Potential new regulatory options for e-cigarettes/ANDS in NZ

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By a group of nine academic tobacco/nicotine researchers*

Smoking e-cigE-cigarette usage is growing in NZ and around the world but the scientific evidence-base regarding the benefits and risks of these types of products remains uncertain. The health-based policy experience is also minimal. In this blog post we outline some of the possible regulatory options around e-cigarettes (alternative nicotine delivery systems – ANDS) that the NZ Government could explore and that further NZ based research could help clarify.

Globally the market for e-cigarettes or alternative nicotine delivery systems (ANDS) is highly dynamic and rapidly evolving (with numerous different product types (1) including non-electronic forms). Alongside dedicated independent producers of ANDS, the tobacco industry has been entering the market, creating two broad competing groups of manufacturers. One of the concerns expressed about regulation (e.g., making ANDS regulated as medicinal products) is that it will slow innovation in the market and may leave the field to the tobacco industry, who then may shape it to their benefit, rather than to the benefit of public health.

The current status of ANDS in NZ parallels Australia and Canada (2): such products cannot be legally sold if they contain nicotine unless they meet regulatory standards for achieving a therapeutic purpose (i.e., as a pharmaceutical grade smoking cessation product as per Medsafe requirements (3)). Nevertheless, ANDS with nicotine and nicotine-containing ‘e-liquid’ can be imported for personal use in NZ. Shops can sell the ANDS devices and e-liquids not containing nicotine (but some appear to sell nicotine containing e-liquid as well, albeit illegally). At present, the extent of imports is unknown. Yet, the level of use by NZ youth suggests a considerable volume, with growth from 7% to 20% in ever-use of “electronic cigarettes” during the 2012-14 period (4). Increasingly, there are advertisements for ANDS in this country (e.g., a radio campaign by “NZ Vapor” in May 2015), some of which could have features that attract youth and non-smokers to ANDS (5).

The published scientific literature on ANDS is now vast. For example, 128 review articles in PubMed when searching for relevant terms (review and ‘e-cigarette’/‘electronic cigarette’); and multiple systematic reviews exist e.g., since 2014: (6-11). Most recently the US Preventive Services Task Force concluded that there are not enough data on the effectiveness of electronic cigarettes to determine whether the devices can help smokers quit (12). The literature may also be influenced by authors with a “conflict of interest” e.g., for 34% of the 76 studies in one systematic review (7). But to summarise, it is probably reasonable to say that there is no scientific consensus on how the potential benefits of ANDS availability compares to the potential harms. That is, in terms of the potential benefit of reduced harm to people who use ANDS to quit smoking or who fully switch from tobacco products to less hazardous ANDS as a long term substitute vs the potential harms. The latter include: (i) being attractive to youth and curious non-smoking adults, and so potentially being a gateway to (or ‘back to’ for ex-smokers) tobacco smoking or at least to nicotine addiction; (ii) potentially “renormalising smoking behaviour” in general; (iii) potentially deterring dual users from quitting smoking; and (iv) ‘second hand’ exposure and nuisance impacts for others. Less directly, there is also the risk that discussions about ANDS regulation may give the tobacco industry a seat at the policy table where they could undermine tobacco control policy more generally.

So in the face of such issues and uncertainties – is it possible to have additional smart regulations around ANDS in NZ? We provide a potential list of regulatory options for nicotine-containing ANDS in the table below. To inform this list we considered some of the recent literature on regulatory options for ANDS, including an expert survey (13), an ethical analysis (14), a NZ specific article (15), and other international work (1, 2, 16, 17). But we note that much of this literature is of limited value when considering ANDS in the context of a country: (i) which is an island nation with strong border controls; (ii) in which nicotine-containing ANDS cannot currently be legally sold (in contrast to many other jurisdictions considering regulatory frameworks where such ANDS are already widely available); and (iii) which has a smokefree nation goal.

Table 1: A list of possible options for regulating nicotine-containing ANDS in New Zealand – from least restrictive to the most restrictive (with some options not being mutually exclusive)

Policy goal/s Brief details and comments
1) To improve the current level of access to ANDS as a quitting aid or long-term nicotine maintenance product in those who cannot quit (i.e., assuming these are net benefits) Permit nicotine containing ANDS to be sold, but in a highly restricted and medicalised way e.g., only by pharmacies alongside pharmaceutical grade nicotine replacement therapy (NRT) products and with a range of quality standards and marketing standards.* This might require a change to the Smoke-free Environments (SFE) Act to permit such sales and to remove ANDS from Medsafe jurisdiction (as per fluoride when added to drinking water which is now specifically defined as not being a medicine and is therefore now clearly not under Medsafe jurisdiction (18)). At the same time the SFE Act could include tight marketing restrictions and restrictions on sales to minors for ANDS. If careful monitoring showed this approach to permitting access to ANDS not to be optimal for advancing public health and the smokefree nation 2025 goal, then it would be politically much easier to discontinue pharmacy sales than to manage product withdrawals from varied retailers (given that pharmacists are health professionals with ethical standards). This approach also has some overlap with the idea of restricting tobacco sales to only pharmacies as part of a tobacco endgame strategy (19).
2) As above for pharmacy only sales – but with even higher access standards (e.g., on prescription) As above, except with a requirement for a doctor’s prescription so as to maximise the benefit of ANDS being targeted to those wanting to quit or for those who have failed after multiple attempts and need to use ANDS as a nicotine maintenance product. Pharmacists selling ANDS could also be required to deliver brief cessation advice at the same time as selling ANDS; this approach could help to medicalise ANDS (as a quitting aid or maintenance treatment for chronic nicotine addiction). Tighter controls on marketing could mean that all marketing is banned, or limited to approved informational brochures attached to each package of ANDS products sold.
3) As above (pharmacy only) but with regular upgrades to quality New regulations under the SFE Act could allow for the quality standards for ANDS to be gradually tightened (e.g., annually) until they approach or reach pharmaceutical-grade quality (in terms of effectiveness for quitting, being an effective harm-reduction substitute for tobacco, and safety). Some NZ work on ANDS product testing has been reported by Laugesen (20)).This incremental approach would probably improve access to ANDS in the short-term relative to the more demanding options of manufacturers trying to:

