Isolated or Synthetic Non-Digestible Carbohydrates that Qualify as Dietary Fiber

FDA has published a guidance that specifies eight (8) additional substances that qualify as dietary fiber for purposes of nutrition labeling: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels: Guidance for Industry (June 2018).

When it revised its Nutrition Facts and Supplement Facts regulatory requirements on May 27, 2016, FDA included a new regulatory definition of “dietary fiber”:

Dietary fiber is defined as non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.

21 C.F.R. § 101.9(c)(6)(i) (emphasis added).  The agency also identified seven (7) non-digestible carbohydrates that it determined have beneficial physiological effects for human health and, therefore, may be declared as dietary fiber in nutrition labeling:

  • [beta]-glucan soluble fiber (as described in § 101.81(c)(2)(ii)(A));
  • psyllium husk (as described in § 101.81(c)(2)(ii)(B));
  • cellulose;
  • guar gum;
  • pectin;
  • locust bean gum; and
  • hydroxypropylmethylcellulose.

In November 2016, FDA had published a summary of its review of the scientific evidence that it had identified for certain isolated or synthetic non-digestible carbohydrates that are not listed as a dietary fiber in 21 CFR 101.9(c)(6)(i).  Its review had relied on the draft guidance for industry, “Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as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).”  On March 1, 2018, FDA finalized that guidance, explaining how the agency evaluates the scientific evidence supporting citizen petitions to add certain isolated or synthetic non-digestible carbohydrates to the regulatory definition of “dietary fiber.”  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) (Feb. 2018).

The eight (8) additional substances that now qualify as dietary fiber for purposes of nutrition labeling 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.

FDA has published its scientific basis for determining these substances to qualify as dietary fiber.  Review of the Scientific Evidence on the Physiological Effects of Certain Non-Digestible Carbohydrates (June 2018); see also Questions and Answers on Dietary Fiber (page last updated 06/14/2018).  The agency prospectively will amend § 101.9(c)(6)(i) to include these additional non-digestible carbohydrates as dietary fiber.  Moreover, FDA is reviewing petitions that have been submitted tor additional substances.

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