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BGH - Muscle building supplements

The judgement of the German Supreme Court of Justice (File Number I ZR 34/01) - Muscle building supplements

The case concerns the distinction between medicines and foodstuffs. Referring to the definition of medicine in the second paragraph of Article 1 of Community Directive 65/65/EEC, the Supreme Court held that the concept of medicine must be interpreted broadly enough to cover all substances capable of affecting the actual functioning of the human organism. It observed that it was for the national authorities, subject to judicial review, to determine whether, given its composition, the potential risks generated by long-term consumption or its side-effects and, more generally, its overall characteristics, including its composition, its pharmacological properties as demonstrated by the current state of scientific knowledge, the mode of administration, the extent of its distribution, consumers’ familiarity with it and the potential risks from using it, a product was or was not a medicine. The Supreme Court held that the entry into force of Regulation No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety had no impact on the demarcation line between foodstuffs and medicines as the Regulation merely introduced the concept of medicine as defined by Directive 65/65 into food law.

Substances preventing muscle loss and accelerating recovery and regeneration after training can be generally considered to be dietetic foodstuffs, if and as long as they meet the special physiological requirements of a given group of persons and do not predominantly serve purposes other than nutrition.

Doping substances, especially anabolic steroids and other performance-enhancing substances with similar effects, being predominantly intended to serve purposes other than nutrition or consumption, i.e. being substances which are intended to influence the nature, the state or the functions of the body, are generally regarded as medicines as defined by Section 2 (1) Nr 5 of the German Pharmaceutical Act.

The provision of Section 73 (2) Nr 6a of the German Pharmaceutical Act provides for an exception from the prohibition of introduction within the meaning of Section 73 (1) Sentence 1 of the German Pharmaceutical Act only for drugs which are allowed to be marketed abroad.

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