The european union and united states laws on the trade of electronic cigarettes experience for vietnam

LIST OF ABBREVIATIONS 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 Tobac

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

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

Tobacco Act Family Smoking Prevention and Tobacco Control Act 2009

Tobacco Products

Directive

Directive 2014/40/EU of 3 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

TABLE OF CONTENTS

OPENING 1

Chapter 1 Theoretical matters concerning the trade of electronic cigarettes 6

1.1 Overview on electronic cigarettes 6

1.1.1 Definition of electronic cigarettes 6

1.1.2 The operation of electronic cigarettes 7

1.1.3 Health effects of electronic cigarettes – helpful or harmful? 8

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 2 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 Vietnam laws and experience 41

2.2 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 2 50

CONCLUSION 50

BIBLIOGRAPHY i

g

OPENING

1 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,4 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 3 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

5 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 cigarettes 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

e-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-la-dien-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 e-cigarettes in Vietnam, in consideration of relevant laws in the EU and US, two pioneering legal systems in terms of regulating e-cigarettes

2 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;

https://en.wikipedia.org/wiki/Regulation_of_electronic_cigarettes (last visited on April 08, 2016)

7 Hanh Thuy, ―Thuoc la dien tu van gay nghien va hai suc khoe‖, hoc/134816/thuoc-la-dien-tu-van-gay-nghien-va-hai-suc-khoe.html (last visited on April 08, 2016)

http://vietnamnet.vn/vn/khoa-8

Ngoc Khai, ―Troi noi ―thuoc la dien tu‖‖, so/20151111/toi-noi-thuoc-la-dien-tu/1000405.html (last visited on April 08, 2016)

http://tuoitre.vn/tin/tuoi-tre-cuoi-tuan/cuoc-song-muon-mau/ho 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 e-cigarettes 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 e-cigarettes, 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

3 Objectives of the thesis

In chapter 1 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 2 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

4 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 e-cigarettes 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 cigarettes, provide valuable reference materials for regulatory proposals on the matter, which are what this thesis seeks to provide

9

See ―Indicative Implementation Plan (up to 2016) – Tobacco Products Directive athttp://ec.europa.eu/health/tobacco/docs/implementation_plan_en.pdf (last visited on May 12, 2016)

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 e-cigarettes 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 e-cigarettes 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

5 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 2 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 1 and Chapter 2 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 2 of this thesis

6 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 1 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 do 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

cigarettes contain tobacco; this is one of the main differences between e-cigarettes and traditional cigarettes

1.1.2 The operation of electronic cigarettes

Structure-wise, a typical e-cigarette is made up of three main parts: a cartridge, a vaporization chamber and a battery.15 At the tip of the cartridge is a mouthpiece The cartridge contains the e-liquid for vaporization, hence its commonly used name of

―nicotine cartridge‖; it is possible to remove the cartridge from the other parts of the cigarette, which allows for the refill of e-liquid once it runs out.16 The e-liquid is drawn inside the vaporization chamber into an atomizer, which includes a heating coil that heats the e-liquid to the point of vaporization.17 There is also a microprocessor inside the vaporization chamber or a switch on the outside of the e-cigarette, depending on the design, to serve the purpose of activating the heating coil.18 At the furthest in the body

e-of the e-cigarette is a lithium battery which provides the electric current for the operation of the e-cigarette; while this battery is rechargeable in most e-cigarette designs, there are products which do not allow for such recharging of the battery.19 In multiple designs, attached at the end of the battery is a LED light which stimulates the glow of a burning cigarette.20 For illustration of an e-cigarette‘s construction, refer to Figure 1 and Figure 2 in the Appendix of this thesis

With the above structure, an e-cigarette operates in an altogether different principle from a combustible cigarette: while a combustible cigarette relies on combustion to burn through the tobacco to produce smoke, an e-cigarette provides the same smoking sensation to ―vapers‖, i.e., people that ―vape‖/use e-cigarettes,21 via the heating of the e-liquid into vapor without producing the smoke and the burned particles, which are commonly referred to as ―tar‖ Specifically, at first the vaper activates the e-cigarette by either inhaling from the mouthpiece (for automatically activated e-cigarettes) or pressing a switch (for e-cigarettes that need to be manually

https://en.wikipedia.org/wiki/Electronic_cigarette#Construction (last visited on 02 June 2016)

18 Id

19

Grana et al., supra note 14, pp 1973

20 US Fire Administration (2014), Electronic Cigarette Fires and Explosions, pp 2

21 The verb ―vape‖ is defined by the Oxford Dictionaries as the action to ―inhale and exhale the vapour

produced by an electronic cigarette or similar device‖ See Oxford Dictionaries, ―VAPE is named Oxford

Dictionaries Word of the Year 2014‖, dictionaries-word-year-2014/ (last visited on June 05, 2016)

http://blog.oxforddictionaries.com/press-releases/vape-named-oxford-activated) After the activating action by the vaper, a sensor detects that activation and

in turn activates the microprocessor; then, the heating coil, by utilizing the electric current generated by the battery, heats the e-liquid to the point of vaporization.22 The vaper inhales the vapor, which contains the substances that were present in the e-liquid, including nicotine, into his lungs and then exhales also vapor For illustration of the operation of a e-cigarette, refer to Figure 3 in the Appendix of this thesis

1.1.3 Health effects of electronic cigarettes – helpful or harmful?

The debate on whether e-cigarettes help or harm vapers has been a heated one, particularly among scientists and researchers in the field of public health.23Nevertheless, they seem to reasonably agree on one benefit of e-cigarettes, which is that they produce much less harmful chemicals than combustible cigarettes,24 by not creating smoke and tar caused by combustion but just vaporizing e-liquids into flavored-smell vapor This is because ―People smoke for nicotine but they die from the tar‖, a famous statement first made by Michael Russell25 and now widely recognized in the tobacco harm reduction community.26 However, that is precisely where the unanimity ends

On the one side, supporters of e-cigarettes claim that they help with the cessation of cigarette smoking From a purely practical perspective, not to mention their superior health effects over traditional cigarettes, e-cigarettes are probable substitutes for traditional cigarettes as the sensation of vaping an e-cigarette is mostly similar to smoking a cigarette, provided nicotine is the only thing that vapers are looking for to satisfy their addiction The vaper will still get the nicotine doses that he craves, if he uses e-liquids that contain nicotine; he will still be able to experience

cigarette smoker switched to e-cigarettes We know that tobacco smoke kills There is no debate about that‖ See

