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New Study Demonstrates Why FDA's Proposed Regulatory Approach to E-Cigarettes Makes No Sense

A new study published today in the journal Tobacco Control demonstrates why the FDA's proposed regulatory approach for electronic cigarettes makes no sense. In fact, the new research shows why the FDA's approach would be a complete bureaucratic nightmare, while not actually protecting the public's health.(See: Zhu S-H, et al. Four hundred sixty brands of e-cigarettes and counting: implications for product regulation. Tobacco Control. Published online ahead of print on June 17, 2014.) In this study, the authors study attempted to determine the number of electronic cigarette products on the market, both in terms of the number of different brands and the number of different flavors. Using comprehensive internet searches, the researchers found as follows:"By January 2014 there were 466 brands (each with its own website) and 7,764 unique flavors. ... Newer brands offered more flavors per brand (49 vs. 32) ... ."The Rest of the StoryThe basic framework that the FDA has proposed to regulate e-cigarettes is that every product on the market (except a very few that were already on the market as of February 2007) must submit a new product application. These applications must demonstrate to the FDA that the introduction of the product to the market is appropriate for the public's health.Because products are substantially equivalent only if they pose no different issues of public health, and because flavorings can affect product efficacy and safety, it is probable that every different flavor of every different brand must submit a separate application. Thus, at a minimum, there are going to be at least 466 x 49 applications, or 22,834 required applications.The FDA's Center for Tobacco Products simply does not have the capacity to review 22,000 new product applications. After all, it has taken more than 4 years for the agency to even begin to process the more than 3,500 substantial equivalence applications submitted by tobacco companies, and as of this date, there are still thousands of those applications pending. It is easy to see that the proposed deeming regulations would create a bureaucratic nightmare.Moreover, the proposed regulations do nothing to directly regulate product safety. For years to come, we would still have exploding batteries, leaking cartridges, and packaging that is not child-proof. After all, it is going to be a minimum of one year before the regulations are promulgated, another two years before the applications are due, and probably 5-6 years before the 22,000 new product applications can be processed (and that is only if the FDA acts in an unprecendentedly speedy fashion). So we're talking 8-9 years before we see any meaningful safety improvements.Instead of this insane regulatory approach, the FDA should scrap the requirement for product applications and should simply promulgate basic safety standards that ensure minimum, uniform requirements for product safety. If the agency allows for a 12-month grace period, we could expect to see these requirements actually take effect within two years.The safety standards should focus on the following issues:1. Battery safety and overcharge protection;2. Packaging (leak-proof cartridges and child-proof containers);3. Basic manufacturing standards;4. Pharmaceutical-quality ingredients in e-liquids;5. Quality control for stated nicotine levels; and6. Regulation of heating temperature and protection against overheating and dry puffs.In addition to ensuring basic safety, such regulations would also address issues such as the presence of formaldehyde in some e-cigarette brands and would regulate the product to minimize the known harmful by-products which have been identified in some e-cigarettes. These by-products are avoidable. We know this because some brands on the market (such as Vuse and NJOY) have been tested and shown to have no detectable/quantifiable levels of any hazardous byproducts.As the agency learns more about these products in all their diversity, the basic safety standards could be enhanced.I can only hope that this new study will help the FDA realize the folly of its proposed approach to electronic cigarettes and develop a new set of regulations that directly set standards for the safety of the product.Original author: Michael Siegel
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Supposed THR supporter demonstrates he still thinks like an ANTZ


by Carl V Phillips I consider Mike Siegel to be a friend and he does a lot of good work documenting lies by the ANTZ.  With that out of the way, I found his latest blog post to be a … Continue reading →Original author: Carl V Phillips
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Tony Gwynn Dies of Oral Cancer Almost Certainly Caused by Smokeless Tobacco

Many tobacco control advocates have asked me why, as a harm reduction supporter, I am always talking about the use of electronic cigarettes to help people quit smoking, rather than the use of smokeless tobacco products.Tony Gwynn's tragic death at age 54 from repeated smokeless tobacco use is the reason why. While it is not common, traditional smokeless tobacco use is clearly associated with oral cancer. In addition, there is little evidence that as marketed and used in the United States, these products are helping a substantial proportion of smokers to stay off cigarettes.For these reasons, I believe that electronic cigarettes are a much more viable option as a harm reduction approach for smoking cessation.Original author: Michael Siegel
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Call to Action: San Diego E-Cigarette Usage Ban

