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 Table of Contents  
REVIEW ARTICLE
Year : 2017  |  Volume : 61  |  Issue : 5  |  Page : 7-11  

Getting real with the upcoming challenge of electronic nicotine delivery systems: The way forward for the South-East Asia region


1 Regional Advisor, Tobacco-Free Initiative, Regional Office for South-East Asia, World Health Organization, Faridabad, Haryana, India
2 Freelance Public Health Consultant, Faridabad, Haryana, India

Date of Web Publication15-Sep-2017

Correspondence Address:
Arvind Vashishta Rinkoo
Freelance Public Health Consultant, 15/8, Faridabad, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijph.IJPH_240_17

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   Abstract 

Electronic nicotine delivery systems (ENDS) are being marketed to tobacco smokers for use in places where smoking is not allowed or as aids similar to pharmaceutical nicotine products to help cigarette smokers quit tobacco use. These are often flavored to make them more attractive for youth – ENDS use may lead young nonsmokers to take up tobacco products. Neither safety nor efficacy as a cessation aid of ENDS has been scientifically demonstrated. The adverse health effects of secondhand aerosol cannot be ruled out. Weak regulation of these products might contribute to the expansion of the ENDS market – in which tobacco companies have a substantial stake – potentially renormalizing smoking habits and negating years of intense tobacco control campaigning. The current situation calls for galvanizing policy makers to gear up to this challenge in the Southeast Asia Region (SEAR) where the high burden of tobacco use is compounded by large proportion of young vulnerable population and limited established tobacco cessation facilities. Banning ENDS in the SEAR seems to be the most plausible approach at present. In the SEAR, Timor-Leste, Democratic People's Republic of Korea, and Thailand have taken the lead in banning these products. The other countries of the SEAR should follow suit. The SEAR countries may, however, choose to revise their strategy if unbiased scientific evidence emerges about efficacy of ENDS as a tobacco cessation aid. ENDS industry must show true motivation and willingness to develop and test ENDS as effective pharmaceutical tools in the regional context before asking for market authorization.

Keywords: Electronic cigarettes, electronic nicotine delivery systems, regulation, Southeast Asia Region


How to cite this article:
Kaur J, Rinkoo AV. Getting real with the upcoming challenge of electronic nicotine delivery systems: The way forward for the South-East Asia region. Indian J Public Health 2017;61, Suppl S1:7-11

How to cite this URL:
Kaur J, Rinkoo AV. Getting real with the upcoming challenge of electronic nicotine delivery systems: The way forward for the South-East Asia region. Indian J Public Health [serial online] 2017 [cited 2017 Oct 20];61, Suppl S1:7-11. Available from: http://www.ijph.in/text.asp?2017/61/5/7/214906


   Introduction Top


Electronic cigarettes (ECs) or the electronic nicotine delivery systems (ENDS) were formally introduced in 2007.[1] They are battery-powered devices that simulate tobacco cigarettes by vaporizing nicotine and other chemicals into an inhalable vapor. A range of products are now in the market, with new improved ones promised, and something almost unheard of in tobacco use – self organizing groups of users who call themselves “vapers” because they inhale vapor, not smoke – are advocating for these products and sharing their experiences. Lately, Electronic Nonnicotine Delivery Systems (ENNDS) are also becoming increasingly popular. ENNDS devices are labeled as not containing nicotine (though labeling may not always be accurate). In practice, these devices are closely related to nicotine addiction because they deal, at least partly, with the behavioral and sensory aspects of smoking addiction (e.g., hand mouth movement).

ENDS are being marketed to tobacco smokers for use in places where smoking is not allowed, such as smoke-free pubs or restaurants, or as an aid similar to pharmaceutical nicotine products to help cigarette smokers quit tobacco use.[2],[3] However, as the vapor is often flavored which can make them more appealing to youth, there are concerns that ENDS use will lead young nonsmokers to take up cigarettes or other tobacco products. Many youngsters who start with ENDS may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes.[4]

The safety of these products has not been scientifically demonstrated. Besides, the current lack of regulation means that there is no way for consumers to find out what is actually delivered by the product they have purchased. The chemicals used in ENDS have not been fully disclosed, and there are no adequate data on their emissions. To further aggravate the scenario, sales of ENDS in countries such as United States have been doubling every year since 2007.[5]

The current situation calls for galvanizing policy makers to gear up to this challenge in countries such as those of the Southeast Asia Region (SEAR) where the high burden of tobacco use is further compounded by large proportion of young vulnerable population, limited established tobacco cessation facilities, and lack of regulatory provisions for ENDS. This review aims to analyze all relevant evidence based on ENDS and suggest plausible measures to regulate this slowly evolving but potentially catastrophic phenomenon in the SEAR.