Sabrina Tavernise, ―F.D.A Imposes Rules for E-Cigarettes in a Landmark Move‖, http://www.nytimes.com/2016/05/06/science/fda-rules-electronic-cigarettes.html?_r=0 (last visited on June 09, 2016); Medical Discovery News, ―Are e-Cigarettes Safe?‖, http://www.medicaldiscoverynews.com/shows/264-

ecigs.html (last visited on June 09, 2016); David Levine, supra note 23

25 See M A H Russell (1976), ―Low-tar medium-nicotine cigarettes: a new approach to safer smoking‖,

British Medical Journal, 1, pp 1431

https://en.wikipedia.org/wiki/Tobacco_harm_reduction#History (last visited on June 12, 2016)

throat hits when inhaling the vapor;27 and he will still have the satisfaction of using a cigarette-like device.28 Furthermore, regarding other nicotine replacements, nicotine patches or gums have been proven in reality to be less effective than e-cigarettes in helping smokers to quit smoking.29 On the scientific side of the matter, there are several other studies to support these claims Specifically, a study delivers results that smokers using e-cigarettes ―are more likely to report continued abstinence‖ from traditional cigarettes than those who employ licenced nicotine replacement therapy products or no aid at all,30 while another concludes that e-cigarettes are decent means

of smoking cessation aid in comparison to placebo e-cigarettes.31 Despite the many limitations of the studies acknowledged by their very authors, e.g., the survey samples are of small quantity or the abstinence is not verified biochemically, they are encouraging initial signs that point at the efficiency of e-cigarettes in helping smokers quit Even in cases where smoking cessation is not achievable, e-cigarettes are recognized by studies to be effective at reducing smokers‘ craving of cigarettes and subsequently their level of cigarette intake.32 As testified by real people, e-cigarettes‘ smoking cessation/reduction effect is backed up even more.33

Moreover, from a societal viewpoint, because the result of vaping is not smoke like cigarette smoking but only a cloud of vapor that dissipates quickly and produces smell of the e-liquid‘s flavor, e-cigarettes bring no, or at least less, annoyingly bad smell of cigarette smoke.34 Coupled with the fact that there are less harmful chemicals

27

http://www.ecigarettedirect.co.uk/content/guides/halo-electronic-cigarette-works/ (last visited on June 05, 2016)

28 While some e-cigarettes come in uncommon shapes like a ―tank style‖, most other e-cigarettes have shapes

of a cigarette, pen, cigar or pipe See Grana et al., supra note 14, pp 1973

29

―[…] Dr William Randall, Jr of Lutherville Personal Physicians, Mercy Health Services […] says he‘s seen many patients successfully quit smoking with the use of e-cigarettes after other nicotine products (gum,

patches, lozenges) had failed‖ See Marijke Vroomen Durning, ―Electronic Cigarettes May Help You Quit

Smoking, New Study Shows‖, cigarettes-may-help-you-quit-smoking-new-zealand-study-shows/#78b01f2c6096 (last visited on June 09, 2016)

http://www.forbes.com/sites/marijkevroomendurning/2013/09/10/electronic-30 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

31 Hayden McRobbie, Chris Bullen, Jamie Hartman-Boyce and Peter Hajek (2014), ―Electronic cigarettes for

smoking cessation and reduction‖, Cochrane Database of Systematic Reviews, 12

32 For example, See Karolien Adriaens, Dinska Van Gucht, Paul Declerck and Frank Baeyens (2014),

―Effectiveness of the Electronic Cigarette: An Eight-Week Flemish Study with Six-Month Follow-up on

Smoking Reduction, Craving and Experienced Benefits and Complaints‖, International Journal of Environmental

Research and Public Health, 11(11), pp 11220-11248

33 Matt Richtel, ―Where Vapor Comes Sweeping Down the Plain‖, http://www.nytimes.com/2014/04/27/business/e-cigarettes-take-hold-in-oklahoma.html?_r=0 (last visited on June

13, 2016)

34

Keith Wagstaff, ―Vaping 101: How Do E-Cigarettes Work?‖, news/vaping-101-how-do-e-cigarettes-work-n88786 (last vistited on June 05, 2016)

http://www.nbcnews.com/tech/tech-in e-cigarette vapor than http://www.nbcnews.com/tech/tech-in cigarette smoke, e-cigarettes‘ second-hand effects are much less dangerous than cigarettes.35 However, it has also been noted, rather fairly, that e-cigarettes are not entirely safe, just safer than combustible cigarettes36 – a lesser evil of the two in case the smoker/vaper cannot get over his addiction of nicotine

On that note, it is also commonly pointed out that e-cigarettes are harmful for human health, in many aspects First, although acknowledged to generate much less free radicals than cigarettes, to the point that is only 1% as much as cigarettes, e-cigarettes still emit enough toxins to potentially damage the human‘s lung and immune system,37 which are the very body parts that cigarettes are well known to adversely affect Nicotine, the essential essence in most e-cigarettes, creates addiction to vapers Moreover, liquid nicotine is potentially lethal with a death and many other cases of poisoning from e-liquid absorption reported in the US alone Other substances, and their reaction while being heated, in e-liquids may also contribute to e-cigarettes doing harm to human‘s health.38 Second, e-cigarettes may affect human‘s well-being in a more unexpected and intense way than just emitting harmful chemicals: they may explode, causing fires and serious injuries According to a document from the US Fire Administration, media reports of 25 incidents from 2009 to 2014 involving e-cigarettes exploding and causing fires were found during an Internet search, with 80% of the incidents occurred while the e-cigarettes‘ battery was being charged.39 The main cause

of these explosions is reportedly the misbehavior of e-cigarettes‘ batteries, which is in

35 ProjectKnow, ―The Vape Debate: Pros and Cons of E-Cigarettes‖, debate-pros-and-cons-of-e-cigarettes/ (last visited on June 09, 2016)

http://www.projectknow.com/the-vape-36 For example, Michael Siegel, a tobacco researcher at Boston University, has noted: ―The relevant question

is not, 'Are these things safe?‖, but are these things much safer than real cigarettes, and do they help people quit

smoking? […]‖ See Emily Sohn, ―How Safe Are E-Cigarettes?‖,

http://abcnews.go.com/Technology/safe-cigarettes/story?id=12789204 (last visited on June 10, 2016)

37 Press Association, ―Vaping may not be as safe as smokers think, research suggests‖, http://www.theguardian.com/society/2015/feb/04/e-cigarettes-toxic-chemicals-research-finds-lung-damage (last visited on 12 June, 2016)

38 See FDA, ―Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted By FDA‖,

http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.htm (last visited on June 13, 2016); 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-a-path-to-tobacco-or-from-it.html (last visited on June 13, 2016); Matt Richtel, ―Some E-Cigarettes Deliver a Puff of Carcinogens, http://www.nytimes.com/2014/05/04/business/some-e-cigarettes-deliver-a-puff-of-carcinogens.html (last visited

on June 13, 2016)

39 US Fire Administration, supra note 20, pp 2

turn caused partly by the lack of regulation on the manufacturing and quality standards

of e-cigarettes.40

Apart from direct health concerns, e-cigarettes have the potential to negatively affect the society in another way: they may serve as a pathway to nicotine addiction and eventually detrimental cigarette smoking for non-smoking vapers, particularly the young.41 This is due to the fact that most e-cigarettes contain nicotine and provide the relatively similar sensation to cigarette smoking As for the young like children and adolescents, e-cigarettes and other forms of ENDS, which come in attractive flavors such as ―chocolate candy bars‖ or ―vanilla cupcake‖ and are being shrewdly advertized

to specifically target the young,42 have got many used to nicotine and may bring cigarette usage.43 At the same time, the very fact that e-cigarettes resemble, and potentially lead to, traditional cigarettes pose another concern that they may encourage smoking-like behavior, thus undo up to half a century of tobacco control and hold back the achievements of that beneficial movement.44

