The European Commission recently published a Notice on the classification of Food for Special Medical Purposes (FSMP) that provides guidance to companies and national regulators on the legal framework applicable to FSMP and on the criteria that are required to classify a product as a FSMP (Notice).
The Notice confirms that FSMP is in principle food and not medicine, although any product presented for the prevention or treatment of a disease or perceived as such by an averagely well-informed consumer cannot be classified as FSMP. FSMP is also different from food supplements or fortified foods, which are foods intended to supplement a normal diet. FSMP may be used as a sole or partial source of nutrition by patients suffering from a certain disease, disorder or medical condition and only under medical supervision. In this respect, products should only be classified as FSMP where it is not realistic, practical, safe or nutritionally/clinically advantageous to satisfy the nutritional requirements of these patients through the exclusive consumption of food that is not FSMP. The Notice sets out factors that are intended to help companies in this assessment, including the availability of other foods with similar composition and dosage on the market (e.g., food supplements), which would unlikely classify the product as FSMP. This would also be the case of a product that can be used without medical supervision within the context of the dietary management of the patients.
To date, the European Commission has not adopted any ‘interpretation decision’ on whether a given food is appropriately classified as FSMP, as it is empowered to do by regulation. Therefore, companies should be cautious and take due consideration of the guidance provided in the Notice as well as of the European Food Safety Authority scientific and technical guidance on FSMP of 2015 when conducting a case-by-case analysis of whether a product complies with the FSMP definition. Caution is key in the FSMP area where, as the Notice clarifies, companies should not benefit from the mutual recognition principle to justify classification of a product as FSMP.
Below we set forth a more detailed review on the Notice.
FSMP is regulated under the Food for Specific Groups Regulation (FSG Regulation), which sets out general compositional and information requirements applicable to FSMP. The FSG Regulation applies since 20 July 2016. In addition, Commission Delegated Regulation (EU) 2016/128 supplements the FSG Regulation as regards the compositional and information requirements for FSMP. As of 22 February 2019 (22 February 2020 for FSMP intended for infants) the Delegated Regulation shall replace the FSMP Directive, which lays down compositional and labelling criteria for FSMP under the former general framework on food intended for particular nutritional uses (PARNUTS Directive). Until such dates, the FSMP Directive remains applicable except in the case of conflict with the FSG Regulation, where the latter shall prevail.
So, what is a FSMP?
FSMP is specially processed or formulated food that is intended for the exclusive or partial dietary management, under medical supervision, of patients who suffer from certain diseases, disorders or medical conditions and whose nutritional requirements cannot be met by normal food. The FSMP legislative framework does not impose pre-authorisation requirements to place a FSMP on the market and is based on a notification procedure (unless a Member State exempts from this obligation). Companies can, therefore, market products on the basis of their own assessment as to the compliance of the product with the FSMP framework, subject to Member States’ enforcement. However, Member States reported concerns about the increasing number of products marketed in the EU as FSMP but where such classification may not be justified or rather respond to unrelated considerations (e.g., seeking reimbursement under medical insurance scheme). Furthermore, Member States may have different approaches regarding the possible classification of a product as FSMP. Within this context, the Notice aims to provide guidance in order to facilitate compliance with the FSMP framework by companies (and national regulators in their enforcement duties) and, in particular, with the criteria required to classify a product as FSMP.
The FSG Regulation defines 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”.
With respect to the above, the Notice provides guidance on:
- The difference between FSMP and other products, especially, medicinal products: It confirms that FSMP is in principle food and not medicine, although any product presented for the prevention or treatment of a disease cannot be classified as FSMP. The Notice makes clear that, while the FSMP shall bear the statement “For the dietary management of […]” – where the blank shall be filled in with the disease, disorder or medical condition for which the product is intended – the dietary management of patients suffering from a specific disease, disorder or medical condition is clearly different from the treatment of such disease, disorder or medical condition. However, when an averagely well-informed consumer can perceive such dietary management statement as being intended for treatment (e.g., a product containing lutein presented for the dietary treatment of age related macular degeneration) the product will be classified as a medicinal product. Furthermore, the FSMP definition has to be interpreted narrowly, so as to distinguish it from foods other than FSMP such as food supplements or fortified foods, which are intended to supplement a normal diet. In addition, a novel food ingredient that has been authorised for use in FSMP would not lead to classify the product as FSMP unless said product meets the FSMP definition set out in the FSG Regulation.
- The concepts “specially formulated”, which refers to the development stage of the product recipe prior to manufacturing, and “specially processed”, which refers to the manufacturing stage where there is substantial alteration of the original product. Products that are neither specially processed nor formulated to be suitable for the dietary management of patients should not be considered as FSMP, yet this does not preclude FSMP from containing ingredients of a ‘natural composition’.
- The concept “to be used under medical supervision”: Consumers of FSMP are patients, where the term “patient” should be understood as “people suffering from specific diagnosed diseases, disorders or medical conditions who, as a result of such disease, disorder or medical condition need to consume FSMP”. In addition, FSMP must be used under medical supervision. Consequently, products (i) intended for consumers who do not suffer from disease, disorder or medical condition (e.g. products intended for healthy infants, healthy pregnant women, sportspeople …) or (ii) that can be used without medical supervision within the context of the dietary management of the patient should not be marketed as FSMP.
- The “dietary management” concept: FSMP aims to provide nutritional support to patients suffering from a specific disease, disorder or medical condition leading to (i) a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or (ii) other medically-determined nutrient requirements. Companies and regulators must, therefore, assess to which extent it is “impossible, impractical, unsafe or nutritionally/clinically disadvantageous” for these patients to satisfy their nutritional needs through the exclusive consumption of food that is not FSMP. If their nutritional needs can realistically be satisfied by consuming exclusively food that is not FSMP (through modification of the normal diet) no product should be labelled as FSMP for the dietary management of said patients on the market.
- The “modification of the normal diet” concept: Food supplements and fortified foods must be considered normal foods apt to modify a normal diet when assessing whether and to which extent it is realistically possible that the patient’s dietary needs be met by modifying the normal diet rather than through FSMP. For the purposes of the assessment, the Notice sets out factors to determine whether consumption of the product at stake is more practical or safer than the exclusive use of other food, or whether it has a nutritional or clinical advantage for the patient over other food (e.g., it would be challenging to classify as FSMP a product that contains a similar composition and dosage than a food supplement that is available on the market).
FSMP can be classified as nutritionally complete products with a standard formulation, nutritionally complete products with a nutrient-adapted formulation, or nutritionally incomplete products with a standard or nutrient-adapted formulation, depending on whether they provide a sole or partial source of nutrition for patients under a standard or nutrient-adapted formulation. In contrast with the nutritionally complete product categories, nutritionally incomplete products do not contain all the essential nutrients or contain them in levels that make them unsuitable as sole source of nutrition and are, therefore, consumed in addition to normal foods, an adapted diet, other FSMP or parenteral nutrition. That being said, nutritionally complete products may also be used for partial replacement or to supplement the patient’s diet.
The European Commission may adopt ‘interpretation decisions’ in the future clarifying whether a given food is appropriately classified as FSMP. Meanwhile, and in any event in the case of other foods, companies should be particularly cautious and follow this guidance to ensure that they market their products in compliance with EU law. The guidance should prove particularly helpful when assessing whether a product complies with the FSMP definition and, in particular, whether it is realistically possible to modify the normal diet of a typical person suffering from the disease, disorder or medical condition for which the product is intended through food other than FSMP.