On 2 March 2023, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling clarifying various aspects around the classification of products as foods for special medical purposes (“FSMPs”). The CJEU reinforced and supplemented its prior ruling in Case C-418/21 Orthomol (see our blog here for further details).
This case touches on a number of concepts in the FSMP definition. As a reminder, Article 2(2)(g) of Regulation (EU) 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).
In summary, the CJEU concluded:
- In determining the borderline between an FSMP and a medicine, all characteristics of the product need to be taken into account to determine whether it is intended to meet particular nutritional requirements or to prevent or cure human disease.
- The concept of ‘dietary management’ has to be understood to require a link between the disease and the nutritional requirements arising from it, the satisfaction of which is indispensable to the patient. The nutritional requirements do not necessarily have to be satisfied through digestion.
- The concept that the dietary management of the patient cannot be met through ‘modification of the normal diet alone’ means that meeting nutritional requirements through supplementing or changing the normal diet is impossible, dangerous or very difficult for the patient.
- The term ‘nutrient’ has to be interpreted in accordance with Regulation (EU) 1169/2011 on food information to consumers (the “FIC Regulation”).
- A product is ‘used under medical supervision’, “if the recommendation and subsequent assessment of a health professional are necessary in light of the dietary management needs arising from a particular disease, disorder or health condition and the effects of the product on the patient’s dietary management and on the patient” (paragraph 81).
- In determining the borderline between an FSMP and a food supplement, all characteristics of the product need to be taken into account to determine whether it is intended to meet the nutritional requirements of a patient that could not be achieved through regular diet or whether it is intended to supplement the normal diet.
1. Background to the Dispute
This ruling arose in the context of proceedings between the Landeshauptmann von Wien (Head of the Government of the Province of Vienna, Austria) (the “Authority”) and Kwizda Pharma GmbH (“Kwizda”).
Kwizda markets four products intended to be taken during urinary tract infections on the basis that the ingredients (D-mannose and cranberry) prevent bacteria from adhering to the mucous membranes of the urinary tract. Kwizda classified the products as FSMPs and notified them to the competent authority in Austria. However, the Authority refused to accept the FSMP classification. The Authority took the view that the products could not be classified as foods since D-mannose and cranberry did not exert their effect by ingestions in the digestive tract but acted on the renal excretory organs.
Kwizda challenged the Authority’s refusal before the Verwaltungsgericht Wien (Administrative Court, Vienna, Austria) (the “Referring Court”), which decided to stay the proceedings and refer a number of questions to the CJEU for a preliminary ruling. In summary, the Referring Court asked the CJEU to clarify (a) the borderline between ‘FSMPs’ and ‘medicinal products’, (b) the concept of ‘dietary management’ in the FSMP definition, (c) the term ‘nutrient’, (d) the concept ‘used under medical supervision’ in the FSMP definition, and (e) the borderline between ‘food supplements’ and ‘FSMPs.’
2. CJEU Judgment
a. Borderline Between FSMPs and Medicinal Products
Firstly, the CJEU addressed the borderline between the concepts of ‘medicinal product’ and ‘FSMP.’
Article 1(2) of Directive 2001/83/EC (the “EU Medicines Directive”) defines a ‘medicinal product’ as:
“(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”
The CJEU heavily relied on its ruling in the Orthomol case, in which it held that FSMPs are foods which are intended to meet the nutritional needs of patients and not to prevent or cure human disease. Accordingly, if a product offers a “general benefit” in that it contributes to preventing, alleviating or curing a disease, then “the product is intended not too feed [the] patient but to treat him,” and thus, cannot be classified as an FSMP (paragraph 31).
Consistent with prior case law, the CJEU emphasized that it was for national competent authorities to assess a product classification “on a case-by-case basis and taking into account all the characteristics of those products” in order to determine whether they could be classified as FSMPs (paragraph 33). However, at the same time, the Court also noted that products which were “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” (paragraph 33).
In any event, the CJEU noted that in case of doubt, Article 2(2) of the EU Medicines Directive gave clear priority to the medicines rules over other regimes. Following the Court’s recent ruling in Joined Cases C-495/21 and C-496/21 Bundesrepublik Deutschland (Nasal Drops), that provision applies to both ‘medicines by function’ (Article 1(2)(b) of the EU Medicines Directive) and ‘medicines by presentation’ (Article 1(2)(a) of the EU Medicines Directive) (paragraphs 34-35).
The CJEU concluded that in determining the borderline between a medicine and an FSMP, it would need to be established whether the product was “intended to meet particular nutritional requirements” or “to prevent or cure human disease, to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to make a medical diagnosis, or where appropriate, [was] presented as such”, taking into account all characteristics of the product (paragraph 36).
b. Concept of ‘Dietary Management’
The Referring Court also asked the CJEU to clarify the meaning of ‘dietary management’ and ‘modification of the normal diet alone’ in the FSMP definition.
In relation to the concept of ‘dietary management’, the Court recalled its conclusions from the Orthomol case, i.e., that an FSMP had two distinguishing characteristics:
- “it is food intended to constitute the exclusive or partial diet of patients suffering from a specific disease, disorder or state of health”; and
- “it is specially processed or formulated to meet the particular nutritional requirements resulting from such a disease, disorder or state of health” (emphasis added) (paragraph 38).
