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Miles Lee
Miles Lee

Botanical Medicine


Products made from botanicals, or plants, that are used to treat diseases or to maintain health are called herbal products, botanical products, or phytomedicines. A product made from plants and used solely for internal use is called an herbal supplement.




botanical medicine


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Many prescription drugs and over-the-counter medicines are also made from plant products, but these products contain only purified ingredients and are regulated by the FDA. Herbal supplements may contain entire plants or plant parts.


Herbal supplements, unlike medicines, are not required to be standardized to ensure batch-to-batch consistency. Some manufacturers may use the word standardized on a supplement label, but it does not necessarily mean the same thing from one manufacturer to the next.


An herb is a plant or plant part used for its scent, flavor, or therapeutic properties. Herbal medicines are one type of dietary supplement. They are sold as tablets, capsules, powders, teas, extracts, and fresh or dried plants. People use herbal medicines to try to maintain or improve their health.


Many people believe that products labeled "natural" are always safe and good for them. This is not necessarily true. Herbal medicines do not have to go through the testing that drugs do. Some herbs, such as comfrey and ephedra, can cause serious harm. Some herbs can interact with prescription or over-the-counter medicines.


Over the past 100 years, the development and mass production of chemically synthesized drugs have revolutionized health care in most parts of the word. However, large sections of the population in developing countries still rely on traditional practitioners and herbal medicines for their primary care. In Africa up to 90% and in India 70% of the population depend on traditional medicine to help meet their health care needs. In China, traditional medicine accounts for around 40% of all health care delivered and more than 90% of general hospitals in China have units for traditional medicine (WHO 2005). However, use of traditional medicine is not limited to developing countries, and during the past two decades public interest in natural therapies has increased greatly in industrialized countries, with expanding use of ethnobotanicals. In the United States, in 2007, about 38% of adults and 12% of children were using some form of traditional medicine (Ernst, Schmidt, and Wider 2005; Barnes, Bloom, and Nahin 2008). According to a survey by the National Center for Complementary and Alternative Medicine (Barnes, Bloom, and Nahin 2008), herbal therapy or the usage of natural products other than vitamins and minerals was the most commonly used alternative medicine (18.9%) when all use of prayer was excluded. A survey conducted in Hong Kong in 2003 reported that 40% of the subjects surveyed showed marked faith in TCM compared with Western medicine (Chan et al. 2003). In a survey of 21,923 adults in the United States, 12.8% took at least one herbal supplement (Harrison et al. 2004) and in another survey (Qato et al. 2008), 42% of respondents used dietary or nutritional supplements, with multivitamins and minerals most commonly used, followed by saw palmetto, flax, garlic, and Ginkgo, at the time of the interview.


The total commercial value of the ethnobotanicals market cannot be ignored. For example, in 1995, the total turnover of nonprescription-bound herbal medicines in pharmacies was equal to almost 30% of the total turnover of nonprescription-bound medicines in Germany, and in the United States, the annual retail sales of herbal products was estimated to be US$5.1 billion. In India, herbal medicine is a common practice, and about 960 plant species are used by the Indian herbal industry, of which 178 are of a high volume, exceeding 100 metric tons per year (Sahoo 2010). In China, the total value of herbal medicine manufactured in 1995 reached 17.6 billion Chinese yuan (approximately US$2.5 billion; Eisenberg et al. 1998; WHO 2001). This trend has continued, and annual revenues in Western Europe reached US$5 billion in 2003-2004 (De Smet 2005). In China, sales of herbal products totaled US$14 billion in 2005, and revenue from herbal medicines in Brazil was US$160 million in 2007 (World Health Organization; _medicine/en/). It is estimated that the annual worldwide market for these products approached US$60 billion (Tilburt and Kaptchuk 2008).


