Electronic cigarettes and public health: a policy brief

Electronic cigarette (e-cigarettes, also known as Electronic Nicotine Delivery Systems or ENDS) use has grown rapidly within a few years, and this rapid expansion of their use took public health professionals in tobacco control by surprise. The e-cigarettes are a diverse group of devices that function by having a battery-operated heating device (non-combustible) to vaporize liquid (known as e-liquid) that usually contains nicotine, flavouring, propylene glycol, vegetable glycerin, heavy metals and many other ingredients. The products are regulated to different extents in different jurisdictions, and new products and forms are being manufactured constantly and added to the markets. Unlike other new tobacco-derived products that had limited sustained interest in them, e-cigarettes have become a major product used globally. E-cigarette use and acceptability vary by country, making it a global health issue in terms of assessing the evidence and reaching consensus about harms versus benefits. The recent outbreak of lethal respiratory distress illnesses that are associated with e-cigarette use gained worldwide attention about serious risks these products may cause. There are major concerns and restrictions regarding e-cigarette use in many countries, largely because of the unknown consequences of epidemic nicotine use by youth; conversely, e-cigarettes are seen as part of the solution to reducing the harm from cigarette smoking in some jurisdictions. The World Health Organization (WHO) report on the tobacco epidemic, released in July 2019, concluded that e-cigarettes are not recommended for smoking cessation and the harm to health must be better evaluated, but the report concluded that the evidence regarding their role in nicotine addiction among young people is convincing. This policy brief represents the position of the International Network for Epidemiology in Policy and provides an overview and assessment of possible policy approaches to address this major public health issue. Although the USA is a rich source of data, this should not imply that this policy brief is focused on the USA, nor is this brief meant to be a review article that covers every aspect of this phenomenon, especially given the uncertainty and rapidly changing situation with regard to harms or potential benefits attributable to e-cigarettes. The e-cigarette was not created by the tobacco industry but rather from small companies, starting with its inventor in China in 2007. This open market led to a dramatic increase in the number of new products, some of which received wide acceptance and had a major share of the market, such as the e-cigarette brand JUUL that is being widely used by teens and apparently marketed for them.1 Most recently the tobacco industry invested billions to own a big share of JUUL.2 This adaptation of the tobacco industry to new products, and global inconsistencies in the regulation of e-cigarette products, are major concerns to the tobacco control community, given the past history of false advertisement and misuse of scientific data by this industry. The methods of using e-cigarettes include, in addition to the conventional ‘vaping’, non-traditional ways such as direct dripping of the e-liquid leading to much higher toxic aldehyde production,3 which is reportedly very popular among teens.4 Using other drugs of abuse or using mixtures of them instead of nicotine when vaping, as well as use of high doses of nicotine, are all related to the lack of effective regulation of e-cigarettes. Flavouring of e-cigarettes is serving to propagate their use among both youth and adults. Based on the existing data, youth (80% of them in the PATH study from the USA and up to 98% in Texas schools) initiate use with flavoured e-cigarettes, which are preferred over non-flavoured types, which is why the large majority of youth continue to use the flavoured type after initiation.5,6 There are over 15 000 flavours, and menthol- or mint-flavoured e-liquid is very popular, but the fruit and candy flavours are the most preferred.7 Further, these flavourings are approved for ingestion but not for inhalation, and there are reports of in vitro studies indicating more oxidative reactivity and injurious response by flavoured e-liquids (especially non-tobacco-flavour additives such as dessert, fruit and candy) compared with non-flavoured e-liquid.8,9 In light of both the recent severe respiratory disease outbreak and other potential risks associated with e-cigarette use, the States of California, Massachusetts, New Jersey, Rhode Island and New York in the USA passed bans on flavouring of e-cigarettes and tobacco. This outbreak was potentially due to the mixing of new products in an unregulated market of e-liquids. Vitamin E acetate and THC in e-liquid were linked to the outbreak. Regarding the use among teens, there is no disagreement that use of e-cigarettes has become the number one product being used illegally at the present time by middle and high school students in the USA.10 US national data also showed that in 1 year between 2017 and 2018, there has been a more than 50% increase in e-cigarette use among middle and high school students from 13.9% to 21.6%.10 There is evidence this is also the trend in the UK where there has been a 