Ref. Ares(2014)1336783 - 29/04/2014
Friday, June 01, 2012 2:50 PM To:
Just forgot to attach it.
Electronic nicotine delivery systems, including electronic cigarettes
This document was prepared in response to the request made by the Conference of the Parties (COP)
at its fourth session (Punta del Este, Uruguay, 15–20 November 2010) to the Convention Secretariat to
prepare jointly with WHO’s Tobacco Free Initiative a comprehensive report based on the experience of
Parties on the matter of electronic nicotine delivery systems (ENDS) including electronic cigarettes for
consideration at the fifth session of the COP.1
ENDS are designed to deliver nicotine to the respiratory system. The term encompasses products
that contain tobacco-derived substances, but in which tobacco is not necessary for operation.2 They are
battery-powered devices that provide inhaled doses of nicotine by delivering a vaporized propylene
glycol/nicotine mixture. ENDS are marketed under a variety of brand names and descriptors, of which the
terms “electronic cigarettes” or “e-cigs” are the most common.
It appears that electronic cigarettes that are capable of providing inhaled doses of nicotine, but that
do not contain nicotine are also available in some Parties. In addition, and separately, vials of various
nicotine concentrations are for sale. These vials can be added to the e-cigarettes (the consumer can determine
the dosage of nicotine).
Recent studies and publications point out that more research on ENDS must be conducted, especially
with regard to their safety and the marketing claims made by the manufacturers (such as “alternative to
smoking” or “helps smokers quit”). It is consistently noted that the popularity of ENDS is growing and that a
thorough examination of these products is needed.3
The report submitted by the Convention Secretariat to the fourth session of the COP4 provided an
explanation of ENDS as well as an overview of recommendations made by the WHO Study Group on
Tobacco Product Regulation and the outcome of a regulatory consultation convened by WHO. In a further
effort to gather and analyse information on ENDS, the Convention Secretariat sent a questionnaire on ENDS
1 See decision FCTC/COP4(14).
2 Report on the scientific basis of tobacco product regulation. Third report of a WHO Study Group.
Geneva, World Health
(WHO Technical Report Series, No. 955).
3 Recent publications include: Vansickel AR, Eissenberg T. Electronic cigarettes: effective nicotine delivery after acute
administration. Nicotine & Tobacco Research
, 2012; Etter J-F et al. Electronic nicotine delivery systems : a research agenda. Tobacco Control
, 2011, 20:243–248; Vansickel AR et al. A clinical laboratory model for evaluating the acute effects of electronic
“cigarettes”: nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiology, Biomarkers & Prevention
2010, 19:1945–1953; Eissenberg T. Electronic “cigarettes”: ineffective nicotine delivery and craving suppression after acute
administration. Tobacco Control
, 2010, 19:87–88.
4 Document FCTC/COP/4/12.
to all Parties in November 2011. The survey included questions on availability, regulatory framework, sales
volume and scientific studies on ENDS. A total of 33 Parties responded to the survey.1
In addition, the reports by Parties on the implementation of the WHO Framework Convention on
Tobacco Control (WHO FCTC) were reviewed with regard to comments on ENDS. Three Parties, two of
which had also responded to the questionnaire, referred to ENDS in their implementation reports. Availability of ENDS
When asked in the questionnaire if ENDS, such as electronic cigarettes, were available for sale in
their country, the response choices were “yes”, “no”, and “do not know”.
Of the 33 Parties that replied, 16 stated that ENDS are available in their country, 13 stated that these
products are not available, and 4 stated that they did not know whether or not ENDS are available. All 16
Parties in which ENDS are available are upper-middle-income or high-income countries. Since the price of a
single electronic cigarette kit may be 10 or more times the price of a packet of “regular” cigarettes, it appears
that the marketing of ENDS is targeted at countries with a sub-population with a relatively high disposable
In all 16 Parties in which ENDS are available, electronic cigarettes are the most common form of
ENDS, followed by e-cigars, sold in 6 countries, and e-pipes, sold in 4 countries.
