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    Demonizing E-Cigarettes Is Not Evidence-based
    By News Staff | February 5th 2014 06:00 AM | 12 comments | Print | E-mail | Track Comments

    Sometimes it's just public relations. We subsidize nicotine patches but regulators are increasingly interested in banning electronic cigarettes.

    Such misguided legislation, not backed by sound data, may have consequences for public health, experts say. With smoking blamed for up to six million premature deaths each year, a lot is at stake in the newest push for regulations.

    Tar, chemicals, and other substances found in tobacco smoke cause most of the health risks from cigarettes, not nicotine. That's why patches work and marketing campaigns using tax dollars endorse patches. Likewise, e-cigarettes deliver nicotine without the smoke. Yet despite users seeing the clear benefit from e-cigarettes, members of the health community, pharmaceutical regulators and governments have voiced concerns. Fears include e-cigarettes encouraging higher nicotine consumption than traditional cigarettes, and perpetuating addiction rather than promoting quitting, though no one takes up nicotine patches and then migrates to cigarettes.

    Potential health effects from long-term e-cigarette use are unknown, unlike marijuana, which is well-documented even without the lung damage but is enjoying a golden age of popular approval. Yet despite any evidence, detractors claim these products will appeal to young non-smokers and make smoking publicly acceptable. The authors of the article argue that these claims are speculative but are often cited in moves to restrict e-cigarettes.

    The authors show that efforts to address these concerns without sound data can lead to unintended consequences: the first draft of the revision of the European Union (EU) legislation proposed in December 2012 attempted to define arbitrary limits to the nicotine content in the liquid of e-cigarettes, a clear indicator of the poor understanding of the problem by legislators.. Only a few months later, the same EU health ministers proposed distinctive amendments to the first draft applying substantial pharmaceutical regulations to e-cigarettes– a move that was rejected by the EU Parliament in October 2013. This would have resulted in higher costs and limiting access (sale via pharmacies only) to consumers. The authors say, "It is counter-productive and hypocritical to over-regulate a product designed to reduce or eliminate the diseases and early deaths caused by smoking." 

    The UK's Medicines and Healthcare Regulatory Agency (MHRA) has moved towards regulating e-cigarettes as medical products - meaning cigarettes are legal but substitutes are not, a move sure to promote cigarettes. In Canada, electronic products that dispense nicotine by inhalation fall under the Food and Drugs Act of the Health Canada, which means it is illegal to smoke e-cigarettes, and stipulates that it must be approved as a new drug before they can be sold or imported. 

    Daniela Saitta, Giancarlo Antonio Ferro and Riccardo Polosa from the University of Catania propose that e-cigarette regulators should consider:

    • Evidence that good manufacturing practices (GMP) have been followed

    • Child-proof caps on fluid containers
    • Official documentation reporting on the contents of e-cigarette fluids to regulators
    • Clear, accurate and detailed labeling about the contents and the hazards associated with e-cigarette use.

    Moreover, regulatory frameworks for electronic products are already available in the EU legislation to cover for the safety issues regarding E-cigarettes' hardware components. The authors note that such legislation may be "impossible to implement" due to the interests of  tobacco and pharmaceutical industries, and, of course, that governments have increasingly raised taxes on cigarettes, making social services more reliant on that revenue.

    "If these obstacles can be overcome, much misery and suffering can be reduced and millions of lives can be saved," the authors declare. "E-cigarettes are not a gateway to smoking but a gateway from smoking, and heavy regulation by restricting access to e-cigarettes would just encourage continuing use of much unhealthier tobacco smoking."



    Article: "Achieving appropriate regulations for electronic cigarettes",  Therapeutic Advances in Chronic Disease.


