Regulatory Situation of Herbal Medicines A worldwide Review

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WHO/TRM/98.1page 8ColombiaIn July 1990, an order was issued by the Ministry of Health setting out detailed legal requirements for naturalproducts and pharmaceutical preparations thereof that have traditionally been used. A natural product isdefined as a material of a natural origin that has traditionally been used for therapeutic purposes, and that hasonly been treated (processed) by physical methods. A pharmaceutical preparation is defined as a productthereof with a pharmaceutical form and a traditional empiric use for therapeutic purposes, used only orally oradministered topically. Products with therapeutic indications have to be registered as medicines, herbal teasare registered as food. Detailed requirements are given that the plant material has to fulfil with respect tocultivation, collection, drying, etc. For the manufacturer of pharmaceutical preparations, a special licence isneeded. Plant material is allowed to be brought into the market, individually packed and not mixed, with aspecial authorization, and a therapeutic use must not be indicated. Pharmaceutical preparations need aregistration that has to be applied for with a technical dossier containing documentation on the manufacturingprocess, quality control and, if necessary, toxicity studies, together with monographs on the material, includingits traditional use, method of application, dose, contra-indications, adverse reactions, and a bibliography. Ifalready registered in two or more countries (which are specifically listed), reference may be made to such aprevious registration with respect to the documentation of efficacy. In the case of a medicinal plant product, ithas to be certified that the plant is included in an official plant list. Drafts of a label and a leaflet have to besubmitted. The registration is valid for ten years and may be renewed [21].In August 1990, a resolution published by the Ministry of Health listed 17 plants, their common and botanicalnames, the parts used, and their traditional use which has been officially accepted, and to which referencemay be made [22].MexicoTraditional medicine represents a culturally accepted link between past and present in Mexico. Pre-Hispaniccultures developed an original and powerful way of classifying knowledge. Research has individualized Pre-Hispanic Mexican medicine, bringing understanding of its classification systems, and recognition of the validityof aspects never included in Western thought. During its long history, traditional medicine was repeatedlyoutlawed and its practices prohibited. However, Mexican traditional medicine has survived, despite thesemeasures, the political tendency to give modern scientific medicine an absolute priority, and the scientists'tendency to minimize traditional knowledge [23].NicaraguaIn 1985, during the war, the Ministry of Health started a project to revitalize popular and traditional medicine, asa strategy in the search for self-sufficiency in response to the difficult situation in this country. As the majority ofsupplies of chemical and pharmaceutical materials had to be imported at high prices, a search for alternativetherapies was started.In April 1989, the Ministry of Health established a National Centre of Popular and Traditional Medicine with thefollowing objectives:- to organize investigations on popular and traditional medicine;- to train health promoters and medical and paramedical persons in these fields;- to promote the cultivation and commercialization of medicinal herbs.Considerable work was done in agrotechnological research, cultivation, and use of appropriate technology. Allproducts have been subjected to quality control, and the products have been distributed through a nationalnetwork of popular pharmacies for medicinal plants, which offers them to the public at very low prices.The Centre forms a part of the National Commission for Essential Investigation, along with the NationalAutonomous University of Nicaragua, and other institutions under the leadership of the Minister of Health.In 1991, the integration of popular and traditional medicine into Nicaragua's local health systems began bytraining nurses, and developing courses in basic plant therapy and health anthropology in the nursingschools. After the change of government in the same year, the National Centre for Popular and TraditionalMedicine became a non-profit foundation, independent from the Ministry of Health, with the followingobjectives:- to recover, preserve, and develop the resources, techniques and procedures of popular and traditional
