E-Cigarette: A Medicinal Product or Medical Device?

The Federal Administrative Court (BVerwG) has decided in several parallel proceedings that nicotine-containing liquids (so-called liquids), which are vaporized and inhaled by means of electronic cigarettes (so-called e-cigarettes), are not medicinal products and accordingly the e-cigarette itself is not a medical device.

In one proceeding, the operator of a retail shop for e-cigarettes and accessories had brought an action against the City of Wuppertal, which had prohibited him from distributing nicotine-containing liquids in various strengths on the grounds that these constituted medicinal products which were not permitted to be marketed due to the absence of the required approval.

In another proceeding, a manufacturer of e-cigarettes and liquid-containing filter cartridges had challenged a published press release from the North Rhine-Westphalian Ministry of Health. In it, a warning was issued against the trade and sale of e-cigarettes and liquids, and it was pointed out, inter alia, that nicotine-containing liquids could only be placed on the market with a medicinal product authorization; e-cigarettes could only be distributed in compliance with the marking requirements under the Medical Devices Act.

Decision of the Court

The BVerwG delivered its judgment of 20.11.2014 – Az.: 3 C 25.13, 3 C 26.13, 3 C 27.13 – and ruled in favour of both the operator of the retail shop and the manufacturer of the e-cigarettes.

In the opinion of the judges, the nicotine-containing liquids are not medicinal products within the meaning of the Medicinal Products Act.

They do not meet the requirements of a presentation medicinal product, since the liquids are not marketed ("presented") as a means for curing, alleviating or preventing diseases; nor does the product presentation create the impression of a medicinal product in the consumer's mind.

The liquids are – according to the court – also not functional medicinal products. Although nicotine is a substance that appreciably affects human physiological functions through a pharmacological effect, the liquids lack therapeutic suitability because the benefit of the e-cigarette as an aid for permanent smoking and nicotine cessation cannot be scientifically demonstrated. Accordingly, consumers do not attribute a medicinal purpose to nicotine-containing liquids in the majority of cases, but rather use them as a consumer product.

Conclusion

According to these landmark judgments, the liquids and e-cigarettes do not fall under the medicinal product and medical device regulations. The e-cigarette is therefore not to be classified as an approval-requiring medicinal product and remains freely available for sale. At least for the time being. By 2016, the new EU Tobacco Products Directive, which also regulates the e-cigarette, must be implemented by the German legislature. The member states may classify these either as tobacco products in accordance with the Directive (provided the nicotine content does not exceed 20 mg/ml) or as medicinal products (if the nicotine content exceeds 20 mg/ml and they are advertised as smoking cessation aids).