Electronic Cigarette Industry Trade Association
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Combined cases: BVerwG 3 C 25.13, BVerwG 3 C 26.13, and BVerwG 3 C 27.13
NOTE: At the time of writing, the Court documents have not yet been published, but in due course, they will be found at http://www.bverwg.de/entscheidungen/entscheidungen.php?sort=datum1
On 20th November 2014, the Bundesverwaltungsgericht ("BVerwG") (the German Supreme Administrative Court) ruled that eliquids containing nicotine as vapourised and inhaled via electronic cigarettes are not medicinal products, and that therefore, electronic cigarettes are not medical devices.
The BVerwG ruling dealt with three revision procedures against decisions of the Administrative Court of Appeals at Münster, from September 2013.
According to the BVerwG's press release:
The Federal Administrative Court in Leipzig has ruled on three appeal proceedings today that nicotine-containing fluids (e-liquids) are not drugs, and the ways in which electronic cigarettes are used do not lead to the conclusion that such devices should be classified as medical devices.
Case no’s. BVerwG 3 C 25.13 and 3 C 26.13
The plaintiff in the first case, a retail store selling e-cigarettes and accessories in Wuppertal since December 2011, had been prohibited from the distribution of nicotine-containing liquids since December 2012, on the premise that e-liquids are unauthorised drugs. The Administrative Court dismissed the case against the prohibition. On appeal by the applicant, the Higher Administrative Court modified the judgement and the contested decision was annulled because it was ruled that the contested e-liquids are not medicinal products and that their sale cannot, therefore, be legally prohibited.
The Higher Administrative Court’s decision was appealed to the Federal Administrative Court, but it was again rejected. The nicotine-containing liquids are not medicines within the meaning of the Medicines Act. Furthermore, they do not satisfy the conditions of a medicine by presentation. According to the Court of Appeals, binding factual findings of the Appellate Court, the liquids are not marketed ("presented") as a means of cure, mitigation or prevention of diseases; nor does the product packaging give the consumer the impression that the e-liquids are a drug product. It was also concluded that e-liquids are not considered as medicines by function, although nicotine is a substance that affects the physiological functions by exerting a pharmacological effect. However, to arrive at a decision as to whether a product falls within the definition of medicinal product by function, all the characteristics of the product must be taken into account.
Based on this overall view, the Federal Administrative Court concluded that the e-liquids play no medicinal role as medicinal products. After the Appeal Court’s decision finding that e-liquids do not possess a therapeutic utility until the benefits of e-cigarettes as a tool for lasting smoking cessation can be proven scientifically, it was concluded that nicotine-containing e-liquids provide no medicinal purpose, acting primarily as a stimulant.
Case no. BVerwG 3 C 27.13
In a second appeal case, a manufacturer of electronic cigarettes and liquid-containing filter cartridges objected to a press release published in December 2011 by the North Rhine-Westphalian Ministry of Health. The M.o.H. warned of the trade and sale of e-cigarettes and e-liquids and had emphasised, in particular, that nicotine-containing e-liquids should only be placed on the market with regulatory approval. It was also stated that e-cigarettes are only likely to be distributed subject to the labeling requirements under the Medical Devices Act. The action for cessation of these comments has remained before the Administrative Court. On appeal by the applicant, the Higher Administrative Court upheld the complaint and the defendant country is prohibited from making these statements.
The Federal Administrative Court has rejected the appeal by the respondent. The plaintiff can claim the omission of the official statements because the state action of providing information has violated their fundamental right of free occupational exercise. After the statements by the Higher Administrative Court, the public statements have impaired the position of the plaintiff in the market place and is equivalent to a sales limitation. Because of this effect, similar to prohibition, the action of the information was the functional equivalent to a classic administration measure by means of sovereign regulation and was defeated, therefore, to the legal standard demanded for it to be valid. It was concluded that the statements of the ministry were illegal because there was no legal basis upon which to make such assertions.
Certainly, the monitoring authorities allow the rules of the medicine law and the medicine product law, if required, and also action through public warnings. Here, however, the presuppositions were not fulfilled, because the e-liquids and e-cigarettes do not fall under the regulatory drug and medical devices legislation.
(Our translation and paraphrasing.)
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