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New Study Provides Strong Empirical Support for New FDA Approach to Tobacco Product Regulation

A new study published in the journal Tobacco Control reports that the modeled cancer risk associated with vaping is less than 1% of that associated with smoking and is only slightly higher than, if not comparable to the cancer risk associated with nicotine replacement therapy (NRT). In select circumstances, electronic cigarettes produced high levels of aldehydes but only when the voltage was cranked up to excessive levels. Thus, under conditions of normal use, this study finds that tobacco-free e-cigarettes present a drastically reduced carcinogenic risk compared to tobacco cigarettes.The study methods were as follows: "The cancer potencies of various nicotine-delivering aerosols are modelled using published chemical analyses of emissions and their associated inhalation unit risks. Potencies are compared using a conversion procedure for expressing smoke and e-cigarette vapours in common units. Lifetime cancer risks are calculated from potencies using daily consumption estimates."The results were as follows: "The aerosols form a spectrum of cancer potencies spanning five orders of magnitude from uncontaminated air to tobacco smoke. E-cigarette emissions span most of this range with the preponderance of products having potencies less than 1% of tobacco smoke and falling within two orders of magnitude of a medicinal nicotine inhaler; however, a small minority have much higher potencies. These high-risk results tend to be associated with high levels of carbonyls generated when excessive power is delivered to the atomiser coil. Samples of a prototype heat-not-burn device have lower cancer potencies than tobacco smoke by at least one order of magnitude, but higher potencies than most e-cigarettes. Mean lifetime risks decline in the sequence: combustible cigarettes much greater than heat-not-burn, which is much greater than e-cigarettes (normal power), which are greater than or equal to nicotine inhaler."The study concludes that: "Optimal combinations of device settings, liquid formulation and vaping behaviour normally result in e-cigarette emissions with much less carcinogenic potency than tobacco smoke, notwithstanding there are circumstances in which the cancer risks of e-cigarette emissions can escalate, sometimes substantially. These circumstances are usually avoidable when the causes are known."The Rest of the StoryThis study should put to rest any doubt within the tobacco control movement about whether vaping greatly reduces health risk compared to smoking. Numerous anti-tobacco groups and health departments have repeatedly asserted that vaping is no less hazardous than smoking, but this claim is false, and the present study adds significantly to the already substantial evidence that vaping is orders of magnitude safer than smoking. The anti-tobacco groups and health agencies that have made such statements should immediately correct them and issue retractions to alert the public to these important findings.These results add strong empirical support to the new FDA approach to tobacco products, announced one week ago by FDA commissioner Dr. Scott Gottlieb, which emphasizes the regulation of tobacco products and e-cigarettes based on the wide differential in their health risk. It makes no sense to lump e-cigarettes in the same basket as tobacco cigarettes, given their drastically different health risks. However, that is precisely what the FDA was doing prior to Dr. Gottlieb's appointment as the new commissioner. Now, the agency is taking a much more sensible and evidence-based approach.While this study does find that there are conditions under which e-cigarettes can be made to produce rather high levels of certain hazardous chemicals -- most notably aldehydes -- these conditions involve jacking up the voltage to excessive levels that typically produce dry puff conditions, something that vapers would almost certainly detect immediately and not tolerate. Nevertheless, the results do suggest that FDA safety standards related to the maximum allowable voltage or coil temperature may be warranted.Original author: Michael Siegel
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FDA’s New Vision for Tobacco Harm Reduction


U.S. Food and Drug Administration Commissioner Scott Gottlieb on July 28 fully endorsed tobacco harm reduction. In a speech (here), he clearly defined the problem: “[I]t’s cigarettes that are the primary cause of tobacco-related disease and death.”  Dr. Gottlieb cited facts about nicotine, emphasizing its addictive qualities and the need to keep children away from all tobacco products. He also made one critical distinction: “[T]he nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.  Yes, it got them all addicted and kept them addicted for the long term.  And it got most of them addicted when they were still teenagers.  But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine.” This has been one of my principle themes for over two decades. Dr. Gottlieb called for reduction of nicotine in cigarettes to non-addictive levels, an idea that I criticized in my 1995 book, For Smokers Only (updated version here) and more recently in my blog (hereand here).  However, I was critical because advocates of nicotine fadeout were deluded in thinking it would work in the absence of viable tobacco substitutes.  Unlike them, Dr. Gottlieb embraces the harm reduction component: “…we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels.  And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them…” The new commissioner underscored the value of less harmful products: “I also hope that we can all see the potential benefits to addicted cigarette smokers, in a properly regulated marketplace, of products capable of delivering nicotine without having to set tobacco on fire.  The prospective benefit may be even greater for the subset of current cigarette smokers who find themselves unable or unwilling to quit.” Note two key phrases above: (1) “less harmful forms [of tobacco], efficiently delivering satisfying levels of nicotine, are available for adults who need or want them;” and (2) “…current cigarette smokers who find themselves unable or unwilling to quit.” I used the latter words in 1994 to describe my vision for a new approach to smoking control: “In a review of the avoidable causes of cancer, Doll and Peto observed that ‘No single measure is known that would have as great an impact on the number of deaths attributable to cancer as a reduction in the use of tobacco or a change to the use of tobacco in a less dangerous way.’  Unfortunately, the second part of this observation has not received attention.  Because smokeless tobacco causes far fewer and considerably less serious health effects than does smoking, it should be promulgated as an alternative to cigarettes for smokers unable or unwilling to overcome their nicotine addiction.” (article here, emphasis added) Dr. Gottlieb’s use of “unable or unwilling” acknowledges the effectiveness of tobacco harm reduction, without judging smokers.  This theme is repeated in Dr. Gottlieb’s closing: “A renewed focus on nicotine can help us to achieve a world where cigarettes no longer addict future generations of our kids; and where adults who still need or want nicotine can get it from alternative and less harmful sources.  FDA stands ready to do its share.” Many of the commissioner’s talking points are virtually identical to the policies I have researched and advocated for two decades.  Dr. Gottlieb notes the rancor in this field, saying, “…there’s the ongoing divisive debate around the pros and cons of e-cigarettes.  Precious little progress has been made as competing camps dig in on the benefits and risks of a harm reductionist approach to this new technology.  Both sides are convinced that they’re right, but we’ve seen little progress, and virtually no common ground.”  He encouraged “…participants from all sectors in the ongoing harm reduction debate…to take a step back and work together to reach greater common ground.” I applaud Dr. Gottlieb’s leadership on this issue and offer my support in turning his vision into reality. Original author: Brad Rodu
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New FDA Commissioner Saves the Day: Embraces Harm Reduction Strategy for Tobacco Control

