10 reasons not to regulate e-cigarettes as medicines

So the MHRA will regulate e-cigarettes as though they are medicines – press release. 10 reasons why is this a bad idea.

1. The real health challenge is to get e-cigarettes to eat into cigarette sales as rapidly as possible, and for as many smokers as possible to switch. This type of regulation works against that. A limited authorised range of dull but perfectly safe medicialised products that no-one wants to use is worthless and counterproductive.

2. E-cigarettes are not medicines – it is poor policymaking to just hammer them into a regulatory framework designed for something else. They should design something specific to the products, starting with consumer protection legislation, and extending it if needed (the approach taken with cosmetics for example) –  see briefing: Are e-cigarettes medicines?

3. Medicines regulation involves disproportionate costs, compliance burdens and restrictions – none of which apply to cigarettes. So this is a good day for the cigarette makers, and their competition will be weakened. We need regulation to encourage these products to compete with cigarettes, not smother them with red tape. See: Medicines regulation for e-cigarettes: when caution can kill

4. Medicines regulation will slow down innovation – the lengthy and costly authorisation process does not lend itself to rapid change or the more experimental approach to innovation that works for consumer products (ie. try lots of things and invest in what works or follow changing tastes and buzz).

5. Medicines regulation will reduce the diversity of products available – the process has to be repeated for each product – slow and time consuming and not worth it for niche products. Many products will be deemed unsuitable or will never be put forward in the first place. This is bad because it narrows the potential appeal and removes some of the pleasures vapers find in experimenting with new products.  It is likely that regulators will impose counterproductive restrictions to the product design – for example the dozens of frivolous flavours are part of the appeal as an alternative to smoking – but will the stern suits of the MHRA really approve ‘pina colada’ flavour?

6.  Medicines regulation requires pharmaceutical ‘clean room’ room manufacturing facilities – this is regulatory overkill, given that most consumer nicotine is delivered in a filthy mix of burning particles of tobacco and hot toxic gases. But the current supply chain is long and extends to China – most factories will not be able to attain this standard, so MHRA will destroy the existing supply chain.

7.  They want to substitute their own view of ‘efficacy‘ (what works) for the consumers’ view. Markets work by people buying the good products and the poor products failing, not by regulators deciding what works. It would be different if they were making health claims, and could be tested to see if the claim are valid. But the e-cig vendors aren’t making any claims. The truth is they don’t know what efficacy means with e-cigarettes.

8. What the e-cigarette sector doesn’t need is ‘boring’.  That has been tried and failed with NRT.  It needs marketing verve, style and buzz, not the dull deadening hand of bureaucratic approvals. That applies to product design, packing, marketing, sponsorship – the works… the public health challenge is to get as many smokers to switch as possible, not to make perfectly safe products that no-one wants.

9.  They will focus on eliminating minute risks but obstruct great potential.  There is great danger they will make the products less attractive to smokers who might otherwise switch.  So they get the risk down from 99% lower than cigarettes to 99.5%. Big deal… and harmful if it means more people stay smoking as a result.  There is no evidence at all of gateway effects – those exist mainly in the imagination of health lobbyists.  E-cigs are a major gateway out of smoking, and an alternative to ever smoking.

10. This will give a boost to the home-made and black market – all likely to be more dangerous than a lightly regulated commercial market. So it will fail anyway.

43 comments to 10 reasons not to regulate e-cigarettes as medicines

  • Jonathan Bagley

    A quote from Deborah Arnott on the MHRA press release,

    “ASH strongly supports the MHRA decision to regulate e-cigarettes…”

    Bet a lot of you weren’t expecting that. Ah, Bless.

    • Clive Bates

      It looks as though ASH didn’t quite understand the MHRA announcement. MHRA didn’t make a “decision to regulate e-cigarettes”. All that was agreed was that the MHRA would regulate e-cigs if they are to be regulated under the EU Tobacco Products Directive as medicines – and that this is the UK government’s preferred option… However, this is not yet law, it may never become law, and the Commission’s proposal may be changed beyond recognition or deleted from the directive.

  • Pharma knows they cannot enforce an ecig ban unless they can buy most of the judges in the chain: the High Court (where the ECITA suit challenging the ban will be heard in the first instance); the Appeal Court; then the Supreme Court if the case gets that far. Every court in every country has overturned the bans where challenged. At least we will see if British justice is for sale, when pharma couldn’t buy it in the USA or even Estonia.

    So this is an interesting development as it begs the question: what is the real motive behind their move? As they have unlimited funds, and it doesn’t matter to them financially if they win or lose a case that will cost them £10m, I think it is probably nothing more than an attempt to influence the EU process. “Look: the UK is going to ban ecigs, so should the EU”.

