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Functional foods are intended to help consumers reduce or manage the risks for certain diseases while main-taining body function and structure. Functional foods are regulated differently depending upon the country. For example, theUnited States has not defined the term functional food in regulation. Thus, functional foods are treated just like conventionalfoods for obtaining regulatory safety approval. However, the sales of soy products, soy-enriched foods, and dietary supple-ments have grown tremendously during the past 3 years because of the increasing consumer awareness of soy as a healthyfood ingredient. Isoflavones in soy are believed to have preventive effects for several hormone-dependent diseases, mainlydue to their weak estrogenic activity. This mini-review discusses some of the important issues to be considered in using soyand isoflavone products as health foods, including production, composition, products, and processing of soy products, and thefate of isoflavones during processing, their bioavailability, and safety. Some of these issues may affect the choice of raw orbasic material sources, processing conditions, quality control procedures/measures, and marketing strategies for both soy-basedfoods and isoflavones.