Electronic Cigarettes: Guilty by Association

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Since their introduction to the US market in 2007, Electronic cigarettes (EC) have caused a major controversy in the Public Health domain. This is partially because they bear the unfortunate name of a product that has been fought for decades and touted as one of the leading causes of preventable deaths in recent years. The problem is further compounded by the bad reputation that nicotine has, as 40% of GPs interviewed in one study ranked nicotine as the first or second riskiest component of cigarettes, wrongfully attributing cancer risk to nicotine by itself, a view that is as misguided as stating that flavorings in alcohol cause Liver Cirrhosis in alcoholics.

Currently, the FDA is planning to classify EC as tobacco products, a move which will harm the EC industry as stakeholders will be required to dedicate enormous resources to conduct testing specifically designed for traditional combustible cigarettes, which is would be inappropriate for EC since they do not have any combustible properties. While well-established tobacco companies like Philip Morris and British American Tobacco will not have an issue with such regulations, startup companies will be at a significant disadvantage due to the cost of these tests. Excessive regulation can have devastating effects on innovation and competition, which are key components for a successful technology. While EC, just like any other consumable product, do need to be regulated to ensure their quality and safety, this regulation should be tailored carefully to ensure a balance of quality and safety assurance on one hand, and on the other avoid limiting access to such promising products that, while having yet to be proven to be entirely safe, are definitely a safer alternative to regular cigarettes.

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13 Responses to “Electronic Cigarettes: Guilty by Association”

  1. jtrunce Says:

    Interesting information about Electronic Cigarettes. Is there evidence to prove that they are in fact less harmful? You make the case that they are perceived to be equally harmful because they contain nicotine. Is the controversy then that they are in fact safer but are not being regarded as such? Or is it that the tobacco companies could be threatened by the potential rise of this tobacco alternative and are supporting these more restrictive regulations?

    Knowing the power and money behind companies like Philip Morris or British American Tobacco, it seems to me like backing these new FDA regulations is just another desperate attempt at self-preservation at the expense of the public. Looking at your graph though, EC’s hardly seem like competition, making up such a small proportion of the market.

  2. hekmatov Says:

    Thanks jtrunce, actually the literature has been limited on studies specifically evaluating electronic cigarettes, however there is plenty of literature on each chemical used in the making of electronic cigarettes (propylene glycol, vegetable glycerine, inhaled nicotine, food grade flavoring etc…). Also the number of studies is seeing a gradual rise due to the increase in interest on the topic, here’s a recent paper that found no health concerns in vapor from EC:
    http://publichealth.drexel.edu/SiteData/docs/ms08/f90349264250e603/ms08.pdf
    I believe that big tobacco companies are playing an active role in stalling the spread of EC until the relevant and important patents expire. Given that the first patent was filed around 2004 and it takes about 15 years for patents to expire, it won’t be until 2019 that tobacco companies will have the full freedom to produce their own brands of the product. Until then I expect a lot of resistance, although it won’t be publicly made by the tobacco companies, but rather through private channels in the industry. I know it sounds a lot like a conspiracy theory, but there is enough motive to expect such behavior.
    As for the market size, electronic cigarettes currently hold about 1% of cigarette sales in the US, making around 500 million dollars in sales, but that number is expected to multiply and reach 10 Billion by 2017. http://www.businessweek.com/articles/2013-06-20/big-tobacco-vs-dot-small-players-as-e-cigarette-smoke-off-begins
    For tobacco companies with dwindling sales, this could be their savior, and when the stakes are this high, expect a lot of fierce competition.

  3. tribaldwin Says:

    According to the FDA website- “Consumers of e-cigarette products currently have no way of knowing whether e-cigarettes are safe … how much nicotine or other potentially harmful chemicals are being inhaled during use, or if there are any benefits associated with using these products.”

    The FDA may not be able to put E-cigarettes into the tobacco regulatory category, but it needs to be able to regulate the content of the inhalation from E-cigarettes. Many view the E-cigarette as the lesser of two evils, but this may not be the case if the content of the inhaled vapor is not known.

    Currently nicotine patches and nicotine gum are widely used in tobacco cessation efforts, and it is valid that a vaporized equivalent of such a replacement method could be helpful in assisting a person in quitting smoking of tobacco. However, given the addictive quality of nicotine, and currently unregulated content of e-cigarettes, using e-cigarettes as a routine habit and not for cessation could be very dangerous.

