Research data clearly indicates the health benefits associated with an increased intake of dietary fiber, including reduced risk of chronic diseases such as coronary heart disease, diabetes, and some forms of cancer. Although scientists generally agree that a healthy diet should include plenty of fiber-rich foods, agreement on the actual definition of fiber has been more difficult to achieve. It has been identified that beneficial health effects are considered to be an important attribute of the definition of the fiber. The FDA defines dietary fiber 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. While plant-based foods are considered a good source of dietary fiber, food industries have been able to isolate or synthesize certain food ingredients (i.e. functional fibers) that can be claimed as “dietary fibers” in the nutrition fact labels due to their beneficial role in human health. These functional fibers may be synthesized, isolated or extracted from plant or animal tissue using a variety of technologies such as chemical, enzymatic, or aqueous steps. FDA has identified the types of physiological effects of dietary fiber on human health, including attenuation of blood glucose, attenuation of cholesterol levels (total or Low Density lipoprotein Cholesterol-LDL), lowering of blood pressure, increased satiety, improved laxation/bowel function, and increased absorption of minerals. Traditionally, chemical/enzyme based assays are used to measure the fiber content in foods. However, the Nutrition Facts Label aims to reflect that amount of fiber in a product that provides a physiological beneficial in human health and therefore available chemical/enzyme-based assays are not sufficient to predict or define physiological effects of fibers in human. Certain fiber ingredients have insufficient data to determine if it meets the definition of dietary fiber to include in the nutrition fact label. In such cases, additional data may require using well controlled human intervention trials to make a regulatory decision. Food processors that would like their products (i.e. functional fibers) to be included in FDA’s list of approved dietary fibers may submit credible and well controlled human clinical data demonstrating the beneficial physiological effects of their products.


Reference: 21 C.F.R. 101.9.