New Paper Critiques the Classification of E-Cigarettes as Medicines
By Lindsay Fox Posted April 7, 2014
Regulating e-cigarettes isn’t a simple matter. The inherent temptation is to force them into a framework originally designed for something else, an approach arguably analogous to a pre-school child determined to get that square block through the triangular hole. Nobody said being a regulator would be easy, so it’s reasonable to expect those charged with the task of regulating e-cigarettes to put some effort in rather than label them as something they’re not.
The FDA seems set to classify e-cigarettes as tobacco products for regulatory purposes, the EU has incorporated them into the Tobacco Products Directive after a failed attempt at medicinal classification, and the UK has opted for medicines regulation. A new paper from Dr. Konstantinos Farsalinos and Professor Gerry Stimson, appearing in the International Journal of Drug Policy, aims to tackle the question of whether medicines regulation is justified for e-cigarettes and also addresses the idea that they should be treated as tobacco products. They conclude – as vapers everywhere sincerely hope regulators will – that a purpose-built and minimal regulation is the most appropriate approach.
What Makes a Product Medicinal?
After an introduction to the technology, the paper addresses the definition of a medicinal product according to European law. According to the legal definition, a product is medicinal if it either serves to modify or correct physiological functioning when taken (as in, if it does something to the human body to correct some issue, in the fashion that insulin lowers blood sugar and manages diabetes, for example) or if it’s presented as having medicinal properties.
They note that there have been seven court cases (in Germany, the USA, Estonia, the Netherlands and Hungary) questioning the medicinal classification of e-cigarettes, and in each case the court ruled that they should not be considered medicines.
The authors address the functional definition by raising issues with the notion that something is medicinal if it exerts physiological functions. They cite numerous examples of non-medicinal products which have impacts on things like metabolism and the hormones, including water, salt, coffee, food in general, tobacco (both combusted and smokeless) and even point out that physical activity has significant physiological effects on things like heart rate. To avoid the absurdity of re-classifying all of these things (and most daily activities) as medicinal, they suggest that medicinal products should be those which have physiological effects beyond those created by ordinary products and daily activities, and cite a German case which specifically mentioned this idea.
Are E-Cigarettes Medicinal Products?
The big problem with saying e-cigarettes are medicinal from a functional perspective is that nicotine is also present in tobacco cigarettes, which do not function as a medicine. The nicotine in e-cigarettes is chemically identical to the nicotine in tobacco (since it’s derived from tobacco) and also found in trace amounts in things like eggplants and tomatoes. they point out the inherent contradiction in classifying nicotine as a consumer product in tobacco but a medicinal one in the form of e-cigarettes. Smoking is technically a “normal daily activity,” and since e-cigarettes deliver less nicotine to the user than cigarettes (as demonstrated by Dr. Farsalinos’ recent research), there is no justification for treating them differently.
Additionally, as we’re all aware, vapers don’t intend to treat nicotine addiction, just to continue it more safely. E-cigarettes are a reduced harm alternative to tobacco smoking, and the authors cite research showing that only a small proportion of e-cigarette users transition to 0 mg liquids even after daily use for up to a year.. Comparatively, nicotine replacement therapies (like gums and patches) are ordinarily limited to three months of use, and are expressly used to reduce and eventually eliminate addiction to nicotine. They argue that classifying e-cigarettes as medicines because they’re used as a reduced harm way to consume nicotine would be equivalent to classing low-fat milk as a medicine because it’s less harmful than full fat milk.
As for presentation as a medicinal product, it’s abundantly clear to anybody who has shopped around for e-cigarettes and accessories that effectively no companies claim that e-cigs are intended to treat nicotine addiction. E-cigarettes are always presented as an alternative, not a treatment, and as such the authors argue that classification as a medicinal product on the basis of presentation isn’t justified. Even if a company was to make such a claim, it should be taken as misleading marketing rather than evidence that e-cigs are medicine.
After putting the definitions aside, Dr. Farsalinos and Prof. Stimson address a relevant argument not repeated often enough when it comes to regulatory discussions. We vape because we like it. We do this for pleasure; a recreational consumption of nicotine, self-titrating our dosages (i.e. having as much or as little as we like) and enjoying the fantastic variety of devices and liquids available. Medicines aren’t intended to be used for pleasure, but e-cigarettes are.
How Should E-Cigarettes Be Regulated?
Aside from all of the problems with defining e-cigarettes as medicines, the authors point out that the effect would be to reduce the availability of products, make them more expensive and ultimately reduce their appeal in comparison to tobacco cigarettes. Additionally, tobacco companies are increasingly involved in the industry, and they would be able to financially weather the storm of restrictions and requirements better than the independent companies. It would hand the industry to tobacco companies.
Tobacco regulation is also wildly inappropriate, because the quite clearly are not tobacco. The paper contests that “it makes no more sense to argue that nicotine is a tobacco product than to argue that biodiesel is a vegetable product because it is derived from plants.” Additionally, everything we know so far says e-cigarettes are dramatically safer than combusted tobacco, and as such it would be disproportionate to treat them in the same way.
The solution, they suggest, is custom made regulation. It needs to be flexible – to facilitate the variety of products and their rapid evolution – and focus primarily on things like e-liquids meeting purity standards (which have already been established), while continuously taking into account that e-cigarettes are designed as a substitute for combusted tobacco. The authors argue that, “there is no need to prove they are absolutely safe. Through testing and research, products will become more effective as smoking substitutes and at the same time any potential harm will be minimized.”
The paper makes a pretty air-tight argument against the regulation of e-cigarettes as medicines, and manages to obliterate the notion that tobacco product regulation is the way to go in just a few paragraphs. However, given that the International Journal of Drug Policy may as well be called the International Journal of Great Ideas Nobody Listens To, it probably goes without saying that regulators won’t quite manage to be as thoroughly reasonable about e-cigarettes as Dr. Farsalinos and Professor Stimson are. But they undoubtedly should be.