Electronic nicotine delivery systems in Brazil: to ban or not to ban, that’s the question
Introduction: Debates on policy options for tobacco “endgame” have suggested that addicted cigarette smokers have access to likely less toxic alternative sources of nicotine. Methods: We discussed facts and challenges pertaining to current regulatory environment on electronic nicotine delivery systems (ENDS) in Brazil, including conventional cigarette smoking prevalence, burden of mortality, morbidity and costs for society associated with smoking, and the current tobacco control policy. Results: In Brazil, advertising/sale of ENDS has been banned since 2009. However, in 2019, under strong pressure from the tobacco industry, the National Sanitary Surveillance Agency decided to include in its regulatory agenda the discussion about the current ENDS restriction. Brazil has achieved the largest decrease in daily smoking prevalence in the world between 1990 and 2015; however, there are still 20 million conventional cigarette smokers and 162 thousand tobacco-related deaths per year, and the annual cost of smoking is US$22 billion. This scenario stimulates a debate about the risks and benefits of changing current ENDS regulation to allow adult smokers to have legal access to non-combusted sources of nicotine, such as ENDS. One of the main concerns is that young people might become more vulnerable to smoking uptake after a massive introduction of ENDS. Conclusions: Understanding how the emerging ENDS market may adversely or positively affect tobacco control outcomes is crucial for developing public health policies. Although this paper focused primarily on the Brazilian context, the issues raised by the authors may be useful for other countries facing the same dilemma.
Electronic cigarettes (EC) are the most known form of Electronic Nicotine Delivery Systems (ENDS) in Brazil. EC are battery-powered devices that vaporize and deliver a liquid solution of nicotine, propylene glycol, and other chemicals to the user. The types of EC have increased rapidly and they vary according to format, battery power, liquid flavor and functionalities, including those the systems of which allow consumers to manipulate the e-liquids contents [1,2].
EC were first introduced in the market in 2004 by a small company and their consumption grew exponentially in some countries in the late 2000s . Big tobacco companies reacted to the threaten to conventional cigarette market, at first, by entering into the EC market as well and, later, by developing heat-not-burn/heated tobacco products (HTP), which are types of hybrid products between combusted conventional cigarettes (CC) and EC [4,5]. HTP also function through a battery-operated heating system (i.e., they are also classified as ENDS), but, differently from EC, heat solid tobacco and have a better performance in delivering nicotine to human brain than EC, resulting in a more CC-like experience [4,6,7].
Analyses of some EC brands showed they had less toxicants than conventional cigarettes [8,9]. In 2016, the World Health Organization (WHO) concluded that it is unlikely that EC are harmless, but it is very likely they are less toxic than conventional cigarettes [10-14]. Although there are less available studies on HTP toxicity, one of the studies showed that, unlike EC, the smoke released by HTP contains elements from thermogenic degradation such as benzopyrene and carbon monoxide that are the same constituents of conventional tobacco cigarette smoke . Moreover, the carcinogenic potency of emissions from HTP is higher than that observed for EC [6,15]. In short, both EC and HTP are not innocuous, as they contain (or generate) carcinogenic substances that also cause damage to the lungs and the cardiovascular system [6-15].
As the effects of traditional tobacco control policies to decrease smoking prevalence to very low levels take time, great part of the current high burden of morbidity and mortality associated with smoking is related to the still widespread use of combusted conventional cigarettes among “remaining smokers” [16-20]. In this sense, debates on policy options for tobacco “endgame” have proposed combusted cigarettes to be made less addictive through reducing their nicotine contents, and that addicted cigarette smokers could have access to likely less toxic alternative sources of nicotine, including ENDS [21-25]. The main rationale behind these proposals is that people smoke for nicotine but die from tar generated by combusted cigarettes . On the other hand, the limited scientific knowledge, particularly about ENDS longer-term effects on health [11,12,27], aid for smoking cessation , dual use , and their potential to be a gateway for smoking conventional cigarette among youth [30,31], are important concerns, which have raised critical questions about how they should be regulated [32-34].