  • [...] réponse à ce communiqué de l’angence, Clive Bates a écrit un article sur son blog sur les 10 raisons de ne pas réglementer les cigarettes électroniques comme des [...]

  • Bill Godshall

    So the MHRA is urging smokers to keep smoking instead of trying e-cigarettes because the agency isn’t certain that all e-cigarette products are 100% safe or effective for quitting smoking.

    I suspect MHRA will change this policy prior to (or shortly after) the agency’s announced 2016 date for e-cigarette prohibition (which they call regulation).

    If e-cigarette sales continue to double annually (as they have since 2009), there will be 8 times more e-cigarettes and corresponding e-cigarette consumers by 2016 (than today).

    It appears that MHRA expects BAT and some of the larger e-cigarette companies to spend tens of millions of pounds doing clinical trials and laboratory tests (for each brand).

    Does MHRA approve medicines for the treatment of “tobacco dependence” (as US FDA does), or does MHRA approve medicines as “smoking cessation aids” (which only requires quitting smoking, not quitting nicotine)?

    The upside of this announcement is that BAT and perhaps several large e-cigarette companies will now fund clinical trials for their e-cig brands.

    Once MHRA approves the first e-cigarette brand as a “medicine”, it will be international news, and everyone interested in this issue will finally know that e-cigarettes are effective for smoking cessation.

    But the biggest economic beneficiaries of this future news story will likely be hundreds of smaller e-cigarette companies (that didn’t spend money on clinical trials and that didn’t apply for MHRA approval) that can sharply undercut the price of the MHRA approved brand and can sell on the Internet, in other countries, and via black/gray marketing.

    • Mark Entwistle

      Thank you for this hint of optimism, to which I intend to cling, but either way the thinking behind this proposed legislation is very worrying. The legislation has the potential and seeming intent to condemn existing and future smokers to death, an effective devesting genocide, I feel this strongly. What at point can be done by ordinary people such as myself other than hope your appraisal of the situation is right.

      • richard kirk

        only thing we can all do is send letters to your local mp and saying how they have helped and chaged your life for the better, it ain’t over till it’s over, chin up.

    • Jonathan Bagley

      Surely BAT et al will expect something in return for this investment? A tacit agreement that the Government will make sure that the smaller ecig companies can’t continue a grey or black market in unlicensed products. A ban on online sales for example.

      • Fergus Mason

        “A ban on online sales for example.”

        I’ll be interested to hear how they would apply that to companies operating out of Hong Kong. I have no intention whatsoever of buying BT and BP’s overpriced, tedious products; I’ll simply buy my supplies from overseas and trust that enough makes it through customs to keep me going.

  • [...] is completely wrong for e-cigarettes: Clive Bates’ (former director of ASH UK) on “10 reasons not to regulate e-cigarettes as medicines“, and Dr. Farsalinos on “MHRA has decided to ban [...]

    • several million people around the world have been using ecigs, but if one side-effect is even remotely linked to using electronic cigarettes then the governments have to be seen to act and put some type of deterrent in place.

  • Mark Entwistle

    My chin remains generally high, and up to now most regulation attempts have failed. Also still have 3 years to buy enough product to last me a life time.

    Am determined to become active on this issue though as it is both personal to me and many other, but also highly political.

  • peter waring

    all i can say on the matter is since switching from cigarettes ,to ecigs I have been able to go to the gym upto 4 times a week, have lost 3 stone in weight feel fitter than i,ve ever felt,so why regulate a product when it has excellent benefits to your health and wellbeing.

  • Dodderer

    It is interesting that much in the MHRA statements now attribute the decisions to the Department of Health – is this tacit confirmation that the decision is now political?If we can persuade a majority of MEPs and MPs that the proposal is wrong,how will the Department of Health respond?

  • John Yu

    This is clearly a financially driven decision for the Government’s benefit. A tax on ecigs would be difficult to justify and loses billions in tax revenue from those switching from real tobacco is also not a option.

    This leaves the only option – ban them or effectively ban them on safety grounds. Those grounds are shaky at best and completely unproven. But, there has to be some excuse to regulate these things.

    But, what this regulation is more likely to do is develop a black market of products which are far less safe than what is currently available.

    Click here for an article on this.

