In a couple of days, on monday 26th, we reach the deadline for submitting an answer to the Norwegian governments consultation on the proposed changes to the tobacco act, including a new section on e-cigarettes. I have written a couple of posts about the proposition earlier and what is wrong with it:
Below is an English translation of the answer I have submitted. I apologize for some weird English in the translation... I've only had time to let google translate most of it and just corrected the most incomprehensible parts :)
I strongly encourage Norwegian vapers to submit their own answers. It does not need to be a long thorough walk-through of everything that is wrong, your own vaping story will help a lot. The more answers the government gets on this, the better are our chances of them re-thinking the whole thing. This has already happened in Denmark so it is not hopeless to try.
Consultation on proposed changes to the tobacco regulations and new
regulations on electronic cigarettes - Consultation response.
Lately
the Minister of Health, Bent Høie, and his government have been
under pressure because of their treatment of research reports on the
effect of standardized snus- and cigarette packaging. Responding to
this the Government defend their conduct saying that they want to use
only quality assured background material as a foundation for the
proposition
(
https://www.regjeringen.no/no/aktuelt/vg-tilslorer/id2511679/). I
fully support this choice so I find it reprehensible that the
proposition is largely based on material that certainly is not
quality assured, and apparently hardly has been read by the ministry.
I also disapprove that the ministry puts forward some adverse and
negative effects as potential problems when good evidence exists that
debunks these theories.
1. Regarding neutral cigarette and
smokeless tobacco packages
First things first. In his defense of
holding back the NIPH study on the effect of standardized snus and
cigarette packages Bent Høie says this: "The simple explanation
is that in February 2016 an extensive Australian report on
standardized tobacco packaging came out. This was so clear in its
conclusions that the ministry believed it was not necessary with a
Norwegian report as well this shortly after ". Australian
authorities have presented the numbers in a way that makes
standardized cigarette packages look like a success, probably because
they do not want to admit that it actually has not been. They claim
is that smoking has decreased from 15.1% to 12.8% after standardized
packages were introduced, which is only a cheap trick. Statistics
show that this decline has taken place from 2010 to 2013,
standardized packages were introduced in 2012. The decline from 2010
to 2013 is virtually the same as it has been in previous years
(approximately 0.75% per year), which rather suggests that neutral
packages have had no effect. In fact, smoking among youth between 12
and 17 has gone up slightly in the period
(
http://www.aihw.gov.au/alcohol-and-other-drugs/ndshs/2013/data-and-references/,
download data excel sheet), but it would of course be very wrong to
argue that this is due to standardized packages, although this would
have been natural if one continues to follow the same erroneous logic
that led to the success conclusion. To find factors that actually
works we should rather have look at why the proportion of smokers in
England have gone from 19.3% to 16.9% between 2012 and 2015 after
they’ve almost had a standstill the 5 preceding years with a
decline of only 0.5% in total.
This shows that the
ministry haven’t analyzed their background material properly and
left out even the simplest form of quality assurance (namely reading
material carefully), thus ending up with a totally ineffective
regulation that will only lead to increased use of resources. One can
even state a hypothesis about the effect of standardized snus
packages that very much seems plausible, namely that the introduction
of standardized packages for both snus and cigarettes will cause
these products to be perceived as equally harmful by the population.
We know with certainty that snus is not nearly as harmful as smoking
tobacco, there are several studies that show this. One can also see
the statistics from Sweden that there is a clear link between the
fact that Sweden is the country in Europe with by far the lowest
cigarette consumption and highest snuff consumption while having the
lowest occurrence of lung cancer. They are also the lowest in the
statistics of oral cancers.
It is in my opinion obvious
that a significant review and quality assurance of the background
material the ministry use as a basis for the introduction of this
regulation is needed before this can be done.