  • meet the existing regulatory requirements under the Medicines Act – as outlined by Medsafe (3).
  • meet the requirements under the new Psychoactive Substances Act (as suggested elsewhere (15)) but probably only after nicotine was included into the scope of this new (and untried) legislation.
4) Reduce potential harm and nuisance to others from vaping (and reduce normalisation of vaping) Amend the SFE Act to ensure that there is 100% consistency with restrictions on vaping (i.e., making it illegal to vape in any smokefree environments). Ideally, policymakers would take this opportunity to have a nationwide ban on smoking and vaping: in cars with children, within 10m of children’s playgrounds, in all stadiums, and on all sports fields etc. In contrast, use of a nicotine-containing metered dose inhaler might still be permitted in such environments (given that this would appear like a typical therapeutic inhaler in shape and function).
5) Encourage smokers to switch to ANDS through price mechanisms (i.e., assuming a net benefit from ANDS) Ensuring a large price gap between untaxed ANDS (GST only) sold by pharmacies relative to smoked tobacco sold elsewhere, could facilitate complete switching from smoked tobacco to ANDS, especially if the excise tax on the former keeps increasing.
6) To have very tight control on ANDS to minimise profit-driven risks – but still allowing some access in NZ (i.e., assuming a net benefit from ANDS) A government purchaser and distributor (Pharmac or even a new organisation) could purchase ANDS products internationally and then supply through government-owned settings e.g., public hospital pharmacies. The brand/s of ANDS supplied could be of the highest quality on the market and could meet all the other criteria detailed in options 1 to 3 above. By excluding the profit motive there would be less chance of any commercial interest undermining the public health goals around making ANDS available.
7) Fully minimise any risk of harm from ANDS to everyone (i.e., assuming no net benefit from ANDS) Maintain current NZ restrictions on the sales of ANDS and potentially enhance enforcement around illegal sales of nicotine cartridges and e-liquid. This option might be favoured by those who suspect that smart regulation of ANDS is too hard for the NZ political and policymaking system (see further comments below). But if illegal sales of ANDS became significant, the viability of this approach could be eroded. Also, although Pharmac is a long-term success story, given that the large savings appeal to both right and left of the political spectrum, other similar sized new government agencies might not survive changes in government.

* Quality criteria for legal sales of ANDS at pharmacies could include: (i) possibly no added flavours (as these probably increase attractiveness to children) – though ideally such additives should also be banned in tobacco products; use of child-proof containers (as per New York State law (2)); prohibition of combustion in the ANDS; no or minimal contaminants; and an appropriate range of nicotine levels in the e-liquid. Regulations could require only “closed” ANDS devices to minimise do-it-yourself additions of tobacco plant juice or cannabis products (though there are complex pros and cons of such a restriction). All manufacturers would be required to have warning labels (e.g., that quitting smoking completely and then quitting ANDS is best for health), to give information on levels of all ingredients, and to not make unproven health claims. No cross-branding practices would be permitted (e.g., the use of tobacco industry logos on ANDS (16)) and marketing could be tightly regulated.

 

Given the complexities of the ANDS issue, the authors of this blog have not collectively agreed on any most favoured option or even a list of favoured options. (Indeed, look out for comments following this joint blog post for any of our own separate extended analyses and recommendations). However, we all agree that it is logical for policymakers to carefully consider the pros and cons of all of the above regulatory options, especially in light of the Government’s Smokefree 2025 Goal. The best option should be informed by local and international research and careful monitoring of sales, use, product quality, and health effects. The “Smoking Toolkit Study” in the UK (21), is an example of a useful monitoring approach that has collected data on the use of ANDS. Furthermore, the best approach should ideally be implemented in tandem with enhanced tobacco control measures e.g., increasing tobacco taxes (22), restricting access to tobacco sales (23), and even reducing nicotine content in tobacco.

In particular, the need for caution is highlighted by the following:

  • Smart policymaking internationally seems very difficult when it comes to tobacco and nicotine. For example, NZ still does not have retail licensing of tobacco outlets; no operationalised controls on tobacco product ingredients (the sugar, menthol, rum and other flavours); still permits duty-free sales of tobacco; still permits smoking in cars with children; is not moving quickly on passing a law on standardised (plain) packaging (24); and the legal situation around smoking in the “outdoor” areas of hospitality settings remains highly problematic (e.g., see this NZ survey: (25)). Other product-related examples of regulatory deficiencies in NZ from a public health perspective include: permitting advertising of prescription medicines (26); the lack of virtually any controls on the sales of vitamins and supplements (though some legislation is pending for these products); the weak regulations around alcohol sales and marketing; and inadequate nutrition labelling of food (compared to state-of-the-art traffic light labelling).
  • Some of the above tabulated options depend on the ability to develop and implement/enforce quality standards. Does NZ have the infrastructure to do this? If not, then it might be necessary to piggy-back on European Union or US Food and Drug Administration (FDA) standards or similar (which will come with its own set of problems).
  • Some participants in the ANDS domain have commercial vested interests – tobacco companies that also own brands of ANDS, and ANDS companies that do not sell tobacco products. The tobacco industry is still very powerful in NZ and is historically opposed to virtually all effective public health measures (see this history (27)). Irresponsible advertising of ANDS in the USA is also well described (2). For these reasons, the tobacco industry should be entirely excluded from the policy development process around any further regulation of ANDS.  

