Wicked Wizard Eliquid Achieving appropriate regulations for electronic cigarette!
E Cigarette Explosions: An In Depth Investigation
by Amber Whaley | Blog, Health & Safety, News, Research | 0 comments
Millions of people worldwide use e cigarettes. They have become popular primarily with people who are looking to cut back or quit their use of regular cigarettes altogether. Since e cigarettes are often related to a decision to live a healthier life, it begs the question in most people’s minds, “How safe are these new-fangled devices?” You only begin to question safety more, especially when reports have increasingly surfaced of e cigarettes exploding or catching fire. If e cigarettes are going to be touted as a safer alternative to cigarettes, then a true investigation of the explosion incidents is needed. To put into perspective how safe they really are and give answers to the questions of why millions use these but only a few experience these explosive results.
Many questions need to be answered when it comes to exploding cigarettes. It’s easy just to be swayed by the headlines that make them seem like ticking time bombs with an inevitable self-destruct mechanisms. However, if this were the case would millions of people still choose to vape?
In order to better understand all of this data that comes flying at us over the Internet and the television news, we have compiled a comprehensive list of significant e cigarette explosions that have occurred in the last 3 years. With this data, we will explore questions regarding how e cigarettes are starting fires. When are fires and explosions occurring. What dangers and injuries are involved, and when possible uncover what the initial cause of the malfunction was itself.
E cigarette 101
E cigarettes were first introduced into the market back in 2007, and since then they have been gaining in popularity at breakneck speeds. With sales of e cigs in the United States alone estimated to be a $1.5 billion yearly market, and sales expected only to grow, settling the controversy of the explosive e cigarette seems more important now than ever.
Let’s start by breaking down the e cigarette itself. The first misnomer in the world of exploding e cigs is exactly what it is that is exploding. Remember, an electronic cigarette is first and foremost and electrical device. Any electrical device, especially those you plug in for charging, will carry some danger of malfunction or explosion. There are three main pieces that make an e cig functional. The cartridge or tank, the atomizer (the heating element) and the battery. Of these elements, the battery, seems to be the most suspect party.
When do they Explode?
According to FEMA, 80% of e cigarette explosions happen during charging. In a variety of reports, several of which we will investigate later, the cause is often linked to the use of an alternative charger, one that was not sold with the battery that was charging. What this means is that the majority of the damage caused by e cigarette malfunction.
In our research we found the same trend; surveying 30 separate cases from 2012 to 2015 we found 22 cases where the fire started while the device was charging. The remaining 8 exploded either in the users’ possession, in their pocket or hand, or it was undisclosed by the media at the time of the incidence.
Charlie Pugsley is a member of the London Fire Brigade, fire investigation team, who has been involved in several e cig explosion cases, including a well-documented April 2014 Londonincident. He said regarding these explosions: “People assume e cigarettes are much safer than ordinary cigarettes, and in most cases they are. The danger is that people sometimes use incorrect chargers, which runs the risk of over-charging, which can potentially have explosive results. As with all rechargeable electrical equipment, it’s of vital importance that people use the correct type of charger for their e cigs to prevent fires.”
Still, not all incidences happen when the battery is charging. There are some cases, roughly around 12% according to FEMA, that occur when the devices are either in use or storage. This may be due to the ever-present risk of using lithium batteries that can pack a large amount of power into a small space. One case study, from the American Journal of Medical Case Reports, looked into a February 2015 incident in New Jersey, could not find a specific cause for the explosion that took place when the e cigarette was stored in the user’s pocket, however, they theorize an answer that is probably and likely in the case of non-charging e cigarette explosions:
“Many e cigarettes use lithium batteries due to their ability to store large amounts of energy in a compact amount of space. However, the inherent characteristics of lithium batteries can pose a risk of fire and explosion. Partial thickness burns caused by spontaneously exploding mobile phones has been described in the literature. The lithium ion battery has separately been described as the ‘mini-bomb in your pocket,’ due to its known ability to spontaneously ignite. Poor design, use of low-quality materials, manufacturing flaws and defects, and improper use and handling can all contribute to a condition known as ‘thermal runaway,’ whereby the internal battery temperature can increase to the point of causing a battery fire or explosion.”
The truth be told; however, we use lithium batteries for many other things, every day. Cameras, phones, laptops, in fact, they are almost becoming the norm in today’s technologically driven culture. However, few people know about their potential risk, especially when they are used with a device that includes a heating element, such as an e cigarette.
What Kind of E cigarettes Explode?
While most of the reports are unclear at best of what makes and brands are the ones that are more apt to explode, we still found a few commonalities. While the batteries are the genesis of the explosion concerns, there are still some e cigarette models and makes that are more potentially hazardous than others. While one report we examined did, in fact, come from a MOD, otherwise known as a personal vaporizer, the majority of the cases came from rechargeable vape pens.
In a MOD or Personal Vaporizer, but also in many rechargeable kits you can find, the battery completely disconnects from the device, allowing it to charge separately, away from your tank and atomizer. According to the data, these styles seem to be safer. The vape pens, conversely, often have a built-in USB port, which allows the user to plug in the whole device. Meaning your heating element is right there next to your charging battery.
Even FEMA, who has put countless hours into e cigarette exploding research, agrees that these styles seem to create more dangerous situations than PVs, E-Gos, or other rechargeable models. In their research, they discovered that “all of the incidents reviewed involved ‘vape pens’ or ‘twists,’ which more closely resemble traditional cigarettes in appearance. These twists are intended to be recharged using a USB port built into the e cigarette and a power adapter supplied with the device.”
MODs, however, do present another risk of their own. Those who successfully create MODS have done their research, and this is essential, to have a safe and effective device. Also, with many MODs, people use batteries that have wrappers, another potential cause for concern. While no cases we surveyed mentioned any battery wrap malfunction, electronics experts agree that any rip, tear, or weakness in the battery wrapping can be dangerous, especially when you consider the amount of power contained in lithium ion batteries. Making sure this seemingly unimportant part of the battery is intact could prevent explosion or potential battery acid leakage.
USB Ports and Charging
Like most rechargeable electronic devices these days, many e cigarettes have a USB port that connects the device to the power adapter. When disconnected from the power adapter that is supplied from the manufacturer, these charging cords appear as though they can easily connect to computers and other power adapters. However, this easy mistake seems to be the cause of the majority of these e cigarette explosions. The use of such non-approved power adapters is a running theme in the potential cause of the incidences involving exploding e cigarettes. The truth is few consumers understand that just because a plug will fit in a USB port, it does not mean it is fully compatible. Without knowing the specific electrical specifications of an alternative USB power source, as well as your battery, you cannot guarantee an effective or a safe charge.
To reduce the risk of an e cigarette explosion users are advised only to plug an e cigarette into a USB port or power adapter that was provided with the battery or e cigarette itself. According to FEMA, using a power adapter or charger “not supplied by the manufacturer may subject the battery to higher current than is safe, leading to thermal runaway that results in an explosion and/or fire.”
Does the Fire Spread?
In most cases of exploding cigarettes the damage stays relatively local, not causing too much damage to the surroundings. However, in many incidences these explosions can spread to fire and create real damage and injury to the people and places that are nearby.
Of the cases we surveyed, almost 1/3 resulted in some sort of significant damage to the home, room or vehicle where it was stored. These case can usually be attributed to where the device was being charged or stored. Several were being stored around things like papers on a desk, or pillow and beddings, all of which are extremely flammable and can lead to a significant spread, when the battery itself only would have resulting in a quick burst, not an ongoing flame. The majority of cases only resulted in minor fire spreading, though some did cause burns and injuries to the users. If the fire spreads it can also cause significant smoke inhalation, which can be harmful to the user and in extreme cases can require medical attention.
