Are foods bearing health claims medicinal products?

Abstract

European legislation on foods and medicine has failed to keep pace with the developments in nutrition and medical science that now recognise many important contributions that diet and individual foods may make to the promotion and maintenance of health. EU food law prevents the communication of these benefits to consumers, whilst the law on medicinal products is established on a very broad basis that also encompasses foods making preventive, therapeutic or curative claims. This legislation, together with the lack of universal definitions in food law, results in divergence and legal uncertainty within and between Member States, and is in urgent need of revision. In this article, these aspects are investigated and illustrated by relevant case law. The legal boundaries of such concepts as "food", "medicinal products", "prevention", "disease risk reduction", etc., based on current EU legislation, national practices and case law, are explored. Finally, the concept of "Disease Risk Reduction", as proposed by various international bodies, is discussed in the light of current legislation, together with a proposal that claims for foods based on this concept should be excluded from the medical scope of the term "prevention". It is concluded that it is necessary to set clear-cut unambiguous definitions for medicinal products and foodstuffs and to clarify in the labelling directive that reduction of disease risk claims do not fall under the prohibition of preventive claims. The recently proposed changes to the definition of medicinal products, the proposed definition of foodstuffs in the general food law regulation, and the discussion paper on health claims on European level fundamentally fail to clarify these issues