Each country has developed regulatory definitions and systems that place dietary supplements, particularly botanicals, into categories of drugs, traditional medicines, or foods. However, in the late 1980s, many countries launched major changes in regulations that may or may not have been approved at the time of this writing. Many regulations are still in draft form.
The US Congress defined the term 'dietary supplement' in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product, taken orally, that contains a 'dietary ingredient' that is intended to supplement the diet. The dietary ingredient includes vitamins, minerals, herbs or other botanicals, amino acids, a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or a concentrate, metabolite, constituent, or extract. Dietary supplements may be found in many forms, such as tablets, capsules, softgels, gelcaps, liquids, or powders. They may also be produced in other forms, such as a beverage, spread, or bar, in which case information on the label must clearly state that the product is a dietary supplement and it is not represented as a conventional food or a sole item of a meal or diet.
Whatever their form, DSHEA places dietary supplements in a special category under the general umbrella of 'foods,' not drugs, and requires that every supplement be labeled a dietary supplement and carry a Supplement Facts Label.
In the United Kingdom, there is a distinct separation of food supplements and herbal medicines. The Food Standards Agency developed the Food Standard Act of 1999 and is responsible for protection of public health. The Food Supplement Directive 2002/46/EC, which harmonizes European Community legislation on food supplements, was published in 2002. This directive is stricter than existing UK standards and regulations but is relatively more liberal than what exists in other European countries. The directive defines the term 'food supplements,' contains a list of vitamin and mineral sources that may be used in the manufacture of food supplements, states labeling requirements, and, in the future, will provide a framework for maximum and minimum levels for vitamins and minerals in food supplements. Herbals and botanicals are not discussed in this directive.
The Foods Supplement Directive defines a food supplement as any food the purpose of which is to supplement the normal diet and which is a concentrated source of a vitamin or mineral or other substance with a nutritional or physiological effect, alone or in combination, and is sold in dose form. Dose form means capsules, pastilles, tablets, pills, and other similar forms, and also powders, ampoules, drops, or other similar forms of liquids or powders, designed to be taken in small measured quantities. Because the directive defines a food supplement as something to supplement the diet, products that are not meant to supplement the diet (e.g., a weight loss product) are outside the scope of the regulations. There remains a complex legal area between food supplements and medicinal products, although the directive indicates that if a product is used for treating or preventing disease, or restoring, correcting, or modifying a physiological function, then it falls under the Medicines Directive 2001/83/ EEC, Medicines Act 1968, or Medicines for Human Use Regulations 1994.
The Trans-Atlantic Business Dialogue (TABD) approved a position statement regarding dietary supplements in 2002. The TABD is a group of corporations that promote closer commercial ties between the European Union and the United States. This position statement established industrywide consensus on standards and definition of permissible claims, as well as defining what is necessary for substantiation of those claims. In keeping with the Foods Supplement Directive, the TABD dealt only with vitamins and minerals, with the understanding that some of the conclusions may be revisited when warranted for herbals, botanicals, or other dietary supplements.
Herbal medicines, on the other hand, are regulated by the Medicine and HealthCare Products Regulatory Agency based in London. A herbal remedy is defined as a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or any other process, or of a mixture whose sole ingredients are two or more substances so produced, or of a mixture whose sole ingredients are one or more substances so produced and water or some other inert substance.
There are two alternative regulatory routes in the United Kingdom for herbal medicines:licensing and exemption from licensing requirements:
• Licensed herbal medicines:To receive a product license prior to marketing, herbal medicines are required to meet safety, quality, and efficacy criteria in a similar manner to any other licensed medicine.
• Herbal remedies exempt from licensing require-ments:The exemption applies to herbal remedies meeting certain conditions set out in Section 12 of the Medicines Act 1968. Section 12 allows a person to make, sell, and supply a herbal remedy during the course of his or her business provided the remedy is manufactured or assembled on the premises and that it is supplied as a consequence of a consultation between the person and his or her patient. Section 12 also allows the manufacture, sale, or supply of herbal remedies where the processing of the plant consists only of drying, crushing, or comminuting; the remedy is sold without any written specification as to its use; and the remedy is sold under a designation that only specifies the plant and the process and does not apply any other name to the remedy.