On Friday, the new FDA Commissioner - Dr. Scott Gottlieb - saved the day for the public's health by officially embracing a harm reduction approach to tobacco control. Commissioner Gottlieb announced a new approach to the regulation of tobacco products that, unlike the FDA's previous strategy, acknowledges the vastly different risks of tobacco cigarettes compared to electronic cigarettes and proposes to regulate each product in alignment with its risk level.Previously, the FDA had simply lumped e-cigarettes into the exact same category as tobacco cigarettes and in fact, regulated e-cigarettes much more stringently. The FDA previously required e-cigarettes to complete burdensome and expensive pre-market applications just to remain on the market, a process from which all cigarettes were exempted. The old approach would have destroyed about 99% of the existing vaping product market, leading to a major reduction in smoking cessation in the U.S. and with that, an increase in smoking-related morbidity and mortality.Instead, the FDA will now delay the implementation of the pre-market application requirement for e-cigarettes while seeking ways to ease the expense and burden of the process. At the same time, the FDA will - for the first time - actually set safety standards for e-cigarettes so that the benefits of these products can be realized while minimizing potential harms. And, to top it all off, the agency will consider - also for the first time - actually setting a safety standard for real cigarettes that would require the reduction of nicotine to non-addictive levels if that is found to be technologically and practically feasible.Commissioner Gottlieb also, for the first time, tied implementation of a harm reduction approach based on vaping products to the idea of making combustible cigarettes less addictive through substantial nicotine reduction, thus reducing the demand for real cigarettes but at the same time, making a viable alternative available to smokers to help ease them through the transition to the tobacco-free, smoke-free cigarettes.Dr. Gottlieb emphasized that while nicotine is largely responsible for the addictive potential of cigarettes, the nicotine itself is not what kills smokers. As he stated: "the nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.  Yes, it got them all addicted and kept them addicted for the long term.  And it got most of them addicted when they were still teenagers.  But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine."Commissioner Gottlieb unveiled his vision of " a world where cigarettes lose their addictive potential through reduced nicotine levels.  And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them."Specifically, the strategy outlined by Commissioner Gottlieb involves the following:1. Implementation of the requirement for pre-market applications for electronic cigarettes will be delayed until 2022, giving vaping product manufacturers another four years to remain on the market and to prepare the necessary application materials.2. New guidance for the pre-market applications will be developed, which will presumably greatly simplify the requirements and reduce the burden and expense of preparing these applications.3. Safety standards for electronic cigarettes will be developed, addressing issues such as battery safety, e-liquid ingredients, and flavorings.4. The agency will examine the effectiveness and feasibility of requiring a reduction of nicotine levels in real, tobacco cigarettes to a non-addictive level.5. Ideally, the reduction of nicotine levels in real cigarettes would be paired with the development and promotion of electronic cigarettes and vaping products as a viable alternative to smoking.The Rest of the StoryThis is truly a great day for public health. For the first time since 2009, when the FDA began regulating tobacco products, we now have a rationale approach to their regulation. This approach explicitly acknowledges the differential in risk between smoking and vaping and proposes to regulate these products according to the level of risk they present. It acknowledges that while nicotine is a critical contributor to the addiction potential of tobacco products, it is not what actually kills smokers. It aims to maximize the benefits of electronic cigarettes while minimizing their harms by both embracing e-cigarettes for harm reduction and easing their ability to stay on the market and setting safety standards to make these products as safe as possible. Finally, it aims to reduce the attractiveness of cigarettes and facilitate a transition from combusted to non-combusted nicotine products by reducing the addictive potential of cigarettes, thus promoting a shift to safer forms of nicotine delivery.More than anything else, the greatest contribution of this new approach is that it is evidence-based, rather than based on ideology or political concerns. Instead of punishing smokers by depriving them of potentially life-saving alternatives, it embraces the idea of giving them much lower-risk choices that have already been shown to help millions of smokers quit.The greatest risk to successful implementation of this sensible approach comes from the anti-tobacco groups themselves. Already, the Campaign for Tobacco-Free Kids is complaining about the pre-market tobacco application deadline extension for e-cigarettes. In a statement released Friday by the Campaign, it attacked the agency for attempting to save the e-cigarette industry, arguing that: "it is a serious error for the FDA to significantly delay critical deadlines for complying with the FDA’s 2016 rule establishing oversight of electronic cigarettes, cigars and other previously unregulated tobacco products. This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight."This complaint is complete crap. There is nothing in the deeming regulations that directs the agency to eliminate "kid-friendly" flavors. To do that, the agency would almost certainly have had to formally consider the issue and make a decision regarding the overall public health impact of such a restriction. It would have also had to carefully consider exactly how to define "kid-friendly" flavors. It is almost inconceivable that such a decision would have been made arbitrarily through the process of approving or denying pre-market tobacco applications. Moreover, in the approach outlined by Dr. Gottlieb on Friday, he specifically stated that the agency would examine the issue of "kid-friendly" flavors and make a decision about whether and how to implement such a policy. In contradiction with the Campaign's false claims, the FDA has full authority and oversight over e-cigarette flavorings and can regulate these flavorings completely independently of the pre-market application process.It is great to see this major change in the FDA's approach to the regulation of tobacco products and especially, to see the shift from an ideologically-driven approach to an evidence-based one. It is time for the anti-tobacco groups to make such a change as well. The ideological crap that is coming out of these groups has to end. Frankly, that crap is the greatest threat to the successful implementation of the sensible, evidence-based public health approach to tobacco control that the FDA has now embraced. Original author: Michael Siegel
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Huge FDA announcement on future tobacco and nicotine strategy