66% increase in ever use by teenagers from 18% in 2014 to 30% in 2018, although no evidence to date of an increase in their regular use.11 But this is expected given that nicotine, delivered by e-cigarettes as vapour, is highly addictive. To date, particularly before the evidence of e-cigarette-associated respiratory diseases, the gateway to tobacco use is the most serious risk of e-cigarettes feared by most public health professionals for teens and young adults, who otherwise may not have tried nicotine in tobacco products nor become addicted to it. In the UK there is limited evidence that young people who have used e-cigarettes may be more likely to start smoking,12 a trend that must be closely monitored. E-cigarettes are currently a public health controversy that requires careful consideration by health policy makers based on a growing research literature. The harm vs benefit assessment should take into consideration the risk of introduction of nicotine to non-smokers and the risk of severe, potentially lethal, lung or other as yet unidentified diseases to users, and the benefits to smokers who are helped to quit combustion cigarettes. The concern of most public health professionals about e-cigarettes is that we are introducing a product that delivers nicotine, which is addictive, with a range of excipients and other additives, the nature and safety of which manufacturers were not required to disclose before putting them io the market. Initiation of use or addiction to nicotine and then adopting combustion cigarettes,12,13 or for smokers to have difficulty in quitting because of higher nicotine consumption from their combination of cigarettes and e-cigarettes,14 would be by all means and measures harmful to those individuals and the health of the public. Before the severe respiratory distress cases linked to e-cigarettes, there was general agreement that e-cigarettes are less harmful than combustion cigarettes and smokers would reduce the serious long-term risks to their health by using them instead of conventional cigarettes.2 However, there is now serious reconsideration about e-cigarettes’ levels of harm. One recent review article questions whether the respiratory health effects of e-cigarettes are less than those of combustible tobacco products.15 Another study found among e-cigarette users specific alterations in serum lipids, especially among females, known to influence normal lung function, and it was independent of tobacco use.16 Due to the lack of consistent and long-term epidemiological data about these products, there are differences in opinion about the harms and benefits in the long term, since they are relatively recent products and it will take some years for them to have measurable impacts on the health of a population. Some products, such as the ‘JUUL’, have clearly shifted the argument about risks of harms and benefits towards harms, because of the wide appeal and targeted marketing to teens1 and the very high nicotine concentration per millilitre of e-liquid, which in some cases is more than double the levels of other e-liquid products and each pod of e-liquid would be equivalent to 20 cigarettes of nicotine content.17 Further, there is growing evidence that short-term exposure to e-cigarette aerosols can cause acute endothelial cell dysfunction, DNA damage, and signs of oxidative stress, as well as temporarily increased heart rate,18 the potential health impacts of which are not yet understood. These factors should be reflected when promoting e-cigarettes as a less harmful product, which nevertheless is not entirely safe.18 Furthermore, another concern for both smokers and non-smokers is new evidence that is emerging to show that e-cigarettes are more harmful than had been claimed, especially the health impact of flavouring as well as nicotine, causing DNA damage (International Agency for Research on Cancer), brain damage among teens (US Surgeon General) and harm from liquid propylene glycol, metals, silicate, ultrafine and nano-particles, and carcinogenic flavouring by-products.18 Very recently it was found that some combustible cigarettes and e-cigarette flavour mint and menthol had 100–1000 higher concentrations of pulegone than what is considered safe by the International Agency for Research on Cancer (IARC), even though pulegone is a known animal carcinogen that causes hepatic and pulmonary and other cancers in animal feeding studies.19 Although these high concentrations are not going to be completely absorbed, they are leading to high levels of exposure with potential risks. It remains to be seen if an effectively regulated market would prevent exposure to harmful levels of these contents. The history of cigarette flavour bans that exempted menthol is an example of failed regulation.20 Risk of poisoning from e-liquid and burn from explosion and malfunctioning of e-cigarettes is another public health hazard that may be overlooked, although reported serious incidents are not uncommon. The American Association of Poison Control Centers reported 3000–4000 cases of poisoning from e-liquid and e-cigarettes every year since 2014, and between 2015 and 2017 there were over 2000 emergency visits in hospitals in the USA.21,22 The majority of e-cigarette burns are severe and require skin grafting. The use of e-cigarettes is increasing rapidly