E-Zig ist kein Medizin, sagt Verwalt
A German high court has ruled that the nicotine liquid used in electronic cigarettes is NOT a medicine, making it possible to sell the products freely. That is, until 2016 when the Tobacco Products Directive (TPD), passed by the Parliament of the European Union last February, goes into effect.
This decision by the Bundesverwaltungsgericht in Leipzig reverses the rulings by appeals courts in Muenster in September, 2013, and Duesseldorf in October, 2012. The new ruling stated that vaping products are not medicines either by presentation or by function. They are a “Genuessmittel” or pleasure-device.
E-cigarettes are not presented as a means for the alleviation of disease, and their function in smoking cessation is not yet proven, says the Verwaltungsgericht.
This contrasts, of course, with the intent of the British MHRA (Medicines and Healthcare Products Regulatory Agency) to treat vaping products as medicines beginning in 2016. It contrasts, but does not conflict, with the European Union’s impending TPD regulation, which allows manufacturers to apply for certification as a medicine, but absent such certification, stipulates that they should be marketed as “tobacco products”, with onerous strictures regarding advertising, packaging, labeling, and nicotine concentrations.
Details of TPD implementation are to be left up to individual member states, as long as they are within the general guidelines. Some EU member nations, Austria for instance, already treat e-cigs as medicines.
The issue promises to undergo further permutations as various European, and even American, regulatory bodies regroup for their final decisions. The TPD is being challenged in the EU courts by a vaping supplies manufacturer in member nation UK, and the US Food and Drug Administration is still conducting fact-finding exercises.