DECLARATION I declare: this graduating thesis is the research result of myself, conducted under the scientific guidance of Master of Arts Nguyen Hoang Thuy Trang, guaranteeing the honesty and complying with rules on reference citation, explanation I shall take full responsibilities for this declaration LIST OF ABBREVIATIONS Abbreviations Full phrases CDC Centers for Disease Control and Prevention Deeming Rule Final Rule on Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products E-cigarettes Electronic Cigarettes ENDS Electronic Nicotine Delivery Systems EU European Union FDA Food and Drug Administration FDCA Federal Food, Drug and Cosmetic Act GDC General Department of Customs MoH Ministry of Health MoIT Ministry of Industry and Trade MoST Ministry of Science and Technology Secretary Secretary of Health and Human Services Sottera Sottera Inc Tobacco Act Tobacco Products Directive Family Smoking Prevention and Tobacco Control Act 2009 Directive 2014/40/EU of April 2014 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 U.S United States WHO World Health Organization TABLE OF CONTENTS OPENING Chapter Theoretical matters concerning the trade of electronic cigarettes 1.1 Overview on electronic cigarettes 1.1.1 Definition of electronic cigarettes 1.1.2 The operation of electronic cigarettes 1.1.3 Health effects of electronic cigarettes – helpful or harmful? 1.1.4 Legal classification of electronic cigarettes 13 1.2 Overview on the trade of electronic cigarettes 18 1.2.1 Definition of trade 18 1.2.2 Forms of trade 18 1.2.3 Situation on the trade of e-cigarettes 19 1.3 Basis for the regulation of the trade of e-cigarettes 22 1.3.1 Public health basis 22 1.3.2 Economic basis 22 1.3.3 Legal basis 23 1.4 Overview of the laws of the EU, US and Vietnam 24 1.4.1 EU laws 24 1.4.2 US laws 25 1.4.3 Vietnam laws 26 Chapter The European Union and United States laws on the trade of electronic cigarettes – Experience for Vietnam 28 2.1 On the standards and manufacturing of electronic cigarettes 28 2.1.1 EU and US laws 28 2.1.1.1 On the standards of electronic cigarettes 28 2.1.1.2 On the manufacturing of electronic cigarettes 34 2.1.1.3 On post-manufacturing obligations 37 2.1.2 2.2 Vietnam laws and experience 41 On the sales of electronic cigarettes 45 2.2.1 EU laws 45 2.2.2 US laws 46 2.2.3 Vietnam laws and experience 47 2.3 On the advertising and promotion of electronic cigarettes 48 2.3.1 EU laws 48 2.3.2 US laws 48 2.3.3 Vietnam laws and experience 49 SUB-CONCLUSION OF CHAPTER 50 CONCLUSION 50 BIBLIOGRAPHY i g OPENING Justifications for the thesis Tobacco products, of which the most commonly-known form is cigarette, have long been prevalent in societies in spite of their well-documented harms to human health Along with time, as tobacco products have evolved and more forms have been created, new products resembling tobacco products in general and cigarettes in particular have emerged One of such products is electronic cigarettes (―e-cigarettes‖) Modern e-cigarettes were first introduced in the Chinese market after being invented by a Chinese pharmacist who had been devastated by the death of his father due to lung cancer caused by heavy traditional smoking.1 Initially enjoyed primarily in China, the success of e-cigarettes soon spreads to various countries in Europe; in 2007, they were adopted by the American market.2 Accompanying the commercial success and societal popularity of e-cigarettes is uncertainty, even confusion Activists working against tobacco products dismiss e-cigarettes as still containing ―harmful chemicals, including carcinogens‖;3 their supporters claim e-cigarettes are considerably less hazardous than traditional cigarettes and may help smokers to quit smoking, while administration institutions adopt the ―neutral‖ view on the matter by staying circumspect.5 Subsequently, legal regulations adjudicating e-cigarettes and their trade are not overly present in legal systems around the world, with only the European Union (―EU‖), through Directive 2014/40/EU of April 2014 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 (―Tobacco Products Directive‖), and the United States (―US‖), with the recently-passed Final Rule on Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Wikipedia, ―Electronic cigarette: History‖, https://en.wikipedia.org/wiki/Electronic_cigarette#History (last visited on April 08, 2016) ―A Look At The History Of Electronic Cigarettes‖, http://www.gosmokefree.co.uk/a-look-at-the-history-ofelectronic-cigarettes/ (last visited on April 08, 2016) American Lung Association, ―E-cigarettes and Lung Health‖, http://www.lung.org/stop-smoking/smokingfacts/e-cigarettes-and-lung-health.html (last visited on April 08, 2016) Medscape, ―E-Cigs 95% Less Harmful Than Smoking and Helpful for Cessation‖, http://www.medscape.com/viewarticle/850083 (last visited on April 08, 2016) For example, the United States Food and Drug Administration used to state the following on their website: ―E-cigarettes have not been fully studied, so consumers currently don‘t know: (i) the potential risks of ecigarettes when used as intended, (ii) how much nicotine or other potentially harmful chemicals are being inhaled during use, or (iii) whether there are any benefits associated with using these products Additionally, it is not known whether e-cigarettes may lead young people to try other tobacco products […]‖ See FDA, Electronic Cigarettes (e-Cigarettes), http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm (last visited on April 08, 2016) Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products (―Deeming Rule‖) of the Food and Drug Administration (―FDA‖), truly leading the way in this regard.6 In Vietnam, e-cigarettes have recently risen to prominence and created significant attraction to traditional-cigarette smokers or non-smokers, especially the young, who wants to experience something new.7 Despite the lack of legal provisions on the matter, e-cigarette trade is very popular, both in person8 and online, with several websites offering the products such as caithuoc.com, thuocladientusaigon.vn, thuoc-ladien-tu.com, chuyenthuocladientu.com… On the other hand, due to the lack of legal provisions on the matter, there are no guarantees to the quality of such products and the potential harms they may cause to users because of the low-quality products Such situations demand the creation of legal provisions to regulate the trade of e-cigarettes, which not only serves to bring the practice into order but also helps the users to have the best possible quality e-cigarettes for usage In light of that, this thesis helps build the foundations for the drafting of legal documents to administer the trade of ecigarettes in Vietnam, in consideration of relevant laws in the EU and US, two pioneering legal systems in terms of regulating e-cigarettes Literature review of the thesis subject Despite the relative popularity of e-cigarette trade in Vietnam, there are not many, to put it lightly, legal documents regulating e-cigarettes and consequently even fewer, if at all, academic researches or legal articles on this matter However, the situation is significantly brighter abroad, with many notable academic articles and researches on multiple aspects concerning e-cigarettes and e-cigarette regulation, including the following: - Rachel Grana, Neal Benowitz and Stanton A Glantz (2014), ―E-Cigarettes: A Scientific Review‖, Circulation, 129, pp 1972-1986: This article provides an overview on important respects concerning e-cigarettes, from the product itself to e-fluid/vapor as well as several aspects concerning health effects of e-cigarettes and the regulatory state as of March 2014; Wikipedia, ―Regulation of electronic cigarettes‖, https://en.wikipedia.org/wiki/Regulation_of_electronic_cigarettes (last visited on April 08, 2016) Hanh Thuy, ―Thuoc la dien tu van gay nghien va hai suc khoe‖, http://vietnamnet.vn/vn/khoahoc/134816/thuoc-la-dien-tu-van-gay-nghien-va-hai-suc-khoe.html (last visited on April 08, 2016) Ngoc Khai, ―Troi noi ―thuoc la dien tu‖‖, http://tuoitre.vn/tin/tuoi-tre-cuoi-tuan/cuoc-song-muon-mau/hoso/20151111/toi-noi-thuoc-la-dien-tu/1000405.html (last visited on April 08, 2016) - M Bradley Drummond and Dona Upson (2014), ―Electronic Cigarettes Potential Harms and Benefits‖, Annals of the American Thoracic Society, 11(2), pp 236-242: This article addresses several key, hotly-debated issues regarding e-cigarettes such as impacts of e-cigarettes on lung functions or e-cigarettes for smoking cessation and gives preliminary evaluations on such issues; - Eric A Feldman (2015), ―Layers of Law: The Case of E-Cigarettes‖, Florida International University Law Review, 111(10), pp 111-131: This article documents the challenges to the regulation of cigarettes, most notably of which is the lack of adequate research on the health effects of e-cigarettes, and cites several legal regulations on ecigarettes from the international and national scale to the smaller scopes of local entities and private organizations; - Daniel F Hardin (2011), ―Blowing Electronic Smoke: Electronic Cigarettes, Regulation, and Protecting the Public Health‖, University of Illinois Journal of Law, Technology and Policy, 2011(2), pp 433-462: This article explores the health hazards of e-cigarettes as well as current regulatory framework on e-cigarettes in the US and proposes strict regulations for the sake of public health; - Matrix Insight for the Executive Agency for Health and Consumers acting on behalf of the EU (2013), ―Economic analysis of the EU market of tobacco, nicotine and related products‖: Completed in 2013 to also serve for the legislative process for the Tobacco Products Directive, this article details the scenes of sales and trade of ecigarettes, besides other tobacco products, in the EU in 2013 and as well as the several regulatory dimensions of the Tobacco Products Directive; - Christopher Snowdon (2015), ―E-cigarettes and Article 20 of the Tobacco Products Directive‖ and Action on Smoking and Health (2016), ―The impact of the EU Tobacco Products Directive on e-cigarette regulation in the UK‖: These articles summarizes the key points in Article 20 of the Tobacco Products Directive and their initial impacts on the regulation of e-cigarettes in the European Union; and - Hayden McRobbie, Chris Bullen, Jamie Hartman-Boyce and Peter Hajek (2014), ―Electronic cigarettes for smoking cessation and reduction (Review)‖: This paper records the results of a research on the health effects of e-cigarettes, which shows that (i) e-cigarettes assist the cessation of traditional smoking; and (ii) short-term use of e-cigarettes is not evidenced to be associated with health risk Other than the articles and research results above, there is also a wealth of articles and researches pertaining to e-cigarettes from respectable sources This thesis seeks to combine the above articles and researches, which specifically focus on the regulation of e-cigarettes in the EU and US, to address the issue of e-cigarette regulation in Vietnam Additionally, this thesis concentrates on the legal