Parties in which ENDS are available reported that they are sold in pharmacies (4 Parties),
supermarkets (6 Parties), kiosks (5 Parties), via the Internet (14 Parties) and other (9 Parties). Parties replied
that “other” places include retail shops, kiosks, supermarkets, specialized shops, markets/market stalls, on
the street, and bars and pubs and leisure venues such as casinos and bingo halls.
Electronic cigarettes are available via the Internet in 14 of the 16 Parties. In terms of Internet sales,
the survey did not attempt to determine where the Internet-based ENDS providers are located or the country
of origin of the shipment.
Very few Parties, whether or not they regulate ENDS, indicated that they are able to monitor sales
levels of ENDS or historical trends. Of the 16 Parties in which ENDS are available, only two (Malaysia and
Republic of Korea) provided any numerical data. With regard to historical trends, only two Parties (Bulgaria
and Republic of Korea) provided data suggesting an increase in sales over time.
Scientific analysis of ENDS including on contents, emissions or health effects
In the questionnaire, Parties were asked if they or a delegated entity had conducted any scientific
analyses of ENDS, including on contents, emissions or health effects. If yes, Parties were asked to state the
conclusions and summary of the outcome of such analyses.
Based on the replies received, only 4 of the 16 Parties in which ENDS are available have carried out
any scientific studies on ENDS. In addition, in its most recent WHO FCTC implementation report, Australia
reported with regard to the progress made in implementation of Article 20 (Research, surveillance and
exchange of information
) that its Department of Health and Ageing was currently commissioning research in
a number of areas to inform future consideration of further regulatory options, including research on options
for further regulation of ENDS and smokeless tobacco products.
The Republic of Korea performed a liquid chromatography-tandem mass spectrometry and gas
chromatography-mass spectrometry to identify and quantify contaminants and additives in e-cigarettes.
1 Australia, Belgium, Bhutan, Brazil, Bulgaria, Canada, China, Germany, Ghana, Hungary, Ireland, Japan, Kuwait, Lesotho,
Lithuania, Malaysia, Mauritania, New Zealand, Norway, Portugal, Republic of Korea, Romania, Rwanda, San Marino, Serbia,
Seychelles, Singapore, South Africa, Trinidad & Tobago, Turkey, Uganda, United Kingdom of Great Britain and Northern Ireland,
Preliminary results suggest that 10 toxicants can be identified and quantified and that there may be
inconsistencies in nicotine content labeling and the actual values of nicotine. Bulgaria and Malaysia
undertook studies to determine if the actual nicotine content was equal to what had been declared.
In Brazil, where electronic cigarettes have been banned since 2009, a preliminary laboratory study
showed that the chemical fingerprint points to the fact that the liquid found in e-cigarette cartridges contains
tobacco extracts. Brazil reported that the results of the study will be shared once finalized.
None of the above studies addresses the claims made regarding the quality, safety, and efficacy of
ENDS. It should be noted in this regard that the WHO Study Group on Tobacco Product Regulation
(TobReg) submitted a report on ENDS to the 126th session of the WHO Executive Board in January 2010.1
In this report, TobReg concluded that the safety and extent of nicotine uptake had not been
established; that the products were marketed as smoking cessation aids, but that not enough scientific
evidence existed to validate this claim; and that delivery to the lung might be dangerous and, independent of
the effects of nicotine, it was of global importance to address lung delivery in scientific studies. TobReg also
concluded that ENDS designed for the purpose of direct nicotine delivery to the respiratory system fall into a
regulatory gap in most countries, escaping regulation as drugs and avoiding the controls applicable to
tobacco products. There is also insufficient evidence currently to assess whether ENDS may be used to aid
cessation, whether they create or sustain addiction, and whether they deliver constituents other than nicotine
TobReg recommended that clinical trials, behavioural and psychological studies, and post-marketing
studies at individual and population levels are needed to answer these questions. Claims that these products
have health benefits, reduce harm, or can be used to aid smoking cessation should be prohibited until they
are scientifically proven. They should be regulated as nicotine delivery devices, and where this regulation is
not possible under tobacco-control laws, should be subject to regulation of contents and labelling,
prohibitions against use in public places, and restrictions on advertising, promotion, and sponsorship.