In reasonable consideration of both sides of the argument, it is appropriate to give e-cigarettes the benefit of the doubt That is mainly because of their significant reduction in harm compared with combustible cigarettes On this matter, critics of e-cigarettes claim that e-cigarettes are risky for human‘s health, but then again few things are completely risk-free It is crucial to understand that e-cigarettes still cause hazards

to human‘s health, however such hazards are minimal in comparison to those created

by continued smoking.45 Undoubtedly, it would be best if both cigarettes and cigarettes were not bothered with at all, but if that is not possible and smokers want their nicotine, e-cigarettes, as confirmed by WHO itself, are a safer alternative for

40 Herb Weisbaum, ―What‘s Causing Some E-Cigarette Batteries to Explode?‖, http://www.nbcnews.com/business/consumer/what-s-causing-some-e-cigarette-batteries-explode-n533516 (last visited on June 14, 2016)

44 Rob Walters, ―E-Cigarette Makers Give Public the Finger‖, http://www.forbes.com/sites/robwaters/2014/01/27/e-cigarette-makers-give-public-the-finger/#4b105fed34f9 (last visited on June 14, 2016)

45 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 (last visitied on June 19, 2016) (―[…] while the US Food and Drug Administration (FDA) found the liquid and vapour to contain traces of toxins […] the level of these toxins is about one thousandth of that in cigarette smoke‖)

them.46 In this regard, e-cigarette is capable of becoming an ―innovative technology‖ similarly to refrigerator: in the 1910s-1920s, stomach cancer was the leading cause of cancer deaths in North America, but after the invention and popularization of refrigerators, the number of stomach cancer cases ―plummeted‖ as the population could eat fresh foods stored in refrigerators instead of those previously preserved by salting, smoking or pickling, which are proven to be the types of foods that increase risk factors of stomach cancer.47 E-cigarettes, which provide nicotine to satisfy vapers‘ addiction without producing the lethal tar loaded with carcinogens like combustible cigarettes, have the potential to help reduce lung cancer and various other tobacco-related diseases in the same way that refrigerators reduced stomach cancer

Regarding concerns that e-cigarettes may serve as a pathway to traditional cigarettes, there are firm evidence suggesting otherwise.48 Indeed, study results pointing at e-cigarettes‘ role leading to conventional smoking have been questioned by respectable scientists that support e-cigarettes. 49 Particularly, with regard to the youth,

it has been reported by the US‘ Centers for Disease Control and Prevention (―CDC‖)

that the smoking rate among US high-school students have ―decreased significantly‖ from 21% in 2013 to 16% in 2015 despite the fact that the vaping rate in the same period has gone up considerably from 4.5%50 to 24.1%.51 Such figures reasonably

46 Conference of the Parties to the WHO Framework Convention on Tobacco Control (2014), ―Electronic nicotine delivery systems – Report by WHO‖, pp 5 (―[…] the reduced exposure to toxicants of well-regulated ENDS used by established adult smokers as a complete substitution for cigarettes is likely to be less toxic for the smoker than conventional cigarettes or other combusted tobacco products‖)

47 theCCF (2016, February 02), Disruptive Technologies: Vaping and Ride-Sharing [Video File] Retrieved from https://m.youtube.com/watch?v=YUjRjcEr6OQ (last visited on June 15, 2016), from 8:53 to 11:06 See

http://www.cancer.org/cancer/stomachcancer/detailedguide/stomach-cancer-prevention (last visited on June 15, 2016) (―The dramatic decline of stomach cancer in the past several decades is thought to be a result of people reducing many of the known dietary risk factors This includes greater use of refrigeration for food storage rather than preserving foods by salting, pickling, and smoking To help reduce your risk, avoid a diet that is high in smoked and pickled foods and salted meats and fish‖)

48 See George Arnett, ―E-cigarettes have not been a gateway to traditional smoking – ONS‖,

britain (last visited on June 16, 2016); Guy Bentley, ―CDC Admits, No ―Concrete‖ Evidence E-Cigarettes Are Gateway To Smoking‖, http://dailycaller.com/2016/01/08/cdc-admits-no-concrete-evidence-e-cigarettes-are- gateway-to-smoking/ (last visited on June 16, 2016)

http://www.theguardian.com/news/datablog/2014/nov/25/e-cigarettes-not-gateway-traditional-smoking-great-49 See Hajek P and McRobbie H (2014), E-cigarettes: an evidence update (Chapter 9, 10), pp 80 (―Two

recent worldwide media headlines asserted that EC use is dangerous These were based on misinterpreted research findings‖); 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-theres-still-no-evidence-e-cigarettes- are-as-harmful-as-smoking (last visited on June 16, 2016)

50

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 (last visited on June 16, 2016)

allow for the conclusion that e-cigarettes help reduce, not stimulate, traditional smoking among the youth in particular and the society in general

In the world, the benefits of e-cigarettes are starting to be recognized, with Public Health England52 and Britain‘s Royal College of Physicians53 publicly encouraging e-cigarettes‘ use Nevertheless, these reports and other studies‘ results has only documented the short-term effects of e-cigarettes; more studies on long-term aspects are necessary to fully and correctly evaluate the effects of e-cigarettes In the meantime, in recognition of e-cigarettes‘ harm reduction in comparison with combustible cigarettes, e-cigarettes should be used, in the monitoring of a strict but reasonable legal framework This will allow e-cigarettes to continue carrying out their harm reduction responsibilities, while helping vapers to have the best possible e-cigarettes for usage

1.1.4 Legal classification of electronic cigarettes

There are three categories that e-cigarettes are commonly classified in, which are medicinal/pharmaceutical products, tobacco products and consumer products.54 As the three are considerably different types of products which are therefore subjected to different legal regimes, it is important to study the differences between such types and the legal regulations applied to them Thereby, reasonable grounds to categorize e-cigarettes can be formed and appropriate legal provisions can be issued particularly for the regulation of e-cigarettes Nevertheless, there is a fair amount of debate around the world as to which of the three classifications is the most appropriate from a regulatory viewpoint.55 Each classification has scientific reasons behind it, and are adopted by different countries with different regulatory histories and mindsets

First, e-cigarettes as medicinal/pharmaceutical products

51 Laura Kann et al (2015), ―Youth Risk Behavior Surveillance — United States, 2015‖, Morbidity and

http://www.cdc.gov/mmwr/volumes/65/ss/ss6506a1.htm?s_cid=ss6506_w (last visited on June 16, 2016)

52 Hajek P and McRobbie H, supra note 49, pp 80 See Gov.uk, ―E-cigarettes around 95% less harmful than

tobacco estimates landmark review‖, than-tobacco-estimates-landmark-review (last visited on June 17, 2016)

https://www.gov.uk/government/news/e-cigarettes-around-95-less-harmful-53

―[…] in the interests of public health it is important to promote the use of e-cigarettes […] as widely as

possible as a substitute for smoking in the UK‖ See Royal College of Physicians (2016), Nicotine without smoke:

Tobacco harm reduction, pp 190

54 Eric A Feldman (2015), ―Layers of Law: The Case of E-Cigarettes‖, Florida International University Law

Review, 111(10), pp 121

55 Virginia Berridge (2014), ―Electronic cigarettes and history‖, The Lancet, 383, pp 2204

Most generally, a pharmaceutical product is a product used to diagnose, cure, treat or prevent disease.56 In the EU, there are two relevant legal terms: ―medicinal product‖57 and ―medical device‖.58 In accordance with definitions in the relevant documents, it has been concluded that a particular e-cigarette product is (i) a medicinal product if ―it is presented as a remedy to get rid of nicotine addiction‖ or if ―it qualifies

as ―restoring, correcting or modifying physiological functions‖ in a significant manner‖; or (ii) a medical device if it is claimed to have an intended medical use.59 As nicotine is the only substance in e-cigarettes that may have medicinal effects, only nicotine-containing e-cigarettes may be considered medicinal products.60 In the US, e-cigarettes that are clearly and expressly marketed to have therapeutic effects are within the FDA‘s authority to regulate as drugs under the FDCA.61

