jueves, 18 de agosto de 2016

CFSAN Constituent Update - Draft Guidance for Industry on Sodium

Center for Food Safety and Applied Nutrition - Constituent Update

FDA Issues Draft Guidance for Industry for Voluntarily Reducing Sodium
August 18, 2016
The FDA is extending the two comment periods for the Draft Guidance to Industry for Voluntarily Reducing Sodium.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 with a Notice of Availability. 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. An updated Notice of Availability containing the extended comment periods will be published in the Federal Register as soon as possible.
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.
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The U.S. Food and Drug Administration (FDA) today issued draft guidance for public comment that provides voluntary sodium reduction targets for the food industry.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The comment period on this draft guidance opens June 2, 2016. Although comments are accepted at any time, to ensure that the agency considers comments on this draft guidance before it begins work on the final version of the guidance, submit comments within 90 days (by August 31, 2016) on Issues 1 through 4 listed in section IV of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 tohttp://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.
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