Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Demarcation of Herbal Borderline Products Medicinal Products or Food Supplements? ***
Anne Althoff (Abschlußjahr: 2006)
Language: English
The demand for products that have a beneficial effect on human health is growing. Many food supplements with herbal ingredients promise to have this effect. These herbal products are often located in a transitional area since they can have attributes of medicinal products as well as of food supplements. The demarcation of these products is unambiguous and often different opinions exist between producers and authorities in terms of the classification of a specific product as food supplement or as medicinal product. Furthermore it is possible that a product is classified as a food supplement in one member state and as a medicinal product in another.
In 2002, a harmonised definition for food supplements was introduced into European legislation with Directive 2002/46/EC. In addition, the definition of medicinal products was amended with Directive 2004/27/EC.
In this thesis it is examined if the classification of borderline products has become easier with these new provisions. The qualification of existing criteria for the classification has been analysed using the example of three herbal products. All of them were classified as food supplements by their vendors.
The first example product derives from the Tibetan traditional medicine. A similar product exists in Switzerland where it is registered as a phytotherapeutic medicinal product. This product is presented as an example for a function medicinal product that has been marketed as a food supplement.
The observation of fewer menopausal complaints in Asia in relation to the typical diet with plenty of soy led to the development of the second example product. This product is an example for products, which fall under the newly introduced provision for cases of doubt.
Before the first distribution, the third example product was relatively unknown in Germany. Therefore there was no perception about the status of the product and the position of customers and authorities was significantly formed by the presentation and promotion of the first suppliers who promised medicinal effects. This product is an example for a presentation medicinal product.
The presented examples show that the classification of borderline products has not become easier with the introduction of a harmonised legislation for medicinal products and food supplements in the European Union.
According to current legislation and case law, the classification of a specific product has to be conducted case by case. For demarcation, the identification of pharmacological properties of a product is an important criterion. However, this criterion is difficult to determine since a legal definition does not exist.
Furthermore the current state of Community law still allows that the classification of specific products as medicinal product or as foodstuff may be divergent between the member states.
A first step for an improvement of the present situation is announced in the frame of the new health and nutrition claims Regulation of the European Commission, which will bring clarity for the promotion of food in relation to statements about the health value of products.
For a further improvement of the current situation some proposals are made:
- The positive lists in Annex I and II of Directive 2002/46/EC relating to food supplements should be amended through extension of the positive lists with more substances suitable for food supplements. Furthermore maximum amounts for these substances should be given.
- The criterion "pharmacological properties"/"pharmacological action" should be legally defined or a more suitable criterion for the demarcation should be evolved.
- A guideline for the demarcation of borderline products on a European level should be developed.
With these measures the legal certainty for producers and suppliers would be enhanced and the work of the regulators in the competent authorities could be facilitated.
Pages: 41