Karin Kraft
University Medicine Rostock, Germany
Title: Medicinal Herbal Products versus Botanicals - the European Position
Biography
Biography: Karin Kraft
Abstract
In Europe, herbal medicinal drugs (HMPs), and food, including food supplements, have different legal definitions (Directive 2001/83/EC and Regulation 1924/2006, respectively). They therefore must be clearly separated. HMPs have pharmacological effects and are used for therapy, relief, prevention or diagnosis of diseases. They are subdivided into HMPs with the status well-established use (proven efficacy by at least one sufficient clinical study, proven quality and tolerability, and indications for mainly mild diseases), and HMPs with the status traditional use (proven quality and tolerability, and indications for minor health problems). On the contrary, foods and food supplements have physiological effects and are primarily used for nutrition or health-related effects by healthy consumers. There is no commitment to control for their quality and tolerability, and they are promoted by a health claim. In the EU, food supplements produced from plants and their preparations (“botanicals”) until now very often have unapproved health claims reminding of the indication of HMPs with traditional use status. However, consumers have to be informed correctly on the nutrition and health value of plants and their preparations contained in food and food supplements in order to be able to choose the appropriate product for their needs. Hence, all health claims should be based on relevant health-related effects that have been proven by adequate scientific evaluation