Monday, January 25, 2016

Science Calls Into Question Benefits Of E-Cigarettes -- Part 1

Note: the blog post below is "part 1" due to the history contained in the post.  I wrote this near the end of 2014.  Since then, new science has emerged and I will be writing a new update -- which will be coming soon.  The content below will give the reader (you) a sufficient understanding of the progress/process of determining how e-cigarettes should be regulated.  Furthermore, the content below shows that indeed, e-cigarettes are dangerous and contain dangerous levels of chemicals which make them an unacceptable 'trade-off' toward 'combustible cigarettes.'  Enjoy!


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There is no doubt as to the emerging popularity of electronic cigarettes (e-cigarettes) here in the United States. With this explosion of attention by marketers and potential investors has come attention from the public in the form of concerns over the advertisement of the new method of getting one’s ‘nic fix’ (nicotine fix from cigarette–a cliche statement from the past–smokers delight). While proponents argue that the new method of delivery by electronic means is healthier than the traditional combustible method, there have been growing concerns about the ingredients contained in the consumables (e-liquids, flavors, etc.) along with the levels of nicotine delivered to a user in a given period of use. The ‘jury is still out’ regarding formal rules by the United States Food and Drug Administration (FDA), although in other countries, outright bans have been put in place before a problem to deal with emerges (Brazil and Norway). Here in the US, a discussion in the traditional newspapers (the Los Angeles Times, the New York Times, etc.) has been ongoing and informative, but the information is starting to sound like a broken record. The FDA is still in debate and rightfully so with the amount of money at stake (a joke). Previously, I wrote a blog discussing the variousconcentrations and unregulated quantities of nicotine that are sold ‘online’that contain lethal amounts of nicotine and provided a couple of examples of dangerous/misguided use of e-liquids for e-cigarettes. In regard to the extent any discussion is occurring in the Scientific Research Community on the safety of e-cigarettes–that remained unanswered in my mind (unknown to me). Therefore, I decided based on a recent editorial in one of the premier science journals–Nature–appeared addressing this issue to look into (in the form of a web search) the discussion that is emerging surrounding the adverse health implications of the new e-cigarettes. Below is an introduction to my initial findings and I will elaborate more in future posts as information comes to light–to inform the reader of the issues at hand.



Discussion In The Science Community Surrounding E-Cigarettes?





While reading the popular news media unraveling of the issues surrounding the emergence of the e-cigarette my mind started to running wild–wondering what discussion was happening (if any?) in the scientific research community. I started to wonder why there has been very little discussion amongst scientists or in the literature regarding the health effects of the e-cigarette use in the population at large. Among the many possibilities for the lack of information that came to mind–a few were standing out and can be summarized in the following 3 points of interest: 1) Extensive research has already been conducted over the last few decades with respect to the adverse health effects of ‘combustible cigarettes’ 2) Scientists needed to understand further what studies to conduct to distinguish between ‘combustible cigarettes’ and e-cigarettes and 3) The majority of research in nicotine can be broad based and not narrowed to e-cigarettes exclusively. These do not encompass the expanding marketing dilemma that could alter the perception and increase the spread of adverse health effects through popular use of e-cigarettes among the population (the world). In addition, the amount of nicotine that is delivered is varied across e-cigarette products and should alone cause concern among the scientific research community. Other important adverse health implications associated with e-cigarettes have recently been brought to light by scientists and professionals in the medical community which have been raised in various journal articles or media platforms which will be touched upon below–briefly.



The ‘New York Times’ ran a four part series of articles highlighting the emergence of the issues surrounding the new market of e-cigarettes. These articles can be accessed by clicking on the links off of one of articles in the series -- "Where The Vapor Comes Sweeping Down The Plain". Of course, there are a whole distribution of media attention from various news media sources regarding the emergence of e-cigarettes—which I will leave to the reader to find—depending on their interest in the subject. One site –‘Gizmodo' has done a decent job of covering the basics and highlighting top science Journal blogs and briefs on the bits of information released regarding preliminary studies or regulatory news that is unfolding. As I mentioned above, I started a search in a couple of the ‘top’ science journals—‘Nature’ and ‘Science.’ I typed into the search bar – ‘e-cigarettes’ and ‘e-cigarette’ to see what stories came up. Additionally, I looked into the ‘American Chemistry Society’ website to see what stories were reported in the last few years. Below are the results which were encouraging toward addressing the negative health aspects of using e-cigarettes.



