Abstract

Native American peoples developed a sophisticated “plant-based medical system” in the course of millennia before the European conquest of America. Despite the significant differences between the systems developed by the various native groups, there were also many broad similarities. Out of the approximately 28,000 species of plants in North America, native Americans used about 2500 medicinally.Out of the thirty-six areas that qualify as biodiversity hotspots, for North America and Central America, only three regions qualify: the California Floristic Province, Madrean pine-oak woodlands, and Mesoamerica.Recently, also the North American Coastal Plain (NACP) has been identified as a global hotspot: this finding they have based on its similarity with the classic definition of a region.The Flora of North America North of Mexico (FNA), is conceived as a multivolume work describing the native plants of North America, in 30 volumes. 17 volumes of the Flora are already available online.Germplasm conservation in the United States is not new. Realizing the importance of genetic diversity, the USDA has been collecting and preserving germplasm since the late 1800s. To date, the National Genetic Resources Program (NGRP) of USDA acquires, characterizes, conserves, documents, and distributes to scientists germplasm of all life forms important for food and agricultural production.The U.S. Department of Agriculture’s Foreign Agricultural Service maintains statistics on imported herbs and spices but there is no systematic process for measuring wild-harvested (a.k.a. wildcrafted) or commercially cultivated herbs used in the medicinal plant market. In view of the increasingly strict quality requirements, the American Herbal Products Association (AHPA) published its Good Agricultural and Collection Practices (GACPs) and Good Manufacturing Practices (GMPs) for botanical materials. In the US, GACP implementation is mandatory only for botanical drug active ingredients: voluntary for botanical dietary supplement ingredients. As the U.S. Food and Drug Administration (FDA) has not yet established its own GACPs for botanical drugs, the agency specifically accepts GACP compliance according to guidelines published by the European Medicines Agency (EMA) and the World Health Organization (WHO).In the US and Canada, pharmaceutical drugs are subject to strict regulations, like in most countries. Their availability is similarly restricted as either prescription drug products (Rx) or nonprescription over-the-counter (OTC) drug products. The regulation of medicinal and aromatic plant (MAP) production, trade and use in North America is the result of the influence of a multitude of contributing “actors” (governmental agencies, intergovernmental organizations, public institutions, standard-setting organizations, and other bodies). Much progress has been made since the 1800s, when the patent medicines (proprietary medicines made and marketed under a patent and available without prescription) first became popular. In the lack of Federal regulations for these products prior to the passage of the Pure Food and Drug Act of 1906 and subsequent United States Federal Food, Drug, and Cosmetic Act of 1938, consumers had no means to distinguish between false and valid claims. Many of these were of plant origin and often had “secret formulations”. There is good reason to believe in the truth of Professor Varro Tyler’s forecast saying: “Looking back, it is obvious that a great deal of progress has already been made. We now look to the future with eager anticipation and great expectations.”

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