A recent decision of the European Court of Justice has delineated the borderline between food and medicine in a case involving a German pharmaceutical importer and the administrative authorities. The Lueneburg district's administration had challenged Hecht-Pharma that their product called "Red Rice" was a medicine by function, and that it could not be legally sold in Germany. A "medicine by function" is a product presented and sold as a food, that is determined to really be a medicine because its function is that of "restoring, correcting or modifying physiological functions in human beings".
Hecht-Pharma, which operates a wholesale pharmaceutical business, marketed in Germany a product composed of fermented red rice under the name ‘Red Rice 330 mg Kapseln [capsules]’.
The capsules were marketed in plastic bottles which stated on their labels, inter alia: ‘Red Rice 330 mg, food supplement with fermented rice. One capsule corresponds to 1.33 mg of monacolin k’. The recommendations for use read as follows: ‘As food supplement, 1 capsule 1 - 3 times daily’.
The Niedersächsisches Oberverwaltungsgericht (Higher Administrative Court of Lower Saxony) held that the legislation on medicinal products was applicable on the ground that the product in question could come within the scope of the definition of a medicinal product by function. It contained significant levels of monacolin k. That active substance is synonymous with lovastatin, an inhibitor of cholesterol synthesis which is contained, as an active substance, in a number of prescription medicinal products.
The Niedersächsisches Oberverwaltungsgericht concluded that the product at issue in the main proceedings was liable to lower excessively high cholesterol levels and therefore contribute to the realisation of a therapeutic objective. It added that inhibitors of cholesterol synthesis could also have serious, undesirable side-effects on the muscles and kidneys.
Hecht-Pharma appealed on a point of law against the judgment of the Niedersächsische Oberverwaltungsgericht. During the course of the appeal, the Bundesverwaltungsgericht (Federal Administrative Court) decided to stay the proceedings and to refer the certain questions to the European Court of Justice for a preliminary ruling.
The decision of the EU Court, which no doubt will be greeted with some relief by European supplement manufacturers as well as consumers, sets down a firm marker that helps us understand where the borderline between food [supplements] and medicinal products is to be drawn. A recent revision of European medicines directives had left considerable confusion and uncertainty in that respect. The court intends to limit the application of pharmaceutical law to only those products sold with claims of prevention or cure of illness, and to products which, by their composition, are scientifically proven to be effective in modifying physiological functions.
The full text of the EU Court of Justice decision is available here on the eur-lex site.
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In essence, the decision says that
"...Directive 2001/83, as amended by Directive 2004/27, does not apply to a product in respect of which it has not been scientifically established that it is a medicinal product by function, without its being possible to exclude that possibility [perhaps better translated as: 'even where that possibility cannot be excluded']."
"...a product cannot be regarded as a medicinal product ... where, having regard to its composition – including its content in active substances – and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action."