among both smokers and non-smokers, but according to independent reviews from Cochrane Review, the United States Surgeon General, the United States Institute of Medicine, United States Prevention Task Force and other entities globally, there is so far insufficient consistent and clear evidence concerning their role in meaningfully helping the smokers who use them to quit, to recommend them universally as a cessation product, without careful and effective regulation to restrict access to never-smokers. In the USA, e-cigarettes are not seen as a cessation product and it is believed that there is not enough evidence to support it as such. This is stated in the Surgeon General’s report,23 by the United States Food and Drug Administration (USFDA)24 and by the National Academies of Sciences,18 which are three authoritative sources for policies in the USA. There are some studies that show benefit for smokers, but these studies are counterbalanced by studies that show there is harm from these products, insufficient evidence for achieving cessation and even encouragement of higher levels of smoking among dual users because of the higher nicotine exposure according to the World Health Organization (WHO).2 The WHO report reached these conclusions and warned that there are many sources of harm from e-cigarettes: for smokers who are dual users hindering their cessation; being taken by non-cigarette smokers; and undermining regulation of tobacco control and smoking bans.2 Accordingly, the WHO’s recent Framework for Tobacco Control Convention Treaty negotiations renewed the restrictions on e-cigarettes and other nicotine and tobacco delivery systems, and there is limited evidence that e-cigarettes may be effective aids to promote smoking cessation.25 The exception to date is the review from Public Health England (PHE)11 which found e-cigarettes to be far safer than cigarettes and, as a result, PHE now recommends e-cigarettes for smokers as a smoking cessation product where all other methods have failed. The German Addiction Society also recommends e-cigarettes only when other cessation products are not effective or declined by the smoker. Epidemiology is a unique science that can be used systematically to address major public health problems, from the 19th century’s cholera epidemics to major contemporary challenges such as risks of chronic non-communicable diseases and the tobacco epidemic. This approach should be applied to e-cigarettes to address the controversy surrounding their use. The recent outbreak of severe and sometimes lethal lung diseases in the USA associated with e-cigarettes use has led to calls by the Centers for Disease Control and Prevention to immediately stop the use of e-cigarettes until proper epidemiological investigation is carried out to determine the cause of this outbreak.26 The recent confirmation of cases of severe respiratory distress linked to using e-cigarette products represents an additional risk not previously accounted for, and its sudden acute impact leading to deaths has brought to attention why proper evidence from epidemiological and clinical studies should guide the use of these products and the policies associated with their use. Inadequate regulation of these products in jurisdictions all over the world has led to manufacturers using chemicals in e-liquids that are a risk for human health and are used by millions.27 The USFDA has issued a ruling to regulate the manufacture of e-cigarettes, but has been slow in applying these regulations. They issued a warning about the widespread use of these products among youth in the past 2 years, attributed to advertisement campaigns targeting minors. There is widespread advertising for these products accessible to teens and youth as well as repeated evidence of targeting young people, by use of celebrity endorsement on social media, introduction of candy, dessert and fruit flavours and even promotion by sex appeal. Epidemiological data are needed to support development of evidence-based policies to limit use of e-cigarettes to those smokers who are likely to benefit from their use by switching and quitting combustion cigarettes. This public health phenomenon has been spreading faster than the pace of research to provide solid evidence about its harms and benefits. Different rules and regulations exist across countries and jurisdictions. It has therefore become a controversial public health topic today, and requires much more research. When there is no robust evidence about the balance of benefits and harms of a new product, this leads to the situation we have with e-cigarettes, where different players will use the evidence that supports their view and especially when there is a vested interest. This difference in opinion may have contributed to a delay in regulation. The lack of policy and evidence and the delay in introducing consistent, effective regulation has left a void being filled in many jurisdictions and the media by inaccurate data, advertisement and inadequately regulated products, all encouraging the widespread and popular use of these products. The precautionary principle invokes the notion that when there is uncertainty about a product or approach in terms of harm to the public, the precautionary approach will not support the widespread dissemination of such product. The