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24 Dec 2010
Nicotine e-cigarette
cartridges can be sold as tobacco products
End Smoking NZ, a
charitable trust focussed on tobacco policy, has identified the sale of
safer, satisfying nicotine products as a top priority for greatly
reducing smoking.1 Tobacco smoke includes thousands of compounds,
including carcinogens, and lung and cardiovascular toxicants. In
contrast, pure nicotine carries far less risk, and can provide a safer
alternative for those too addicted to yet quit smoking.
Medsafe’s
interpretation of the Medicines
Act is that nicotine electronic (e-)cigarettes
(which vapourise nicotine into a mist for
inhalation) are medicines
“even if they are not represented as aids to smoking
cessation”,2 and cannot be sold unless medicinally
licensed. As no such licensing is imminent, a virtual ban is in place.
Instead, we argue that nicotine e-cigarettes are
primarily recreational nicotine alternatives to smoking, though some
brands may obtain licensing as medicines at some future date. We argue
they already qualify as tobacco products under the Smoke-free
Environments (SFE) Act, which has regulated all tobacco products for
(recreational) human consumption since 1990. For example, at Section 30,
the Act bans their sale to those under 18 years
of age, while at Section 31 it has powers to reduce or remove any
substances deemed hazardous. All that e-cigarette distributors would have
to do, is strictly refrain from making
therapeutic claims, and abide by current or future regulations of the SFE
Act. We now examine how the SFE Act can accommodate nicotine electronic
cigarettes.
The SFE Act’s interpretation section
defines a tobacco product as:
“any product manufactured from
tobacco and intended for use by smoking, inhalation, or mastication and
includes nasal and oral snuff, but does not include any medicine (being a
medicine in respect of which there is in force a consent or provisional
consent under section 20 or section 23 of the Medicines Act 1981) that is
sold or supplied wholly or principally for use as an aid in giving up
smoking.”
Thus the nicotine e-cigarette can be classified
as a tobacco product, if its nicotine is manufactured from tobacco (it
is) and it is not supplied wholly or principally as an aid in giving up
smoking.3 Nicotine
e-cigarettes, unlike medicinal nicotine patches or gum, are shaped and
designed to provide nicotine-based and smoking-ritual-based pleasure by
inhalation, and so can be regarded as tobacco products provided no
medicinal claims are made. A recent United States district court decision,4 upheld on appeal in December 2010,
supports the classification of e-cigarettes as inhaled tobacco products,
and recognises that almost all nicotine is consumed for recreational, not
medicinal purposes.
According to the definition above, tobacco products
can be used for smoking, inhalation or mastication. Of these three, the
SFE Act permits sale for smoking, but not for oral use, and does not
mention sale for inhalation:
“No
person shall import for sale, sell, pack, or distribute any tobacco product
labelled or otherwise described as suitable for chewing, or for any other
oral use (other than smoking)”.5
Sale of nasal tobacco snuff for
inhalation remains legal. Sale of nicotine electronic cigarettes for
inhalation is not mentioned; and their import, distribution and sale can
we believe, be allowed under the SFE Act. This is reinforced by
observations on how e-cigarettes are used – for inhalation, not
oral use.
As with cigarettes the e-cigarette mist is
inhaled, but more negative pressure is needed,6
requiring inhalation directly to the lungs. Smokers switching to
e-cigarettes, instead of holding smoke in the mouth before inhalation as
many smokers do, learn to inhale mist into the lungs in a one-stage
manoeuvre. The mouth has a separate secondary role as part of the
respiratory tract, and the inhaled mist transits the mouth in seconds,
whereas oral products (snuff or nicotine gum) are normally held in the
mouth for half an hour. For the above reasons, we believe the sale of
electronic cigarettes is not caught by the Act’s ban on sale of
oral tobacco products.
As nicotine e-cigarettes contain no tobacco,
they attract no tobacco excise. Nicotine-free electronic cigarettes are
widely advertised and sold, but most users want nicotine cartridges
– which, being tobacco products, cannot be advertised (Section 22,
SFE Act). Every nicotine cartridge sold means a pack of cigarettes not
sold. UK surveys have shown 52% of smokers
have heard of e-cigarettes but never tried them, 6% of smokers have tried
them but no longer use them, and 3% currently use them.7
The Maori Affairs Select Committee
Tobacco Inquiry recommended further research into the benefits and risks
of alternative products.8
A recent review backs e-cigarettes as
much safer than cigarettes, although absolute safety is yet to be proven.9 Further reliance, however, on
regulation solely under the Medicines Act, as at present, would deny
satisfaction to the thousands of smokers who have already bought
e-cigarettes without nicotine, as currently advertised. No
hospitalizations or deaths have been reported globally so far from over 3
years of nicotine e-cigarette sales.