July 28th, 2017

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IN MY VIEW: American Lung Association Guilty of Public Health Malpractice

Yesterday, researchers from the University of California, San Diego published a landmark paper in the BMJ (British Medical Journal) which reported that for the first time in 15 years, the smoking cessation rate among adults in the U.S. has increased. The researchers tie this unprecedented increase in the smoking cessation rate to the availability of electronic cigarettes. The paper reports that the advent of electronic cigarettes was associated with a significant increase in the population smoking cessation rate. It also finds that smokers who use e-cigarettes are more likely to quit smoking than those who do not.Combined with abundant existing research, the findings of this study make it clear that among adult smokers, electronic cigarettes have had a huge public health benefit. They have increased the number of quit attempts as well as the proportion of successful quit attempts. The reason for this is clear: many smokers have trouble quitting not simply because of nicotine addiction, but because of addiction to the physical, behavioral, and social aspects of smoking. None of these are addressed by existing FDA-approved cessation methods, but they are specifically addressed by e-cigarettes, which replace almost all aspects of the smoking experience other than the tar, smoke, and high levels of 60+ carcinogens and 10,000+ toxins.It is also clear that smokers who are able to quit using e-cigarettes have greatly improved their health. Even dual users have improved their health, as lung disease risk drops with a decline in cigarette consumption, albeit not as much as quitting entirely. There is also a decline in cancer risk, although again, not as much as quitting altogether. (There is probably not a significant decline in heart disease risk among dual users).One would think that public health groups would hail this study and, if making recommendations to smokers, advise them to quit any way they are able to, including with the use of e-cigarettes if that works for them.  But no ... that's not the case with many health groups. One in particular -- the American Lung Association -- is still urging smokers not to quit using e-cigarettes. Instead, they are urging smokers to only use FDA-approved methods that are clearly not going to work for many smokers. And if you are one of those smokers, the American Lung Association would apparently rather that you continue smoking than try to quit by switching to vaping.While many public health researchers affirmed the value of electronic cigarettes for many adult smokers, an article on the new study in the San Diego Union-Tribune quoted the American Lung Association as continuing to advise smokers not to try to quit using e-cigarettes. There was no qualifying clause, so the American Lung Association is giving this advice even to those smokers who are unable to quit using FDA-approved drugs.According to the article: "People who had tried e-cigarettes in the previous 12 months were significantly more likely to have quit smoking traditional cigarettes than in previous years. The quit rate remained virtually the same for those who didn’t try e-cigarettes. ... “It’s important to remember that no e-cigarette has yet been found by the FDA to be safe and effective in helping smokers quit,” said Erika Sward, the American Lung Association’s assistant vice president of national advocacy."The Rest of the StoryThe American Lung Association's advice is tantamount to a physician telling a smoker who has failed to quit multiple times using FDA-approved drugs and who expresses interest in e-cigarettes that she should not try vaping and instead should stick to the failed methods in which she has no interest. This is precisely the advice that the American Lung Association is giving to America's smokers. And it is inappropriate and health-damaging advice. I view it as a form of public health malpractice.Most physicians will advise smokers to quit in whatever way they are able to. Quitting smoking is so difficult, and individuals are so different in what works for them, that physicians should not take any reasonable options off the table. It is one thing for a physician to make recommendations about what methods are most effective based on the evidence. But it is quite another for a physician to tell a patient for whom those methods have failed to continue hitting their head against a wall, rather than trying a new, promising method in which the patient has expressed interest and which has worked successfully for millions of other smokers. This is exactly the medical advice that the American Lung Association is giving.In my opinion, the American Lung Association should either correct this misinformed and dangerous advice or it should get out of the business of making medical recommendations altogether. With this advice, the American Lung Association is doing far more harm than good. The central principle of medicine and public health is "to do no harm." The American Lung Association is violating this core principle.The rest of the story is that the American Lung Association is guilty of public health malpractice because despite clear evidence that e-cigarettes have helped millions of smokers quit, it continues to advise smokers not to use this method to quit. Apparently, the American Lung Association is more concerned that smokers quit "the right way" than that they quit. Smoking is apparently a moral issue, not merely a health issue, and if you quit the wrong way, you apparently haven't paid the proper penance for your addiction.Original author: Michael Siegel
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Government’s Abstinence from Smokeless Truth Detailed by Wall Street Journal


