Norwegian e-cigarette consultation - My answer

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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: Norway status update: The Norwegian government don't understand the vaping market  New Norwegian Tobacco Act proposal based on lies and misinformation Norway status update: Plain packaging and e-cigs regulated as tobacco 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.  For my Norwegian speaking readers: My original answer in Norwegian. 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.

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:

• Norway status update: The Norwegian government don't understand the vaping market 
• New Norwegian Tobacco Act proposal based on lies and misinformation
• Norway status update: Plain packaging and e-cigs regulated as tobacco

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. 

For my Norwegian speaking readers: My original answer in Norwegian.

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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.