FROM WHO

Countries vindicate cautious stance on e-cigarettes

Countries signed up to an international tobacco control treaty have embraced
controversial WHO proposals to regulate electronic cigarettes. Armando
Peruga tells Fiona Fleck why.
Armando Peruga has spent the last two decades working in tobacco control. At the
World Health Organization (WHO) in Geneva, since 2006, and before that, at the Pan
American Health Organization in Washington. From 1986 to 1990, he worked for the
District of Columbia's Commission of Public Health as a behavioural change
epidemiologist in the United States. In his native Spain, he held several regional and
national posts in public health from 1983 to 1989, including as acting dean of the
National School of Public Health and director of the Research Institute on Health and
Welfare in Madrid. He holds a medical degree from the University of Zaragoza,
Spain, as well as a master's and doctoral degree in public health from the Johns
Hopkins University in the United States.

Bulletin of the World Health Organization 2014;92:856-857.

doi: http://dx.doi.org/10.2471/BLT.14.031214
Q: What are the health risks of using e-cigarettes and how do they differ from
conventional cigarettes?
A: Conventional cigarettes burn the tobacco leaf. E-cigarettes the most common
type of what we call electronic nicotine delivery systems or ENDS vapourize
liquid that contains nicotine for the purposes of inhaling. These devices have
become popular over the last four or five years, so there are only a few studies
on the health risks and we dont know the long-term effects. We dont have
epidemiological studies, such as those on the links between tobacco and cancer,
because such studies take decades to complete. We do, however, have some
evidence and part of the debate is about how to draw conclusions from this. The
WHO report released at the end of August took into consideration contributions of
more than a 100 scientists and regulators, and covers three areas where we
believe there is enough evidence to draw conclusions: the health risks of
nicotine, of inhaling other toxic emissions contained in these products and of
inhaling second-hand emissions.
Q: Why? The harmful parts of cigarettes are surely the tar and various toxic
additives.
A: Nicotine is highly addictive and we dont want non-smokers to start using it. It
has a role in neuro-degeneration and there is evidence of brain development
problems in children and fetuses that have been exposed to nicotine. WHO does
not recommend the use of any form of nicotine for those who have never smoked
or for children and pregnant women, and our report on e-cigarettes is consistent
with this position.
Q: At a meeting in Moscow in October of the countries signed up to the WHO
Framework Convention on Tobacco Control (FCTC), the countries welcomed
WHOs proposals for regulating e-cigarettes and other similar devices. Has
WHOs cautious stance on these products been vindicated?
A: The countries agreed on a set of goals in line with the WHO recommendations.
These seek to prevent non-smokers and young people ever starting to use ENDS;
to protect bystanders from ENDS emissions; to minimize the potential health
risks posed by ENDS and to challenge unproven health claims used to market
these products. To achieve their goals, the countries said that they would deploy
any regulatory measures they see fit to limit the use of ENDS or ban their use
altogether.
Q: Critics of WHOs cautious stance on e-cigarettes argue that these devices are
important for helping people quit smoking in the same way that people with
heroin dependence are treated with methadone. Do you feel that this is a
realistic comparison and can e-cigarettes be used effectively to help people stop
smoking?
A: For now the evidence is inconclusive about whether ENDS can be an effective
smoking cessation aid. The debate about ENDS will indeed continue. As pointed
out by the WHO report to the Conference of Parties, the evidence and
recommendations presented in it are subject to rapid change and in coming
years we will build up a solid body of evidence on this matter that will allow us to
reach a definitive conclusion.
Q: So shouldnt people use nicotine delivery products to help them give up
smoking?
A: WHO recommends licensed forms of nicotine replacement therapy to help
adult smokers quit. While the nicotine in electronic cigarettes does not pose
additional health risks for adult smokers, as our report notes, the evidence for the
effectiveness of e-cigarettes as a method for quitting smoking is limited and
requires further research.
Q: What is the problem with second-hand fumes from e-cigarettes?
A: Currently there are no studies that link the exhaled aerosol from e-cigarettes
to specific diseases, but we know that it contains nicotine and particulate matter.
These are the tiny particles to which some toxicants are attached. We also know
that when this aerosol is exhaled into the indoor air, the background level of
these particulates and of nicotine goes up. WHO has long maintained that there
is no safe level of such particulates and that we should minimize these levels as
far as possible, regardless of their source. The level of particulate matter from e-
cigarettes is lower than from conventional cigarettes, but there is a dose
response relationship, which means that the higher the concentration the
greater the health risks. So why expose people unnecessarily to a level of
particulate matter that is higher than the background levels?
Q: What toxic substances are produced by vaping?
A: There are about 500 e-cigarette brands out there, and only a few have been
analysed. This literature shows a great variety in the levels of the toxicants and
nicotine they produce. Some of the analysed brands are known to have very low
toxic emissions compared with conventional cigarettes. Some e-cigarettes have