The global tobacco control community is, in fact, divided. Both the 6th and 7th Conference of the Parties (COP) held in 2014 and 2016, respectively, among countries that had ratified the WHO framework convention on tobacco control (WHO FCTC)  did not reach a clear consensus on how to regulate ENDS use [10,36]. Parties were invited to consider applying regulatory measures to prohibit or restrict the use of ENDS, as appropriate to their national laws and public health goals. And the WHO FCTC COP8 held in 2018 encouraged countries to regulate HTP as if they were conventional tobacco products .
Meanwhile, the fact that ENDS have been promoted both as safer alternatives to conventional cigarettes and as aid for smoking cessation by tobacco companies has led to a fast increase of its consumption in the world [37-39]. At the beginning of EC dissemination, some countries banned their trade . Comparisons across countries showed that, as expected, the use of EC became more common in places with little or no regulation [37-39]. After that, some countries started to review their regulations to legalize smokers’ access to EC, while adopting at the same time measures to restrict their access for children and adolescents [17,40,41]. In the United States of America (USA), for example, with no restrictions whatsoever until 2016, the prevalence of EC use grew fastly among high school students (from 1.5% in 2011 to 20.8% in 2018) [42-44], mainly when Juul, an EC brand shaped like a USB flash drive and with high level of nicotine, entered the USA market in 2017 . In 2019, the USA faced an outbreak of acute lung injury associated to e-cigarette/vaping-product use (EVALI) . The median age of patients was 24 years and 16% of patients were under 18. Despite most of these patients reported using tetrahydrocannabinol-containing products in their electronic devices, some reported exclusive use of nicotine-containing products. In December 2019, the USA government issued a new law raising the federal minimum age of sale of tobacco products, including EC and HTP, from 18 to 21 years . The most recent example of a country-specific regulatory action on ENDS came from Uruguay, a country that has one of the lowest proportions of ENDS use among smokers/ex-smokers , which changed its current ban on ENDS to allow only HTP to legally enter into the market .
The objective of this paper was to discuss facts and challenges pertaining to current regulatory environment on ENDS in Brazil, including conventional cigarette smoking prevalence, burden of mortality, morbidity and costs for society associated with smoking, and the current tobacco control policy.
Electronic cigarettes restriction in Brazil
In May 2009, São Paulo state, which is the most populous state in Brazil, launched a new law banning smoking in enclosed public places . And, in June 2009, in opposition to that law, the National Inventors Association announced in the national media the intention to import an e-cigarette brand named Smoking Everywhere saying that, “in times of hard siege to smokers, e-cigarettes are the solution to the inconvenience caused by tobacco smoke” . However, in August 2009, the National Sanitary Surveillance Agency (ANVISA) published a resolution stating that the authorization of sales and imports of any “electronic smoking device” intended for smoking cessation or as a substitute for conventional cigarettes was subject to confirmatory epidemiological and toxicological studies . This restriction was extended to all accessories and all formats of “electronic smoking devices”, regardless of their nicotine contents; moreover, the resolution also banned their advertising at national level. As no manufacturer has complied with these requirements so far, the 2009 measure “has been acting, in fact, as a ban”. On the other hand, the resolution did not prohibit individuals to bring these devices from other countries outside Brazil when for personal use.
What did happen next?
Seemingly the prompt answer from ANVISA prohibiting ENDS advertising and restricting sales may have had some effect in delaying their dissemination in the national territory, as Brazil still has lower proportions of ENDS use compared to countries with less restrictive measures on them [37-39,52-55]. However, the two most recent nationally representative studies to address this issue found that between 2015 and 2019 the prevalence of ENDS use among individuals aged 15-65 years increased from 0.45% (about 0.7 million people) to 0.72% (about 1.1 million people) [52,53]. And the International Tobacco Control Policy Evaluation Project (ITC) conducted in three of the most populous Brazilian cities showed that the proportions of EC awareness and EC ever use increased between 2013 and 2017 both among smokers and non-smokers who came to know and acquired the products through the internet, outside country, and/or in popular markets .