Let’s rewind back to 2008, in an article in ‘Chemical & Engineering News Magazine’(C&ENews) that addressed the introduction to the chemistry community. ‘Chemical & Engineering News’ is a publication of the American Chemical Society–a Professional Society of Chemist’s from around the world. The title of the brief was ‘Newscripts.' Here is the description of the new device which introduces the emerging problem quite succinctly:



E-cigarettes work like this: Nicotine is dissolved in propylene glycol, and the combination is stored in a cartridge that is designed to look like a traditional orange cigarette filter. The nicotine cartridge screws onto the main body of the e-cigarette, which contains a rechargeable battery that powers an electrical circuit. When the smoker inhales, a sensor in the circuit is activated. This causes a red-light-emitting diode at the tip to turn on. More importantly, the nicotine and propylene glycol are heated up so that they vaporize and get sucked into the smoker’s lungs. Propylene glycol—found in shampoo, food coloring and onstage theater smoke—is used as a solvent because plain water vapor is invisible. Vaporized propylene glycol looks like smoke, adding to the pseudo-smoking experience without causing a stinky smell. Most users say that e-cigarette smoke tastes sweeter than a normal cigarette, possibly because the nicotine cartridges come in fruit, than, and even coffee flavors.



The description above captures the simplicity of an e-cigarette along with the emerging issues that the government is starting to grapple with in terms of regulation here in the US along with other countries. As I have observed there is smoke that is expelled out of a persons mouth when ‘vaping’ that is commonly mistaken to be water vapor–when in fact the smoke is actually the chemical ‘propylene glycol.’ Propylene glycol is used in a variety of consumer products ranging as described above from shampoo to theater smoke. At the time of this newscript, there was very little discussion within the science community that was circulating regarding the new electronic cigarettes. A possible reason for this could have been attributed to the fact that most smokers were unaware of the product and were still use to smoking traditional cigarettes. Of course, the availability of e-cigarettes and accessories (e-liquids, devices, etc.) were not as widespread compared to today in tobacco shops and online shopping platforms. At the same time, other smoking cessation methods were popular and the majority of smokers might not have heard of the ‘supposed health benefits’ proposed by marketers.



A few controversial studies have been conducted with fierce criticisms from the scientists on either side of the debate which is why society still finds itself in a holding pattern in the form of concrete answers and Federal regulation. In the US and other parts of the world, government regulators are grappling with the classification of such devices as ‘smoking cessation’ tools or in the same class as traditional ‘combustible cigarettes.’ I will touch upon this last sentence a little later in this post. First, a closer look into the exact components of the e-cigarette are needed to again give the reader a better idea of how to distinguish between a ‘combustible cigarette’ and an e-cigarette. Only then can a person start to see the difficulties from both the scientific standpoint along as well as a regulatory standpoint.



Fast forward to the present year and articles have been emerging in the popular news press stating the popularity of the new e-cigarettes. The explosion of consumer interest has accelerated marketing efforts by tobacco companies and Federal Agencies to address claims and regulation of the new products. Finally, the science community is starting to address the issue of ‘supposed health benefits’ that are claimed by the big tobacco business’s that stand to make A LOT OF MONEY. As a result of my initial search, I found a good info-graphic that shows a current device (or electronic cigarette from a current article in 'C&E News'–titled ‘Clouds Controversial E-Cigarettes." I show the picture below from the article to demystify the ‘anatomy’/design of the internal components of an e-cigarette:








With high resolution images and a succinct description as the one above from the cited article, the anatomy of an e-cigarette is easily ‘demystified.’ In addition, by inspecting the individual components that combine to make up the entire product, one can start to see where issues might emerge. As an instrument manager myself (my occupation at a university chemistry department), I find this picture to be very telling of the dangers. Having knowledge of the chemistry of the product and the instrumentation, the dangers are completely apparent to my eyes. At the same time, if the general public has very little understanding of the possible dangers that the e-cigarette pose, then the above picture has no meaning aside from aesthetic purposes. Or a person that is trying to market such a device could fill in the blanks with complex language to confuse the consumer into believing that the above device really is healthier than a traditional cigarette. With the aid of the info-graphic above along with both descriptions from the listed two briefs from C&E News, the reader is equiped to start to understand the description of the challenges that face the research community on the surface dealing with investigating the hazards posed by e-cigarettes.