matters concerning the trade of e-cigarettes, an aspect of e-cigarette regulation that is not dedicatedly discussed in the above articles and researches Objectives of the thesis In chapter of this thesis, the author seeks to lay down the most basic information regarding e-cigarettes, the trade of e-cigarettes and the reasons for legal regulations on e-cigarette trade Based on that foundation, the aim of the author with chapter is to draw appropriate legal lessons on the regulation of e-cigarette trade for Vietnam through the study of relevant US and EU laws and subsequently helps improve Vietnamese laws on this matter Additionally, this thesis seeks to somewhat address the serious dearth of legal works concerning e-cigarettes in Vietnam and set the cornerstones for further research in the future Research objects and scope of the thesis The most important research objects of this thesis are obviously the legal documents regulating e-cigarettes In the US, they are federal laws, including the directly-adjudicating Deeming Rule and the Family Smoking Prevention and Tobacco Control Act (―Tobacco Act‖) as well as the more general Federal Food, Drug and Cosmetic Act (―FDCA‖) In the EU, such documents include the Tobacco Products Directive and the two Commission Implementing Decision for the Tobacco Products Directive.9 In both these legal systems, relevant case laws are also important sources for research and analysis On the contrary, as Vietnam‘s legal system is a civil-law one, only Vietnamese legal documents are subject to scrutiny in this thesis On this matter, due to the lack of regulation to date, the most relevant documents regulating ecigarettes in Vietnam are only the several Official Letters issued back in 2013 and 2014 Other than these, the Law on Preventing, fighting harmful effects of tobacco 2012 and its guiding decrees and circulars, despite not directly adjudicating ecigarettes, provide valuable reference materials for regulatory proposals on the matter, which are what this thesis seeks to provide See ―Indicative Implementation Plan (up to 2016) – Tobacco Products athttp://ec.europa.eu/health/tobacco/docs/implementation_plan_en.pdf (last visited on May 12, 2016) Directive In addition to the above legal documents, this thesis also aims at exploring and evaluating the various sources of information, knowledge and viewpoints on both ecigarettes themselves and the legal regulation of e-cigarettes From the research objects stated above, the author does not conduct research on all legal aspects concerning e-cigarettes but rather focuses only on the trade of ecigarettes within the EU, US and Vietnam, particularly the specific forms of e-cigarette trade and the relevant legal provisions regulating such trade forms, on the basis of previously stated theoretical matters and multiple relevant viewpoints on e-cigarettes Research methods used in the thesis In this thesis, the author combines the following legal research methods: Firstly, the thesis is a comparative study, therefore the comparison method is of essential value Under this method, relevant research objects are considered together so that similarities and differences between them are found, which in turn helps the author to realize the pros and cons of each object as well as explain and evaluate the similarities and differences to find appropriate proposals to improve Vietnamese laws on e-cigarette trade The comparison method will be mainly utilized in Chapter of this thesis Secondly, the synthesis method is equally important in terms of helping the author to synthesize diverse research sources, which may be preliminary, secondary or both combined, such as cases, books, legal journals, online articles, etc The synthesis method will be utilized in Chapter and Chapter of this thesis Thirdly, this thesis would not be a legal analysis work without the analysis method, which helps the author to utilize the collected and synthesized information for the purpose of explaining and interpreting relevant legal provisions and viewpoints to clarify the legal issues concerning the trade of e-cigarettes The analysis method will be mainly utilized in Chapter of this thesis General outline of the thesis There are two chapters in this thesis: Chapter 1: Theoretical matters concerning the trade of electronic cigarettes Chapter 2: The European Union and United States laws on the trade of electronic cigarettes – Experience for Vietnam The European Union and United States laws on the trade of electronic cigarettes – Experience for Vietnam Chapter Theoretical matters concerning the trade of electronic cigarettes 1.1 Overview on electronic cigarettes 1.1.1 Definition of electronic cigarettes Before discussing the definition of e-cigarettes, it is worth exploring briefly the definition of cigarettes As for that matter, the Oxford Dictionaries Online define cigarette as ―a thin cylinder of finely cut tobacco rolled in paper for smoking‖.10 Therefore, the main ingredient of cigarettes is tobacco, which is a product prepared from the leaves of the tobacco plant It is common knowledge that cigarette smoke contains many harmful chemicals, including carcinogens These carcinogens, along with nicotine which is an addictive substance contained in tobacco, have long been the main talking points when it comes to discussion on the health effects of cigarettes.11 With regard to e-cigarettes, they are the most commonly-known devices in the line of Electronic Nicotine Delivery Systems (―ENDS‖), which are defined by the World Health Organization (―WHO‖) as ―devices that not burn or use tobacco leaves but instead vaporise a solution the user then inhales‖ The main constituents of the solution, usually referred to as ―e-liquid‖ or ―e-juice‖, include ―nicotine when nicotine is present‖ and some other chemicals including propylene glycol, glycerol and flavoring agents.12 The WHO uses the phrase ―nicotine when nicotine is present‖ because not all e-cigarettes contain nicotine; there are several levels of nicotine concentration in different types and brands of e-cigarettes, ranging from the ―super strong‖ level to absolutely no nicotine at all.13 The other substances in e-liquid also vary between different lines of e-cigarettes: there may be glycerol or no glycerol, while there is a wide range of additives and flavors.14 However, one constant remains: no e- 10 Oxford Dictionaries, ―Definition of cigarette in English‖, http://www.oxforddictionaries.com/definition/english/cigarette (last visited on May 26, 2016) 11 For instance, See National Cancer Institute, ―Harms of Cigarette Smoking and Health Benefits of Quitting‖, http://www.cancer.gov/about-cancer/causes-prevention/risk/tobacco/cessation-fact-sheet (last visited on May 30, 2016) 12 World Health Organization, ―Electronic cigarettes (e-cigarettes) or electronic nicotine delivery systems‖, http://www.who.int/tobacco/communications/statements/eletronic_cigarettes/en/ (last visited on May 31, 2016) 13 Matt McConnell, ―Looking For An Electronic Cigarette Without Nicotine?‖, http://www.electroniccigaretteconsumerreviews.com/looking-for-an-electronic-cigarette-without-nicotine/ (last visited on May 31, 2016) 14 Rachel Grana, Neal Benowitz and Stanton A Glantz (2014), ―E-Cigarettes: A Scientific Review‖, Circulation, 129, pp 1972 Other than the above restriction, the Deeming Rule currently does not subject ecigarettes to other requirements on promotion provided in Section 1140 of 21 CFR, including restrictions on self-service displays and sponsorship of events.233 2.3.3 Vietnam laws and experience Currently, there are no legal provisions on the advertising and promotion of ecigarettes in the Vietnam legal system In consideration of the relevant regulations in EU and US laws presented above, this thesis makes the following proposals as the most basic foundation for the drafting of regulations on the advertising and promotion of ecigarettes in Vietnam laws in the future: First, e-cigarette advertising shall be prohibited This step shall be taken to limit the exposure of e-cigarettes to the population, in fair consideration of the fact that ecigarettes have the potential to cause harms, including nicotine addiction, to consumers, especially the young Moreover, from the authorities‘ perspective, as ecigarettes, particularly those containing nicotine, have been considered by several state bodies to be a tobacco product,234 it is easy to conceive that no-advertisement requirements for tobacco products235 will be applied to e-cigarettes once such provisions are required Furthermore, a uniform regulation between e-cigarettes and tobacco products on this respect will also create minimal functioning changes to the authorities, in terms of setting out administration actions, as well as to the distributors of e-cigarettes, who will most likely be tobacco manufacturers and as such is familiar with regulations on the prohibition of advertising Second, indirect marketing activities concerning e-cigarettes shall be permitted It is observable that both the EU and US laws have relatively lenient provisions on the marketing activities concerning e-cigarettes Specifically, while the US currently sets out no restrictions whatsoever on the marketing of e-cigarette products, the EU‘s Tobacco Products Directive only prohibits active marketing/promoting activities, e.g., contributions to events with the aim of promoting e-cigarettes Additionally considering the fact that the Law on Preventing, fighting harmful effects of tobacco does allow for the indirect marketing of tobacco to consumers, 236 the right to conduct indirect marketing activities shall also be extended to distributors of e-cigarettes 233 Section VIII.I of the Deeming Rule, pp 255 See supra note 81 235 Article 9.2 of the Law on Preventing, fighting harmful effects of tobacco 2012 236 Article 9.2 of the Law on Preventing, fighting harmful effects of tobacco 2012 only prohibits direct marketing of tobacco to consumers 234 49 SUB-CONCLUSION OF CHAPTER Regarding the standards and manufacturing of e-cigarettes, the EU and US laws regulate e-cigarette products in three respects: (i) product standards; (ii) manufacturing of such products; and (iii) post-manufacturing obligations for manufacturers, while there are no relevant regulations in Vietnam laws on this matter In consideration of the EU and US provisions as well as other social and legislative factors in Vietnam, Vietnam laws can implement the following proposals to improve their legislation on this respect: (i) designate specialized state bodies to administer e-cigarette trade in general and manufacturing thereof in particular; (ii) issue a National technical regulation for e-cigarettes; (iii) impose a pre-manufacturing authorization regime on e-cigarette importation/manufacturing; and (iv) issue provisions on e-cigarette packaging and labeling Regarding the sales of e-cigarettes, while the EU laws only regulate an obligation on providing sales information for manufacturers of e-cigarette products and leave other areas for Member States to regulate domestically, the US