„Medicinal Herbs: drugs or dietary supplements? What are the legal consequences in terms of quality, safety and efficacy of each option?“

Within the group of herbal or botanical products there is a large variation with regard to the properties and the legal status worldwide of these products. Some herbal products come closer to or are medicines, while others are close or even identical to foods such as dietary supplements, functional foods, novel foods etc. And still others are considered as cosmetics or medical devices.

It is therefore not surprising that recently appropriate regulatory actions have been undertaken to regulate and harmonize the legal status of these various groups of plant preparations throughout the different Western countries.

The European Union has recently considered herbal products in several legislative texts. Medicinal use has been harmonized through the Traditional Herbal Medicinal Products Directive (Directive 2004/27EC amending Directive 2001/83/EC as regards THMPs).

Use of herbal preparations in unit dose form under food law is covered in the Food Supplements Directive (FSD) 2002/46/EC. Regulations on nutritional and health claims and the addition of vitamins and minerals and certain other substances to foods were adopted on October 12, 2006. (Directive 2006/C80E/02 and 03).

Nevertheless, the distinction between traditional herbal medicinal products and food supplements containing herbal products without nutritional value but having physiological effects remain vague and controversial.

Moreover, at the occasion of the organization of the 7th Joint Meeting of AFERP, GA, PSE, SIF and ASP the opportunity is seized to confront the European lecturers with representative speakers of the US Food and Drug Administration (FDA) and the American Herbal Products Association (AHPA).

While the US FDA was unwilling to approve herbal medicinal products for many years and more than 30.000 dietary supplements are currently being marketed in the US, it has opened its policy with the publication in 2000 of the „Guidance for Industry, Botanic Drug Products“. However, up to date only few botanical drug product applications were filed.

It is the aim of this workshop to discuss the implementation of the current European regulations at the level of EU Member State authorities and manufacturers in terms of quality, safety and efficacy of these herbal products.

Both the US and European concepts shall be compared and evaluated. Advantages and disadvantages of both concepts shall be highlighted taking into account not only quality, safety and efficacy, but also aspects such as access to the market, cost prize and prospects for innovation of herbal products.