Therefore, the classification of a product as an FSMP “requires a match between the food, in its composition, consistency or form, and the nutritional requirements, caused by a disease, disorder or health condition, which that food is intended to meet” (emphasis added) (paragraph 40). The CJEU therefore concluded that the concept of ‘dietary management’ meant that the use of an FSMP could not be “merely advisory” (paragraph 42).
However, the Court importantly noted that ‘dietary management’ could not be limited to the satisfaction of nutritional requirements through digestion alone, as certain FSMPs may be used in response to “mechanical or neurological deficiencies that prevent patients from ingesting sufficient food or to the inability of certain patients to excrete certain nutrients” (paragraph 46).
In relation to the ‘modification of the normal diet alone’, the Court cited recital 3 of Commission Delegated Regulation (EU) 2016/128 (the “FSMP Regulation”) and the provision therein that FSMPs are designed “to feed patients affected by or malnourished because of a specific diagnosed disease, disorder or medical condition that makes it impossible or very difficult for those patients to satisfy their nutritional needs through the consumption of other foods” (emphasis added) (paragraph 47). As such, the nutritional requirements served by FSMPs cannot be met through the consumption of ordinary food alone, and therefore the modification of a patient’s normal diet would not suffice. This applies both where it is impossible for nutritional needs to be met through the consumption of ordinary food and where such consumption could only satisfy nutritional needs with great difficulty (paragraph 49). This is to be assessed on a case-by-case basis (paragraph 50).
c. Definition of ‘Nutrient’
The CJEU also set out the criteria for determining whether a substance is a ‘nutrient’, in light of the absence of a definition in the FSG Regulation and the FSMP Regulation.
The CJEU held that the FSMP legislation should be understood in the context of other legislation applicable to foods – given that FSMPs were ultimately foods themselves – and, as such, the concept of ‘nutrient’ should be defined in accordance with the FIC Regulation (paragraphs 59-60). According to Article 2(2)(s) of the FIC Regulation, the term ‘nutrient’ means “protein, carbohydrate, fat, fibre, sodium, vitamins and minerals […] and substances which belong to or are components of one of those categories.”
d. ‘Used Under Medical Supervision’
The Referring Court also asked the CJEU to clarify the meaning of ‘used under medical supervision’ in the FSMP definition and whether such use was a requirement for a product to be classified as an FSMP.
Despite the definition of an FSMP at Article 2(2)(g) of the FSG Regulation including this concept, the CJEU held that it cannot be inferred that ‘use under medical supervision’ is a necessary condition for classification as an FSMP, given that “the fulfilment of such a qualification condition depends on random circumstances independent of the producer of the product in question and materialising, downstream of such a qualification, through the use of that product” (paragraphs 68-69).
However, the Court noted that it was one aspect which competent national authorities had to take into account when verifying for a product placed on the market as an FSMP that the classification is appropriate and whether the product complied with the FSG and the FSMP Regulations (paragraph 70). The Court noted that the mere supply of a product in a pharmacy did not suffice to consider that such a product was used under medical supervision.
The CJEU also clarified that ‘used under medical supervision’ implied that medical supervision was necessary prior to the sale of the product, in the sense it was recommended to the patient by a health professional in light of the former’s dietary management needs (paragraph 74). The concept also implies that medical supervision extend beyond simply the delivery of the product and “continue for the duration of its consumption so that the health professional concerned can assess the effects of the product on the patient’s nutritional needs and on the patient” (paragraph 75).
The Court concluded that “a product must be used under medical supervision if the recommendation and subsequent assessment of a health professional are necessary in light of the dietary management needs arising from a particular disease, disorder or health condition and the effects of the product on the patient’s dietary management and on the patient” (paragraph 81).
e. Borderline Between FSMPs and Food Supplements
Finally, the CJEU also clarified the borderline between FSMPs and food supplements. The Court made clear that while it could not “be ruled out that their uses may overlap”, the two concepts, and the legal qualifications which they entail, remain “necessarily exclusive” (paragraph 83).
The Court pointed out that while FSMPs were intended for “dietary management [which] cannot be effected solely by means of modification of the normal diet”, food supplements were intended to “supplement the normal diet” (paragraph 87).
Ultimately, the CJEU concluded that whether a product should be classified as an FSMP or a food supplement should be determined on a case-by-case basis taking into account all the characteristics of the product.
This judgment builds on the earlier judgment in the Orthomol case and provides further clarifications around a number of aspects of the FSMP definition.
Taking a step back, the products in this case contained D-mannose and cranberry, marketed for use in urinary tract infections. It is worth noting that in 2017, the European Commission adopted Implementing Decision (EU) 2017/1445 under the then applicable Medical Devices Directive 93/42/EEC, concluding that
“The group of products whose principal intended action, depending on proanthocyanidins present in cranberry (Vaccinium macrocarpon) extract, is to prevent or treat cystitis, does not fall within the definition of medical devices set out in point (a) of Article 1(2) of Directive 93/42/EEC.”
This was based on an opinion by the European Medicines Agency on the medicine/ medical device borderline (see our blog post on this topic from 2017 here). This CJEU judgment has now expanded the classification for these products to cover not only the medicine/ medical device borderline but also consider the question of FSMPs and food supplements.