Should Electronic Cigarettes be Considered a Medical Device?

The first time I saw someone smoking an electronic cigarette, also known as an e-cigarette or e-cig, was at half time during a football match at Old Trafford, the home of Manchester United Football Club. The issue of smoking at the ground has been an ongoing concern for me. As a season ticket holder with the same seat at the club for nearly 20 years I’ve witnessed a sea change, from people smoking everywhere in the stadium to an almost smoke free environment when the smoking ban was brought into UK law a number of years ago. However, some fans still smoke normal cigarettes secretly in the toilets serving the area where I sit, despite attempts by the club to curb it.

When I first saw the person smoking the e-cigarette, just a few rows behind me, I originally thought it was a tobacco product. I saw a large cloud of what I thought was smoke coming from his mouth, in full view of the security guards. Assuming it was a tourist who wasn’t aware of the fact that it is illegal, I carried on reading my programme. But then I noticed there was no smell of tobacco, and when I looked back I saw that the device he was holding was a shiny metallic object with a blue light. It then dawned on me that it was an e-cigarette.

My understanding of the original concept behind e-cigarettes is a device to provide nicotine replacement therapy for smokers trying to quit tobacco products. The devices wee designed to complement other nicotine replacement therapies like patches, chewing gum and tablets. Smokers used these therapeutic products to help them stop smoking by gradually weaning themselves off nicotine, the addictive chemical naturally present in tobacco, by carefully reducing dosages over periods of several weeks. Eventually, the idea was that the smoker phases nicotine out of their system completely.

Today, e-cigarettes have become multi-functional. Far and away the biggest demand for these products come from people who smoke e-cigarettes recreationally. Some of these inhale nicotine in places where smoking tobacco is banned. Others use e-cigarettes as an alternative to regular cigarettes without the harmful effects of the tobacco. Furthermore, the technology has being used to develop electronic shisha pipes (shisha is a type of flavoured tobacco commonly smoked in Arabic countries) as well as flavoured e-cigarettes.

The website of e-cigarette manufacturer Blu Cigs projects the number of e-cigarette users to quadruple by 2014, with annual sales growth of 40%. The marketing and packaging of this company is clearly aimed at generating e-cigarette users for life, and not as temporary medicines, with “starter kits” and “fun stuff” being two of the tabs on the site.

There is also a patented feature of the technology, a wi-fi enabled “social feature”, which makes the e-cigarette pack “socially aware”, compatible with Facebook, Myspace and Twitter, and notifies you if there is another e-cigarette user nearby. In the company’s promotional video the product is introduced and explained in relative detail, but there is no mention of the idea that the product may help to quit smoking tobacco. The brand image here is clearly one of a highly developed and high tech commodity device to take with you everywhere you go, more like a mobile phone.

In June the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced that e-cigarettes are to be classed as "medicines" under new proposals to tighten up the regulation of nicotine-containing products.

A vocal group of supporters for reclassification are the tobacco manufacturers themselves. One could say “they would say that”, because many of these firms actually manufacture the e-cigarettes. It has been reported that they see the burgeoning e-cigarette industry one which might have the potential to replace dwindling tobacco sales.

But a leading smoking cessation expert has challenged the call to reclassify e-cigarettes.

In a comment piece published in July 2013 in The Lancet Respiratory Medicine, Prof Peter Hajek—a professor of clinical psychology and director of the Tobacco Dependence Research Unit at Barts and The London School of Medicine and Dentistry, Queen Mary University, London—has called for medicines regulators to “hold their fire”.

Professor Hajek says: “Compared with hypothetical risks that seem unlikely in view of current knowledge about e-cigarettes, we know that the product e-cigarettes are replacing is seriously dangerous. If any new risks emerge, then appropriately tighter regulation can be implemented.”

E-cigarettes are designed to deliver nicotine without the toxins which are present in tobacco smoke. Placing e-cigarettes under the same regulation as medical devices now is likely to lead to increased costs and less product innovation, which Professor Hajek argues could ultimately lead to a winning situation for the tobacco industry. 

He adds: “Since e-cigarettes are a recreational consumer product that are competing with much more dangerous cigarettes, which are not regulated as medicines, mandatory medicinal regulation is not required for public safety and can harm public health by restricting the ability of e-cigarettes to compete with cigarettes in the marketplace. Excessive regulation of e-cigarettes would protect the market monopoly of cigarettes and have the potential consequences of disease in and death of millions of smokers who were prevented from moving on to the next generation of e-cigarettes.

“For the first time in the history of the tobacco control movement, a realistic possibility is emerging that the tobacco problem might get resolved, and that this could happen with minimal or no government involvement or expenditure. Regulators of medicines should hold their fire.”

For me, as a former smoker who used nicotine replacement therapy successfully and quit smoking a number of years back—before e-cigarette technology was available—I believe that e-cigarettes should be classed as medical devices in applications where they are genuinely being used as a temporary measure to help smokers remove both tar and nicotine from their body. That said, if e-cigarettes have become “good” enough to warrant them being a recreationally enjoyable activity which allow smokers to “smoke” in areas where tobacco is banned, and manufacturers encourage addiction by making them stronger in terms of nicotine dosage, I would see this as an exploitation of the definition of a medical device.

Recreational usage raises an important question for people making decisions about healthcare spending, for example state-funded national healthcare providers and insurance companies. How can they encourage that devices are used as intended—ie for smokers to stop inhaling tar and other poisons—and not as a substitute for normal cigarettes in banned areas.

Another issue which may need to be addressed is one of temporality. Should the e-cigarette, as a medical device, be a temporary therapy to wean smokers off tobacco? Or should it be a permanent alternative, perhaps for patients who have been smoking for many tens of years and who have tried tens of times to quit, which accepts that patient’s nicotine addiction but which sees a major gain in the fact that they are no longer inhaling highly toxic fumes.

I guess, like all medicines, the decisions will rest with the prescribing clinician who is best placed to decide the course of treatment suitable for each individual patient.

Speaking exclusively to Medical Plastics News, Peter summarised: “E-cigs are not only a treatment or a bridge for situations where smoking is prohibited. Their main potential is as a recreational product. They need to get better, but can in theory one day completely replace cigarettes if they do the same thing but safely. People prefer to get their fun in a safe rather than a risky way. Once the danger is removed, there is no big deal with some ex-smokers remaining hooked on nicotine—many people are hooked on coffee, TV, sweets—the latter being much more risky than nicotine. Regulation would be needed to prevent advertising targeting children and so on but this does not need medicinal licensing.

So next time you’re in a public place and you hear a click, see a bright blue or red light at the end of a small cigarette-shaped metallic device followed by a cloud of vapour coming from the mouth of the person holding it, it’s a good chance you’re looking at one of fastest selling consumer products of the 2010s—the e-cigarette.