    Comments

    How refreshing to read an article about e-cigs that is not a cut and paste of a press release to put pressure on regulators. The current EU regulation, Article 18 of the Tobacco Products Directive, which is based on uninformed fears does nothing but give a cartel to the companies that can afford very expensive and pointless testing. It also cripples the effectiveness of the product by setting arbitrary limits. In its justification document it cites 4 scientific articles, the authors of 3 of these documents have complained about the misuse of there work. http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/149...
    The purpose of the regulation is given the best explanation by completely independent financial analysts
    'Fitch the ratings agency: points out via Reuters on 11 October 2013 that more regulation will raise barriers to entry and favour the tobacco industry while limiting the impact of e-cigarettes on cigarette sales: 
    Further regulation or demand for scientific studies could make it easier for the tobacco companies to bridge the gap – thanks to their deep pockets and experience of dealing with a highly regulated trading environment. Tougher regulation, as well as providing a relative advantage to their e-cigarette divisions, would result in higher prices for e-cigarettes – which could also benefit tobacco companies by limiting their attraction for smokers and slowing the decline in tobacco sales.''
    One of the ironies is that one of the leverage's to get regulation was the threat of Big T not been regulated. British American Tobacco did a press release over the weekend saying the were happy to comply with the regulation and casting doubt on why other distributors & manufacturers opposed it. Maybe its the millions it will cost to test the products and that the superior products they supply will be banned.

    While I agree with the gist of both the article & the comment above. First, the article compares e-Cigs and Nicotine patches as if they are equivalent. While they both do deliver Nicotine to the bloodstream, the are still differences that I believe are significant differences. First, the rate of delivery of e-Cigs is equivalent to Cigarettes, while the patches are designed to deliver the drug over a much longer time. Secondly, the e-Cigs mimic the rituals of smoking, which have been widly cited as a barrier to quitting. I, thus, hold the opinion that e-Cigs are useless for quitting smoking. that opinion has been supported by personal experience, with 2 members of my family still puffing their e-Cigs after 4 months. They are showing no inclination to wean themselves off the devices. Frankly, people who can ignore the health risks of smoking will have no problem continuing, or increasing their Nicotene use, because, after all, it must be safe, there's no tobacco ! Which brings me to my mild disagreement with the comment above. While I can agree that overzealous & excessive regulation would be bad, both generally & in this particular case, I think we differ on what we consider 'overzealous &/or excessive. The commenter above seems to be argueing that ANY regulations are overzealous & excessive, and will drive all e-Cig suppliers out of business, immediately. I see nothing wrong with requiring that the ingredients be disclosed to the customer & that they be safe for human consumption. At this point theres no telling what that 'secret ingredient ' is , nor any sort of assurance that it isn't mixed with swamp water, or any of millions of other potential contaminates. We regulate the food industry, there's no reason the suppliers of
    e-Cigs can't comply with the same sort of regulations.

    Hank
    Secondly, the e-Cigs mimic the rituals of smoking, which have been widly cited as a barrier to quitting.
    Well, no. There are catalysts to smoking but those are not the actual ritual of putting something to your mouth. Instead, there are habits that lead to craving smoking, along with the smoking itself. For a while, I got in the habit of eating chips and drinking a soda while watching a movie. My weight went up. I had associated chips and sodas and movies by habit, it was not the act of drinking that led to weight gain but I physically missed the chips and soda for a while. It is the smoke that causes the health issues - there are no articles about second-hand nicotine or third-hand smoking mimicry that implicate those in lung cancer.

    Outside that, I think you are spot on, though so is the article. Barriers to things proven to help people quit, and E-cigarettes seem to do that as well as patches, and process quality assurances seem obvious.
    First, the rate of delivery of e-Cigs is equivalent to Cigarettes - No they are not. For cigs it's about 8 seconds and ecigs is about 20 to 30 minutes or so.
    Your family members do they still smoke. If not then they quit smoking. If yes they probably decreased the number of cigs smoked which is also a good thing. Yes they still use nicotine but that is not the same as smoking!
    For e-liquid just some consumer product regulations should be enough anything more is excessive.