2. Regarding
regulation of e-cigarettes
Minister of health, Bent Høie, and
other ministers have repeatedly stated that the government wants to
remove the unnecessary ban on e-cigarettes on the basis that this has
a great harm reduction potential compared to smoking tobacco. This is
consistent with, among others, the English health authorities report
(
https://www.gov.uk/government/news/e-cigarettes-around-95-less-harmful-than-tobacco-estimates-landmark-review)
that concludes that e-cigarettes are at least 95% less harmful than
cigarettes. Royal College of Physicians strongly recommend that
e-cigarettes are promoted as widely as possible as a substitute for
smoking
(
https://www.rcplondon.ac.uk/news/promote-e-cigarettes-widely-substitute-smoking-says-new-rcp-report), and Norwegian government politicians statements in
the media suggests that the government also wants to give smokers the
opportunity to switch to e-cigarettes. Nevertheless, it is proposed
here a regulation scheme which will counteract this to great extent.
The proposed regulation will make e-cigarettes less accessible, less
secure and knowledge of e-cigarettes and its relative harmfulness in
the population will be much lower. In sum this will lead to that
fewer people will be able to quit smoking but also that more people
will start smoking. A number of experienced tobacco researchers have
stated that e-cigarettes are the biggest health revolution since
penicillin, and it is a consumer-driven revolution with the potential
to end the tobacco epidemic once and for all if it is allowed to
continue. Here I would encourage you to read Karl Erik Lund's comment
about the e-cigarettes 'role in "the tobacco endgame", that
describes this very well:
http://www.degruyter.com/downloadpdf/j/nsad.2016.33.issue-3/nsad-2016-0018/nsad-2016-0018.xml.
2.1. Known
misconceptions and myths
The purpose of the regulation of
e-cigarettes should be to make safer products, protect the public
from potential harm while preventing smoking initiation, especially
among young people. Many of the proposed provisions are based on
misconceptions, myths and poor quality assured background material.
At the same time a lot of good background material is
omitted.
Minister of Health Høie has repeatedly stated a
concern that young people would start with e-cigarettes and then move
to smoking. To this there is NO evidence and this "gateway"
theory is disproved in virtually all serious investigations, such as
the aforementioned study by Public Health England
(
https://www.gov.uk/government/news/e-cigarettes-around-95-less-harmful-than-tobaccoestimate-landmark-review), which concludes that "there is no
evidence so far That e-cigarettes are acting as a route into smoking
for children or non-smokers". NIPH's report from 2015
(
https://www.fhi.no/globalassets/migrering/dokumenter/pdf/helserisiko-ved-bruk-av-e-sigaretter-pdf.pdf)
also concludes this: "This seems to imply that e-cigarette
smoking in Norway may have served as a means to quit regular smoking,
and until now has not served as a gateway to start regular smoking."
For us as former smokers, now vapers, this is also quite obvious.
Going from a product that is relatively harmless, tastes good and
gives good effect to a less efficient, more expensive and extremely
much more harmful product makes no sense, neither when it comes to
e-cigarettes / cigarettes or other product choices they make in life
.
It also expressed concern about the effects of
"secondhand vaping", and to protect non-vapers and
non-smokers is the reason for a part of the regulation stating that
e-cigarettes should be covered by the smoking ban. The 2015 NIPH
report is largely used as justification for this. If you read this
report in its entirety you will see that the aerosol from
e-cigarettes is regarded as virtually harmless in terms of exposure
to all substances other than nicotine. However, the report highlights
that "passive exposure to aerosols from e-cigarettes causes
about as high nicotine levels in the blood, as of a passive smoker of
regular cigarettes. This means that one can expect similar harmful
nicotine-related effects of passive smoking of e-cigarettes as for
regular cigarettes. ". This is absolutely correct, but the
report then claims that "this does not mean that passive
exposure to aerosols from e-cigarettes provide carcinogenic effects,
but that such passive smoking may affect the cardiovascular system,
have stimulant effects and contribute to addiction.". This is
completely wrong. Nicotine in passive smoking has never until now
been an issue or a problem, and the reason for that is that the
amount of nicotine taken up by passive smoking is not big enough to
provide
any biological effect at all. This is pointed
out explicitly by Dr. Konstatinos Farsalinos, one of the world's
leading independent researchers in the area here:
http://www.ecigarette-research.org/research/index.php/whats-new/whatsnew-2015/204-niph.