URGENT UPDATE 6-16-14:  On Wednesday June 18th at 2 PM, the San Diego City Council’s Public Safety and Livable Neighborhoods Committee will hold a critical public hearing on a proposed ordinance that would senselessly ban the use of smoke-free e-cigarettes  everywhere that smoking is banned. To stop this ordinance, please (1) attend and testify at the June 18th hearing in San Diego on the 12th Floor of City Hall (202 C Street) and/or (2) call or e-mail the City Council members to express your opposition. (Contact information for City Council members as well as talking points are included in the full Call to Action below.)We ask that if you attend the hearing, you refrain from vaping as a sign of respect.*********************************Link to Agenda for February 26th, 2014 meeting

The Committee on Public Safety and LivableNeighborhoods of the San Diego City Council will be receiving a report fromCouncil District Five regarding updating San Diego’s municipal code to regulatee-cigarettes at its meeting tomorrow.  It is likely that there will be a discussion about amending the municipal code to, among other things, ban e-cigarette use wherever smoking is prohibited.

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CASAA Public Service Announcement #7

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People do all sorts of risky things in life, from jumping out of airplanes, to climbing mountains to driving on a freeway. All of these things have the risk of death or severe injury. For all of these things, technology has reduced the risks for those who choose to do them. If we can't get people to stop doing risky things, we find ways for them to do it as safely as possible.

About 90,000 people die each year in the U.S. doing things like walking down the street, driving a car, playing sports, climbing mountains, hunting, skiiing, diving, riding ATV's, bicycling, motorcycling, boating, swimming, horse riding and parachuting. More people used to die from these "every day" things before harm reduction products were developed such as: seat belts, air bags, helmets, better parachutes and life preservers.

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CASAA Public Service Announcement #6

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The concept of harm reduction is acknowledging that you cannot ban everything that poses health risks and that if you cannot get people to stop doing things that have safety risks, public health has an obligation to encourage the use of alternative products that significantly reduce risk. 

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CASAA Public Service Announcement #5

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Although 69% of smokers say they want to quit, the fact remains that only 52% of them actually try and only 1% to 2% of smokers actually succeed at quitting for more than a year. That means that the 45 million Americans who continue to smoke every year need an alternative that has far less health risks than smoking. The alternatives have been quit or die - until now.

Electronic cigarettes were invented to serve as a safe alternative to traditional cigarettes - for those who cannot or will not quit smoking. They are meant to be a replacement for tobacco cigarettes, not a replacement for nicotine gums and patches. For these smokers, gums and patches are either not an option or simply don't work for them. The effectiveness of e-cigarettes is measured by how many people quit smoking conventional cigarettes, not how many people quit using nicotine.

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CASAA Public Service Announcement #4

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In 1990, the CDC reported that the smoking rate was 25.5% (around 46 million) adult smokers, so when the smoking rate dropped to 19.3% in 2010 there were only...45 million smokers.  How can that be? Well, the population went up, so even though the number of smokers remained virtually unchanged, the percentage of smokers went down - making it appear as though there was a significant drop over that 20 year period.Twenty years of tobacco control policies and there was only a 2.2% drop in the number of smokers! This is especially disappointing when you consider that the Healthy People 2010 objective of a 12% smoking rate would have meant 28 million smokers in 2010 - a goal missed by a whopping 17 million.

Tobacco control organizations prefer point to the smoking rates as evidence that their "abstinence only" policies - which aim only to get people to quit or stop people from starting - are working. So, they use those rate drops to support calls for more smoking bans, more product bans and more "sin" taxes. They also use this smoke-and-mirror "progress" to justify opposition to tobacco harm reduction policies and products, arguing that those are "unproven" to help smokers quit or reduce health risks, so we should continue to use their "evidence-based" policies that work.

