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Updated
1 August 2009
Electronic cigarettes
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July 2009 Row breaks out over safety of e-cigarettes. FDA report (www.fda.gov ) finds fault with
e-cigarettes
“They are
not going to die from an e-cigarette – but they could die
tomorrow from a heart attack due to their smoking” The
carcinogens that we have found are in very, very small quantities, just
above the level of detection.”
- Dr Murray Laugesen
http://www.3news.co.nz/Video/Lifestyle/tabid/372/articleID/113909/cat/64/Default.aspx#video>
3 June 2009 Health
warning: precautions required with e-cigarettes
Open Letter
to the Electronic Manufacturers Association of America and e-cig forums
Avoid bottled nicotine. Liquid nicotine (e-liquid) is
commonly sold in small bottles of up to 30 mL
or more, on the internet, or from stores in the USA, often meant to last
consumers one month; often unlabelled as to nicotine dose. Health New
Zealand Ltd does not recommend sale or use of e-liquid permitting a
lethal dose of nicotine to be swallowed.* Nicotine solution sold in
child-proofed cartridges avoids this risk. Lethal dose for a child is
10mg nicotine. Many bottles on sale contain many times this amount.
Even if the cap of a liquid nicotine bottle is child proofed, the risk
remains if someone else leaves it open.
For adults, absorption of a
fatal dose of 40-60 mg of nicotine could rapidly occur due to spilling
the liquid on one’s skin while using liquid nicotine to (cheaply)
fill an e-cigarette – a risk heightened by inattention
(distraction, fatigue, alcohol, drugs). (Wash it off immediately).
Gloves should always be worn.
Avoid gravity feed. E-cigarettes
should not be tipped up above mouth level, as the e-cigarette liquid
can ooze out and drain nicotine on to the lips.
Avoid child-openable
brands of e-cigarette and refill cartridges. Some brands of
e-cigarette and of refill cartridges can be pulled apart or opened by
young children, giving access to the nicotine solution in which the
refill wick is soaked. These brands are a potential hazard.*
*The solvents and flavours of
the liquid in the wick can mask the bitter taste of nicotine, so when a
child tastes it, the liquid is not immediately spat out, but absorbed
from the mouth, with risk of nicotine overdose.
Dr Murray Laugesen, e-cigarette researcher, Health New Zealand
Ltd. 3 June 2009
2 June 2009. Dr Laugesen’s
on-line letter to the New York Times
in response to NY Times
Katie Zezima Cigarettes Without
Smoke, or Regulation
http://www.nytimes.com/2009/06/02/us/02cigarette.html?_r=1&scp=1&sq=electronic%20cigarettes&st=cse
“During 2008-9 I have coordinated
rigorous safety tests by 8 laboratories on the Ruyan e-cigarette,
funded by Ruyan. www.healthnz.co.nz/coynews.htm Of over 50 priority tobacco smoke
toxicants, none was found in any but trace quantity. Nicotine is safe
used as medicine. Propylene glycol has been used on bedfast children in
1942-43 as an aerosol germicide by University
of Chicago researchers,
without adverse effect. All up, we find the Ruyan e-cigarette safe in
the common meaning of that word, and much safer than smoking tobacco.
The FDA and other drug regulators
will hopefully keep the
e-cigarettes on sale (as in the UK),
while further research can be conducted and suitable approvals applied
for. Simply banning e-cigarettes will simply consign thousands of
e-smokers back to smoking tobacco and an early death. That would be
crazy.
Murray Laugesen public health physician “ Christchurch,
New Zealand
87 letters were received by the NYTimes on 2 June, many of them enthusiastic quitters
with help of e-cigarettes
1) E-cigarette Safety: Ruyan e-cigarette benchtop tests. Poster 5-11.
See. www.healthnz.co.nz/DublinEcigBenchtopHandout.pdf The poster itself is found in the following
two powerpoint files: http://www.healthnz.co.nz/DublinEcigPoster1.ppt
and http://www.healthnz.co.nz/DublinEcigPoster2.ppt
The mist of the e-cigarette has been
rigorously tested. Of over 50 priority-listed cigarette smoke toxicants
tested, none was detectable in the mist of the Ruyan® e-cigarette,
except for a trace of mercury close to the limit of detection. Some
toxicants remain to be tested before the results are submitted for
publication shortly in a peer-reviewed journal.
On the basis of findings to date, inhaling
mist from the e-cigarette is rated several orders of magnitude (100 to
1000 times) less dangerous than smoking tobacco cigarettes. The
nicotine dose per puff is comparable to that of a medicinal nicotine
inhaler. E-cigarette nicotine is apparently not absorbed from the lung,
but from the upper airways.
Comment:
Given that continued smoking of cigarettes carries a cumulative 1 in 2
death risk, the findings, argue for
1) less stringent regulation for very
low-risk non-medicinal nicotine cigarette substitute products
2) the sale of
this brand as a non-medicinal
cigarette substitute, as its emissions have been tested.
2) E-cigarette efficacy. Poster
5-50, Effect of an E-cigarette on Cravings
and Withdrawal, Acceptability and Nicotine Delivery: Randomised Cross-over Trial.
On behalf
of Ruyan, manufacturer of the Ruyan V8 e-cigarette, Health New Zealand
Ltd sponsored this research carried out in Auckland by researchers at the School of Population Health, University of Auckland. See http://www.healthnz.co.nz/ecig_effect-2.pdf The study
has been submitted for publication in a peer-reviewed journal.
