4 things to know about food for special medical purposes (FSMP)

Published on 29 September 2022 Read 25 min

Food for Special Medical Purposes, or FSMP, can be quite hard to apprehend. What are they exactly? How are they different from other food supplements? How are FSMP regulated? What are the related market opportunities? Alcimed studied these food for special medical purposes and highlighted 4 key elements to know about them.

FSMP as part of Foods For Special Dietary Uses (FSDU)

According to the International Special Dietary Foods Industries, food for special medical purposes are a subtype of Food for Special Dietary Use (FSDU). FSDUs include FSMP but also baby food, gluten-free food or sports food.

In particular, the role of FSMP is to feed exclusively or partially people whose nutritional requirements cannot be met by normal foods. This includes, for example, patients suffering from cancer, from dysphagia or even children suffering from rare genetic metabolic diseases.

At the opposite, some products are not considered food for special medical purposes: it is the case of food supplements, or parenteral nutrition products. The condition for being considered a FSMP is to be administered orally or via the gastrointestinal tract with a tube or catheter, based on a healthcare professional decision.

Food for special medical purposes do not undergo pharmaceutical regulation

If parenteral nutrition bags follow the pharmaceutical regulations, FSMP don’t. In Europe, they benefit from a lighter regulation under the supervision of the EFSA (European Food Safety Authority).

The main pillars of FSMP regulations are:

  • Pesticides concentration in the final product
  • Vitamins and mineral quotas to respect
  • Labelling

In the US, where FSMP are commonly called “medical foods”, FDA states that “only food regulations apply to medical foods”, meaning that once again, FSMP do not undergo pharmaceutical regulation.

Regulators promote a flexibility in composition, and therefore allow manufacturers to innovate in their products. Flavors, textures or even environment-friendly packaging are some of the interesting topics to explore in the FSMP market!

You wouldn’t have thought that FSMP indications are diversified and reach every age group

Malnutrition is the main reason food for special medical purposes are used: indeed, in Europe, it is estimated that 40% of hospitalized adults suffer from it. If cancer-related-malnutrition and gastro-intestinal diseases are well known for using FSMP, they are not the only indications.

Dysphagia post-stroke: dysphagia is the difficulty to swallow and can be caused by various etiologies. Stroke is one of them, because it can cause weakening of swallowing mechanisms.

Rare metabolic diseases: for example, phenylketonuria is a rare inborn disease causing an error of amino acid metabolism characterized by elevated blood phenylalanine and low levels or absence of phenylalanine hydroxylase enzyme. For those patients, FSMP without phenylalanine are required for life.

Dehydration: diarrhea episodes in children are more dangerous than in adults because the dehydration is much faster considering their smaller fluid volume. Oral rehydration solutions can be given during diarrhea episodes, and are FSMP as well.

Food for special medical purposes are a growing market

The global food for special medical purpose market size is expected to reach about $19.41 billion by 2030. And even if the COVID-19 pandemic might have slowed down the pace because of supply chain disruptions, the demand is growing back.

From healthcare professionals’ point of view, there is a real rise of awareness about the role that nutrition can have on diseases. Moreover, the increasing prevalence of chronic conditions and the ageing of population increase the number of patients that could benefit from FSMP. These trends are global and are relevant also for emerging markets (Asia Pacific, Middle East & Africa, Latin America), meaning that their need for FSMP is growing.

For sure, food for special medical purposes will occupy an important place in the future of healthcare as there are various products that can target different age groups. Healthcare professionals are becoming more and more aware of FSMP possibilities of use, and new markets are emerging. Their regulation encourages flexibility and innovation as long as safety, efficacy and suitability of ingredients are proved, then why not deciphering your possibilities in FSMP? Alcimed can help you exploring FSMP market and opportunities, and patient pathways.

About the authors,

Margaux, Consultant and Hélène, Project Manager in Alcimed’s healthcare team in Italy

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