Are there Cases of Injury?
Since most of the incidences of e cigarette explosions occur when charging is taking place, injuries are fewer than incidences of a fire spreading. Still, with faulty batteries and negligent use, some e cigarettes have exploded in user’s hands, pockets, and mouth, resulting in burns and mainly topical injuries. These injuries can sometimes be gruesome, but they are definitely in the rare category, as the incidence of e cigarette explosions in comparison to e cig users is so small.
One case in Scotland does have some questioning the extremity of what can happen in an e cigarette explosion. One gentleman died, due to a massive explosion that was triggered by a charging e cigarette that was near an oxygen machine. Since the danger of the flammability of oxygen is so well known, it is completely inaccurate to say that an e cigarettes explosion was the lone culprit in this unfortunate tragedy. Again, the cause of the initial spark appeared to be the use of an incompatible charger to power up the e cig device.
Ultimately, it is hard to fault a product like e cigarettes for being so rarely dangerous when they are designed to replace one of the already proven most dangerous products on the market. Regular cigarettes smoking in the United States alone is responsible for 480,000 deaths a year. There is an average of about7,500 residential home fires started by cigarettes each year. Cigarettes are clearly still more of a threat to everyone’s safety, especially when there are ways to prevent many of the causes of e cigarette explosions.
While you can’t always protect yourself from faulty devices. Whether they be e cigarettes, cell phones, or laptops, you can take a few simple precautions to lower your risk of your e cigarette ending in fiery disaster.
1) Always know your brand and avoid counterfeits. Buy from a reputable source, read reviews and ask those in the know for advice if you need to. If in doubt, just stick with an American brand. The manufacturing standards in the USA are superior to China, where the majority of these devices come from, making your Made in the US items safer in general and less likely to malfunction.
2) Only charge with the charger and power adapter that comes with the battery.
3) Do not plug into computers, or other USB-capable devices.
4) Find a device that has a battery you remove from the atomizer to charge, these appear to be safer than the models that stay attached when charging.
5) Never overcharge your battery. Do not leave it plugged in unattended, when you are asleep or away from the home.
Survey of Cases
We have included a short synopsis of the cases we examined to compile our data, so you can explore each case yourself. They are presented in chronological order.
February 2012 – Niceville, Florida – Man experienced an exploding e cigarette while in use. The cause of the explosion was still unsure at press time but suggested to be the result of an overcharged or faulty battery. Other supplemental reports also indicate the man had modified his e cig, which could have contributed to the incident. Man experience significant injury to the face and several burns as a result.
March 2013 – Corona, California – An e cigarette exploded due to a faulty battery while being charged in a car. It resulted in minor burns to the vehicle and operator.
June 2013 – Tulsa, Oklahoma – An e cigarette plugged into a laptop to charge exploded causing moderate fire damage in one woman’s home.
July 2013 – Sherman, Texas – A man had been charging his e cigarette battery in his laptop for about 2 hours when it exploded creating moderate fire damage to his electronics and home. The man, who was near the device at the time, suffered several burns, and both he and his wife were treated for smoke inhalation as a result of the subsequent fire.
August 2013 – Oklahoma City, Oklahoma – 15 minutes after it began charging, a woman’s e cigarette exploded leaving minor carpet damage and destroying the device itself. The woman said she bought the e cigarette from a place that told her any charger would work, despite the fact incompatible chargers seems to be the number one cause of e cigarette fires.
September 2013 – Atlanta, Georgia – A woman charging her e cigarette with her laptop experienced minor fire damage when her battery exploded as a result of not being charged with the provided charging equipment.
September 2013 – Mount Pleasant, Utah – A woman charging her e cigarette in her car suffered burns to herself and young child when it exploded during charging. While the cause was still unclear at press time, charging an e cigarette in a warm car can often cause the battery to overheat, which can lead to malfunction.
November 2013 – Eugene, Oregon – After an e cigarette was left charging in a car for two hours, it exploded causing damage to a man and a woman’s passenger truck.
November 2013 – Kootenai County, Idaho – An e cigarette was plugged into a laptop to charge and created explosive results. The incident left no injuries, only minor home damage.
November 2013 – Queens Creek, Arizona – An e cigarette caught fire while charging causing damage one man’s home. While the man denied using an incompatible charger. The investigation appears to show that the charger in use was not one provided by the manufacturer.
November 2013 – Colorado Springs, Colorado – A man’s e cigarette exploded while charging causing his mattress to catch on fire. Though he was able to smother the flames to keep damage at a minimum, he still suffered a few minor burns. It has not been determined whether it was a faulty battery, an incompatible charger, or another malfunction that caused the initial spark.
December 2013 – Batley, England – A faulty battery was the cause of this e cigarettes explosion that took place when the device was charging. Only minor home damage was reported.
January 2014 – Springfield, Missouri – Another charging e cigarette explosion; though it was unclear at press time the consensus is that an incompatible charger seems to be the likely culprit for this blaze. The explosion resulted in second-degree burns to the user.
January 2014 – Sneads Ferry, North Carolina – Unfortunately, the official cause of this case is still unreported. However, the explosion took place in the user’s possession near his mouth, causing serious burn and injury to the user’s eyes.
February 2014 – Birmingham, England – An e cigarette was left on a desk in an office building, connected to a computer for charging. The fire damage was minimal, and no one was injured.
February 2014 – Abertillery, South Wales – A man was charging his e cigarette in his laptop when it caught fire and shot across the room, leaving minor damage on his furniture, carpet and electronic equipment.
April 2014 – London, England – A woman was treated for smoke inhalation and shock when her e cigarette exploded while charging with an incompatible charger.
April 2014 – North Yorkshire, England – An e cigarette was being charged behind the bar in a busy pub, when it exploded near a waitress who was understandably shocked by the incident. The e cig was being charged using an iPad charger and left the waitress with burns and one customer with a burn mark from the shrapnel that came from the exploding battery.
April 2014 – Leicester, England – A woman admits to using the wrong adapter to charge her e cigarette device. Which is likely the cause of the fire that started in her car after about 20 minutes of charging. She has said she will be using the disposable e cigarette models from now on.
May 2014 – Solihull, England – A woman had to evacuate her house with her young children when her e cigarette ignited into flames in her home. The e cigarette was connected to an incompatible charger designed for an iPhone. The flames caused significant home damage but no injuries.
July 2014 – Marsden, England – A woman’s e cigarette exploded in her kitchen while charging in a regular wall socket. However, it was not reported whether she was using the factory supplied charger or not. The fire resulted in small damaged to her kitchen wall and appliances but no injuries were sustained.
August 2014 – Wallasay, Scotland – One of the most noted cases of e cigarette explosions comes from Scotland where a man was unfortunately killed when an e cigarette went into flames near his oxygen tank. The result was, of course, tragic. The origin of the e cigarette fire was attributed to an incompatible charger being used to recharge the battery.
November 2014 – South Hampton, England – A non-manufacturer-supplied charger was the cause of another e cigarette fire for a young couple in South Hampton. The battery exploded into flames while charging, but they were able to extinguish the flames before severe structural damaged occurred.
February 2015 – Ramona, California – A man was raising his e cigarette to his mouth when he noticed the increasing temperature of the device. He pulled the device away, but as he was doing so, the battery exploded, causing burn damage to the user’s face and hand. The cause of the malfunction was still under investigation at the time of the report.
February 2015 – New Jersey – A gentlemen in New Jersey sustained serious burns to his leg when his e cigarette exploded in his pocket. The actual cause of the malfunction was not specified.