The Ruyan® (nicotine)
e-cigarette
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This
nicotine inhaler mimics the smoking experience more closely than
any smokeless product to date and provides nicotine without causing
smokers to cough.
It
looks and acts like a cigarette.
It
gives the pleasure of drawback, and maximum nicotine effect is
reached within 20 minutes. It is likely to be popular as a much
cleaner and safer alternative to smoking, by eliminating the tar
and the toxicant gases. More frequent puffs are desirable, as the
nicotine dose is less than from a tobacco cigarette, and holding it
in the lung for longer before breathing out may increase
satisfaction. Deeper puffs,
however, may not increase satisfaction.
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Description The Ruyan® e-cigarette
is a battery-operated nicotine delivery device, without the
carcinogens and toxicants. The white segment contains a re-chargeable
battery (charged overnight from the mains),
the dark coloured body contains a vapourising
chamber. Near the mouthpiece a replaceable wisp of plastic foam is
soaked in a nicotine-containing solvent (propylene glycol).
Marketing. For a You-tube depiction
of the e-cigarette in action see:
http://www.youtube.com/watch?v=qEmdU7j9K2s
The company wants to market it as a
cigarette substitute, for the smoker who wants to continue to enjoy
the act of smoking, but without the risks. Most countries, however,
only provide for the sale of nicotine as a medicine, to aid quitting.
Cost is less costly than
smoking in countries with high cigarette taxes. The rechargeable
battery lasts for 1300 puffs.
Mechanism. Inhalation at the
mouthpiece activates the electric circuit, sparking vapourisation of nicotine in a mist of propylene
glycol, an FDA approved solvent. A few percent of the solvent weight
in some brands is tobacco essence. The white vapour mist exhaled is
not smoke, so it can be “smoked” indoors. An artificial
red light glow at the tip is generated by the drawback.
Table 1 Nicotine doses deliverable from a
tobacco and a Ruyan® nicotine
e-cigarette
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Per
puff
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Per
15 puffs or one cigarette
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Per
300 puffs (20 cigarettes or 1 nicotine cartridge)
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Manufactured
tobacco cigarette
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0.1
mg
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1.5
mg
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30
mg
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Ruyan® 16 mg cartridge
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0.010
mg
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0.15
mg
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3 mg
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Ruyan® 0 mg cartridge
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0.0
mg
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0.0
mg
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0 mg
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Health New Zealand Ltd.
Dosimetry. It is available in pipe and cigar
forms. The nicotine in the cartridge comes in four strengths, of 16 mg,
11 mg, 6 mg
and 0 mg nicotine content. Ten e-puffs equal one
tobacco puff for nicotine for the Ruyan brand, but this is
approximate only.
Biological
effect. Five
minutes smoking gives maximum effect within 20 minutes. The battery and cartridge
must be fresh.
Legal
status.
New Zealand The only pleasurable drug
so far permitted to be sold without regulation is coffee. Current
legislation does not encompass the concept of pleasurable, largely
harmless nicotine. Nicotine has wrongly acquired a reputation as
dangerous, by long association with its serial-killer half-brother
Cigarette Smoke, and so nicotine is regarded as a drug to be avoided
and abstained from, although it is true that once embraced it is
difficult to escape from.
Nicotine patches and gum are aids to
total and permanent nicotine abstinence. However relapse to take up
smoking and cigarette nicotine is common.
Ministry of Health (Medsafe) ruled (August 2007) that the Ruyan® e-cigarette
comes under the requirements of the Medicines Act, and cannot be sold
except as a registered medicine. If it is legal to sell it, then, as
it is not a tobacco product, it would be permissible to advertise it
in New Zealand.
United States
From March 2008, the Ruyan®
E-Cigarette and its cartridges have been imported,
distributed, marketed and sold in the US
as a smoking substitute or cigarette alternative, but not as a
smoking cessation device. Ruyan America cite
“compelling public health reasons to market the e-cigarette and
its nicotine cartridges to smokers, to satisfy cravings and urges for
nicotine, and without producing second hand smoke and without
endangering the health or well-being of family members, associates
and/or bystanders.
As a
substitute or alternative, Ruyan maintained that products as of March
2008 are exempt from FDA regulations in that the US FDA in
1996 assumed powers to regulate nicotine and tobacco. The US Supreme
Court in 2000 reversed this assumption. Meantime, Ruyan assumes that as
long as Ruyan does not make therapeutic claims the drug is not
regarded as a medicine it can be sold in the USA
as a cigarette alternative.
During
2009, FDA stopped shipments of some other brands.
Contra-indications:
Non
smokers. Nicotine-naïve non-smokers
using the 16 mg version may possibly experience the same effects as first-time
smokers. They may cough and gag at the throat. Inhaling into the
lungs can cause nausea, dizziness and vomiting. Non-smokers should
use only the 0 mg strength.
Pregnancy As this device can deliver nicotine,
it is contra-indicated in pregnancy, unless the woman has not been
able to quit smoking by other means.
Cardiovascular
disease. Nicotine increases the
work of the heart and in high dose may trigger heart beat
irregularities.
Children
or adults.
The Ruyan V8 e-cigarette is difficult to unscrew at the
mouthpiece-end. Children would be at risk of nicotine poisoning if they
put the unscrewed cartridge in their mouth, just as if they swallowed
cigarettes or tobacco, or any nicotine product.
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