Conclusions

There are many unknowns when it comes to ANDS and even potential hazards with reopening the regulatory toolkit in the NZ setting. Nevertheless, policymakers may wish to consider further the pros and cons of the above options. But all such policymaking needs to be done very carefully, given the genuine scientific uncertainties and the vested commercial interests involved.

*Authors of this blog: Associate Professor Nick Wilson, Professor Richard Edwards, Professor Janet Hoek, Associate Professor George Thomson, Professor Tony Blakely, Frederieke Sanne van der Deen (PhD candidate), Dr Brent Caldwell, Professor Julian Crane, and Professor Chris Bullen. From: Auckland University (CB) and University of Otago (the others).

References

  1. Kaufman N, Mahoney M: E-cigarettes: policy options and legal issues amidst uncertainty. Journal of Law, Medicine & Ethics 2015, 43 Suppl 1:23-26.
  2. Lindblom E: Effectively regulating e-cigarettes and their advertising – and the First Amendment. Food and Drug Law Journal 2015, 70(1):57-94.
  3. Medsafe: Categorisation of electronic cigarettes. (Revised 5 November 2010).
  4. White J, Li J, Newcombe R, Walton D: Tripling use of electronic cigarettes among new zealand adolescents between 2012 and 2014. Journal of Adolescent Health 2015, 56(5):522-528.
  5. Baker L: Concerns e-cig ads attract non-smokers. Radio New Zealand News (14 May 2015)
  6. McRobbie H, Bullen C, Hartmann-Boyce J, Hajek P: Electronic cigarettes for smoking cessation and reduction. Cochrane Database of Systematic Reviews (Online) 2014, 12:CD010216.
  7. Pisinger C, Dossing M: A systematic review of health effects of electronic cigarettes. Prev Med 2014, 69:248-260.
  8. Pepper JK, Brewer NT: Electronic nicotine delivery system (electronic cigarette) awareness, use, reactions and beliefs: a systematic review. Tob Control 2014, 23(5):375-384.
  9. Yang L, Rudy SF, Cheng JM, Durmowicz EL: Electronic cigarettes: incorporating human factors engineering into risk assessments. Tob Control 2014, 23 Suppl 2:ii47-53.
  10. Gualano MR, Passi S, Bert F, La Torre G, Scaioli G, Siliquini R: Electronic cigarettes: assessing the efficacy and the adverse effects through a systematic review of published studies. J Public Health (Oxf) 2014.
  11. Rahman MA, Hann N, Wilson A, Mnatzaganian G, Worrall-Carter L: E-cigarettes and smoking cessation: evidence from a systematic review and meta-analysis. PLoS One 2015, 10(3):e0122544.
  12. US Preventive Services Task Force: Tobacco smoking cessation in adults and pregnant women: behavioral and pharmacotherapy interventions [draft recommendation statement]. May 2015.
  13. Blaser J, Cornuz J: Experts’ consensus on use of electronic cigarettes: a Delphi survey from Switzerland. BMJ Open 2015, 5(4):e007197.
  14. Hall W, Gartner C, Forlini C: Ethical issues raised by a ban on the sale of electronic nicotine devices. Addiction 2015, [E-publication 5 April].
  15. Hertogen A, Killeen A: The burning issue of combustible tobacco: The inconvenient truth. N Z Law Rev 2014, 2014(2):239-263.
  16. Lobb B: Vaping: Towards a regulatory framework for e-cigarettes. Report of the Standing Committee on Health. Canada: House of Commons, Chambre des Communes; 2015.
  17. Crowley RA, Health Public Policy Committee of the American College of Physicians: Electronic nicotine delivery systems: executive summary of a policy position paper from the american college of physicians. Annals of Internal Medicine 2015, 162(8):583-584.
  18. Medsafe: Proposed Amendments to Regulations under the Medicines Act 1981. Report of analysis of submission and final decisions. (2015).
  19. van der Deen FS, Pearson AL, Wilson N: Ending the sale of cigarettes at US pharmacies. JAMA 2014, 312(5):559.
  20. Laugesen M: Nicotine and toxicant yield ratings of electronic cigarette brands in New Zealand. N Z Med J 2015, 128(1411):77-82.
  21. Shahab L, Beard E, Brown J, West R: Prevalence of NRT use and associated nicotine intake in smokers, recent ex-smokers and longer-term ex-smokers. PLoS One 2014, 9(11):e113045.
  22. Cobiac LJ, Ikeda T, Nghiem N, Blakely T, Wilson N: Modelling the implications of regular increases in tobacco taxation in the tobacco endgame. Tob Control 2014, [E-publication 21 August].
  23. Pearson AL, van der Deen FS, Wilson N, Cobiac L, Blakely T: Theoretical impacts of a range of major tobacco retail outlet reduction interventions: modelling results in a country with a smoke-free nation goal. Tob Control 2014, 24:e32-e38.
  24. Hoek J, Edwards R, Daube M: Standardised packaging: The time for implementation has come. N Z Med J (In press).
  25. Vega S, Wilson N, Thomson G: Survey of smoking areas at bars in central Wellington City: scope for further hazard reduction? N Z Med J 2013, 126(1387):187-190.
  26. Mintzes B: Advertising of prescription-only medicines to the public: does evidence of benefit counterbalance harm? Annual Review of Public Health 2012, 33:259-277.
  27. Thomson G, Wilson N: The Tobacco Industry in New Zealand : A Case Study of the Behaviour of Multinational Companies. Public Health Monograph Series. Wellington: University of Otago. 2002.