In a recent editorial which surprised and interested me at the same time from the Journal ‘Nature Neuroscience’, there is a definite concern in the form of written words that was communicated to the scientific research community at large (Researchers, including Mental Health/Medical Health Care Professionals, Students, etc.). Professional organizations follow or consult (not all but some) written words from editorials, commentaries, and other excerpts conveyed to the science community to keep current with the progress of research and the associated issues that are being confronted or brought to light in the form of obstacles/challenges. The editorial that I just mentioned is titled ‘Clearing The Smoke’. In the article, the authors raise two concerns regarding FDA regulation in their introduction that surround the issues of: 1) Warning Labels–What would information would be written on a container? 2) How broad would the marketing restriction be? Addressing the rise in use of e-cigarettes based on statistics was briefly discussed in the piece. These two issues are addressed in other arenas (legal, marketing, consumer product activists, etc.) by the popular news media. Getting to the science is where I would like to see the discussion move toward–which is a good start at least.



What caught my eye was the next issue–Problems with experimental design in studies assessing the toxicity of the compounds used or produced in these newly emerging devices. I think that this was crucial as the words on the page speaks volumes to the science community to think critically regarding the need to address issues of addiction to nicotine and exposure to chemicals from the start (filling the device with e-liquids) to the endpoint(exhalation of smoke and bystanders of second hand smoke). The authors address the issues in the excerpt shown below taken from the editorial:



One of the reasons previous studies have not been able come to a consensus on the effects of e-cigarette use is that the products themselves are heterogeneous. Nicotine absorption varies among different devices, and may even vary among users of the same device for those devices that allow users to refill nicotine liquid themselves. Although it is clear that different dosing regimens and methods of administration of nicotine can have vastly different effects on people, this is a factor that is not often considered carefully enough in studies in humans or animals. There are of course technical limitations inherent in getting experimental animals to smoke cigarettes, but animal researchers should try to replicate human administration methods as closely as possible, both for nicotine and for other drugs. One major distinction is having an animal self-administer a drug versus having an experimenter administer it; self-administered drugs have been shown to cause changes in the brain and behavior in some cases in which experimenter-administered drugs do not. Beyond this simpler distinction, however, the method of administration of drugs varies widely, and is not always aligned with human consumption habits. For example, some rodent studies involve animals drinking nicotine or inhaling alcohol vapor, neither of which is commonly done by humans. Studies investigating the efficacy of e-cigarettes as smoking cessation aids, for example, should carefully examine different rates of nicotine absorption, as this may profoundly influence results.

These issues of route of administration also apply to toxins or potential carcinogens found in e-cigarettes. For example, one chemical found in most e-cigarettes is propylene glycol, a common constituent of many foods. Although it may be safe to eat, whether it is safe to inhale is unknown. Some e-cigarettes may also contain known carcinogens (such as nitrosamines), and nicotine itself may be a carcinogen (a question that has been hard to decisively answer in the past given all of the other carcinogens present in cigarettes). Further research on the effects of all of the chemicals found in e-cigarettes and their long-term effects on users, as well as those exposed second-hand, is clearly necessary.



