Important for E-Cigarette Manufacturers: E-Cigarettes are considered to be Medications

In the view of the Federal Government of Germany, the nicotine tanks or liquids for the operation of e-cigarettes are subject to the German Medicine Act.

Hamburg/Berlin (hib/MPI) – In the view of the Federal Government of Germany, the nicotine tanks or liquids for the operation of e-cigarettes are subject to the German Medicine Act. In their answer (17/8772) to the small inquiry of the parliamentary party Die Linke (17/8652) the government refers in this context to the pharmacological effect of the substance nicotine. Furthermore, the government mentions that according to the prevailing opinion these nicotine products are not regarded as tobacco products. Therefore, the exception for tobacco products provided in the German Medical Act is not applied.

The government explains that according to their opinion the placing of nicotine depots, tanks or liquids, to be used in e-cigarettes without statutory approval for pharmaceutical products would violate the German Medicine Act. This does not apply for the mere use of e-cigarettes containing nicotine. However, according to the stipulation of the law for the protection of non-smokers in the federal republic prohibits smoking even of e-cigarettes in federal agencies in public, means of transportation and train stations. Due to the corresponding laws for the protection of non-smokers there may be other limitations in the different countries.

According to the Federal Government e-cigarettes are products, at which an evaporating liquid is inhaled when smoking. The inhaled vapor shall be experienced similar to tobacco smoke. In the reply it further says that contrary to conventional cigarettes no combustion is taking place. The liquid may contain nicotine, flavoring agents, ethanol, glycerin and/or other humectants such as propylene-glycol. The government says there are “references that carcinogenic substances (e.g. formaldehyde, acetaldehyde and acrolein) are being formed when the liquids are vaporing and their concentrations are above the admissible limit values for interior spaces, when inhaling the vapors during examinations.”

The government says further on that the cigarette body of the e-cigarettes (without nicotine solution) “should be classified as medical product with charging device and nebulizer, if the manufacturer determines that it is being used to administer a nicotine solution which is classified as medicine product”. If the nicotine depot is firmly related with the e-cigarette and not determined to be re-used, “the e-cigarette is classified as medicinal product and not as medical product”, it says in the answer further on.

Source: German Bundestag (hib - heute im bundestag No. 131, News of the committees and current parliamentary initiatives)