Furthermore, participants of a Regulatory Consultation on the Safety of ENDS convened by WHO in
May 2010 expressed the concern that the quality and safety of ENDS have not been established. They urged
regulators of medical and tobacco products to collaborate in assessing the regulatory framework within their
own countries to determine the most effective means of regulating (or possibly banning) ENDS to protect
public health. They also recommended that in instances where health and/or therapeutic claims are being
made or implied, quality, safety and efficacy data substantiating those claims should be presented to the
appropriate national regulatory body.2
Regulatory strategies undertaken by Parties
Of the 13 Parties that stated that ENDS are not available for sale in their jurisdictions, only 4 –
Brazil, the Seychelles, Singapore and Uruguay – have laws banning the manufacturing, importation,
distribution, and sale of ENDS. The strategy taken by the Seychelles and Singapore3 is to consider ENDS as
a tobacco imitation product, regardless of accompanying health claims and the presence or absence of
tobacco or nicotine extracts. Article 11 of Seychelles’ Tobacco Control Act of 2009 states that “a person
shall not manufacture, import, supply, display, distribute or sell any sweets, snacks, toys or other non-
tobacco products resembling a tobacco product” (emphasis added). Singapore’s Tobacco Act, section 16,
states that “No person shall import, distribute, sell or offer for sale any confectionery or other food product
or any toy or other article that is designed to resemble a tobacco product or the packaging of which is
designed to resemble the packaging commonly associated with tobacco products” (emphasis added).
1 Document EB 126/37.
2 See document FCTC/COP/4/12 for details of this meeting.
3 While Brazil and Uruguay also banned ENDS, their survey responses did not provide information on whether ENDS are regarded
as an imitation tobacco product or whether they are banned on another basis.
Eight Parties reported that they regulate ENDS marketed with health claims and containing nicotine,
but that ENDS are not available. It can be concluded that market authorization for ENDS has not been
requested, or that it has been requested, but not granted.
Of the 16 Parties in which ENDS are available, 9 do not regulate ENDS.1 The remaining 7 Parties
regulate ENDS in different ways, covering either only their sale, or only their production, or covering their
sale, distribution, advertisement, and promotion. One Party replied that ENDS are available and regulated as
a pharmaceutical product. This would mean that ENDS have been given market authorization; however, that
Party also stated that no scientific analysis had been conducted.
A table showing the availability of ENDS in Parties, and whether or not and how ENDS are
regulated is attached as Annex 1.
It can be concluded from the survey that there are four types of ENDS that could be regulated, each
with and without health claim(s): ENDS with tobacco extracts, ENDS with nicotine and tobacco extracts,
ENDS with nicotine, and ENDS with neither nicotine nor tobacco. Annex 2 indicates the scope of regulation
of the different types of ENDS in Parties.
As indicated in Annex 2, some Parties stated that they regulate nicotine-containing ENDS if health
claims are made. Based on the replies, it can be concluded that ENDS containing nicotine and that make
health claims could only be sold in these countries with prior market approval by a competent national
regulatory authority. On the other hand, several Parties in which ENDS are available do not regulate
nicotine-containing ENDS, even if health-claims are made.
It appears from the survey responses that ENDS are being regulated by Parties under both tobacco
and medicines regulation. The survey also shows that some Parties have taken a more radical approach by
banning ENDS regardless of whether or not they contain tobacco extracts or nicotine or make health claims.
Concurrently, under a Party’s medicines framework, ENDS that make health claims could undergo
regulatory scrutiny and pre-market approval by a competent national regulatory body to verify the claims
made regarding quality, safety and efficacy. This two-pronged approach would prevent a situation in which
ENDS are available and unregulated simply because no health claims are made.
