(PTFS16-05-24) FDA Scientific Evaluation for Declaring Dietary Fiber on Nutrition and Supplement Facts Labels: Non-Digestible Carbohydrates That Meet the FDA Regulatory Definition

Objectives: The U.S. Food and Drug Administration (FDA) amended its regulations for the Nutrition and Supplement Facts Labels in 2016 and included a new regulatory definition of dietary fiber to help consumers maintain healthy dietary practices. The new regulatory dietary fiber definition requires, in part, isolated or synthetic non-digestible carbohydrates (NDCs) to have physiological effects that are beneficial to human health, as determined by FDA based on our evaluation of the scientific evidence. We describe the criteria used in our scientific evaluation for dietary fiber and provide a current list of NDCs that FDA has determined meet the dietary fiber definition.

Methods: To determine whether a dietary fiber meets the regulatory definition, FDA evaluates the strength of the totality of scientific evidence from publicly available human studies satisfying certain critical elements, e.g., the study must measure the independent effect of the NDC and include appropriate statistical analyses, among other criteria. Besides outcome (i.e., whether the NDC has a beneficial, adverse, or no effect), factors such as, number of studies, sample size, dose, type of food (e.g., solid, beverage, or dietary supplement), consistency of findings, and relevance to the general U.S. population are considered.

Results: To date, FDA has identified the following isolated or synthetic NDCs as meeting our regulatory definition of dietary fiber: beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum, hydroxypropylmethylcellulose, 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), and mixed plant cell wall fibers (a broad category that includes fibers like sugar cane fiber and apple fiber, among many others).

Conclusions: The FDA regulatory definition of dietary fiber, based on beneficial physiological effects to human health, ensures that the amount of dietary fiber declared on the Nutrition and Supplement Facts labels will assist consumers to maintain healthy dietary practices.

Funding Sources: No external funding