The electronic cigarette - (personal nicotine vaporizer) Murray Laugesen Health New Zealand Ltd
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The electronic cigarette
(personal nicotine vaporizer)
Murray Laugesen
Health New Zealand Ltd
nicotine and tobacco product researchers
www.healthnz.co.nz
Christchurch, New Zealand
(c) www.healthnz.co.nz 2009 1Respects to the indigenous people
and a note on pituri
• In Australia smokeless tobacco (pituri) has been gathered from certain
shrubs and treated with ash for thousands of years, Tobacco leaf is chewed
in other indigenous communities. (Tom Calmo) Pituri contains nicotine and
appears to discourage protect some communities from smoking.
a) Pituri deserves serious chemical and toxicological research. What if any
carcinogens are in pituri? Can they be removed? What else does it
contain besides nicotine?
b) Pituri use could be affirmed and protected for indigenous communities.
b) Pituri be investigated as a possible ally in reducing the high tobacco
smoking prevalence among indigenous communities.
c) The rights of indigenous people to traditional drugs and remedies such as
pituri and patents deriving therefrom be protected in Australian law.
d) Although Australian law bans sale of smokeless tobacco, and taxes imports
for personal use, indigenous communities should be given the right to trade
pituri as a commodity if they wish, and pay no tax.
(c) www.healthnz.co.nz 2009 2NZ End game website
• www.endsmoking.org.nz
End Smoking NZ trust founded 2006
Dedicated to the phase-out of cigarette and
tobacco sales by 2020.
Not prohibition: no ban on home growing for
personal use.
(c) www.healthnz.co.nz 2009 3E-cigarette research funding
• E-cigarette safety tests were funded by Ruyan
through Health New Zealand Ltd, who then
contracted with laboratories in New Zealand
and Canada.
• Duke University, North Carolina and British
American Tobacco research division (UK)
contributed analyses at no cost.
• Disclaimer: Health NZ has no financial interest
or otherwise benefits from any tobacco,
pharmaceutical or nicotine company.
(c) www.healthnz.co.nz 2009 4Ruyan V8 classic e-cigarette
(c) www.healthnz.co.nz 2009 5E-cigarette, first of a new product class
of flameless nicotine “cigarettes”
– Invented 2004 by Hon Lik
– Patent for atomiser owned by Ruyan
– Sells best in countries where cigarette prices and
health concerns high.
– Operating temperature 54C maximum
– Battery generates 0.1mW
– Propylene glycol 0.8 g /cartridge the solvent
– Nicotine 16 mg, 11mg, 6 mg, 0 mg /cartridge
More at www.healthnz.co.nz/ecigarette
and at www.endsmoking.org.nz
(c) www.healthnz.co.nz 2009 6The research question:
Does it give a safe and satisfying smoke?
• Marketed as cigarette substitutes;
• Claim to deliver nicotine without smoke
toxicants and the risks of smoking.
We ask:
1) Is this product safe – relative to
cigarettes and in absolute terms?
2) Is this product efficacious? Does it relieve
cravings and does it raise blood nicotine?
(c) www.healthnz.co.nz 2009 7Is this product safe – relative to
cigarettes and in absolute terms?
Relative risk: Is it safer than smoking?
Emissions comparisons.
Absolute risk: Does it pose new risks?
Other risks Child safe?
Cross-infection?
(c) www.healthnz.co.nz 2009 8Laboratories involved
• NZ:
– Environmental Science and Research Institute (ESR), Porirua.
– Hort Research, Hamilton
– Lincoln University, Canterbury .
– Syft Analytics Ltd, Christchurch
– Hills Laboratories, Hamilton
• CANADA Labstat International, Ontario, Canada
• USA
– Center for Nicotine and Smoking Cessation Research, Duke
University, NC, USA.
• UK
- British American Tobacco Group R&D, UK.
(c) www.healthnz.co.nz 2009 9E-cigarette mist tested for 62
smoke toxicants: 11 measurable
• Aldehydes
Acetaldehyde, butyraldehyde, crotonaldehyde,
formaldehyde.