March 2015 – Santa Ana, California – A Southern California man experience an e cigarette explosion while holding the device, resulting in serious injuries. While the cause was not entirely determined on the report, it is believed an overcharged lithium battery may have been a contributing factor.
May 2015 – Western France – A man in France experience an e cig explosion while in use. Likely attributed to a faulty battery that was manufactured in China, though the report alludes to the possibility that the device had been modified incorrectly.
July 2015 – Austin, Texas – An e cigarette exploded in one man’s pocket resulting in burn injuries. He reported feeling a vibration from his pant’s pocket where he kept an extra e cigarette battery, soon it turned into flames. The battery is believed to have been a counterfeit.
August 2015 – Newport, Wales – A young family had to evacuate their residence when an e cigarette caught fire while charging. The device was plugged into an incompatible charger that did not come with the device.
Achieving appropriate regulations for electronic cigarettes
Daniela Saitta, Giancarlo Antonio Ferro, and Riccardo Polosacorresponding author
Author information ► Copyright and License information ►
This article has been cited by other articles in PMC.
A growing body of scientific studies show that e cigarettes may serve as an acceptable substitute for smoking tobacco cigarettes, thereby reducing or eliminating exposure to harmful elements in smoke. The success of e cigarettes is such that sales of these products are rapidly gaining on traditional cigarettes. The rapidly evolving phenomenon is raising concerns for the health community, pharmaceutical industry, health regulators and state governments. Obviously, these products need to be adequately regulated, primarily to protect users. Depending on the form and intended scope, certain regulatory decisions may have diverse unintended consequences on public health and may face many different challenges. Ideally, before any regulations are enacted, the regulatory body will require sufficient scientific research to verify that a problem does exist, quantify the problem, explore all potential solutions including making no change at all, determine the possible consequences of each, and then select the solution that is best for public health. Here we present an overview on the existing and deeming regulatory decisions for electronic cigarettes. We challenge them, based on the mounting scientific evidence with the ultimate goal of proposing appropriate recommendations while minimizing potential unintended consequences of ill-informed regulation.
Keywords: cigarette smoking, electronic cigarettes, nicotine use, regulation, regulatory agencies, tobacco harm reduction
Cigarette smoking is a deadly and remarkably addictive behaviour. Smoking is such a difficult addiction to break that millions of people smoking today will never be able to quit [Tobacco Advisory Group of the Royal College of Physicians, 2007]. Many smoking cessation medications [i.e. nicotine replacement therapy (NRT), bupropion and varenicline] are accessible to those determined to quit [Polosa and Benowitz, 2011], but they lack high levels of efficacy in real-life settings [Casella et al. 2010]. Clearly, a different, more effective approach is needed to reduce the harm from cigarette smoking.
Electronic cigarettes (e cigarettes or electronic nicotine delivery systems) are battery-operated devices designed to vaporize a liquid solution of propylene glycol or vegetable glycerine which also contains water and flavourings and may or may not contain nicotine. Puffing activates a battery-operated heating element in the atomizer and the liquid in the cartridge is vaporized as a plume of mist that is inhaled. Because e cigarettes do not burn tobacco, these products are a much lower risk alternative to traditional cigarettes [Caponnetto et al. 2012].
In addition to creating vapour which visually resembles smoke, e cigarettes replace most of the sensory, behavioural and social components associated with smoking. For this reason, they are increasingly used as substitutes for tobacco cigarettes [Caponnetto et al. 2013b]. Moreover, internet surveys [Etter, 2010; Siegel et al. 2011] and clinical trials [Polosa et al. 2011, 2013] show that the e cigarettes may help smokers quit smoking or reduce harm by smoking fewer tobacco cigarettes, without any remarkable adverse events or risks [Caponnetto et al. 2013a], for the user or for the bystander [Burstyn, 2013]. Even compared with NRTs, such as nicotine patches, e cigarettes prove to be more effective and with a tolerability rate similar, if not better, to that obtained with the patches [Bullen et al. 2013]. As a consequence, popularity of these products has increased exponentially in developed countries. According to a mail-in survey of more than 10,000 US citizens conducted by the Centers for Disease Control and Prevention (CDC), ever use of e cigarettes quadrupled to 2.7% from 2009 to 2010 [Regan et al. 2013]. Moreover, a follow-up survey from the CDC indicates that e cigarette use doubled again from 2010 to 2011 [King et al. 2013]. The success of e cigarettes as a tobacco cigarette substitute is such that these products are rapidly gaining on traditional cigarettes [Adelman et al. 2013]. Their popularity appears to be related to the fact that they can be used in smoke-free areas, to their competitive price, and to the perceived potential for harm reduction compared with traditional cigarettes [Etter, 2010; Siegel et al. 2011].
Obviously, these products need to be adequately regulated, primarily to protect users. But policy makers and regulators must be careful. Depending on the form and intended scope, certain regulatory decisions may have diverse unintended consequences on public health and may face many different challenges.
In this article, we appraise existing regulatory decisions in the light of current scientific evidence and consumer insights with the goal of assisting policy makers identifying and addressing concerns while minimizing potential unintended consequences of ill-informed regulation.
The precautionary principle
Many antitobacco organizations have called for restrictive regulations, pointing out that the health risks have not been studied extensively. The precautionary principle may be invoked when a phenomenon, a product or a process with potentially dangerous effects has not been subjected to full scientific and objective evaluation so that the harm cannot be determined with sufficient certainty. Resorting to the precautionary principle requires the adoption of proportional measures to the level of protection sought. In other words, policies based on the precautionary principle tend to avoid the production of possible risks, not yet scientifically proven. Therefore, they are precautionary and preventive policies [Wiener, 2013; Grandjean, 2004].
This principle has been recognized in international law, especially in environmental matters. A first reference to the precautionary principle is found, in fact, as a general recommendation, inthe Final Declaration of the United Nations Conference on Environment held in Stockholm in 1972 [United Nation Environment Programme, 1972]. But the real consecration of the principle in the international field is in the Declaration adopted at the conclusion of the United Nations Conference on Environment and Development (UNCED) held in Rio de Janeiro from 2 to 14 June 1992 [United Nations Conference on Environment and Development, 1992]. From the protection of the environment, the application of the precautionary principle has been extended subsequently to the protection of human and animal health in the food [Convention on Biological Diversity, 2000].
The precautionary principle has also been introduced in EU law by the Treaty of Maastricht, which makes it one of the fundamental principles of Community environmental policy. The Lisbon Treaty confirmed the location of the precautionary principle [European Union, 2008].
Although the first formulations of the precautionary principle were related to the sphere of environmental protection, they were extended to the areas of health, food policy and consumer protection, especially thanks to the intervention of the Court of Justice of the European Union and the Court of First Instance. That court, in fact, in an important decision on the revocation of the marketing authorization of antiobesity drugs [Court of First Instance, 2002, 2003], has stated that, despite being mentioned in the treaties only in relation to environmental policy, the precautionary principle covers a wider application. It is intended to be applied to ensure a high level of health protection, consumer safety and the environment in all areas of Community action. The same interpretation was given by the Court of Justice [Court of Justice, 1998, 1999, 2000].
The Community law laid down the characters of the precautionary principle. The Court of Justice, in fact, in many judgments [Court of Justice, 2010a, 2010b], specified that it is not sufficient that the precautionary measures taken by Member States are objective and respectful of the principles of proportionality and nondiscrimination, but it is also necessary that they are based on the existence of a risk to health endorsed by clear scientific evidence and not purely hypothetical considerations.