Smokers merely want the choice now, without having to order the
nicotine cartridges from China.
Conclusion The Smoke-free
Environments Act provides a comprehensive framework for governing
recreational tobacco and nicotine, and already permits the import,
distribution, and sale of nicotine electronic cigarettes as tobacco
products.
Murray Laugesen,
Marewa Glover, Trish Fraser, Ross McCormick,
John Scott. (board members, End Smoking NZ
trust).
________________________
1. Laugesen M. Glover M,
Fraser T, McCormick R, Scott J.
Four policies to end the sale of cigarettes and smoking tobacco in
New Zealand by 2020. NZ
Med J 14 May 2010, Vol 123 No 1314; ISSN 1175
8716 URL: http://www.nzma.org.nz/journal/123-1314/4107/
2 Medical devices, Categorisation of
electronic cigarettes. Medsafe website,
accessed 22 Dec 2010. http://www.medsafe.govt.nz/regulatory/medicaldevices/electroniccigarettes.asp
3. Laugesen M.
Nicotine
electronic cigarette sales are permitted under the Smokefree
Environments Act. Letter. 29-Jan-2010 - Vol 123 No 1308 NZ Med J 29-January-2010, Vol 123 No 1308.
4. Smoking Everywhere Inc and Sottera
Inc c/b/a NJoy v. US Food and Drug
Administration et al (defendants). Civil case 09-771 (RJL) Memorandum
Opinion Jan 14, 2010. US District
Court for the District of Columbia.
5. Smoke-free Environments Act, section 29(2). http://www.legislation.govt.nz/act/public/1990/0108/latest/DLM224309.html?search=ts_act_Smoke-free+Environments+Act_resel&p=1
6. Trtchounian A, Williams Williams
M, Talbot P. Conventional and electronic cigarettes (e-cigarettes) have
different smoking characteristics, Nicotine
Tob Res. 2010
Sep;12(9):905-12. Epub 2010 Jul 19.
7. Dockrell M. What smokers tell us about e-cigarettes. Society for Research on Nicotine and
Tobacco Conference (Europe), Bath, England 2010.
8. Maori Affairs
Committee. Inquiry into the tobacco industry in Aotearoa
and the consequences of tobacco use for Maori. Report. Forty-Ninth Parliament. Hon Tau Henare, chairperson. Wellington, November 2010. p.40.
http://www.parliament.nz/NR/rdonlyres/C6AAA494-A706-48C6-8F91-6CAF5EA7CA51/164754/DBSCH_SCR_4900_InquiryintothetobaccoindustryinAote.pdf
9. Cahn Z, Siegel M. Electronic cigarettes as a harm
reduction strategy for tobacco control: A step forward or a repeat of
past mistakes? J Public Health Policy. 2010, 9 Dec. doi:10.1057/jphp.2010.41,
1-16.
_________________________________________________________________________________________
June 2006: Three options for
smokers. (Written before the
advent of e-cigarettes)
Without using the internet, the only
way New Zealand smokers can get
addictive nicotine today is to smoke. The nicotine gum patch and lozenges
at the pharmacy are useful for smokers wanting to quit smoking, but most
smokers are not ready to quit if that means giving up addictive nicotine.
Quitting smoking and nicotine at the same time means that most quitters
soon go back to smoking to get their addiction needs met.
Smokeless New Zealand (now End Smoking
NZ) a new charitable trust has been formed to advocate for more choices
for smokers, so smokers don’t have to give up nicotine just to
quit smoking. Chair Dr Murray Laugesen says “The smoke is what
kills people, but the nicotine is what smokers want, and the two can be
separated.”
Smokers smoke for nicotine, and 4000 smokers a year leave their
quitting too late. They often get no second chance, as by the time they
know they have lung cancer it has spread too far. The new warnings on
packets next year will increase the pressure on smokers to quit, but too
many will still find it very difficult. Is there some way for smokers to
quit smoking and still get their nicotine?
