FDA Issues Draft Guidance for Voluntarily Reducing Sodium in Commercially Processed, Packaged, and Prepared Foods

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Sets short-term sodium intake targets to about 3,000 mg per day, long-term targets to 2,300 mg per day

On June 1, 2016, the U.S. Food and Drug Administration (FDA or the Agency) issued a Draft Guidance for Industry, "Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods" (Draft Guidance). The Draft Guidance provides voluntary sodium reduction targets for commercially processed, packaged, and prepared foods. FDA also issued as an appendix to the Draft Guidance a table of target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods, as well as a summary of the same.

The Draft Guidance applies to processed, multiple-ingredient foods that have been packaged for direct sale to consumers, for use in food establishments (including, but not limited to, restaurants), or for resale to other members of the food industry, as well as to foods that are prepared by establishments for direct consumption. In addition, the focus of the Draft Guidance is on foods to which sodium has been added, not those foods that contain only intrinsic sodium (e.g., milk).

The Agency sets forth voluntary draft short-term (i.e., 2 years) and long-term (i.e., 10 years) goals for sodium content in its Draft Guidance, which seek to decrease sodium intake to roughly 3,000 milligrams (mg) per day over the short term, and 2,300 mg per day over the long term. Given that the current average sodium intake in the U.S. is approximately 3,400 mg per day, FDA's long-term target calls for an almost 33 percent reduction in sodium intake.

The purpose of the sodium concentration goals set forth in the Draft Guidance are intended by FDA to:

  • Support increased food choice for consumers seeking to consume a diverse diet that is consistent with recommendations of the 2015-2020 Dietary Guidelines for Americans;
  • Support the 2015-2020 Dietary Guidelines and the Healthy People 2020 recommendations of less than 2,300 mg per day for many individuals;
  • Provide shared goals as metrics (mg/100 g) for voluntary reduction efforts by various industry stakeholders;
  • Support successful efforts already under way in the private sector to reduce sodium content;
  • Focus on total amount of sodium in a given food as opposed to any individual sodium-containing ingredient; and
  • Support and extend industry's voluntary efforts to reduce sodium across the range of commercially processed, packaged, and prepared foods.

The comment period on the Draft Guidance opens on June 2, 2016. Although comments may be submitted at any time, to ensure that FDA considers comments before it starts to finalize the guidance, industry should submit comments by August 31, 2016 on Issues 1 through 4 listed in section IV of the notice of availability of the Draft Guidance (notice), and by October 31, 2016 on Issues 5 through 8 listed in section IV of the notice.

If you have questions regarding the issues raised in this alert, or would like to submit comments to FDA regarding its Draft Guidance, please contact one of the authors.