the market” regarding sodium concentrations in each category in 2010.  Using these baselines, FDA developed quantitative target mean concentrations for the identified food categories, including both short-term (2-year) and long-term (10-year) goals.  Significantly, FDA does not:  recommend any specific methods and technologies for sodium reduction; prescribe how much of any individual sodium-containing ingredient should be used in a formulation; focus on foods that contain only naturally-occurring sodium; or address salt that individuals add to their food.

  • In the Federal Register notice announcing availability of the draft guidance, FDA poses a series of specific questions to stakeholders, specifically related to:

    • (1) Whether the Agency has appropriately grouped the food categories for the purpose of goal-setting, and whether any foods that contribute to sodium intake have not been effectively captured;

    • (2) Whether the baseline sodium concentration values used by the Agency are reasonably representative of the state of the food supply in 2010;

    • (3) Whether there are categories for which the 2-year target concentration goals are infeasible (and if so, why);

    • (4) Whether the short-term (2-year) timeframe for these goals is achievable (and if not, which timeframes would be possible);

    • (5) Whether there are categories for which the 10-year target concentration goals are infeasible (and if so, why);

    • (6) Whether the long-term (10-year) timeframe for these goals is achievable (and if not, which timeframes would be possible);

    • (7) Which specific research needs or technological advances could enhance the food industry’s ability to meet these goals; and

    • (8) What amendments to FDA’s standard of identity regulations are needed to facilitate sodium reduction by permitting alternative ingredients to be used in standardized foods.

  • FDA is accepting comments on the draft guidance in two waves, with comments on issues 1-4 (as numbered above) due by August 31, 2016, and comments on issues 5 through 8 (as numbered above due by October 31, 2016.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...