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24 thoughts on “Potential new regulatory options for e-cigarettes/ANDS in NZ

  1. No one has asked me my thoughts of swapping cigarettes for vaping and yet all these people want to make decisions for me. I feel better than I have in years after smoking for nearly 40 yrs. I have reduced the nicotine intake and plan on being on zero soon.. I tried everything my GP had to offer and nothing worked and yet vaping has. All this sounds like Big tobacco behind it getting it restricted so much that people go back to smoking like requiring a prescription. You don’t need a script to buy cigarettes do you.

  2. Unfortunately none of these solutions are solutions at all. Arguably they are better than the current outright ban, but at the same time I would wager that smokers in NZ are better served by the channels vapers are using to obtain nicotine containing e-liquid. The situation will not improved by tinkering with a system that doesn’t work for the good of smokers, the system needs to change entirely.
    In the UK we’ve just seen figures released that show 1.1m EX smokers in 4 years thanks to ecigs, 400k in the last year alone – this is astonishing & largely due to the ease of availability.
    Smokers do not generally want medicating not the stigma that comes with it, only 8% of UK smokers access cessation services. To reap the benefits of e-cigs they must be as easily accessible as cigarettes are, smokers must WANT to use them so they must be appealing. There is plenty of data to show the importance of non tobacco flavoured e-liquid being fundamental to the dissociation of the old habit. I’m 36, a vaper for 2 1/2 years & I’ve never used tobacco or straight menthol, the sweet flavours have changed my associations & without them I’d still be smoking. I’m not just one anecdote, I’m one of millions globally & you need to talk to us to understand why you’re positions are not going to help smokers in NZ.

    Yes this is an improvement on the current e-cigs status – technically, but it’s fiddling in a system that’s not fit for something so utterly different to everything that’s gone before. Smokers are embracing vaping, talk to them & understand why.

  3. All of these options are designed around dismantling ecig popularity and usage. From my own experience and that which I personally know of others, it’s a positive tool in helping people quit cigarettes. There really hasn’t been any certain evidence it is worse for you than cigarettes, in fact the evidence is contrary to that entirely. I agree with Lorien, especially regarding the flavoured eliquid. It is important, for me because it has meant that the few occasions I was tempted to smoke a cigarette, the taste was unbearable and I actually couldn’t finish said cigarette.

    Let’s not forget that big-pharma is also hurting from the popularity of these. They make huge money on all of those smoking cessation devices and drugs, which we the smoker often won’t see because it’s subsidized, but they are making huge amounts from the government paying for that. They want control of this just as much as big-tobacco, hence why the law’s are so pro-big-pharma.

  4. Why does the tobacco industry have to be involved at all, they sell a product that has nicotine, they also sell a product that kills millions of people, how many people have died vaping? Just because it has nicotine it doesn’t mean the TOBACCO industry (emphasis on TOBACCO) have anything to do with vaping? They sell tobacco, vapers don’t want tobacco they want nicotine in a way that doesn’t kill them, the tobacco industry is just that, tobacco, so let the killers sell their tobacco, it would be a shocking thing to allow the tobacco industry to be involved at all, they sell tobacco which is something vapers are not at all interested in. If the tobacco industry was called the NICOTINE INDUSTRY it might make a bit more sense but they are not. If NZ wants to be smoke free they need to allow any retailer to sell juice that meets certain standards like FDA. Why is NZ so backward and always so late to react? Typical, leave it to the last minute and then screw everyone. Allowing people to import it but not allowing anyone to sell it shows that the authorities don’t actually have a clue what they are doing, how contradictory is that. I don’t think this is about the health of vapers at all, it’s about money.

    VAPING IS NOT SMOKING! Stop comparing them!

  5. What is the real objective here? an ideological opposition to a habit? or harm minimization?
    I have tried to quit smoking several times over the past year, I can’t afford it and my health was deteriorating. I really wanted to quit but found it extremely difficult with the standard methods of quitting. Then a friend who smoked a lot heavier than me got an E cig kit from the USA, in one week he went from spending more than $100 on tobacco to zero, he hasn’t purchased tobacco in over a month now and finds an 18mg e liquid completely sufficient to end any craving. Then he got one for his mother who had been smoking for nearly 70 years, she quit tobacco cold turkey, she has uses about 5ml of menthol e-liquid per week and hasn’t had a tobacco smoke since. Based on this experience I purchased a starter kit from the USA. Before I got my e-cig I was smoking about 40gm of roll your own tobacco a week, I have had the kit for just over 2 weeks, in that time I have had a total of 3 tobacco smokes, (all within the first 3 days) and each tasted foul as the e cig seems to change your tolerance to tobacco taste and makes it seem too bitter. I still have some tobacco left and haven’t touched it since. I already feel 10 times better than I did when smoking, I am using about 10ml of e-liquid per week and I plan to wean myself off nicotine altogether, which is incredibly easy to do with the e-liquids available. It is absolute insanity to not properly consider how effective these devices are as a quitting tobacco device, or a harm minimization device. I am on the path to being completely nicotine free in a way that causes no distress and has already improved my health. For the love of all that is good, do not ban these devices or the ability to obtain the e-liquid. These things can save lives.

