E-cigarette court forbids warning

Court agrees with plaintiff: The e-cigarette is not a medicine

A defeat at the Higher Administrative Court in Münster had to accept the North Rhine-Westphalian Ministry of Health. The Ministry can no longer warn about e-cigarettes in its current form. The electric cigarettes are not drugs, as judges judge. The ruling can also have far-reaching consequences for other state ministries of health and public authorities.

Proponents and opponents have been arguing for some time about the health hazards of electronic cigarettes, also known as e-cigarettes. By interim injunction, the NRW Higher Administrative Court in Münster has now banned the Ministry of Health in North Rhine-Westphalia from warning of electrical smoldering. The Health Minister Barbara Steffens (Greens) had a few months ago (December 2011) press-related to possible negative health aspects for the users and warned at the same time against consumption. Certain statements may no longer be made by the Ministry.

E-cigarettes according to the law no drugs
NRW Health Minister Barbara Steffens is no longer allowed to warn against e-cigarettes, at least not in the form that she did in part in the past. As Steffens said in a statement at the time, "What is currently not marketable and not tested on the market." In some cases, the liquids have high levels of nicotine and are therefore classified as "medicinal products". In the course of this, she had argued in favor of a ban and speculated that the trade in "unauthorized drugs" was punishable. However, in contrast to the Minister's opinion, in the opinion of the Higher Administrative Court, e-cigarettes and nicotine-containing cartridges are not to be assigned to the pharmaceutical or medical device law. A further progress of the legal dispute is excluded, since it concerns an unannounced judgment (file reference: 13 B 127/12). Already the Administrative Court of Cologne made it clear: The e-cigarette is not a medicine.

The judges in Münster stated in their judgment that the nicotine liquids for e-cigarettes do not meet the legal requirements for a classification as a medicine. Although many consumers report that they have achieved a cessation of conventional cigarettes through consumption, the hoped-for abstinence is not in the foreground. In addition, the electric cigarettes and accessories "have no therapeutic or preventive purpose required for a drug," said the judges in the verdict. "With regard to the media coverage of the e-cigarette's marketability, it is predominant that the disputed statements of the ministry acted as a ban." For this reason, "the ministry's legal assessment is not just to verify its justifiability; the court has its own legal evaluation on the scale of the Medicines Act and the Medical Devices Act. "Thus, the statements made in the press release of the Ministry and the position represented in the decree are unlawful.

Plaintiff an e-cigarette producer and dealer
An entrepreneur, who runs a company for the production and distribution of e-cigarettes, had filed the lawsuit. As a lawyer acted the Left Party faction leader Gregor Gysi. In the first instance, the request for an injunction was still rejected, in the second, the plaintiff was successful.

After the end of the trial, a spokesman for the state health ministry, after a first review of the judgment, said that "neither a revocation nor a correction of statements made so far has been imposed". The spokesman left open how the ministry will decide in the future and how the verdict will be judged in its entirety.

Ulrich Lau, spokesman for the Higher Administrative Court, emphasized that the judgment applies only to the two parties to the proceedings. It is conceivable, however, that other ministries of health and public authorities agree with the legal opinion of the court.

Health warnings are still not prohibited
It is expressly not prohibited that the NRW Minister of Health may continue to comment on the possibly negative health aspects of the e-cigarette, as Laut explained. The Minister just can not continue to claim that the e-cigarette is a drug subject to authorization. Such a position would give the appearance of a ban. According to the OVG, the liquids offered are not covered by the German Medicines Act, as they are not superficially used to "quit nicotine consumption or to relieve nicotine addiction". The verdict is binding and immediately applicable to the North Rhine-Westphalian ministry. Since it was a case of interim relief, there was no possibility of calling a higher instance than the OVG.

According to the manufacturers consume about 2 million people in Germany, the electric cigarette. Consumers also refer to the use of "steaming". The e-cigarette consists of a battery with electronics, air sensor, a tank and a chamber for evaporation. In this chamber, a liquid is inserted that contains flavored liquid with or without nicotine. To inhale the "steamer" presses a small button on the device. But there are also brands where the mechanism is automatically activated when pulled. From the outside, the device looks very similar to a conventional cigarette.

No scientific long-term experience
Which health risks actually exist and which long-term consequences are threatening, is from a scientific point of view not yet sufficiently researched. Although there are some minor comparative studies that have yielded some positive results, the long-term experience is lacking due to the relative novelty of the product. It is precisely this argument that is repeatedly led by the advocates to the field. They say, "There is no study showing that the e-cigarette is more harmful than a stink." The industry therefore hopes that the electronic smoking devices will soon be classified as a stimulant, so that the products can be sold not only in special shops or pharmacies, but also in the supermarket.

The Federal Center for Health Education warns even after the verdict against the dangers of e-cigarettes. Consumption is "associated with health risks," said a spokesman. The cartridges used in addition to "the narcotic nicotine and other harmful substances". (Sb)

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