EU - CJEU: Definition of medical foods should be interpreted strictly
Nov 07, 2022
For a product to be classified as a food for special medical purposes (FSMP) it is not sufficient that the patient benefits from taking it because the substances it contains counteract the disorder or alleviate its symptoms. Rather, it is necessary that the food covers the specific nutritional requirements caused by the disease.
The long-awaited ruling from the Court of Justice of the EU related to the classification of “Orthomol Immun” and “Orthomol AMD extra” as FSMPs. The products were promoted in Germany by stating that the first was used to ‘support the immune system using nutritional science’ for ‘the dietary management of nutrition-related immune deficiencies’ (for example, recurrent respiratory infections’)’ and that the second is used for the ‘dietary management of advanced age-related macular degeneration’ (‘AMD’).
Article 2(2)(g) of Regulation No 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control reads:
‘“food for special medical purposes” means food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone’.
The legal issue was determining whether “[patients] with other medically determined nutrient requirements” would cover situations where the nutrient intake is intended to counteract illnesses in another way and the consumer can derive a particular benefit from the controlled intake of certain nutrients, as it was the interpretation of the German Federal Court of Justice.
Basing its interpretation in the wording, context and objectives of the FSMP rules, the EU Court ruled that “[t]he suitability required between the foodstuff, in its composition, consistency or form, and the nutritional needs, caused by a disease, disorder or medical condition, which the foodstuff seeks to address, precludes a product from being classified as a food for special medical purposes solely on the ground that the nutrients of which it is composed have positive effects in the sense that they bring general benefit to the patient and contribute to preventing, alleviating or curing that patient’s illness, disorder or medical condition”.
JUDGMENT OF THE COURT (Second Chamber) of 27 October 2022 in Case C‑418/21 Orthomol pharmazeutische Vertriebs GmbH v Verband Sozialer Wettbewerb eV, available here