1. The first option
is to keep on smoking, but the risks from smoking are extreme -
cigarettes eventually kill half of those who continue to smoke past age
35. Almost anything else (including being a soldier in war for a few
years) is safer.
2. The second option is to quit smoking
and tobacco all at once
Smokers wanting to quit smoking and tobacco together should
contact their doctor or the QuitLine 0800 778 778, or if they are ready to do it and sure of
success, go cold turkey. This is the ideal, for those who have decided to
be drug-free. www.quit.org.nz
3. The third
option is to switch to addictive nicotine. Those who
don’t want to quit nicotine just yet,
should still quit smoking for their own safety. Several products that can
provide smokers with addictive nicotine:
3.1 Patches and gum First, many nicotine addicts find it
difficult to get enough nicotine from patches and gum. If they use
both together they find they do better.
A nicotine patch gives a steady background level of nicotine.
To take care of sudden urges to smoke, many quitters chew on 4mg
nicotine gum which they gives them a nicotine effect after say ten
minutes. Gum and patches are sold in supermarkets and pharmacies. If
people smoke at the same time as using these nicotine medications, they
may feel slightly sick, it means they are getting as much nicotine as
they need, and should now cut down on cigarettes until they rely on
the nicotine gum and patch only for their nicotine. www.endsmoking.org.nz/nrt.htm
3.2 Nasal snuff. This traditional product will be going on sale in 2006. Regular users
obtain high levels of nicotine, equal to cigarettes. It gives a nicotine hit quickly,
within two minutes. It is legal to sell it, and specialist tobacconists
are likely to stock it. It is addictive, may cause disease, but is
much safer than cigarettes. Now that smoking is known to kill half of
continuing smokers, snuff could come back into fashion.
Because it has not been used it has not been studied, and little
is known about its effects. The safest nasal snuff with the lowest
nitrosamines is from Swedish Match. As the risks are likely to be similar
to oral snuff, (see below) nasal snuff, if it helps smokers to switch off
smoking, will avoid the high risks of smoking, and used for the first
year or so after stopping smoking, will reduce the risk of relapse to
smoking. Because of its fast action, it will be useful if kept handy as
an emergency source of nicotine, and used to satisfy and counter the urge
to smoke. Like glasses at parties it is best not shared between friends. www.endsmoking.org.nz/nasalsnuff.htm
3.3 Oral snuff. This Swedish traditional
smokeless tobacco has to be ordered on the internet. It is barred
from sale in New Zealand. It costs about
two thirds as much as cigarettes. The only snuff worth using is made in Sweden, and is
very low in nitrosamines (under 5 parts per million) and is unlikely to
cause cancer. It is used by a million Swedes, mostly men, many times
daily. Some 200,000 Swedish women now dip snuff. It is spitless,
and used in the form of a small teabag under the upper lip. It is
kept there for half an hour and over the course of a day provides
nicotine levels higher than nicotine patches or gum. Dry snuff does not
have to be refrigerated before sale.
It is about 5% as dangerous as cigarette smoking, and the risk of the
uncommon mouth cancer, is one in five of the risk for smokers. Smokers
use it instead of going outside in the cold to smoke. As long as people
are satisfying their need for nicotine by not smoking, they are 95%
better off health-wise. www.endsmoking.org.nz/snusaidsquitting.htm
www.endsmoking.org.nz/snus.htm
3.4. Fast nicotine
Fourthly, pure addictive
nicotine products are under research and development here in New Zealand. Nicotine
tea-bag-like pouches placed under the upper lip like Swedish snuff are to tested later this year in Auckland; also other oral
forms. In Wellington
,
nicotine inhalers are being tested. These products are several
years away from commercial sale, but they have virtually zero risks,
and eventually if they are shown to be addictive for smokers, may be
able to do away with the need for smokeless tobacco snuff altogether. A
world wide market awaits the successful biotech companies which can make
this happen. www.endsmoking.org.nz/fastnic.htm
To policy writers:
- Addiction to
tobacco varies greatly among smokers. Some give up smoking without
difficulty, others never, though they know the risks.
- Non smokers
may find it repugnant, but many smokers are nicotine addicts, and
this fact is accepted by health workers who deal with smokers, and
listen to their story.
- Seeing it
from the smokers’ point of view, perhaps nonsmokers will
concede that smokers have a right to be informed and to make their
own nicotine choices.
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