FHI has answered this criticism and must therefore be aware of this
(http://www.ecigarette-research.org/research/index.php/whats-new/whatsnew-2015/207-niph2),
but will still not retract their claims. If this
serious error
in the NIPH report had been corrected, one is left with no reason to
include e-cigarettes in the smoking ban because of a need to protect
the surroundings. It is worth noting that Public Health England's
report from 2015 comes to a different conclusion regarding the amount
of nicotine that is released into the air through the use of
e-cigarettes (
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/457102/Ecigarettes_an_evidence_update_A_report_commissioned_by_Public_Health_England_FINAL.pdf.
One is thus left with a very thin basis for the inclusion in the
smoking ban, namely odors and visual similarity with smoking.
Prohibiting the use of e-cigarettes because of odors should be up to
the individual house owner, not the state. When it comes to visual
similarity with smoking, this will only apply to the tobacco
industry's so-called "cig-alikes" (e-cigarettes that look
like cigarettes) and we can assume that e-cigarettes are now so
familiar in the population that mistakes will occur very rarely.
Again the government's own desire to use only quality assured
material as basis for the regulation is disregarded by using a
conclusion that obviously is proven to be incorrect.
Another
concern, that is the reason for several of the rules, is direct
exposure to e-liquid with nicotine on the skin or by ingestion. In
other words users spilling liquid on themselves or others, or that
someone (usually children) unwittingly drinks nicotine e-liquid. The
toxicity of nicotine is strongly exaggerated and the doses that are
generally accepted as lethal are based on rather questionable
self-experimentation in the last century
(
http://link.springer.com/article/10.1007%2Fs00204-013-1127-0). In
general, nicotine will not cause serious harm by spilling a little or
that one is unlucky enough to swallow a few drops. Bernd Meyer, among
others, has shown this here:
http://www.bernd-mayer.com/electronic-cigarettes-and-nicotine-poisoning/.
Note that this is based on three articles, quality assured and
published in scientific journals (links are at the bottom of the
article). Media has also regularly written stories about how nicotine
poisoning cases have started to appear more often. Again, it's about
quality assuring the background material. Looking at the real numbers
behind this shows that there is often about phone calls due to
worried users and ignorance being recorded without having
particularly serious consequences, maybe just a little nausea and
dizziness. In addition, we know that many other household products
are sold completely unregulated and has much more damage potential if
for example a kid get hold of it, than e-liquid. Comparing the number
of serious poisonings from these substances to the number of
poisonings due to e-liquid accidents, the latter number will be
vanishingly small. Of course we want to avoid such exposure to
nicotine e-liquid, but one must look at the relative harmfulness. I
will return to this below. The consultation paper refers to an EU
report which reported 277 cases of poisoning connection to the use
of e-cigarettes. This in itself is a very low figure if one takes
into account that this is over 3 years in 8 countries with millions
of users. It is omitted in the consultation paper that only 6.8% of
these (only 19 cases) have moderate or severe consequences
(
http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri = CELEX:52016DC0269&from=EN). Here too, it is worth referring to
Public Health England's "Evidence update" from 2015 which
shows that there are very few unintended severe poisonings:
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/457102/Ecigarettes_an_evidence_update_A_report_commissioned_by_Public_Health_England_FINAL.pdf
The
addictive properties of nicotine itself is also a widely debated
topic. To date there is little or no evidence of nicotine dependence
that has occurred without the use of tobacco. This is because
nicotine itself is assumed not to be able to create dependency, but
interaction with other substances in tobacco is required to create
dependency (see
https://nicotinepolicy.net/karl-fagerstrom/520-dependence-on-tobacco-and-nicotine). A relatively strong support for this among
scientists exists and millions of e-cigarette users report that they
feel less dependent on e-cigarettes than the cigarettes. Professor
Robert Molimard summarizes the scientific knowledge about the actual
effects of nicotine on smokers here:
http://www.formindep.org/The-myth-of-nicotine-addiction.html#report.