burden of proof is then on the producers to demonstrate their product does not cause harm, before making it widely available to the public. Health policy makers should have invoked the ethical precautionary principle before allowing the propagation, advertising and large-scale consumer sales of e-cigarettes and related products. This would mean, in any jurisdiction, making accessible these products for smoking cessation in adults only in the presence of consistent independent research evidence of benefit substantially outweighing harm, and ongoing evaluation to support such measure. Introducing policies with penalties regarding advertising, marketing, sponsorship and sale to under-age individuals, and prohibiting flavours that appeal to children would lead to restrictions similar to those covering cigarettes and other smoking tobacco products. Swift and effective regulation should be imposed to protect consumers and hold manufacturers legally responsible, to prevent unregulated products from reaching markets. Following the precautionary principle, there is a need to prohibit the sale of any new forms before providing evidence of safety from comparative and large-scale epidemiology studies by independent research and evaluation. Public health professionals need to promote short-term and long-term evidence-based policies to address the negative and harm reduction contribution of this product. Lack of effective policies and regulations are allowing the production, advertising and sale of e-cigarettes to continue with limited restrictions and often lack of enforcement in many countries. Even where national regulation is robust, the social media and internet market provide largely unregulated platforms for advertisement and promotion of the products. Some countries, including Japan, Brazil, Australia, India and Norway, have strict restrictions or bans on e-cigarettes, and severe sanctions for those found in possession. San Francisco, where JUUL has its headquarters, has recently (25 June 2019) become the first city in the USA to ban e-cigarettes but, in the wake of the respiratory disease outbreak, the State of Michigan is planning a ban, Massachusetts is to ban e-cigarettes for 4 months, and Rhode Island and New York City are planning a ban on flavoured e-liquid sales. In the State of California, in the USA, the Governor has applied policies to e-cigarette use and sales that are very similar to those applicable to cigarette use and sales. In some countries, for example Australia, nicotine-free e-cigarettes are excluded from the very stringent restrictions on sales of nicotine-containing e-cigarettes. The recent rise in use of e-cigarettes among teens in the United States has prompted tobacco control entities such as the Centers for Disease Control& Prevention (CDC) and the Food and Drug Administration (FDA) in the USA to focus on the impact of nicotine upon youth. The ‘Real Cost’ media campaign is targeting 12–17-year olds through social media sites to make them aware of the risks of harm from e-cigarettes. However, without a robust e-cigarette cessation to the addicted has not been effective in this The youth in the USA in who according to the for Disease Control reported e-cigarettes use, some of are using high nicotine will need attention and cessation with media campaigns and effective regulation. There were warning signs of this emerging epidemic among but no serious was in e-liquids and e-cigarettes are much more than cigarettes in many jurisdictions, due in large part to much making it for in to addicted to the often high levels of nicotine in this relatively unregulated market. for new the precautionary principle to e-cigarette regulations and policies of producers of e-cigarettes, as well as manufacturers of other new products, such as products, to demonstrate that such products are not associated with harmful health impacts or new before being and then with and to those for products. This also to introduction of existing products to countries that previously not for existing regulation should be immediately by each jurisdiction, regarding the of nicotine and other in existing e-cigarettes, including a ban on and that make them particularly to youth. of restrictions and There are likely a of unknown health impacts from e-cigarette use in the There is a need for effective enforcement of regulation to advertising and sales of e-cigarettes to especially and through social media, industry to the known risks of harm of using e-cigarettes on and and from they are Based on that some individuals are in quitting smoking cigarettes by the use of e-cigarettes, the use of e-cigarettes on a can be by health to people to quit smoking if other cessation measures as long as consumers are aware of the and as yet possible long health risks of e-cigarettes and the known risks of tobacco products. This is especially to countries that promote its use for such as the access to cessation and support for those teens who become addicted to these products, to the cigarette smoking cessation accessible to smokers of combustion cigarettes. policies to require and national epidemiological including large clinical as well as long studies in different countries with different with e-cigarettes, to the evidence of all and long-term harms and benefits attributable to e-cigarettes.