   Toxicology Top


Studies measuring the content of ENDS cartridges have found varying nicotine levels as well as unlisted, dangerous ingredients.[6] ENDS brands not only differ in their efficacy but also in their consistency of nicotine vaporization.[7] Potentially harmful constituents have been documented in some ENDS cartridges, including irritants, genotoxins, and animal carcinogens.[8] Nicotine concentration in e-liquid is not well related to nicotine in vapor.[9] To further complicate the scenario, an increase in (ultra) fine particles (FP/UFP) and volatile organic compounds (VOC) could be determined after the use of the ENDS. Prominent components in the gas phase are 1,2-propanediol, 1, 2, 3-propanetriol, diacetin, flavorings, and traces of nicotine. “Passive vaping” may thus be associated with the consumption of ENDS.[10] More rigorous chemical analyses of these products and their emissions are urgently needed.[11]


   Health Effects Top


The health effects of vaping include the potential negative impact of nicotine on adolescent brain development, risk for nicotine addiction, and initiation of the use of conventional cigarettes or other tobacco products.[2] An addictive substance, nicotine use can lead to increased blood pressure and heart rate as well as nausea, sweating, and diarrhea, according to the National Institutes of Health.[12] Spain's Association of Pneumology and Thoracic Surgery says that ENDS immediately increase the airway resistance and decrease the power to draw air through, and this effect is greater in the group of nonsmokers and healthy smokers. It is well documented that nicotine contributes significantly to the harms to the developing fetus, probably through direct effects on the placenta as well as from passing across the placenta into the fetus.[13] Furthermore, generally, ENDS require stronger vacuums (suction) to smoke than conventional brands and the effects of this on human health could be adverse.[14] Besides, with design modifications, next generation ENDS would have the potential to deliver nicotine like a true combustible cigarette with a highly titratable (and escalating) dose potential direct to the brain. Such products would greatly change the equation in terms of cardiac safety, misuse, and addiction.[15] Latest research corroborates the neurologic effects of ENDS on human brain beta-2 nicotinic acetylcholine receptors, likely contributing to abuse liability by providing adequate alternative nicotine delivery system for cigarette smokers.[16] In terms of long-term health effects, it takes decades to look at the effects researchers are interested in. Thus, we have to understand that what comes out of ENDS is probably less toxic, but it is definitely more toxic than breathing clean air.[13]

Addition of flavoring agents to the e-liquid in ENDS/ENNDS to make these products more attractive to youth contributes to potential health hazards. Notably, close to 8000 e-liquid unique flavors have been reported. The health effects of heated and inhaled flavorings used in e-liquids have not been well-studied. Heated and inhaled popcorn, cinnamon, and cherry flavorings are potentially hazardous, with the limited literature on the topic indicating that most flavorings may pose appreciable health risks from long-term use, especially those that are sweet.[3]

The adverse health effects for third parties exposed cannot be excluded because the use of ENDS leads to the emission of fine and ultrafine inhalable liquid particles, nicotine, and cancer-causing substances into the indoor air. A recent systematic review of the health risks from passive exposure to exhaled aerosol from ENDS/ENNDS users – or secondhand aerosol (SHA) concluded that “the absolute impact from passive exposure to EC vapor has the potential to lead to adverse health effects.”[3] A WHO-commissioned review found that while there are a limited number of studies in this area, it can be concluded that SHA is a new air contamination source for particulate matter, which includes fine and UFP as well as VOC, some heavy metals, and nicotine.[17]


   Electronic Nicotine Delivery Systems for Smoking Cessation Top


The main argument put forward by the tobacco companies in some countries is that the ENDS can be used as devices for smoking cessation. These companies are putting these arguments quite subtly because they are careful not to make health claims which would lead to regulation of these products as medicines – as is the case in many countries such as Denmark, Lithuania, and Slovenia.[18] Studies also claim that ENDS are rarely, if at all, used by people who have never used tobacco.[19] Tobacco companies try to downsize anticipated addiction to ENDS by citing studies that show thousands of former smokers addicted to nicotine gum – the same is not considered a major public health problem.[20] Actually, those in support of ENDS have now focused on the potential of these products to serve as the centerpiece of a harm reduction strategy, with the argument that ENDS can drive down smoking faster.[21]

However, the Cancer Research UK-commissioned study identified four broad areas of uncertainty pertaining to the harm reduction use attributed to ENDS. These include the effects pertaining to the individual, tobacco control movement, political environment, and philosophical issues. The report highlights questions raised by the tobacco control and public health community relating to the involvement of the tobacco industry, personal choice, political decisions, and the question of how ethical it is to promote an addictive product.[22]