This also provides support for concluding that a transition from
e-cigarettes to cigarettes is highly unlikely.
2.2.
Objections to the smoking ban and the ban on
advertising
Incorporating e-cigarettes in the general smoking
ban can, as explained above, not be justified by a need to protect
the environment for health reasons. It should, however, be up to the
individual homeowners to regulate this. A restaurant owner is such
pretty free, as far as I know, to make their own rules for example
about how guests must be dressed. Likewise, they should be free to
ban the use of e-cigarettes in their premises if they believe this is
a nuisance to other guests.
English health authorities recommend
businesses to not force users of e-cigarettes to go outside with
smokers to vape as this can lead to relapse to smoking. This sounds
very reasonable, and it is again a great encouragement to replace
cigarettes with a less harmful alternative if you can use this
indoors and in places you normally can not smoke. There are many
stories about smokers who just tried e-cigarettes to curb nicotine
cravings in situations where they are not allowed to smoke (eg. on
airplanes or airports) and have ended up quitting cigarettes
completely. These are often called "accidental quitters"
and is a common phenomenon.
I observe that the ministry
considering proposing exemptions from the advertising and display ban
when it comes to e-cigarettes. This is good. If we want as many
people as possible to quit smoking it should be possible to promote
e-cigarettes. It should also be legal to inform customers that
e-cigarettes means a much lower risk than regular cigarettes.
2.3. Objections to
the registration requirements
The requirement for registration
of all products including all varieties of both e-liquid and
electronic cigarettes shows that the regulatory body have very low
knowledge about the market to be regulated. The fees proposed are
based on an assumed record of approximately 200 products that are
based on projections from Denmark. The same applies to cost
estimates. It is evident that the ministry has not made any
investigations on their own or tried to understand the present
market.
When it comes to e-liquid, the way I read the
proposal, one will have to register each nicotine strength for each
variant. E-liquids are often sold in 4-5 different strengths. This
means that 40-50 different varieties of e-liquids will count as 200
products. This is no more than the range one finds from 2-3
producers. In many cases, manufacturers also have a selection of over
50 different flavors.
When it comes to e-cigarettes and
equipment, over 20,000 products currently exists. A Norwegian dealer
stated that they have approximately 1200 different products in stock.
Of these probably more than half will be replaced within six months
because they are outdated. Many manufacturers also produce a very
limited number of items, so-called high-end products. None of these
will be sold in Norway under such conditions. It goes without saying
that you will not be able to make any money if you have to pay 47600
NOK to register a product that you usually sell around 10 units of. A
processing time of six months we also see is a hopeless hurdle to get
over, when a very large part of the products are outdated and
replaced with new, improved versions by that time. One can also
mention that if the government had allowed the state to take a large
part of the estimated cost of around 10 million that these fees are
intended to cover, this would have been an investment in public
health who had paid for itself many times in a short period of time.
The Directorate of Health has estimated that smoking costs society
between 8 and 80 billion a year
(
https://helsedirektoratet.no/Lists/Publikasjoner/Attachments/90/Samfunnsokonomiske-kostnader-av-royking-en-vurdering-av-metodikk-og-kostnadenes-storrelsesorden-iS-1825.pdf) and it is obvious that if we can get
more people to stop by using e-cigarettes this will lead to enormous
savings. In this context, 10 million is a really small number.
It
is obvious that the fees presented here will eradicate much of the
market, as there are costs that make it impossible to operate in the
market. The few who have the resources to cover these fees are large
companies, mainly the tobacco industry with its so-called
"cig-alikes". The tobacco industry is currently losing the
market to independent producers but with such regulation their
competition will largely disappear and tobacco giants will be left
with the entire market virtually alone.
It is not the
tobacco industry that drives innovation in the e-cigarette market.
This is done by independent companies which are striving, not only
for high performance, but also a high degree of product safety. This
innovation and the desire to develop ever safer and more effective
products will be seriously hampered by such a scheme with such
consts. It also appears meaningless that all EU countries should have
their own registration systems instead of a joint one.
