Regulating the ‘wild west’ of e-cigarettes
E-cigarettes have exploded onto the market in recent years and there are multi-billion dollar questions swirling around them. Advocates say that they offer a safe and effective smoking cessation aid while opponents are concerned that they may erode the success of decades of tobacco reduction efforts.
E-cigarettes have the appearance of tobacco cigarettes and simulate smoking without the combustion. Fluid, made up of mostly vegetable glycerin combined with a range of flavours and sometimes infused with nicotine, fills a metal battery-powered ‘cigarette’ or ‘vaping’ canister. ‘Smoking’ an e-cigarette means inhaling the vapour which is generated.
E-cigarettes do not contain many of the carcinogens present in tobacco cigarettes like tar. However, more evidence is needed around long-term health effects of inhaling vapour from heating the mixture of chemicals found in e-cigarette fluids.
“More research is urgently needed to clearly establish … overall benefits and harms”
While there are strong voices for and against e-cigarettes, there is no definitive evidence about the long-term harms of e-cigarettes. In addition, claims that e-cigarettes are a smoking cessation aid have not been definitely proven.
An additional challenge is that there are many different designs, ingredients and manufacturers of e-cigarettes. This makes the study of the mix of chemicals in e-cigarette liquids and vapours difficult to assess, and the results from one product difficult to generalize to others.
Supporters of e-cigarettes argue they are more effective for tobacco smoking cessation than traditional nicotine-replacement products like patches and gum. However, evidence supporting these claims is not well established.
A randomized controlled trial published in The Lancet in September 2013 compared the effectiveness of nicotine patches, nicotine containing e-cigarettes and non-nicotine e-cigarettes. 7.3% of tobacco smokers enrolled in the study who used nicotine e-cigarettes abstained from smoking for 6 months, compared to 5.8% using nicotine patches. The difference between the two groups was not statistically significant. The study did not have enough participants for the results to definitively point to the best option. The authors concluded that “e-cigarettes were modestly effective at helping smokers quit” and that “more research is urgently needed to clearly establish their overall benefits and harms at individual and population levels.”
Another area of research has been about whether people are using e-cigarettes to help quit smoking, or if they are a gateway to tobacco cigarettes.
A 2013 survey from the United Kingdom suggests that the vast majority of e-cigarette users are current or past smokers, and they are using e-cigarettes to curb or reduce tobacco smoking. However, there are no accurate data on the number of Canadians who have used, or are current e-cigarette users, and their characterstics.
Reductions in the number of youth smoking tobacco cigarettes has been a major public health victory in Canada, with the proportion of youth aged 15 to 19 who reported that they had tried smoking halved from 50% in 1999 to just under 25% in 2012. While many claim that e-cigarettes will further decrease tobacco smoking, others fear that they could erode this progress. Robert Strang, Chief Public Health Officer for Nova Scotia is concerned that e-cigarettes, by mimicking and glamourizing smoking could “renormalize smoking behavior.”
A study published in JAMA Pediatrics earlier this month found a correlation between tobacco smoking and e-cigarette use in teens. The study concluded that “the use of e-cigarettes does not discourage, and may encourage conventional cigarettes among U.S. adolescents.”
However, the study has been widely criticized. David Sweanor, adjunct professor at University of Ottawa Faculty of Law and a tobacco control expert says “it confuses correlation and causation, making conclusions that the data doesn’t support.”
Sweanor says that while the study shows that the youth using e-cigarettes also smoked tobacco cigarettes, this could mean e-cigarettes are being used by teens to quit, or reduce, tobacco use.
While more research is needed about e-cigarettes’ long-term health effects, relationship to tobacco smoking and use for smoking cessation, there is no question that e-cigarette use is growing.
Massive growth predicted for e-cigarettes
Bonnie Herzog, managing director of Beverage, Tobacco & Convenience Store Research with with Wells Fargo Securities in New York City estimates that the global e-cigarette market in 2013 was around $2 billion. Models developed by Herzog predict this market will continue to grow to about $10 billion by 2017.
The global tobacco market is estimated at $800 billion. However industry sees huge potential in e-cigarettes. Herzog’s model suggests that by 2017 the profit margins for e-cigarettes will surpass tobacco for retailers.
Big tobacco has taken notice, with major growth in the acquisition of small e-cigarette manufacturers in the past few years. One of the largest global manufacturers, British American Tobacco recently launched an e-cigarette known as ‘Vype’ in the UK with accompanying advertisements promising “Pure satisfaction for smokers … experience the breakthrough.” Some experts point to the growing hand of ‘Big Tobacco’ in manufacturing e-cigarettes as a sign that they are a gateway or bridge to tobacco smoking.
Given the growth of e-cigarettes, regulators are under pressure to make decisions about this increasingly popular product.
Challenges regulating e-cigarettes in Canada
Robert Reid, a smoking cessation researcher at the Ottawa Heart Institute says that jurisdiction for monitoring and control of e-cigarettes falls under a number of different groups within Health Canada, such as Drugs & Health Products and Consumer Product Safety, and that “none have complete jurisdiction.”
A November 2013 editorial in the Canadian Medical Association Journal called Canada’s laws around e-cigarettes “among the most restrictive in the world”. However, while they are tough on paper, they are difficult to enforce in practice.
Health Canada has advised Canadians not to use e-cigarettes, saying “these products may pose health risks and have not been fully evaluated for safety, quality and efficacy.”
E-cigarette liquids that contain nicotine, or make a claim that they can help smokers quit, are considered a health product, and require approval as a drug or device by Health Canada. Kendal Weber, Director General of the Policy, Planning and International Affairs Directorate of Health Canada says that no e-cigarette or e-liquid manufacturers have received Health Canada approval to make smoking cessation claims.
