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Sweden: Supreme Administrative Court Declares E-Cigarettes Not Medical Devices

(Feb. 26, 2016) On February 17, 2016, the Swedish Supreme Administrative Court issued a decision in which it found that e-cigarettes are not medical devices and therefore are not regulated by the Läkemedelsverket (Medical Products Agency). (Supreme Administrative Court 2016-02-17 ref 1385-15 (Case 1385-15), download at Press Release, E-cigaretter är inte läkemedel (Feb. 17, 2016), Supreme Administrative Court website.)

Facts of the Case and Lower Court Rulings

The Medical Products Agency had prohibited a seller from selling e-cigarettes and had referred to the Swedish Medical Act (Läkemedelslag [Medical Act] (Svensk Författningssamling [SFS] 1992:859), NOTISUM [in force at the time the case was first brought]; Läkemedelslag [Medical Act] (SFS 2015:315)  NOTISUM [replaced earlier Act].)  The Medical Products Agency had based its prohibition on the fact that e-cigarettes and similar products contain nicotine at a level often used as a means to wean a person from addiction to smoking.  The prohibition was also coupled with a fine (lopande vite) of SEK700,000 (about US$82,000).  (Case 1385-15, at 2.)

The District Court of Uppsala heard the case on appeal and changed the Agency’s decision by limiting the prohibition to only the specific products listed by the Agency. (Id. at 2.)  The Appellate Administrative Court upheld the District Court’s decision, finding that e-cigarettes are medical devices, even if users may use them for recreational purposes.  (Id. at 3.)

Appeal

In its appeal to the Supreme Administrative Court, the representative for the seller of the e-cigarettes quoted both European Union Court decisions and three cases from the German Bundesverwaltungsgericht, which concluded that e-cigarettes are not medical devices. (Id. at 4; for more information see Jenny Gesley, Germany: Electronic Cigarettes, CONGRESSIONAL REPORTS (July 2015); Jenny Gesley, Germany: Federal Court of Justice Classifies Liquids for E-Cigarettes as Tobacco Products, GLOBAL LEGAL MONITOR (Feb. 23, 2016).)

The Medical Products Agency, for its part, stated that the alleged purpose of the device should not be taken into consideration; the mere fact that the device could be used as a medical device was enough to classify it as such. In the specific circumstances of this case, the Agency also pointed out that the seller had marketed the product as a “tobacco weaning product.”  (Case 1385-15, at 4-5.)

Decision

The Supreme Administrative Court concluded that the fact “that a product includes a substance that affects bodily functions is not sufficient for it to be included in the function-based definition of medical devices. In addition, the product must have the function of preventing or treating an ailment.” (Id. at 8.)

The specific products at issue had been designed and marketed as a “healthier stimulant than cigarettes,” the Court noted, and found that the e-cigarettes had thus been produced with the express purpose of “emulating ordinary tobacco cigarettes.” The e-cigarette could also, through the use of scents, be made enjoyable, in the Court’s view.  Thus, the Court found that the e-cigarettes in question were not medical devices and that therefore the Medical Products Agency lacked the authority to prohibit their sale.  (Id. at 9-10.)