The entry of big tobacco companies in the HTP market posed additional pressure on current ENDS restriction in Brazil [4,5,56]. In March 2017, ANVISA started a public consultation to improve its general resolution on tobacco product registration in force since 2007 [57,58]. The original definition of the tobacco products regulated by this 2007 resolution includes “manufactured products derived from tobacco using leaves or extracts of leaves or other parts of tobacco plants in their composition, intended to be smoked, chewed or inhaled”. In order to try to circumvent the 2009 resolution , the tobacco industry proposed to consider HTP as products derived from tobacco, and EC as a “new non-tobacco special product” [56,59]. Moreover, this public consultation called the attention of the international scientific community supported by the tobacco industry and, therefore, ANVISA also received contributions from outside Brazil. For instance, one of these urged ANVISA to amend the resolution by including HTP and EC as “low-risk alternative nicotine delivery systems” (ANDS) and establishing an appropriate regulatory and fiscal framework for their registration . It is worth mentioning that, in Brazil, tobacco products are subject to the measures of the WHO FCTC (35) ratified by the country in 2005 related to the reduction of demand for tobacco (or to the reduction of supply of tobacco), which clearly explains why the tobacco industry tried to exclude ENDS from this more restrictive regulatory environment applied to conventional tobacco products. At the end of the public consultation process, the original resolution remained unaltered .
In June 2019, in the light of updated scientific studies and growing international experiences about ENDS use and their impact on tobacco control outcomes [12-15,28-31,44,61], ANVISA decided to include in its regulatory agenda the discussion about the ENDS restriction in force since 2009 [51,62,63]. At the same time, the Philip Morris International launched in Brazil the campaign entitled “We need to talk about better alternatives to combusted cigarettes”  and promoted several seminars convening health professionals and scientists to present its HTP as a harm reduction tool. In order to allow a broad participation of the actors involved in this regulatory discussion, a “social participation plan” was outlined by ANVISA and included two public hearings held in 2019 . All scientific and technical evidence presented during the public hearings was evaluated and consolidated through year 2020 to be included in a “final broader regulatory impact assessment”. The “social participation plan” was originally conceived to establish an additional independent expert working group to review the existing literature on ENDS . However, based on publicly available minutes of several meetings held in 2019 [65,66], the tobacco industry took advantage of the fact that ANVISA is obliged to meet with the economic sectors regulated by the public authorities to question impartiality of this working group, thus interfering with the regulatory agenda. The deadline for completion of the regulatory impact assessment and, therefore, for also a final decision on a new resolution on ENDS, is October-December 2021. Meanwhile, as strange as it can be, in 2020, the Philip Morris International tried to register its HTP in the Brazilian market, which was denied by ANVISA’ technical staff in view of both 2007 and 2009 legal resolutions and the ongoing discussion around the regulatory agenda that started in 2019 [51,57,62,63,67].
Brazil: challenges and dilemmas
IIn Brazil, the implementation of several tobacco control measures in the last 30 years has contributed to a marked decrease in smoking prevalence [68,69]. For instance, among 195 countries, Brazil is the country with the greatest reduction in prevalence of daily smokers aged 15 years or older between 1990 and 2015 . It is also worth mentioning that Brazil has achieved a large and progressive decrease in smoking prevalence among young adults (18-24 years old), which may reflect both a decrease in smoking initiation rate among adolescents [20,70], and an increase in cessation rate among young adult smokers . However, there are still 20 million conventional cigarette smokers [37,46] and, every year, smoking is responsible for 162 thousand deaths that contribute to 4.2 million years of potential life lost and cost the country US$ 22 billion .
Considering the high achievements of tobacco control policy in Brazil, it is of paramount importance to understand what would be the risks and benefits if ANVISA changed its current resolution to allow smokers to have legal access to ENDS. Would this change allow low income and low education smokers, which represent the vast majority of the Brazilian smoking population [53,69], to shift from conventional cigarettes to more expensive ENDS? Based on available scientific evidence [28-31,44,66, 72-75], would such a decision contribute to reduce even more the prevalence of conventional cigarette smokers or would it slow down the current trend by stimulating initiation among young never smokers and/or increasing dual use? Finally, would it contribute to reduce morbidity and mortality associated with smoking in the future?
