Navigating the borderline between food and medicine: further clarifications released by CJEU
Global law firm Covington recently publicised the court ruling (made 2nd March 2023) in its recent ‘Food and Drug Regulatory’ feature.
The legal experts explain in their post that the associated dispute arose following proceedings between Landeshauptmann von Wien (Head of the Government of the Province of Vienna, Austria) and Kwizda Pharma GmbH, whereby the company had attempted to classify four of their products as FSMPs to treat UTIs.
The existing definition of Article 2(2) of regulation (EU) 609/2013 states an FSMG is a: “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 key points that were clarified from this included establishing a borderline between FSMPs, medicines and food supplements, the concept of ‘dietary management’ with regards to the link between nutrients and the disease, as well as the phrase ‘cannot be met by diet alone’. Additionally, the terms ‘nutrient’ and ‘used under medical supervision’ were also clarified.
Brian Kelly, co-chair of Covington’s Global Food Industry Group, tells NutraIngredients: “It is always a bit of a tightrope trying to navigate the borderline between foods and medicines, and the job is all the more difficult when trying to classify FSMPs versus medicines as both have a disease component.
“The up-shot is that a case-by-case assessment is required and companies wishing to notify their FSMPs in the future should review the principles in these cases and make sure that their marketing of their products aligns with the Court's reasoning. For products already on the market, I think it would be prudent to review in particular marketing material to ensure that the positioning of products remains in the FSMP lane,” he stresses.
Borderline Between FSMPs and Medicinal Products
The report regards the definition of a medicinal product as stated by Article 1(2) of Directive 2001/83/EC:
“(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.”
It was specified by the CJEU that if the product offers a “general benefit” to the prevention of a disease, then it cannot be classified as a FSMP. They concluded that establishing such a borderline would lie in concluding if the product was “intended to meet particular nutritional requirements” or “to prevent or cure human disease”.
Concept of ‘Dietary management’
The CJEU iterated that for a product to be classified as an FSMP, 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” is required.
“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,” Kelly specified in the release, with regards to the ‘modification of the diet alone’ aspect.
Yet he adds that this would be further assessed on a case-by-case basis.
Definition of a ‘Nutrient’
With the lack of definition for a ‘nutrient’ with regards to both FSG and FSMP regulations, the CJEU sought to clarify this utilising the concept used for FIC regulation whereby it is defined as a “protein, carbohydrate, fat, fibre, sodium, vitamins and minerals […] and substances which belong to or are components of one of those categories.”
‘Used under medical supervision’
The report cited the court’s conclusion for the ambiguity: “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.”
Borderline Between FSMPs and Food Supplements
Kelly explains the court’s awareness of the inevitable overlap in the uses of FSMPs and food supplements yet highlights how their legal qualifications still remain exclusive. It is emphasised how supplements are an addition to the diet, whilst FSMPs are for “dietary management [which] cannot be effected solely by means of modification of the normal diet.”