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Federal Register Notice Now Available—Comment Period Extension for Draft Guidance to Industry for Voluntarily Reducing Sodium

Federal Register Notice Now Available—Comment Period Extension for Draft Guidance to Industry for Voluntarily Reducing Sodium

What's New

August 29, 2016

Federal Register Notice Now Available—Comment Period Extension for Draft Guidance to Industry for Voluntarily Reducing Sodium

The FDA is extending the two comment periods for the Draft Guidance to Industry for Voluntarily Reducing Sodium.

  • The comment period for issues primarily related to the draft short-term (2-year) sodium reduction targets will end on October 17, 2016.
  • The comment period for issues primarily related to the draft long-term (10-year) sodium reduction targets will end on December 2, 2016.

The comment period for the draft sodium guidance opened on June 2, 2016. That notice originally provided a 90-day comment period requesting comments on Issues 1 to 4 (or issues mainly related to the 2-year draft targets) by August 31, 2016 and a 150-day comment period for Issues 5 to 8 (mainly on the 10-year targets) by October 31, 2016.

The FDA received eight requests from industry trade associations to extend both comment periods to provide a total of 180 days for comment on the short- and long-term targets and three requests from consumer and public health organizations for the comment period regarding the short-term targets to remain unchanged.

For more information:

Federal Register Notice: Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry; Extension of Comment Periods

Original Constituent Update

June 1, 2016

The U.S. Food and Drug Administration (FDA) today issued draft guidance for public comment that provides voluntary sodium reduction targets for the food industry. The draft short-term (2-year) targets seek to decrease sodium intake to about 3,000 mg per day. The long-term (10-year) targets seek to reduce sodium intake to 2,300 milligrams per day. The targets, which cover nearly 150 food categories, are intended to complement many existing efforts by food manufacturers, restaurants and food service operations to reduce sodium in foods.

Americans consume almost 50 percent more sodium than what most experts recommend. One in three individuals has high blood pressure, which has been linked to diets high in sodium and is a major risk factor for heart disease and stroke. The majority of sodium intake comes from processed and prepared foods.

The comment period on this draft guidance opens June 2, 2016. Although comments are accepted at any time, to ensure that the agency considers comments on this draft guidance before it begins work on the final version of the guidance, submit comments within 90 days (by August 31, 2016) on Issues 1 through 4 listed in section IV of the notice announcing the availability of the draft guidance and within 150 days (by October 31, 2016) on Issues 5 through 8 listed in section IV of this notice. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2014-D-0055, as listed in the notice of availability that publishes in the Federal Register.

For More Information