The borderline between medicinal products and food supplements

Abstract

The borderline between medicinal products and food supplements is an issue which cannot be solved merely by legislation. The interpretations of the European Court of Justice are therefore important for understanding the underlying problem. Medicinal products are classified by two aspects. Products, which are presented as being a medicine, are by definition to be classified as a medicine. And products, which contain substances that are used with a view to restoring correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action or to making a medical diagnosis, are also to be classified as a medicine.

In its interpretations of the borderline the European Court of Justice came to the following conclusions:

The evaluation of a product has to be performed on a case-by-case basis taking into account its pharmacological properties. If a product falls equally well under the definition of a medicinal product and under the definition of another product group, the definition of a medicine applies. Therefore Member States may classify a product as medicinal product (even if food supplement in another) if all characteristics of both medicinal products and food supplements are equally well met.

The risks of substances and nutrients have to be evaluated on a case-by case basis by the Member State. Therefore multiples of RDAs are no means of setting maximum levels for food supplements. The burden of prove is generally with the Member States.

A complete ban is only justified if in the interest of public health and/or consumer protection. And the absences of nutritional need no justification for ban of a product.