Ref. Ares(2014)1336783 - 29/04/2014
Thursday, September 20, 2012 11:36 AM To:
FW: e-cigarettes release toxic chemicals indoors, should be included in clean indoor air
laws and policies
Here is a recent article about ecigs. Also, pls find attached the report on ecigs which will be
presented to COP5 in November 2012. Apologies in advance for the cross-posting.
Announcements regarding tobacco control.
20 September 2012 02:59 To:
e-cigarettes release toxic chemicals indoors, should be included in clean indoor air laws
A study published in Indoor Air
from the Fraunhofer Wilhelm-Klauditz-Institut in
Germany examined secondhand emissions from several e-cigarettes in a human exposure
chamber. Each e-cigarette was puffed 6 times and data were collected for a conventional
cigarette, also puffed 6 timed.
While the e-cigarette produced lower levels of toxins in the air for nonsmokers to breathe
than the conventional, there were still elevated levels of acetic acid, acetone, isoprene,
formaldehyde and acetaldehyde, averaging around 20% of what the conventional
cigarette put into the air.
Thus, while not as polluting as a conventional cigarette, the e-cigarettes are
detectable levels of several significant carcinogens and toxins in the air.
No one should have to breathe these chemicals, whether they come out of a conventional
or e-cigarette. No one should smoke e-cigarettes indoors that are free of other forms of
tobacco smoke pollution.
This posting, together with the link to the study, is on my blog at http://tobacco.ucsf.edu/e-
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Conference of the Parties to the
WHO Framework Convention
on Tobacco Control
Seoul, Republic of Korea, 12–17 November 2012
18 June 2012
Provisional agenda item 6.5
Electronic nicotine delivery systems,
including electronic cigarettes
Report by the Convention Secretariat
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 electronic 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
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 Organization, 2009 (WHO Technical Report Series, No. 955).
“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.1
The report submitted by the Convention Secretariat to the fourth session of the COP2 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 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.3
In addition, the reports by Parties on 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 income.
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
1 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.
2 Document FCTC/COP/4/12.
3 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, and Uruguay.
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 2
(Malaysia and Republic of Korea) provided any numerical data. With regard to historical trends, only
2 Parties (Bulgaria and Republic of Korea) provided data suggesting an increase in sales over time.
SCIENTIFIC ANALYSIS OF ENDS INCLUDING ON CONTENTS, EMISSIONS OR
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
The Republic of Korea performed a liquid chromatography-tandem mass spectrometry and gas
chromatography-mass spectrometry to identify and quantify contaminants and additives in electronic
cigarettes. 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
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 electronic
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
In that 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
1 Document EB 126/37.
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 to smokers.
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.1
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 Singapore2 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).
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.
1 See document FCTC/COP/4/12 for details of this meeting.
2 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.
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 electronic cigarettes interfered with pharmaceutical
rules. It was necessary to make internationally coordinated efforts in the field of combating illicit
tobacco replacement products.
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 electronic 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
three 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. Electronic cigarettes (including accessories such as fruit and
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.
confectionery flavourings) are also widely advertised on the Internet, and a study monitoring Internet
search engine queries from January 2008 to September 2012 reported that online interest in electronic
cigarettes had surpassed that of oral tobacco (snus) and nicotine replacement therapies.1
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 In 2009, a European company that produces a range of products that it describes as being
for nicotine replacement therapy was purchased by another large United States tobacco manufacturer,
and a producer of nicotine delivery systems has agreed a marketing and distribution agreement with a
company within the corporate group of yet another major tobacco manufacturer.3 These developments
demonstrate that traditional cigarette companies are taking notice of the emerging products.
In addition, recent estimates indicate that the electronic cigarette market is growing rapidly in
the European Union, and that the total value of the market in 2011 was €400–500 million.4 Additional
statistics confirm that the use of electronic cigarettes has grown markedly in recent years: 7% of
citizens of the European Union have reported that they have at least tried electronic cigarettes,5 and in
the United Kingdom of Great Britain and Northern Ireland, the number of electronic cigarette owners
is expected to rise from a small number in 2006 to over 1 million by 2013.4
Finally, a recent press release6 by a market analyst7 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”.8
1 Ayers JW, Ribisl KM, Brownstein J. Tracking the rise in popularity of electronic nicotine delivery systems
(electronic cigarettes) using search query surveillance, American Journal of Preventive Medicine
, 2011, 40:448–453.
2 See: http://online.wsj.com/article/SB10001424052702304723304577365723851497152 html.
3 See: http://www.euroinvestor.no/nyheter/2009/12/09/reynolds-american-inc-completes-acquisition-of-niconovum-
4 Information provided by the European Commission’s Directorate General for Health and Consumers from its own
5 Special Eurobarometer 385: Attitudes of Europeans towards tobacco
. European Commission, 2012. Available
6 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.
7 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.
8 Details of the Euromonitor International report, “The Future of Tobacco” may be found at:
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
) is Norm change.
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 ...”.1 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 could 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 electronic 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 tobacco cessation.
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. However, Parties may again wish
to consider the desirability of allowing the sale of new products that may have the capacity to maintain
a nicotine addiction.
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
1 The Guidelines for implementation of Article 12 of the WHO Framework Convention on Tobacco Control
available at: http://www.who.int/fctc/protocol/guidelines/adopted/article_12/en/index.html.
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.
In summary, ENDS are a new type of product entering the market with or without regulation by
Parties. Specific complexities as derived from the review above could be summarized as follows:
there are many different product categories (with or without tobacco, with or without
nicotine, with cartridge or single use, battery driven or chargeable);
the market for ENDS has increased significantly;
Parties regulate ENDS differently, resulting in legal complexity, possible uncertainty and
a regulatory gap in most countries;
health and safety concerns have not been resolved;
products may be subject to heavy marketing, including promotion to young people and
use of flavourings;
the role of ENDS is not clearly established: they are perceived in some quarters as
smoking cessation aids, and in others as a starter or dual-use (to maintain nicotine addiction)
The review expected by the COP at its fifth session would represent an important step in
addressing developments, challenges and future action in relation to ENDS.
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 PARTIES1
Regulated (including banned)
As a tobacco
As a product with health/therapeutic
Only if do not
whether or not
contain nicotine or and/or no
therapeutic claims claims are made
Does not Regardless of
whether or not
Great Britain Malaysia, Portugal, Hungary, New
and Northern Romania, Serbia,
Kingdom of Great
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 been granted.
SCOPE OF REGULATION OF ENDS1
1 Based on the replies received from Parties.
2 This Party has banned ENDS.
= = =