On the 27 October 2022, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling regarding the definition of foods for special medical purposes (“FSMP”). The CJEU held that for a food product to be classified as an FSMP, it must cover the increased or specific nutritional requirements caused by the disease. It is not sufficient that the product counteracts the disease or alleviates its symptoms, as that would blur the lines between foods and medicinal products.
1. Background to the Dispute
This ruling arose in the context of an action brought by Verband Sozialer Wettbewerb e.V. (“VSW”) against Orthomol pharmazeutische Vertriebs GmbH (“Orthomol”) regarding two Orthomol products classification as FSMPs. This action was brought before the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany) at the first instance and was then appealed to the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany) which then referred the case to the CJEU for a preliminary ruling.
In the national proceedings, VSW challenged Orthomol’s classification of two of its products (Orthomol Immun and Orthomol AMD extra) as FSMPs. Orthomol marketed Orthomol Immun as being used to “support the immune system using nutritional science’ for ‘the dietary management of nutrition-related immune deficiencies’ (for example, recurrent respiratory infections’)” and Orthomol AMD extra as being used for the “dietary management of advanced age-related macular degeneration’ (‘AMD’).” VSW submitted that these products did not meet the definition of an FSMP and therefore should not be marketed as such.
Article 2(2)(g) of Regulation 609/2013 (the “FSG Regulation”) defines an FSMP as “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” (emphasis added).
VSW argued that the illnesses which Orthomol claimed the products were indicated for did not “lead to a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foods or certain nutrients contained therein, or metabolites, within the meaning of the first situation envisaged under [Article 2 (2)(g)]” (paragraph 16). Furthermore, VSW argued that the second limb of the FSMP definition, specifically “medically-determined nutrient requirements”, only covers diseases “giving rise to a particular energy and nutritional need, such as cystic fibrosis, cancerous cachexia, serious wounds/burns/pressure ulcers, and not the substances used to treat the disease itself” (paragraph 16).
The referring court asked the CJEU to clarify the concept of “other medically determined nutrient requirements” under the second limb of the FSMP definition. In particular, the German court asked whether the phrase meant that the disease must give rise to increased nutritional requirements or whether it was sufficient that the patient benefitted generally from the intake of that food because it contained certain substances, which counteract the disorder or alleviate symptoms.
2. CJEU Judgment
The CJEU analyzed the FSMP definition in detail:
- Per definition, FSMPs are “‘specially processed or formulated’ to meet particular nutritional needs of patients and which may be used only under medical supervision” (paragraph 29).
- There are two possible intended uses:
- “for patients whose capacity to take, digest, absorb, metabolise, or excrete ordinary food or some of its ingredients or metabolites is limited, impaired or disturbed” (limb 1); or
- “for patients whose medical condition gives rise to other medically determined nutrient requirements which cannot be satisfied by a modification of the normal diet alone” (limb 2) (paragraphs 31 and 32).
- For a product to qualify as an FSMP, it must be clearly suitable to address the “nutritional needs, caused by a disease, disorder or medical condition” (paragraph 34). It is not sufficient for the product to have a general benefit to the patient and otherwise combats disease (paragraphs 34 and 35).
- There has to be a clear distinction between the FSMPs and medicinal products. In accordance with Article 1(2) of Directive 2001/83/EC, a product presented as having properties for treating or preventing disease or which is intended to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action would qualify as a medicinal product (paragraph 38). FSMPs are not intended for such purpose, as they are intended to meet a patient’s nutritional needs (paragraph 39).
- The provisions of the FSG Regulation and Delegated Regulation (EU) 2016/128 (“FSMP Regulation”) confirm this interpretation:
- Article 9 FSG Regulation requires that the composition of FSMPs must be appropriate to satisfy the nutritional requirements of the patient for whom they are intended and the labelling must not suggest that the food has properties of preventing, treating or curing disease (paragraphs 45 and 46).
- The FSMP Regulation requires that the composition of an FSMP must be adapted to meet the nutritional needs of the relevant disease, disorder or medical condition and the needs of the intended patient (para. 49).
- The FSMP Regulation also requires that the food information indicates the nutritional requirements, the disease, disorder or medical condition and the properties or characteristics that make the product useful for the specific nutritional requirements. The Court concludes that these requirements imply that the FSMP is supposed to meet “the nutritional needs caused by the disease, disorder or medical condition” (paragraphs 50 and 51). As such, a product which has a general benefit to a patient does not have the properties or characteristics to meet the specific nutritional needs (paragraph 52).
- This interpretation is also supported by the general objectives of the FSG Regulation, including the need to ensure a uniform interpretation of different food categories. As such, it would not be appropriate to interpret the FSMP definition so broadly that it would blur the lines with other product categories (paragraphs 53 to 55).
- Classifying a product that has a general benefit to patients as an FSMP because it counteracts a disorder or alleviates symptoms would blur the lines between food and medicinal products. A product, which counteracts or alleviates disease but does not meet specific nutritional needs of a patient would need to be classified as a medicinal product and would require a marketing authorisation (paragraphs 56 and 57).
Consequently, the CJEU concluded that “the concept of ‘other medically determined nutritional requirements’ must be interpreted as meaning that a product constitutes a food for special medical purposes if the disease results in increased or specific nutritional requirements which the food is intended to cover, such that it is not sufficient, for the purposes of such a qualification, 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” (paragraph 59).
This is the first CJEU ruling which engages in detail with the FSMP definition. It offers an important clarification that in order for a product to be positioned as an FSMP, it must be intended to address nutritional needs, which arise from a specific disease, disorder or medical condition, a general benefit is not sufficient. This judgment clarifies the delineation between FSMPs and medicinal products.
The judgment does not touch on the delineation between FSMPs and food supplements. However, that distinction also appears reasonably clear. FSMPs are intended to address specific nutritional needs arising from a disease, disorder or medical condition, “which cannot be achieved by modification of the normal diet alone”, while food supplements are intended to “supplement the normal diet” (Article 2(a) Food Supplements Directive 2002/46/EC).
Companies marketing FSMPs in the EU should therefore assess whether the CJEU judgment has any bearing on their FSMP classifications.