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Stop demonising a potentially useful product for smokers


Clive Bates does not appear to have read in the Tobacco Directive 2014/40/EU that it envisages three categories of e-cigarette, i.e. consumer e-cigarettes, e-cigarettes marketed as medical devices, and e-cigarettes marketed as medicinal products. Directive 2014/40/EU applies ONLY to consumer e-cigarettes. The relevant wording in the Directive reads as follows: "Electronic cigarettes and refill containers should be regulated by this Directive, unless they are – due to their presentation or function – subject to Directive 2001/83/EC [...] or to [...] Directive 93/42/EEC." Directive 2001/83/EC is the Medicinal Products Directive; Directive 93/42/EEC is the Medical Devices Directive. This seems to me to be an entirely rational approach. If a manufacturer wants to market an e-cigarette for use as a smoking cessation aid to compete with existing nicotine replacement products, then he has to negotiate the same regulatory hurdles as have to be negotiated by the manufacturers of these existing products for exactly the same quality and safety reasons ... the origins of which can be traced back directly to the consumer protection measures that were put in place following the thalidomide tragedy. And, it is also reasonable to expect consumer e-cigarettes to meet the specified quality and safety standards laid down in the Tobacco Directive 2014/40/EU. If they were not subject to the requirements of the Tobacco Directive 2014/40/EU, they would still be subject to the requirements of the Dangerous Substances Directive 2001/59/EC and the General Product Safety Directive 2001/95/EC. There is a big difference between the tobacco in a cigarette and the e-liquid cartridge of an e-cigarette. The latter contains nicotine, a dangerous neurotoxin, in a form that can quickly be absorbed on skin contact or following ingestion to cause serious poisoning. Older gardeners will remember the days no so long ago when a 40% nicotine solution could readily be bought from garden centres for use as an insecticide. That was dangerous material in the hands of the unwary. And nicotine, if not rigorously purified, can contain anabasine. This is a known teratogen that has been linked to oral clefting in newborns following maternal tobacco use. So, it comes as no surprise to me that the Tobacco Directive 2014/40/EU requires that "only ingredients of high purity are used in the manufacture of the nicotine-containing liquid", allowing only "trace levels" of impurities that "are technically unavoidable during manufacture". So, irrespective of whether Clive Bates has "worked with 53 specialists in nicotine science and public health", I can't understand the basis upon which he makes his assertion that "The measures [in the new Tobacco Directive] were negotiated behind closed doors with no credible scientific or legal basis."

Posted date

12 SEP 2014

Posted time



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