The Wall Street Journal on July 21 reported what readers of this blog already know: “Many scientists agree that…smokeless tobacco, including chewing and dipping tobacco, is significantly less harmful than cigarettes.  But rather than encouraging the country’s 37 million smokers to switch to less-risky products, U.S. health officials have so far stuck with an abstinence-only message to the public.” Journalist Jennifer Maloney underscored the government’s withholding of relative risk information about smokeless tobacco: “Online fact sheets published by the Centers for Disease Control, the Food and Drug Administration and the National Cancer Institute list multiple health risks associated with smokeless tobacco…but give no indication it is less harmful than cigarettes. ‘There is no safe form of tobacco,’ the cancer institute says on its website.” Scientific research says otherwise.  Although it is impossible to prove absolute safety, dozens of epidemiologic studies over three decades have documented that health risks among American chewers and dippers are not significantly elevated.  Last year, a government study failed to find any mouth cancer risk among men who chew or dip (here).  The CDC claims that it is unable to provide risk estimates for smokeless users (here, hereand here).  Yet researchers from Altria produced them from CDC data; these are seen in the chart above (source here).  Smokeless users’ risks were comparable to those of nonusers of tobacco, whereas smokers had twice the risk of dying. That Altria was able produce these dramatic results from CDC’s data underscores the government’s refusal to acknowledge the scientific truth about smokeless tobacco’s reduced harm profile. That is irresponsible and contrary to public health interests. Federal health officials told Maloney, “more research needs to be done on the potential population-level consequences of broadcasting the fact that some tobacco products are safer than cigarettes.”  Such facts should not be withheld from the American public.  Here is the consequence of public health officials’ persistent obfuscation and mendacity: There were 8.1 million smokeless users in 2014, according to the National Survey on Drug Use and Health (NSDUH) (here), and 41% of them were also smokers.  This means that 3.36 million Americans are equally comfortable and satisfied using nearly harmless chew or dip, and smoking, which is deadly.  Government data shows that smokers have no idea that they are needlessly putting their lives at risk (here).  Federal agency leaders are aware of the differential risks, but choose not to push that potentially life-saving information to the public.  The Wall Street Journal is to be applauded for helping to expose this transgression. Original author: Brad Rodu
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Yet Another Group of Anti-Tobacco Researchers Encourage Lying to Kids About Relative Health Effects of Vaping and Smoking

It seems that honesty has disappeared as a core principle in tobacco control. Today, I report that yet another group of tobacco control researchers is bemoaning the fact that many youth understand the relative health effects of vaping and smoking and is encouraging lying to kids instead.In a paper published in Tobacco Prevention and Cessation, investigators from the University of Louisville examined YouTube videos promoting electronic cigarettes. They found that one of the major selling points for vaping in these videos was the claim that using e-cigarettes is safer than smoking and switching from cigarettes to e-cigarettes can therefore improve health. However, here is how they report this finding and how they describe its implications:"Our findings extend similar conclusions in related work: that the majority of YouTube videos promoting e-cigarettes demonstrate the social benefit and acceptability of e-cigarettes in part by claiming that using e-cigarettes is safer and healthier than consuming traditional tobacco products. This comparison perpetuates a narrative that e-cigarettes are safe because they are “healthier” or “safer” than other traditional tobacco products. Promoting a product by claiming that it is better than a hazardous substance, like traditional tobacco, only has merit when targeting cigarette users who are considering quitting or cutting back. Given that scientific information about safety is largely inconclusive, claims using words like “safer” to describe e-cigarettes could contribute to confusion about the overall safety of these products, especially among youth. A recent analysis found that 34.2% of youth believe that e-cigarettes are less harmful than traditional cigarettes, and 45% are not sure. Furthermore, e-cigarette use among youth who did not use traditional cigarettes was more likely when they perceived e-cigarettes to be less harmful than traditional cigarettes."The paper concludes that: "There is a need for “anti” e-cigarette videos on YouTube, especially ones targeted at youth, to more accurately convey current scientific understanding about the safety of these products."The Rest of the StoryTo be clear, this paper is suggesting that e-cigarette promotional videos are inaccurately asserting that vaping is safer than smoking. The paper calls for anti-vaping videos that "more accurately" convey scientific understanding about the safety of these products, condemning videos that claim that e-cigarettes are safer than real, tobacco cigarettes.In other words, the paper is clearly calling for public health practitioners to lie to our nation's youth by telling them that vaping is no safer than smoking or by hiding the fact that vaping is much safer than smoking.Ironically, the paper argues that telling kids the truth - that vaping is safer than smoking - is creating "confusion" because a recent analysis showed that one-third of youth believe that e-cigarettes are less harmful than traditional cigarettes. How is that confusion? What the paper calls "confusion" is actually the truth.The investigators appear to be upset that many youth have a correct understanding of the relative safety of vaping compared to smoking.A core principle of public health is honesty. Another core principle of public health is transparency. And a key element of health communication is telling the truth. We do not mislead, deceive, or lie to the public in order to promote health behavior change. That is what we have incessantly attacked the tobacco companies for doing. Deceiving people is not a valid or appropriate strategy in public health.But the rest of the story is that many tobacco control practitioners are encouraging precisely such a strategy. They can't stand the fact that youth may have a correct understanding of the relative health effects of vaping compared to smoking, and they want youth to be lied to in order to confuse them or even worse, deceive them into thinking that vaping is actually just as hazardous as smoking.While the overall goal of this dishonesty may be valid - trying to discourage kids from vaping - the means being urged to reach this end are inappropriate. In public health, we do not lie to the public to promote our agenda. That's what the tobacco companies used to do. And there is no excuse for us to sink to that level.Original author: Michael Siegel
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Challenging the prohibitionists – submissions to Australian parliamentary inquiry into e-cigarettes