WHO/TRM/98.1page 9medicine;- to ensure the application of technical resources and knowledge acquired by investigation andinterchange of information on popular and traditional medicine;- to design and implement a national programme for the promotion of the use of medicinal plants andthe prevention and cure of illnesses; and- to create a network for distribution and commercialization of medicinal plants and their derivativesthrough popular, private, and state pharmacies.The Ministry of Health has included herbal products in the basic list of medicines to be made available throughcommunity pharmacies in the local health systems. This is considered to be a significant step towards theintegration of traditional medicines into the national health care system of Nicaragua [24].United States of AmericaMarket Importance of Herbal ProductsThe use of herbal medicines in the USA is less widespread than in the majority of developed nations. Thereason is that their distribution has mostly been limited to health food stores which are frequented by only asmall proportion of the population. Wider distribution through pharmacies is difficult because no medicalclaims may be made and consumers are dependent on advice from pharmacists who, in a majority of cases,have little knowledge about medicinal herbs [25].Legal StatusIn the late 1930s, the Food, Drug and Cosmetic Act was passed and, from that time on, the Food and DrugAdministration (FDA) has regulated as drugs any products which claim to treat, cure, mitigate or prevent adisease. Thus, for any herbal medicine claims to be allowed, the same procedures must be followed as for achemical drug. Most natural products in the United States are regulated as foods or food additives even thoughmany are used by consumers as folk medicines. As such, most of the regulatory action occurs in the area ofsafety. Where a herb is "generally recognized as safe" (GRAS), this means ensuring that no claims are madeand products are not being misbranded or adulterated. Natural products theoretically have GRAS status, solong as qualified experts confirm this and are not contradicted by other experts. According to a court case in1983, the requirement of "common use in food" was not restricted to use in the USA, but applied also to herbswithout a history of use in the USA [25].Some better known medicinal herbs are listed by the FDA for over-the-counter status. However, an 18-yearreview of over-the-counter drugs has resulted in most of those medicinal herbs being dropped, mainlybecause the US herbal industry failed to submit evidence to support their use as such. In November 1992, theFDA established a new advisory committee of outside experts for over-the-counter drugs [25].New LegislationSince 1976, following the "Proxmire Bill", a civil regulation for the Health Food Market states that foods,including dietary supplements and herbs, are not drugs. This law kept the FDA from making monographs ondietary supplements, vitamins, minerals and herbs, as has been done for several kinds of drugs [25].In 1990, Congress passed the Nutrition Labelling and Education Act (NLEA) which required that all foodproducts must have nutritional labelling, and that the FDA has to establish criteria for approving health benefitlabelling for foods. An exemption to the NLEA was introduced noting that vitamins, minerals, herbs and similarnutritional substances are consumed differently from conventional food and thus should be subject to morelenient standards of evidence for their health benefits. Congress gave the FDA one year to receive publiccomment as to how to establish standards and procedures for the assessment of health claims for thesupplements that where exempted from the rest of the NLEA. A proposal submitted by the American HerbalProduct Association was rejected by the FDA [25].Dietary Supplements, not Food AdditivesIn October 1994, the Dietary Supplement Health and Education Act [26] recognized that dietary supplementshave been shown to be useful in preventing chronic diseases and therefore help limit long-term health carecosts. Herbs and other botanicals, vitamins and minerals now fall under the definition of a dietary supplementwhich is presented in a dosage form such as capsules, tablets, liquids etc., and which is not represented as aconventional food, but which is labelled as a dietary supplement. Dietary supplements do not include
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Page 7 and 8: WHO/TRM/98.1page 3medical practices
Page 9 and 10: WHO/TRM/98.1page 5Traditional medic
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Page 17 and 18: WHO/TRM/98.1page 13DenmarkUnder the
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Page 21 and 22: WHO/TRM/98.1page 17IrelandThe Medic
Page 23 and 24: WHO/TRM/98.1page 19substances from
Page 25 and 26: WHO/TRM/98.1page 21leaflet [92].Swi
Page 27 and 28: WHO/TRM/98.1page 23The requirements
Page 29 and 30: WHO/TRM/98.1page 25chemical identif
Page 31 and 32: WHO/TRM/98.1page 27Western PacificA
Page 33 and 34: WHO/TRM/98.1page 29- combined prepa
Page 35 and 36: WHO/TRM/98.1page 31The Working Part
Page 37 and 38: WHO/TRM/98.1page 33results, etc. ar
Page 39 and 40: WHO/TRM/98.1page 35In New Zealand,
Page 41 and 42: WHO/TRM/98.1page 37to be seen by TC
Page 43 and 44: WHO/TRM/98.1page 39IV. REFERENCES[1
Page 45 and 46: WHO/TRM/98.1page 41[43] 580. Verord
Page 47 and 48: WHO/TRM/98.1page 43[87] Association
Page 49: WHO/TRM/98.1page 45viewpoint. Drug

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