First, the Court pointed out that the proper application of the precautionary principle presupposes the identification of potentially negative consequences for the health arising from the use of a particular product. Second, the precautionary principle requires an overall assessment of the risk to health based on the most reliable scientific data available and the most recent results of international research. If the available data is insufficient or imprecise and doesn’t allow to determine with certainty the existence or extent of the risk feared, but there is the likelihood of real harm to public health in which the risk materialize, the precautionary principle justifies the adoption of restrictive measures, provided that they are objective and non-discriminatory.
For these reasons, for example, in the case law Commission versus French Republic in 2010 [Court of Justice, 2010a], the Court of Justice has found no grounds for the restrictive measures imposed by France on the placing of foodstuffs additive on the national market from other Member States. In this case, the restrictions were introduced by the French legislature to avoid the potential risks to public health posed by certain categories of admixtures. However, the Court of Justice has found that, even in the presence of risks relating to certain categories of foodstuffs additive, the national legislation must be specific and clearly justified in relation to these categories and cannot be limited to generally exclude the use of all addictive drugs or of foods in which they are employed. The restrictive measures adopted, therefore, were not based on the demonstration of the conditions for the application of the precautionary principle.
In the Community context, especially in light of the considerations contained in the European Commission Communication of 2 February 2000 on the application of the precautionary principle [European Commission, 2000], any burden of proving the danger associated with a product is up to the consumers or to the associations that represent them. In contrast, in the face of a measure taken under the precautionary principle, producers, manufacturers or importers may be required to demonstrate the safety of the product subject to limitations.
In particular, the potential consequences of specific actions to prevent the risk to public health must be assessed. But this would require risk assessments studies necessitating many years to complete. The Network for Public Health Law stated, ‘This is precisely when the precautionary principle should be applied’ [Subramaniam, 2013]. Moreover, the Science and Environmental Health Network stated, ‘The key element of the principle is that it incites us to take anticipatory action in the absence of scientific certainty’. However, the consortium points out that the process of applying the principle must be ‘open, informed, and democratic, and must include potentially affected parties. It must also involve an examination of the full range of alternatives, including no action’ [Science & Environmental Health Network, 1998].
So far, most regulatory bodies have failed to include the parties most deeply affected by the regulation of e cigarettes: consumers. Regulators have also failed to examine the full range of alternatives, including taking into account the health risks of maintaining the status quo, continued smoking. Rulings of national and international bodies around the world range from no regulation at all to complete bans [WHO, 2009].
The first report by the World Health Organization (WHO) Study Group on Tobacco Product Regulation that addressed e cigarettes advised a precautionary approach, for the most part, because the evidence about the safety and cessation or harm reduction efficacy of e cigarettes was virtually nonexistent at that time [WHO, 2009]. The report also stated that more research on e cigarettes had to be conducted to prove efficacy and safety of these products. Today, a growing body of scientific studies on e cigarettes and liquids supports the efficacy and safety of these products. Even smokers who do not want to quit may do so when introduced to e cigarettes [Polosa et al. 2011, 2013] and the overall level of risk is much lower than cigarette smoking, with no chemicals raising serious health concerns in e liquids [Cahn and Siegel, 2011; Goniewicz et al. 2013]. In the most comprehensive systematic review of chemical studies to date, Burstyn concluded that there is no evidence that ‘vaping’, that is neologism, coined to indicate the act of vaporizing the liquid contained in e cigarettes, produces inhalable exposures to contaminants of aerosol that would warrant health concerns [Burstyn, 2013]. However, chronic inhalation data in humans are needed before any definite conclusions are made.
From a public health perspective it is important to consider the impact of e cigarette use on bystanders. The existing evidence from environmental exposure and chemical analyses of vapour indicates that the effects of e cigarette use on bystanders are minimal compared with conventional cigarettes [McAuley et al. 2012; Schripp et al. 2013]. This is not surprising considering the nature and levels of contaminants in the vapour and the notion that, unlike tobacco cigarettes, sidestream smoke exposure is nonexistent in e cigarettes, that is, the only vapour released into the air is that exhaled by the user, not by the e cigarette itself.
Regulatory authorities have expressed concern about e cigarette use by youngsters or by never smokers, with e cigarettes becoming a gateway to smoking or becoming a new form of addiction. However, such concerns are unsubstantiated by existing data that e cigarette use by youngsters is virtually nonexistent unless they are smokers [Centers for Disease Control and Prevention, 2013; Dockrell et al. 2013; Camengaa et al. 2014] and in fact the use of e cigarettes may serve as a gateway ‘out’ of smoking [Polosa and Caponnetto, 2013a].
In Canada, electronic products that dispense nicotine by inhalation fall under the Food and Drugs Act of Health Canada and thus cannot be imported, marketed or sold in Canada without being approved as a new drug. Likewise, the delivery system of an e cigarette containing nicotine must meet the requirements of the Medical Devices Regulations. This ruling has resulted in a regulatory grey zone whereby e cigarette cartridges and liquids that contain nicotine are illegal and cartridges and liquids without nicotine (and with no accompanying health claim) are legal. This irrational situation is contributing to the paradox that many Canadian smokers have to break the law to use an e cigarette that helps them to refrain from smoking.
If e cigarettes were being marketed to the general public as a new gadget that every man, woman and child should try, it would make sense to slow down product development and severely limit distribution. But the intended use of e cigarettes is to serve as a substitute for the practice of smoking tobacco cigarettes. Therefore, it is a product marketed for and to smokers; and inhibiting the distribution serves to harm public health by perpetuating exposure to substances in smoke that cause serious diseases and early death.
Long-term nicotine use and smoking abstinence
The harm of tobacco smoking to the individual and to the society is well known. It is the single most important cause of avoidable premature mortality in the world, killing nearly 6 million people a year [WHO, 2008; US Department of Health and Human Services, 1990]. The WHO Framework Convention on Tobacco Control advises that the key to reducing the health burden of tobacco is to encourage abstinence among smokers [WHO, 2003]. In fact, all medically approved treatments for smoking, whether pharmaceutical or behavioural, have focused on total abstinence from nicotine. That approach would make sense if nicotine caused smoking-related diseases. However, nearly all the health risks come from tar, chemicals and other substances found in the smoke, not from nicotine [US Department of Health and Human Services, 2010]. Products that deliver nicotine without the smoke carry no more than 1% of the health risks of smoking [Phillips et al. 2006]. Decades of research on Swedish smokers who switched to snus (a type of moist snuff) showed no increased risk of any type of cancer, cardiovascular disease or lung disease [Lee, 2011]. Similarly, a review of 120 studies on NRT products found that NRT is associated with adverse effects that may be discomforting for the patient but are not life threatening [Mills et al. 2010].
If the nicotine abstinence approach was working to rapidly reduce the number of smokers, it might make sense to continue insisting. But this is not the case. Using simulation models, Levy and colleagues predicted that even if the current number of quit attempts in the USA instantly doubled and the number of smokers using pharmacotherapy instantly doubled as well (and these changes were sustained over time), the nation could not reach its goal of lowering adult smoking prevalence to below 12% by 2020 unless the effectiveness of pharmacotherapy increased as well [Levy et al. 2010]. A doubling in treatment effectiveness alone would lower smoking prevalence in 2020 from a predicted 17.5% to 15.9%. We all agree that complete smoking cessation is the best outcome for smokers, but for those who experience very long-term, perhaps lifelong, disruption of brain function, mood or cognitive ability following smoking cessation, nicotine cessation may not be the healthiest approach. Such individuals may require long-term treatment support or nicotine maintenance to enable them to maintain smoking abstinence [Tobacco Advisory Group of the Royal College of Physicians, 2007; Piasecki et al. 1998; Caponnetto et al. 2013c]. Consequently, many smokers will keep smoking because when given only the options of smoking or completely giving up nicotine many will not give it up. Bearing in mind that nicotine per se does not cause much risk when separated from inhaling smoke, it is important to consider that a third option is also available to smokers; the reduction of smoking-related diseases by taking nicotine in a low-risk form. Tobacco harm reduction (THR), the substitution of low-risk nicotine products for cigarette smoking, is likely to offer huge public health benefits ‘by fundamentally changing the forecast of a billion cigarette-caused deaths this century’ [Sweanor et al. 2007].