Out of the three classifications, e-cigarettes classified as medicinal/pharmaceutical products are regulated most strictly, as they have to satisfy multiple standards required by law to be granted a pharmaceutical licence.62 Because of that and several other reasons, this classification of e-cigarettes has commonly faced fierce opposition from both the industry and vapers, especially due to the fact that e-cigarettes could face stricter regulations than the much more harmful traditional cigarettes. 63 Furthermore, at the root of the classification lies a potential weakness: the European Court of Justice itself has ruled that a product must ―strictly speaking have the function of treating or preventing disease‖ to be considered a medicinal product,64

while till date it is very hard to say with conviction that e-cigarette can prevent, let alone treat, any disease In fact, through the draft Tobacco Products Directive released

in 2012, the European Commission proposed to classify ―nicotine containing

Article 1.2(a) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

59 European Commission‘s Health & Consumer Protection Directorate-General (2008), Orientation Note –

Electronic Cigarettes and the EC Legislation, pp 1

60 Eugenie Syx (2014), ―The case of the electronic cigarettes in the EU‖, European Journal Health Law,

21(2), pp 165, 166

61 See infra note 76

62 Press Association, ―E-cigarettes to be classed as ‗medicines‘ in attempt to tighten regulation‖, https://www.theguardian.com/society/2013/jun/12/e-cigarettes-medicines-tighten-regulations (last visited on June

21, 2016)

63 James Meikle, ―E-cigarette classification as medicines plan angers industry‖, https://www.theguardian.com/business/2013/jun/12/e-cigarette-classification-medicines-industry (last visited on June 27, 2016)

64

Commission of the European Communities v Federal Republic of Germany, C-319/05, EU:C:2007:678,

part 64

products‖, one of which is nicotine-containing e-cigarette, containing over a level of nicotine as medicinal products.65 However, in October 2013, the European Parliament voted against that proposal after a strong lobbying campaign by the e-cigarette industry, which were backed by vapers wary of having their e-cigarettes confined to sales in pharmacies.66 As of now, countries regulating e-cigarettes as medicinal products are mostly those from the EU, including Austria, Belgium and Denmark.67

Second, e-cigarettes as tobacco products

Legally, tobacco products are commonly defined as products consisting wholly

or partly of tobacco for human consumption.68 With that definition, as nicotine is a derivative from tobacco leaves, it is technically possible to classify e-cigarettes as tobacco products However, since nicotine can also be derived from everyday vegetables such as eggplants or potatoes69 or even synthesized70 which leaves no other substance in e-liquids originating from tobacco, such a classification is not entirely sound Coupled with the fact that e-cigarettes are seen as the safer alternatives to traditional cigarettes, their classification as tobacco products has also encountered objections.71

Concerning e-cigarettes‘ classification as tobacco products in the US, the case

Sottera, Inc v FDA is a landmark one In this case, Sottera Inc (―Sottera‖), an

65 Section 3.7 of the Explanatory Memorandum within the Proposal for a Directive of the European Parliament and of the Council 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

66

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-of-vapers-e-cigarette-industry-woos-and-wins- europe.html?_r=0 (last visited on June 20, 2016)

67 E-Cigarette Politics, ―E-Cigarette Laws Worldwide‖, cigarettes-global-legal-status.html (last visited on June 20, 2016)

http://www.ecigarette-politics.com/electronic-68 For example, according to US laws: ―The term 'tobacco product' means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product […]‖ (Section 101(a) of the Family Smoking Prevention and Tobacco Control Act 2009); EU laws:

―‘tobacco products‘ means products that can be consumed and consist, even partly, of tobacco, whether genetically modified or not‖ (Article 2.4 of the Tobacco Products Directive); and Vietnam laws: ――Tobacco products‖ means products manufactured from the whole or part of tobacco raw materials and […] used for pipes and other types for smoking, chewing, snuffing‖ (Article 3.2 of 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)

69 Shuh J Sheen (1988), ―Detection of Nicotine in Foods and Plant Materials‖, Journal of Food Science,

importer and distributor of e-cigarettes, filed a preliminary injunction against the FDA‘s blocking of a Sottera e-cigarettes‘ shipment from importation into the US.72

In blocking the import, the FDA claimed that the e-cigarettes appeared to be ―adulterated,

misbranded, or unapproved drug-device combinations‖ (emphasis added), thereby

falling within the FDA‘s regulatory authority over medical devices pursuant to the FDCA.73 In filing the injunction, Sottera responded that e-cigarettes were merely tobacco products and as theirs were not marketed with claims of therapeutic effects, they should be regulated as tobacco products under the Tobacco Act alongside traditional cigarettes.74 In the first instance with the case Smoking Everywhere Inc v

FDA, Judge Richard Leon found that ―[…] the Tobacco Act, in effect, serves as an

implicit acknowledgement by Congress that FDA‘s jurisdiction over drugs and devices

does not, and never did, extend to tobacco products, like electronic cigarettes, that are

marketed in customary fashion for purely recreational purposes‖75 (emphasis added) and granted Smoking Everywhere Inc the preliminary injunction it sought The Court

of Appeals affirmed this judgment of the first-instance court while repeating that ―[…]

the FDA has authority to regulate customarily marketed tobacco products—including

e-cigarettes—under the Tobacco Act It has authority to regulate therapeutically

marketed tobacco products under the FDCA's drug/device provisions‖ (emphasis added).76 Notably, in reaching this disposition, Circuit Judge Merrick Garland believed

that the use of the term ―tobacco products‖ by the Supreme Court in FDA v Brown &

Williamson, a main debating point in the case, does not extend to products not

containing tobacco, but he then immediately noted that the Tobacco Act ―expressly extends to products that are merely ―derived from‖ tobacco‖, which makes e-cigarettes become within its adjudicating scope.77

In summary, while showing that the FDA only had the jurisdiction to regulate non-therapeutically marketed e-cigarettes pursuant to the Tobacco Act, the procedure

of Sottera, Inc v FDA also revealed a crucial knowledge: the US legislation considers

cigarette as a type of tobacco product and definitively rules out the notion that

72 Sottera, Inc v FDA, 627 F.3d 891 (D.C Cir 2010) Retrieved from

http://caselaw.findlaw.com/us-dc-circuit/1593752.html (last visited on June 21, 2016)

73 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

74 Laura Kirshner, supra note 73, pp 194, 195

75 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 (last visited on June 22, 2016)

76

Id

77 Id

cigarettes, unless marketed to have therapeutic effects, are medicinal products Currently, through the Deeming Rule, the FDA itself has continued this regulatory trend.78 Not many other countries have adopted this classification,79 although France,

as shown in a landmark court ruling,80 and Vietnam, as shown in communications between ministries in Official Letters, seemed to be some of those countries.81

Third, e-cigarettes as consumer products

Since classification of e-cigarettes as medicinal/pharmaceutical products or tobacco products, as stated above, are neither entirely scientifically sound, their classification as consumer products seems the most appropriate approach Defined as

