Drugs derived from plant sources are generally labeled as phytomedicines, botanical products, natural products, and so on. Botanical products are finished, labeled products that contain vegetable matter as ingredients. A botanical product may be a food (including a dietary supplement), a drug (including a biological drug), a medical device (e.g., gutta-percha), or a cosmetic. The term botanical includes plant materials, algae, macroscopic fungi, and combinations thereof.

The World Health Organization (WHO) estimates that four billion people— 80% of the world population—use herbal medicine for some aspect of primary healthcare. Herbal medicine is a major component in all indigenous peoples' traditional medicine and is a common element in Ayurvedic, homeopathic, naturo-pathic, traditional oriental, and Native American Indian medicine. Opinions about the safety, efficacy, and appropriateness of medicinal herbs vary widely among medical and health professionals in countries where herbal remedies are used. Some countries' professionals accept historical, empirical evidence as the only necessary criterion for herbal medicine's efficacy. Others would ban all herbal remedies as dangerous or of questionable value.

Early humans recognized their dependence on nature in both health and illness. Led by instinct, taste, and experience, primitive men and women treated illness by using plants, animal parts, and minerals that were not part of their usual diet. Physical evidence of use of herbal remedies goes back some 60,000 years to a burial site of a Neanderthal man uncovered in 1960. All cultures have long folk medicine histories that include the use of plants. The invention of writing was a focus around which herbal knowledge could accumulate and grow. The first written records detailing the use of herbs in the treatment of illness are the Mesopotamian clay tablet writings and the Egyptian papyrus, which contains 876 prescriptions made up of more than 500 different substances, including many herbs. The Middle Eastern era is followed by the Greco-Roman era that saw the writing of the De Materia Medica, which contains 950 curative substances, of which 600 are plant products and the rest are of animal or mineral origin. The Arab medicine was built on Greco-Roman and the text of Jami of Ibn Baiar (died 1248 ad), which lists more than 2000 substances, including many plant products. India's Ayurvedic book on internal medicine, the Characka Samhita, describes 582 herbs. In China, the Classic of the Materia Medica, compiled no earlier than the first century ad focuses on the description of individual herbs. It includes 252 botanical substances, 45 mineral substances, and 67 animal-derived substances. Traditional Chinese medicine was brought to Japan via Korea, and Chinese-influenced Korean medicine was adapted by the Japanese during the reign of Emperor Ingyo (411-453 ad).

In North America, early explorers traded knowledge with the Native American Indians. In 1716, French explorer Lafitau found a species of ginseng, Panax quinquefolius L., growing in Iroquois territory in the New World. This American ginseng soon became an important item in world herb commerce. The Jesuits dug up the plentiful American ginseng, sold it to the Chinese, and used the money to build schools and churches. Even today, American ginseng is a sizable crude U.S. export. Whereas herbal medicines played a significant role in the lives of Americans, they have lost touch with it with the onslaught of allopathic medicines. One of the most significant reports on the use of botanical drugs in North America is the Baseline Natural Health Products Survey among consumers, March 2005, conducted by Health Canada. This survey concluded that 71% have used botanical, 38% use it on a daily basis, 37% seasonally, 11% weekly, 57% use vitamins, 15% Echinacea, and 11% use other herbal remedies, algal and fungal products. Almost 80% of North Americans believe that botanical drugs are safer and their use is likely to increase in the future. However, despite a long history of use, botanical drugs are generally considered to be anecdotal and ineffective by the regulatory agencies and allowed for sale only as food supplements. Recently, this trend of rejecting botanical drugs was reversed, mainly due to pressures from consumers, that the United States Food and Drug Administration (U.S. FDA) issued its first botanical guideline and established a separate division within the agency to evaluate and approve botanical products as drugs, both prescription and over-the-counter (OTC).

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