• FDA’s definition of “dietary fiber” at 21 CFR 101.9(c)(6)(i) identifies seven soluble, isolated or synthetic non-digestible carbohydrates (NDCs) that have been determined by FDA to have physiological effects that are beneficial to human health and, thus, may be declared as dietary fiber on Nutrition and Supplement Facts labels.  In 2018, FDA issued guidance which, as discussed here, identifies eight additional NDCs that may be declared as dietary fiber under FDA’s enforcement discretion pending rulemaking to revise 21 CFR 101.9.  As of January 10, 2020, with the addition of “glucomannan,” as discussed here, FDA had recognized a total of ten isolated or synthetic NDCs that may be used subject to regulatory discretion in response to citizens petitions requesting addition of the substances to the definition of dietary fiber.
  • On December 17, 2021, FDA announced that it intends to propose that “Acacia (Gum Arabic)” also known as gum acacia, be included in the definition of dietary fiber at 21 CFR 101.9(c)(6)(i).  Based on available evidence, FDA determined that the scientific evidence suggests that gum acacia can help reduce blood glucose and insulin levels after it is eaten with a meal containing a carbohydrate that raises blood glucose levels.  With the addition of gum acacia, there are now 18 categories of isolated or synthetic NDCs which are either included in the definition of dietary fiber (i.e., beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, hydroxypropylmethylcellulose) or may be included in the dietary fiber declaration on the Nutrition and Supplement Facts labels under FDA’s continuing exercise of enforcement discretion until FDA completes rulemaking to add additional fibers to the regulatory definition of dietary fiber (i.e., mixed plant cell wall fibers, arabinoxylan, alginate, inulin and inulin-type fructans, high amylose starch (resistant starch 2), galactooligosaccharide, polydextrose, resistant maltodextrin/dextrin, cross linked phosphorylated RS4, glucomannan, acacia (gum arabic)).  FDA will continue to evaluate citizen petitions that could result in the recognition of additional substances as dietary fiber.
  • Keller and Heckman assisted in the submission of the citizen petition to expand the list of substances considered by FDA to fall within the definition of dietary fiber to include gum acacia.