Prof. Dr. Edmundo Brito de la Fuente, Executive Vice-President of Kabi Innovation Centre, Business Unit Enteral Nutrition, Germany (edmundo.brito@fresenius-kabi.com), February 2009.
The term Enteral Nutrition (EN) is used to comprise all forms of nutritional support that imply the use of “dietary foods for special medical purposes also known as FSMP” as defined in the European legal regulation of the commission directive 1999/21/EC of 25 March 1999. This definition is independent of the route of application. It includes oral nutritional supplements (ONS) as well as tube feeding via different tubes placed inside patients (e.g., nasogastric, nasoenteral or percutaneous). This definition differs from others which may include blenderized food. Important to highlight here is the fact that prescription and thus reimbursement of EN products is in many countries (most Europeans) dependent of the use of industrial products rather than the route of application. EN is part of a qualified nutritional regimen in the in-and outpatient setting, and usually one of the tasks of professionals with special training in EN or the nutritional support team. The reader may already note that we are talking here of foods/nutrition for critically and chronically ill patients as well as those who need a specialized nutritional support as a consequence of disease specific treatments.
FSMP products either for tube feeding or as an ONS, may be (1) nutritionally complete (i.e., when given in the recommended amount, to be used as a sole source of nutrition or as a supplement to the patient’s normal intake) or (2) nutritionally incomplete, this means to be used as a supplement only and not as a sole source of nutrition. FSMP products can also be classified as (1) standard formulae – their composition should reflect the reference values for macro and micronutrients for a healthy population, and (2) disease-specific formulae which should include macro and micronutrient compositions adapted to the needs of a specific disease and/or digestive or metabolic disorder.
FSMP products are not clearly differentiated from Functional Foods at least from the definition side. Functional Foods have been defined by the European Commission’s Concerted Action on Functional Food Science in Europe (FuFoSE) as “functional if together with the basic nutritional impact it has beneficial effects on one or more functions of the human organism thus either improving the general and physical conditions or/and decreasing the risk of the evolution of diseases”. It is clear that both FSMP and Functional Foods may have similar health claims which should be clinically proven. It is also clear that these products, FSMP and Functional Foods, are in a so-called grey area which describes the overlapping interest of food and pharmaceutical industries.
From a business perspective, FSMP products are sold to hospitals and nursing homes, at least in Europe and they follow a special and complex regulation and registration pathway. On the other hand, Functional Foods are normally distributed through the massive food channels or supermarkets and health stores. FSMP products should be prescribed in order to get reimbursement whereas Functional Foods are usually a customer choice and thus they have to pay for them. Even though health claims for Functional Foods and thus registration is becoming increasingly complex, at least in Europe, FSMP are still far away in the regulatory frame and in many cases these products are treated as drugs for registration purposes (e.g., China and many LAM countries).
FSMP products have an attractive market, close to 3.6 Billions of Euros, with a double digit growth, in particular in some Asia Pacific countries like China. In most Western European countries, USA and Japan it is a well established market with big pharmaceutical companies (e.g., Abbott, Novartis, Fresenius-Kabi) being the main players. Recently, giant food companies like Nestle and Danone have entered more aggressively into this market and they expect to leverage from the scientific approach usually followed to design and develop new FSMP products, to increase their health image in the normal massive food retail market which includes the Functional Food sector.
As it has already been mentioned above, it is not clearly defined which products should be considered as Functional Foods, even if we only look at the food retail market. Therefore, it is rather difficult to estimate the market size for Functional Foods. Some authors (Hilliam, 2000 – The World of Food Ingredients, 12, 50-52) have estimated the global market to at least 33 billions US$. Other experts have suggested being close to 50 billion US$ (Sloan, 2002 – Food Technology, 56, 32-57).
Finally, the FSMP market is under huge pressure from different national governments in particularly in two fronts; reimbursement and costs. Nowadays, several governments are trying not to reimburse anymore all or part of the FSMP products offer by industry and transfer this specialized feeds/nutrition to the patient’s pocket and budget. The result of this will be a substantial decrease in the quality of life of many patients under Enteral nutrition regimes and in a substantial cost increase in the health care system, because nutrition has been recognized as an important variable that significant reduce the length of stays in hospitals.
On the other hand, regulatory constrains mainly related to health claims and use of specific healthy functional ingredients for Functional Foods is making this food business sector quite challenging. For both FSMP and Functional Foods, the common challenge is to identify efficient and effective responses to patients and consumer expectations for health-enhancing-supporting food and nutrition.