    • hekmatov Says:

      I have to disagree with you on this one. the information you are citing from the FDA is slightly outdated, not that the FDA does not say that anymore, but because we now know what’s in the electronic cigarettes. The same argument that the FDA cites can be used about almost any supplement pill that consumers take, there’s no way for the consumers to find out what’s in that pill unless they have their own chemistry lab, otherwise they’ll have to take the company’s word that the information on the nutrition sticker is correct. Electronic cigarettes are now in the same league, reputable EC manufacturers do print the content of their EC liquid, including nicotine content and type of humectant used and concentration. Studies that have been done so far have shown that the content of vapor from EC does not have any components that pose a serious threat to health, and while the FDA is citing the one study that showed trace amounts of contaminants in a couple of samples out of the 14 or so that they tested, they failed to mention that the levels are far below Threshold Limit Values and are much lower than the amount you find in traditional cigarettes, in fact those levels are similar to levels found in nicotine gum and patches. All what I’m saying is that the knee jerk reaction to ban electronic cigarettes is unwarranted, and reveals that there are other agendas on the table besides protecting consumers.

  4. jackakent Says:

    Thanks for this entry. I like how the both big tobacco and EC start-up stakeholders are identified here. The conspiracy theory of patent issues was especially interesting – I had not considered that before.

    However, your comments about overly burdensome regulation killing innovation and start-ups is a common one. This is true for other products regulated as well, including medical devices and pharmaceuticals. An entire argument can be made around this.

    But, if we accept the current regulatory paradigm for what it is, EC companies have been pretty foolish, thinking that they deserve less regulation because they are different than cigarettes. In reality, the EC companies make pretty strong claims (e.g., safer, cession products, etc. – see the other blog post), which are completely unsubstantiated. I have no qualms with FDA seeking additional information from these companies, for FDA is simply carrying out its mandate to protect public health. FDA does the same for new medical device and pharmaceutical technologies.

    In my opinion, EC companies are trying to pull one over on the American public to make quick money.

    If you want to advocate that these products should be available at less regulation, there needs to be less regulation for everyone. Change the paradigm. Don’t give EC a pass simply because e-cigs are “better” than cigarettes.

  5. adeenatoll Says:

    Great topic! I agree with previous comments about need to get a closer look at ingredients and regulation of the e cigarettes.

    In July, Tracy Kane, the tobacco dependence treatment specialist where I work was quoted on a local news website. She points out how much do we really know about the ingredients and concerns about what they are:

    “There’s no standard formula for an e-cigarette. But one of the things found in them is propylene glycol. It’s a substance not to be trifled with. It’s something you would find in antifreeze, and it is what’s in e-cigarettes,” she explains. “That’s why I encourage people to use the FDA-approved nicotine replacement therapies instead of the e-cigarettes — because we know what’s in the FDA-approved ones.” ”http://philadelphia.cbslocal.com/2013/07/17/should-e-cigarettes-be-banned-like-smoking-health-expert-has-surprising-view/

    E cigarettes is a business and one with a lot of potential for growth as more people/companies are looking for answers to smoking cessation. However, just like other manufacturers in the food industry, money is the dominant driver. Think diet soda and while marketed as a product for those who want an alternative to sugar/calories in regular soda, it’s not without its own concerning ingredients with health effects that are coming out more these days.

  6. annebert623 Says:

    I think the assumption behind most comments, that e cigarettes are designed only for use in smoking cessation, is interesting, as hekmatov’s post never presents that as a reason for their use. Tribaldwin’s reply explicitly states what seems to be of concern, that nicotine is addictive, and therefore dangerous.

    Yet nicotine in isolation, taken in the doses that smokers take, is no more dangerous than the caffeine to which most of us are mildly addicted. In fact, nicotine has a number of beneficial effects and is being explored as a therapeutic to improve cognition in schizophrenia and Alzheimer’s, and to support vascularization for diabetics (http://health.howstuffworks.com/wellness/drugs-alcohol/nicotine-health-benefits.htm).

    Maybe it is hard for us to separate nicotine from its harmful companions in tobacco smoke. hekmatov’s post made me, a never smoker, reassess my attitudes to nicotine.

  7. duggals2013 Says:

    This is a very interesting post, as I was driving behind a truck the other day which had ads promoting E cigarettes. When I saw this ad I started thinking about the differences of E cigarettes and regular cigarettes, and while you state that E cigarettes are less harmful than regular cigarettes, I still wonder if there are any negative side effects to using E cigarettes. In the past, many people promoted regular cigarettes via commercials, but soon this was all stopped as studies demonstrated the potential harm of using cigarettes. I believe E cigarettes are relatively a new invention and yes it may not have as many side effects as regular cigarettes do, but still it is relatively a new invention. It is hard to determine what the side effects are to this product, without proof and studies. Thus, I believe regardless of the cost resources should be used to test the safety of the e-cigarettes.

