Volume 16 Part 1 Article 5: Safety and Efficacy Substantiation of Fungal Products for the Nutraceutical Industry

Volume 16 Part 1 Article 5
Year 2004
Title: Safety and Efficacy Substantiation of Fungal Products for the Nutraceutical Industry
Author: A.G. Schauss

Abstract:

There is a growing demand for fungal products and derivatives by the nutraceutical industry, including dietary supplements, sports nutrition products, and functional foods. In the past, marketing of these products relied on marketing skills. This will no longer be the case as the industry matures and comes under increasing scrutiny by regulatory agencies such as the Food and Drug Administration (FDA), Federal Trade Commission, the media, practitioners, consumer groups and consumers. FDA has set a plan in motion that is now approaching its fourth year to shift the focus from a marketing paradigm to a science-driven paradigm. Similar demands for scientific substantiation are in place for these products worldwide, based on an analysis of new regulations adopted in over 50 countries in the last three years. This will place considerable pressure on raw material suppliers of fungal products targeted for the nutraceutical industry to produce non-clinical and clinical documentation to support claims of safety and efficacy. What kinds of testing procedures, studies, and research will satisfy this new paradigm and recent regulatory concerns will be discussed and illustrated.

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