by Annegret Wiedemann
On first sight, you would think it is very clear to define what is a food and what is a medicine. But with some products it can be quite challenging to draw a distinct line between these two categories. These kinds of products are often referred to as “borderline products” and if you are faced with one it is important to know the legal basis for a classification as food or medicinal product.
The definition of a medicinal product used to be very simple according to Directive 65/65/EC which has stated that a medicinal product is “any substance or combination of substances presented for treating or preventing disease”. But this definition was further amended by Directive 2004/27/EC (still valid under “European drug law” 2001/83/EC), which specifies a medicinal product by a “pharmacological, immunological or metabolic action” modifying physiological functions. Thus, a medicinal product can be defined by its presentation or by its action.
On the contrary, food or better “foodstuff” is regulated by 178/2002/EC and defined as “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans”. It especially excludes medicinal products within the meaning of 65/65/EC and it creates the European Food Safety Authority (EFSA), to oversee the control and evaluation of food.
In generally it is not allowed to attribute the property of preventing, treating or curing a human disease to food except it complies with the health claim regulation 1924/2006/EC. This regulation states that a health claim is “any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health” and which is substantiated by “generally accepted scientific evidence”.
In the case a product can fall under both definitions, it would fall in the category of a medicinal product according to directive 2001/83/EC.
The definitions about medicinal product and food may easily be applied on “classic” foods like vegetables, meat and fruits. But what is with “lifestyle products” like dietary food or food supplements. How can we draw a line there and what differentiates a food supplement or dietary food of a medicinal product? To answer these questions, we must have a closer look into the food legislation.
Food for special medical purposes
The grounds for dietary foods or more exactly foods for special medical purposes are laid down in the directive 609/2013/EC. This directive defines food for special medical purposes as “food specially processed or formulated and intended for the dietary management of patients (…) to be used under medical supervision (…) intended for the exclusive or partial feeding of patients with limited or 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”. This directive is supplemented by the delegated regulation 2016/128, which specifies compositional and information related requirements for foods for special medical purposes. Moreover, the delegated regulation determines the labelling information which should include e.g. a statement that the product must be used under medical supervision and the statement “for the dietary management of…” filled with the disease or medical condition it is intended to be used for. Especially the last statement makes foods for special medical purposes an interesting category because it allows drawing a relationship to a disease without the use of a specific health claim, which would have to be pre-authorised by EFSA. Nevertheless Article 9.5 of the directive 609/2013/EC forbids “to attribute to such food the property of preventing, treating or curing a human disease, or imply such properties”. Thus, labelling has to be selected with caution to fulfill all criteria.
Food supplements are defined by regulation 2002/46/EC as “foodstuff the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form”. But isn’t a substance with a physiological effect falling under a medicinal product by function? According to the European Court of justice (Case C-140/07) this definition does not apply to a product that “if used as intended, is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action”. This ruling suggests that the action must be significant, but unfortunately no further definition of significance is available. Furthermore, marketed in dose form means e.g. as pills, tablets, powder etc. and as such the food supplements strongly resemble the appearance of a medicinal product. Nevertheless article 6.2. forbids to attribute the property of preventing, treating or curing a human disease. Consequently, every claim that states or suggests a relationship between the food supplement and health has to be assessed for scientific evidence by EFSA according to the Health Claim regulation 1924/2006 before placing the product on the market.
As you can see the assignment of a “borderline product” to the category of a medicinal product or a food can be quite challenging especially for the so called “Lifestyle products” like dietary food or food supplements. Therefore, a careful evaluation of the product and the underlying legislation is indispensable.