In addition, Hungary indicated in its most recent WHO FCTC implementation report that since a
stricter smoking ban had been put in place, demand for ENDS had increased. As nicotine was a
pharmaceutical active ingredient, the marketing of e-cigarettes interfered with pharmaceutical rules. It was
necessary to make internationally coordinated efforts in the field of combating illicit tobacco replacement
Parties are invited to note some recent developments. First, disposable electronic cigarettes have
appeared on the market. These products are aimed at consumers who prefer not to charge batteries or who do
not have enough money to buy e-cigarettes for long-term use. The price of “regular” electronic cigarettes
ranges from US$ 50 to US$ 150 depending on the brand, with a lifespan of up to 3 years. In contrast, the
price for a disposable electronic cigarette ranges from US$ 2 to US$ 13, depending on the number of puffs it
can provide. It is also possible to buy a pack of individual cigarettes or disposable nicotine atomizers only.
Some companies are only selling disposable nicotine atomizers, which are very easy to use.
Secondly, one prominent tobacco manufacturer in the United States recently purchased an electronic
cigarette company, making it the first major tobacco firm to buy or invest in electronic cigarettes.2 This
demonstrates that traditional cigarette companies are taking notice of the emerging products.
1 In addition, Latvia in its WHO FCTC implementation report noted that electronic cigarettes were not subject to regulation, and that
existing legislation had to be amended.
2 See: http://online.wsj.com/article/SB10001424052702304723304577365723851497152 html.
In addition, a recent press release1 by a market analyst2 announcing its global report on the projected
tobacco industry in 2050 predicted that “the concept of reduced harm tobacco products is expected to pick up
pace as innovation in non-combustible, cigarette mimicking nicotine delivery devices are developed by
cigarette companies. The e-cigarette and the (non-e) nicotine aerosol cigarette will lead the nicotine delivery
market over the long-term… By 2050, … [the market analyst] expects the novel nicotine delivery device
(NNDD) market (including e-cigarettes) to be equal in value size to the whole other tobacco products (OTP)
market”.3 ENDS and the WHO FCTC
It should be noted that ENDS are products resembling cigarettes and could therefore undermine the
denormalization of tobacco use upheld by the WHO FCTC. One of the guiding principles of the guidelines
for implementation of Article 12 (Education, communication, training and public awareness
) is Norm
It stipulates that it is “essential to change social, environmental and cultural norms and perceptions
regarding the acceptability of the consumption of tobacco products, exposure to tobacco smoke...”.4 Parties
are therefore invited to consider that a ban of ENDS as already undertaken by some Parties would contribute
to changing the social norms regarding the consumption of tobacco products.
Another aspect to consider is that if ENDS are regarded as imitation tobacco products and banned,
all ENDS would be covered, regardless of whether or not they contain nicotine, tobacco extracts, or make
health claims. Parties may wish to consider that strong measures to prevent further spread of ENDS could be
considered under a number of provisions of the WHO FCTC, including Article 5.2(b) which requires Parties
to “adopt and implement effective ... measures … for preventing and reducing … nicotine addiction …”.
Most ENDS contain nicotine, and would therefore contribute to maintaining an addiction to nicotine.
Furthermore, under Article 13.2, Parties have an obligation to undertake a comprehensive ban of all
tobacco advertising, promotion and sponsorship. “Tobacco advertising and promotion” is defined in Article
1(c) as “any form of commercial communication, recommendation or action with the aim, effect or likely
effect of promoting a tobacco product or tobacco use either directly or indirectly”. Therefore, Parties may
also wish to consider whether the sale, advertising, and even the use of electronic cigarettes can be
considered as promoting tobacco use, either directly or indirectly. Regardless of whether or not ENDS
contain nicotine or tobacco extracts, they are used to mimic smoking, which can be considered as a (direct or
indirect) promotion of tobacco use. Article 16.1(c) could also be relevant since it requires Parties to prohibit
“the manufacture and sale of … any other objects in the form of tobacco products which appeal to minors”.
