The decision concerns four products from Kwizda Pharma which were marketed as food for special medical purposes.

The Austrian authorities refused to approve the products as food for special medical purposes. Kwizda Pharma disputed this assessment and the case was referred to the European Court of Justice for a preliminary ruling. 

In this ruling, the CJEU establishes that the concepts of medicinal products, food for special medical purposes and food supplements are all mutually exclusive. Moreover, the decision establishes that foods for special medical purposes are classified as a medicinal product if these two categories of products overlap. However, when distinguishing between foods for special medical purposes and food supplements, the classification should be determined on a case-by-case basis, and so the classification into one of these categories of products is no longer done automatically as with medicinal products. 

The distinction between foods for special medical purposes and medicinal products

The CJEU establishes that foods for special medical purposes are foods that do not in themselves make it possible to combat a disease, a disorder or a health condition, but are instead characterised by their nutritional function. The nutritional function is understood as being food that has been made or composed especially to meet specific nutritional needs in a patient. 

A product presented as having curative properties in respect of a disease but which are not intended to meet the nutritional needs of patients cannot be marketed as food for special medical purposes.

The distinction between foods for special medical purposes and food supplements

In the distinction between foods for special medical purposes and food supplements, the CJEU finds it important whether it is a supplement to the normal diet or not. 

The characteristics of food for special medical purposes are that it meets certain nutritional needs that cannot be met by altering the normal diet alone. By contrast, a food supplement is an integral part of the normal diet and supplements this.

Food for special medical purposes is also directed towards patients. However, the content of a food supplement is based on a number of maximum levels for vitamins and minerals which are based on the general population’s need for additional vitamins and minerals. 

So the two categories of products are intended for different consumer groups due to their respective characteristics.

Read the judgment of the CJEU.

Do you want to know more?

If you want to know more about the rules on the classification of products like medicinal products and medical devices, please contact Plesner's Life science Team.