As of now, ENDS are not proven cessation aids. In fact, the role of ENDS is not clearly established. they are perceived in some quarters as smoking cessation aids and in others as a starter or dual-use (to maintain nicotine addiction) product.[3] Very few studies have assessed them as a harm reduction or cessation aid and that too with conflicting findings. One of the largest studies to date was based on a sample of 5939 current and former smokers across four countries. It found that ENDS' users were not more likely to quit smoking than nonusers.[23] Similarly, a New Zealand-based study also talks with uncertainty about the place of ENDS in tobacco control.[24] Research shows that drugs that contain nicotine are unattractive and not very effective in aiding cessation.[25] In fact, the vast majority of people who quit smoking do so without help.[18]

Public health enthusiasts for ENDS see their promise as a way to get smokers to quit or reduce toxic exposure, but they seem blasé about the other possible effects.[26] The large numbers of impassioned, vocal testimonies that ENDS have helped many thousands to quit or cut down smoking are countered by the researches that prove that there are no differences in smoking quit rates between ENDS users and nonusers.[23] Further, in this context, cutting down cigarettes rather than quitting confers little if any health benefit, so dual use may be as bad as continued smoking in terms of health outcomes.[27] Many studies have already shown that far from replacing cigarettes with ENDS, the most common pattern of ENDS use is dual use with cigarettes.[2] A Swedish cohort study of youth followed into late adolescence suggested that ENDS could lead to smoking cigarettes.[28]

Thus, scientific evidence regarding the effectiveness of ENDS/ENNDS as a smoking cessation aid is scant and of low certainty, making it difficult to draw credible inferences.[3] A 2014 review based on two randomized clinical trials concluded that although the analyzed ENDS had low efficacy for quitting smoking, the overall quality of the evidence was low.[29] A recent analysis based on decision-theoretic model concludes that use of vaporized nicotine products (VNPs) generally has a positive public health impact. However, very high VNP use rates could result in net harms. Notably, the study underscores that more accurate projections of VNP impacts will require better longitudinal measures of transitions into and out of VNP, cigarette, and dual use.[30] Similarly, a recent 2017 review concludes that the available evidence, which is of low or very low quality, can neither verify nor exclude the hypothesis that, because they address nicotine addiction and potentially deal with behavioral and sensory aspects of cigarette use, ENDS may be more effective than other nicotine replacement strategies. The review specifically underlines the need to conduct well-designed trials in this field measuring biochemically validated outcomes and adverse effects.[31] Likewise, a recent Cochrane review concludes that more studies of ENDS are needed before safety and effectiveness of these products as cessation aids can be established. The review emphasizes that the quality of available evidence overall is low because it is based on only a small number of studies.[32]


   Marketing and Advertising Strategies Top


In their present unregulated state, manufacturers are free to promote ENDS in any way they choose.[33] They are being promoted on social media including cable TV, the web, and YouTube by sexy movies and rock stars, who urge the youth to “take their freedom back.”[1]

Big tobacco, adept at targeting young consumers, is eyeing the ENDS market.[34],[35] The tobacco industry sees a future where ENDS accompany and perpetuate, rather than supplant, tobacco use, especially targeting the youth. Fears therefore arise that a new generation of youth who would not otherwise take up smoking could be enticed by ENDS into nicotine addiction and subsequent tobacco use. New ENDS' outlets are appearing, in some cases beside schools, as in Slovenia. ENDS marketing (including television commercials) encourages the use of the products anywhere, specifically in smoke-free environments in an effort to reestablish positive social norms for nicotine addiction.[36]

Furthermore, online publicity presents particular difficulties – websites can be set up outside a country's jurisdiction, for instance, and website age protection remains rudimentary. The current swathe of ENDS marketing is chillingly reminiscent of the early days of tobacco advertising; this past experience suggests that there is a good reason to be deeply concerned.[37] Studies show that these adverts exert a strong influence on the targeted audience – NJoy's Super Bowl ad in US prompted a 40% uptick in sales in the five markets where it ran. An unquantified amount of advertising uses deceptive health claims, targets youth, and incites rebellion against smoke-free policies. There are also concerns that some companies are using or might use ENDS/ENNDS advertising to promote smoking, advertently, or unintentionally.[38],[39] Notably, Internet sales, as opposed to those in retail stores, accounted for one-third of the worldwide market in 2014. In three regions – Asia Pacific, Australasia, and Latin America – Internet sales accounted for the largest share of the market (70%, 85%, and 94%, respectively).[3]

