FSMP: ECJ on nutrient requirements. End in sight?
On 27.202022 the long-awaited decision of the ECJ on the questions referred by the OLG Düsseldorf (EuGH C-418/21, 27.10.2022).).
In summary, the OLG Düsseldorf sought to understand what is to be understood by an other medically related nutritional need according to Art 2(2)(g) of Regulation No 609/2013, specifically whether this justifies a broad understanding, as was the case, in particular, in the past case law of the BGH, or a narrow one. The ECJ sees a narrow understanding and states in the operative part:
Article 2(2)(g) of Regulation (EU) No 609/2013 [...], and in particular the term 'other medically necessary nutritional requirements', must be interpreted as meaning that a product constitutes a food for special medical purposes if there is an increased or specific nutrient requirement due to illness, which is to be covered by the food, so that it can be used for such classification is not sufficient, so that the patient generally benefits from the intake of this food because substances contained in it counteract the disorder or alleviate its symptoms.
So does that answer the question of whether the disease has to be causal, for the nutrient needs to be met?
The ECJ justifies this as follows:
34 However, the requirement that the food be adequate in composition, nature, or form for the nutritional requirements imposed by and intended to be met by a disease, disorder, or complaint precludes classifying a product as a food for special medical purposes solely because the nutrients of which it is composed have beneficial effects in the sense that they confer a general benefit on the patient and help to prevent, alleviate, or cure his disease, disorder, or complaint.
35 Indeed, first, although foods for special medical purposes must be designed to meet specific nutritional requirements caused by a disease, disorder or medical condition, it by no means follows from Article 2(2)(g) of Regulation No 609/2013 that, for a product to be classified as a food for special medical purposes, it is sufficient that it has such effects and that it confers a general benefit on the patient.
36 Second, this adequacy requirement illustrates the specific nature of the nutritional function of foods for special medical purposes. Thus, a product that provides a general benefit to the patient or, as claimed by Orthomol with respect to the products at issue, counteracts a disease, disorder or discomfort by providing nutrients, but has no such nutritional function, cannot be classified as a food for special medical purposes.
Unfortunately, this is not a comprehensible justification, because when a nutritional function is present and when it is not is not discussed further. A detailed discussion of the concept of nutrition does not take place at all.
Also in the further one speaks of a nutrition, without going into it, when a nutrition is present and why this should not be given with ingestion of nutrients:
41 However, if a patient derives a general benefit from the ingestion of a product to the extent that its ingredients help prevent, alleviate, or cure a disease, then that product is not intended to nourish that patient but to cure, prevent a disease, or restore, correct, or affect human physiological functions through a pharmacological, immunological, or metabolic action, which argues for classifying that product other than as a food for special medical purposes.
That the reference to dietary management of diseases, disorders or medical conditions for which the food is intended shall not be considered as attributing a property with regard to the prevention, treatment or cure of a human disease is explicitly stated in recital 25 of Regulation 609/2013/EU. Furthermore, recital 15 states "These food categories are essential for the regulation of certain medical conditions and/or, to meet the nutritional requirements of certain clearly designated vulnerable populations." Regulating a clinical picture is therefore the explicit purpose of an FSMP.
The demarcation between diet management for a disease also to regulate a clinical picture from contributing to prevent, alleviate or cure a disease is a linguistic finesse with no meaningful nutritional or medical aspect.
Therefore, without evidence that the disease for which the FSMP is to be taken is causal to the nutrient requirement, FSMPs will not be able to be justified in the future, even if it is shown that the FSMP regulates the disease pattern. This is further confirmed by the ECJ:
50 Furthermore, it follows from Article 5(2)(e) and (g) of Delegated Regulation 2016/128 that any food for special medical purposes must contain, on the one hand, an indication of the nutritional requirements and the disease, disorder or condition for which it is intended and, on the other hand, a description of the properties and/or characteristics to which the product owes its usefulness in relation to the disease, disorder or condition for the dietary management of which it is intended.
51 Such a claim requires identification of the nutritional requirements imposed by the disease, disorder, or medical condition that the food is intended to meet for specific medical purposes.
52 The requirement of this claim clearly confirms that a food for special medical purposes must meet the nutritional requirements determined by a specific disease, disorder, or condition, and that a product that provides a general benefit to the patient does not, in principle, have such properties and characteristics because it is not intended to meet such specific nutritional requirements. It follows that, for this reason, such a product cannot be classified as a food for special medical purposes.
In the end, the ECJ leaves a small hope open when it argues with the sense and purpose of the legal situation and with the fact that these should not overlap with other regulated matters (specifically medicinal products).
56 An interpretation according to which it was sufficient for classification as a food for special medical purposes that the patient generally benefited from the ingestion of a product because substances contained therein counteracted a disorder or alleviated its symptoms would misjudge the special features of foods for special medical purposes and, in particular, call into question the distinction between such foods and medicinal products.
57 If this were done, a product could be classified as a food for special medical purposes if it counteracts a disease or disorder present in the patient, even though it does not meet the nutritional requirements arising from that disease or disorder, but falls under the regulation for medicinal products, which makes the marketing of such products subject to authorization.
This execution could be interpreted again to the effect that a (positive) effect on the disease is harmless, so to speak, as a side effect of the satisfaction of a nutritional requirement resulting from this disease or disorder.
In 2018, we wrote an article about the status quo and future prospects of FSMP (read here). 2022 these are no longer positive, although the arguments of the ECJ raise questions in many places or do not find their coverage in the legal situation with the desirable comprehensibility. A legal situation which existed in the provisions in need of interpretation defacto unchanged since the Diet Framework Directive (RL 89/398/EEC). Distributors of FSMP must now take another close look at their products.