July 21st, 2017

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Simple Simon would refuse to meet the pieman


by Carl V Phillips

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United Kingdom Doubles Down on Support for Tobacco Harm Reduction


The United Kingdom Department of Health’s new position statement (here), “Towards a Smokefree Generation,” is, as Clive Bates wrote (here), “probably the first significant government policy paper anywhere that recognises and pursues the opportunities of tobacco harm reduction, rather than defining these technologies as a threat to be suppressed.  For that, the Department of Health and its allies deserve considerable credit.” Indeed. British health authorities have been telling smokers the truth about vaping since 2011 (as I have noted here, here, hereand here), and British smokers have listened – the UK’s vaping population has ballooned to 2.9 million (here), while smoking has significantly declined.  In fact, a Public Health England official recently reported (here) that the UK smoking rate is now the second lowest in the European Union, after SWEDEN! Meanwhile, the U.S. persists in advocating for a “tobacco-free society” and a “tobacco endgame,” demonizing smoke-free products with untruths and giving continuing life to urban anti-vaping myths.  The UK paper underscores this stark contrast. “Towards a Smokefree Generation” sets forth the facts about e-cigarettes’ relative safety: “… the evidence is increasingly clear that e-cigarettes are significantly less harmful to health than smoking tobacco.” The UK Department of Health promises to help smokers make the switch: “The government will seek to support consumers in stopping smoking and adopting the use of less harmful nicotine products. Public Health England has produced guidance for employers and organisations looking to introduce policies around e-cigarettes and vaping in public and recommend such policies to be evidence-based.” The paper dismisses the unfounded claim that second-hand vapor is a health threat: “Public Health England recommends that e-cigarette use is not covered by smokefree legislation and should not routinely be included in the requirements of an organisation’s smokefree policy.” Additionally, the document invites the introduction of new tobacco harm reduction products, an apparent reference to products like Philip Morris International’s heat-not-burn iQOS: “… there has been the development and very recent introduction of novel tobacco products that claim to reduce the harm of smoking. We welcome innovation that will reduce the harms caused by smoking and will evaluate whether products such as novel tobacco products have a role to play in reducing the risk of harm to smokers.” Concluding, the UK pledges: “Public Health England will continue to provide smokers and the public with clear, evidence based and accurate information on the relative harm of nicotine, e-cigarettes, other nicotine delivery systems and smoked tobacco, to enable informed decision-making.” American health authorities, are you listening?Original author: Brad Rodu
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English tobacco control plan embraces tobacco harm reduction – world first


Positive…

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American experts call for risk-based reform of FDA regulation of tobacco and nicotine


July 14th, 2017

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IN MY VIEW: Campaign for Tobacco-Free Kids is Deliberately Lying to the Public