  6. The manufactured theories in the introduction ie gateway,normalisation,dual use are just that….theories, no real world evidence to support these concerns exist
    Similarly the concern at the tobacco industry involvement ignores the fact that they are involved in an increasingly marginalised sector of the market :- cigalikes,that are relatively expensive,ineffective and shunned by experienced vapers who very quickly discover ‘tank’ systems, that are cheaper to operate and shown in recent studies (McNeil et al 2015) to be more effective – this market segment in the UK is now 66% and exclusively produced by independents
    Lorien above correctly dismisses the mish mash of alternatives offered in the tabled 7 options. The object of the exercise is surely to embrace the use of e-cigs at the expense of traditional tobacco smoking . Smokefree targets will only be met anywhere in the World when a multitude of attractive alternatives exist -‘More of the Same’ is not an option that will meet any target, the massive public health prize offered by e-cigs that many in this field advocate will be lost .
    I suggest that further options are advanced involving minimal regulation eg a free market allowing nicotine containing products with age restrictions, child proof caps, batch testing of the liquids.
    ‘Responsible’ advertising as per UK could also be incorporated to further allay fears
    The ‘realpolitik’ is that e-cigs are here to stay and without any compelling current evidence of harm it seems perverse to continue with a denialist approach to the topic ,which ultimately does a great disservice to the people this should be all about – Smokers!

  7. E cigs are a great market driven solution to the tobacco problem and are currently being utilised by millions world wide.
    And therein lies probably it’s biggest problem. It falls outside traditional tobacco control circles.
    E cigs could be a game changer in the fight against tobacco.
    They need to be available as an alternative to tobacco,not prescription only and not pharmacy only.Hell I can buy harmful products at the supermarket.
    What next will be pharmacy only? Salt,sugar,soft drinks alcohol.What about communities without pharmacies.What about the cost of prescriptions.
    There may need to be sensible regulations concerning age of purchasers and quality, but ecigs should be readily available also.
    With little research the gateway argument should be discounted as studies have found it is not valid.
    To place any credence in the youth uptake argument we need to see the corresponding smoking rate. Studies in the UK show as e cig use amongst youths increases there is a corresponding drop in cigarette use.

  8. I have been following the ecig debates in various countries.The common theme is that Tobacco Control policies almost always rely on bans and restrictions-the only exception being pharmacological therapies which we know now have little real impact on prevalence.
    Here in UK,since the indoor ban in 2007,we have had static prevalence and an increasing black market.Prevalence finally starting moving downwards again in 2013 iat the same time as our ASH survey showed 700k exclusive users and would expect similar for 2014 following ASH’s recent estimate of 1.1m exclusive users.
    The ASH survey also showed insignificant uptake of ecigs by non-smokers of any age.
    Given an unbiased assessment of the existing evidence(and it is questionable whether this is possible for a TC academic) it would appear that maximum benefit lies in minimum restrictions and regulation – a novel policy solution for many in TC.

  9. It may be worthwhile introducing a basic licensing scheme for dedicated vape shops, with requirements similar to a food handling certificate, but not too onerous; they could be adults only shops and this should satisfy the main concerns about access to minors. It also ensures that vape shops are not conflicted in selling tobacco as well, so there is a business motivation to helping people off cigarettes entirely. E-cigarettes work because they are enjoyable, this is not the domain of a pharmacy. They are much more effective if sold by vapers themselves, as most vape shops are run by vapers in the UK. We should look at proven models of success, like the UK, and we risk reducing their impact significantly by medicalising them and being concerned about vanishingly small differences in safety, when 99% of the harm reduction is simply through being non-combustible. The “buzz” and “hype” of new products and new liquids with a soft touch regulatory environment encourages smokers to make the switch and we should do nothing to make them less attractive. It would be good to get the junk tobacco company service station ecigs off the shelves, as they may actually act as an “immunisation” against more effective non tobacco company open tank systems. “I tried them and they were crap, ecigs are no good.”

  10. To comment directly on the possible options:

    1) Improving level of access for nicotine containing “ANDS”. This initially raises the question of the precise restrictions that would likely be placed on the products. Would it only restrict available strengths and not flavours, or would there be a regimented “step-down” programme, such as already in place for more traditional NRT?

    From a consumer perspective (assume smoker), many are reluctant to purchase current NRT from a Pharmacist without any kind of support, which raises the question, are the pharmacists going to receive some kind of training to correctly advise on the use of the products?

    2) Application of even higher access standards such as prescription only would involve a step that realistically shouldn’t be necessary if there are currently smoking cessation services available. Delivery of advice is of course crucial to the success of any cessation product, however most ANDS, specifically personal vaporisers are generally not intended as a cessation method, indeed most PVs are used long term.

    3) Monitoring the devices, liquids and other aspects is also crucial to ensure that they are as safe as can be for the users. However, there would need to be consistent identification of items that need to be improved. Many aspects of personal vaporisers (such as the device itself and batteries) specifically can be monitored and improved via more generic guidelines for consumer electronic items.

    4) Implementing widescale restrictions where vaping is allowed, or combining vaping with the current SFE Act would seem to be more of an ideological step. By all means, limit smoking/vaping in municipal buildings only, then subsequently produce specific guidelines for use by all other indoor premises that allow the business owner to decide. Possibly even allow designated indoor areas for vaping with clear signage along with the appropriate ventilation.

    5) Encouraging the use of ANDS would need a top-down approach with the current Government and associated bodies openly supporting the alternative methods with positive media and guidelines. Pricing is a definite incentive for a switch.

    6) Whilst this option would seem a “better fit” than the previous five, a governmental purchaser and distributor would be driven to find the most cost effective solution which may not be of any benefit to those looking to switch. In order to provide the best possible service, a wider variety would need to be acquired whilst staying abreast of new developments in that arena (such as the emerging temperature controlled PVs).