Several smoke-free nicotine products have been proposed for THR, including NRTs, snus, and dissolvable tobacco orbs, strips, and sticks. Realistic alternatives need to be as readily available as cigarettes, competitively priced, socially acceptable, and approved for regular long-term recreational use rather than as short-term cessation aids. In the UK, NRT products have been recently licensed for longer term use, as well as other harm reduction purposes [Beard et al. 2013]. Likewise, in April 2013, the United States Food and Drug Administration (FDA) announced changes in labelling of NRT products that would eliminate warnings against smoking while using NRT or using multiple NRT products. The directions to stop using the NRT after a specified number of weeks will be replaced with a statement that encourages use as long as needed to prevent relapse [FDA, 2013a]. Because of their similarities to smoking, including the hand-to-mouth repetitive motion and the visual cue of a smoke-like vapour [Caponnetto et al. 2012, 2013b], e cigarettes are proving to be an attractive and popular long-term alternative to tobacco cigarettes. The entry of several major tobacco companies into the e cigarette market, either by acquisition or new product introduction, is another clear indicator of product popularity [Coghlan, 2013; Esterl, 2012]. Hopefully, the e cigarette business will accelerate transformation of tobacco corporations into becoming nicotine companies, which would be a corporate and public health win.
E cigarette regulation and associated challenges
The rapidly evolving phenomenon of the e cigarette is raising concerns for those in the health community, for those in the pharmaceutical industry, health regulators and state governments [The C.S. Mott Children’s Hospital, 2013; Sullum, 2013; Knight, 2013; Tierney, 2011]. Among their concerns, there is the fact that e cigarette use may encourage higher consumption of nicotine, may perpetuate smokers’ addiction to nicotine making them less susceptible to quitting altogether, may expose users to the risk of accidental ingestion of e liquid or as yet unknown health risks from long-term e cigarette use, may make smoking socially acceptable again thus undermining current no-smoking policies, and may act as a gateway to tobacco, especially for youngsters. Although these concerns are mostly theoretical and not based on scientific evidence, international agencies and regulatory authorities in many countries are investigating or planning to introduce restrictions on the quality, marketing, sale and use of e cigarettes.
Addressing these diverse concerns may be difficult. The challenge faced by regulators is determining which interventions will have the greatest beneficial impact on public health [Freiberg, 2012]. Addressing one concern without gathering sufficient data or considering other viewpoints often results in unintended consequences. For example, the draft EU Tobacco Products Directive (TPD) circulating late in 2012 called for a limit on nicotine content of no more than 4 mg per ml of liquid [European Commission, 2012]. EU regulators may have believed that 1 ml of liquid is equivalent to one cigarette. However, 1 ml of liquid delivers as many puffs of vapour as the puffs of smoke from an entire pack of cigarettes. Certainly they would not expect a pack-a-day smoker to meet his or her daily nicotine needs with the equivalent of one piece of nicotine gum.
In the first half of 2013, EU health ministers tried to move towards a more restrictive change to the text of the TPD in that all e cigarettes would have been subject to pharmaceutical regulation regardless of their nicotine content. But during the first reading of the TPD, on 8 October 2013, there was a successful turnaround: e cigarettes should be regulated, but not be subject to the same rules as medicinal products unless they are presented as having curative or preventive properties. Those for which no such claims are made should contain no more than 30 mg/ml of nicotine, should carry health warnings and should not be sold to anyone under 18 years old. Manufacturers and importers would also have to supply the competent authorities with a list of all the ingredients that they contain. Finally, e cigarettes would be subject to the same advertising restrictions as tobacco products [European Parliament, 2013].
Classifying them as medical products in the EU would have meant they would undergo a costly and lengthy authorization process before marketing. As a consequence, product prices would increase, possibly to the point at which switching to a low-risk e cigarette would be much more expensive than continued smoking. Access to e cigarettes would be hindered not only because they would only be purchased in accredited pharmacies, but also because their internet sales would be strictly regulated. In these authors’ opinion, it is counterproductive and hypocritical to over regulate a product designed to reduce or eliminate the diseases and early deaths caused by smoking. The above-mentioned points have been extensively debated in recent commentaries [Hajek et al. 2013; Cobb and Cobb, 2013; Polosa and Caponnetto, 2013b].
However, the unintended consequences of regulating e cigarettes as medical products have been ignored by the Medicines and Healthcare Products Regulatory Agency (MHRA). In June 2013, MHRA announced UK government backing on medicinal regulation of e cigarettes and other nicotine containing products in the belief that this is the only way to ensure high-quality products, correct monitoring of the risks and proper control of advertising [Medicines and Healthcare Products Regulatory Agency, 2013].
Of note, the above-mentioned issues may not apply when considering countries with a very low smoking prevalence. Let us take the example of Australia. The Australian Government believes it is not worth the risk of introducing e cigarettes because they are already gaining substantial success in reducing smoking prevalence with their current antismoking laws [Department of Health and Ageing, 2011]. Thus the decision of the Australian Therapeutic Goods Administration to ban ciga-like e cigarettes, that is e cigarettes resembling in shape conventional tobacco cigarettes, is understandable [Therapeutic Goods Administration, 2013]. However, it must be appreciated that Australia is the first nation to sponsor a government-funded trial aimed to test the viability of e cigarettes as a safer, permanent replacement for tobacco [Duff, 2013].
The FDA first attempted to regulate e cigarettes under the Food, Drug, and Cosmetics Act as a ‘combination drug-device product that requires pre-approval, registration, and listing with the FDA’ [US District Court for the District of Columbia, 2010]. The US Court of Appeals for the DC Circuit, in Sottera, Inc. versus Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), held that e cigarettes and other products made or derived from tobacco can be regulated under the Family Smoking Prevention and Tobacco Control Act unless they are marketed for therapeutic purposes, in which case they are regulated as drugs or devices.
On 25 April 2011, the FDA announced that it would abide by the court decision [FDA, 2011]. The announcement went on to delineate a number of controls that the FDA could bring to bear on e cigarettes and other tobacco products. Among these, there were premarket review requirements for products first marketed or modified after 15 February 2007. Products introduced after that date would need to prove that they are ‘substantially equivalent’ to products that were on the market on or before 15 February 2007. The unintended consequence of applying this provision to e cigarettes would be to remove from the market products that have undergone significant improvements, freezing the technology at a stage of development when battery life was too short, vapour production was inconsistent and cartridges leaked [Trtchounian et al. 2010]. In addition, the general controls described by the FDA such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions will all cost money to implement and these costs will, no doubt, be passed on to the consumer. When e cigarettes first entered the US market, it was more expensive to use an e cigarette than it was to smoke. Prefilled cartridges tended to last as long as 5 or 10 cigarettes but cost more than half the cost of a pack. As refillable cartridges and refill liquids became available, prices came down and acceptance of the new products grew. Regulation brings with it the potential of a spike in prices that will not only prevent smokers from becoming new e cigarette consumers but that may also drive a sizable percentage of former smokers back to tobacco smoking.
