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Medicinal Claims

Prohibition, Enforcement and Delineation: Food in Fact but Medicine in Law?

Bernd van der Meulen
Keywords: Medicinal claims, Food law, Pharmaceutical law, Medicinal product, presentation

Under EU medicinal law, substances presented as having properties for treating or preventing disease are medicinal products by virtue of their presentation. EU food law prohibits attributing to any food the property of preventing, treating or curing a disease. However, if certain conditions are fulfilled, it is allowed to make health claims for foods. Authorities in the Netherlands take the position that the EU prohibition on medicinal claims for foods is redundant because all products with such claims are medicinal products by virtue of their presentation. Thus, claims not (fully) authorised are enforced as infringements on medicinal law. The author systematically and comparatively analyses the food law prohibition on medicinal claims in relation to the concept of medicinal product by presentation. He argues 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. 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. The author argues against the Dutch interpretation and in favour of an interpretation adhered to by most other EU Member States.

Prof. dr. B.M.J. van der Meulen is food legal consultant and professor of food law at Wageningen University (the Netherlands). Comments and updates are welcome at <>. The author is grateful for information gathered and provided by Ioanna Bousoula (consultant in Greece); Jürgen Conzen (attorney in Sweden); Patrick Coppens (consultant in Belgium); Péter Dévényi (Government of Hungary); Susie Stærk Ekstrand (attorney in Denmark); Malin Erliden (attorney in Sweden); Nicole Grmelová (researcher in Czech Republic); Christine Grit (FNLI in the Netherlands); Joost van Hilten (Waar&Wet in the Netherlands); Martin Holle (Professor of food law in Germany); Małgorzata Iwanow (professor of food law in Poland); Wendela Meijer (consultant in the UK); Katia Merten-Lenz (attorney in Belgium and France); Francesco Montanari (food law consultant in Portugal); Andreas Natterer (attorney in Austria); Ants Nõmper (attorney in Estonia); Valeria Paganizza (food law scholar in Italy); Hanna Paloheimo (attorney in Finland); Ruta Pumputiene (attorney in Lithuania); Ioana Rătescu (EMA); Vicente Rodriguez Fuentes (attorney in Spain); Raymond O’Rourke (Food & Consumer Lawyer in Ireland); Elena Todorova (attorney in Bulgaria); Xenia Tsitou (Scientific and Regulatory Affairs Manager at Nestlé Switzerland); Marie Vaale-Hallberg (attorney in Norway); Jan Vavrečka (researcher in Czech Republic).


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