• Today, June 15, 2018, FDA published in the Federal Register a notice that it has issued “Guidance for Industry: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels”.  This direct-to-final guidance provides additional clarity on which isolated and synthetic non-digestible carbohydrates (NDCs) will be recognized by FDA as fiber for nutrition labeling purposes.  In the May 27, 2016 final nutrition labeling rule, FDA identified seven NDCs that may be declared as dietary fiber.  They are:
  • [beta]-glucan soluble fiber (as described in 21 CFR § 101.81(c)(2)(ii)(A));
  • Psyllium husk (as described in 21 CFR § 101.81(c)(2)(ii)(B));
  • Cellulose;
  • Guar gum;
  • Pectin;
  • Locust bean gum; and
  • Hydroxypropylmethylcelluylose.
• Today’s guidance and a supporting science review identified an additional eight NDCs that FDA intends to propose adding to the regulation as dietary fiber.  FDA also announced that they will exercise enforcement discretion regarding the declaration of dietary fiber for these NDCs pending the completion of rulemaking to revise 21 CFR 101.9,  provided a caloric value of 1 kcal/g for polydextrose, and provided clarity on recordkeeping requirements.  The eight newly identified NDCs are:
  • Mixed plant cell wall fibers;
  • Arabinoxylan;
  • Alginate;
  • Inulin and inulin-type fructans;
  • High amylose starch (resistant starch 2);
  • Galactooligosaccharide;
  • Polydextrose; and
  • Resistant maltodextrin/dextrin.

Mixed plant cell wall fibers are a general category of isolated NDCs.  Mixed plant cell wall fiber ingredients contain two or more of the following plant cell wall fibers in varying proportions: cellulose; pectin; lignin; beta-glucan; and arabinoxylan. The Scientific Review further elaborates on Mixed plant cell wall fibers and includes the following list of examples:  “apple fibers, bamboo fibers, barley fibers, carrot fibers, citrus fibers, cocoa fibers, corn fibers (e.g., corn hull fiber), cotton seed fibers, oat fibers (e.g., oat hull fiber), pea fibers (e.g., pea hull fiber, pea seed coat fiber, inner cotyledon pea fiber), rice bran fibers, soy fibers (e.g., soy hull fiber, soy polysaccharide, soy cotyledon fiber), sugar beet fibers, sugar cane fibers, and wheat fibers.”  The guidance also provides further information on FDA’s position regarding “intrinsic and intact.”

• FDA also responded to five citizen petitions requesting that additional NDCs be added to the definition of “dietary fiber.”  Two responses were granting fiber status to resistant dextrin/maltodextrin, one response was to grant fiber status to inulin, one response denied fiber status to isomaltooligosaccharides (IMOs), and the last one was indicating that FDA will continue to review the citizen petition for Modified Wheat Starch, Resistant Starch 4. Several citizen petitions for determination that NDCs qualify as dietary fiber are still pending with FDA.  Additionally, FDA will review new citizen petitions for a determination on a rolling basis.