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Classification about e-cigarette

Number of visits: Date:2012-03-27 10:51
Since e-cigarettes do not contain any tobacco, they are not a tobacco product (the nicotine, if used, could come from any vegetable source or be synthesised - tobacco is simply the cheapest source). As they are a consumer product, they cannot be classified as a medicine or a medicinal device; this is because a medicine is defined by any one or more of these factors: 1. 'Delivery of a drug with a significant pharmacological effect.' Although this would not apply if zero-nicotine refills are used, even for with-nicotine use this is an illogical definition that cannot be enforced in isolation since it would apply to many other consumer products. Coffee, wine, whisky, cigarettes, cigars are not pharmaceuticals but would need to be re-classified as such if this definition can be applied to a consumer product such as an alternative smoking system. In addition, coffee percolators, cocktail shakers, cigarette holders, tobacco pipes and teapots would need to be re-classified as devices that deliver active drugs. Even tea is involved as it shows measurable effects, perhaps not surprising as most tea contains nicotine. And in that case we would also need to include aubergines or any dish used to present an aubergine, since they have a relatively high nicotine content compared to the nicotine content of other vegetables. Nicotine is a natural and normal part of the diet, so classifying its use as medicinal is rather problematic. 2. 'Sold as or generally accepted as a device or drug to treat or cure a disease.' This would be a valid legal argument if e-cigarettes were designed as or sold as a way to stop smoking, since smoking (or nicotine use) is defined as an addiction and therefore a disease, which can be treated or cured. E-cigarettes were invented for the purpose of replacing smoking, as a clean nicotine delivery system that replicated smoking in every way except the delivery of smoke. A water-based mist replaces the smoke. The whole point of electronic cigarettes is that they are a permanent replacement for tobacco cigarettes, to be used instead of tobacco. Neither the inventor of e-cigarettes, the manufacturers of e-cigarettes, nor the users of e-cigarettes intend to quit. The whole point of an e-cigarette is that it can be used for the purpose of continuation of a habit that is dangerous unless modified. Just as Snus consumption is not cessation, it is harm reduction, so e-cigarette use is not cessation. It is quite true that an occasional rogue trader may market e-cigarettes as a quitting aid, but steps need to be taken to remove rogue internet marketers and there is plenty of legislation available for that purpose. Such persons are not members of the trade association, are not approved by the consumer association, are not registered with any community forum or other resource, and are generally recognised by everyone as outlaws who need to be shut down. 3. 'The product is presently unregulated and there is a likelihood of harm being caused'. The UK is probably the only place where e-cigarettes are efficiently regulated, and there is abundant proof that no contaminants are present at toxic levels. If something like 'dosage' is envisaged, for a general consumer product, then we would have to accept regulated dosages for coffee and wine as well. This seems highly unlikely. Consumer products with uncontrolled 'dosages' are the norm. Very few people check the nicotine content of a cigarette before they smoke it, or the alcohol content of wine before they drink it, or the caffeine quantity in coffee before they consume it. In fact it is impossible to do this in some cases. Masses of people are not being harmed by 'uncontrolled dosages' of caffeiene even though there is no possible way to check it: the consumer can easily judge the result, as this aspect of result is precisely what is desired and carefully monitored. E-cigarettes are no different: their effect is obvious when the amount consumed is too great, and significant effects are easily avoided. In addition, if there is clear potential for harm, then after millions of user-years of product usage worldwide, the effects should be obvious: many deaths and even more examples of serious harm caused. It is no surprise to learn that the FDA and the MHRA looked very hard indeed and could not find a single instance of morbity, let alone mortality. Compare this with the licensed drug Chantix, a psychotropic drug for smoking cessation introduced at about the same time as e-cigarettes, which in the same timescale has left a swathe of hundreds of deaths and hundreds of thousands of heart attacks, and is regarded as the most dangerous prescription drug. It's highly profitable, of course. Enforcing a pharmaceutical classification It would be impossible to enforce legal classification of e-cigarettes as a pharmaceutical product in a UK court, and the same holds true for any valid legal system. This is why such actions have been overturned in every country where such a restriction has been imposed by government: in the USA, Holland and Germany, actions overturned at lower court level have been taken to higher or supreme court level on appeal by governments and the removal of the unjust restrictions has been upheld. Clearly, if a consumer switches to oral tobacco in order to avoid lung cancer then they are not using a medicine - it is simply a consumer purchase decision. The same holds true for e-cigarettes. All such choices are consumer-driven or they simply don't work - in fact the term Harm Reduction itself is a definition of consumer purchasing choices. When Harm Reduction is medically managed, it is properly referred to as Harm Management.

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