However, e-cigarettes and e-liquids that do not contain nicotine are legal for sale in Canada. Health Canada has recently announced a contract to study the retail sale of e-cigarettes and other nicotine replacement therapies in Canada. There has been some speculation about whether this research could be used to craft new legislation.
David Sweanor is critical of Health Canada’s approach saying legislation needs to be flexible, given the rapid pace of innovation and change around e-cigarettes, arguing that “an ongoing ban on e-cigarettes is not feasible.” He points to a large and growing market for these products and says “once you get a significant number of people using these products, its impossible to ban it.”
“There is no difficulty in accessing nicotine-containing e-cigarettes or e-liquids, which are both widely available” says Robert Reid.
Experts have noted that Health Canada has limited capacity to enforce the claims made on such products – which are widely available online and from storefront retailers.
Robert Strang characterizes the current Canadian market for e-cigarettes as the ‘Wild West’ pointing out that there is no required testing or labeling for e-cigarette products being sold to Canadians.
A study published earlier this month in the American Journal of Preventative Medicine analyzed advertising claims on e-cigarette retail websites and found 95% made implicit or explicit health-related claims about the products, like their use as a smoking cessation device, their environmentally ‘clean’ nature and absence of dangerous second hand smoke.
Stephanie Smith is a Vancouver e-cigarette user who replaced a decades-long smoking habit with e-cigarettes. Smith highlights that one aspect of e-cigarettes that helped her quit was the similarity of vaping an e-cigarette to smoking. “It gives you the good part of your habit – the pleasurable feeling of inhaling – in a cleaner nicotine delivery system” she says.
In contrast to e-cigarettes, cigarettes and tobacco products are tightly controlled under the federal Tobacco Act, which regulates how tobacco products are manufactured, labeled and sold.
Further restrictions on tobacco use and sales are in place across Canada through provincial and municipal regulations. For example, the Smoke-Free Ontario Act and Tobacco Reduction Act in Alberta tightly control where people can smoke, and have banned smoking in restaurants, bars and patios. None of these regulatory frameworks apply to e-cigarettes and related products.
What are other countries doing?
Advocates and experts are calling on governments to make choices about how to regulate e-cigarettes. Some voices argue that tight control is needed to ensure that e-cigarettes do not erode major public health gains made in the fight against tobacco, while others say open access is needed so that e-cigarettes can help curb or reduce tobacco smoking. A point of agreement, however, is the need for an evidence-based approach to regulating e-cigarettes.
At the end of February this year, the European Parliament voted for tighter restrictions on the e-cigarettes containing nicotine. These include banning advertising for e-cigarettes, warnings about the addictiveness of nicotine and nicotine-containing products, and establishing standards for the amount of nicotine in e-liquids. Stephanie Smith says e-cigarette users are concerned that “only big tobacco will be able to comply with restrictive regulations, and drive small manufacturers out of the business” – reducing the options for users.
In the United States, the regulatory status of e-cigarettes has been described as being “in limbo” with those containing nicotine and explicitly marketed as smoking cessation devices regulated through the Food and Drug Administration Centre for Drug Evaluation and Research.
However, e-cigarettes that are not explicitly marketed as a smoking cessation product, including those containing nicotine, are not regulated by the FDA and are widely available. Variability in quality, and no restrictions on selling e-cigarettes to minors have been highlighted as problems in the US e-cigarette market. However, the FDA stated in fall 2013 that it “intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protecting public health.” `
Will e-cigarettes ‘re-normalize’ smoking or help people quit?
Nova Scotia has proposed to revise its’ Smoke Free Places Act, and to restrict the use of e-cigarettes in public places, in line with regulations in place around public tobacco smoking. Robert Strang, Chief Public Health Officer for the province says that e-cigarettes “run the risk of renormalizing smoking behavior, and have the potential to erode the success of tobacco control strategies.”
Strang’s logic is echoed by a recently published editorial in the Canadian Medical Association Journal which notes that in the past 5 decades, the most important interventions responsible for declining tobacco smoking rates have not been nicotine replacement therapies, or the advice of health care professionals – rather it has been “the concerted public health and policy efforts that have gradually de-normalized, restricted and marginalized smoking behavior.”
Strang says that he has shared the proposed changes to Nova Scotia’s smoking legislation with colleagues from across Canada through the Tobacco Control Liaison Committee. He says committee members, including public health officers from across Canada are watching responses to the proposed legislative changes with interest.
However, many e-cigarette users contend that they are a useful tool in the fight against tobacco. Stephanie Smith says e-cigarettes were a “painless way to quit smoking”. Tim, a New York based artist who recently started using e-cigarettes and was previously a social tobacco smoker says that e-cigarettes “offer the pleasurable physical experiences associated with smoking a cigarettes – without the downsides.”
Robert Reid agrees, saying “there is a strong social condition aspect to smoking – its not just about the nicotine – its about the ritual of smoking, pulling in smoke through the mouth and the feeling that this has for smokers.”
Many experts are enthusiastic about the potential of e-cigarettes as a smoking cessation aid. A January editorial in the Journal of the American Medical Association says “applying overly burdensome, expensive regulatory hurdles to e-cigarettes could stifle innovation and favor the market domination of tobacco companies, which potentially promote dual use of cigarettes and e-cigarettes to minimize losing market share for their primary cigarette products.”
With the health-related burdens associated with smoking, as well as the fate of the multi-billion dollar tobacco industry implicated in any regulatory decision, there are high stakes around regulating e-cigarettes.
What all experts agree upon is that more research into e-cigarettes is needed to support evidence-based policy making.
Read the opinion of Healthy Debate editor & respirologist Sachin Pendharkar & his colleague Michael Roman, who say there is Too little data for doctors to recommend e-cigarettes.