A
solution where manufacturers and importers must register and be
responsible for that regulations are followed without recording every
single product had been much more appropriate. The independent
industry could then continue to exist and innovate.
2.4. Objections to
product requirements
The maximum nicotine content of 20 mg / ml
is inappropriate. Many smokers who want to switch to vaping will not
experience this as satisfactory and this will lead to many more
unsuccessful attempts to quit. In addition, different types of
equipment produces different amounts of vapor and thus more or less
nicotine is delivered. In more advanced models often used by more
experienced vapers lower nicotine content is used since more vapor is
produced. In models for beginners, which is the ones most often used
when attempting smoking cessation, much less vapor is produced and
the need for higher nicotine content is present. 36 mg / ml has
traditionally been the highest content in the ready mixed liquid, but
newer models that are specifically designed to get the over the first
"hurdle" also contains even more than this to deliver
enough nicotie with an even smaller amount of vapor. The limit of 20
mg / ml is justified by surveys that show that most people who vapes
today use lower nicotine content than this. This is correct because
all experience indicates that vapers gradually lowers their preferred
nicotine content, partly because addiction becomes weaker and partly
because of better equipment. Thus, this limit will most likely not
lead to many of todays vapers relapsing to cigarettes, but it will be
serious barrier for current smokers that want to switch.
The limit of
10 ml for refilling containers also appears to be inappropriate and
will only lead to increased costs for consumers without providing
greater product safety. The possibility that the small bottles are
left lying around, accessible to children and pets, are at least as
great as the larger bottles, if not greater. A requirement for child
safety of the bottles is appropriate but the size limit like this
will provide no noticeable security gain. Many household products are
much more dangerous than e-liquid and come in larger containers and
these should of course be kept out of reach of children, regardless
of the size of the bottles. The same applies to the limitation of 2
ml for disposable cartridges. This will make e-cigarettes less user
friendly, and decrease the chance of quitting, without causing any
security gains.
The rules for
refilling mechanism is unnecessary and will not provide any
significant benefit to safety. As mentioned above, the potential for
poisoning by getting nicotine liquid on the skin is quite exaggerated
and even at concentrations far above 20 mg / ml will not cause any
noticeable effect if a few drops are spilled on the skin if you wash
this off quickly.
2.5. Objections to
the requirements of user manual and labeling
The requirement for
manual in Norwegian should apply to products produced in Norway, but
it should also be opened for the English manuals. To oblige foreign
producers to make Norwegian versions of the instructions could lead
to so much more work and higher costs that one refrains from selling
to Norway and we will thus have a narrower range of products, which
in turn will lead to fewer people finding the model that makes them
able to quit smoking.
The
requirements on labeling also seems poorly conceived. Health warnings
will indicate that this product is as harmful as smoking and will not
encourage people to quit smoking. It also seems very out of place to
have a reference to slutta.no on e-cigarette accessories.
3. Consequences of
over regulation
As mentioned earlier e-cigarettes represent a
health revolution that we seldom see the likes of. Today's market is
developing rapidly and more and more efficient models are released
rapidly. In addition, there exists a commitment and enthusiasm for
the products that we've never seen before for a product that is
intended for smoking cessation. A regulation like the one proposed
here will, as I have described, slow the progression and force a
large portion of today's players out of the market. This will lead to
the loss of jobs and income to the state, fewer people will be able
to quit smoking, more people will start smoking and we have a net
negative effect on public health.
With high
probability this regulation, and other countries' corresponding
regulation of e-cigarettes, will lead to that in a few years only a
few large rich players will be left in the legal market. This is
mainly the tobacco giants. In addition there will be a huge black
market where safety and health will not be the driving factors to the
same extent that we see today. Many of the players in this market
will probably be idealists who is currently operating in the legal
market. This means even the black market will in all probability
paradoxically contribute positively to public health, but in the
black market we will also see forces pulling the other way.
