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E. YETLEY and V. Wilkening. Food and Drug Administration, 200 "C" Street, Washington, DC 20204

Current food-labeling regulations in the U.S. provide for the mandatory declaration of dietary fiber in nutrition labels. These regulations are based on the recognized concept of dietary fiber as "the polysaccharides and remnants of plant material that are resistant to hydrolysis by human alimentary enzymes." For verification of compliance with nutrition labeling regulations, FDA has specified that dietary fiber in food will be quantified by official methods of analysis of the AOAC International. These include AOAC official methods 985.29, 991.43 and 992.16. Because certain food components with physiological effects similar to those of "traditional" dietary fiber are excluded by these analytical methods based on solubility considerations, questions have been raised of whether and how the current definition of dietary fiber should be revised. Questions of how to define dietary fiber for food labeling purposes and how to describe the health benefits that may be associated with consumption of specific sources of dietary fiber have been the focus of the recent AACC dialogue. From FDA's perspective, discussions of these issues also take place in the context of the several types of claims that can be made regarding dietary fiber and of recent changes in Federal regulations that have expanded procedures for authorizing specific types of claims on foods. For example, FDA is currently involved in a dialogue to develop the scientific and regulatory framework for the use of "structure/function" claims on conventional foods and is initiating rulemaking to implement the FDA Modernization Act which includes a simplified process for authorization of health claims. The regulatory need for defining dietary fiber in a quantifiable manner must be considered, as must the uncertainty as to whether a public health need exists for a revised definition and whether such a change would benefit consumers. Increasing interest in international harmonization in food labeling policies adds another dimension to the on-going debate about a possible revision of the definition for dietary fiber.