In SEAR, ENDS are currently marketed as “health cigarettes” and are mostly available online, including on social networking and e-commerce sites. They are becoming more visible in shopping malls and kiosks, mostly in the metros. The marketing messages mislead consumers to believe that these products have been proven to be safe, both for users and for people who would be exposed to secondhand emissions. The situation is reminiscent of the ENDS market in the UK and the US 5–6 years back, and given the past trends in these countries, these products could be burgeoning across the SEAR within the next couple of years.[40]


   The Way Forward for the Southeast Asia Region Top


Worldwide, countries have adopted various regulatory strategies with respect to ENDS/ENNDS, such as an outright ban on their manufacturing, importation, distribution, and sale; the adoption of regulation similar to that applicable to medicines; their control as tobacco products; or their control as consumer products with tobacco control-like measures, while there are other countries that have not regulated these products at all. Thus, different countries regulate ENDS differently, resulting in legal complexity, possible uncertainty, and regulatory gap. Excessive regulation could marginalize ENDS in favor of conventional cigarettes. On the other hand, deficient regulation might contribute to the expansion of the ENDS market – in which tobacco companies have a substantial stake – potentially renormalizing smoking habits and negating years of intense tobacco control campaigning.[41] If prior interest of the tobacco industry in reduced-risk products serves as a precedent, their interest lies in maintaining the status quo for as long as possible. The promotion of ENDS comes with such messages some of which are difficult to harmonize with the core tobacco control message and others are simply incompatible. Findings' support increased monitoring and regulation of ENDS marketing to prevent deceptive marketing tactics and ensure consumer safety.[42] Use of ENDS in places with established indoor smoking laws could be a step backward for public health when it comes to air quality as well as a negative for someone who may have otherwise quit nicotine. Several health organizations recommend that the use of ENDS be prohibited in public places and in workplaces.[43] The current evidence shows that the legitimacy of these products is fragile and regulations should be based on careful discursive management.[44]

Tobacco control in itself is an enormous public health challenge in SEAR. In the absence of established facilities for tobacco cessation, ENDS provide an opportunity to the industry to tap the large population of tobacco users in SEAR who want to quit tobacco use. Besides, given the rapid increase in their use and youth's susceptibility to social and environmental influences to use these products, developing strategies to prevent marketing, sales, and use of ENDS among youth is most critical. It may be relevant to mention here how the public health community was fooled by the concept of light cigarettes when the tobacco industry deceptively manipulated cigarettes to decrease the amounts of toxic compounds measured by smoking machines. It took many years to show that light cigarettes were in fact as dangerous as regular cigarettes. The countries of the SEAR cannot allow ENDS to establish themselves the way light cigarettes did and many years from now when all the scientific questions are answered, try to stuff the genie back in the bottle. The countries of the SEAR may, however, choose to revise their strategy if unbiased scientific evidence emerges about efficacy of ENDS as a tobacco cessation aid. In the long run, the countries of the SEAR should be open to more research. Such an open approach would create real incentives for the ENDS industry to conduct research and to generate adequate scientific knowledge about the quality, efficacy, and safety of these products. Just as it is for all other drugs and medical devices, ENDS industry must show true motivation and willingness to first develop and test ENDS as effective pharmaceutical tools in the regional context before asking for market authorization.

In this background, the decision FCTC/COP7(9) adopted at the seventh session of the Conference of the Parties to the WHO Framework Convention on Tobacco Control (COP7) should serve as a guide for the countries of the SEAR to effectively regulate ECs/ENDS.[45] The countries of the SEAR should consider regulatory measures to holistically ban manufacture, importation, distribution, presentation, sale, and use of ENDS/ENNDS, as appropriate to their national laws. Regardless of whether these products contain nicotine or not, ENDS/ENNDS mimic smoking and should be considered as a (direct or indirect) promotion of tobacco use.

In SEAR, law provides for ban on ENDS in Sri Lanka and Timor-Leste. Maldives and Nepal also regulate ENDS. India has some examples of ban on ENDS at subnational level. Certain States/Union Territories in India such as Karnataka, Maharashtra, Punjab, and Chandigarh have banned ENDS under the relevant provisions of the Drugs and Cosmetics Act, 1940.

In view of challenges involved in implementing tobacco control laws, rampant tobacco industry interference, large proportion of vulnerable youth population, negligible support available for tobacco cessation, ban on ENDS/ENNDS is a plausible and cost-effective approach subject to effective implementation and monitoring. The member states should follow the examples set by other countries within the region and should ban ENDS/ENNDS in the larger interest of public health and well-being. However, the actual success of such a ban strategy will eventually depend on how the countries of the SEAR control illicit trade and cross-border internet sales of ENDS/ENNDS.

Disclaimer

The opinions or views expressed in this article are solely those of the authors and do not express the views or opinions of the organization to which the authors are affiliated.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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