title: [Pharmacological properties as criterion of demarcation].
abstract: Because of the growing healthcare market and the increasing health consciousness of the population, more and more food supplements are being placed on the market in addition to medicinal products. Concerning the demarcation of medicinal products to food supplements, not only is the intended purpose of the product critical, but the mode of action of the respective preparation also plays an important role. Following the legal definition, a drug has a pharmacological effect, without it being further defined. Therefore, many courts have already tried to interpret the term pharmacological effect, including the terms metabolic or immunologic effect, and try to describe this in more detail.It should be noted that the pharmacological effect, which means an interaction of the substance of a medicinal product with cellular constituent of the human body - unlike the effect of a foodstuff - must significantly affect the physiological functions and must therefore exert targeted effects on the human body and its functions, more than with the consumption of a conventional quantity of a food would be possible. These modifying physiological functions of the body must be addressed positively, which means beneficial to human health. Products which are consumed only for euphoria purposes, or even have a harmful effect, shall not be classified as medicinal products, despite their pharmacological mechanism of action.
authors.affiliation: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland. kerstin.stephan@bfarm.de.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Stephan
mesh_terms: D019587:Dietary Supplements / Q000145:classification* / Q000592:standards*; D005858:Germany; D033161:Government Regulation; D006801:Humans; D007880:Legislation, Drug; D007881:Legislation, Food; D004364:Pharmaceutical Preparations / Q000145:classification*; D009626:Terminology as Topic
chemical_list: D004364:Pharmaceutical Preparations
keywords: Demarcation; Food supplement; Medicinal product by function; Pharmacological properties