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CASAA Public Service Announcement #3

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"Harm reduction" is the act of making a risky behavior safer. There are risks we take every day - including driving. In fact, getting in a car is one of the riskiest activities we do. According to the National Safety Council, there are about 10 million car accidents a year - from parking lot bumps to multi-car pileups. More than 2 million people are injured in accidents every year. Yet only about 3 in every 1,000 (about 30,000) of those accidents results in a fatality. That is because of harm reduction policies. Seat belts, air bags, headlights, speed limits and traffic signs all reduce the high risks of driving and save lives.

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CASAA Public Service Announcement #2

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Just about everything we do or consume has some risk involved. Even something as innocuous as fresh produce, such as spinach, can have hidden dangers. Every day we take simple actions that reduce our risks - from washing our vegetables, to crossing the street at crosswalks, to using condoms. Those actions are called "harm reduction," because while they don't make us 100% safe, they significantly reduce the risk of getting sick. Of course, never smoking is the most effective way to reduce the risk of lung cancer and heart disease, but even that is no guarantee.

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Glantz Asserts that Pulmonary Effects of Smoking May Be No Worse than those of Vaping

In a comment submitted to the FDA, Dr. Stan Glantz has asserted that in terms of pulmonary effects, the use of electronic cigarettes may not be any less hazardous than smoking conventional cigarettes.Of course, this is the same thing as stating that cigarette smoking may be no worse than vaping in terms of its effects on pulmonary function.Dr. Glantz writes: "Evidence that e-cigarette aerosol has the same effects on an important measure of lung function as cigarette smoke undermines the assumption that e-cigarettes are uniformly less risky than conventional cigarettes."This assertion is based on a new study which found that electronic cigarette use, like smoking, results in reduced levels of exhaled nitric oxide. As Dr. Glantz writes:"The paper, "Short-term effects of electronic and tobacco cigarettes on exhaled nitric oxide," by Sara Marini, et al, just published in Toxicology and Applied Pharmacology (Volume 278, Issue 1, 1 July 2014, Pages 9–15), reports important data showing that nicotine e-cigarettes, non-nicotine e-cigarettes, and conventional cigarettes all have similar effects of depression of exhaled nitric oxide."Based on this single study, Dr. Glantz concludes: "the FDA must be extremely careful about assuming that e-cigarettes uniformly pose less risk than conventional cigarettes."Stated another way, Dr. Glantz is cautioning the FDA against assuming that e-cigarettes are safer than conventional cigarettes in terms of their effects on lung function.The Rest of the StoryIn my opinion, Dr. Glantz's conclusion from this study is unscientific, illogical, and extremely damaging and destructive to the FDA's consideration of this issue as well as to the public's appreciation of the severe hazards of cigarette smoking.Dr. Glantz is simply wrong. There is abundant evidence which demonstrates that while vaping does cause some degree of respiratory irritation (and probably triggers a bit of inflammation), it is far safer than smoking and has far less of an effect on lung function.In fact, in a study by Flouris et al., the investigators found that real cigarettes, but not the fake ones, had a significant detrimental effect on pulmonary function, measured by spirometry. This study documents that while active smoking has immediate, clinically meaningful effects in reducing lung function, electronic cigarettes do not. The study found that: "Neither a brief session of active e-cigarette smoking (indicative: 3% reduction in FEV1/FVC) nor a 1 h passive e-cigarette smoking (indicative: 2.3% reduction in FEV1/FVC) significantly affected the lung function (p > 0.001). In contrast, active (indicative: 7.2% reduction in FEV1/FVC; p < 0.001) but not passive (indicative: 3.4% reduction in FEV1/FVC; p = 0.005) tobacco cigarette smoking undermined lung function."The main study finding was as follows: "The assessment of lung function demonstrated that neither a brief session of active e-cigarette smoking nor a 1 hour passive e-cigarette smoking session significantly interfered with normal lung function. On the other hand, acute active and passive tobacco cigarette smoking undermined lung function, as repeatedly shown in previous studies." The study concluded that: "e-cigarettes generate smaller changes in lung function but similar nicotinergic impact to tobacco cigarettes."In order to draw the conclusion that Dr. Glantz drew in his comment, one would have to completely ignore this study. Obviously, Dr. Glantz has done exactly that. He has based his comment on one narrow study and ignored the rest of the literature.But it doesn't end there.The Marini study demonstrates that electronic cigarettes do lead to a reduction in exhaled nitric oxide, which suggests that they have a mild respiratory irritant effect and induce some inflammation in the airways. This is a finding which has been reported previously in a number of studies. It is not surprising because propylene glycol is known to be a mild respiratory irritant.But what is the clinical meaning of this effect? In order to find that out, one needs to conduct