On 27th March the U.S. Food and Drug Administration announced today that it intends to propose that “cross-linked phosphorylated RS4” – regardless of source – be added to the definition of dietary fiber. The action was taken in response to a citizen petition from MGP Ingredients Inc.
Dietary fiber that can be declared on the Nutrition and Supplement Facts labels includes certain naturally occurring fibers that are “intrinsic and intact” in plants and added isolated or synthetic non-digestible soluble and insoluble carbohydrates that FDA has determined have beneficial physiological effects to human health.
The FDA established a definition for dietary fiber in its Nutrition Facts label final rule, which was published in the Federal Register on May 27, 2016. Based on available evidence, FDA has determined that the scientific evidence suggests that cross-linked phosphorylated RS4 can help reduce insulin levels following a meal containing a carbohydrate that raises blood glucose levels.
Including this current notification, 16 categories of non-digestible carbohydrates (e.g. mixed plant cell wall fibers, a broad category) are either included in the definition of dietary fiber or are non-digestible carbohydrates that FDA intends to propose to be added to the definition of dietary fiber (see Questions and Answers on Dietary Fiber for a list). Seven of these fibers were identified in the Nutrition Facts label final rule as meeting the dietary fiber definition.
Until FDA completes rulemaking regarding adding additional fibers to the regulatory definition of dietary fiber, the agency intends to exercise enforcement discretion to allow manufacturers to include the amount of these additional fibers in the dietary fiber declaration on the Nutrition and Supplement Facts labels. Firms can submit citizen petitions requesting that additional fibers be added to the definition of dietary fiber. Those petitions will be reviewed on a rolling basis.
(Source: FDA website)
For Additional Information:
The FDA is extending the two comment periods for the Draft Guidance to Industry for Voluntarily Reducing Sodium.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
(Source: FDA website)