The arguments in favor of keeping the current restrictive measures on ENDS are based on the divergent results on their effectiveness as aid for smoking cessation when compared with other methods , the unknown benefits and risks of dual use with conventional cigarettes [29-31,75], the risks of manipulation and poisoning with EC liquids containing nicotine [45,75], the risks of EVALI (46), and the risks of liquid leaks and devices explosions . One of the main arguments is that the legal entry of these products in Brazil could generate a substantive increase in experimentation among adolescents, as it has happened in some countries of Europe [38,77-79] and in the USA [30,43,44], and that the ENDS could become a gateway for conventional cigarette consumption in this population group, including those who otherwise would have never tried tobacco products [30,31,72-74]. The entry of traditional tobacco companies in the ENDS market further increased this concern considering their unfair practices to promote conventional cigarette use by targeting youth . On the other hand, the main argument in favor of regulating ENDS as if they were conventional cigarettes (i.e., to regulate them as tobacco products) is supported by the guidelines for the implementation of articles 9 and 10 of the WHO FCTC [35,81] and/or policy options for tobacco endgame [21-25], which allow addicted smokers to replace conventional combusted cigarettes and similar products by likely less toxic, although not innocuous, alternative sources of nicotine [6-15].
There are many other important country-specific questions that could be considered by ANVISA in its final regulatory impact report: i) how to manage the ban on ENDS advertising by e-commerce and the ban on selling them to minors, when Brazil is already struggling to enforce compliance with already existing anti-tobacco laws for conventional combusted cigarettes ? ii) would the large use of flavors additives in liquids for EC make more difficult to win a lawsuit filed by the tobacco industry in the Supreme Court in 2012, which suspended ANVISA’ resolution prohibiting the use of additives in tobacco products [83,84]? iii) one of the arguments used by the tobacco industry to pressure ANVISA to review its current restrictions on ENDS use is based on a commitment with “products of potential lower risk”, and statements that they will be leaving the market of conventional combusted cigarettes ; thus, would it be a conducive moment to subject the changes in the current ENDS resolution to a legal obligation from tobacco industry to exclude any kind of combusted tobacco products from their business within a given period? If so, how will tobacco companies react to avoid the disruption of their business model designed to sustain high levels of addicted consumers? iv) can one assume that articles 9 and 10 of the WHO FCTC [35,81], which support the implementation of effective actions to test, measure, regulate and disclose the contents and emissions of tobacco products, currently provides the necessary tools to watch over and to monitor changes in the engineering and chemistry of so many different types of new tobacco products as well as their impact on health? Moreover, although in 2012 ANVISA inaugurated the first tobacco laboratory in Latin America, it has not started functioning on a regular basis due to budget restrictions. These are important issues, as articles 9 and 10 of the WHO FCTC are deeply aligned with policy options for harm reduction and prevention of smoking initiation that encourage new products to be made less toxic, less addictive through reducing their nicotine contents, and less attractive through eliminating additives [21-25]; v) finally, it is worth mentioning that the implementation of tobacco control policies and/or the decision to change current regulatory measures are also dependent on the country-specific tobacco epidemic curve. For instance, the entry of ENDS in countries where conventional cigarette smoking prevalence appears to be stagnant could show results that may not be replicated in other countries, where smoking prevalence and selected tobacco-related diseases still follows a sustained downward trajectory, as it is the case of Brazil [69,86,87].
Understanding how the emerging ENDS market may adversely or positively affect tobacco control outcomes is crucial for developing public health policies. Further research is necessary to better understand the best regulatory approach to this emerging market. For this purpose, as stated by article 5.3 of the WHO FCTC , it is of paramount importance to recognize the fundamental conflict of interest between the tobacco industry and public health policies.
Although Brazil implemented strong tobacco control policies and, as a consequence, experienced a large decline in smoking prevalence, the entry of the tobacco industry in the business of electronic nicotine delivery devices, including EC and HTP, has built pressure on ANVISA to allow these products to formally enter in the Brazilian market. The issues raised by the authors may be useful for current/future debates on ENDS regulation in Brazil and for other countries facing the same dilemma.
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