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Stop demonising a potentially useful product for smokers


Clive Bates argues that electronic cigarettes should not be classified and regulated as either tobacco products or medical products because, or so he asserts, they are neither. In which case, I would suppose that he would agree that the General Product Safety Directive 2001/95/EC would apply by default? The General Product Safety Directive is a so-called horizontal Directive the purpose of which is to "cover lacunae" where specific consumer safety legislation for a particular type of consumer product does not otherwise exist. The primary objective of the General Product Safety Directive is "to ensure that products placed on the market are safe [...] under normal or reasonably foreseeable conditions of use including duration [...] ". Clive Bates goes on to argue that nicotine is not as toxic or dangerous as the literature would suggest. Having read the article by Mayer (2014) [], I would not dispute this point. But there is more than just the acute toxicity of nicotine that needs to be considered. Individuals who are exposed to nicotine acquire a tolerance to it. This is a confounding factor when trying to determine a value for what might be described as the "LD50" in man. Consumer safety laws have to provide protection for those who have never previously been exposed to nicotine, in whom the "LD50" will be much lower. Moreover, electronic cigarettes are not simply delivering nicotine. They are delivering nicotine that has been co-vaporised with a glycol-containing solvent. It is normal from a toxicological perspective to assume, until otherwise proven, that something unexpected might happen chemically during this co-vaporisation process, to produce a new toxic entity. So, whilst I would not disagree that "vaping" is probably safer that "smoking", I would drawn attention to my use of the word "probably". The fact remains that, scientifically, neither I nor Clive Bates nor anyone else can be sure that vaping is safer than smoking. So it is not so much the [possibly arbitrarily selected] 20mg/ml limit for the nicotine in consumer e-cigarettes that is the issue, but whether an unexpected toxin is produced by the co-vaporisation of nicotine with its glycol-based flavour-containing solvent. So, how can the e-cigarette manufacturer (or importer) assure the consumer that their e-cigarettes are safe to use in the longer term? I'm not sure they can yet. This is why I believe that the way in which the issue has been addressed in the Tobacco Directive 2014/40/EU is a sensible compromise. The 20mg/ml nicotine concentration limit applies only to consumer e-cigarettes. Manufacturers who want to put higher strength products on the market are free to do so (or so I understand from the wording in the Tobacco Products Directive), so long as they comply instead with the requirements of the Medical Devices Directive 93/42/EEC or the Medicinal Products Directive 2001/83/EC. And what is the difference between the three options? Perhaps only the paperwork burden as regards the size of the dossier of evidence needed to demonstrate the safety of the product. But in each case, there is an unavoidable requirement for the manufacturer / importer to satisfy the appropriate government competent authority of the safety of the product, and to accept full legal responsibility for quality and safety. Would Clive Bates want anything less, I wonder? I'm not sure that a judicial review challenging the alleged procedural "behind closed doors" issues will serve any purpose. I do not know how the judicial review process works at the European level, but if it mirrors the process at the national level, then all that might be achieved is that the regulators will be asked to revisit the decision-making process. It does not follow that the decision they originally made will necessarily have to change.

Posted date

21 SEP 2014

Posted time



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