In a press release issued yesterday lamenting the passage by the House Appropriations Committee of a bill that grandfathers in existing e-cigarettes from the pre-market approval requirements of FDA vaping product regulations, the Campaign for Tobacco-Free Kids claimed that the bill strips the FDA of authority to review the public health impact of e-cigarettes.Specifically, the Campaign for Tobacco-Free Kids stated that the bill:"would “grandfather” e-cigarettes and cigars already on the market and exempt them from FDA review of their public health impact, including whether they appeal to kids." The Rest of the StoryThe rest of the story is that the Campaign for Tobacco-Free Kids is lying. And I now believe that they are doing so deliberately with the specific intention of deceiving the public.The truth is that the Bishop-Cole bill would not exempt e-cigarettes from FDA review of their public health impact. All it does is to prevent the FDA from requiring expensive and burdensome pre-market applications in order for e-cigarettes to remain on the market. The bill does nothing to take away the FDA's ability to review the public health impact of these products and to issue product standards, including restrictions on product flavorings, to protect the public's health.For as long as I could, I tried to convince myself that the Campaign was just stretching the truth to protect its political interests and was not deliberately lying. While the Campaign was spreading misinformation, I did not necessarily believe that the Campaign lacked ethical integrity.However, it is now clear to me that the Campaign for Tobacco-Free Kids is a organization that has neither scientific nor ethical integrity.How do we know that the Campaign is deliberately lying? Well, later in the press release, the Campaign essentially admits as such. In trying to downplay the significance of a provision in the bill which requires the FDA to promulgate a standard regarding product flavorings within three years, the Campaign emphasizes that the FDA already has the authority to issue product standards, including standards to regulate flavorings. They state: "In one change this year, the House bill gives the FDA three years to develop a product standard addressing “characterizing flavors” in e-cigarettes. The FDA already has the authority under current law to issue such a product standard, so this provision does not provide the FDA with any new authority."So any thought that the Campaign's false statement that the bill strips the FDA of its ability to review the impact of e-cigarettes was just an oversight is clearly laid to rest. The Campaign is fully aware that this is not the case and in fact makes this very argument in response to its opponents.Furthermore, the Campaign for Tobacco-Free Kids is wrong on this point. The Bishop-Cole bill is significant because it requires the FDA to promulgate standards to regulate vaping product flavorings. The agency has had the authority to do so for 8 years, but has failed to issue a single product standard during that time. Thus, forcing the FDA to act within 3 years is a very significant impact of the Bishop-Cole legislation.The bottom line is that I now believe the Campaign for Tobacco-Free Kids is intentionally lying, with a deliberate aim of deceiving the public and its constituents. It is no more ethical than many of our public health opponents. However, I view their dishonesty as more troubling because the Campaign has incessantly attacked the tobacco companies for lying to the American people. The Campaign should therefore be beyond reproach in its own statements to the public.Original author: Michael Siegel
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FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (postscript)

by Carl V Phillips

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The Illogic of Condoning Vaping & Condemning Smokeless – Both Are Safer for Smokers


While many American tobacco researchers and policy experts have, of late, moved to endorse reasonable regulation of e-cigarettes and vaping, most persist in condemning smokeless tobacco products, which have been proven to be nearly harmless.  It is irrational to support one and prohibit the other, when both are legitimate harm reduction options for smokers. The illogic of this dual position is displayed in the work of Dr. Dorothy Hatsukami, a prestigious tobacco researcher, author of 250 published articles (here) and recipient of tens of millions of dollars in NIH funding (available here,including $13 million to study reducing nicotine in cigarettes).  Dr. Hatsukami recently signed a letter to FDA Commissioner Scott Gottlieb (here) and published an article in Tobacco Control (here). In the letter to the commissioner, Dr. Hatsukami applauded his “openness to the concept of tobacco harm reduction…There is already a considerable body of science and experience suggesting that a harm reduction approach…could yield substantial and highly cost-effective public health benefits…at this time we do not believe that the current regulatory framework for the low-risk nicotine products such as e-cigarettes and smokeless tobacco is appropriate or will deliver the substantial public health benefits we hope and expect FDA’s oversight will bring.”  The letter encouraged the FDA to regulate tobacco products according to risk and to “support informed choice through truthful communication of risk.” However, in her Tobacco Control commentary, Dr. Hatsukami took a contrary view, fully endorsing the FDA’s proposed standard for NNN, which I have eviscerated hereand here.  She wrote, “If [FDA] puts the proposed rule into effect, it would be a significant and important step towards minimising the harms from smokeless tobacco use.”  Surprisingly, she asserted that “the risk for oral cancer is considerably higher for smokeless tobacco users,” and cited a federal study documenting that American men who dip or chew tobacco have no mouth cancer risk (here). Notably, other signatories to the Gottlieb letter are genuine tobacco harm reduction advocates who have endorsed the substitution of smoke-free tobacco by smokers.  They include Clive Bates of the UK and Canada’s David Sweanor, who filed a comment (here) labeling the NNN rule “reckless and pointless.”  American signatories who are on record about the relative safety of smokeless are Sally Satel (hereand here), Kenneth Warner (hereand here), David B. Abrams (here) and Raymond S. Niaura (here).  Original author: Brad Rodu
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IN MY VIEW: Position of Australian Medical Association (and Many U.S. Health Groups) on Vaping is Just Plain Evil