Overall, the restrictions that some stakeholders wish to impose on e cigarettes appear to be most often disguised in the form of the same regulations used for medicinal products. Excessive and ill-conceived regulation will marginalize these products by making them unattractive to smokers and less competitively priced compared with tobacco products by preventing clear communication about reduced risks or by making them hard to access. What is worse, these restrictions are being introduced without taking into account the users’ point of view.
For consumers, safety is a concern but secondary in view of the hazards of the product being replaced. Most consumers would be content with safety regulations that helped to assure product consistency and prevent contamination, and labelling that supports making informed buying decisions (e.g. precise specification of nicotine content), but see no need to apply the strict regulations used for pharmaceutical products that would lead to unnecessary increase in products’ price [The Wall Street Journal, 2010].
Concerns about e cigarette users increasing their overall intake of nicotine may be misplaced. Surveys consistently find that around two-thirds of e cigarette users choose nicotine concentrations of over 12 mg/ml [Foulds et al. 2011]; however, one study found that using a cartridge labelled as containing 16 mg of nicotine resulted in blood levels of nicotine only one-tenth of the levels produced by smoking [Bullen et al. 2010]. Despite the low delivery of nicotine, participants reported that using the ‘high nicotine’ e cigarette quelled desire to smoke more effectively.
Another factor that seems to have a positive effect on diminishing desire to smoke is the availability of nontobacco flavours. Etter and Bullen reported that although tobacco flavour had the most users (39%), it was rated lower than all other flavours combined [Etter and Bullen, 2011]. In a web-based survey of over 2000 e cigarette users, 70.1% reported that they used fruit, beverage or candy-flavoured liquid at least occasionally, and over half reported using these flavours regularly, often or always. In addition, only 27% reported that the availability of such flavours was not influential in their continued use of e cigarettes [The Consumer Advocates for Smoke-free Alternatives Association, 2010]. Thus, the accusation that only children would want nontobacco flavours appears unfounded.
Ideally, before any regulations are enacted, the regulatory body will require sufficient scientific research to verify that a problem does exist, quantify the problem, explore all potential solutions including making no change at all, determine the possible consequences of each, and then select the solution that is best for public health.
Mitch Zeller, the new director of the FDA Office of Tobacco Products, stated, ‘The FDA is committed to making science-based decisions on all product applications and providing the agency’s scientific rationale behind its actions to ensure the most transparent and efficient process possible for all involved parties, according to the law’ [FDA, 2013b]. Hopefully, other world governments will follow this lead.
E cigarette regulation recommendations
On the basis of current evidence of benefits and harms relative to tobacco cigarettes and in line with users’ desire, future regulatory measures should primarily address quality standards and monitoring of e cigarettes and e liquids and should require the following:
evidence that good manufacturing practice (GMP) has been followed;
child-proof caps on fluid containers;
official documentation reporting on the contents of e cigarette fluids to regulators;
clear, accurate and detailed labelling about the contents and the hazards associated with e cigarette use.
One such regulatory framework already exists; e liquids may be marketed as dietary supplements providing no claims about preventing or treating disease are made. Under dietary supplements regulation, manufacturers must indicate a product is not dangerous prior to introduction. Being compliant with national GMP policies is all that is required to ensure that e liquids are produced in a quality manner: they must not contain contaminants or impurities, they should be accurately labelled, and they must be held under conditions to prevent adulteration. Additional safety principles can be implemented, including a rule requiring that e liquid manufacturers submit reports of serious adverse events linked to the use of their products. Obviously, the simple scheme of dietary supplements regulation must be integrated by the already existing directives about electronic products safety (for example, in the EU, these classes of products must comply with CE marking and accompanying Declaration of Conformity before marketing).
Ostensibly, prohibitions on where smoking may take place were enacted to protect the public from exposure to harmful substances in second-hand smoke. Indeed, many such laws include the phrase ‘clean air’ in the name of the statute. All testing of vapour to date has found no evidence that exhaled vapour produces exposures to contaminants that would warrant health concerns by the standards that are used to ensure safety of workplaces [Cahn and Siegel, 2011; Goniewicz et al. 2013]. In addition, there has been no study confirming concerns that the use of e cigarettes in smoke-free areas might undermine smoke-free laws. Most people have no difficulty differentiating vapour from smoke. Therefore there is no justification for a blanket inclusion of e cigarettes in existing ‘clean air’ regulations. Seeing e cigarettes being used where smoking is prohibited may encourage smokers to make the switch to a product that could save their health and their lives, thereby helping to denormalize smoking by reducing the overall number of smokers.
However, it is reasonable to consider restrictions about e cigarette use in places frequented by very young children. Likewise, it is prudent to institute controls on marketing of e cigarettes to nonsmokers and to apply the same prohibition on sales to children and young people as for tobacco products.
Last but not least, if e cigarettes can be developed to become more reliable and equally as satisfying to smokers as use of tobacco cigarettes, and as readily available and at least as affordable, there will be little incentive for smokers to continue to smoke far more harmful cigarettes. As such, e cigarettes are not a gateway to smoking but a gateway from smoking, and heavy regulation by restricting access to e cigarettes would just encourage continuing use of much unhealthier tobacco smoking.
The rationale of tobacco harm reduction is to make nicotine products that are satisfying as a smoking substitute available to smokers at least as easily as cigarettes, and at competitive prices, hence providing all smokers with an easily obtainable lower-risk alternative to smoking. Clive Bates, former director of the UK’s Action on Smoking and Health, pointed out that for these alternative products, ‘there is place for regulation, but it should be to create an “enabling framework” for these new, much less risky, alternatives to smoking to enter the market in a way that gives consumers confidence in switching from smoking’ [Bates, 2012].
Simple regulatory frameworks already exist: e liquids can be marketed as dietary supplements or as cosmetic products, whereas marketing and safety of e cigarettes’ electronics, batteries and spare parts are already regulated by the existing directives on electronic product design. Therefore, it should be easy to implement a reasonable regulation that is very much in line with consumers’ aspirations. Unfortunately, this may be politically impossible to implement because the growing popularity of e cigarettes is a threat to the interests of the tobacco industry, the pharmaceutical industry and to their associated stakeholders due to the substantial decrease in cigarette consumption and NRT sales. The fat revenues generated by tobacco excise taxes are very much needed by authorities to run their national state and local governments. Fees and investments from the pharmaceutical industry for the marketing of antismoking drugs and medications intended to treat tobacco-related diseases are much needed by regulatory bodies, health authorities and medical societies for the running of their statutory activities.
If these obstacles can be overcome, much misery and suffering can be reduced and millions of lives can be saved.
Funding: DS is expert in Health Communication at the Department of Clinical and Molecular Biomedicine and she is supported by the University of Catania, Italy. GAF is assistant Professor of Constitutional Law at the Department of Law and he is supported by the University of Catania, Italy. RP is full Professor of Internal Medicine with tenure and he is supported by the University of Catania, Italy. RP’s research on smoking, electronic cigarettes and tobacco regulation is currently supported by University of Catania and LIAF (Lega Italiana AntiFumo).
Conflict of interest statement: None of the authors have any competing financial interests to declare, with the exception of RP. RP has received lecture fees from Pfizer and GSK, a research grant from Pfizer, and he served as a consultant for Pfizer, Global Health Alliance for treatment of tobacco dependence, and Arbi Group Srl (the Italian distributor for Categoria electronic cigarettes).
Daniela Saitta, Department of Clinical and Molecular Biomedicine, University of Catania, Catania, Italy.