Additionally, the use of ENDS could hamper the implementation of Article 8 (Protection from
exposure to tobacco smoke
) as ENDS users in public places may claim that their e-cigarette does not contain
tobacco and/or does not produce second-hand tobacco smoke. Parties may also wish to note that Article 14
(Demand reduction measures concerning tobacco dependence and cessation
) and its guidelines for
implementation refer to evidence-based treatment for tobacco dependence and tobacco cessation, and to
making available medications that have been clearly shown by scientific evidence to increase the chances of
If ENDS are not banned, a two-pronged strategy – regulating ENDS as both a tobacco and a medical
product – could close potential loopholes in their regulation.
1 The press release may be found at: http://www marketwatch.com/story/the-future-of-the-global-tobacco-industry-1-billion-smokers-
in-2050-reports-euromonitor-2012-05-15. It was published by MarketWatch, which is published by Dow Jones & Co., and is part of
The Wall Street Digital Network, which includes WSJ.com and Barrons.com.
2 Euromonitor International, which describes itself as “the world's leading provider for global business intelligence and strategic
market analysis”. It is headquartered in London, with regional offices in Chicago, Singapore, Shanghai, Vilnius, Santiago, Dubai,
Cape Town, Tokyo, Sydney and Bangalore, and has a network of over 800 analysts worldwide.
3 Details of the Euromonitor International report, “The Future of Tobacco” may be found at: www.euromonitor.com/the-future-of-
4 The Guidelines for implementation of Article 12 of the WHO Framework Convention on Tobacco Control
are available at:
http://www.who.int/fctc/protocol/guidelines/adopted/article 12/en/index html.
If a Party decided to categorize and regulate ENDS as tobacco products, all provisions of the WHO
FCTC would also apply to ENDS. However, Parties may wish to consider that as ENDS are new products
resembling tobacco products that would maintain a nicotine addiction, regulating them rather than banning
them could grant these new products a level of legitimacy in terms of market access, even though they may
be subject to the provisions of the WHO FCTC or to regulation as medical products. Parties may wish to
consider that admitting such new products would not support the objective of the WHO FCTC as stated in
Article 3, which is to “… reduce continually and substantially the prevalence of tobacco use …”.
Regulating ENDS as medical products would most likely be the case for ENDS that are marketed
with health or therapeutic claims. In this case, ENDS would be subject to the Party’s relevant regulations,
most notably the requirement to provide data substantiating those claims in order to obtain market
authorization. This could be seen as a positive development. However, Parties may again wish to consider
the desirability of allowing the sale of new products that would maintain a nicotine addiction.
ACTION BY THE CONFERENCE OF THE PARTIES
The COP is invited to note this report and to provide further guidance.
Availability and regulation of ENDS in Parties
Regulated (including banned)
As a tobacco
As a product with health/therapeutic
Only if do not
whether or not
contain nicotine or
claims are made
Does not Regardless
Serbia, South Africa,
Trinidad and Tobago
1 Based on the replies received from Parties.
2 These products are regulated as medicines only if they are promoted as a smoking cessation aid (if promoted as an alternative to
smoking, they are not regulated as medicines).
3 ENDS implements are available for retail sale, but the retail sale of nicotine in the form used in ENDS is illegal. Electronic
cigarettes making claims of therapeutic benefits may be available, although they are required by law to have therapeutic claims
approved; electronic cigarettes have not been approved as a therapeutic device.
4 According to the survey response, ENDS in this form are unregulated and may or may not be available.
5 This Party has banned ENDS.
6 The distribution, sale and advertisement of these products would require market authorization. To date, no such authorization has
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Scope of regulation of ENDS1
ENDS with nicotine
Australia, Belgium, Bhutan,
Hungary, Japan, Norway, New
Bulgaria, Ghana, Ireland,
Kuwait, Lesotho, Lithuania,
Malaysia, Mauritania, Portugal,
Romania, Rwanda, Serbia,
South Africa, Trinidad and
Bulgaria, Ghana, Ireland,
Kuwait, Lesotho, Lithuania,
Malaysia, Mauritania, Norway,
Portugal, Romania, Rwanda,
Serbia, South Africa, Trinidad
and Tobago, Turkey, United
1 Based on the replies received from Parties.
2 This Party has banned ENDS.