―any tangible product for sale that is used by a person or household for non-business purposes‖,82 consumer product is a categorization that fits e-cigarettes, as vapers buy them simply for everyday usage, not for medicinal purposes and not as tobacco products Apart from a libertarian view of promoting the free trade of common goods, this classification bears reason partly from the view that regulating e-cigarettes within a strict set of rules would inhibit a chief reducer of tobacco use.83 E-cigarettes classified

as consumer products will be easier to access, as they can be sold in a wide range However, such a classification also subjects e-cigarettes to much less rigorous legal regulations than in the case of medicinal/pharmaceutical products or tobacco products, which might lead to issues including low-quality products Presently, the majority of countries that legally permit e-cigarettes regulate them as consumer products,84

78 FDA, ―Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah‖, http://www.fda.gov/TobaccoProducts/Labeling/ucm388395.htm (last visited on June 22, 2016)

https://en.wikipedia.org/wiki/Regulation_of_electronic_cigarettes (last visited on June 23, 2016)

80 In 2013, a court in Toulouse ruled that e-cigarettes, despite containing no tobacco, were ―substitute tobacco

products‖, thus subject to France‘s legal regulations on tobacco products See Henry Samuel, ―French shop

cigarettes-after-tobacconist-complaint.html (last visited on June 17, 2016)

http://www.telegraph.co.uk/news/worldnews/europe/france/10507096/French-shop-banned-from-selling-e-81 Specifically, in Official Letter No 3154/BKHCN-TDC dated 01 October 2013 on opinions regarding the management of importing e-cigarettes, The Ministry of Science and Technology opined that ―nicotine-containing e-cigarettes may be considered a type of tobacco product‖, while the General Department of Customs, in Official Letter No 17180/BTC-TCHQ dated 12 December 2013 on opinions regarding the management of importing e- cigarettes, gives opinion that imported e-cigarettes shall be regulated in the same way to imported conventional cigarettes

82

Boundless.com, ―Consumer Products‖, marketing-textbook/products-9/types-of-products-67/consumer-products-334-712/ (last visited on June 23, 2016)

https://www.boundless.com/marketing/textbooks/boundless-83 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

84

Specifically, in a 2014 survey conducted by the WHO, 27% out of 49% and 35% out of 44% of WHO members that have regulated ENDS regulate nicotine-containing ENDS and non-nicotine-containing ENDS,

including Israel, the Netherlands, Poland, Switzerland,85 the United Kingdom,86 and Ireland.87

1.2 Overview on the trade of electronic cigarettes

1.2.1 Definition of trade

Most simply, the word ―trade‖ means ―exchanging one item for another‖, which

is more commonly understood to be the exchanging of goods for money, or in other words, the buying and selling of goods and services.88 From a legal perspective,

―trade‖, or ―business‖, is generally defined as ―any business or professional activity conducted by a taxpayer with the objective of earning a profit‖.89

In this definition, the

―objective of earning a profit‖ is a crucial factor in determining whether a business or professional activity conducted by a taxpayer is trade or not In Vietnam, the Law on Enterprises 2014 define business as the ―continuous execution of one, some, or all stages of the investment process such as manufacturing, selling products or providing services on the market to earn profit‖.90 This definition focuses on the nature of trade, which is the ―stages of the investment process‖, and the objective of the traders, which

is to earn profit.91

1.2.2 Forms of trade

There are two ways to classify trade/business forms First, based on the operation mode of business, there are service business, merchandising business and manufacturing business.92 Specifically, a service business provides intangible products such as hairdressing, banking, accounting or legal consultancy; a merchandising business buys finished products and sells them at a higher price to make profits; while

a manufacturing business buys products and uses them to create new products, which

respectively, as consumer products See Conference of the Parties to the WHO Framework Convention on Tobacco Control, supra note 46, pp 9

85 Institute for Global Tobacco Control – Johns Hopkins Bloomberg School of Public Health (2015), Country

Laws Regulating E-cigarettes: A Policy Scan, pp 3

86 Gov.uk, ―E-cigarettes: regulations for consumer products‖, regulations-for-consumer-products (last visited on June 23, 2016)

https://www.gov.uk/guidance/e-cigarettes-87 Irish Heart Foundation (2014), Position on Electronic / E-Cigarettes, pp 3

http://www.oxforddictionaries.com/definition/english/trading (last visited on June 24, 2016)

89

Bryan A Garner (2004), Black’s Law Dictionary – Eighth Edition, West Publishing, pp 1533

90 Article 4.16 of the Law on Enterprises 2014

91 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

92

MissCPA, ―Types of Business Organizations‖, http://misscpa.com/types-of-business-organizations/ (last visited on June 26, 2016)

transforms the products purchased at the beginning of the manufacturing process.93Second, based on the trade scope, there are internal trade, which includes wholesale/retail trade, and external trade, which includes import/export and entrepot trade.94

In Vietnam, regarding trade forms, the Law on Commercial 2005 provides the definition of ―commercial activities‖, which is a closely synonymic term to ―business‖ defined in the Law on Enterprises,95 as ―activities for the purpose of generating profits, including the sale and purchase of goods, provision of services, investment, commercial promotion and other activities for the purpose of generating profits‖.96

Accordingly, it is identifiable of several forms of commercial activities: sale and purchase of goods, service provision, investment and commercial promotion More specifically, there are five categories of commercial activities/trade stipulated in the Law on Commercial 2005, which are (i) purchase and sale of goods; (ii) provision of services; (iii) commercial promotion, including sale promotion and advertising; (iv) intermediary activities; and (v) other forms of commercial activities, including processing, bidding, auction, logistics services… Similarly, in the case of tobacco trade, the Law on Preventing, fighting harmful effects of tobacco 2012 defines it as

―the continuous performance of one, several or all of the stages of the process from manufacturing, importing to the consumption of tobacco on the market for the purpose

of generating profits‖.97

Regarding the trade of e-cigarettes, due to the constraints on length, this thesis only focuses on the trade forms that mostly occur concerning e-cigarettes, including their manufacturing, sales and advertising/promotion

1.2.3 Situation on the trade of e-cigarettes

Invention of the modern-day e-cigarettes is widely credited to Hon Lik, who patented it in 2003.98 A year later, the Ruyan company, for which Hon Lik worked, introduced e-cigarettes to the Chinese market, making them an instant hit.99 They

Ho Chi Minh City University of Law, supra note 9, pp 14

96 Article 3.1 of the Law on Commercial 2005

97 Article 2.6 of the Law on Preventing, fighting harmful effects of tobacco 2012

98 Wikipedia, supra note 1

99

QuitDay, ―History of Electronic Cigarettes‖, cigarettes/ (last visited on June 27, 2016)

https://quitday.org/electronic-cigarettes/history-of-electronic-quickly spread to the rest of the world, including Europe in 2006 and America in