• Ketones:
Acetone, methyl ethyl ketone
• Metal: Mercury
• Tobacco-specific Nitrosamines
NNK, NNN NAT
(c) www.healthnz.co.nz 2009 10FDA doesn’t know if e-cigarettes
any better than cigarettes
• (E-smoker:} "This is something the government should
be pushing for, a clean way of allowing people to
smoke," Woessner said.
• Delancey (FDA) disagreed. "I feel their pain," she said.
"We don't know if this (e-cigarette) is any better for
them." (than cigarettes)
• Jim Merkel. Users love e-cigarettes but FDA wants to
take a closer look. St Louis Today 30 Sep 2009
http://suburbanjournals.stltoday.com/articles/2009/10/01/
south/news//0930sc-ecig0.txt
(c) www.healthnz.co.nz 2009 11FDA findings on e-cigs July 2009
Released 25 Jul 2009- Preliminary report
• Variation between cartridges in nicotine dose.
• One cartridge of Smoking Everywhere brand
contained about 1% diethylene glycol (DEG).
• Some cartridges contained traces of tobacco
specific nitrosamines.
• N-Joy brands contained traces of nicotine
impurities eg beta-nicotyrine.
(c) www.healthnz.co.nz 2009 12Carcinogens (TSNAs) in e-cigarettes
- FDA
ng/g TSNAs Maximum
per piece exposure / day
Ruyan cartridge 16mg 8 8
Labstat 2007
CQ patch 4 mg 8 8
Stepanov 2006
Nicorette gum 4 mg 2 24
Stepanov 2006
Marlboro Red regular 6 600 81 200
www.endsmoking.org.nz/snuffregulations.htm
(c) www.healthnz.co.nz 2009 13FCTC mandated reductions for top 9 toxicants
asked for by WHO TobReg
in 2008: achievable now by e-cigarette
0
Formaldehyde
Benzene
1,3-butadiene
NNN
NNK
Benz(a)pyr
Acetaldehyde
Acrolein
CO
-50
-100
Nicotine adjusted
(c) www.healthnz.co.nz 2009 14Toxicants levels in smoke >> mist
Per cigarette, or Marlboro E-
Per e-cigarette of same puffs Regular cigarette
Aldehydes microg (ug)
Acetaldehyde 458 4
Butyraldehyde, Formaldehyde 29, 27 2
Crotonaldehyde 14 1
Ketones microg (ug)
Acetone, Me Et Ketone 262, 58 44
NNN, NNK, NAT ng 71,58, 64 0.5
Mercury ng 2.8 0.17
Chyrsene PAH ng 3.7 0.1
(c) www.healthnz.co.nz 2009 15Toxic emissions score
adjusted for nicotine
150 134
126
109
100
100
50
1
0
NZ Holiday Marlboro Red NZ Holiday Canadian Ruy an V8
Ex tra-mild Regular regular regular brands ecigarette
Laugesen, Fowles NZMJ 2005 (c) www.healthnz.co.nz 2009 16Cigarette smoking increases breath
and alveolar CO: vaping does not
15 14.27
9.77
10
CO before
CO ppm
5
CO after
1.5 1.5
0
Tobacco cigarette Ruyan® flameless
(48 subjects) nicotine cigarette (non-
tobacco smoker)
First cigarette of the day, by type of cigarette
l
Laugesen 2008
(c) www.healthnz.co.nz 2009 17The e-cigarette: low nicotine
Active ingredient: Nicotine
Dose 10 micrograms / puff
Absorption site Upper respiratory tract
Count median diameter (CMD) 40 nm
< cigarette CMD
(c) www.healthnz.co.nz 2009 18Nicotine content < label says
18
16 Label
16
14 12.9 Test
12 11
mg nicotine
9.3
10
8
6
6 5.1
4
2
0 0
0
full strength medium low zero
ESR (c) www.healthnz.co.nz 2009 19Nicotine content
similar across products
Cigarette NRT E-cigarette
Marlboro Inhaler Ruyan
Regular Nicorette
Content 13 mg 10 mg 13 mg
/cigarette /cartridge /cartridge
Nicotine 260 mg 60 mg 13 mg
purchased (1 packet) (6 carts.) (1 cartridge)
for 1 day’s
use
(c) www.healthnz.co.nz 2009 20Nicotine delivery
Cigarette NRT E-cigarette
Marlboro Inhaler Ruyan
Regular Nicorette
Delivery / 0.1 mg 0.01 mg 0.01 mg
35 ml puff
(c) www.healthnz.co.nz 2009 21Nicotine content, delivery,
absorption
Cigarette NRT E-cigarette
Marlboro Inhaler Ruyan
Regular Nicorette
Delivery / 0.1 mg 0.01 mg 0.01 mg
35 ml puff
Absorption 1.0 mg ?0.05 mg ?0.05 mg
/10 puffs
Absorption % 100% ? 50% ? 50%
(c) www.healthnz.co.nz 2009 22Nicotine per puff, mist v. smoke
160 147
140
micrograms per puff
120
ISO 101
100
Intense
80
60 48
40
20 10 14
9
0
Ruyan V8 e- Supersmoker mini Marlboro Red
(c) www.healthnz.co.nz 2009 23
cigarette E-cigarette regularClinical trial of e-cigarette efficacy
• by Clinical Trials Research Unit University
of Auckland, 2008. N=40.
