The Prohibition of Medicinal Claims: Food in Fact But Medicinal Product in Law?

Abstract

Under EU medicinal law, any substance or combination of substances presented as having properties for treating or preventing disease in human beings is a medicinal product by virtue of its presentation. Under EU food law it is prohibited to attribute to any food the property of preventing, treating or curing a human disease. However, if certain conditions are fulfilled, it is allowed to make health claims for foods. Medicines are excluded from the definition of food. A product cannot at the same be both a food and a medicinal product.

Authorities in the Netherlands take the position that the EU prohibition on medicinal claims for foods is redundant because every product for which such claim is made, is a medicinal product by virtue of its presentation. By consequence, claims not (fully) authorised as health claims are enforced as infringements on medicinal law.

Against this background, the authors systematically and comparatively analyse the food aw prohibition on medicinal claims in relation to the concept of medicinal product by presentation. They argue that the presentation criterion is structural in nature and depends on the overall impression an averagely well-informed consumer acquires regarding a product. The prohibition on medicinal claims is behavioural in nature. In the view of the authors, it is possible to promise consumers too much regarding beneficial properties of a food without actually making them believe that the food is a medicinal product. Thus, they argue against the Dutch interpretation regarding the delineation of EU medicinal law and EU food law and in favour of a interpretation adhered to by most other EU member states.

Keywords: Medicinal claims, Food law, Pharmaceutical law, Medicinal product by virtue of presentation

JEL Classification: K23, K32