FDA Makes Public the Scientific Data Evaluated and Provides Draft Guidance Regarding the Inclusion of Certain Fibers in the Definition of Dietary Fiber

getty_rm_photo_of_whole_grain_breakfast_nutritionAs previously reported here, in May 2016, the Food and Drug Administration (FDA or agency) published new final regulations on Nutrition and Supplement Facts labeling.  As part of the final rules, FDA defined “dietary fiber,” in relevant part, 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.”[i]  The final rule identified only 7 isolated or synthetic fibers that met this definition.[ii]  Under the prior method of identifying “dietary fibers” for labeling (which involved analytical methods for measuring levels of fiber present), there were many other types of isolated or synthetic non-digestible carbohydrates that manufacturers routinely declared as dietary fiber on Nutrition Facts labels.  In drafting the final regulations, FDA indicated that there was insufficient evidence of a beneficial physiologic effect for other previously considered dietary fibers to be included in the definition, but indicated that anyone could provide evidence to support the addition of other dietary fibers through the Citizen Petition process.  This immediately led to questions about what data had been reviewed and the standard the agency would apply to determine beneficial physiological effects.

The new report and draft guidance issued on November 22, summarized the results of the agency’s scientific review of 26 routinely identified, non-digestible carbohydrates by providing brief summaries of each study reviewed with an identification of whether each study met or failed FDA’s criteria for inclusion.

The 26 non-digestible carbohydrates included in the report are:

Gum Acacia

Alginate

Apple Fiber

Corn Hull Fiber Cottonseed Fiber Galactooligosaccharides

Oat Hull Fiber Pea Fiber Polydextrose

Rice Bran Fiber High Amylose Corn/Maize Starch (Resistant Starch 2) Retrograded Corn Starch (Resistant Starch 3)

Soy Fiber Sugar Beet Fiber Sugar Cane Fiber

Xylooligosaccharides Carboxymethylcellulose Karaya Gum

Xanthan Gum Bamboo Fiber Inulin/Oligofructose/Synthetic Short Chain Fructooligosaccharides

Potato Fibers Resistant Wheat and Maize Starch (Resistant Starch 4)

Wheat Fiber
Pullulan

The draft guidance addresses the type of evidence that should be provided as part of a Citizen Petition and the agency’s planned approach for evaluating the evidence, which is similar to the approach described in the 2009 guidance for evaluation of health claims.[iii]  In providing examples of types of beneficial physiological effects that would make a carbohydrate eligible for listing as a “dietary fiber,” the agency has identified: lowering blood glucose and cholesterol levels, lowering blood pressure, improved laxation and bowel function, increased mineral absorption in the intestinal tract, and reduced energy intake (for example, due to the fiber promoting a feeling of fullness).  The agency has indicated, however, that it will consider other physiological endpoints if scientific evidence exists to support inclusion.

FDA invites for the submission of additional information, comments, and scientific data regarding the physiological endpoints and review of evidence for each of the 26 non-digestible carbohydrates for review by January 9, 2017.  Comments regarding the FDA’s draft guidance are due January 23, 2017.

 Comments on the request for scientific data may be submitted here and on the draft guidance here.

[i] 21 C.F.R. §101.9(6)(i) (emphasis added).

[ii] The 7 non-digestible carbohydrates meeting the dietary fiber definition are: Beta-glucan Soluble Fiber, Psyllium Husk, Cellulose, Guar Gum, Pectin, Locust Bean Gum, and Hydroxypropylmethylcellulose.

[iii] U.S. Food and Drug Administration, Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims – Final, http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm073332.htm, accessed on December 14, 2016.

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