Giancarlo Antonio Ferro, Department of Law, University of Catania, Catania, Italy.
Riccardo Polosa, UOC di Medicina Interna, Edificio 4, Piano 3, AOU ‘Policlinico-V. Emanuele’, Università di Catania, Via S. Sofia 78, 95123 Catania, Italy.
Adelman D., Grainger M., Ayala V., Paxton K. (2013) Tobacco: New Years’ Resolutions + E cigs = Weaker Volumes? New York: Morgan Stanley Research North America
Bates C. (2012) European Union making bad policy on nicotine – five ways to make it better. The counterfactual. Available at: (accessed 30 August 2013).
Beard E., Bruguera C., Brown J., McNeill A., West R. (2013) Was the expansion of the marketing license for nicotine replacement therapy in the United Kingdom to include smoking reduction associated with changes in use and incidence of quit attempts? Nicotine Tob Res 15: 1777–1781 [PubMed]
Bullen C., Howe C., Laugesen M., McRobbie H., Parag V., Williman J., et al. (2013) Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet 382: 1629–1637 [PubMed]
Bullen C., McRobbie H., Thornley S., Glover M., Lin R., Laugesen M. (2010) Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob Control 19: 98–103 [PubMed]
Burstyn I. (2013) Peering through the mist: what does the chemistry of contaminants in electronic cigarettes tell us about health risks? Drexel University: Philadelphia, PA: Available at: publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08.pdf (accessed 17 August 2013).
Cahn Z., Siegel M. (2011) Electronic cigarettes as a harm reduction strategy for tobacco control: a step forward or a repeat of past mistakes? J Public Health Policy 32: 16–31 [PubMed]
Camengaa D., Delmericob J., Kongc G., Cavallo D., Hyland A., Cummings K., et al. (2014) Trends in use of electronic nicotine delivery systems by adolescents. Addict Behav 39: 338–340 [PMC free article] [PubMed]
Caponnetto P., Campagna D., Cibella F., Morjaria J., Caruso M., Russo C, et al. (2013a) EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PLoS One 8: e66317. [PMC free article] [PubMed]
Caponnetto P., Campagna D., Papale G., Russo C., Polosa R. (2012) The emerging phenomenon of electronic cigarettes. Expert Rev Respir Med 6: 63–74 [PubMed]
Caponnetto P., Russo C., Bruno C., Alamo A., Amaradio M., Polosa R. (2013b) Electronic cigarette: a possible substitute for cigarette dependence. Monaldi Arch Chest Dis 79: 12–19 [PubMed]
Caponnetto P., Keller E., Bruno C., Polosa R. (2013c) Handling relapse in smoking cessation: strategies and recommendations. Intern Emerg Med 8: 7–12 [PubMed]
Casella G., Caponnetto P., Polosa R. (2010) Therapeutic advances in the treatment of nicotine addiction: present and future. Ther Adv Chronic Dis 1: 95–106 [PMC free article] [PubMed]
Centers for Disease Control and Prevention (2013) Notes from the field: electronic cigarette use among middle and high school students – United States, 2011–2012. MMWR Morb Mortal Wkly Rep 62: 729–730 [PMC free article] [PubMed]
Cobb N., Cobb C. (2013) Regulatory challenges for refined nicotine products. Lancet Respir Med 1: 431–433 [PubMed]
Coghlan A. (2013) E cigarettes may soon be sold as life-saving medicine. New Scientist 2905: 6–7
Convention on Biological Diversity (2000) Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Available at: bch.cbd.int/protocol/background/ (accessed 9 November 2013).
Court of First Instance (2002) Artedogan and others vs Commission. Joined Cases T-74/00, T-76/00, T-83/00 to T-85/00, T-132/00, T-137 / 00 and T-141/00. Second expanded section. Available at: curia.europa.eu/juris/liste.jsf?language=en&num=T-74/00 (accessed 10 November 2013).
Court of First Instance (2003) Solvay Pharmaceuticals vs Council. Case T-392/02. Available at: curia.europa.eu/juris/liste.jsf?language=en&num=T-392/02 (accessed 10 November 2013).
Court of Justice (1998) C-180/96, United Kingdom/Commission. European Court Reports. I: 2265. Available at: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:61996CJ0180:EN:HTML (accessed 10 November 2013).
Court of Justice (1999) C-175/98, Lirussi. European Court reports. I: 06881. Available at: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:61998CJ0175:GA:NOT (accessed 10 November 2013).
Court of Justice (2000) C-6/99 Greenpeace, European Court reports. 1651. Available at: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:61999CJ0006:EN:PDF (accessed 10 November 2013).
Court of Justice (2010a) C-333/08, Commission vs French Republic, G.U.C.E. C 63/7. Available at: (accessed 10 November 2013).
Court of Justice (2010b) C-343/09 Afton Chemical Limited c. Secretary of State for Transport. Available at: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62009CJ0343:EN:NOT (accessed 10 November 2013).
Department of Health and Ageing (2011) Important changes to the sale of tobacco products in Australia. Department of Health and Ageing, Australian Government; Available at: (accessed 27 December 2013).
Dockrell M., Morison R., Bauld L., McNeill A. (2013) E cigarettes: prevalence and attitudes in Great Britain. Nicotine Tob Res 23 May 2013. (Epub ahead of print).
Duff E. (2013) Cigarette phase-out considered as trial tests if vapour safer. The Sidney Morning Herald 15 September Available at: –2trj1.html#ixzz2ogR7WjDF (accessed 27 December 2013).
Esterl M. (2012) Got a light-er charger? Big tobacco’s latest buzz. The Wall Street Journal 25 April
Etter J. (2010) Electronic cigarettes: a survey of users. BMC Public Health 10: 231. [PMC free article] [PubMed]
Etter J., Bullen C. (2011) Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction 106: 2017–2028 [PubMed]
European Commission (2000) Communication from the Commission on the precautionary principle COM/2000/0001 final. Available at: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52000DC0001:EN:NOT (accessed 7 November 2013).
European Commission (2012) Proposal for a Directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products. Available at: ec.europa.eu/health/tobacco/docs/com_2012_788_en.pdf (accessed 15 September 2013).
European Parliament (2013) Amendments adopted by the European Parliament on 8 October 2013 on the proposal for a directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products. Available at: (accessed 8 October 2013).
European Union (2008) Consolidated version of the treaty on the functioning of the European Union. Official J Eur Union C 115: 132. Available at: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2008:115:0047:0199:en:PDF (accessed 9 November 2013).
Foulds J., Veldheer S., Berg A. (2011) Electronic cigarettes (e cigs): views of aficionados and clinical/public health perspectives. Int J Clin Pract 65: 1037–1042 [PubMed]
Freiberg M. (2012) Federal approaches to the regulation of noncigarette tobacco products. Am J Prev Med 43(5 Suppl. 3): S249–S254 [PubMed]
Goniewicz M., Knysak J., Gawron M., Kosmider L., Sobczak A., Kurek J., et al. (2013) Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control 6 March 2013. (Epub ahead of print). [PMC free article] [PubMed]
Grandjean P. (2004) Implications of the precautionary principle for primary prevention and research. Annu Rev Public Health 25: 199–223 [PubMed]
Hajek P., Foulds J., Le Houezec J., Sweanor D., Yach D. (2013) Should e cigarettes be regulated as a medicinal device? Lancet Respir Med 1: 429–431 [PubMed]
King B., Alam S., Promoff G., Arrazola R., Dube S. (2013) Awareness and ever use of electronic cigarettes among U.S. adults, 2010–2011. Nicotine Tob Res 28 February (Epub ahead of print). [PMC free article] [PubMed]
Knight C. (2013) E cigarettes – the unanswered questions. Cancer Research UK Science blog. 30 May Available at: cigarettes-the-unanswered-questions/ (accessed 27 December 2013).
