The 13th Senate of the Higher Administrative Court today ruled in three cases that nicotine-containing liquids (so-called liquids) that are vaporized and inhaled by using e- cigarettes, no drugs are , accordingly, the e -cigarettes are not medical devices themselves .
In the first case, a woman had complained that a store for cigarettes and e- liquids operates in Wuppertal and had the health department of the city of Wuppertal prohibits the sale of nicotine liquids on the grounds that it states that it is not authorized medicines . The administrative court in Dusseldorf dismissed its application in the first instance . On appeal, the Supreme Administrative Court granted the application .
Subject of the second method was a press release from the Ministry of Health of North Rhine -Westphalia on 16 December 2011 , in which it was warned of the distribution of nicotine to keep liquids because they are drugs whose distribution is punishable without approval. Again, the Administrative Court of Dusseldorf had rejected the claim of a manufacturer of such liquids to cease this statement , although the Supreme Administrative Court had given in a previous fast-track the state of North Rhine -Westphalia by interim order , to refrain from this statement : Such liquids are not medicinal products (see press release the OVG NRW of 23 April 2012). Again, the Supreme Administrative Court upheld the action in the main proceedings .
In the third case, two companies that nicotine-containing cigarettes and e- liquids complained manufacture or distribute . They wanted to leave to the Federal Institute for Drugs and Medical Devices judicial notice that no liquids and medicines necessary for the evaporation of e- cigarettes are not medical devices . That action, the Cologne Administrative Court had already upheld. The Supreme Administrative Court upheld this ruling on appeal.
In support of the three judgments , the Supreme Administrative Court has essentially decided that nicotine -containing liquids are not a medicinal product by presentation because they are not indicated or recommended as a means to cure, mitigate or prevent disease ( presented ) would . But also the liquids are not a medicinal product by function . According to settled case law of the European Court had to decide whether a product is a medicinal product by function , are taken on a case by case basis, taking all the features of the product are considered , ie, composition , methods of use , volume of distribution , brand awareness among consumers and risks of use . The application of these criteria leads to the conclusion that nicotine-containing liquids are not medicinal products . Drugs typically have a therapeutic fitness and a therapeutic purpose . Both conditions are not met in nicotine- hold liquids . Thus, these liquids are neither suitable nor intended to achieve a lasting cessation . Walked away from both the Federal Centre for Health Education as well as the German Cancer Research Center and the latest scientific studies.
The Higher Administrative Court has approved in all three cases, an appeal to the Federal Administrative Court.
Case number : 13 A 2448/12 , 13 A 2541/12 and 13 A 1100/12
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