few and low levels of toxicants, but some contain levels of cancer-causing agents,
such as formaldehyde, that are as high as those in some conventional cigarettes.
Nevertheless, average e-cigarettes are likely to be less toxic than conventional
cigarettes, although they are not without risks. Some people say these risks are
very very low, but our question is how low? If smoking a cigarette is like
jumping from the 100th floor, using an e-cigarette is certainly like jumping from a
lower floor, but which floor? We dont know.
Q: When are we likely to know more?
A: Some research programmes are already under way but given that e-cigarettes
have been popular in the last four or five years, research has barely started and
its early days yet. It would take about five or 10 years before we have evidence
that could change the current picture. Regulation can help generate more
evidence by requiring manufacturers to disclose the ingredients in these products
and by requiring surveillance to be carried out on their effect on human health.
Q: The European Union (EU) is concerned about refillable e-cigarettes and some
EU countries want to ban them. Why are they considered particularly harmful for
human health?
A: There are several reasons. First, the users fill the e-cigarettes container
themselves, so its not the manufacturer who establishes the level of nicotine,
but the user. The liquid may accidentally come into contact with the users skin
and give them nicotine poisoning and children might drink it. The United States
of America, the United Kingdom of Great Britain and Northern Ireland and
possibly other countries are surveying such poisoning accidents. Both countries
have seen a tremendous increase in nicotine poisoning reports, often involving
children. Another concern about refillable devices is that they can be used for
illegal substances. So there are many safety issues concerning refillable e-
cigarettes that can be minimized with the appropriate regulation.
Q: Why then has there been a controversy over WHOs proposals to regulate e-
cigarettes in the media and on social media?
A: WHO received several letters from health professionals and scientists,
including one from a group of 53 people and another from 133 people. The first
was from people in the United Kingdom, the United States and some other
developed countries. The second was from people living all over the world. These
letters gave different interpretations of the scientific evidence and while the
second concluded that significant regulatory action was needed, the first did not
consider such regulation justified. When compiling our report, we gave due
consideration to their arguments and weighed our assessment of the evidence
against theirs, reflecting on what was reasonable on both sides.
Q: So are they right or wrong?
A: There is some difference of opinion on how to interpret the science. But the
main disagreement is over what to do in terms of regulation and what regulation
can achieve, given that current scientific evidence on e-cigarettes is limited. Our
view is that regulation should bring the best out of any product while minimizing
the worst: a very difficult balance to achieve. In this case, probably, there is no
clear right or wrong. Thats why we have to be very careful in our report about
limiting our own conclusions to a small number of regulatory areas. While we
think that there is enough evidence to regulate some key aspects of e-cigarettes,
ultimately, the proof of the pudding is in the eating. The effect of such
 regulations also needs to be monitored closely. In the end, the key issue is
whether e-cigarettes can truly and safely move people out of conventional
cigarettes into other less risky forms of nicotine and, eventually, out of nicotine
altogether. There is very little science to assess if they can do this, but a lot of
debate.
Q: What role do multinational companies play in the new and growing e-
cigarettes market?
A: Some people say that WHO is more concerned about beating the tobacco
industry than ending the smoking epidemic, even if one of their products, namely
e-cigarettes, can help. This view is naive, because the tobacco industry only
markets products that it considers capable of perpetuating their core and most
profitable product conventional cigarettes. Unlike those who advocate e-
cigarettes as a form of harm reduction, the tobacco industry is clearly not
convinced that e-cigarettes will advance smoking cessation efforts, otherwise
they would not be aggressively buying up small e-cigarette companies. There
have been an estimated 100 million deaths due to tobacco over the last century.
How can we trust the companies that caused this human disaster? By appearing
to offer a solution with one hand, while continuing to create mass destruction
with the other, the tobacco industry is trying to regain the respectability it lost
long ago. The manufacturers of cigarettes and other tobacco products cannot be
legitimate partners in any public health discussion.
Q: By burdening small e-cigarette companies with regulation, wont you be giving
a free hand to multinational tobacco companies which are keen to take over the
e-cigarettes market?
A: The tobacco industry is already overpowering the smaller e-cigarette
manufacturers as a result of market competition and in the absence of significant
regulation. The fate of the small e-cigarette producers is being decided by the
tobacco industry, which is attacking other players with the intention of expelling
them from the marketplace so that it can take complete control. E-cigarette
regulations are designed to protect public health and to be effective. They should
be applied to all market players, large or small, the same way other products are
regulated. As indicated in the WHO report, our proposed regulatory measures aim
to maximize the potential benefits of e-cigarettes and minimize their risks.

