About us  · Patent law  · Trademark law  · Contact  · Legal notice  · Privacy Policy  · Links  ·

horak.
Attorneys at law

Health law  · Pharmaceutical law  · Foodstuff law  · Medical devices  · Medical Law  · Health care system  · Pharmacies Law  · Case law  ·

attorney at law hannover germany health law health law firm food lawyer medicine law food right pharmaceutics law pharma lawyer europe european law german food law healthlaw pharma law cosmetic law biotechnology law biotech law health insurance law

health lawyer health law sport law pharmacies law gene technology law medical profession law new foodstuff law food supplements law funtional food law  attorney germany draft of medicine law contracts check of agremments attorney at law

novel food law haelth care products law medicines law lawyer attorney law firm specialised in health care law distribution of medicine health care insurance product liability health care claim law hccr lawyer physicians law clinic law

health care attorneys germany europe pharmacies law hospitals law lawyer plant varities law patent law trademark law

... health-lawyer ... Case law ... OLG-Celle-Fitness
health-lawyer
Case law
EuG-Bayer Crop Science
OLG-Celle-Fitness
EuGH-DocMorris
BGH-Muscle building supplements
EuG-Williams


horak.
LawyerS
Attorneys-at-law

Georgstr. 48
30159 Hannover
Germany

Fon +49/511/357356-0
Fax +49/511/357356-29
E-Mail
info@healthlawyer.de

OLG Celle Fitness

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.

 

gesundheitsrecht anwalt medizinrecht medizinrechtler kanzlei arztrecht deutsch health law haelth attorney food stuff attorney competition law sience lawyer english

© Attorney at law Michael Horak 2002-2018

health_lawyer_german_germany_europe print  attorney-at-law-hannover-germany-europe-food_law_pharma_lawyers save attorney-solicitor-medical_devices_health_care_system back german-law-european-law-eurpean-lawyer-specialist-expert-german-law_healthlawyer  medicine law food law pharma law cosmetic law medical law biotechnology law hospital law patient law health insurance law health care system law pharmacies law sports law Online-Request