Health Claims and Dietary Fiber

by Mark Kantor, EAS Consulting Group Independent Consultant

Health claims are allowed voluntarily in food labeling if sufficient scientific evidence exists that a specific food or food component – referred to as a “substance” by FDA – may reduce the risk of a disease or a health-related condition. FDA recognizes three general categories of health claims: authorized health claims, qualified health claims, and FDA Modernization Act claims. These categories are based on the level of scientific evidence for the claim, or the source of that evidence. All three categories include claims related to dietary fiber, but only authorized health claims include the term “fiber” in the claim’s description. The others refer to “whole grains,” which are sources of dietary fiber.

Authorized health claims require the strongest level of scientific support for the substance/disease relationship, i.e., there must be “significant scientific agreement” (SSA) and a high level of confidence among experts that the claim is valid. Three authorized health claims specific for dietary fiber are found in Title 21 of the Code of Federal Regulations: (1) Fiber-containing grain products, fruits, and vegetables and cancer risk (§ 101.76); (2) Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease (§101.77); and (3) Soluble fiber from certain foods and risk of coronary heart disease (CHD) (§ 101.81).

This latter health claim has an interesting history because the number of substances allowed for the claim increased over time. When FDA first authorized a health claim for soluble fiber and CHD in 1997, the original claim language was “Soluble fiber from whole oats and risk of coronary heart disease.” At that time, FDA determined that the appropriate substance for the claim was beta-glucan soluble fiber (a group of non-starch polysaccharides concentrated in the cell wall of the endosperm containing D-glucose units linked by β-glycosidic bonds), and the only sources of beta-glucan soluble fiber eligible for the claim were whole oats, oat bran, rolled oats, and whole oat flour. However, FDA acknowledged the likelihood that other sources of beta-glucan soluble fiber – as well as other sources of soluble fiber in general – might also have beneficial effects on blood lipids and CHD risk.

In 1998, FDA amended 21 CFR 101.81 by adding psyllium seed husk as an eligible source of soluble fiber. The agency also broadened the language of the claim to cover additional food sources of soluble fiber by replacing “whole oats” with “certain foods.” In effect, FDA re-structured §101.81 into an “umbrella” regulation to facilitate amending the claim if future research identified other soluble fiber-containing foods that reduced CHD risk. For example, if a manufacturer documented that a soluble fiber product was effective in lowering blood cholesterol, it could petition FDA to amend 101.81 to include its product in the regulation. FDA felt it was necessary to take this “case-by-case” approach because soluble fiber is comprised of very heterogenous substances that vary in how they affect the risk of CHD.

Over the years, the list of eligible sources of beta-glucan soluble fiber expanded to include oatrim (2003), whole grain barley and dry milled barley (2006), and barley betafiber (2008). Oatrim was originally developed by USDA researchers to replace fat in low calorie foods. It is derived from oat bran or whole oat flour and is produced through a multi-step process involving the enzyme alpha amylase. Barley betafiber, which is made from whole grain barley flour, is also produced through an enzymatic process. The sources of beta-glucan soluble fiber derived from whole oats and barley that are eligible for the dietary fiber SSA claim are codified in 21 CFR 101.81(c)(2)(ii)(A)(1-6). No new fibers have been added to this rule since 2008, although FDA still receives petitions from industry to do so.