laws stipulate a legal age limit for the use of e-cigarette products at 18 and provide for measures to ensure compliance of such age limit In consideration of the EU and US provisions as well as other social and legislative factors in Vietnam, Vietnam laws can implement the following proposals to improve their legislation on this respect: (i) regulate the different levels of entities in the sales structure of e-cigarettes; (ii) introduce the legal age for e-cigarette use at 18; and (iii) provide for sales measures to ensure compliance of such age limit Regarding the advertising and promotion of e-cigarettes, while the EU laws prohibit the advertising of e-cigarettes and promotion thereof in the form of contributions, the US laws permit e-cigarette advertising subject to specific restrictions In consideration of the EU and US provisions as well as other social and legislative factors in Vietnam, Vietnam laws can implement the following proposals to improve their legislation on this respect: (i) prohibit e-cigarette advertising; (ii) and permit indirect marketing activities for e-cigarettes CONCLUSION Overall, this thesis has stated an overview on the nature of e-cigarettes and outlined the basis for the legal regulation thereof Afterwards, through the study of EU and US laws, this thesis has made several proposals in the hope of providing the basic foundations for legislation and research work on e-cigarette trade in Vietnam 50 BIBLIOGRAPHY A Legal regulations In Vietnamese Law on Commercial 2005 Law on Enterprises 2014 Law on Preventing, fighting harmful effects of tobacco 2012 Decree No 67/2013/ND-CP dated 27 June 2013 on detailing a number of articles and measures for the implementation of Law on Preventing, fighting against harmful effects of Tobacco with respect to the tobacco business Decree No 89/2006/ND-CP dated 30 August 2006 on labeling of goods Joint Circular No 05/2013/TTLT-BYT-BCT dated 08 February 2013 on guiding the labeling, printing of health warning on tobacco packages Circular No 21/2013/TT-BCT on detailing a number of articles of Decree 67/2013/ND-CP on detailing a number of articles and measures for the implementation of Law on Preventing, fighting against harmful effects of Tobacco with respect to the tobacco business In English Statutes In the EU Council Directive 93/42/EEC of 14 June 1993 concerning medical devices Decision 2016/586 of 14 April 2016 on technical standards for the refill mechanism of electronic cigarettes Directive 2014/40/EU of April 2014 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 Directive 2001/83/EC of November 2001 on the Community code relating to medicinal products for human use In the US Code of Federal Regulations Family Smoking Prevention and Tobacco Control Act 2009 Federal Food, Drug and Cosmetic Act i Final Rule on Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products Case laws In the EU Commission of the European Communities v Federal Republic of Germany, C-319/05, EU:C:2007:678 Pillbox 38 (UK) Ltd v The Secretary of State for Health, C-477/14, EU:C:2016:324 In the US Sottera, Inc v FDA, 627 F.3d 891 (D.C Cir 2010) B Reference materials Action on Smoking and Health (2016), The impact of the EU Tobacco Products Directive on e-cigarette regulation in the UK, pp 4-5 Aruni Bhatnagar et al (2014), ―Electronic Cigarettes: A Policy Statement From the American Heart Association‖, Circulation, 130, pp 14190 Bernd Mayer (2014), ―How much nicotine kills a human? Tracing back the generally accepted lethal dose to dubious self-experiments in the nineteenth century?‖, Archives of Toxicology, 88, pp 5-7 Bonnie Herzog, Jessica Gerberi and Adam Scott (2015), Equity Research: “Tobacco Talk” – Q4 US Vapor Retailer Survey, pp Bryan A Garner (2004), Black’s Law Dictionary – Eighth Edition, West Publishing Christopher Snowdon (2015), E-cigarettes and Article 20 of the Tobacco Products Directive Ellen Martin (2014), ―Looking Through the Smoke: Electronic Cigarettes and Taxation‖, Robert Morris University Honors Program - 2014 Honor Theses, pp 168 Eric A Feldman (2015), ―Layers of Law: The Case of E-Cigarettes‖, Florida International University Law Review, 111(10), pp 121 Eugenie Syx (2014), ―The case of the electronic cigarettes in the EU‖, European Journal Health Law, 21(2), pp 165, 166 European Commission (2010), Interpretative Document of the Commission’s Services: Placing on the Market of Medical Devices ii European Commission (2014), E-cigarettes Myth Buster European Commission‘s Health & Consumer Protection Directorate-General (2008), Orientation Note – Electronic Cigarettes and the EC Legislation Hajek P and McRobbie H (2014), E-cigarettes: an evidence update (Chapter 9, 10), pp 80 Hayden McRobbie, Chris Bullen, Jamie Hartman-Boyce and Peter Hajek (2014), ―Electronic cigarettes for smoking cessation and reduction‖, Cochrane Database of Systematic Reviews, 12 Ho Chi Minh City University of Law – Faculty of Administrative Law (2013), Tap bai giang Ly luan ve phap luat (Textbook on the theories on law), pp 13-14 Ho Chi Minh City University of Law (2013), Giao trinh phap luat ve chu the kinh doanh (Textbook on the laws on business entities), Hong Duc Publishing House, pp 13 Institute for Global Tobacco Control – Johns Hopkins Bloomberg School of Public Health (2015), Country Laws Regulating E-cigarettes: A Policy Scan, pp Irish Heart Foundation (2014), Position on Electronic / E-Cigarettes, pp Jamie Brown et al (2014), ―Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study‖, Addiction, 109, pp 1531-1540 Jonathan K Noel, Vaughan W Rees and Gregory N Connolly (2011), ―Electronic cigarettes: a new ‗tobacco‘ industry?