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:
On 3rd May 2018 the U.S. Food and Drug Administration has issued a final rule to extend the compliance dates for updating Nutrition Facts and Supplement Facts labels, from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will receive an extra year to comply – until January 1, 2021. The agency published a proposed rule to extend the compliance date in September 2017, and this rule finalizes that extension.
After considering a range of stakeholder comments, the FDA recognizes the need for manufacturers to have additional time to make required changes. The approximately 18-month extension accomplishes this goal and will provide sufficient time to transition to the new version of the Nutrition Facts label.
The FDA is also committed to ensuring that all manufacturers have guidance to help implement the required label changes by the upcoming compliance dates. A full list of Nutrition Facts-related guidance documents is available on the FDA website.