studies with longer-term end points.Well, Polosa et al. have conducted exactly such a study. They examined the changes in asthma symptoms among smokers who continue to smoke versus those who switch to electronic cigarettes. These investigators reported that in contrast to real cigarettes, the fake ones result in actual harm reversal. Lung function, asthma control, and asthma symptoms were significantly improved among patients who switched from regular cigarettes to electronic cigarettes. These improvements were even observed among patients who became dual users of both real and fake cigarettes. It is clear from the overall evidence that electronic cigarettes are not as risky as tobacco cigarettes in terms of acute effects on lung function. On this issue, Dr. Glantz's comment is simply wrong.The very idea that one would extrapolate from a study finding that vaping, like smoking, reduces exhaled nitric oxide levels to the conclusion that smoking may be no more hazardous than vaping in terms of its acute pulmonary effects defies scientific logic. It also shows a misunderstanding, or at least a misinterpretation of the meaning of exhaled nitric oxide findings.The finding of reduced exhaled nitric oxide is an indication that an exposure is causing some sort of inflammatory effect on cells lining the respiratory tract. It doesn't mean anything more or less than that. You can't take two exposures - each of which causes respiratory tract inflammation - and make the statement that the effects of both exposures are equal. Risk posed by an exposure depends on many other factors, including the degree of inflammation induced, the reversibility of the effect, the nature of the exposure, the chronicity of the exposure, etc.To understand how ridiculous Dr. Glantz's extrapolation is, consider some of the other exposures that also cause reductions in exhaled nitric oxide:1. Taking an examWhen students take their final exam in my course, they are all experiencing acute effects on their respiratory tracts. In fact, if you were to measured their exhaled nitric oxide levels, you would find that there is a significant reduction, just as is observed with smoking.In fact, this is precisely what Trueba et al. demonstrated in a study of changes in exhaled nitric oxide levels in 41 healthy college students.  Would one therefore conclude that taking an exam is just as risky, in terms of respiratory effects, as smoking a cigarette? Apparently, Dr. Glantz would draw such a conclusion. But it is easy to see why this is an inappropriate conclusion. And we would never disseminate messages to the public that smoking is no more hazardous than taking an exam.Can you imagine if the tobacco companies used the same logic as Dr. Glantz? They would, according to his scientific reasoning, be perfectly honest in communicating to the public statements like this:"Smoking is not uniformly more hazardous than simply taking an exam.""In terms of acute effects on respiratory function, active smoking is exactly equivalent to the effects of taking a math test.""Smoking is no more hazardous than taking an exam in terms of its acute respiratory effects."To be completely honest, Trueba et al. actually found that not only did taking an exam affect nitric oxide levels, but it also produced decreases in lung function measured by spirometry. This is something that has not been observed for electronic cigarettes.  2. Feeling sadTrueba et al. also found that higher depressive mood was associated with greater reductions in exhaled nitric oxide. Using Dr. Glantz's reasoning, the cigarette companies would be perfectly honest in putting out headlines stating:"Smoking no worse on the lungs than feeling a little sad.""By improving symptoms of depression, smoking may actually enhance respiratory health."You can see the quality of the scientific reasoning we are dealing with.Hopefully, the FDA will not be swayed by this nonsense.It is worth noting that the conclusions which Dr. Glantz is disseminating are destructive because they undermine decades of public education about the severe hazards of smoking. If the public thinks that smoking is only as risky as vaping, then it is likely that many smokers will decide to continue smoking rather than quitting using electronic cigarettes. And many ex-smokers who have quit with electronic cigarettes may return to smoking, thinking that they might as well since they are not getting any definite health benefit from having made the switch.Original author: Michael Siegel
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Nicotine and cardiovascular disease

There are frequent warnings of adverse cardiovascular effects of nicotine, claiming nicotine may cause atherosclerosis leading to an enhanced risk of severe diseases, such as myocardial infarction or stroke. The harm caused by tobacco smoke is well established, but the contribution of nicotine to cardiovascular disease is less clear. In this post, I will try […]

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Nicotine and cardiovascular disease

There are frequent warnings of adverse cardiovascular effects of nicotine, claiming nicotine may cause atherosclerosis leading to an enhanced risk of severe diseases, such as myocardial infarction or stroke. The harm caused by tobacco smoke is well established, but the contribution of nicotine to cardiovascular disease is less clear. In this post, I will try […]

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Third Call to Action for FDA Proposed Regulations - Demand Congressional Hearings Investigating FDA and CDC's Actions

On Thursday, May 8th, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations.  