In a submission to the Australian government, the Australian Medical Association (AMA) argues that there is no evidence that e-cigarettes can help smokers quit, that e-cigarettes are harmful to health because they simply substitute one addiction for another, and that physicians must fight to prevent vaping from becoming an acceptable alternative to smoking.According to an article published by the Australian Journal of Pharmacy: "Commenting on its submission to an inquiry into the devices, the AMA says it believes that there is currently no compelling evidence that e-cigarettes are successful in helping people to stop smoking. ... AMA President Dr Michael Gannon says that the growth in e-cigarette products internationally has provided sections of the tobacco industry with the opportunity to rebrand themselves as part of the effort to reduce smoking – but there is no evidence that e-cigarettes work as a deterrent. ... “E-cigarettes must not be allowed to be marketed with claims that they are a smoking cessation aid,” Dr Gannon says. “There is no such evidence. ... “We must not allow e-cigarettes to become a socially acceptable alternative to smoking.”"The Rest of the StoryUp to this point, I have been criticizing many anti-tobacco groups for presenting false information about the relative safety and effectiveness of vaping and for supporting public policy that would harm the public's health. However, I have refrained from attacking the motives or intentions of these groups, assuming instead that they are simply misguided or uninformed about the scientific evidence.That all changes today.After reading the position statement of the Australian Medical Association, it is now clear to me that there is thinking going on in the anti-tobacco movement that is just plain evil.Specifically, I am now convinced that in order to preserve a certain misguided ideology in tobacco control (the idea that addiction itself is unacceptable under any circumstances), anti-tobacco groups are willing to sacrifice the health and lives of smokers.In other words, this really isn't about helping smokers and reducing the morbidity and mortality from smoking-related diseases. This is instead about protecting the world from the scourge of addiction itself, without regard to the impact of these statements and policies on the lives of smokers.Smokers are literally being sacrificed for what is viewed as the "greater good," which is protecting the world from nicotine addiction.To be blunt, the idea that anyone might actually derive enjoyment from, and health benefit from the use of nicotine is so unacceptable to anti-tobacco groups that it must be destroyed, even if that comes at the expense of smokers' lives.I apologize, but this is just plain evil. This is not what public health and medicine are supposed to be about.These groups are now admitting that they would rather not see smokers have a safer alternative that could save their lives. They do not want to see vaping become an alternative to smoking.Think about that: They would rather smokers continue to smoke than to quit smoking if they are still deriving pleasure from nicotine. This equates to the position that they would rather see smokers die than save their lives but continue to derive pleasure from the use of nicotine.This is a cruel position to take.Many readers have inquired as to why the frequency of my posts have decreased recently. Part of that is of course due to the summer season. But a major part of it has been that I have been beset with a sense of utter frustration and disillusionment. I have realized that the ultimate goals of the modern anti-tobacco movement do not align with my goals and I fail to see any change in the movement, no matter how much I point out the incoherence of current tobacco policy. I can't think of a single anti-smoking groups that has revised or corrected its false statements on the health effects of vaping after being informed about the errors in their communications. It's not clear that anyone actually cares.But today marks a turning point from even that level of frustration. Because it is now clear that we are not just dealing with scientific misinterpretation, poor communication, and misguided policy. We are dealing with cruel intent. And that is not something that some posts on a blog are able to change.Original author: Michael Siegel
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Reckless and pointless at the same time – FDA proposes NNN standard for smokeless tobacco


Just looking for our submission? Here it is: Submission by Clive Bates & David Sweanor – PDF

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Sunday Science Lesson: toxicology and “the chains” in American football

by Carl V Phillips

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Comment on FDA's unreasonable smokeless tobacco rule - DUE by July 10th!

The deadline for commenting on an FDA rule regarding product standards for smokeless tobacco (ST) is Monday, July 10th, 2017.

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NIAAA Prostitutes Its Scientific Integrity and Helps Alcohol Industry Promote Drinking

