Translation of a-t 2022; 53: 88
 

IN BRIEF

FOOD FOR SPECIFIC MEDICAL PURPOSES NOW STRICTLY DEFINED

In a ruling (1) issued in late October 2022, the European Court of Justice (ECJ) defined the conditions under which food for specific medical purposes can be offered. This was a result of a suit filed by the Sozialer Wettbewerb e.V. association aiming to prohibit the company Orthomol from selling ORTHOMOL IMMUN and ORTHOMOL AMD as foods for special medical purposes (balanced diet) for nutritional medical support of the immune system and for diet management in patients with advanced age-related macular degeneration (AMD). The competition association justified this by stating that the areas of application mentioned are not diseases that lead to a disorder of the uptake and utilisation of usual foods or the nutrients contained therein. The district court with which the suit was initially filed confirmed this opinion. Since the company lodged an appeal, the case ended up with the ECJ for clarification of how the term food for special medical purposes is to be interpreted on the basis of the currently applicable EU Regulation No. 609/2013 (2). According to the ECJ, the categorisation only applies "if the disease results in increased or specific nutritional requirements which the food is intended to cover" (1) and a modification of the normal diet alone is not sufficient. It is not sufficient, however, "that the patient derives a general benefit from the intake of that food because the substances that it contains counteract the disorder or alleviate its symptoms" (1). Effects of this type come under the regulations on medicinal products that are subject to market authorisation. Orthomol responded in advance and now simply categorises the products in question as food supplements (3). Other providers of balanced diets may also have to amend their instructions for use and advertising, -Ed.

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