There are a variety of avenues (experimental design, variables) that researchers can proceed down in the quest to gain insight into the above listed issues and concerns. Bringing to light simple differences in experimental design, such as the route of administering nicotine and alcohol to rodents (through a liquid for nicotine and a vapor for alcohol) is crucial to future research efforts. One can see immediately that traditionally, alcohol is not usually consumed in the vapor form (I cannot remember a time when I would have chosen to ‘vape’ alcohol over just drinking a beer). Additionally, smoking was in the past decades traditionally narrowed to ‘smoking’ and not ‘drinking nicotine. Of course, one could argue that has not been the case in the immediate past with the introduction of smoking cessation therapies — (nicotine gum, patches, etc.). Still, this simple statement in the editorial above highlights the need on the research side to think critically about the new experiments that need to be done to address the adverse effects of all toxic substances–not just those associated with e-cigarettes and ‘combustible cigarettes.’ Nor does the research conducted so far need to be disregarded (undermined or underestimated) in its entirety. As science research progresses there are new insights–which leads me to believe the emergence in research addressing the use of e-cigarettes will have a positive outcome/complementary outcome on other toxic substance research proposed and conducted in the future.



At this point, there has been a few data points (studies, experiments) that have been carried out exclusively on e-cigarette users to address the above concerns of the science community. I show below a couple of studies addressing different aspects of concern regarding the vapor that is expelled after inhalation from an e-cigarette. Reading an editorial such as the one above gives me hope that progress on the research front will move forward toward addressing the growing concerns of the adverse health effects of using e-cigarette–both to the user and others that are in the immediate vicinity of them. Now that the possible adverse health effects have been introduced (at least a few of them above), lets look at some of the results that have been published so far to this point–which provide evidence in the form of data collected during an experiment. To start with, why not look into the smoke that is inhaled by the user to deliver the nicotine.



What Chemicals Are In E-Cigarette Smoke?





Vaporizers or e-cigarettes are different than traditional combustion cigarettes–no one really can argue against that fact–scientist or not. This fact does not make this device healthier though as a result of that argument. One has to dig deeper into the science or lack thereof to find the current scientific belief behind these emerging products. By cutting down on the possible products of combustion in a cigarette, one has already improved the situation–so the argument is thought to go. But upon closer inspection, there is a heating element that is activated to bring the chemicals (nicotine, propylene glycol, glycerol, flavoring, etc.) to an elevated temperature at which a vapor is formed. Assuming that there is no combustion might imply that compared to a traditional combustion cigarette an e-cigarette is possibly reducing the amount of chemicals a user inhales. If one has no prior information then this assumption might be a normal ‘first approximation’ or a guess. Scientific studies have been conducted on the composition of the smoke in e-cigarettes as highlighted in the above 'C&EN' article 'Controversy Clouds E-Cigarettes' as shown in the excerpt below taken from the source:



To look inside, Goniewicz and colleagues recently enlisted a robotic smoking machine to take puffs of 12 different brands of e-cigarettes. Using chromatography and mass spectrometry, the team analyzed four types of potentially harmful compounds in the vapor (Depth. Control 2014, DOI: 10.1136/tobaccocontrol-2012-050859). 
The researchers found small amounts of six toxic substances that are also found in tobacco cigarette smoke at 9 to 450 times as great a level as what is found in e-cigarette vapor. The substances include three carbonyl compounds: formaldehyde, a carcinogen, as well as acetaldehyde and acrolein. The team also found the volatile organic compound toluene and traces of two carcinogenic nitrosamines. 
Additionally, they found small amounts of cadmium, nickel, and lead in the vapor—less than 1 µg per 150 puffs—that are also present in tobacco cigarette smoke. Another research team has also found metal particles in e-cigarette vapor (PLoS One 2013, DOI: 0.1371/journal.pone.0057987). 
Inhaling particles containing metals and other compounds can trigger lung and throat inflammation. But predicting the risks for the average e-cigarette user is challenging, Goniewicz notes, because e-cigarette design variation and how deeply a user inhales affect exposure. According to Goniewicz, the larger, unanswered question is, “What will happen after many years of vaping? To see some of the long-term effects we just need time.” 
Bystanders are exposed to nicotine when others vape near them but not necessarily to other toxicants found in e-cigarette vapor, Goniewicz and other groups have found (Nicotine Tob. Really. 2013, DOI: 10.1093/ntr/ntt203 ). Nicotine from the vapor is also deposited on surfaces, according to data the group presented at last month’s meeting of the Society for Research on Nicotine & Tobacco. Nicotine residue can react with other compounds in air to form carcinogenic nitrosamines. “Parents using e-cigarettes around small kids should be aware of these findings,"Goniewicz Says.