    7) The current restrictions on all existing *NDS, whilst the easiest option from a policy point of view, would have zero benefit for the existing *NDS users, nor those smokers that are looking at alternatives rather than cessation. Full restrictions with enforcement would be a major backward step for the overall health of the public.

    Specific commentary:

    Monitored access to ANDS is a crucial aspect of a longer term plan, there would need to be a degree of flexibility however. Considering that many users of Personal Vaporisers (PVs) do not consider cessation as the “endgame” for the switch. It is clear from statistics gathered from the UK that an additional 1.1 million EX smokers are ceased tobacco use in the last four years, 400K in the last year alone thanks to PVs. These figures are astonishing, and are largely due to the devices and liquids being readily available, and of course cost effective in comparison to longer term NRT or the continuation of the tobacco habit.

    Many smokers do not see themselves as suffering from any specific ailment that requires “treatment” and do often feel isolated and specifically targeted. Moreover, they also feel a level of pressure to “kick the habit” when they have simply made a choice.

    Ironically, the following snippet:

    “The published scientific literature on ANDS is now vast. For example, 128 review articles in PubMed when searching for relevant terms (review and ‘e-cigarette’/‘electronic cigarette’); and multiple systematic reviews exist e.g., since 2014: (6-11). Most recently the US Preventive Services Task Force concluded that there are not enough data on the effectiveness of electronic cigarettes to determine whether the devices can help smokers quit (12). The literature may also be influenced by authors with a “conflict of interest” e.g., for 34% of the 76 studies in one systematic review (7). But to summarise, it is probably reasonable to say that there is no scientific consensus on how the potential benefits of ANDS availability compares to the potential harms.”

    Demonstrates that the evidence needed to form a possible framework for a new ruling is already available. The primary factor in any ruling is flexibility to amend the rules when new evidence emerges.

  11. As an author of this blog post, I can say it is very valuable to get so much commentary on it – especially from experienced users of e-cigarettes/ANDS. It will inform our thinking if we develop a more detailed set of options for the Ministry of Health. But commentators themselves may also be able to make future submissions to government on their views – if for example there are Select Committee hearings on new regulations around ANDS in NZ.

    Some of the arguments above suggest that current ANDS users are keen for a much more liberal arrangement eg, of licensed vaping shops or indeed any retailer. This would undoubtedly improve access to smokers/vapers over say pharmacies only, but it would also potentially increase experimentation by non-smokers – a downside if society as a whole wishes to also reduce the overall burden of nicotine addiction.

    A dilemma for regulators is such trade-offs and so it is important to remember that helping smokers to shift to vaping/quitting should not be the only goal of any new regulations in this area. That is regulators need to also consider other populations such as:
    • Children who are at risk of poisoning from any nicotine e-liquid that becomes more available;
    • Youth experimenters who are at risk of future nicotine addiction (to either ANDS use or potentially to tobacco smoking);
    • Non-smokers/non-vapers who get nuisance impacts from the aerosol or who are confused when they see someone vaping in a “non-smoking indoor area”.

    So the best designed policy needs to consider all such population groups and attempt to get any maximal value from e-cigarettes/ANDS – while minimising the risks.

    Anyway, thanks again for your comments and at some point a future blog post might update the issue – including a closer look at some of the interesting data emerging from the UK.

    Kind regards

    Nick Wilson
    (University of Otago)

  12. Give me access to a well stocked (and well regulated) vape-shop, and ten smokers, and I’ll give you at least three non-smokers. The variety of devices, and attachments, and e-liquid, is the strength of this technology. Every different combination of device, attachment, and e-liquid (flavour, nicotine strength, and type of base) will appeal to different people. It can be as simple as the asthetics of the devices, or whehter it has a built in or removable batteries. It can come down to a particular attachment just being too fiddly for one user , while another user may find the same attachment excitingly technical. A flavour that appeals to one smoker may cause another to gag. The benefit of a vape shop would be that a smoker could walk in, be helped to find the best-fit for them, and walk out vaping immediately. In contrast, at the moment it is a bit daunting for new-comers to essentially order-blind from overseas, wait a week or two for their orders to arrive, then find that they don’t really like what they’ve ordered, and then either try again or give-up in frustration.

  13. This response adds to Nick’s. I will not repeat the things he has said, but will add a few more observations.

    1. One of the themes in some of the feedback is that tobacco control people don’t talk to vapers and should. I agree. However, although I have no doubt we could do more, many of us do talk to vapers both informally and through research (our group has recently carried out a series of in-depth interviews with ANDS users).
    However, we sometimes come at things from a different perspective. My perspective is as a doctor (formerly working in respiratory medicine) who has seen at first hand the disastrous and tragic health consequences of smoking, often among people who have desperately tried to stop but can’t due to the addictive nature of nicotine. As a public health practitioner I try to work out how I can best reduce smoking (and its health effects) at a population level. I fully understand that some people will have quit smoking through e-cigarettes and that is a good thing for those people, and they will have an extremely positive view of ANDS as a result. However, I want to know if the overall impact of ANDS is positive and how we can take steps to ensure that is the case.

    2. Another theme in some of the posts is that by controlling or over-regulating ANDS availability we are working in the interests of the tobacco industry. In response to that I would say that public health people in tobacco control are usually seen as public enemy number one by the tobacco industry, and furthermore much of the criticism of ANDS regulation and policy put forward by tobacco control people comes from directly or indirectly tobacco-industry affiliated people – so that hardly seems to suggest we are doing their work.