Currently, herbs are applied to the treatment of chronic and acute conditions and various ailments and problems such as cardiovascular disease, prostate problems, depression, inflammation, and to boost the immune system, to name but a few. In China, in 2003, traditional herbal medicines played a prominent role in the strategy to contain and treat severe acute respiratory syndrome (SARS), and in Africa, a traditional herbal medicine, the Africa flower, has been used for decades to treat wasting symptoms associated with HIV (De Smet 2005; Tilburt and Kaptchuk 2008). Herbal medicines are also very common in Europe, with Germany and France leading in over-the-counter sales among European countries, and in most developed countries, one can find essential oils, herbal extracts, or herbal teas being sold in pharmacies with conventional drugs.


WHO has recognized the important contribution of traditional medicine to provide essential care (World Health Organization, _medicine/en/). In 1989, the U.S. Congress established the Office of Alternative Medicine within the National Institutes of Health to encourage scientific research in the field of traditional medicine ( , last access: November 5, 2010), and the European Scientific Cooperative on Phytotherapy (ESCOP) was founded in 1989 with the aim of advancing the scientific status and harmonization of phytomedicines at the European level (www.escop.com, last access: November 5, 2010). This led to an increase in investment in the evaluation of herbal medicines. In the United States, the National Center for Complementary and Alternative Medicine at the National Institutes of Health spent approximately US$33 million on herbal medicines in the fiscal year 2005; in 2004, the National Canadian Institute committed nearly US$89 million for studying a range of traditional therapies. While this scale of investment is low compared to the total research and development expenses of the pharmaceutical industry, it nevertheless reflects genuine public, industry, and governmental interest in this area (Li and Vederas 2009).


With tremendous expansion in the interest in and use of traditional medicines worldwide, two main areas of concern arise that bring major challenges. These are international diversity and national policies regarding the regulation of the production and use of herbs (and other complementary medicines) and their quality, safety, and scientific evidence in relation to health claims (WHO 2005; Sahoo et al. 2008).


The diversity among countries with the long history and holistic approach of herbal medicines makes evaluating and regulating them very challenging. In addition, there are a great number of different herbs used. Legislative criteria to establish traditionally used herbal medicines as part of approved health care therapies faces several difficulties. In a survey conducted across 129 countries, WHO reported the following issues regarding herbal medicines: lack of research data, appropriate mechanisms for control of herbal medicines, education and training, expertise within the national health authorities and control agency, information sharing, safety monitoring, and methods to evaluate their safety and efficacy. The support needed from different countries includes information sharing on regulatory issues, workshops on herbal medicines safety monitoring, general guidelines on research and evaluation of herbal medicines, provision of databases, herbal medicine regulation workshops, and international meetings.


National policies are the basis for defining the role of traditional medicines in national health care programs, ensuring that the necessary regulatory and legal mechanisms are established for promoting and maintaining good practice, assuring the authenticity, safety, and efficacy of traditional medicines and therapies, and providing equitable access to health care resources and their resource information (WHO 2005). Another fundamental requirement is harmonization of the market for herbal medicines for industry, health professionals, and consumers (Mahady 2001). Herbal medicines are generally sold as food supplements, but a common regulatory framework does not exist in different countries. As a result, information on clinical indications for their use, efficacy, and safety are influenced by the traditional experience available in each place. A brief outline of the legislation in United States, Canada, and Europe is given in this section, and could be used to guide the legal aspects of the herbal medicine industry in other countries.


In Canada, herbal remedies must comply with the Natural Health Products Regulations (Health Canada 2003). According to these regulations, all natural products require a product license before they can be sold in Canada. In order to be granted a license, detailed information on the medicinal ingredients, source, potency, nonmedicinal ingredients, and recommended use needs to be furnished. Once a product has been granted a license, it will bear the license number and follow standard labeling requirements to ensure that consumers can make informed choices. A site license is also needed for those who manufacture, pack, label, and import herbal medicines. In addition, GMPs must be employed to ensure product safety and quality. This requires that appropriate standards and practices regarding the manufacture, storage, handling, and distribution of natural health products be met. The GMPs are designed to be outcome based, ensuring safe and high-quality products, while giving the flexibility to implement quality control systems appropriate to the product line and business. Product license holders are required to monitor all adverse reactions associated with their product and report serious adverse reactions to the Canadian Department of Health. 041b061a72


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