Medics, money, and e-cigarette regulation

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    Here is a discussion of the issues surrounding electronic cigarette regulation. The article is based around a radio appearance by a tobacco control academic in the UK. It discusses the role of the medical profession, e-cigarette regulation (with specific relevance to the UK although the issues are universal), and some of the financial implications of successful uptake of e-cigarettes by smokers.

    BBC Radio 4 in the UK ran a feature on electronic cigarettes, and interviewed Prof John Britton, a well-known UK academic who broadly supports tobacco harm reduction.
    BBC iPlayer - Inside Health: 28/02/2012

    We have placed it in The Library because it shines useful light on several of the core issues surrounding e-cigarette regulation: especially the financial implications for the pharmaceutical industry, and the way in which health services act as agents for the pharma industry. In general, people probably do not understand why electronic cigarettes face bans, and here are some of the answers.

    Medical professionals are so closely involved with pharmaceutical interventions that any other way to improve health seems unprofessional to them. Given an opportunity to reduce the smoking death rate by 50%, they will oppose any such solution if it does not have a pharma origin or threatens pharma's interests. Indeed, even the medics who approve of such seemingly-unconventional methods to reduce the death and sickness rate seem to have very little understanding of many of the issues.

    In addition, the medical profession as a whole does not seem to support harm reduction. This is hard to understand since the most efficient way by far to reduce sickness and death is by promoting less-harmful ways of consumption. People will not, in general, stop doing what they like; but they can be persuaded to do it more safely. This situation is even more strange because doctors themselves estimate that up to 80% of patients they see in general practice are there because of lifestyle choices. The rational observer would imagine that low-fat foods, low-alcohol beer, smokeless tobacco, e-cigarettes, decaff coffee and suchlike would be at the top of every doctor's agenda, since the results obtained would be far in excess of anything achievable with pharmacotherapy: the reduction of disease in the first place instead of having to treat the symptoms. This does not seem to be the case: pills seem preferable to solutions. The implications of this are among the issues discussed below.

    This article was originally posted here:

    Radio 4
    The BBC Radio 4 program was interesting as it had a positive air to it. Prof Britton was the expert consulted and he is known for being sympathetic to our aims. His material was generally accurate and balanced, though there are four important points I would take issue with:
    • That e-cigarettes are unregulated in the UK
    • That the MHRA should for some reason be involved in regulating them
    • That "we don't know what's in them"
    • That the UK has a 'permissive attitude to tobacco alternatives'

    The UK is unique in that it is the only country in the world in which e-cigarettes are regulated. They are regulated in the same way all foodstuffs or consumer products are, because no items sold to the public are 'unregulated' - this is against the law. The Trading Standards authorities visit, inspect, take away, and analyse e-cigarette hardware and refills from all UK stores and UK-registered websites. Contaminants are tested for and the products are either permitted or removed from sale. Vendors are either passed on each inspection or prosecuted.

    A statement that 'e-cigarettes are unregulated' is the same as saying 'cigarettes are unregulated' or 'alcohol is unregulated' or 'food is unregulated' or 'consumer products are unregulated'. They are 'unregulated' until you sell some with toxic contaminants, and then at that stage you will be regulated into court. This would be a fair description of consumer product regulation to any reasonable person. If cigarettes get the same treatment, and they kill 100,000 to 120,000 a year in the UK, it sounds like a fair deal. E-cigarettes have never killed anyone and there is no evidence they ever will. Statistically, it is inevitable they will, just as water or salt will - perhaps 0.0001% of those killed by smoking. Consumer product regulation seems entirely appropriate unless substantial evidence can be produced to show it is not sufficient and that serious harm has been caused. There is no such evidence; indeed, after millions of user-years of safe and harmless use, it seems unlikely that significant evidence will be found as no disease vectors are apparent.

