CHAPTER 9 REGULATORY AND SAFETY CRITERIA FOR FUNCTIONAL FOODS AND DIETARY SUPPLEMENTS AND PHARMACEUTICAL MEDICINES; THE ROLE FOR MEDICINAL MUSHROOMS Synopsis The regulatory and safety aspects of dietary supplements in general are reviewed with reference to European, USA and Japanese laws. Herbal extracts are given special consideration and consumer product information should give special mention of active ingredients, dosage, mode of administration etc. Dietary supplements from medicinal mushrooms are analysed in detail and current approaches to safety are examined. A central feature of the purported medicinal or chemopreventive role of mushroom extracts must be the undoubted synergistic interaction of the many constituents. For time immemorial mankind has used traditional medicines for human healthcare with terrestrial plants occupying a significant therapeutic role (Pezzuto, 1997). Recently, the World Health Organisation has estimated that approximately 80% of the world’s inhabitants still depend on traditional (mostly herbal but also including fungal) medicines for primary health purposes (Cragg and Newman, 2001), while plant-derived pharmaceutical products play an important role with the remaining 20% of the world’s population in developed countries. At least 120 important drugs are obtained from plants (Farnsworth, 1988). Many of the now clinically useful anticancer drugs are either natural plant products or derivatives of natural products, e.g. paclitaxel (Taxol) from Taxus brevifolia L. and vincristine (Oncovin) from Cantharanthus roseus G.Don. (Pezzuto, 1997). Plants continue to offer a wide range of compounds with diverse structures and activities which will continue to occupy an important role in modern cancer therapy, especially within the sphere of chemotherapy.