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Science of Electronic Cigarettes

Germany: E-Cig Regulatory Environment

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Germany’s E-Cig Industry Strives to Overcome Challenges

German newspaper Suddeutsche Zeitung recently estimated that two million Germans regularly use e-cigarettes. The import, sale and use of e-cigs containing nicotine are perfectly legal in Germany; however, similar to many countries in Europe, it is widely alleged that German public health officials have conspired with the pharmaceutical industry in attempts to medicalize e-cigs time and time again.

In September 2013, the Higher Administrative Court of North Rhine-Westphalia declared that e-cigs have no therapeutic benefits, so therefore they should not be subject to the same standards as pharmaceutical drugs like traditional tobacco cessation products. This decision directly contradicted the position of the North Rhine-Westphalia’s Ministry of Health, which threatened legal action against producers of e-liquid containing nicotine on the grounds that they were selling medical products without a medical license. As a result of the court ruling, a German e-liquid manufacturer was able to successfully sue the government for an injunction. According to the court’s logic, medical products are intended to treat specific illnesses, but e-cigs with nicotine are not.

In early 2015, Berlin hosted the inaugural event in a series of conferences that
have drawn the greatest minds in the e-cig industry to address pertinent issues affecting the business. One of the hot topics was creating industry standards for e-cig safety, which everyone agrees is necessary to gain public trust. Given that some countries have gone down the medicalization route while others like Germany, France and The Netherlands regulate e-cigs as consumer goods, international manufacturers and distributors face a significant challenge in catering to both situations.

The German Cancer Research Center has been critical of the industry for its lack of standardization: They have accused e-cigs of containing dangerous chemicals and their concerns echo a study published in the New England Journal of Medicine, which made a blanket claim that some e-cigs contain formaldehyde. An analysis of the article penned by Jacob Sullum of Reason.com identified that a determining factor in formaldehyde emissions was the voltage settings of the device. Sullum also notes that the temperatures used to test each e-cig were unrealistic when compared to the temperatures humans actually use when they vape, so even if a device could potentially produce formaldehyde, it would not do so if used as intended under normal circumstances. Nonetheless, this gives e-cig advocates plenty to think about when it comes to combating negative press and trying to win the public’s approval.

The blind prejudice against e-cigs found in the medical field is certainly not restricted to Europe. The follow up to the Berlin conference took place in the capitol of the United States where the Center for Disease Control has stated, “If you only cut down the number of cigarettes you smoke by adding another tobacco product, like e-cigarettes, you still face serious health risks.” First and foremost, e-cigs are not tobacco products. The rest of the official statement, “Smokers must quit smoking completely to fully protect their health – even a few cigarettes a day are dangerous,” expresses the ignorance of many in the medical community. Generally speaking, smoking a few cigarettes a day is safer than smoking a pack a day, and switching completely to e-cigs is less harmful than both. The all-or-none approach to smoking cessation is what keeps so many people in the world locked into their addiction. The availability of products that provide potentially safer alternatives to existing combustible tobacco, such as e-cigs, can have a significant impact on public health by helping smokers exit tobacco for good.

Things in Germany look positive now, but the E.U. Tobacco Product Directive will present all kinds of new challenges for the market. Hopefully those in the German health, scientific and policy fields can work together to create evidence-based regulations that will allow smokers to make smarter consumer decisions and live longer in the process.