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R. BLACK, Dir., Nutrition/Regulatory Affairs, Novartis S.A., Basal, Switzerland, United Kingdom

Consumer perception and marketing strategies drive the food industry to provide products that are more healthful. The functional foods category demands that corporations conduct extensive and expensive basic and clinical research to support a proprietary food ingredient or unique food process. This approach is essential to substantiate health claims demanded by the general consumer. The international regulatory environment lacks the consistency required for claims substantiation, often placing the food industry at a marketing disadvantage to provide consumers more products that are healthful. The rapid development and cost-effective marketing of these kinds of products will rely on international harmonization of basic and clinical assessment criteria for functional foods, and on the establishment of uniform safety evaluation standards for novel ingredients and extracts of GRAS substances.