• No previous experience using e-cigarette.
Norms not known for e-cig puffing.
• After overnight abstinence, inhale product.
• Ask “How much do you want a cigarette
right now?” Marked on scale 0 to 10.
• Blood nicotine over 1 hour. N = 9
• Observed for 8 hours, reactions noted.
(c) www.healthnz.co.nz 2009 24Efficacy. Does the e-cigarette
relieve cravings?
• When puffed like a cigarette for 5 minutes,
relieves cravings, but less than own
cigarette.
• Smoking reduced to 2 cigarettes on first
day (without anyone intending to quit)
• E-cig acts more rapidly than Nicorette
inhaler, but not as rapidly as own
cigarette.
(c) www.healthnz.co.nz 2009 25Cravings relief by product,
after overnight abstinence from smoking
cravings, maximum =10 7
6
5 0 mg e-
4 cigarette
3 16 mg e-
2 cigarette
1
own
0
cigarette
nd
10
15
20
25
30
40
50
60
5
ha
re
fo
Be
minutes after sm oking
(c) www.healthnz.co.nz 2009 26Cravings relief from medicinal
inhaler, e-cigarette, own cigarette
cravings for a cigarette 7
6
5
4
16 mg e-
3 cigarette
2
0 mg e-
1 cigarette
0
Nicorette
5 d
m s
15 s+
25 in
30 in
in
20 s
s
s
s
an
10 min
in
in
in
in
m
m
m
in
m
m
m
m
eh
40
50
60
or
ef
B
own
Minutes after first cigarette cigarette
(c) www.healthnz.co.nz 2009 27Pharmacokinetics
Cigarettes puffed 5 mins;
Nicorette puffed for 20 minutes.
T max C max
(minutes) ng / ml
Own brand 14.3 13.4
cigarette
Ruyan e- 19.6 1.3
cigarette
Nicorette 32.0 2.1
inhaler (10 mg)
(c) www.healthnz.co.nz 2009 28Serum Nicotine after inhaling
16 mg ecig Cigarette
5
Seru m N ico tin e
30
4
n ic o t in e
n g /m l
20
S e ru m
n g /m l
3
2 10
1
0
0
0 8 14 20 33 37 62
0 3 7 12 16 23 39 58
minutes since first puff minutes since first puff
• S. Nicotine increases 4 • S. Nicotine increases 20
ng/ml in 7 minutes in this ng/ml in 8 minutes in this
e-smoker. smoker
(c) www.healthnz.co.nz 2009 29Patent law enforcement necessary
for registration as a medicine
• Ruyan holds world patent applications for atomiser.
• Sales going to copycat companies, undercutting Ruyan’s price.
• World sales were estimated at US100 million annually in 2008.
• Low cigarette prices in China make sales economic only in West.
• Ruyan has prosecuted several rivals successfully under IP law.
• Cigarette companies have the resources to improve reliability and
nicotine delivery of the product, but cannot sell without a patent.
• No e-cigarette has been approved as a medicine by any regulator.
• Without enforcement of IP law by the patent holder in China and
importing countries, even the patent holder cannot afford to register
any e-cigarette as a medicine.
• No registration as a medicine expected for Australia and NZ for 3
years. Meantime personal-use imports permitted into NZ.
(c) www.healthnz.co.nz 2009 30You can also read
