The judgement of the Regional Appeal Court in Celle of 24th June 1999 – Case No.: 13 O 320/98 – “S G” fitness product – delineation between dietary supplement and medicine

1. The question to be answered is, whether a product supporting muscle exercises (4-aminobutyric acid) which has been advertised in a bodybuilding magazine should be regarded as a medicine, the sale of which without the authorisation required under the Pharmaceutical Act constitutes an infringement of § 1 of the Unfair Competition Act.

2. Dietary supplements are not articles of food within the meaning of § 2 (3) No. 1 of the Pharmaceutical Act, § 1 of the Food and Commodity Goods Law, if they are consumed for purposes other than nourishment.

Court’s reasoning:

1. Summary of facts:

The judgement was based on the fact that the defendant advertised her preparation “S G”, which consists only of 4-aminobutyric acid, using among others the expression “100% pharmaceutical quality”. The Regional Court ordered the defendant to cease and desist, reasoning that gamma-amino-butyric-acid is a medicine, whereas the preparation did not have an authorisation required by pharmaceutical law.

2. Reasoning of the Regional Appeal Court in Celle

The Regional Appeal Court in Celle held a claim under § 1 of the Unfair Competition Act in connection with §§ 2, 16 of the Pharmaceutical Act for unfounded. Going back to § 2 (3) No. 1 of the Medical Preparations Act in connection with § 1 of the Food and Commodity Goods Law, the Court examined the question at first, whether we are concerned here with an article of food as defined by § 1 of the Food and Commodity Goods Law. In accordance with this regulation, articles of food are defined as substances which are intended to be consumed by human beings, which excludes substances being consumed predominantly” for purposes other than nourishment or pleasure. Considering the purpose of a substance and its actual role on the market, the possible ways it can be used are decisive as objective characteristics. Thus, dietary supplements can be regarded as articles of food, only if their consumption can be put down to nutrition grounds, i.e. if insufficient nutrition leads to consuming such dietary supplements. From the point of view of its role on the market, “S G” seems to be intended for purposes other than nutrition, since it has no consumption value, its advertising by means of the expression “100% pharmaceutical quality” does not speak for a dietary supplement. Furthermore, gamma-amino-butyric-acid is generally regarded as a medicine, and the dosage instructions on the package do not speak for a dietary supplement from the point of view of the user (“3 to 4 g a day; 2.6 g 30 minutes before sleep and 1.3 g in the morning on an empty stomach…”). Although effects are not specified on the package, there is, however, a reference to specialised literature, in which the preparation is spoken of as a medicine.

3. Comment

The effect of the judgement deserves approval. According to § 2 (1) of the Pharmaceutical Act, medicines are substances and preparations made from substances which, by application on or in the human or animal body are intended among others to cure, alleviate, prevent or diagnose diseases, suffering, bodily injury or disease symptoms. Furthermore, according to § 2 (1) No. 5 of the Pharmaceutical Act, medicines are also substances intended to influence either the nature, the state or the functions of the body or mental health conditions. According to § 1 (1) of the Food and Commodity Goods Law, articles of food are defined as substances which are intended to be consumed by human beings, which excludes substances being consumed “predominantly” for purposes other than nourishment or pleasure. § 2 (3) No.1 of the Pharmaceutical Act constitutes the delineation between medicines and foodstuffs, stating that drugs shall not be foodstuffs as defined in § 1 of the Food and Commodity Goods Law. Thus, substances as such cannot be foodstuffs and drugs at the same time. This was established by the Federal Supreme Court already in the Garlic-Capsule-Decision (Knoblauch-Kapsel-Entscheidung, BGH NJW 1995, 1615). Trying to answer the question whether you are concerned with a foodstuff or a medicine, you should start with the question, whether you are concerned with a foodstuff. If a product consists of substances which are mostly intended for purposes other than nourishment or pleasure, this is not a foodstuff or a dietary supplement. The second step is to establish on the basis of advertising leaflets, instruction for use, etc. whether the product in question is a medicine as defined in § 2 (1) of the Pharmaceutical Act. The matter becomes critical, when the “influence on the functions of the body” is predominant. The reasoning of the Regional Appeal Court in Celle offered sufficient indications in this case.