These initial findings based on the work highlighted above in the article should be concrete evidence that there are possible dangers associated with e-cigarettes. As with any scientific study, there are issues that can arise in either the experimental design or with the results that are being reported to the public or to influence policy decision. Presently, there are multiple avenues being pursued to find more information regarding the emerging use of new products that satisfy a tobacco craving. Ultimately, one should be concerned with the underlying question: Is the amount of nicotine dispensed by these devices healthy over time? Over the last few decades, health activists have been working hard to demystify the dangers of addictive nicotine — the major compound of interest in cigarettes. Just a couple of decades ago, the tobacco industry was sued over their conspiracy to cover up the experimental results that showed nicotine to be extremely addictive. In the present case with e-cigarettes, the amount of nicotine being delivered in the device itself has increased and presents potential dangers.



A couple of months ago, I wrote a blog about the dangers of the consumables(e-liquids, flavoring, etc.) or accessories of e-cigarettes titled "How much nicotine is in a bottle of e-liquid? Is the level toxic?". At the time, I had decided to focus on the content of nicotine that was being sold in various amounts in purchasing e-liquids to fill an e-cigarette. In that blog, I touched on the reported LD50 dose of nicotine (Median Lethal Dose of Nicotine) and compared that to various quantities being marketed ‘online’ and a couple accidents that were reported at the time. The LD50 is commonly misunderstood in the public in relation to most toxic substances and as a result causes misinterpretation of a lethal dose of a given substance. E-cigarettes users are falling susceptible to this misinterpretation presently as is shown in the comment section of articles discussing the concerns with variable dose of different e-cigarette products. The calculations presented in that blog are based on values from previous research studies. This blog is an extension of the previous blog — expanding a search into the dangers posed by e-cigarettes and current knowledge from the scientific research community. Obviously, I cannot know every study that has failed but been carried out in the scientific research realm–therefore this is an initial search into the subject. At least I can bring highlights into the dangers to a more visible level.



With the lethal quantities being sold online and/or at tobacco shops along with the quantity of an e-liquid to load into a given e-cigarette left to the consumer/user, one cannot help but wonder how these elevated levels of nicotine are affecting user’s ‘vaping.’ In addition, as was pointed out in the excerpt above, concerns surrounding second-hand smoke/vapor are starting to bring the negative health implications of e-cigarettes to a higher priority. Aside from the potential carcinogens and other toxic chemicals that are suggested above based on current studies, tobacco research is progressing substantially by widening the age groups involved in research. Traditionally, the age groups involved in tobacco related research were confined to either healthy adults who started smoking or adults who had been smoking with varying degrees of years and addictions. I use the word ‘addiction’ because the major component that is in dispute (neglecting the carcinogens and other toxins) is nicotine. In addition, substantial progress has been made on decreasing the amount of ‘combustible’ cigarettes smokers over the decades and there is worry that the current emergence of e-cigarettes might reverse any progress on the tobacco cessation movement. The possibility of gaining a higher percentage of the world back into the consumption of nicotine should in itself motivate the US FDA along with other governments from around the world to decide on regulations that minimize the potential adverse health effects on the human population. Below is a brief highlight of the commentary circulating in the science community.



What Is Happening In Terms Of The Regulation of E-cigarettes?