‖, Tobacco Control, 20, pp 81 Konstantinos E Farsalinos et al (2013), ―Evaluation of Electronic Cigarette Use (Vaping) Topography and Estimation of Liquid Consumption: Implications for Research Protocol Standards Definition and for Public Health Authorities‘ Regulation‖, International Journal of Environmental Research and Public Health, 10, pp 2501 Laura Kirshner (2011), ―D.C Circuit Rules FDA Cannot Block E-cigarettes Imports – Sottera, Inc v FDA‖, American Journal of Law & Medicine, 37, pp 194 Lynne Dawkins, John Turner, Amanda Roberts and Kirstie Soar (2013), ―‘Vaping‘ profiles and preferences: an online survey of electronic cigarette users‖, Addiction, 108, pp 1118, 1134 M A H Russell (1976), ―Low-tar medium-nicotine cigarettes: a new approach to safer smoking‖, British Medical Journal, 1, pp 1431 iii Matrix Insight for the Executive Agency for Health and Consumers acting on behalf of the EU (2013), Economic analysis of the EU market of tobacco, nicotine and related products, pp 69 Rachel Grana, Neal Benowitz and Stanton A Glantz (2014), ―E-Cigarettes: A Scientific Review‖, Circulation, 129, pp 1972 Shuh J Sheen (1988), ―Detection of Nicotine in Foods and Plant Materials‖, Journal of Food Science, 53(5), pp 1572-1573 Shu-Hong Zhu et al (2014), ―Four hundred and sixty brands of e-cigarettes and counting: implications for product regulation‖, Tobacco Control, 23, pp iii3 US Fire Administration (2014), Electronic Cigarette Fires and Explosions, pp Virginia Berridge (2014), ―Electronic cigarettes and history‖, The Lancet, 383, pp 2204 Zachary Cahn and Michael Siegel (2011), ―Electronic cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes?‖, Journal of Public Health Policy, 32(1), pp 13-14 Materials from the Internet ―A Look At The History Of Electronic Cigarettes‖, http://www.gosmokefree.co.uk/alook-at-the-history-of-electronic-cigarettes/ ―Indicative Implementation Plan (up to 2016) – Tobacco Products Directive athttp://ec.europa.eu/health/tobacco/docs/implementation_plan_en.pdf ―The Best E-Liquid Guide and Expert Reviews for 2016‖, https://quitday.org/eliquid/ AccountingVerse, ―Types and Forms of Business‖, http://www.accountingverse.com/accounting-basics/types-of-businesses.html Akshay Jashnani and Allison Silverstein, ―E-cigarettes: Lighting Up in France and Beyond‖, http://knowledge.wharton.upenn.edu/article/e-cigarettes-lighting-francebeyond/ Alexandra Sifferlin, ―E-Cigarettes Are a Gateway to Tobacco, Study Says‖, http://time.com/4024822/ecigs-gateway-tobacco/ American Lung Association, ―E-cigarettes and Lung Health‖, http://www.lung.org/stop-smoking/smoking-facts/e-cigarettes-and-lung-health.html iv Amy Ridenour, ―Pro/Con: Should the FDA regulate e-cigarettes?‖, http://www.duluthnewstribune.com/opinion/national-view/3720010-procon-shouldfda-regulate-e-cigarettes Andrew Higgins, ―Aided by Army of ‗Vapers‘, E-Cigarette Industry Woos and Wins Europe‖, http://www.nytimes.com/2013/11/10/world/europe/aided-by-army-ofvapers-e-cigarette-industry-woos-and-wins-europe.html?_r=0 Association, ―Vaping may not be as safe as smokers think, research suggests‖, http://www.theguardian.com/society/2015/feb/04/e-cigarettes-toxic-chemicalsresearch-finds-lung-damage Boundless.com, ―Consumer Products‖, https://www.boundless.com/marketing/textbooks/boundless-marketingtextbook/products-9/types-of-products-67/consumer-products-334-712/ Breitbart, ―European Commission Puts Money Before Health With E-Cigarette Tax Proposal‖, http://www.breitbart.com/london/2015/02/19/european-commission-putsmoney-before-health-with-e-cigarette-tax-proposals/ Britt E Erickson, ―Boom In E-Cigarettes Sparks Calls For Regulation‖, http://cen.acs.org/articles/93/i7/Boom-E-Cigarettes-Sparks-Calls.html#1 Business Wire, ―Technavio Announces Top Six Vendors in the Global E-Cigarette Market from 2016 to 2020‖, http://www.businesswire.com/news/home/20160615005016/en/TechnavioAnnounces-Top-Vendors-Global-E-Cigarette-Market CDC, ―E-cigarette use triples among middle and high school students in just one year‖, http://www.cdc.gov/media/releases/2015/p0416-e-cigarette-use.html Julia Belluz, ―The Wild West of e-cigarettes just ended with a new, sweeping federal rule‖, http://www.vox.com/2016/5/5/11595784/fda-rule-e-cigarettes-tobacc Dan Mangan, ―E-cigarette sales are smoking hot, set to hit $1.7 billion‖, http://www.cnbc.com/id/100991511 David Levine, ―Are e-cigarettes harmful or helpful?‖, https://www.elsevier.com/connect/are-e-cigarettes-harmful-or-helpful E-cigarette Direct, ―How Electronic Cigarettes Work‖, http://www.ecigarettedirect.co.uk/content/guides/halo-electronic-cigarette-works/ E-Cigarette Politics, ―E-Cigarette Laws Worldwide‖, http://www.ecigarettepolitics.com/electronic-cigarettes-global-legal-status.html v Ecigarette Research, "Scientific Errors in the Tobacco Products Directive: A letter sent by scientists to the European Union‖, http://www.ecigaretteresearch.com/web/index.php/2013-04-07-09-50-07/149-tpd-errors Emily Sohn, ―How Safe Are E-Cigarettes?