    Granted this will hurt small industries as it will cost a lot of money to perform these tests and generate proof, but in the long run this will be better for our community as a whole. We will have a better understanding of e-cigarettes without many people being at risk for any potential danger that this new product may cause.

    http://www.ecigs-coupon-codes.com/what-are-the-side-effects-of-electronic-cigarettes/

  8. likobayashi Says:

    Thanks for this post – I also wrote one on e-cigs. I noticed that you stated “Currently, the FDA is planning to classify EC as tobacco products, a move which will harm the EC industry as stakeholders will be required to dedicate enormous resources to conduct testing specifically designed for traditional combustible cigarettes, which is would be inappropriate for EC since they do not have any combustible properties.”. Do you know how tobacco products are specifically tested? From what I had heard/found, e-cigs already are classified as tobacco products, and therefore regulated more for their availability to minors (and advertising/labeling components) rather than for their safety or ingredients. However, you made a good point that e-cig regulations would cause difficulty for start-up companies and likely stifle innovation. I think e-cigs could pose some benefit as tobacco cessation devices if regulated, as there would then be some quality control.

    You do also bring up the good point that at this time, the safety of the product is not known, though you stated e-cigs are “definitely a safer alternative to regular cigarettes.” I think one of the reasons why it’s hard to determine the safety is because there is no regulatory body yet, and we still don’t even know the exact dangers (or lack of) of nicotine. It’s always a balance, I think, between regulation and safety for the public good, and I personally tend to agree with jackakent’s viewpoint.

  9. emilybeaudoin Says:

    I agree with likobayashi. While EC may very well be beneficial as a harm-reduction approach to smoking cessation, the evidence is still building as to what the exact harms may be – something that the link posted to the article in Forbes is making the case for.

    The issue of patents and regulation effects on small companies is an interesting one as well. While it may be easier to view the small companies as stakeholders with better intentions compared to the big tobacco companies, their initial marketing strategies to minors is one that mimics those of tobacco companies which brings into question what their actual interest is. I think the FDA’s position on regulation is valid, but the issue of whether they should be regulated as tobacco products or not is another issue.

    All in all, an interesting post. Thanks.

  10. bishwaa Says:

    EC can be buzzword for harm reduction. Certainly there might be few advantages of EC over the regular cigarettes. I am not in favor of EC since they still contain the harmful compound, the nicotine. There are so many non-combustion tobacco products the (e.g. chewing tobacco) that are found to be very harmful and they cause cancers of mouth, throat and digestive system. Tobacco is simply one of the most harmful products for human no matter what shape and forms it comes. Moreover, EC can serve as a launching pad for the tobacco addiction. It looks cool and attractive to children and young adults and eventually it leads to an addiction. Government should not encourage this product to replace tobacco/cigarette. The EC industry intends to sell very harmful product to people and damage public health. Government must regulate heavily or ban them completely to reduce the burden of tobacco use and should not be worry about their existence.

  11. jhsphpeter Says:

    Thanks for the post. While the body of evidence around EC’s is still growing, it’s worth considering who should own the burden of proof: the government in demonstrating potential harm or the EC companies in proving a lack of harm? With the tobacco- and related-industries, which have a long history of sacrificing safety in the aim of greater profits, I believe the onus should be on the EC companies must demonstrate substantial proof of a lack of harm before this new product becomes more widespread.

  12. cmeghea Says:

    E-cigarettes have not been well studied yet, so it is not clear if they are more or less harmful than conventional cigarettes. It is difficult to argue that e-cigs are “definitely a safer alternative to regular cigarettes.”
    It is not known what is the potential risks of e-cigarettes when used as intended, how much nicotine or other potentially harmful chemicals (such as metals, as found by this study http://pubs.rsc.org/en/content/articlelanding/2014/em/c4em00415a#!divAbstract) are being inhaled during use.
    Additionally, it is not known whether e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.
    To conclude, it took decades to fully establish the effects of conventional cigarettes. It can be dangerous to make definitive statements when, simply put, we just don’t know yet.
    On a related note, there is evidence of direct contributions of nicotine to cancer onset and growth
    (http://www.nature.com/nrc/journal/v14/n6/full/nrc3725.html)

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