From decades of research, I do not think anyone can dispute that nicotine is not addictive (that is not to say that there still does not exist someone in the world who does not agree). As mentioned above, the reversal of any tobacco cessation over the last few decades stands to be reversed with the emergence of e-cigarettes. A new study published in the Journal ‘Nature’ recently titled ‘Cigarette Exposure, Dependence, and Craving Are Related toInsula Thickness in Young Adult Smokers’ found a difference in the size of the ‘insula’ (insular cortex) presumably from ‘combustible cigarette’ use. Here is the abstract in full to explain further the results shown below:




The age period spanning late adolescence to emergent adulthood is associated with the highest prevalence of cigarette smoking in the United States, and is also a time of continued brain development. Nonetheless, although prior research has shown group differences in brain structure associated with smoking status in adults, few studies have examined how smoking and associated behavioral states relate to brain structure in this age group. Neuroimaging and lesion studies have suggested that the insula, a cortical region that integrates heterogeneous signals about internal states and contributes to executive functions, plays an important role in cigarette smoking behavior. Using high-resolution structural magnetic resonance imaging, we therefore measured cortical thickness of the insula in 18 smokers and 24 nonsmokers between the ages of 16 and 21 years. There were no group differences in insula thickness, but cigarette exposure (pack-years) was negatively associated with thickness in right insula. Cigarette dependence and the urge to smoke were negatively related to cortical thickness in the right ventral anterior insula. Although the results do not demonstrate causation, they do suggest that there are effects of cigarette exposure on brain structure in young smokers, with a relatively short smoking history. It is possible that changes in the brain due to prolonged exposure or to the progression of dependence lead to more extensive structural changes, manifested in the reported group differences between adult smokers and nonsmokers. Structural integrity of the insula may have for predicting long-term cigarette smoking and problems with other substance abuse in this population.



If these findings are validated over time by other studies, then more research would be needed to narrow down the source of the results–meaning to attribute the cause directly to ‘combustible cigarette’ use. In addition, the method of ‘Functional Magnetic Resonance Imaging’ (Click –here– to read wiki page) offers a promising method to ‘map addiction’ of various disorders (or so it is currently thought to) and shed a better understanding of the cause of disorders or anatomical changes occuring in the brain. The area under debate was the ‘insular cortex’ of the brain that is well known to be attributed to nicotine addiction — with a high abundance of ‘nicotine acetylcholine receptors’ residing within. These receptors change or (are stimulated) in response to chemicals such as nicotine (and possibly others–unknown). Of significance aside in this study aside from the results (in the form of imaging) is the age group that was studied. This is the first young age group that was studied regarding tobacco use. Future studies should follow suit and include a wider range of ages and types of smokers — a current problem of studies that have been done in the past decades among others. There is a lot of room for improvement, yet these results are encouraging.




The reason why I included this lengthy abstract was to bring up a few points regarding research which in turn will guide the regulatory agencies around the world. There are multiple studies as mentioned above that are surfacing with questionable research methods showing up in the scientific community. Also, as I mentioned above, this does not mean that the research itself is not correct. The assertions or conclusions might not be as ‘dramatic’ as a policy would like them to be — more ‘black and white’ results are easier to sell to the public. What is amazing about the above research is that the science community’s ability to investigate complex problems has advanced tremendously and is finally starting to bear more fruitful data (with less objection from either other scientists or the public at large) which is good. We are possibly nowhere near where we need to be to conclusively state the dangers, but advances are starting to bear results that have definite meaning in terms of dangers. Part of the reason why research has been very difficult is due to the ‘big corporations’ unwillingness to comply and release their toxicity data (in terms of product toxicity studies) and other related research into the potential dangers associated with their products available on the market.




The mere fact presents regulatory agencies ranging from the Environmental Protection Agency through to the Food and Drug Administration along with other governments regulatory bodies a large amount of difficulty in actually coming down with rules to enforce in the form of laws. Time and time again, these types of issues show up in the general news media under different categories–which should be troubling. In all fairness to the industries, if there is indeed no danger, then no regulatory policy should be tough and unnecessary. In the case of the regulation of tobacco and e-cigarette use, there is still a large amount of debate with each side well prepared to battle in hope of their individual cause. To give an example of each side of the debate ‘building up an army’ to battle science, a big corporation that produce e-cigarettes –’NJOY' has hired respectable past government official to assist in dealing with the scientific issues that stand to debated in discussing regulation. Back in February of this year in the Journal ‘Science’ an interview was conducted with Dr. Richard Carmona, former US Surgeon General during the second Bush presidency gave an interview answering questions regarding his choice to join the e-cigarette maker’s board and what he hopes to contribute. The title of the article is ‘A Former Surgeon General Lends His Support toE-Cigarettes’. Below are three questions in the form of an excerpt that I thought might bear some light on the above blog:




