Herbal products: Marketing strategies and legislation

Abstract

Marketing of herbal products in the European Union (EU) has been regulated under national legislation for years, leading to differences in legal status of these herbal products. In one member state, a product may be regulated as a food supplement, while in the other member state the same product is considered a medicinal product, thereby subjected to medicinal law. To provide free movement of these products in the inner market, new legislation has been set to improve harmonization. This raises the question what the appropriate positioning and marketing strategy for a herbal product will be under this new EU legislation. This review describes the legal status and registration procedures of different categories of herbal products, taking into account technical requirements and interesting market perspectives. Information was collected from legislation, guidance and official documents published by the European Commission, European Food Safety Authority and the European Medicines Agency. In addition, information was found in conference presentations and the scientific literature from Medline and Scopus. The EU market of herbal products will change considerably in the near future. Many products now marketed as food supplements will be expected to be registered as traditional herbal medicinal product in the future. However, it will take years for the EU to fully implement the new rules for harmonization. Key words: Herbal medicinal products, food supplements, harmonization of European legislation