Backgrounder on WHO report on regulation of e-cigarettes and

similar products
26 AUGUST 2014 - The report on Electronic nicotine delivery systems (ENDS), of which
electronic cigarettes are the most common prototype, is on the agenda of the 6th
Conference of the Parties (COP) to the WHO Framework Convention on Tobacco Control
(WHO FCTC), being held 13-18 October 2014, in Moscow.
E-cigarettes and similar devices are frequently marketed by manufacturers as aids to quit
smoking, or as healthier alternatives to tobacco, and require global regulation in the
interest of public health, this new World Health Organization (WHO) report states.
The report states that while e-cigarettes represent an evolving frontier filled with
promise and threat for tobacco control, regulations are needed to:
Impede e-cigarette promotion to non-smokers and young people;
 Minimize potential health risks to e-cigarette users and nonusers;
Prohibit unproven health claims about e-cigarettes; and
Protect existing tobacco control efforts from commercial and other vested
interests of the tobacco industry.
It explains that while additional research is needed on multiple areas of e-cigarette use,
regulations are required now to address health concerns, in particular for:
Advertising: An appropriate government body must restrict e-cigarette advertising,
promotion and sponsorship, to ensure that it does not target youth and non-smokers or
people who do not currently use nicotine.
Indoor use: legal steps should be taken to end use of e-cigarettes indoors in public
and work places. Evidence suggests that exhaled e-cigarette aerosol increases the
background air level of some toxicants, nicotine and particles.
Since 2005, the e-cigarette industry has grown from one manufacturer in China to an
estimated US$3 billion global business with 466 brands, a market in which the tobacco
industry is taking a greater stake. The report highlights WHOs concern about the role of
the tobacco industry in this market.
The regulations outlined in the report include a ban on e-cigarettes with fruit, candy-like
and alcohol-drink flavours until it can be proved they are not attractive to children and
adolescents. E-cigarettes have been marketed in almost 8 000 different flavours, and
there is concern they will serve as a gateway to nicotine addiction and, ultimately,
smoking, particularly for young people. Experimentation with e-cigarettes is increasing
rapidly among adolescents, with e-cigarette use in this group doubling from 2008 to
2012, the report says.
Among other conclusions, the document found there was currently insufficient evidence
to conclude that e-cigarettes help users quit smoking or not. Therefore, WHO currently
recommends that smokers should first be encouraged to quit smoking and nicotine
addiction by using a combination of already-approved treatments.
In addition, the report says existing evidence shows that e-cigarette aerosol is not merely
"water vapour" as is often claimed in the marketing of these products. While they are
likely to be less toxic than conventional cigarettes, e-cigarette use poses threats to
adolescents and foetuses of pregnant mothers using these devices.
E-cigarettes also increase the exposure of non-smokers and bystanders to nicotine and a
number of toxicants, the report says.
The COP is the central organ and governing body of the Convention and comprises 179
Parties as of today.
The WHO FCTC was adopted by the World Health Assembly on 21 May 2003 and entered
into force on 27 February 2005. It has since become one of the most rapidly and widely
embraced treaties in United Nations history.