  • Mark Entwistle

    The problem seems to be threefold;
    1) Big tobacco and Big Pharma are acting on vested interests to push legislation in their favour.
    2) Governments themselves have a huge vested in interest in regulation as a revenue raiser,
    3) Officials at national and European level are caught between two stools, held captive by irresponsible media. Despite agreeing entirely with the article I do have some sympathy with WHO representatives who cant support the use of SNUS and e cigarettes (please read linked articles). SNUS has documented health consequences and should there turn out to be long term consequences with e cigarettes promoting them is professional and political suicide. Imagine the headlines. This is not to say that I agree with the stance just that it is understandable.
    The upshot is insane and dangerous legislation that ultimatley will favour the vested interests of big tobacco, big pharma and career health officials, and continue to kill us.

    • Jonathan Bagley

      Your links haven’t appeared. I like to see these documented health consequences of snus. Sweden has low rates compared to other EU countries of all cancers claimed to be related to snus use and the lowest male lung cancer incidence in the developed world. As for ecigs, nothing is certain, but the chance of theatre smoke/medical use propellent and nicotine causing some form of cancer which shows up after decades is vanishingly small. By now, several million people round the world have been using ecigs for at least three years, and no serious ill effects have been reported. Officials at national and European level are either stupid or corrupt or both.

      • Mark Entwistle

        Sorry Jonathon was refer to links in original article, in terms of the snus, I was not trying to imply that it is a dangerous as tobacco smoke or that it is not a good harm reduction strategy to use it. As an vaper myself I agree totally with your assessment, and with your proposal that official both stupid and corrupt, or at least there corruption makes them look stupid. I was trying to convey the sentiment that this is also compounded by the media, who are currently doing there best to ignore reason and play on emotion, see in particular articles in Guardian. Should any official stick there head above the parapet and the worst case scenario come true or one person had a bad adverse effect, that official would be held personally responsible, this also pushes officails to a conservative approach to the issue of ecigs.

  • Dave Atherton

    I was on BBC Radio Ulster with a lady called “Neve Hoy” talking about e-cigs. We have a right 10 minute ding dong. 35.20 in.

    Typically ill informed anti smoker.

    http://www.bbc.co.uk/programmes/b02vdlp4

  • Tine

    Can this 10 reasons be used for e-mails to the MEPs?

    • Clive Bates

      Hi Tine – yes you can use whatever you want from this site. However, I would recommend using that to brief yourself up, and then write about your own experience and feelings about these developments. MEPs have really valued hearing directly from vapers in their own words and it has changed the way they think about this…

      Clive

  • Dave Atherton

    I have just commented in the Cancer Society blog:

    In 2003 the MHRA was formed by the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency. The National Audit Office was moved to say “The Agency is also unusual in having a stated objective to facilitate the development of the UK pharmaceutical industry.”

    http://www.nao.org.uk/wp-content/uploads/2003/01/0203255.pdf

    The current Chair of the MHRA Alasdair Breckenbridge said in 2005 “In addition, from November 2005, European regulations will require that staff have no financial or other interests that could affect their impartiality.”

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1246088/#ref2

    It gets worse.

    Sir Alasdair Breckenridge was a “Q780 John Austin: Can I raise the issue of Seroxat and your knowledge and involvement. In 1998, I believe you were on the advisory board of GlaxoSmithKline or SmithKline Beecham, as it was at the time.

    Professor Sir Alasdair Breckenridge: No, let me just clarify that. From 1992 to 1997 I was a member of a scientific advisory committee of SmithKline. I resigned from that in 1997. This had been an extremely valuable exercise for my development in medicines regulation. We did not discuss specific products on that board; it was a matter of the larger picture of industry. I resigned from that in 1997 and this post had been taken up with the full cognisance of the then MCA. I discussed this with the MCA and I acted in a totally appropriate manner with respect to the decisions that I was party to there and in drugs and medicines regulation.

    http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/5012003.htm

    What is going on here?

    http://scienceblog.cancerresearchuk.org/2013/06/12/licensing-e-cigarettes-opportunities-and-risks/#comment-12576

  • danny webb

    would anybody on here drink chinese water????

  • David Sweanor

    For a very readable overview of key issues concerning e-cigarettes, including issues of regulation and relative risk, I highly recommend reading Professor Lynn Kozlowski’s recent piece in the Huffington Post:
    http://www.huffingtonpost.com/lynn-t-kozlowski-phd/e-cigarettes_b_3492528.html

    Dr. Kozlowski is a very thoughtful and credible public health leader on a range of tobacco and nicotine issues. He’s worked in the field for decades, and has long advocated the simple strategy of ‘tell the truth’. He does so admirably.

