March 27, 2019
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.
For Additional Information:
- MGP Ingredients Granting Letter
- Questions and Answers on Dietary Fiber
- Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30)