    3. Going back to the population perspective.
    The main areas where ANDS can result in population health benefit is by helping smokers to quit or if smokers fully substitute ANDS use for smoking. If smokers cut down and use a mix of ANDS and smoking to get their nicotine, that will probably result in a small benefit, but most epidemiological evidence suggests cutting down on smoking has only a modest impact on reducing its adverse health effects. Another potential benefit is if youth who would have taken up smoking instead use ANDS. Several of these benefits assume that long term use ANDS, although probably not completely safe has far less health effects than long term smoking, which seems highly likely.
    The possible downsides of ANDS on population health include: (i) gateway effect if use of ANDS by youth results in subsequent smoking initiation which would not otherwise have occurred without ANDS use; (ii) smokers who might have quit smoking entirely but don’t because they decide instead to cut down and use ANDS as well &/or find that they can get their nicotine fix by using ANDS in areas where they previously couldn’t smoke (due to smokefree laws etc) – so have no pressing need to give up; (iii) long term health effects of ANDS on health among youth who use ANDS and continue to use ANDS and who wouldn’t otherwise have smoked (see comment above, long term health effects may be relatively minor, though that is not certain); (iv) ‘renormalising’ effect of ANDS (particularly e-cigs that look like tobacco cigs) in making smoking seem more socially acceptable (v) all of the above effects may be magnified by the tobacco industry using ANDS for their own purposes (e.g. through devious marketing strategies) to promote rather than undermine the continuation of tobacco smoking and nicotine use among new generations in society.
    The evidence on much of the above is simply not there yet – we do not know what the impact of widespread ANDS use will be among populations in different contexts (types of ANDS available, patterns of ANDS use and smoking, ANDS and tobacco control regulatory contexts etc etc). However, as public health scientists I think we have to be careful and critical about the evidence, admit where we are uncertain and evaluate dispassionately the evidence for or against the population benefits and harms.
    So for example, I think the evidence for a gateway effect of ANDS is pretty thin at best (Poland may be an exception), with in many cases (e.g. US) a possibly worrying increase in use of ANDS by youth, but reassuringly a reduction in smoking in the same groups. So the gateway effect is unproven.
    However, the evidence cited about the impacts of ANDS on quitting also needs to be viewed with the same critical lens.
    For example, several commentators repeat uncritically the assertion that e-cigarettes have resulted in 1.1million people quitting in the UK, 400,000 in the last year. That is based on some projections in a publication by ASH in England from data from the Smokefree Britain surveys of approx. 12,000 adults in 2010 and 2012-2015, in which an estimated 1.1m out of 2.6m e-cigarette users were ex-smokers. 1 The assumption that is made is that everyone of those 1.1m ex-smokers who use e-cigarettes quit smoking only because of e-cigarettes (i.e. they would not have quit otherwise). That is clearly nonsense. Many would have found another way to quit, but a (uncertain) proportion only quit successfully due to e-cigarettes.
    However, an estimated 1.4m current e-cigarette users based on the same surveys were still smoking. Of these around 40% gave as the reason that they wanted to stop smoking entirely, which from a public health perspective is promising. However, over 40% said they were using e-cigarettes to help them reduce their smoking but NOT to stop entirely. Another 25% (the totals add up to over 100% presumably because people could give more than one response) said they wanted to continue to smoke and e-cigs allowed them to get nicotine in areas like bars and restaurants where they couldn’t smoke). For the latter two groups, ANDS use may reduce the motivation to quit and quit rates. Indeed a recent paper reported that quit rates among e-cigarette users in the UK who were followed up were LOWER than in non-e-cigarette users (tank users were slightly more likely to quit, but they were only a small proportion of e-cigarette users in this study). 2 So at a population level, unexpectedly, e-cigarette use may reduce quitting among smokers. Findings in other papers that have examined this have had mixed results.
    So, in summary there is widespread uncertainty about the overall public health impacts and impacts on smoking of ANDS, but on the current evidence there is probably pretty good grounds to restrict the availability of ANDS to smokers who are most likely to use them to quit, and who have tried and failed to quit with other methods. The case for making them more widely and easily available is not yet clear. However, we should be open to new evidence and the experience of countries with different approaches, and if it becomes clear that the public health benefits are real and reasonably certain, then we need to think again.

    References
    1. ASK UK. ASH Factsheet on the use of electronic cigarettes (vapourisers) among adults in Great Britain. London: Action on Smoking and Health (England);2015.
    2. Hitchman SC, Brose LS, Brown J, Robson D, McNeill A. Associations Between E-Cigarette Type, Frequency of Use, and Quitting Smoking: Findings From a Longitudinal Online Panel Survey in Great Britain. Nicotine Tob. Res. 2015.

    • Re youth uptake

      “Summary of findings
      Regular use of electronic cigarettes amongst children and young people is rare and is confined
      almost entirely to those who currently or have previously smoked.” ASH UK 2015

      Re the gate way effect

      “Regular use of the devices is confined to
      current and ex-smokers and use amongst never smokers remains negligible.9” ASH UK 2015

      I also notice your second reference relates to a 2012 study. E cigs have changed an awful lot since then, especially with tanks.
      I know the e cig area is a very difficult at this time.We suffer from a lack of up to date data, misinformation, and many vested interests.I think that vested interests are the single biggest obstacle to be overcome.

    • “That is clearly nonsense. Many would have found another way to quit, but a (uncertain) proportion only quit successfully due to e-cigarettes.”

      This could be said of all quit aids and services. What is certain is that these people all gave up smoking after using e cigs.
      It would be interesting to know what other quit aids had been tried before using e cigs.

  14. A third way.

    If as a society we continue to tolerate recreational use of nicotine and as such permit ANDS as safer alternatives to tobacco this raises three questions.
    Who profits from the delivery of nicotine via ANDS? Who carries the risk of harm to users? Who helps individuals withdraw from use when they wish to?