    It must also be recognised that the UK trade association ECITA is the strongest and best-organised in the world. It has by far the best documented practices and management of vendors of any ecig trade group, and enjoys a good relationship with the regulators, Trading Standards, who described the ECITA ISE (standards) as 'a code any industry would be proud of'. They work together to ensure materials testing is comprehensive and accurate. Because ECITA is known to manage its vendors efficiently (they have their own GC-MS machine for example), the regulators can concentrate more effectively on non-member vendors since that is where any toxic ingredients are more likely to be found.

    It is important to realise that regulation needs to be restricted to contamination by toxins - as it already is. Trying to legislate for other aspects of the system would immediately render the legally-compliant market ineffective, and create a black market for effective products. As an example, one vendor alone has over 7,000 e-liquid variants when the differing base liquids, strengths and flavors are multiplied out. As there over 1,000 vendors just in the US for example, the range of product variants is vast - there are at least 10,000 available basic e-liquid variants (the total of all possible combinations offered by all vendors is uncountable). It has to be so, as that is what the success of the system depends on. If you could only buy green tea, and only one brand of it, you probably wouldn't think much of tea as a drink, and it would have very few buyers; but you can buy thousands of variants from fine Darjeeling to cheap breakfast teabags. It's what makes it work. As long as it is not contaminated then there is no problem. Electronic cigarettes provide a mild consumer stimulant and stress reliever like coffee and cigarettes. Consumers ingest what they need and no more.

    Trying to regulate the 'dose' of coffee or how it is provided is a completely pointless exercise, as most would recognise. It would be an expensive exercise in pointless bureaucracy, as the huge cost would be wasted. Any regulations would be circumvented by unregulated sales of products that provide what people want. In order to get a good cup of coffee, people would buy outside the system. Trying to tell people what coffee they should drink or how to drink it is utterly futile. The same thing goes for e-cigarettes: check the materials for toxic contamination and leave it at that. Taking it further has no possible health benefits (no harm has been caused), and would be a self-defeating exercise since buyers will shop elsewhere; the internet cannot be banned.

    The MHRA are a medical licensing authority and e-cigarettes are not a medicine. They don't have the slightest relationship to a medicine and neither does low-alcohol beer or decaff coffee. Why an alternative type of tobacco can be considered as some kind of medicine is beyond comprehension. If people change to oral Snus tobacco or dissolvable tobacco or any other safer alternative to smoking it is not a medicine.

    In addition, the MHRA are in the running for the most corrupted of any UK government agency, so we'd rather not be involved with them in any way, thanks. They get the award for Regulatory Captured Agency of the Year. Some would say that everything they do has an ulterior motive, and that motive is to protect and nurture the pharmaceutical industry. The only possible regulation the MHRA is interested in is to regulate e-cigarettes out of existence, as that is what their paymasters want. The idea of 'light touch' regulations is lunacy. The pharmaceutical industry don't want light-touch regulations for ecigs - they want ecigs killed stone dead. How can they preserve their monster drug trade for sick smokers if ecigs take away 60% of smokers? Who is going to buy their chemotherapy drugs, cardiac drugs, COPD drugs and all the rest of the gravytrain that keeps them afloat? Their MHRA poodle might start out with light-touch regs, but you can bet your bottom dollar that year by year those regs would squeeze tighter and tighter until ecigs are choked.

    The issue of rogue e-cigarette marketers selling products as a medicine is entirely different. You could sell a brick as a therapy given the marketing skills - but it doesn't affect the fact that bricks are not a medicine. Someone should shut any such fraudulent internet marketers down and if it's the MHRA doing it, then we have no objection at all. Their realm is medicines and if someone is claiming some sort of therapeutic value for e-cigarettes - then have at 'em. Electronic cigarettes are a consumer product that replaces tobacco cigarettes, for permanent use. If somebody wants to claim otherwise then let them take the consequences - medical licensing.

    Oh no - not this one again
    Unfortunately, the standard "We don't know what's in them" was raised, yet again. At an individual level - for any given brand - maybe; in that case ask Trading Standards to take a look, as this statement assumes they are not doing their job. If you are saying that Trading Standards are not doing their job then just come out and say so - let's please stop all this innuendo and nonsense.