    My apologies if I am implying no regulation is a good thing. I will use the UK as the example I know. Ecigs are currently they are covered in the UK as a general consumer product, CE electrical regulations & COSH chemical labelling regulations which includes things like a list of ingredients. From 2008 all the suppliers I know of were talking to trading standards and other relevant bodies. They voluntarily introduced child proof caps and no sales to under 18's and more. Trading standards have commented on how effective this relationship has been. To date this all seems to have worked very well. But this was when the market was young the majority of users were educating themselves and suppliers had a limited market where a couple of bad reviews could seriously effect there business. Its also an advantage that the ingredients are so cheep, there isn’t a cheaper but more dangerous alternative to propylene glycol.
    We are now in a different situation with 7 million users in Europe and rapid growth. I do see the need for regulation, industry standards, clear and informative labelling, appropriate warnings and lots of study of these products and the users. I do not think the currently planned regulation will drive all ecig suppliers out of business but that it as the possibility to give a small number of companies a cartel and could seriously hamper the public health benefits.
    I just want to see the job done properly regardless of whether it suits my personal whim. One person suggestions I would recommend is Clive Bates http://www.clivebates.com/. He has an excellent track record as director of ASH (Action on Smoking) . A lot of what is there now is addressing the planned regulations but there is suggestions for regulations as well.
    Another thing you mention is interesting. People exchange smoking for vaping. There is a lot of debate here far more than I can deal with now. A couple of things, delivery of nicotine from an e-cig is different from smoking. It takes time for a build up in the blood plasma and does not have the same spike effect. During the change from smoking to vaping higher percentages of nicotine seem to be needed. There seems to a trend for vapers to then lower the nicotine concentration. An example, I started with 36mg per ml juice and am now happy with 6mg/ml juice. This seems very common and is reflected in sales figures. . (Look at this slide 29 http://www.slideshare.net/lindsayfox/research-on-safety-of-electronic-ci... This bizarrely is the presentation the EU as cited to justify limiting nicotine content to 20mg. They say that’s all what is needed in the cessation period. The author as complained.) A lot of people myself included find not vaping for long periods does not cause the agitation not smoking.did. There are a lot of questions to be answered on how nicotine dependency works.
    What we seem to be getting is not so much an addiction to vaping but a vaping culture. Its difficult to classify bit its more like coffee drinking. Some people are using very high quality devices. The quality of the tastes in some of the juices available are extraordinary if mixed with the right device.
    I personally do not see the need to regulate this type of thing more than we regulate coffee or similar pastimes adults enjoy. Currently the regulation the EU are proposing for ecigs are far tighter than the regulations on cigarettes? I think that is an area to debate though and its refreshing to be looking at serious questions about e-cigs with somebody who does not use the devices.

    Hank
    Despite the fact that there is no evidence basis, one party in Congress has unsurprisingly insisted they be banned anyway, saying the evidence is unclear that they are safe, "both for current users and for bystanders exposed to their vapor.”

    Oh, you mean we should ban things even when there is no evidence they are harmful? Luckily, it's not just a kooky California thing, other Democrats have jumped onto the social authoritarian 'precautionary principle' train.
    Nicotine patches are said to work in 7% of cases [ and that's optimistic and probably exaggerated] if it were true then nicotine patches true cost is about 14 times the patches retail cost as 13 out of 14 do not work. Whereas the electronic cigarette is not subsidised, no Medics are paid to prescribe it so it costs the public purse nothing, it reduces the tobacco harm effects of cigarettes and therefore adds to the public purse by reducing health costs, and if the smoker doesn't like it they stop buying it. So why the resistance from the tobacco harm people? Competition to Big Pharmas NRT, and tobacco harm related drugs [ and they finance the charity's], competition to Big Tobaccos cigarette empire, and erosion of customer base for all the tobacco harm charity's. It's a pure business decision for those that live off tobacco misery those pretenders are gradually being exposed.

    Hank
    And, as noted, the government. In the US, tobacco company settlements have paid for an entire industry - anti-smoking PSAs, which are billions of dollars. And when the government wants more money, they raise taxes on cigarettes, so it isn't a Big Tobacco conspiracy, lots of taxpayers are fine with raising taxes on someone else.

    CVS is walking away from all tobacco sales and risking $2 billion to do so. They will be proof of concept for how much government and corporations want to leave tobacco behind. 
    It's my opinion that Normalising the Nicotine will help to ReHumanise smokers.

    liquid Nicotine has a warning on the label not to take it all at once because it will poison you. Inhaling poison in any form is not harmless. When sitting next to someone vaping you can taste exactly what they are vaping, why should I as non- vapper have to taste it? Even if it's 100% harmless allot of places require you to bathe and not to were offensive perfumes, general public don't want to smell what's been in your body, basic courtesy. If you want to do that to yourself fine; however wouldn't it be wise to know exactly what your inhaling and what it's doing to your body and others?

    If you drink a bottle of perfume you will probably die also. Stay far away of that beautiful women that smell so good.

    In your opinion everybody should stop breathing then. Thanks for that.