    The three main phases of nicotine use are initiation, consumption and withdrawal (often not permanent so the cycle repeats).
    Neither Tobacco nor ANDS companies claim any role in initiating nicotine use.
    However both tobacco and ANDS businesses seek to profit by delivering nicotine to the initiated. Brand choice is the only influence they claim.
    Assisting in withdrawal from nicotine is currently the commercial domain of regulated pharmaceutical products and various other behavioural change based programmes. Alone or in combination.
    Permitting ANDS will erode the need and relevance of regulated pharmaceutical products for withdrawal thus reducing options for users to become nicotine free.

    Therefore it seems reasonable that those profiting from the delivery of ‘safer’ nicotine should carry the risk of harm and the cost of withdrawal when desired.

    A way forward could include a prospective settlement/bond arrangement whereby a license to sell ANDS would include insurance cover for future health claims, a contribution to research on the health effects and the funding of users’ withdrawal programmes.

    If no harm is caused by ANDS the sellers can get the bond money back plus interest. By definition there will be less need for withdrawal if no harm is done and the research to prove one way or the other is assured of funding.
    If in time we as a society decide that nicotine use is no longer acceptable or the harm from ANDS too great then funds are available to wean the population off.

    A third way to avoid repeating mistakes learned the hard way with tobacco.

    Initiation, consumption and eventually withdrawal (often not permanent so the cycle repeats).
    Neither Tobacco companies nor ANDS claim any part in initiating nicotine addiction.
    However both tobacco and ANDS businesses profit from delivering nicotine for consumption. Brand choice is the only influence they seek.
    ANDS to help withdraw from nicotine is the domain of regulated pharmaceutical products and other behavioural change based programmes. Alone or in combination.
    In a world where safer e-cigs replace tobacco the rationale for regulated nicotine withdrawal products fades as does the market.

  15. Why haven’t these scientists ever asked the government to consider restricting actual cigarettes to pharmacies, and only available with a doctors prescription?

    This beggars belief. Finally a much, much safer alternative to smoking comes along, of it’s own accord. Finally something that no one has to make expensive TV commercials to get people to use, something that doesn’t require government subsidies. And you want to restrict it to being an inferior product, made by drug companies or the tobacco industry and only sold in a pharmacy.

    Where were you 30 years ago when I took up smoking?

  16. Vapers fully understand that TC sees the Tobacco companies as their main opponents.
    When we tell you that you are playing into the hands of the TI we do not think think you are colluding with them,we are trying to point out that the type of regulatory policies you propose match the type of regulatory policies they would like to see.The irony would be comical if the issue was not so serious.
    As a smoker of 30yrs and an exclusive vaper of 3yrs I would also like to point out that every punch TC has ever thrown at the TI has landed squarely on smokers themselves,again tragic comedy.
    I can appreciate the need to look at things at the population level vs the individual but what scale is in use here?,how many young people taking up a habit does it take to override the health gains made by many individuals in switching from tobacco to vaping?
    That is a question I would like answered,I want to know how many of us you are prepared to discard to save one young person from picking up a habit.A simple ratio would suffice as an answer.

  17. I don’t understand the big worry about nicotine .
    In Australia it was announced that NRTs could be used endlessly if needed. ie recent research suggests that nicotine (minus all the other additives in a tobacco cig) is not very addictive !
    So if it is ok to use NRTs as much as one wants what is the scare mongering re ecigs all about ?
    Also serious doubts about its toxicity.

  18. That is ridiculous!
    I’ve finally found myself away from cigarettes and now this!
    I don’t even know how you guys compare tobacco and Ecigs.. They are completely different things!
    Start listening to vapers instead of the tobacco companies.
    Shame on you guys!

  19. The problem I see with your academics is that we ex smokers have found a way of getting nicotine without your express permission. You just can’t abide the idea of being side stepped! Your input is not required in our lives, we do not set out to do anything to control what drugs you take, why can’t you just butt out of our lives too, this is none of your business.

    However, I started vaping on June 5th 2014, that was the last day I had a cigarette too. In fact I discovered I don’t even like the flavour of tobacco. Often I go out and forget to take my vaporizers with me, and don’t crave a cigarette either. I am a non smoker.

    Where we vapers need regulation is to know that the e-liquids do indeed have the amount of liquid in the bottles we buy, and the level of nicotine they say they have. I also vape nicotine free e-liquids, how do you propose to ban breathing out?

    If you do get your way and tax my devices and products as if they were tobacco, I’ll get your lozenges, extract the nicotine from them, and vape on. Or I’ll grow my own tobacco plants, or my own potato plants, or my own egg plants, all of which contain nicotine, and I don’t need that much.

    Oh and the W.H.O. calls them ENDS “Electronic Nicotine Delivery Systems” when did you lot decide to rename them ANDS?

  20. I would have thought anyone concerned with public health would appreciate ‘harm reduction’ if vaping is 50percent as damaging (and it is way way less-when you discount ravings of the Stanton Glantzs’ of this world) then massive public health win–way more than the cumulative effect of 40yrs of anti-smoking regulation.
    As vaping is way safer and nicotine itself innocuous(possibly even beneficial in the case of Altzheimers etc) certainly no worse than caffine-then nicotine addiction isn’t a public health issue but a moral one and has no place in the debate.

  21. Now that there is a body of evidence that vaping is not a gateway to smoking and no evidence to suggest it is,could the authors please amend their proposals accordingly?

  22. Pingback: E-Cigarettes: lifesavers or smokescreen? | Nursing Review

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