On the European market there cohabit pharmaceutical and food products containing plant derivatives. As a general rule if a herbal product has a therapeutic value in itself or in its use, it should be marketed as a medicinal product. Herbal products sold as food supplements should have nutritional properties to enrich the normal diet. Moreover, herbal medicinal products are considered on a risk/benefit basis when evaluating their safety and efficacy. A food-based product must be absolutely safe.
Of course, this is a too simple vision of the market. Nowadays, you can find the same herbal product sold at the same dosage in the same member state as a medicine, as a food supplement and, simply, as a food. Also, licensing requirements, permissible claims and routes of sale vary from country to country. The reason can be found in the lack of a common legal framework at a European level applicable to food products and in the lack of coordination between the medicine and food offices of the member states' health authorities. This means that, for instance, if a herbal medicinal product is sold as food, the medicines authority simply ignores the problem, because it cares about registered medicines only, and the foods authority considers the medicines authority competent to act, because the product is truly a medicine. This lack of coordination allows the presence on the market of borderline products, sometimes dangerous or with a very low quality profile.
Due to the uncertain interpretation of rules and the lack of a harmonized legislation, anyone who has ever tried to market food supplements containing herbs, having in mind to sell the same product in the majority of EU countries, will experience the range of complications and practical difficulties which may arise. For instance, the first problem may be the legal status of the herbal product: in certain countries it will be deemed as a medicine, in others as a food or a food ingredient. Talking about dietary supplements in Europe means considering both the above-mentioned categories because of the different legal basis that a single product can have in different states. As a matter of fact, we must not limit our discussion to food products. From the description of a herbal product as a medicine or as a food can derive the practical feasibility of marketing it in a number of countries. A good example of this can be marketing a Ginkgo biloba product, claiming its capability to improve brain blood flow, in the United Kingdom. The medicine control agency could consider it a medicine and ask the producer to submit a full pharmaceutical dossier as for a new chemical entity.
After a brief overview of the EU legal models, we will examine the regulatory schemes for herbal products in the main member states.
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