12 Jul 2019

An Update to the Dietary Fiber Inclusion List

In May 2016, the United States (U.S.) Food and Drug Administration (FDA) published, in Regulation 21 CFR 101.9 (c)(6)(i), a new definition for dietary fiber indicating that dietary fibers are "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". In other words, non-digestible carbohydrates (NDCs), which are intrinsic and intact in plant-based foods, meet the definition of a dietary fiber in the U.S. and can therefore be listed as such on the Nutrition and Supplement Facts label of a food product.  Any NDC that has been isolated from a food, or synthetically produced, will only meet the definition of a dietary fiber if the NDC demonstrates a beneficial physiological effect to human health or if the NDC is the subject of an authorized health claim.  As part of the Regulation, the FDA included 7 isolated or synthetically produced NDCs approved as dietary fibers, namelypectin, locust bean gum, guar gum, cellulose, hyroxypropyl methylcellulose, psyllium, and β-glucan soluble fiber.  In June 2018, the U.S. FDA issued an additional guidance document, wherein they identified 8 more NDCs [i.e., mixed plant cell wall fibers, arabinoxylan, alginate, inulin and inulin-type fructans, high amylose starch (resistant starch 2), galactooligosaccharide, polydextrose, and resistant maltodextrin]that will be added to the definition of dietary fiber upon rulemaking; until then, the FDA indicated that the agency intends to exercise enforcement discretion in order to allow manufacturers to include these fibers in the dietary fiber declaration on the Nutrition and Supplement Facts labels.  The FDA indicated that "Firms can submit citizen petitions requesting that additional fibers be added to the definition of dietary fiber.  Those petitions will be reviewed on a rolling basis".  MGP Ingredients Inc. did just that; they submitted a citizen petition to the U.S. FDA (on 28 October 2016) that 'Modified Wheat Starch (Fibersym® RW and FiberRite® RW)' [which is part of the resistant starch 4 (RS4) family] be added to the definition of dietary fiber.

On 27 March 2019, the U.S. FDA announced that it intends to propose that 'cross-linked phosphorylated RS4'1—regardless of source—be added to the definition of dietary fiber.  The FDA indicated that, "Based on available evidence, FDA has determined that the scientific evidence suggests that cross-linked phosphorylated RS4 can help reduce insulin levels following a meal containing a carbohydrate that raises blood glucose levels".  Cross-linked phosphorylated RS4 is the first ingredient to be approved as a NDC to be added to the definition of dietary fiber since the publication of the 7 NDCs in the 2016 Nutrition Facts label final rule and the 8 NDCs in the 2018 guidance document.  Cross-linked phosphorylated RS4 will be added to the list of acceptable dietary fibers, for which the FDA will exercise enforcement discretion. 

Do you currently use an ingredient in your product formulations that you think meets the definition of a dietary fiber in the U.S.?  Do you need help filing a citizen petition to the FDA to request its inclusion in the regulatory definition?  If so, Intertek Scientific & Regulatory Consultancy can assist you!  Feel free to send me a message or contact Intertek directly:  Food.sci-reg@intertek.com

Additionally, you can access our free webinar on dietary fiber regulations in Canada, the European Union and the U.S. using the following link: https://www.intertek.com/knowledge-education/webinars/dietary-fiber-regulations/.

Available at: https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm634462.htm


Carolina Venditti, Ph.D.,
Scientific & Regulatory Consultant, Food & Nutrition Group
Health, Environmental & Regulatory Services (HERS)

Today's expert blogger, Carolina Venditti, is a Scientific & Regulatory Consultant with experience in evaluating the efficacy of health claims for foods and food supplements globally; including such jurisdictions as Canada, the United States and the European Union. As part of the Health Claims and Clinical Trials group, she assists clients in critical interpretation of strengths and gaps in the scientific evidence to support health claims and, she provides support with the development and placement of clinical trial protocols. 

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