BVL and BfArM position paper on FSMP – Characterization of Food for Special Medical Purpose (balanced diets)
The BVL (Federal Office of Consumer Protection and Food Safety) and the BfArM (Federal Institute for Drugs and Medical Devices) compiled a position paper, which will be the basis for future assessments of FSMP products (Food for Special Medical Purposes). The document outlines the legal basis of this food category with a focus on the demarcation of FSMPs and drugs.
Seven assessment criteria are defined, enabling an objective and comprehensive classification of a product as a FSMP. All these criteria were already documented in the previous regulation, but until now, German authorities have interpreted them with great tolerance. This may change in the future:
As a general term of reference, consumers of FSMP are a specific group of patients with a) a limited, impaired, or disturbed capacity to take, digest, absorb, metabolize, or excrete ordinary food or certain nutrients contained therein, or metabolites or b) patients “with other medically-determined nutrient requirements“. The position paper makes it clear that there must be a causal relationship between “other medically-determined nutrient requirement” and the disease, e.g. an increased salt requirement for patients suffering from cystic fibrosis, because of increased salt excretion. A requirement for omega-3 fatty acids for patients with inflammatory joint disease will no longer be accepted according to the position paper.
Another point that will be handled in a more restrictive way in the future concerns the subsidiarity clause. It requires that the effects of that FSMP cannot be reached by modification of the common nutrition including food supplements. For example, for people suffering from lactose intolerance or from hyperlipidaemia, a modification of the nutrition can be sufficient and FSMPs may not be required.
a&r comments: The position paper of the BVL/BfArM provides more transparency concerning the assessment criteria for FSMPs in Germany. Important to note that BVL/BfArM will evaluate FSMPs based on the above mentioned criteria from now and will not wait until 2019, when the new delegated acts come into force. It remains to be seen how the regional supervisory bodies will deal with already marketed products. If you are interested in more specific information about the new approach taken by BVL/BfArM, please contact us!