    We know far more about what is in e-cigarettes than what is in tobacco cigarette smoke. At the last count 9,600 compounds had been identified in cigarettes and tobacco smoke but there are more to be identified [4]. E-cigarette vapour generally has around 10 components (or less) so it's not exactly hard to figure out what's going on. After more than 50 clinical trials, studies and lab analyses it's pushing it a bit to say we don't know what's in them. On the contrary, we know exactly what's in them. If someone is talking about a specific product then get Trading Standards to do their job.

    We know exactly what is in e-cigarettes and it is all GRAS / Acceptably Safe, apart from the chocolate flavour. We don't know much about that - but at this point in time assume it won't kill too many thousands of people.

    Permissive attitude
    A statement that the UK has a permissive attitude to tobacco alternatives frankly beggars belief. The UK is one of the world's most restrictive countries in this regard, and almost all safer tobacco alternatives are banned, resulting in the unnecessary deaths of at least 10,000 people a year - smokers who are denied access to safer products. The only exception is the e-cigarette, which has fallen between the cracks as it is simply a consumer product and cannot be classified as tobacco or medicine as it doesn't contain any tobacco and it has no therapeutic value. It's a clean nicotine delivery system and as such, something completely new.

    Electronic cigarettes are currently only permitted because of government paralysis: there is an impasse in a fight between two powerful groups - the agents of the pharmaceutical industry within the Department of Health, who want to shut down e-cigarettes at any cost; and the anti-regulation camp in the Conservative party. If Labour were in power, e-cigarettes would have been banned by now. While this impasse continues, e-cigarettes are in position of temporary safety. When the battle is decided, that changes.

    The pharma industry stands to lose billions when e-cigs become popular, and they are desperate to stop e-cigarettes any way possible. The vast sales of all the drugs used to treat sick smokers, plus considerable numbers of staff at the DoH, depend on maintaining the status quo: 20% smoking prevalence and plenty of disease. Introduction of Snus or confirmation of permission for e-cigarettes would be a disaster for pharma: a loss of billions just in the UK. The chemotherapy drugs, COPD drugs, cardiac drugs, vascular drugs and other treatments for sick smokers would take a 50% hit or more, causing the biggest disaster to the pharmaceutical industry they have ever experienced. The 50,000 lives a year saved or thereabouts is of no consequence at all to them. Drug pushers [1] just need move product at any cost; and their friends at the DoH will help them any way they can.

    The UK government is complicit in the EU-wide ban of Snus that probably kills a minimum of 10% of EU smokers a year, and which benefits pharma so handsomely. Sweden reduced their smoking prevalence by 64% by male prevalence comparison with the UK at 2013, and their smoking mortality falls in parallel. It's why they have the lowest smoking-related death rate of any developed country by a wide margin; the lowest number of smokers of any developed country by a wide margin (calculated at Q4 2012 as 11% average male/female; only about 8% of Swedish men now smoke and prevalence falls by 1% per year); the lowest male lung cancer rate and oral cancer rate in Europe. They negotiated an exemption to the EU Snus ban when they joined the EU. Who would join a federation that guarantees to kill thousands of your citizens?

    It's known as the 'Swedish Miracle': a way of fixing the smoking death problem and with no cost to the government except for the loss of pharma's personal benefits for government staff. It is light years ahead of any other country's efforts: Sweden is the world leader in reducing smoking prevalence, the world leader in reducing smoking-related mortality, and the world leader in reducing smoking-related morbidity.

