FDA published a request for scientific data, information and comments to help it determine whether certain fibers should be added to the definition of “dietary fiber” published as part of the Nutrition Facts label final rule. FDA’s final rule, published on May 27, 2016, required that only certain naturally occurring dietary fibers such as those found in fruits, vegetables and whole grains, and added isolated or synthetic fibers that FDA has determined have a physiological effect that is beneficial to human health, could be declared on the label under “Dietary Fiber.”
Previously, fibers in foods could be labeled as dietary fiber without necessarily providing physiological effects that are beneficial to human health. Naturally occurring fibers contained in foods have already been determined to have physiological benefits. In addition to fiber that is naturally occurring in foods, the rule identified seven fibers that, when added to foods, could be declared as “dietary fiber.”
The request for information, along with an accompanying draft guidance, will help the industry understand how FDA reviews the scientific evidence to determine whether other fibers beyond the seven identified in the rule should be added to the regulations. It also provides an opportunity to add to or comment on FDA’s review of the science with respect to whether any of 26 additional specific types of fiber provide a physiological effect that is beneficial to human health and thus should be included in the fiber definition.
The comment period for the Request for Information opens on November 23, 2016 and will be open for 45 days.
Resources:
- Federal Register Notice for the Request for Information
- Federal Register for the Draft Guidance
- Draft Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as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)
- Science Review of Isolated and Synthetic Non-Digestible Carbohydrates
- Questions & Answers
- Changes to the Nutrition Facts Label