Canada has been estimated to have approximately 3% of the market share of the global nutritional market. Health Canada established the Office of Natural Health Products. Premarket assessment, labeling, licensing, and monitoring of herbal supplements are items in its mandate. The definition of a natural health product includes products for the use in ''diagnosis, treatment, mitigation, or prevention of a disease, disorder, or abnormal physical state or its symptoms in humans; restoring or correcting organic function in humans; or modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.'' These products include homeopathic preparations, substances used in traditional medicine, a mineral or trace element, a vitamin, an amino acid, an essential fatty acid or other botanical-, animal-, or microorganism-derived substance. Foods are not included in this product category called natural health products. Canada's Food and Drugs Act of 1953 regulates foods and drugs but does not specifically deal with natural health products. Therefore, these types of products are regulated as either a food or a drug depending on the type and concentration of active ingredient and whether claims are made on the products.
Germany regulates vitamins and minerals as food if they are sold to complement the nutritive value of the diet and do not exceed safe levels. However, if the vitamin or mineral is used for disease treatment or prevention and is used at pharmacological levels, then it is considered a drug. Safety and efficacy of drugs must be established by clinical research. Medicinal plants are regulated differently depending on what plant and in what form it is sold. In general, extracts of plants are considered drugs and must be prescribed. Teas, on the other hand, are sold over-the-counter in pharmacies. Other teas, such as those that contain alkaloids, must be sold by prescription only. Beginning in 1980, an extensive analysis of the literature on more than 300 herbal remedies was undertaken by the German Kommission E. Approximately two-thirds of the herbals were listed as safe and at least minimally effective. The results were published as a series of monographs by the German Kommission E, and this body of work was summarized and translated into English by the American Botanical Council. These substances are generally purchased at the pharmacy and are reimbursable through health insurance. One caveat regarding the German herbal preparations is that they are not likely to be the same preparations that are produced by other countries; thus, the safety and efficacy statements in the Kommission E are only for the preparations that are prepared in German pharmacies.
Australia regulates therapeutic goods under the Therapeutic Goods Act of 1989. Therapeutic goods include vitamins, minerals, plants and herbals, nutritional food supplements, naturopathic and homeopathic preparations, and some aromatherapy. The Therapeutic Goods Administration (TGA) developed the Office of Complementary Medicine to evaluate new substances and products. Basically, the TGA regulates these therapeutic goods as they do pharmaceutical products, and thus their criteria are more rigorous than the criteria of other countries. Most of the therapeutic goods are 'generally listed' rather than regulated. Listed medicines are considered to be relatively harmless, so the regulations allow for manufacturers to 'self-assess' their products in some situations. The majority of listed medicines are self-selected by consumers and used for self-treatment, and they are all manufactured with well-known established ingredients, such as vitamin and mineral products or sunscreens. These are assessed by the TGA for quality and safety but not efficacy. This does not mean that they do not work; rather, it means that the TGA has not evaluated them individually to determine if they work. It is a requirement under the act that sponsors have information to substantiate all of their product's claims.
The Japanese Ministry of Health and Welfare does not define or recognize a distinct category known as dietary supplements. Instead, there are only two
Table 1 Regulatory categories of different countries
United States, DSHEA Europe, Food Supplement Act United Kingdom, Medicine and Health Care Canada, Office of Natural Products
Germany, Kommission E
Australia, Therapeutic Goods Administration
Japan, Ministry of Health and Welfare
Vitamins, minerals, herbal, other botanical, amino acid, enzymes, organs, glands Vitamin and minerals Medicinal plants
Mineral; trace element; vitamin; amino acid; essential fatty acid; botanical-, animal-, or microorganism-derived substances; homeopathic preparation; traditional preparations Vitamin and mineral as both foods and drugs, botanicals (approved and not approved), teas as prescription and as over-the-counter Vitamin and mineral, plants, herbs, nutritional food supplements, naturopaths and homeopathic preparations, aromatherapies No definition of dietary supplements, regulations for foods, drugs, and Kampo classifications, food and drugs. In 1993, Japan defined a group of foods known as Foods for Specific Health Use (FOSHU). As of 2004, approximately 342 foods had been approved as FOSHU. The dietary ingredients are sold in the form of foods, not in the form of capsules, tablets, or powders.
The herbal supplements market in Japan has been strongly influenced by the practice of Kampo. Kampo (or Kanpo) is the adaptation of Chinese herb formulas to Japanese medicine. Approximately 25 years ago, the Japanese Ministry of Health formally recognized that certain traditional Chinese herb formulas (and a few formulas of similar nature developed in Japan) were suitable for coverage by national health insurance. These formulas are prepared in factories under strict conditions.
In summary, developing global data on dietary supplement sales depends on how they are defined. Table 1 summarizes the differences in regulatory categories of different countries.
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