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Why the most important ecig news of the week is Swedish Match’s MRTP application


by Carl V Phillips Swedish Match broke the ice for the FDA’s “Modified Risk Tobacco Products” process this week, boldly applying for the removal of misleading warning labels on their smokeless tobacco products in the USA.  There is no point in … Continue reading →Original author: Carl V Phillips
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Related Suppliers

NEW YORK -- Convenience store retailers may have been a little hesitant to dip their toes in the electronic cigarette pool a few years ago, but they are showing less reluctance with new vapor products.Wells Fargo Securities LLC's latest Tobacco Talk survey revealed that retailers are excited about vapors/tanks/mods (VTMs) -- the growing subsegment of vapor products. In addition, more than 92 percent of respondents believe VTMs are taking share from e-cigarettes.Tobacco Talk surveyed tobacco retailer and wholesaler contacts representing 30,000-plus convenience stores in the United States."We continue to be encouraged by the burgeoning presence of VTMs in c-stores. We believe VTMs will drive momentum in the entire vapor category for retailers, which should help generate greater margins and gross profit dollars," said Bonnie Herzog, managing director of beverage, tobacco and convenience store research at Wells Fargo Securities.The survey also found that nearly all respondents (95 percent) either currently carry VTMs or expect to carry them in the next six months."Given retailers' excitement around VTMs, these products are expected to comprise 45 percent of the vapor category in c-stores in six months, up from 26 percent today," Herzog explained. "This is consistent with our independent vapor manufacturer survey, which indicated that VTMs are growing twice as fast as the overall category."According to Herzog, survey respondents also reported that VTMs offer attractive margins for retailers, approximately 30 percent, which is more than double the average cigarette margins. However, retailers are concerned about margin compression if, or when, the Big Three tobacco companies -- The Altria Group Inc., Reynolds American Inc. and Lorillard Inc. -- control the vapor category.As for the Big Three's efforts in the electronic cigarette segment, Tobacco Talk found that blu and NJOY are expected lose share to VUSE and MarkTen as they roll out nationwide over the next few months. MarkTen is Altria's e-cigarette product; VUSE is RAI's digital vapor product; and blu is Lorillard's e-cigarette."Though we acknowledge VUSE and MarkTen could result in some share disruption for blu, we believe technological advancements on blu should not be underestimated," Herzog said. "For instance, blu's new cherry rechargeable e-cigarette should help blu bridge the performance gap between e-cigs and VTMs, ultimately driving share growth."Original author: James
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Glantz takes a vacuous swing at Bates; Pruen eviscerates Glantz


by Carl V Phillips I was not planning to comment on the recent mass-signed letter that was sent to the WHO, telling them how they should think about e-cigarettes.  But then Tom Pruen wrote this gem of an analysis responding … Continue reading →Original author: Carl V Phillips
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Swedish Match Files to Change Smokeless Tobacco Warnings

