Review of the Scientific Evidence on the Physiological Effects of Certain Non-Digestible Carbohydrates Prepared by Office of Nutrition and Food Labeling Center for Food Safety and Applied Nutrition Food and Drug Administration U.S. Department of Health and Human Services June 2018 Table of Contents I. Introduction ............................................................................................................................................................... 4 II. Previously Identified Non-Digestible Carbohydrates that Meet the Dietary Fiber Definition ................................ 5 Cellulose ................................................................................................................................................................... 5 Guar Gum ................................................................................................................................................................. 6 Locust Bean Gum ..................................................................................................................................................... 6 Pectin ........................................................................................................................................................................ 6 Hydroxypropylmethylcellulose ................................................................................................................................ 6 Beta-Glucan .............................................................................................................................................................. 7 Psyllium Husk ........................................................................................................................................................... 7 References ................................................................................................................................................................. 7 III. Additional Isolated Non-Digestible Carbohydrates that Meet the Dietary Fiber Definition .................................. 8 Mixed Plant Cell Wall Fibers ................................................................................................................................... 8 References ............................................................................................................................................................. 9 Arabinoxylan .......................................................................................................................................................... 10 Background ......................................................................................................................................................... 10 Blood Glucose and Insulin Levels ...................................................................................................................... 10 Strength of the Scientific Evidence..................................................................................................................... 11 References ........................................................................................................................................................... 12 Alginate................................................................................................................................................................... 14 Background ......................................................................................................................................................... 14 Blood Glucose and Insulin Levels ...................................................................................................................... 14 Strength of the Scientific Evidence..................................................................................................................... 15 References ........................................................................................................................................................... 16 Inulin and Inulin-Type Fructans ............................................................................................................................. 18 Background ......................................................................................................................................................... 18 Calcium Absorption & Markers of Bone Health ................................................................................................ 18 Strength of the Scientific Evidence..................................................................................................................... 24 References ........................................................................................................................................................... 25 High Amylose Starch (Resistant Starch 2) ............................................................................................................. 28 Background ......................................................................................................................................................... 28 Blood Glucose and Insulin Levels ...................................................................................................................... 28 Strength of the Scientific Evidence..................................................................................................................... 33 References ........................................................................................................................................................... 34 2 IV. Additional Synthetic Non-Digestible Carbohydrates Subject to FDA’s Consideration of Enforcement Discretion if Declared as Dietary Fiber ........................................................................................................................................ 38 Galactooligosaccharides (GOS) .............................................................................................................................. 38 Background ......................................................................................................................................................... 38 Calcium Absorption ............................................................................................................................................ 38 Strength of the Scientific Evidence..................................................................................................................... 39 References ........................................................................................................................................................... 39 Polydextrose ........................................................................................................................................................... 41 Background ......................................................................................................................................................... 41 Energy Intake ...................................................................................................................................................... 41 Strength of the Scientific Evidence..................................................................................................................... 44 Caloric Value ...................................................................................................................................................... 44 Summary of the Scientific Evidence................................................................................................................... 46 References ........................................................................................................................................................... 46 Resistant Maltodextrin/Dextrin ............................................................................................................................... 49 Background ......................................................................................................................................................... 49 Calcium Absorption/Retention ........................................................................................................................... 49 Strength of the Scientific Evidence..................................................................................................................... 50 References ........................................................................................................................................................... 51 3 I. Introduction The Food and Drug Administration (FDA or we) is providing a summary of the scientific evidence that we identified for isolated or synthetic non-digestible carbohydrates that meet the definition of dietary fiber. We intend to propose this list of isolated or synthetic non-digestible carbohydrates be added to the dietary fiber definition, based on a review of the scientific evidence related to at least one physiological endpoint that is beneficial to human health. We previously identified two dietary fibers for which health claims may be made (beta-glucan soluble fiber and psyllium husk) (21 CFR 101.81). In the Federal Register of May 27, 2016 (81 FR 33742), we published a final rule amending our Nutrition Facts and Supplements Facts labels regulations (hereafter “the final rule”). The final rule, among other things,