On 27 October 2022, the Court of Justice of the European Union (CJEU) ruled in Case C-418/21 that a product constitutes a food for special medical purposes (FSMP) only where the product is intended to cover specific nutritional requirements resulting from a disease, disorder, or medical condition. The CJEU clarified that it is not sufficient that the patient derives a general benefit from the intake of a product for that product to be classified as an FSMP.
Companies operating in the FSMP space in the EU should be aware of this development and may want to consider assessing the impact on their product portfolio. To ensure compliance with applicable requirements, companies may also wish to review EFSA’s scientific opinion which lists the information and scientific data a manufacturer of an FSMP must provide upon request in order to verify and determine whether this product is to be classified as an FSMP. If a product does not meet the criteria of an FSMP, the product may instead need to be re-qualified as a ‘regular’ food or potentially a medicinal product, with respective implications (e.g. withdrawal from market until a marketing authorization is obtained, complex clinical trials, etc.).
CJEU clarifies the two characteristics of FSMP
Prior to the judgment’s release, some FSMP companies mentioned to the Sidley team that they were concerned that the entire definition of an FSMP could be overhauled, and they also wondered how likely it would be that the indications in which FSMPs may be marketed would be limited. Neither happened.
In its judgment, the CJEU dissects the definition of an FSMP in the wider legislative context. In particular, it assessed the part of the definition that refers to “other medically determined nutrient requirements,” see second alternative in Article 2(2)(g) of Regulation No 609/2013. The CJEU juxtaposes this part of the definition with the General Food Law, Regulation (EC) No 178/2002, concluding that an FSMP must be more than a foodstuff: “[I]t does not at all follow from Article 2(2)(g) of Regulation No 609/2013, [that] (…) it is sufficient that a product (…) provides a general benefit to the patient” (emphasis added).
Rather, according to the CJEU, an FSMP must intend to cover increased or specific nutritional requirements resulting from a disease. At the same time, any food business operators should emphasize the specific nature of [the FSMP’s] nutritional function to avoid the classification as a medicinal product. Thus, as its name suggests, an FSMP must neither be a “regular” food nor must it be a medicinal product – it should be a food for special medical purposes.
Accordingly, the CJEU comes to the conclusion (on the basis of the wording of Article 2(2)(g) of Regulation No 609/2013) that FSMPs have two characteristics that distinguish them from other categories of products: First, they are foodstuffs intended for the exclusive or partial feeding of patients with a specific disease, disorder, or medical condition. Second, they are specially processed or formulated to meet the particular nutritional needs resulting from such a disease, disorder, or medical condition.
Companies currently marketing FSMPs or intending to place FSMPs on the market in the EU should evaluate their product’s indication and how they market it. The CJEU did not per se overhaul the definition of FSMPs. But it clarified that it is not sufficient that the consumer derives (only) a general benefit “from the intake of that food because the substances that it contains counteract the disorder or alleviate its symptoms” clarifying that FSMPs “are not ordinary foodstuffs.” FSMPs must, instead, be intended for the exclusive or partial feeding of patients with a specific disease, disorder, or medical condition and specially processed or formulated to meet the particular nutritional needs resulting from such a disease, disorder, or medical condition.
If these conditions are not met, then the product cannot be classified as an FSMP but would rather be regarded by authorities as either a foodstuff or a medicinal product.
Companies operating in the FSMP space in the EU should be aware of this development, assess the impact on their product portfolio, and make the necessary changes to avoid regulator or competitor actions (e.g. in the form of cease-and-desist letters under unfair competition rules) and/or reclassification as a food or even a medicinal product (which would require a marketing authorization).
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