4. Summary and
Conclusion
The proposed regulation of e-cigarettes appears to be
completely unfit for purpose, which must be to improve public health
and save lives. It is pointless to regulate products that help people
quit smoking, are demonstrably much less harmful than tobacco and
which in addition contain no tobacco by including them in the tobacco
act. E-cigarettes represent an enormous opportunity to save millions
of lives worldwide but regulation such as the ones presented here
will be a serious obstacle to this. E-cigarettes should either be
governed by a separate own regulation scheme or under current
regulation of foodstuffs and electronics products.
The
government should also reconsider its introduction of standardized
snus cans and cigarette packets as the figures and surveys that exist
today shows that this will have little or no effect. Working with a
sensible regulation of e-cigarettes would have been much better use
of resources.
It emerges very clearly that the proposed
regulation of e-cigarettes is an implementation of the EU's new
tobacco directive on those points. Although Norway has a tradition of
introducing EU directives in spite of that we are not members, it
should be expected from our elected representatives that they make a
thorough analysis of the impact of such directives. There are
examples of misguided directives and perhaps the best and most
relevant in this context is the EU's ban on snus. Again, we can look
at the statistics and see that the the countries that have exemptions
from this prohibition (Sweden) are destroying the other countries on
the cancers statistics. Although many of our elected officials have
been out in the media claiming that we are committed to implementing
the EU's tobacco directive this is not true. We have our full right
to reserve ourselves against this and we should do it in this case. I
expect from our elected representatives that they manage to put the
Norwegian people's lives and health in front of strawberries and
champagne in Brussels and withstand pressure and threats. Take this
opportunity to show that Norway is a pioneer where we are able to
think for ourselves and not let us influence by they tobacco and
pharmaceutical industry lobbyists at the expense of public
health.
This regulation proposal show strong signs of lack
of knowledge about the fields to be regulated. I will persistently
ask Health and Care reconsider this regulation and obtain knowledge
that can enable them to regulate in a way that allows us to benefit
from the lifesaving potential of e-cigarettes. This knowledge exists,
even here in Norway. Researchers from SIRUS that are now incorporated
in NIPH has massive amounts of knowledge, but one must not forget the
users who are organized into NDS.
5. My
Story
Finally, I will briefly share my own story and experiences
with the transition from cigarettes to steaming. I am now 36 years
old and 4-5 years ago I saw someone using an e-cigarette in a movie
trailer. I began to research online and tried some models, with and
without nicotine. Finally I found a model that suited me well and
e-liquid with enough nicotine that enabled me quit smoking the day I
got it. Since then I have never looked back.
As a smoker
my health was ailing to say the least. I coughed and spluttered
almost all the time, I was overweight, much because I was not able to
engage much in physical activities and my kids were probably pretty
worried. After I switched to I noticed that my breath and stamina
recovered quickly. I was able to start exercising and eventually I
ended up being able to run long distances and not at least come along
with the kids on skiing and hiking. Now I am in relatively good
physical condition, have no problems with coughing or breathing and
the frequent 3-week colds which virtually replaced each other when I
smoked is completely gone. I have not been home sick from work for
one single day since I switched to vaping.
For me and many
others vaping have not only been a means to stop smoking. It has
become a hobby and a committed and enthusiastic community has sprung
around the products. This is also one of the reasons why vaping
works. With traditional smoking cessation products you remove the
cigarettes that for many represents both coziness and relaxation
without replacing it with anything. Vaping replaces the physical act
of smoking and many users also feel they get a community and a hobby
in addition that helps one keep cigarettes away long enough to
prevent a relapse.
Ever since I started with vaping I
have followed developments in the industry, politics and research and
would say that I have pretty thorough overview of how the market and
the community work and the research that has been done.
Public
Health England estimated that the vaping is at least 95% less harmful
as smoking. At least. That does not mean you necessarily get 5% of
the harm. My own experience suggests that this figure could well have
been higher than 95% and many other vapers I've talked share this
view. I often see people crying out for evidence that vaping works
and actually helps people quit. There are now millions of living
proof! I am one of them.
Tested on: Aromamizer Supreme (Dual Fused Clapton @ 0.2 ohms, 70 watts)