Lee P. (2011) Summary of the epidemiological evidence relating snus to health. Regul Toxicol Pharmacol 59: 197–214 [PubMed]
Levy D., Mabry P., Graham A., Orleans C., Abrams D. (2010) Exploring scenarios to dramatically reduce smoking prevalence: a simulation model of the three-part cessation process. Am J Public Health 100: 1253–1259 [PMC free article] [PubMed]
McAuley T., Hopke P., Zhao J., Babaian S. (2012) Comparison of the effects of e cigarette vapor and cigarette smoke on indoor air quality. Inhal Toxicol 24: 850–857 [PubMed]
Medicines and Healthcare Products Regulatory Agency (2013) Press release: UK moves towards safe and effective electronic cigarettes and other nicotine-containing products. Medicines and Healthcare Products Regulatory Agency, Department of Health, UK Government; Available at: (accessed 27 December 2013).
Mills E., Wu P., Lockhart I., Wilson K., Ebbert J. (2010) Adverse events associated with nicotine replacement therapy (NRT) for smoking cessation. A systematic review and meta-analysis of one hundred and twenty studies involving 177,390 individuals. Tob Induc Dis 8: 8. [PMC free article] [PubMed]
Phillips C., Rabiu D., Rodu B. (2006) Calculating the comparative mortality risk from smokeless tobacco versus smoking. Poster presentation. Congress of Epidemiology conference. American Journal of Epidemiology 163: S189
Piasecki T., Fiore M., Baker T. (1998) Profiles in discouragement: two studies of variability in the time course of smoking withdrawal symptoms. J Abnorm Psychol 107: 238–251 [PubMed]
Polosa R., Benowitz N. (2011) Treatment of nicotine addiction: present therapeutic options and pipeline developments. Trends Pharmacol Sci 32: 281–289 [PubMed]
Polosa R., Caponnetto P. (2013a) Time for evidence-based e cigarette regulation. Lancet Oncol 14: e582–e583 [PubMed]
Polosa R., Caponnetto P. (2013b) Regulation of e cigarettes: the users’ perspectives. Lancet Respir Med 1: e26. [PubMed]
Polosa R., Caponnetto P., Morjaria J., Papale G., Campagna D., Russo C. (2011) Effect of an electronic nicotine delivery device (e cigarette) on smoking reduction and cessation: a prospective 6-month pilot study. BMC Public Health 11: 786. [PMC free article] [PubMed]
Polosa R., Morjaria J., Caponnetto P., Campagna D., Russo C., Alamo A., et al. (2013) Effectiveness and tolerability of electronic cigarette in real-life: a 24-month prospective observational study. Intern Emerg Med 20 July (Epub ahead of print). [PubMed]
Regan A., Promoff G., Dube S., Arrazola R. (2013) Electronic nicotine delivery systems: adult use and awareness of the ‘e cigarette’ in the USA. Tob Control 22: 19–23 [PubMed]
Schripp T., Markewitz D., Uhde E., Salthammer T. (2013) Does e cigarette consumption cause passive vaping? Indoor Air 23: 25–31 [PubMed]
Science & Environmental Health Network (1998) Wingspread Conference on the Precautionary Principle. Available at: (accessed 1 September 2013).
Siegel M., Tanwar K., Wood K. (2011) Electronic cigarettes as a smoking-cessation: tool results from an online survey. Am J Prev Med 40: 472–475 [PubMed]
Subramaniam S. (2013) E cigs and minors: kid taste, adult problem? The Network for Public Health Law. Available at: (accessed 16 May 2013).
Sullum J. (2013) The lunatic war on e cigarettes. New York Post 23 October
Sweanor D., Alcabes P., Drucker E. (2007) Tobacco harm reduction: how rational public policy could transform a pandemic. Int J Drug Pol 18: 70–74 [PubMed]
The Consumer Advocates for Smoke-free Alternatives Association (2010) Results of web-based survey, 2010. Available at: (accessed 10 August 2013).
The C.S. Mott Children’s Hospital (2013) Adults worry e cigarettes will encourage kids to start smoking tobacco. The C.S. Mott Children’s Hospital National Poll on Children’s Health 20(1). C.S. Mott Children’s Hospital, University of Michigan; Available at: cigarettes-will-encourage-kids-start-smoking-tobacco (accessed 27 December 2013).
Therapeutic Goods Administration (2013) Electronic cigarettes. Therapeutic Goods Administration, Department of Health, Australian Government; Available at: cigarettes.htm#.Ur2A9_TuJJd (accessed 27 December 2013).
The Wall Street Journal (2010) Question of the day: should e cigarettes be regulated as drug-delivery devices by the FDA? Available at: online.wsj.com/community/groups/question-day-229/topics/should-e cigarettes-regulated-drug-delivery-devices (accessed 15 September 2013).
Tierney J. (2011) A tool to quit smoking has some unlikely critics. The New York Times 7 November
Tobacco Advisory Group of the Royal College of Physicians (2007) Harm reduction in nicotine addiction: helping people who can’t quit. A report by the Tobacco Advisory Group of the Royal College of Physicians, Royal College of Physicians, London: Available at: (accessed 18 August 2013).
Trtchounian A., Williams M., Talbot P. (2010) Conventional and electronic cigarettes (e cigarettes) have different smoking characteristics. Nicotine Tob Res 12: 905–912 [PubMed]
United Nations Conference on Environment and Development UNCED (1992) The Earth Summit. Available at: (accessed 9 November 2013).
United Nations Environment Programme (1972) Declaration of the United Nations Conference on the Human Environment. Available at: (accessed 9 November 2013).
US Department of Health and Human Services (1990) The Health Benefits of Smoking Cessation: A Report of the Surgeon General. Rockville, MD: Public Health Service, Centers for Disease Control, Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health
US Department of Health and Human Services (2010) How Tobacco Smoke Causes Disease. TheBiology and Behavioral Basis for Smoking-Attributable Disease Fact Sheet. A Report of the Surgeon General. Rockville, MD: Public Health Service, Office of the Surgeon General
US District Court for the District of Columbia (2010) Smoking Everywhere, Inc., and Sottera, Inc. v. U.S. Food and Drug Administration et al. Case 1:09-cv-00771-RJL Document 1. Available at: casaa.org/uploads/SE-vs-FDA-Ruling.pdf (accessed 15 September 2013).
US Food and Drug Administration (2011) Regulation of E cigarettes and other tobacco products. Available at: (accessed 15 September 2013).
US Food and Drug Administration (2013a) Nicotine replacement therapy labels may change. Available at: (accessed 2 April 2013).
US Food and Drug Administration (2013b) FDA announces first decisions on new tobacco products through the substantial equivalence pathway. Available at: (accessed 26 June 2013).
WHO (2003) WHO Framework Convention on Tobacco Control. Available at: (accessed 10 September 2013).
WHO (2008) Report on the global tobacco epidemic, 2008. Available at: whqlibdoc.who.int/publications/2008/9789241596282_eng.pdf (accessed 20 August 2013).
WHO (2009) Study group on tobacco product regulation, report on the scientific basis of tobacco product regulation: third report of a WHO study group. WHO Technical Report Series 955. Available at: whqlibdoc.who.int/publications/2009/9789241209557_eng.pdf (accessed 20 August 2013). [PubMed]
Wiener J. (2013) The politics of precaution, and the reality. Regulation Gov 7: 258265