Stakeholders say the guidance leads towards the potential for more products with health benefits demonstrated on clinical rather than healthy populations as are currently favoured by the EU nutrition and health claims regulation (NHCR).
It follows a European Commission request as the category gains more and more interest across European member states as governments and other stakeholders invest more in the idea of managing sick or diseased people via nutrition to reduce burgeoning public healthcare costs.
“great market opportunity”
Dr Annegret Auinger, head of consulting at German contract research organisation and consultancy, analyse&realize, said the guidance presented a “great market opportunity”.
“We see opportunities for scientifically justified nutritional products in the area of joint health and cognition. It could solve the problem for products having clear nutritional benefits in diseased populations, but which find it difficult to demonstrate this in healthy populations as required for health claims applications.”
A 1999 EU Directive defined medical foods as being “intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two."
But as the market has evolved EU member states have moved in different directions creating a “challenging” situation where the definition of a medical product varies amid a landscape where foods for particular nutritional purposes such as meal replacements and sports foods have also been subject of regulatory rethinking about what they are and at which outlets they should be available and to whom.
In this way, the foods for specific medical purposes (FSMPs) guidance is careful to exclude infant formula, follow-on formula, processed cereal-based food, baby food, gluten-free foods, lactose-free foods as well as total diet replacement and meal replacement for weight control as they are covered by other category-specific regulations.
“Member States' experts have in particular flagged that an increasing number of products are notified as FSMPs in their territory, very often with doubts arising on whether these products really comply with the definition of FSMP,” EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) writes in the guidance.
“This situation may be detrimental to the interests of consumers, can affect competition and may pose challenges for the free circulation of goods in the EU.”
The NDA said the document could also help member state enforcement agencies police markets.
The full guidance is here: