Question

In regard to the herbal products industry, give detailed explanations of the legislation, regulations and codes of ethics which apply to the herbal products marketing activities. (400 words)

Answer 1

By definition, ‘traditional’ use of herbal medicines implies substantial historical use, and this is certainly true for many products that are available as ‘traditional herbal medicines’. In many developing countries, a large proportion of the population relies on traditional practitioners and their armamentarium of medicinal plants in order to meet health care needs. Although modern medicine may exist side-by-side with such traditional practice, herbal medicines have often maintained their popularity for historical and cultural reasons. Such products have become more widely available commercially, especially in developed countries. In this modern setting, ingredients are sometimes marketed for uses that were never contemplated in the traditional healing systems from which they emerged. An example is the use of ephedra (= Ma huang) for weight loss or athletic performance enhancement (Shaw, 1998). While in some countries, herbal medicines are subject to rigorous manufacturing standards, this is not so everywhere. In Germany, for example, where herbal products are sold as ‘phytomedicines’, they are subject to the same criteria for efficacy, safety and quality as are other drug products. In the USA, by contrast, most herbal products in the marketplace are marketed and regulated as dietary supplements, a product category that does not require pre-approval of products on the basis of any of these criteria. These matters are covered extensively in Section 3 below.

The role of herbal medicines in traditional healing

The pharmacological treatment of disease began long ago with the use of herbs (Schulz et al., 2001). Methods of folk healing throughout the world commonly used herbs as part of their tradition. Some of these traditions are briefly described below, providing some examples of the array of important healing practices around the world that used herbs for this purpose.

Traditional Chinese medicine

Traditional Chinese medicine has been used by Chinese people from ancient times. Although animal and mineral materials have been used, the primary source of remedies is botanical. Of the more than 12 000 items used by traditional healers, about 500 are in common use (Li, 2000). Botanical products are used only after some kind of processing, which may include, for example, stir-frying or soaking in vinegar or wine. In clinical practice, traditional diagnosis may be followed by the prescription of a complex and often individualized remedy.

Traditional Chinese medicine is still in common use in China. More than half the population regularly uses traditional remedies, with the highest prevalence of use in rural areas. About 5000 traditional remedies are available in China; they account for approximately one fifth of the entire Chinese pharmaceutical market (Li, 2000).

Japanese traditional medicine

Many herbal remedies found their way from China into the Japanese systems of traditional healing. Herbs native to Japan were classified in the first pharmacopoeia of Japanese traditional medicine in the ninth century (Saito, 2000).

. Indian traditional medicine

Ayurveda is a medical system primarily practised in India that has been known for nearly 5000 years. It includes diet and herbal remedies, while emphasizing the body, mind and spirit in disease prevention and treatment (Morgan, 2002).

Introduction of traditional herbal medicines into Europe, the USA and other developed countries

The desire to capture the wisdom of traditional healing systems has led to a resurgence of interest in herbal medicines (Tyler, 2000), particularly in Europe and North America, where herbal products have been incorporated into so-called ‘alternative’, ‘complementary’, ‘holistic’ or ‘integrative’ medical systems.

During the latter part of the twentieth century, increasing interest in self-care resulted in an enormous growth in popularity of traditional healing modalities, including the use of herbal remedies; this has been particularly true in the USA. Consumers have reported positive attitudes towards these products, in large part because they believe them to be of ‘natural’ rather than ‘synthetic’ origin, they believe that such products are more likely to be safe than are drugs, they are considered part of a healthy lifestyle, and they can help to avoid unnecessary contact with conventional ‘western’ medicine.

While centuries of use in traditional settings can be used as testimony that a particular herbal ingredient is effective or safe, several problems must be addressed as these ingredients are incorporated into modern practice.

One problem is that ingredients once used for symptomatic management in traditional healing are now used in developed countries as part of health promotion or disease prevention strategies; thus, acute treatment has been replaced by chronic exposure (e.g., herbal products used for weight loss, Allison et al., 2001). This means that a statement about ‘thousands of years of evidence that a product is safe’ may not be valid for the way the product is now being used. This does not expressly mean that an ingredient is unsafe; it does mean that safety in the modern context cannot be assumed.

Origin, type and botanical data

Plants and their secondary metabolite constituents have a long history of use in modern ‘western’ medicine and in certain systems of traditional medicine, and are the sources of important drugs such as atropine, codeine, digoxin, morphine, quinine and vincristine.

Use of herbal medicines in developed countries has expanded sharply in the latter half of the twentieth century. Monographs on selected herbs are available from a number of sources, including the European Scientific Cooperative on Phytotherapy (ESCOP, 1999), German Commission E (Blumenthal et al., 1998) and the World Health Organization (WHO, 1999). The WHO monographs, for example, describe the herb itself by a number of criteria (including synonyms and vernacular names) and the herb part commonly used, its geographical distribution, tests used to identify and characterize the herb (including macroscopic and microscopic examination and purity testing), the active principles (when known), dosage forms and dosing, medicinal uses, pharmacology, contra-indications and adverse reactions. Other resources that provide detailed information about herbal products in current use include the Natural Medicines Comprehensive Database (Jellin, 2002) and NAPRALERT (NAtural PRoducts ALERT) (2001). Information about other available databases has been published by Bhat (1995).

Medicinal applications, beneficial effects and active components

In some cases, the active principles of plant-derived products have been isolated and characterized, and their mechanisms of action are understood (e.g., ephedrine alkaloids in some species of Ephedra). For many, however, including virtually all of the most common products in the marketplace, such information is incomplete or unavailable. This is in large part due to the complexity of herbal and botanical preparations; they are not pure compounds. It is also a function of the traditionally-held belief that the synergistic combination of several active principles in some herbal preparations is responsible for their beneficial effects.