Safety of electronic cigarettes

From Wikipedia, the free encyclopedia
The safety of electronic cigarettes is uncertain.[1][2][3] There is little data about their
safety, and considerable variability among e-cigarettes and in their liquid
ingredients[4] and thus the contents of the aerosol delivered to the user.[5] Reviews on
the safety of e-cigarettes have reached significantly different conclusions. [6] A
2014 World Health Organization (WHO) report cautioned about potential risks of using
e-cigarettes.[7] Regulated US Food and Drug Administration (FDA) products such
as nicotine inhalers are likely safer than e-cigarettes,.[8] A systematic review suggests
that e-cigarettes are less harmful than smoking and since they contain no tobacco and
do not involve combustion, users may avoid several harmful constituents usually found
in tobacco smoke.[9][10][11] However, e-cigarettes cannot be considered harmless.[12]
E-cigarettes have been found to reduce lung and myocardial function, increase
inflammation, and have toxic content including carcinogens, but to a much lower extent
than combustible cigarettes in virtually all cases.[3][13] The long-term effects of e-cigarette
use are unknown.[13][14][15] A 2015 study found serious adverse events related to e-
cigarettes were hypotension, seizure, chest pain, rapid heartbeat, disorientation, and
congestive heart failure but it was unclear to the degree they were the result of e-
cigarettes.[16] Less serious adverse effects may include abdominal pain, headache,
blurry vision,[16] throat and mouth irritation, vomiting, nausea, and coughing. [5] A 2014
WHO report said, "ENDS [electronic nicotine delivery system] use poses serious threats
to adolescents and fetuses."[7] Aside from toxicity exposure in normal use, there are also
risks from misuse or accidents [9] such as nicotine poisoning (especially among infants
and children),[17] contact with liquid nicotine,[18] fires caused by vaporizer malfunction,
[5]
and explosions resulting from extended charging, unsuitable chargers, or design
flaws.[9] Battery explosions are caused by an increase in internal battery temperature
and some have resulted in severe skin burns. [1] There is a small risk of battery explosion
in devices modified to increase battery power.[19]
The cytotoxicity of e-liquids varies,[20] and contamination with various chemicals have
been detected in the liquid.[21] Metal parts of e-cigarettes in contact with the e-liquid can
contaminate it with metals.[9] Many chemicals including carbonyl compounds such as
formaldehyde can inadvertently be produced when the nichrome wire (heating element)
that touches the e-liquid is heated and chemically reacted with the liquid. [22] Normal
usage of e-cigarettes,[23] and reduced voltage (3.0 V[24]) devices generate very low levels
of formaldehyde.[22] Later-generation e-cigarettes used with higher power may generate
equal or higher levels of formaldehyde than compared to smoking. [14][Notes 1] A 2015
review found that these levels were the result of overheating under test conditions that
bear little resemblance to common usage. [25] A 2015 Public Health England (PHE) report
found that high levels of formaldehyde only occurred in overheated "dry-puffing".
[26]
Users detect the "dry puff" and avoid it, and they concluded that "There is no
indication that EC users are exposed to dangerous levels of aldehydes." [27] However, e-
cigarette users may "learn" to overcome the unpleasant taste due to
elevated aldehyde formation, when the nicotine craving is high enough. [19] E-cigarette
users who use devices that contain nicotine are exposed to its potentially harmful
effects.[24] Nicotine is associated with cardiovascular disease, potential birth defects, and
poisoning.[28] In vitro studies of nicotine have associated it with cancer, but
carcinogenicity has not been demonstrated in vivo.[28] There is inadequate research to
demonstrate that nicotine is associated with cancer in humans. [29] The risk is probably
low from the inhalation of propylene glycol and glycerin. [13] No information is available on
the long-term effects of the inhalation of flavors. [21]
E-cigarettes create an aerosol that consists of fine and ultrafine particles of particulate
matter, with the majority of particles in the ultrafine range. [5][30] The vapor have been
found to contain flavors, propylene glycol, glycerin, nicotine, tiny amounts
of toxicants, carcinogens, heavy metals, and metal nanoparticles, and other
substances.[5][13] Exactly what the vapor comprises varies in composition and
concentration across and within manufacturers.[24] E-cigarette vapor potentially contains
harmful substances not found in tobacco smoke. [31] The majority of toxic chemicals
found in tobacco smoke are absent in e-cigarette vapor. [9] E-cigarette vapor contains
lower concentrations of potentially toxic chemicals than with cigarette smoke.[32] Those
which are present, are mostly below 1% the corresponding levels permissible
by workplace safety standards.[33] But workplace safety standards do not recognize
exposure to certain vulnerable groups such as people with medical ailments, children,
and infants who may be exposed to second-hand vapor. [5] Concern exists that some of
the mainstream vapor exhaled by e-cigarette users may be inhaled by bystanders,
particularly indoors.[34] E-cigarette use by a parent might lead to inadvertent health risks
to offspring.[35] A 2014 review recommended that e-cigarettes should be regulated
for consumer safety.[36] There is limited information available on the environmental
issues around production, use, and disposal of e-cigarettes that use cartridges