2007.100 After that, e-cigarettes have evolved into a full-blown phenomenon, which creates huge values not only to the society but also to the industry Globally, the number of e-cigarettes sold has increased ―exponentially‖ year by year,101 with annual growth rate at a significant 57% helping the value of e-cigarette sales worldwide jump from an estimated US$461 million to more than US$1 billion in the period from 2010

to 2012.102 In 2013, the revenue was in the region of US$1.7 billion,103 while the figure

in 2015 was about US$6 billion.104 Along with the staggering increase in sales value comes a big number of suppliers and products concerned: there are currently over 500 e-cigarette vendors operating and selling under different brand names over the world,105 with an estimated figure in 2014 of 466 brands and 7764 unique flavors.106 It has been estimated that the global e-cigarette sales value will continue to grow at a rate

of over 20% to reach US$50 billion in 2025, albeit at varying degree of growth.107

In the US – the dominating e-cigarette market in the world, sales value had been doubling on a year-on-year basis, with estimates rising significantly from US$20 million in 2008 to around US$1.5-1.7 billion in 2014.108 Presently, such figure has been forecast to exceed the US$10 billion mark in 2017.109 Even more bullishly, Wells Fargo Securities has predicted that the sale of e-cigarettes, together with other non-

100 Jonathan K Noel, Vaughan W Rees and Gregory N Connolly (2011), ―Electronic cigarettes: a new

‗tobacco‘ industry?‖, Tobacco Control, 20, pp 81

101 Aruni Bhatnagar et al (2014), ―Electronic Cigarettes: A Policy Statement From the American Heart

105

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/Technavio-Announces-Top-Vendors- Global-E-Cigarette-Market (last visited on June 28, 2016)

106 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

107 ResearchandMarket, ―Global E-Cigarette & Vaporizer Market – Analysis & Forecast Through 2015 to 2025‖, http://www.researchandmarkets.com/research/j38d6n/global (last visited on June 28, 2016)

108 See Trefis Team, ―Who Stands To Gain From The E-Cigarette Phenomenon?‖, http://www.forbes.com/sites/greatspeculations/2015/06/23/who-stands-to-gain-from-the-e-cigarette-

phenomenon/#4483fe124876 (last visited on June 28, 2016); Statistic Brain, ―Electronic Cigarette Statistics‖, http://www.statisticbrain.com/electronic-cigarette-statistics/ (last visited on June 28, 2016)

109 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/ (last visited on June 28, 2016)

combustible products, in the US could surpass the sale of combustible cigarettes by

2023.110 Such impressive development is partly aided by the fact that the US cigarette business has a strong manufacturing base111 alongside the usual sales activities and big vendors participating in the supply chain, particularly the Big Tobacco – the three big tobacco corporations in the US including Altria Group with the

e-MarkTen brand, Reynolds American with VUSE and Lorillard Inc previously with the

best-selling blu.112

Contrary to that, the EU e-cigarette market is mainly composed of distributors rather than manufacturers and dominated by small companies, which makes sales figures uncertain and and volatile.113 As a result, there are not many figures concerning sales value of the market and when there are, they project contrasting pictures: while it was estimated that the total EU market for e-cigarettes and other ENDS was ―likely to

be worth between €400 and €500 million‖ in 2013,114 ECigIntelligence estimated that the total European sales in 2013 for e-cigarettes alone were in the range of €1bn-1.6bn ($1.4bn-2.25bn).115 E-cigarettes in the EU are commonly produced in China, then imported and retailed to consumers.116 Most of the trade is done online and vendors claim to sell their products across Europe.117

In Vietnam, although e-cigarettes in general and e-cigarette trade activities in particular has not been legally regulated, e-cigarettes and e-liquids of no clear origin are still available for purchase in shops at prices ranging from several hundreds of thousands to millions VND, with main buyers being the young, particularly university students, who want to experience new things and consider vaping as ―sophisticated‖.118

110 Bonnie Herzog, Jessica Gerberi and Adam Scott (2015), Equity Research: “Tobacco Talk” – Q4 US

Vapor Retailer Survey, pp 1

111 Jillian Mincer, ―Quality issues push e-cigarette production to US from China‖, http://www.reuters.com/article/us-usa-tobacco-ecigarettes-idUSBREA4O06420140525 (last visited on June 29, 2016)

112 James Ellis, ―Vaping: Big Tobacco‘s Big Gamble On The Future‖, tobacco-big-gamble-future-451074 (last visited on June 29, 2016)

http://www.newsweek.com/vaping-big-113

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

114 Matrix Insight on behalf of the EU, supra note 113, pp 108

115 Barnaby Page, ―Report: European e-cig market could be worth more than $2bn‖, http://ecigintelligence.com/european-e-cig-market-could-be-worth-more-than-2bn/ (last visited on June 29, 2016)

116 Matrix Insight on behalf of the EU, supra note 113, pp 70

117 Matrix Insight on behalf of the EU, supra note 113, pp 90

118

Ngoc Khai, supra note 8; Vinh Ha et al., ―Lo ngai voi con sot hut vape‖,

http://tuoitre.vn/tin/song-khoe/20160512/lo-ngai-voi-con-sot-hut-vape/1099351.html (last visited on June 29, 2016)

1.3 Basis for the regulation of the trade of e-cigarettes

1.3.1 Public health basis

As stated above, although e-cigarettes are widely recognized to be less harmful than conventional cigarettes, they still pose several threats to human‘s health.119 As a result, they need to be regulated to protect the public health Regulating e-cigarette trade could help protect public health in the following aspects:

Firstly, e-cigarette trade regulation will maximize e-cigarettes‘ biggest beneficial factor in comparison with traditional cigarettes: harm reduction If and when e-cigarettes are legally regulated and therefore guaranteed, more smokers will know about them and use them instead of traditional cigarettes, which will help reduce the prevalence of smoking and consequently the many diseases that come with it

Secondly, e-cigarette trade regulation could aid in preventing the pressing concern that nicotine-containing e-cigarettes may serve as a gateway to nicotine addiction and subsequently use of combustible tobacco products for non-smoking vapers, especially adolescents who are more likely to be strongly addicted to nicotine.120 Proper regulations on the sales of e-cigarettes, including the prohibition of sales to minors like one the US will soon apply,121 will help allay these dangers

Thirdly, e-cigarette trade regulation may support to reduce the worry that the action of vaping, which physically resembles smoking behavior, may encourage smoking In other words, it will help to stop the vicious circle that presents real threats

to the public health: not only do e-cigarettes potentially lead to nicotine addiction and tobacco use for vapers, their vaping could also stimulate others to try e-cigarettes and repeat the exact process

Finally, reasonable regulation of e-cigarette trade will create a common standard

of product quality that e-cigarette manufacturers must adhere to, which helps reduce cases of e-cigarette malfunctions posing significant health risks, particularly explosions that causes severe injuries to vapers and surrounding people.122

Firstly, it will help better monitor the fast-growing and high-value e-cigarette markets Along with the recent booming popularity of e-cigarettes and their uncertain long-term effects to human‘s health, the sheer size and value of the market has long called for legal regulations from governments.123

Secondly, on the opposite direction, e-cigarette trade regulation is trusted to boost the e-cigarette market even further Specifically, reasonable e-cigarette trade regulations do not aim at banning e-cigarettes from the market or even putting small e-cigarette companies out of business; instead, they seek to provide a clear and harmonized legal framework that all e-cigarette businesses, no matter small, medium or big, can adhere to and be benifitted.124 Granted, in the wake of e-cigarette trade regulations, larger companies with greater resources will benefit more than the small ones; nevertheless, governments have the power to support such small businesses to ensure as level a playing field as possible in the e-cigarette market without compromising the effectiveness of the relevant legal provisions.125