  • [...] have uncritically followed the Commision proposal and seek full medicines regulation for e-cigs (a dreadful idea).  But the argument is moving towards the more liberal minded MEPs, who include UK Liberal [...]

  • [...] UK ban petition was quickly established for people to sign. Clive Bates released a great article on ’10 reasons not to regulate e-cigarettes as medicines’ and thefreesociety.org investigated the reasons behind the MHRA’s decision, revealing that [...]

  • [...] UK ban petition was quickly established for people to sign. Clive Bates released a great article on ’10 reasons not to regulate e-cigarettes as medicines’ and thefreesociety.org investigated the reasons behind the MHRA’s decision, revealing that [...]

  • It’ll never pass …..
    1-battery’s will never be illegal
    2-resistance wire will never be illegal
    3-string will never be illegal
    4-Propylene Glycol will never be illegal
    5-Vegitable Glycerin will never be illegal
    6-food flavourings will never be illegal
    6-distilled water will never be illegal
    7-nicotine will never be illegal

    Win for the vapers

    • Clive Bates

      Mark – it may well pass. They’ve managed to ban snus for 20 years without any evidence of harm and plenty of evidence that it is reducing harm.

      Your argument is actually a good counter to the lovers of zealous regulation – they will create a cottage industry for more risky than the one they are trying to regulate! The trouble with relying on DIY is that it will always be an enthusiasts market – like people who choose to grow all their own food. There;s nothing wrong with that of course, but hard to imagine at the scale we might hope for

  • Paul

    This shows the side effects of what the medical world prescribe. Its not about health… its about MONEY! http://www.chantix.com/safety-information-side-effects.aspx

  • [...] 10 reasons not to regulate e-cigarettes as medicines [...]

  • [...] for regulating e-cigarettes as if the were medicines: the arguments for this are weak and the arguments against it are strong, not least because e-cigarettes are not medicines, and there are plenty of applicable [...]

  • [...] e-cigarettes as medicines (see, for example: The case for regulating e-cigarettes as medicines; 10 reasons not to regulate e-cigarettes as medicines; Medicines regulation for e-cigarettes – when caution can kill – and pointed out it is [...]

  • [...] Firstly, there is a lot of hysteria in the media about ecigs (misinformation). It’s also true that European parliment is trying to heavily regulated them. Before you get sucked into the political rubbish, I suggest you read this post by Clive Bates, an ecig advocate. [...]

  • Jeroen Spijker

    The tobacco industry makes its money selling a product that kills. People know that know which is why smoking rates have generally drastically declined (at least in the western world); also because government legislation around the world have also finally caught up with this fact by making smoking costly and prohibiting its use in public places. Now the tobacco industry has found an alternative in e-cigarettes. It is basically substituting one addiction for another and they are finding ways to legitimise its use through biased scientific research that suggests that it helps to quit smoking (people in the 80s and 90s either died from smoking or just quit without using patches, e-cigarettes or whatever – in the end it’s all between the ears). Governments are caught up in the middle, perhaps not so much because of possible (though it seems unlikely) adverse health effects but perhaps more so because it may also create a need among younger people to start vaping (through advertising that is clearly directed at them) that then may lead to the uptake of ordinary cigarettes. The (moral) question for me is just that: do we want these big, unscrupulous, corporations to create another addiction without exactly knowing what the consequences are?

  • The problem with your argument (apart from the many inaccuracies) is that we already know what the result is: smoking gradually declines so much that there is a realistic prospect of it being rendered such a minority activity that (a) it finally becomes vulnerable to real regulatory control, and (b) smoking-related mortality and morbidity reduce in proportion – as has happened in Sweden. Male smoking prevalence in Sweden falls at 1% per year and will be at 5% around 2016. No other similar country has the remotest prospect of achieving that. All done at zero cost to the taxpayer, by unhindered access to a suitable alternative to smoking. When Sweden has a male smoking prevalence of 2%, most other countries will still be arguing about how to get below 20% (if ecigs are banned). The gateway effect is nothing more than rent-seekers’ propaganda – THR products are proven to be a gateway out of smoking. If smoking disappears in a given country (which is the way it is going in Sweden, at least for the male population) then all such arguments are shown to be valueless. It’s a well-recognised propaganda technique: create uncertainty where there is none. We already know the result.

  • Alan Fletcher

    If the E.U. get their way, then we have 100% proof of bribery. Proof that they’re willing to walk over corpses to serve the tobacco and pharma industries rather than save thousands of lives. All they will achieve is that this massive market wanders all the way back to China and perhaps into the black market and everyone will thus miss out.Perhaps this is a decent thing. After all the Chinese invented ecigs in the first place.

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