Q:As a doctor and former surgeon general, why did you join the board of an electronic cigarette manufacturer? 
R.C.:At first, I immediately rejected their offer. But with some due diligence I came to see that they were willing to do the necessary science and that we could be allies in the anti-tobacco movement. That said, I offered to join only under certain conditions: that they request FDA regulation—which is in the public’s best interests—that they conduct and publish their own research in peer-reviewed journals, even if the findings hurt the bottom line; that they don’t use my name or refer to the surgeon general in their advertising campaigns; and that they don’t market to kids. So far, they’ve delivered on all those promises. 
Q:How can you be sure they’re safe? 
R.C.:As research priorities, we’re asking about cons from long-term nicotine use, and we’re examining the different components in side-stream vapor to make sure they’re not unsafe. So far we don’t see any problems. And we’re also looking into long-term efficacy: How many people who use e-cigarettes quit and for how long? We just have to craft the right questions and then report back to the public. 
Q:How would you respond to critics who say you shouldn’t be doing this? 
R.C.:Making tobacco obsolete is part of NJOY’s value … and it’s consistent with my efforts to move people away from cigarettes with combustible toxins that lead to cancer and cardiovascular diseases. I accept that my colleagues have concerns and that the anti-tobacco world is divided on this. You’ve got two camps here: an abstinence-only camp that thinks anything related to tobacco should be outlawed, and those of us who say abstinence has failed, and that we have to take advantage of every opportunity with a reasonable prospect for harm reduction.




After reading through the questions and answers, one cannot notice that the issue is anything but clearly ‘black and white’ or ‘cut and dry.’ There are definite issues that the regulatory agencies will have to work out in the form of debates over time as science research becomes more conclusively weighed in favor or against any type of regulation. This seems to be an issue over in the UK as there are as a many as 1.3 million potential users currently engaging in ‘vaping’. The last article that I would like to show from my initial finding is from the UK and is not an issue that I usually think about but came up in my search. I was taken by the title of this article, although after thinking about the issue further–I am no longer surprised. My initial surprise shows how focused I am only on the total human body and not thinking specifically about one area in focus–the mouth. The title is ‘PatientsAre Asking About E-Cigarettes. What Do We Tell Them?’. The authors are from the University of Sheffield School of Dentistry and have written about the impact on the patients from a standpoint of the Professionals in the Dentistry Field. Concerns are raised in the form of questions in the article of the following nature: “1) What are e-cigarettes? 2) Who uses e-cigarettes and why? 3)What is the current legislation and regulation of e-cigarettes in the UK? 4) What is the proposed legislation and regulation of e-cigarettes in the UK? 5) What evidence is there about the safety, quality and efficacy of e-cigarettes? 6)What do we tell patients?–Advice about e-cigarettes for patients? 7) What are the public health arguments for and against e-cigarettes?” According to the article, the proposed legislation was amended in February of 2014 as highlighted by the following excerpt:



However in February 2014 the European Parliament approved a revised EU Tobacco Products Directive (TPD).24 The TPD makes a distinction between e-cigarettes that make medicinal claims such as aiding smoking cessation, and e-cigarettes which don’t, referred to as ‘consumer cigarettes’ in the TPD. E-cigarettes that make medicinal claims will be regulated under medicines regulation and ‘consumer e-cigarettes’ will need to meet the TPD regulations listed below: 
Nicotine containing liquids placed on the market should not exceed 20 mg/ml:
–E-cigarettes placed on the market should deliver a consistent nicotine dose
–E-cigarette products must be child and tamperproof
–E-cigarettes must meet certain safety and quality requirements
–E-cigarette packaging must include health warnings, information on addictiveness and toxicity and a list of all the ingredients. 
In addition there is to be monitoring of the market for evidence of e-cigarettes leading to nicotine addiction or acting as a gateway to tobacco consumption. It will be up to each Member State to decide on age limits, regulation of flavouring and rules on ‘vape’ free environments.24, 25 The decision by the European Parliament not to regulate all e-cigarettes as medical products ‘has raised some uncertainty about the MHRA licensing plans’.2 The MHRA will continue to advise e-cigarette companies to licence their products.23