Thirdly, legal regulations on e-cigarette trade will also bring economical gains

to the states in the form of taxes, especially if excise tax is chosen to be applied,126although such proposals are currently met with understandable opposition from the industry and vapers, who fear that the policy will significantly increase the price of the products thus hinder their availability as well as harm-reduction effectivity.127

1.3.3 Legal basis

From a legal perspective, regulations on e-cigarettes trade is necessary because

of the following reasons:

Firstly, the most important and valued function of the law is adjudicate the complex and ever-changing social relations to guarantee social order and harmony in benefits of different social groups in the society.128 In this case, e-cigarettes in general

123

Laurie McGinley and Brady Dennis, ―The federal government is about to begin regulating the booming cigarette market‖, https://www.washingtonpost.com/national/health-science/the-federal-government-is-about-to- begin-regulating-the-booming-e-cigarette-market/2016/05/05/d22ddec0-130b-11e6-93ae-

e-50921721165d_story.html (last visited on July 01, 2016

124

European Commission (2014), E-cigarettes Myth Buster, pp 1, 2

125 Action on Smoking and Health (2016), The impact of the EU Tobacco Products Directive on e-cigarette

regulation in the UK, pp 4-5

126 Reuters, ―EU finance ministers call for higher taxes on e-cigarettes‖, taxation-ecigarettes-idUSL5N16G3Z4 (last visited on July 01, 2016)

http://www.reuters.com/article/eu-127 Breitbart, ―European Commission Puts Money Before Health With E-Cigarette Tax Proposal‖, http://www.breitbart.com/london/2015/02/19/european-commission-puts-money-before-health-with-e-cigarette- tax-proposals/ (last visited on July 01, 2016)

128

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

and e-cigarette trade in particular are new phenomena that create new social relations and have the potential to adversely affect such relations Indeed, the distinction of e-cigarettes and e-cigarette trade requires a separation of legal provisions adjudicating e-cigarettes from those applying to conventional cigarettes Specifically, in nature, e-cigarettes are different from conventional cigarettes: ingredient-wise, they do not contain tobacco like conventional cigarettes while operation-wise, they function in an alternative way129; from a health perspective, e-cigarettes also pose less threats than cigarettes Consequently, in order to protect benefits of the society considering the newness of e-cigarettes, e-cigarette trade shall be governed by specialized law

Secondly, regulating e-cigarette trade in particular and e-cigarettes in general will ensure consistency with regulations on traditional cigarettes, thus maintain the effectiveness of such regulations For example, with regard to bans on public smoking which are prevalent in any tobacco law, it has been reasoned by several US local governments that e-cigarette use in public must also be banned to protect the enforceability of such smoking bans; without such cohesive regulations, vaping and smoking are so similar in appearance that it would be an ―enforcement nightmare‖ to differentiate them and accordingly apply the appropriate provisions.130 Furthermore, such a consistent regulation between e-cigarettes and traditional cigarettes will help perfect the legal system of a country or institution (in the case of the EU), which will in turn be beneficial for its global integration, both in a legal and economic sense

1.4 Overview of the laws of the EU, US and Vietnam

1.4.1 EU laws

With regard to e-cigarette in general and e-cigarette trade in particular, the Tobacco Products Directive is the first legal document to officially address the issue within the EU The legislative process that results in the Tobacco Products Directive is

a lengthy one: it took almost two years when the European Commission proposed the draft in December 2012 until it was finally approved by the European Parliament and adopted by the European Council in February – March 2014, before the entry into force

on 19 May 2014 and deadline for Member States to incorporate its regulation into the national laws on 20 May 2016 has recently passed.131

129 See Section 1.1.2

130 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 455

131 European Commission, ―Revision of the Tobacco Products Directive‖, http://ec.europa.eu/health/tobacco/products/revision/index_en.htm (last visited on July 02, 2016)

In the Tobacco Products Directive, e-cigarettes are not considered as tobacco products, since they are regulated in Title III named ―Electronic Cigarettes and Herbal Products for Smoking‖ in separation with other tobacco products addressed in Title II

At the same time, e-cigarettes classified as medicinal products or medical devices - due

to their presentation or function - are separately adjudicated other relevant documents.132 E-cigarettes within the adjudication scope of the Tobacco Products Directive are merely consumer products.133 Furthermore, the Tobacco Products Directive only regulates nicotine-containing e-cigarettes; those that do no contain nicotine is subject to the national laws of the Member States.134 Specifically, the Directive focuses on regulating the quality standards of e-cigarette products and the communication regarding the products, including the introduction of compulsory health warnings, as well as laying out a monitoring and reporting regime to help enable the proper management of e-cigarette in general and e-cigarette trade in particular,135with the ultimate aim of protecting human health and safety within the EU

1.4.2 US laws

In the US, Sottera Inc v FDA was the legal ruling that ignited the debate for

definition and regulation of e-cigarettes.136 After the FDA had been denied the right to regulate therapeutically marketed e-cigarettes in the case,137 in April 2011 the agency announced its intention to propose a regulation that would give it the authority to regulate ―other categories of tobacco products that meet the statutory definition of

―tobacco product‖‖138 as amended by the Tobacco Act In April 2014, the proposed rules, which included strict regulations on e-cigarette trade, were introduced.139Ultimately, in May 2016, the FDA issued the Deeming Rule140 attracting large amount

of the US public attention141 as it was the first legal document to regulate e-cigarettes

132 Recital 36 of the Tobacco Products Directive

133 European Commission, ―Questions & Answers: New rules for tobacco products‖, http://europa.eu/rapid/press-release_MEMO-14-134_en.htm (last visited on July 01, 2016) (―The new rules […] will cover all consumer electronic cigarettes placed on the EU market‖)

134 European Commission, ―E-cigarettes Myth Buster‖, pp 2

135 See Chapter 2

136

Ellen Martin (2014), ―Looking Through the Smoke: Electronic Cigarettes and Taxation‖, Robert Morris

University Honors Program - 2014 Honor Theses, pp 168

137 See supra note 72

138 FDA, ―Stakeholder Letter: Regulation of E-Cigarettes and Other Tobacco Products‖, http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm (last visited on July 02, 2016)

http://edition.cnn.com/2014/04/24/health/fda-e-cigarette-regulations/ (last visited on July 02, 2016)

140 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‖,

The 499-page Deeming Rule, which will be effective from August 08, 2016, continues to classify e-cigarettes as tobacco products under the definition originally provided in the FDCA and amended by the Tobacco Act.142 Specifically, in accordance

to the authority provided by Section 901(b) of the Tobacco Act,143 the FDA, through the Deeming Rule, ―deems‖ all types of tobacco products other than cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, thereby including ENDS in general and e-cigarettes in particular, subject to the regulations in Charter IX

of the FDCA as amended by the Tobacco Act In addition, the Deeming Rule adds to and amends several regulations in Sub-Chapter K, Chapter I, Title 21 of the Code of

Federal Regulations (―21 CFR‖), thereby subjecting the newly-deemed products to

such regulations.144 Overall, the Deeming Rule sets out several provisions on many activities concerning the trade of e-cigarettes from the manufacturing phase to the advertising and sales stage.145

