World Health Day: Labelling of FSMPs, a determining factor for manufacturers and users

The “purpose of the food” is a key concept in food law as it is the determining factor for defining a food product category. The article below will articulate how this is embedded in the labelling requirements of foods for special medical purposes (FSMPs).

The composition or formulation of a food product cannot determine per se its product category. For example, a specific vitamin can be present in a general food, in a food supplement, in a sport food or a FSMP, etc. The presence of a nutrient or ingredient does not determine a food product category.

In the drug regulatory framework, the presence of an active pharmaceutical ingredient (API) will be a determining factor for a classification as a drug. A nutrient or ingredient-based categorization would certainly be a simple and handy approach, but unfortunately it does not work in food law. Sometimes, the absence of a nutrient or ingredient can on the contrary be a determining factor for the categorization of a food product (e.g. gluten free or lactose free products).

In food law, it is the intent of use of a product, its purpose, that determines the food category. The determination is made by the manufacturer. It will impact the regulatory framework that will apply to the food product.

The category might determine some aspects of the formulation of the product (E.g., nutritional profile, additives that can be used, levels of contaminants allowed). But more importantly it will determine the labelling requirements – beyond the general food ones applicable to all food.

Labelling is essential in food – to inform the consumer on the characteristic of the food. The importance of labelling is even more significant in foods for special dietary use (FSDU) as the purpose of the food – the specific dietary use – is a key aspect of this category. The significance of the purpose is even more obvious for FSMPs – as their very name emphasizes the special medical purpose of this specific type of FSDU.

FSMPs are highly specialized foods designed and developed for the specific dietary management of patients who have a disease, disorder, or medical condition. Those will either temporarily or permanently affect their ability to achieve a suitable nutritional intake from normal foods alone.

FSMPs are then often subdivided based on being a complete or incomplete formula – where a complete formula may be suitable to be used as the sole source of nutrition. To be noted some complete FSMPs can be used as both sole or supplemental source of nutrition, depending on the instructions of use. The delivery mode of an FSMP is also a distinctive feature with oral nutrition or enteral nutrition. Those elements are important information that must be provided though the labelling.

The main determining factor for an FSMP is linked to the presence on the label of the following information: [“For the dietary management of …” followed by the name of the disease, disorder or medical condition for which the product is intended, or any equivalent language or suggestion]. This is mandatory statement on an FSMP that must appear somewhere on the label. Important to note that this information is different from a voluntary health claim.

Labelling plays therefore a key role in the determination that a food is an FSMP.

This also explains why it is crucial to be able to provide some information on the key characteristics and properties on front of the FSMP pack of the FSMP product, in order to help ensure a safe selection and administration of the product by the health care professional and the patient.

The FSMP can have a disease specific nutrient adapted formulation or be based on a more standard nutrient composition (i.e., non-disease specific formulation). The description of the product may include on the label the specific nutrients that have been reduced, increased, or are absent. Or the label could stipulate the specific source or nature of the ingredients used, or any relevant element linked to the disease considered.

FSMPs may be used in a diverse range of medical conditions or diseases. Their composition in terms of nutrients, ingredients or even product format, may vary to provide health care professionals with options that are appropriate for the specific need.

The reference to specific nutrients on the label participates to describing the properties and characteristics of the FSMP product. It cannot be considered as a voluntary nutrient content claim. As a result, the necessary description of the properties and/or characteristics may include descriptions such as, ‘With Fibre’, ‘High Energy’, ‘High Protein’.

These descriptions are important so that all involved in prescribing, dispensing and selecting a product can easily identify its content and suitability.

Labelling in FSMPs plays therefore a double critical role, by determining the FSMP categorization and properly informing the health care professionals and patients. It is also essential to ensure that important, determining and discriminative information is present in front of pack.

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