Food for special medical purpose

Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (as amended by Directive 2006/141/EC)sets out rules for the composition and labelling of foods that are specifically formulated, processed and intended for the dietary management of diseases, disorders or medical conditions of individuals who are being treated under medical supervision. These foods are intended for the exclusive or partial feeding of people whose nutritional requirements cannot be met by normal foods. The Directive gives guidance for the minimum and maximum levels of vitamins and minerals. Directive 2006/141/EC amended the levels of manganese in products intended for infants and young children. The Scientific Committee on Food has in its opinion (see below) on foods for special medical purposes of December 1996 provided the scientific advice on which these rules are based. Nutritional substances that may be used in the manufacture of foods for special medical purposes are laid down in Commission Regulation (EC) No 953/2009.

Food for special medical purpose (FSMP) is an alternative route to bring efficient products to market; the use of this opportunity is in some European countries more used than others. Nevertheless FSMP is in our experience an opportunity used much too little.

The characteristics of this category are quite unique, read more about them below:          

Marketing options are limited to one indication per product.

In most member states this product cannot be marketed directly to the consumer but instead to pharmacists, GP’s, hospitals etc.

The distribution path is in most member states very different from those of supplements.

It is mandatory that the claim states: “For the dietary management of XXXX” where XXXX is the name of the disease.

The upper hand for FSMP compared to food supplements is that you are not allowed to say that food supplements can benefit/help you with anything specific unless you hold a health claim which is very expensive to achieve. Consequently the best marketing statement on your product is the mandatory claim.

Still one of the challenges when bringing a FSMP product to market is the product description. The words must be chosen carefully and the indication described without interfering with medicinal legislation.

We believe that if the product has a proven efficacy this is the category with the best business opportunities in Europe, though depending on your distribution strategies. However it is our experience with the FSMP products we have brought to market for our clients, that food authorities have tightened the requirements for the product documentation regarding efficacy.

As a consequence hereof market opportunities emerge and become interesting if you have the right idea/product.

We can be at your service from the very beginning. You may have an idea and a start for a FSMP product which you want us to help finish up and make ready for a FSMP application or perhaps you are already holding the finished product receipt. We can develop a full product concept for you or we can assess what you bring, no matter what, we will make sure that the regulatory part is fulfilled with ingredients, label etc. and if you wish for us to help with market strategy or commercialization we will of course be able to assist you with that as well.

We have the scientific and legal knowledge to help your product safely through this minefield of legislation. We help you define the widest possible limits for your product thus ensuring the necessary background for a legal, safe and for the consumer attractive product.