Regulatory Situation of Herbal Medicines A worldwide Review

WHO/TRM/98.1page 10substances first sold as drugs and later as dietary supplements, nor do they include substances undergoingclinical studies which were not first sold as dietary supplements. The law provides that a dietary supplement isconsidered to be a food which does not need pre-market approval by the Food and Drug Administration (FDA),and not as a food additive which needs a pre-market approval by the authority. A statement on the label of adietary supplement is allowed if a benefit is claimed related to a classical nutrient deficiency, if the role of thenutrient or dietary ingredient is described, or if the documented mechanism of action to maintain a function ischaracterized. In addition, however, it must be clearly stated that this statement has not been evaluated by theFDA, and that this product is not intended to diagnose, treat, cure or prevent any disease. Furthermore, theingredients, and the plants or parts of plants respectively, and their quantity must be clearly listed. If thesupplement claims to conform to an official compendia standard (USP) for which there is an officialspecification, and fails to meet that standard, the product is regarded as misbranded. This also applies in thecase of a product which is not covered by an official compendium, but which fails to have the identity, strength,quality, purity which it may claim to have.The new law provides for the establishment of an Office of Dietary Supplements within the National Institutesof Health, which should explore the role of dietary supplements to improve health, and should promotescientific studies of the benefits of the dietary supplements [26].The signing into law of the Dietary Supplement Health and Education Act in October 1994 may accelerate therecognition and increase the importance of herbal products in the US market, because the law may give anopportunity to market these products as dietary supplements, providing there are data to show that theproducts are safe and to support any claims with reasonable substantiation. The chances, however, to marketa herbal product as a drug and to give it medicinal claims are low, because at present the FDA does notaccept bibliographic evidence of effectiveness, but prefers randomized controlled trials as evidence of efficacy[27].Eastern MediterraneanOmanIn the Sultanate of Oman, the following groups of traditional medicines are in the market:- Chinese herbal medicines available through Chinese clinics;- Indian herbal medicines available through Ayurvedic clinics;- traditional homoeopathic medicines available through homoeopathic clinics; and- traditional treatments of illnesses in villages or rural areas.Until a new framework for regulatory control becomes available, which is expected in the near future, the fewcontrols which exist are regulated by guidelines issued for import and traditional drugs in 1995. Theseguidelines state which documents have to be submitted to the Directorate General of Pharmaceutical Affairsand Drug Control to receive permission for marketing these products:- free sale certificate issued by the country of origin together with a GMP certificate;- labelling including active ingredients, quantitative composition, route of administration, date ofmanufacture and expiry, badge number, and storage conditions;- a scientific report from the manufacturer indicating the origin of each ingredient, its pharmacologicaleffect and therapeutic uses, side effects, adverse reactions, precautions, overdose effects andantidotes, and a list of countries where the product is marketed;- a guarantee that the product does not contain other drugs such as corticosteroids, sex hormones, orimpurities such as insect parts or other products [28].Saudi ArabiaIn accordance with articles 44 and 50 of the Act for the Practice of the Pharmacy Profession and Trade inPharmaceuticals and Medical Products, issued by the Royal Decree No. M/18 of 18/03/1398, registration ofmedicinal products by the Ministry of Health is obligatory. Paragraph 13A of the special provision of regulationfor registration which was amended through the Ministerial Resolution No. 1214/20 dated 17/06/1409 subjectsto registration, in addition to drugs, products with medicinal claims or containing active ingredients withmedicinal effects such as herbal preparations, health and supplementary food, medicated cosmetics,antiseptics or medical devices. A herbal preparation is defined as a product prepared for therapeutic and/orprophylactic use, the active ingredients of which are of plant origin. The definition is limited to preparations tobe administered locally, orally, rectally, or by inhalation [29].