%0 Journal Article %A Wasser, Solomon P. %A Didukh, Marina Ya. %D 2004 %I Begell House %N 3 %P 18 %R 10.1615/IntJMedMushr.v6.i3.30 %T Dietary Supplements from Culinary-Medicinal Mushrooms: A Variety of Regulations and Safety Concerns for the 21st Century %U https://www.dl.begellhouse.com/journals/708ae68d64b17c52,1b1b20957ef5c8f4,6f006c327f030c0e.html %V 6 %X In the second half of the 20th Century, mushroom producing technologies grew enormously. Mushrooms represent a valuable source of bioactive agents with potent and unique medicinal properties. Many of them are not strictly pharmaceutical products (real medicines) but represent a novel class of dietary supplements (DSs) or "mushroom nutriceuticals." The agents derived from medicinal mushroom fruit bodies, cultured mycelium, and/or culture filtrates exert a wide range of beneficial biological effects when tested in vitro or using animal models. Recent years have seen a surge of commercial interest in medicinal mushroom DSs, the common market value of which is approximately $9 billion US dollars. The safety advantages of using mushroom-based DSs, as opposed to herbal preparations are: (1) The overwhelming majority of mushrooms used for production of DSs are cultivated commercially (and not gathered in the wild); this provides very good chances of proper identification, pre- and unadulterated products. In many cases it also means genetic uniformity. (2) Mushrooms are easily propagated vegetatively, and thus keep to one clone. The mycelium can be stored for a long time, and the genetic and biochemical consistency may be checked after considerable time. (3) The main advantage, in our opinion, is that many mushrooms are capable of growing in the form of mycelial biomass in submerged cultures. In this article, we discuss legal and regulatory issues up to 2004 introducing and controlling DSs from medicinal mushrooms in different countries, including the United States, the European Community (EU), Canada, Australia, New Zealand, Japan, and Israel, as well as the guidelines of the World Health Organization. A lot of attention is drawn to the safety and diversity of DS types from culinary-medicinal mushrooms. We hope that these and future regulations will continue to provide and protect stable medicinal mushroom products of reliable quality and that culturing biotechnology will continue to be the best and the most progressive technique for obtaining consistent and safe mushroom products. %8 2004-10-27