A new study published today in “International Journal of Environmental Research and Public Health” rejects the reasoning for electronic cigarette regulation proposed in the new Tobacco Product Directive by the European Commission.
The new proposal of the EU ENVI committee suggests that all liquids containing more than 4milligrams per milliliter nicotine concentration should be banned unless they are approved as medicinal products. According to the official document, this nicotine threshold was established by considering the nicotine content of Nicotine Replacement Therapy medicinal products (NRTs).
To evaluate electronic cigarette use and consumption and to compare it with tobacco cigarettes and NRTs, researchers from the Onassis Cardiac Surgery Center in Athens-Greece and Abich Toxicological laboratory in Italy, led by Dr Konstantinos Farsalinos, recruited 45 experienced users. They used an electronic cigarette device according to their own use-preference during two specific time-periods: 5 minutes, corresponding to the time needed to smoke one tobacco cigarette, and 20 minutes, corresponding to the time needed for a pharmaceutical nicotine inhaler to deliver 4mg of nicotine. Liquid and nicotine consumption was measured by the researchers, while puff duration and inter-puff interval were simultaneously recorded. The results of the study showed that in order to deliver nicotine amount similar to one tobacco cigarette from 5 minutes of use (1milligram of nicotine), a liquid with more than 20milligrams per milliliter nicotine concentration should be used. To deliver amount similar to medicinal nicotine inhaler in 20 minutes (4milligrams of nicotine), a 24milligram per milliliter nicotine-containing liquid should be used.
“This study evaluated use of electronic cigarettes in the real word”, said leading researcher Dr Farsalinos. He continued: “Most users consume liquids with nicotine concentration much higher than those proposed by the European Union. We knew that it was inappropriate to compare 1ml of liquid with 1 tobacco cigarette or 1 unit of NRTs. You need a lot of time in order to evaporate 1milliliter of liquid; in fact this amount represents one-third to one-fourth of the total average daily consumption, while NRTs are recommended in maximum doses of 12 (nicotine inhaler) to 20 (gums) per day. Therefore, the reasoning provided by the European Commission was rejected by the results of our study. As we mentioned in the study manuscript, banning effective liquids may result in a lot of people going back to smoking, and we should definitely avoid that.”
The use of electronic cigarettes by smokers is growing rapidly over the past few years. Public health authorities have raised some concerns on their safety and efficacy. Dr Farsalinos said: “Undoubtedly, more research needs to be performed since this is a relatively new product. None can say that they are absolutely safe. However, currently available evidence is so overwhelmingly in favor of electronic cigarettes that it is surprising to realize that public health authorities have not endorsed them in the field of tobacco harm reduction. Perhaps it is a matter of ideology: they resemble smoking and contain nicotine; a lot of people do not like this. However, we have to realize that these are the main reasons for being successful. And it seems that they have the potential to save lives.”