The MHRA cited in the excerpt is referring to the Medicine and Healthcare Regulatory Agency (MHRA). In the article, the authors also point out the five questions that are supposed to be asked in order to make a decision as to whether to allow the public to e-cigarettes in their establishments. Here are the questions from the article in this excerpt:



What are the issues you are dealing with? 
What do you need to control? 
Do you have concerns about the possibility of harm from NCPs? 
Will restricting or prohibiting the use of NCPs support compliance with smoke-free policies? 
Do you want your policy to help improve people’s health?



Basically, the weight of the decision is left to the owner of the establishment or director of the organization. As for the ‘Dental Teams’ across the UK, the advice that is suggested to give to patients –again in an excerpt is highlighted below:




The long term safety of e-cigarettes is not yet established16, 25, 26 
E-cigarettes are likely to be less harmful than tobacco cigarettes1, 
The effectiveness of e-cigarettes as either a smoking cessation tool or a harm reduction tool is not yet established25, 26 
At present no e-cigarettes are licensed as a medicine16, 44 and patients are recommended to use licensed NRT products to quit or reduce tobacco consumption1, 43, 45 
Advice to patients who are unable or unwilling to use licensed NRT products is that although the safety of e-cigarettes cannot be assured they are likely to be a lower risk option than continuing to smoke 1 
Advise patients that there is the potential for advice about e-cigarettes to change as findings from research about the safety and effectiveness of e-cigarettes is published 
Advise patients that referral to the Stop Smoking Services is an option to consider




As one can see, the UK Parliament is further along than the US FDA on asking the relevant questions and putting in place a regulatory system in place. I would ask based on what is present in the popular news media regarding either ‘combustible cigarettes’ or e-cigarettes — should we be surprised at the lack of regulation or the lack of progress moving forward toward regulation e-cigarettes here in the US? My initial and uninformed guess was–YES. After looking into this brief search, I am still confounded by the lack of legislation/regulation here in the US. I admit that I am no politician or government official–therefore–no expert in the flow of policy into regulations from a science perspective. I went a step further and looked into what the US FDA is asking by visiting their website on e-cigarette proposed regulation. Evidently, until today August 8, 2014, the FDA is accepting comments withinstringent guidelines to help navigate them on deciding whether to consider categorizinge-cigarettes in the same category as tobacco/ ‘combustible cigarettes’ . After reading the progress that the UK has made regarding e-cigarette, I would hope that the FDA gives a detailed account as to the guidelines that are released. Up until now, the FDA has accepted complaints regarding the use of e-cigarettes which have been compiled by year and are available for download to read (there are alot). I chose one complaint that I found to represent a reoccurring theme of complaints in the documents which is shown below in the final excerpt of this blog post:




From page 55 of FDA adverse effect document: 
Employee inhales Vapors all day throughout the office. One employee was out with respiratory illness, one has persistent cough and I ended up with bronchitis. I nor anyone in my family has ever smoked and yet in a month and a half, 3 people have become ill since “vapors” were introduced into our environment.




That comment was in the ‘Adverse Events’ from 10/5/13 to 3/12/14 that is available online by clicking-here. Note: under the ‘Special Interest Topics — E-Cigarette Adverse Events’ (scroll down to bottom of the page to access adverse events pages -- choose comment period). I am not disputing the validity of these supposed complaints–just merely bringing the open forum of complaints to the public's mind to give credit to the FDA for public participation. Of course, the real work is ahead in the regulation of these potentially lethal products.



In closing, I hope that the reader is better informed than at the beginning of the post on the possible hazards associated with e-cigarettes and their emerging use. I hope that on either side, there is more discussion and regulation proposed to get the process of refinement into the future moving. I leave the reader to form their own opinion to the relevance of the possible lethality and dangers posed by ‘vaping.’ Have a great weekend.


2 comments:

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