‖, http://abcnews.go.com/Technology/safe-cigarettes/story?id=12789204 European Commission, ―E-Cigarettes‖, http://ec.europa.eu/health/tobacco/docs/fs_ecigarettes_en.pdf European Commission, ―Health Warnings‖, http://ec.europa.eu/health/tobacco/docs/fs_health_warnings_en.pdf European Commission, ―Questions & Answers: New rules for tobacco products‖, http://europa.eu/rapid/press-release_MEMO-14-134_en.htm European Commission, ―Revision of the Tobacco Products Directive‖, http://ec.europa.eu/health/tobacco/products/revision/index_en.htm FDA, ―Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah‖, http://www.fda.gov/TobaccoProducts/Labeling/ucm388395.htm FDA, ―Stakeholder Letter: Regulation of E-Cigarettes and Other Tobacco Products‖, http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm FDA, ―Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA‖, http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm FDA, ―Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS)‖, http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm 456610.htm#regulation FDA, Electronic Cigarettes (e-Cigarettes), http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm Federal Register, ―Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products‖, https://www.federalregister.gov/articles/2016/05/10/2016-10685/deeming-tobaccoproducts-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-bythe vi National Cancer Institute, ―Harms of Cigarette Smoking and Health Benefits of Quitting‖, http://www.cancer.gov/about-cancer/causesprevention/risk/tobacco/cessation-fact-sheet Framework Convention Alliance, ―Health warnings growing globally‖, http://www.fctc.org/media-and-publications/media-releases-blog-list-view-of-all313/industry-interference/1243-health-warnings-growing-globally Gaurav Akrani, ―What is Trade? Meaning and Nature – Different Types of Trade‖, http://kalyan-city.blogspot.com/2011/03/what-is-trade-meaning-and-nature.html Gov.uk, ―E-cigarettes: regulations for consumer products‖, https://www.gov.uk/guidance/e-cigarettes-regulations-for-consumer-products Guy Bentley, ―CDC Admits, No ―Concrete‖ Evidence E-Cigarettes Are Gateway To Smoking‖, http://dailycaller.com/2016/01/08/cdc-admits-no-concrete-evidence-ecigarettes-are-gateway-to-smoking/ Hanh Thuy, ―Thuoc la dien tu van gay nghien va hai suc khoe‖, http://vietnamnet.vn/vn/khoa-hoc/134816/thuoc-la-dien-tu-van-gay-nghien-va-haisuc-khoe.html Henry Samuel, ―French shop banned from selling e-cigarettes after tobacconist complaint‖, http://www.telegraph.co.uk/news/worldnews/europe/france/10507096/French-shopbanned-from-selling-e-cigarettes-after-tobacconist-complaint.html Herb Weisbaum, ―What‘s Causing Some E-Cigarette Batteries to Explode?‖, http://www.nbcnews.com/business/consumer/what-s-causing-some-e-cigarettebatteries-explode-n533516 How To Vape, ―Exactly how does the electronic cigarette function?‖, http://www.howtovape.com/page4/page4.html James Ellis, ―Vaping: Big Tobacco‘s Big Gamble On The Future‖, http://www.newsweek.com/vaping-big-tobacco-big-gamble-future-451074 James Meikle, ―E-cigarette classification as medicines plan angers industry‖, https://www.theguardian.com/business/2013/jun/12/e-cigarette-classificationmedicines-industry Jennifer Fuentes, ―Teen E-Cig Users More Likely To Smoke‖, https://vitalrecord.tamhsc.edu/adolescents-most-at-risk-with-e-cigarettes-yet-teenusage-soars/ vii Jillian Mincer, ―Quality issues push e-cigarette production to US from China‖, http://www.reuters.com/article/us-usa-tobacco-ecigarettesidUSBREA4O06420140525 JP Mangalindan, ―For e-cigarette makers, a $10 billion market at stake‖, http://fortune.com/2014/05/01/for-e-cigarette-makers-a-10-billion-market-at-stake/ Karl Tate, ―Vaping: How E-cigs Work (Infographic)‖, http://www.livescience.com/41211-how-electronic-cigarettes-work-infographic.html Keith Wagstaff, ―Vaping 101: How Do E-Cigarettes Work?‖, http://www.nbcnews.com/tech/tech-news/vaping-101-how-do-e-cigarettes-workn88786 Konstantinos E Farsalinos, Alketa Spyrou, Kalliroi Tsimopoulou, Christos Stefopoulos, Giorgio Romagna and Vassilis Voudris, ―Nicotine absorption from electronic cigarette use: comparison between first and new-generation devices", http://www.nature.com/articles/srep04133 Laura Kann et al (2015), ―Youth Risk Behavior Surveillance — United States, 2015‖, Morbidity and Mortality Weekly Report – Surveillance Summaries, available at http://www.cdc.gov/mmwr/volumes/65/ss/ss6506a1.htm?s_cid=ss6506_w Lauren Davidson, ―Vaping takes off as e-cigarette sales break through $6 bn‖, http://www.telegraph.co.uk/finance/newsbysector/retailandconsumer/11692435/Vapi ng-takes-off-as-e-cigarette-sales-break-through-6bn.html Linda Bauld, ―No, there's still no evidence e-cigarettes are as harmful as smoking‖, https://www.theguardian.com/science/sifting-the-evidence/2015/dec/31/no-theresstill-no-evidence-e-cigarettes-are-as-harmful-as-smoking Maggie Fox, ―E-Cigarette Ads Target Millions of Kids, CDC Says‖, http://www.cnbc.com/2016/01/06/e-cigarette-ads-target-millions-of-kids-cdcsays.html Marijke Vroomen Durning, ―Electronic Cigarettes May Help You Quit Smoking, New Study Shows‖, http://www.forbes.com/sites/marijkevroomendurning/2013/09/10/electroniccigarettes-may-help-you-quit-smoking-new-zealand-study-shows/#78b01f2c6096 Matt McConnell, ―Looking For An Electronic Cigarette Without Nicotine?‖, http://www.electroniccigaretteconsumerreviews.com/looking-for-an-electroniccigarette-without-nicotine/ viii Matt Richtel, ―E-Cigarettes, by Other Names, Lure Young and Worry Experts‖, http://www.nytimes.com/2014/03/05/business/e-cigarettes-under-aliases-elude-theauthorities.html?_r=0 Matt Richtel, ―Where Vapor Comes Sweeping Down the Plain‖, http://www.nytimes.com/2014/04/27/business/e-cigarettes-take-hold-inoklahoma.html?_r=0 Medical Discovery News, ―Are e-Cigarettes http://www.medicaldiscoverynews.com/shows/264-ecigs.html MedLine Plus, ―Nicotine https://www.nlm.nih.gov/medlineplus/ency/article/002510.htm Safe?