    Unfortunately it is a disaster for pharma in Sweden, as their sales of drugs to treat sick smokers, their sales of Nrts, and their sales of many other drugs boosted by smoking (e.g. diabetes, cholesterol, blood pressure meds) are, as can be expected, very poor indeed. That's why they are desperate to stop the Swedish scenario spreading further afield, and why they successfully maintain the EU Snus ban. The UK government help them by banning Snus and other safer tobacco products. The UK government is complicit in the deaths of those who would switch to Snus if they had the opportunity (Snus has no elevation of risk for any disease including any kind of cancer or heart disease - a Snus user has the same risk as a non-smoker; more than 150 clinical trials and surveys over more than 25 years demonstrate it; but more importantly, the national health statistics prove it). Perhaps 10% of UK smokers would eventually convert to Snus (vs the 50% or so who converted in Sweden), although it could be more. The UK government in effect kills those smokers - about 10,000 a year or more [2].

    The UK will also kill e-cigarette users who are forced to return to smoking, if it folds up under pharma pressure to license (i.e. ban [3]) e-cigarettes. That number will eventually run into millions.

    It's about the money, not health
    Unfortunately, almost every medic we come across reveals the fact they are politically naive beyond belief. This is a political issue, not a health issue, because it's all about money, corruption, power and tax. The health issues aren't of any importance, and never will be.

    If the UK government currently gets away with killing around 10,000 of its citizens a year to support pharma, and this issue isn't even broached in the press, how can it have anything to do with health? The basic issue is simple: is it or is it not right and proper for an industry to control public health policy and remove its commercial competitors, thereby sentencing thousands to death? Apparently it is not just proper, but also government policy to help and support that industry.

    There is a school of thought that feels that some in the medical profession are partly responsible for this state of affairs. It accuses them of institutionalised cowardice because the solution to the high smoking morbidity and mortality rates is obvious, but the problem is that doctors involved with health and smoking issues are so financially conflicted or timid they cannot act.

    Patients themselves are having to take the action doctors should themselves have insisted on long ago. The public are having to take on the suborned in the health industry and governments, because health workers cannot or will not. There are too many with financial conflicts; too many obviously subject to moral cowardice that prevents them refuting the torrent of propaganda and lies in this area in order to protect their careers; and too many suffering from the usual crushing inertia seen in the medical profession that means they are so often ten or even twenty years behind the curve.

    The medical profession are a major part of the problem. They are deeply implicated in the ongoing massive deathrate from smoking. Cowardice and financial conflicts prevent action to stop it - action that is easy, cheap and proven effective; unlike the current solution, which is expensive and useless.



    [1] It is long past time we stopped thinking of the pharmaceutical industry as the good guys. Just because they also sell aspirin or antibiotics does not make them squeaky clean. The opposite in fact: elements of the pharmaceutical industry are the most heavily-fined criminal fraudsters in the world. As criminal liars and corruptors on a mammoth scale, they are certainly 'good' at it, as none have achieved their scale of fraud, lies, corruption or fines as a result. Just google for 'bbc pfizer criminal fraud'. Having to pay billions (yes - that's billions) in fines for criminal fraud and corruption on an epic scale does not make you the good guy.

    There is a valid argument that they are criminals on a mammoth scale and need to be treated as such; and that a drug cartel is a drug cartel whether its headquarters is in Medellin, Colombia or Geneva, Switzerland. They are also a power for good; so there is an essential dichotomy in their activities that needs to be recognised. Simply emphasising the good, at the expense of their proven corruption of public health in the search for profit at any cost, does not help.

    [2] It is not satisfactory to say that the EU kills all those UK citizens and not the UK government. If some other EU-induced factor killed thousands of UK citizens every year, it is certain that something would be done about it. Unfortunately there are two issues that permit this scale of disease and death:
    a. Smokers have been cleverly transformed into society's lepers, who can have all their rights taken away without issue; they can even legitimately be killed.
    b. Government staff are clearly very friendly indeed with the pharmaceutical industry.

    [3] Medical licensing for e-cigarettes is equivalent to a ban because there are thousands of products and each would require a separate license. So far it has cost the only UK company to apply for a license about £2.25m for one product, and rising. In effect it means 99.999% of products would be removed from the market. The largest black market ever seen in the UK would then be created.

    [4] Rodgman, Perfetti 2103.
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