Swedish Match has filed a Modified Risk Tobacco Product (MRTP) application with the FDA Center for Tobacco Products (CTP). The landmark event was announced in an AP story (here). The company wants to change three health warnings on ten of its snus products manufactured by the company in Gothenburg, Sweden and sold in the U.S.: 1. Remove the current warning, “This product can cause mouth cancer.”2. Remove the current warning, “This product can cause gum disease and tooth loss.”3. Replace the current warning, “This product is not a safe alternative to cigarettes,” with this text: “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”4. Retain the current warning, “Smokeless tobacco is addictive.”Numerous studies document that the three targeted warnings have essentially no scientific basis (discussed here). I previously noted the bogus nature of the mouth cancer warning, which was mandated in 1986, five years after Dr. Deborah Winn mischaracterized the magnitude and scope of smokeless tobacco’s mouth cancer risk (discussed previously in this blog here and here). There is no foundation for an oral cancer warning for today’s American and Swedish smokeless products.The gum disease/tooth loss warning is equally inappropriate. Even in 1986, there was virtually no scientific evidence that smokeless tobacco was an independent risk factor for any dental problem. The same is true today. The not-a-safe-alternative warning is particularly egregious. The purpose of this 1986 warning was to deceive smokers into believing that smokeless tobacco was just as dangerous as smoking. As I wrote in my book, “For Smokers Only” (here), this warning is simply ludicrous. Swedish Match’s replacement warning is identical to a change requested by RJ Reynolds in a citizen petition filed with the FDA three years ago (discussed here). The FDA ignored that petition, but it is obligated to consider the Swedish Match MRTP application. After an administrative review for completeness, the agency must refer the application to the Tobacco Products Scientific Advisory Committee (TPSAC) and ask TPSAC to report its recommendations on the application to FDA within 60 days. The FDA will also make the application public and request comments. “FDA intends to act upon your MRTP application no later than 360 days after receipt…”The misinformation in the current warnings has been shown to discourage smokers from switching (here). The welcome filing by Swedish Match could dramatically alter the landscape for tobacco harm reduction.Original author: Neville
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UCSF Scientists Tell FDA They are Not Sure Smoking is Any More Dangerous than Vaping

In a comment submitted to the FDA regarding its proposed e-cigarette deeming regulations, a trio of UCSF scientists argue that it is premature to declare that there is a continuum of risk among nicotine-containing products, including tobacco cigarettes and electronic cigarettes.They write: "The idea of a “spectrum of risk” or “continuum of risk” among tobacco and nicotine delivery products is logical. However at this time it is a hypothesis lacking sufficient empirical evidence to use as a basis for regulatory decisions. ... The FDA should not predicate regulatory actions on the assumption that any tobacco or nicotine delivery product is substantially safer than another until the improved safety profile has been demonstrated by a substantial body of peer-reviewed scientific research."They conclude: "Taken together, these studies demonstrate unequivocally that products and devices that deliver respirable particles and nicotine are inherently dangerous. The “Spectrum of Risk” is an unproven hypothesis with potentially deadly effects on the public health. FDA should not deem any tobacco or nicotine product to be safer than another, until it is proven to be safer through a substantial and consistent body of peer-reviewed scientific research."The Rest of the StoryThese scientists are arguing that it is premature to declare that there is any difference in risk between a tobacco cigarette, which burns tobacco, and an electronic cigarette, which contains no tobacco and involves no combustion, but merely heats nicotine in a solution of propylene glycol and glycerin.In other words, they are telling the FDA that at the present time, they cannot conclude that cigarette smoking is any more harmful than vaping.What a damaging and irresponsible public statement to make!They are essentially telling smokers that they are perhaps just as well off continuing to smoke cigarettes as switching to electronic cigarettes because we are not sure that the e-cigarettes are any safer.We have an epidemiological term for what we would call it were a physician to make precisely such a statement to a patient: ...... malpractice.There is absolutely no question that vaping is safer than smoking and that smokers who switch to electronic cigarettes are improving their health. To suggest otherwise is scientifically irresponsible, in my opinion. It undermines years of public education about the dangers of cigarette smoking. Even Big Tobacco would not claim that their products are as safe as non-combusted, non-tobacco-containing, electronic cigarettes.However, these UCSF scientists are making precisely such a claim.These researchers conclude, in the same comment, that electronic cigarettes cause heart disease, heart attacks, and pulmonary disease. There is inadequate evidence for any of those assertions.The ultimate irony is that while these researchers do not believe there is sufficient evidence to conclude that smoking is any more harmful than vaping, they do believe there is enough evidence to conclude - already - that vaping causes heart disease, heart attacks, and pulmonary disease. Even the most hardened e-cigarette opponents, including Glantz himself, have not gone that far.Original author: Michael Siegel
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E-Cigarettes and Youth: Addressing and preventing underage e-cig access

Let’s come right out and say it – if you’re younger than legal smoking age, we don’t want your business. And most, if not all, of our competitors would say the exact same thing.

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