In one of the greatest episodes of corruption of a U.S. governmental health agency during my career, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) has sold itself out to the alcohol industry by agreeing to accept $68 million for a shoddily-designed study intended to examine the potential health benefits of moderate drinking but without similarly assessing the potential risks.According to the New York Times: "the National Institutes of Health is starting a $100 million clinical trial to test for the first time whether a drink a day really does prevent heart attacks. And guess who is picking up most of the tab? Five companies that are among the world’s largest alcoholic beverage manufacturers — Anheuser-Busch InBev, Heineken, Diageo, Pernod Ricard and Carlsberg — have so far pledged $67.7 million to a foundation that raises money for the National Institutes of Health, said Margaret Murray, the director of the Global Alcohol Research Program at the National Institute on Alcohol Abuse and Alcoholism, which will oversee the study."The Rest of the StoryAccording to the New York Times article: "George F. Koob, the director of the alcohol institute, said the trial will be immune from industry influence and will be an unbiased test of whether alcohol “in moderation” protects against heart disease. “This study could completely backfire on the alcoholic beverage industry, and they’re going to have to live with it,” Dr. Koob said. “The money from the Foundation for the N.I.H. has no strings attached. Whoever donates to that fund has no leverage whatsoever — no contribution to the study, no input to the study, no say whatsoever.”"What a bunch of crap!The money has huge strings attached: namely, the money is to be used for a trial to examine the potential benefits of drinking! In other words, the alcohol industry doesn't need any further leverage because they have already won. They have succeeded in getting the NIAAA to spend 20% of its entire budget on a study which is designed to identify potential benefits of drinking. The study is not examining potential negative health effects of moderate drinking: namely, increased cancer risk, and especially breast cancer risk.Very few people understand that the greatest influence that industry can have on research is not on the way the research is conducted, but on the topic of the research in the first place. The tobacco industry also funded research with "no strings attached." The tobacco industry completely divorced itself from the decisions of many of its funded scientists. However, the industry had already won because it essentially dictated the research agenda. The industry made decisions about what to fund and what not to fund. That is the true, critical point of leverage.So, for example, the tobacco industry funded many studies on genetic causes of lung cancer, non-tobacco-related causes of cancer, etc., while funding few, if any, studies on the severity of nicotine addiction, nicotine addiction in youth, the exposure of youth to tobacco advertising, the positive impact of anti-tobacco regulations, etc. No strings attached? The strings have already been attached.If the alcohol companies were willing to donate money to NIH that could be used for any purpose that an NIH researcher proposed, such as a study to examine the effects of increased alcohol taxes on reducing youth alcohol consumption, then one could say that there are no strings attached. But this money is clearly earmarked - and beyond that, earmarked for a study that is essentially designed to show some positive health effects of moderate alcohol consumption. Dr. Koob's contention that this trial is an "unbiased" test is also laughable. How can it be unbiased when its major funder is the industry that markets the product under study? But the bias doesn't end there. It turns out that many of the investigators running the study have individual conflicts of interest with the alcohol industry. At my institution, such researchers would not even be allowed to be involved in a clinical trial in which they have a significant conflict of interest. Our general policy is that an investigator with a significant conflict of interest cannot conduct a clinical trial on a product made by the relevant company. We do allow conflicted investigators to conduct pre-clinical studies, such as laboratory research; however, the line is drawn definitively at the level of a clinical trial.Just how strong are the conflicts of interest of the lead researchers for the study?According to the New York Times article: "Harvard, the hub of the clinical trial, has a long relationship with the alcoholic beverage industry. In 2015 the university accepted $3.3 million from the Foundation for Advancing Alcohol Responsibility, a group founded by distillers, to establish an endowed professorship in psychiatry and behavioral science." In addition: "One of the trial’s principal investigators, Dr. Eric Rimm of the Harvard T. H. Chan School of Public Health, has acknowledged through various financial disclosures that he has been paid to speak at conferences sponsored by the alcohol industry and received reimbursement for travel expenses."Moreover: "Dr. Diederick Grobbee, another principal investigator, who is based in the Netherlands and is in charge of clinical sites outside the United States, said in a telephone interview that he has received research money from the International Life Sciences Institute, an industry group that supports scientific research."Furthermore: "In Baltimore, the trial will be run by Dr. Mariana Lazo-Elizondo of Johns Hopkins, who received research grants in 2013 and 2014 totaling $100,000 from the Alcoholic Beverage Medical Research Foundation. She declined to be interviewed."And to add insult to injury: "The Barcelona study arm will be run by Dr. Ramon Estruch, who in February helped lead a “Wine & Health” conference in the wine region of La Rioja, Spain, that was supported by the wine industry. Dr. Estruch recently refused to disclose his financial conflicts of interest to The Journal of Studies on Alcohol and Drugs and has not responded to requests for comment."It is clear that many of the principal investigators in the trial have personal conflicts of interest with the alcohol industry. And the lead investigator for the Barcelona study arm not only has severe personal conflicts of interest but has failed to disclose them, apparently despite numerous requests from the journal to do so. But his conflicts with Big Alcohol run deep. As I revealed in a 2016 column:Dr. Ramon Estruch - is on the board of or receives money from three different research foundations, each of which is funded by alcohol companies. According to a published article: "Dr. Estruch reports serving on the board of and receiving lecture fees from the Research Foundation on Wine and Nutrition (FIVIN); serving on the boards of the Beer and Health Foundation and the European Foundation for Alcohol Research (ERAB)."Well, it turns out that the Research Foundation on Wine and Nutrition is funded by alcohol companies.And the Beer and Health Foundation is funded by the Spanish beer industry. And the European Foundation for Alcohol Research acknowledges that it: "is supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production."I have also previously discussed why Harvard's objectivity regarding this research has already been severely compromised (see: Harvard Medical School Teams Up with Makers of Bacardi Rum, Smirnoff Vodka, Jim Beam Bourbon, and Jack Daniels Whiskey, Providing Great PR at Bargain Rates).The study design doesn't even pass the laugh test in terms of basic epidemiology. The study is excluding nondrinkers, who are the only people who really matter because they are the ones who would potentially benefit - or be harmed - by efforts to promote moderate drinking. People who are already drinking aren't the ones who would be most affected by such a campaign.The study is also excluding problem drinkers. People who are already drinking, but are not problem drinkers, have already demonstrated that they are capable of moderate drinking. The real issue is what happens when you successfully convince a non-drinker to start drinking every day. This trial specifically avoids (and is designed to avoid) examining that research question. But that research question is really what is at the heart of any evaluation of whether promoting moderate drinking might have public health benefit.Even the tobacco industry, to the best of my knowledge, never succeeded in persuading the prestigious NIH to accept industry funding for a study of interest to the tobacco companies. The tobacco companies had to resort to funding their own research bodies (e.g., the Council for Tobacco Research). But here, the NIAAA is giving the alcohol industry an unprecedented gift: the acceptance of industry money to conduct a clinical trial, under the pretense of being an objective government study.The rest of the story is that by accepting this funding from the alcohol industry to support what is supposed to be an objective NIH research agenda, the NIAAA has compromised its scientific integrity, selling out to the alcohol industry and helping the industry to promote drinking. This is not the appropriate role of the NIAAA.This clinical trial is tainted before it has even begun. Hopefully, its participants will be informed that the study is essentially a sham - that it is funded by the alcohol industry, which has -- in a dream come true scenario -- somehow gotten the NIAAA to agree to conduct a study that is designed only to examine potential positive health effects of moderate drinking, while ignoring (and not looking for) any serious potential risks, such as cancer.The study investigators may not reveal this critical information to the human subjects in these trials; however, there are a number of public health groups that are planning to publicize this information so that the public is aware of this scam before it does real damage to the public's health. It has already done damage to the scientific credibility of the NIAAA specifically, and of government public health research in general. Original author: Michael Siegel
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