‖, poisoning‖, Medscape, ―E-Cigs 95% Less Harmful Than Smoking and Helpful for Cessation‖, http://www.medscape.com/viewarticle/850083 MissCPA, ―Types of Business Organizations‖, http://misscpa.com/types-of-businessorganizations/ National Health Services, ―Some types of e-cigarettes to be regulated as medicines‖, http://www.nhs.uk/news/2013/06June/Pages/e-cigarettes-and-vaping.aspx Ngoc Khai, ―Troi noi ―thuoc la dien tu‖‖, http://tuoitre.vn/tin/tuoi-tre-cuoituan/cuoc-song-muon-mau/ho-so/20151111/toi-noi-thuoc-la-dien-tu/1000405.html Oxford Dictionaries, ―Definition of cigarette in English‖, http://www.oxforddictionaries.com/definition/english/cigarette Oxford Dictionaries, ―Definition of trading in English‖, http://www.oxforddictionaries.com/definition/english/trading Oxford Dictionaries, ―VAPE is named Oxford Dictionaries Word of the Year 2014‖, http://blog.oxforddictionaries.com/press-releases/vape-named-oxford-dictionariesword-year-2014/ Press Association, ―E-cigarettes to be classed as ‗medicines‘ in attempt to tighten regulation‖, https://www.theguardian.com/society/2013/jun/12/e-cigarettesmedicines-tighten-regulations ProjectKnow, ―The Vape Debate: Pros and Cons of E-Cigarettes‖, http://www.projectknow.com/the-vape-debate-pros-and-cons-of-e-cigarettes/ QuitDay, ―History of Electronic Cigarettes‖, https://quitday.org/electroniccigarettes/history-of-electronic-cigarettes/ ResearchandMarket, ―Global E-Cigarette & Vaporizer Market – Analysis & Forecast Through 2015 to 2025‖, http://www.researchandmarkets.com/research/j38d6n/global ix Rob Walters, ―E-Cigarette Makers Give Public the Finger‖, http://www.forbes.com/sites/robwaters/2014/01/27/e-cigarette-makers-give-publicthe-finger/#4b105fed34f9 Sabrina Tavernise, ―A Hot Debate Over E-Cigarettes as a Path to Tobacco, or From It‖, http://www.nytimes.com/2014/02/23/health/a-hot-debate-over-e-cigarettes-as-apath-to-tobacco-or-from-it.html Sabrina Tavernise, ―F.D.A Imposes Rules for E-Cigarettes in a Landmark Move‖, http://www.nytimes.com/2016/05/06/science/fda-rules-electroniccigarettes.html?_r=0 Sarah Zhang, ―E-Cigs Are Going Tobacco Free With Synthetic Nicotine‖, http://www.wired.com/2016/06/vaping-industry-wants-go-post-tobacco-syntheticnicotine/ Saundra Young, ―FDA proposes crackdown on e-cigarettes‖, http://edition.cnn.com/2014/04/24/health/fda-e-cigarette-regulations/ See Reuters, ―EU finance ministers call for higher taxes on e-cigarettes‖, http://www.reuters.com/article/eu-taxation-ecigarettes-idUSL5N16G3Z4 Smoking Everywhere, Inc v FDA, 680 F Supp, 2d 62 (D.D.C 2010) Retrieved from https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 Statistic Brain, ―Electronic Cigarette Statistics‖, http://www.statisticbrain.com/electronic-cigarette-statistics/ Susan Cassidy, ―How Electronic Cigarettes Work‖, http://science.howstuffworks.com/innovation/everyday-innovations/electroniccigarette1.htm Trefis Team, ―Who Stands To Gain From The E-Cigarette Phenomenon?‖, http://www.forbes.com/sites/greatspeculations/2015/06/23/who-stands-to-gain-fromthe-e-cigarette-phenomenon/#4483fe124876 Tripp Mickle, ―FDA to Regulate E-Cigarettes, Ban Sales to Minors‖, http://www.wsj.com/articles/fda-to-regulate-e-cigarettes-ban-sales-to-minors1462455060 Vapestaff, ―Electronic Cigarettes 101‖, http://vapestaff.com/e-cigs-101-info-guide/ Vinh Ha, Lan Anh, Van Tien, Than Hoang, ―Lo ngai voi sot hut vape‖, http://tuoitre.vn/tin/song-khoe/20160512/lo-ngai-voi-con-sot-hut-vape/1099351.html Wikipedia, ―Electronic cigarette: Construction‖, https://en.wikipedia.org/wiki/Electronic_cigarette#Construction x Wikipedia, ―Electronic cigarette: https://en.wikipedia.org/wiki/Electronic_cigarette#History Wikipedia, ―Pharmaceutical History‖, drug‖, https://en.wikipedia.org/wiki/Pharmaceutical_drug Wikipedia, ―Regulation of electronic https://en.wikipedia.org/wiki/Regulation_of_electronic_cigarettes cigarettes‖, Wikipedia, ―Regulation of electronic https://en.wikipedia.org/wiki/Regulation_of_electronic_cigarettes cigarettes‖, Wikipedia, ―Tobacco harm reduction: https://en.wikipedia.org/wiki/Tobacco_harm_reduction#History History‖, World Health Organization, ―Electronic cigarettes (e-cigarettes) or electronic nicotine delivery systems‖, http://www.who.int/tobacco/communications/statements/eletronic_cigarettes/en/ xi APPENDIX PHOTOGRAPHS/CHARTS: Figure 1: Construction of an electronic cigarette (taken from http://science.howstuffworks.com/innovation/everyday-innovations/electroniccigarette1.htm) Figure 2: Construction of an electronic cigarette (taken from US Fire Administration (2014), Electronic Cigarette Fires and Explosions, pp 2.) xii Figure 3: Operation of an electronic cigarette (taken from http://www.howtovape.com/page4/page4.html) Figure 4: Value (in British pounds) of e-cigarette sales worldwide up to 2014 and projected figures to 2019 (taken from http://www.telegraph.co.uk/finance/newsbysector/retailandconsumer/11692435/Vaping -takes-off-as-e-cigarette-sales-break-through-6bn.html) xiii ... Union and United States laws on the trade of electronic cigarettes – Experience for Vietnam The European Union and United States laws on the trade of electronic cigarettes – Experience for Vietnam. .. United States laws on the trade of electronic cigarettes – Experience for Vietnam 2.1 On the standards and manufacturing of electronic cigarettes 2.1.1 EU and US laws 2.1.1.1 On the standards of electronic. .. Vietnam laws 26 Chapter The European Union and United States laws on the trade of electronic cigarettes – Experience for Vietnam 28 2.1 On the standards and manufacturing of electronic