1.4.3 Vietnam laws

In Vietnam, the first regulations on e-cigarettes emerged sporadically over a long period of time, from 2010 to 2013 and 2014 Moreover, they were not issued in the form of legal documents but only as several Official Letters,146 which only briefly addressed some aspects of e-cigarette trade Most of the relevant state bodies, including

the Ministry of Industry and Trade (―MoIT‖), Ministry of Health (―MoH‖), Ministry of Science and Technology (―MoST‖) and the General Department of Customs (―GDC‖),

were involved in the issuance of such Official Letters Nevertheless, till date there has not been any other documents on this subject

federal-food-drug-and-cosmetic-act-as-amended-by-the (last visited on July 02, 2016)

https://www.federalregister.gov/articles/2016/05/10/2016-10685/deeming-tobacco-products-to-be-subject-to-the-141 Sabrina Tavernise, ―F.D.A Imposes Rules for E-Cigarettes in a Landmark Move‖, http://www.nytimes.com/2016/05/06/science/fda-rules-electronic-cigarettes.html?_r=0 (last visited on July 02, 2016)

142

See Response of FDA to Comment 166 in the Deeming Rule, pp 258 (―ENDS are tobacco products‖);

Response of FDA to Comment 162 in the Deeming Rule, pp 255-256 (―With this rule, FDA is deeming all products that meet the definition of ―tobacco products‖, including e-liquids, to be subject to the tobacco product authorities in Chapter IX of the FD&C Act […])

143

Specifically, Section 901(b) within Chapter IX of the Tobacco Act states: ―This chapter shall apply to all

cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco and to any other products that the

Secretary by regulation deems to be subject to this Chapter‖ (emphasis added)

144 Specifically, the text of the Deeming Rule starts with the following: ―Therefore, under the Federal Food,

Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR chapter

1 is amended as follows […]‖ (emphasis added)

145 See Chapter 2; 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-tobacco (last visited on July 02, 2016)

146

Both the Law on Promulgation of Legislative Document 2008 and 2015 do not list official letters as a type

of document within the Vietnam system of legislative documents

SUB-CONCLUSION OF CHAPTER 1

1 E-cigarettes, which are battery-powered devices used to vaporize liquids into vapor for inhalation, have been the source of heated debate on whether they are harmful or helpful to the society in general and vapers/smokers‘ health in particular Careful consideration of both sides of the argument suggests giving e-cigarettes the benefit of the doubt, due to their significant harm reduction in comparison with conventional cigarettes, is the appropriate approach

e-E-cigarettes are classified into three categories: medicinal/pharmaceutical products, tobacco products and consumer products, with each classification being adopted by different countries for different reasons

2 E-cigarette trade, which takes different forms from the manufacturing to the sales phase, is booming with remarkable growth and value globally The sector in the US, the EU and Vietnam is no exception to such situation

3 E-cigarettes, being the new, high-value phenomena that has the potential

to adversely affect the society particularly from the public health viewpoint, need to be legally regulated

4 The EU and US are two of the first countries/institutions to have official legal provisions on e-cigarettes in general and e-cigarette trade in particular Such provisions present valuable experience for the Vietnam legislation, which is significantly short on e-cigarette legal regulations

Chapter 2 The European Union and United States laws on the trade of

electronic cigarettes – Experience for Vietnam

2.1 On the standards and manufacturing of electronic cigarettes

As a result, the provisions cover many aspects of e-cigarettes and e-liquids (or ―nicotine-containing liquid‖ as the wording of the Tobacco Products Directive) that may cause harm to human‘s health

Regarding nicotine-containing liquids, the Tobacco Products Directive sets out the following three standards:

First, on the threshold of nicotine concentration

Article 20.3(b) prescribes that nicotine-containing liquid must not contain nicotine in excess of 20 mg/ml; e-cigarettes with higher nicotine concentration levels shall be subject to the EU pharmaceutical legal framework.148 The Tobacco Products Directive‘s reasoning for this provision is that such a concentration ―allows for a delivery of nicotine that is comparable to the permitted dose of nicotine derived from a standard cigarette during the time needed to smoke such a cigarette‖,149 which would ensure that they do not absorb more nicotine than what would be by a typical smoker.150 Indeed, the EU, citing the work of Konstantinos E Farsalinos, claimed that

an e-cigarette with a nicotine concentration of 20 mg/ml delivers approximately 1 mg

of nicotine in 5 minutes, which is the time needed to smoke a traditional cigarette.151However, this reasoning has been questioned In the very work that the EU cited, Farsalinos also stated that seemingly ―liquids with even higher than 24 mg/mL nicotine concentration would be comparable to one tobacco cigarette‖.152 Farsalinos himself

147

Recital 36 of the Tobacco Products Directive

148 European Commission, supra note 134

149 Recital 38 of the Tobacco Products Directive

150 Christopher Snowdon (2015), E-cigarettes and Article 20 of the Tobacco Products Directive, pp 2

found in another study that the nicotine concentration in e-liquids ―should be close to

50 mg/ml in order to approximate nicotine delivery from smoking‖,153 the figure of which is supported by other studies.154

To further support the limitation of e-liquids‘ nicotine concentration at 20 mg/ml, the EU stated ―The most commonly sold strength of e-cigarettes is 17-18 mg/ml3 and strengths of 20 mg/ml and lower were shown to be effective for the majority of smokers in their cessation efforts‖.155 That the EU implied that the most commonly used nicotine concentration of e-liquids is around 18 mg/ml and such concentration helps with cessation efforts of ―the majority of smokers‖ is backed up by both the e-cigarette business reality156 and research studies.157 Nonetheless, this reasoning is still disputed on the basis that vapers who are highly addicted to nicotine, will not find the 20 mg/ml concentration to be enough for their needs.158

In consideration of both sides of the above argument, it is fair to conclude that restricting e-liquids‘ nicotine concentration at 20 mg/ml is a reasonable provision by the EU That is because the vapers and objectors who claim for higher nicotine-concentrated liquids only constitute a less-than-majority part of the community, as such the law cannot and will not tailor to suit such minorities Furthermore, since the EU still leaves an opportunity for e-cigarettes with nicotine concentration higher than 20 mg/ml to be placed on the market as pharmaceutical products, those who want e-liquids with high nicotine concentration can still buy them as such.159 At the same time, the lower in nicotine concentration e-liquids are allowed to be on the market, the less risks there are of exacerbating nicotine dependance within the society

Second, on the volume of e-cigarettes/cartridges and refill containers

Article 20.3(a) stipulates that ―nicotine-containing liquid is only placed on the

market in dedicated refill containers not exceeding a volume of 10 ml, in disposable electronic cigarettes or in single use cartridges and that the cartridges or tanks do not

155 European Commission, supra note 151

156 ―The Best E-Liquid Guide and Expert Reviews for 2016‖, https://quitday.org/e-liquid/ (last visited on July

04, 2016) (E-liquid with nicotine at 18 mg is used by most former smokers and vapers)

157 Lynne Dawkins et al (2013), ―‘Vaping‘ profiles and preferences: an online survey of electronic cigarette

users‖, Addiction, 108, pp 1118, 1134 (the 18-mg e-liquid, used by 49%, was the most popular type among the

survey‘s respondents and 89.4 of them found e-cigarette has ―very much‖ helped them to stop smoking)

158

Christopher Snowdon, supra note 150, pp 2

159 Pillbox 38 (UK) Ltd v The Secretary of State for Health, C-477/14, EU:C:2016:324, paragraph 94