The expert group of BVL and BfArM (Germany) have drawn up a policy paper (in German only) on the interpretation of the pharmacological effect in contrast to the nutritional/physiological effect. This is intended to support the industry in categorising products as functional medicinal products or foods. Differences in the use and understanding of the pharmacological effect in the legal and scientific sense are explained.
In addition to other points, the significance threshold is given in-depth attention. Accordingly, a functional medicinal product is one that restores, corrects or influences physiological functions "to an appreciable extent". In other words, it is influenced in a way that exceeds the effects of food consumed in reasonable quantities. This implies that a product does not have to be classified as a functional medicinal product if it can be shown that comparable amounts of a substance are or can be consumed as part of a normal balanced diet.
In the past, the assessments of the joint expert commission from Germany have also been used as an aid in Switzerland. We therefore assume that this will also be the case for this review.
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Pharmacological effect vs. nutritional/physiological effect - where is the boundary?
