On 20 November 2014 the German Supreme Administrative Court (Bundesverwaltungsgericht, “BVerwG”) confirmed that nicotine-containing liquids that are vaporised and inhaled via e-cigarettes are not medicines and therefore e-cigarettes are not medical devices.
The BVerwG issued this ruling on three revision procedures against decisions of the Appeal Administrative Court of Münster of September 2013. The decisions are not yet available online, so this report is based on the BVerwG’s press release (available in German only).
The BVerwG ruled that nicotine-containing liquids are not medicines in the sense of the German Medicines Act (“AMG”). They do not fulfil the conditions of a medicine by presentation, as they are not marketed (“presented”) as means for the treatment, alleviation or prevention of disease. Also, their presentation does not give the consumer the impression of a medicine.
The BVerwG found that the liquids are not medicines by function either. Nicotine is indeed a substance that appreciably influences human physiological functions through a pharmacological action. However, the assessment of a product as a medicine by function must follow on a case by case basis and take into account all characteristics of the product. On this basis, the BVerwG agreed with the Appeal Court that such liquids do not possess any medicinal property. These liquids do not have a therapeutic ability because use of e-cigarettes as an aid for a long-term smoking and nicotine withdrawal is not scientifically proven. As a result, consumers do not attribute any medicinal purpose to nicotine-containing liquids but use them as consumer goods (the German term is “Genussmittel”, which can be literally translated as “means for pleasure”).
The BVerwG also found that warnings by public authorities against sales of e-cigarettes and liquids do not fulfil the conditions of the AMG and the German Medical Devices Act for issuance of such warnings because liquids and e-cigarettes do not fall under the provisions for medicines and medical devices.
The references of the three cases are the following:
BVerwG 3 C 25.13 – Decision of 20 November 2014
OVG Münster 13 A 2448/12 – Decision of 17 September 2013 (appeal)
VG Düsseldorf 16 K 2585/12 – Decision of 10 October 2012 (first instance)
BVerwG 3 C 26.13 – Decision of 20 November 2014
OVG Münster 13 A 1100/12 – Decision of 17 September 2013 (appeal)
VG Köln 7 K 3169/11 – Decision of 20 March 2012 (first instance)
BVerwG 3 C 27.13 – Decision of 20 November 2014
OVG Münster 13 A 2541/12 – Decision of 17 September 2013 (appeal)
VG Düsseldorf 16 K 3792/12 – Decision of 10 October 2012 (first instance)