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Mountain Vapor Blog

Welcome to the blog area of our site where we hope to keep you updated on the trends of the e-cigarette industry as well as product reviews.

“Deception or Evasion” by FDA CTP & National Cancer Institute Regarding Smokeless Tobacco?


“A majority of adults do not think smokeless tobacco is less harmful than cigarettes,” according to a study by the FDA Center for Tobacco Products and the Tobacco Control Research Branch of National Cancer Institute (abstract here).  Sheri P. Feirman and colleagues analyzed responses to a question in the Health Information National Trends Survey (HINTS), 2012, 2014, and 2015: “Do you believe that some smokeless tobacco products, such as chewing tobacco and snuff, are less harmful than cigarettes?”  Do You Believe that Some Smokeless Tobacco Products…Are Less Harmful Than Cigarettes?201220142015Yes9.4%12.0%10.9%No73.5%72.1%66.8%Don’t Know17.1%15.9%22.2% Simply put, only 9 to 12% of Americans correctly believe that smokeless tobacco is less harmful than cigarettes. In a PubMed Commons commentary on this study, David Sweanor and I note: “The article failed to specify that the correct answer [to the question] is:  ‘Yes, smokeless tobacco products are less harmful than cigarettes.’  The article instead focuses on the majority of participants who inaccurately answered ‘No’ or ‘Don’t Know,’ which demonstrates the misperception fostered by an effective ‘quarantine’ of truthful risk information by federal agencies (Kozlowski and Sweanor, 2016). “Decades of epidemiologic studies have documented that the health risks of smokeless tobacco use are, at most, 2% those of smoking (Rodu and Godshall, 2006; Rodu, 2011; Fisher 2017; Royal College of Physicians, 2002; Lee and Hamling, 2009).  Unlike cigarettes, smokeless tobacco does not cause lung cancer, heart and circulatory diseases or emphysema.  The Royal College of Physicians concluded in 2002: ‘As a way of using nicotine, the consumption of non-combustible [smokeless] tobacco is on the order of 10–1,000 times less hazardous than smoking, depending on the product.’” (Royal College of Physicians, 2002) ”Low risks from smokeless tobacco use extend to mouth cancer.  A 2002 review documented that men in the U.S. who use moist snuff and chewing tobacco have minimal to no risk for mouth cancer (Rodu and Cole, 2002), and a recent federal study found no excess deaths from the disease among American men who use moist snuff or chewing tobacco (Wyss, 2016). “As one of us recently wrote, ‘Deception or evasion about major differences in product risks is not supported by public health ethics, health communication or consumer practices.  Public health agencies have an obligation to correct the current dramatic level of consumer misinformation on relative risks that they have fostered.’ (Kozlowski and Sweanor, 2018).” The FDA and NCI must be more forthcoming with the American public.Original author: Brad Rodu
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Mythic Tobacco Endgames



A new $1.2 million campaign to promote tobacco prohibition on college campuses was announced on September 19 (here).  As I have noted, the federal government annually spends hundreds of millions of dollars in support of academic anti-tobacco research (here).  This time, the money is coming from pharmacy giant CVS’s Health Foundation as part of a five-year, $50 million campaign.  CVS collaborators include the misnamed Truth Initiative (see hereand here) and the American Cancer Society, whose numerous prohibitionist exploits are reported in this blog (here, here, here, here, here, here, here, here, here, here). Campaign awards to several Texas schools were reported in a Houston Chronicle article (here) that included illustrations offering and refuting four tobacco “myths”.  In this effort, the paper (or the campaign) repeated fantastical claims that are often made by prohibitionists. Myth #1: “Almost no one smokes any more [sic].”  A myth, by definition, is a widely held view, so this attempt fails from the start. The latest data from the CDC, for 2016, shows 38 million smokers in the United States – a substantial and highly visible group of people, all in need of effective quit-smoking tools and support. Myth #2: “e-Cigarettes, hookahs and cigars are safe alternatives.”  Again, few people hold this view (here).  Scientists, the industry and public health officials agree that no form of tobacco use is perfectly “safe.”  Eminent authorities like Britain’s Royal College of Physicians, however, have pronounced that vaping “is unlikely to exceed 5% of the harm from smoking tobacco.” (here)  Furthermore, FDA data shows that smoking one or two cigars a day have almost no health risks (hereand here). Myth #3: “Infrequent, social smoking is harmless.”  This is creating a myth when one doesn’t exist. Myth #4: “Smoking outside eliminates secondhand smoke dangers.”  Myths convey false information.  This statement is entirely true. Ironically, some viewers of the online Chronicle article are shown an advertisement for Nicorette gum, reproduced here.  While pharmaceutical nicotine has a known 93% quit-smoking failure rate (here), this ad touts one day of success – an extraordinarily low bar for cessation. Original author: Brad Rodu
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2016 CDC Data Shows E-Cigarette Use Declines Again



Some 7.8 million American adults used e-cigarettes in 2016, according to data from the 2016 National Health Interview Survey, the source for CDC national smoking estimates.  That is about half a million fewer than a year earlier, and 1.1 million fewer than in 2014, the first year NHIS surveyed for vaping.  As the CDC reported a month ago (here), the 2016 data indicates 3.2% adult prevalence – 3.9% (about 4.5 million) for men, and 2.6%, (about 3.3 million) for women.   The 2.62 million former smokers who are current vapers comprised an increasing percentage of all vapers, from 22% in 2014, to almost 34% in 2016.  This is more evidence that smokers are using e-cigarettes to quit their habit.  As the following chart shows, 87% of former smokers currently using e-cigarettes quit in the last 5 years, suggesting that e-cigarettes played a significant role.  Meanwhile, 13% of former-smoker current-vapers quit over 6 years ago.  The CDC admits that relapse among former smokers is common (here), so health advocates should applaud these former-smokers’ choice of e-cigarettes over far more dangerous cigarettes. As noted previously (here), the 2.6 million former smokers represent more than mere anecdotal evidence; their documented experience ought to carry substantial weight with government policymakers.  In view of the important positive health implications of switching to smoke-free products, the number of former smokers ought to be growing faster.  Unfortunately, the sustained war on all smoke-free products is likely suppressing broader transition away from cigarettes.Original author: Brad Rodu
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Guest post: BAT executive on disruption of the tobacco industry

On June 12th, I published a blog, Pariahs, predators or players? The tobacco industry and the end of smoking, in which I tried to guess how tobacco companies are thinking about the future from my vantage point on the sidelines.  But I also asked if any industry figures would like to offer an informed insider’s view and offered a right of reply. Well, to my surprise one executive did reply.  David O’Reilly is BAT’s Group Scientific and R&D Director, and here is his perspective.

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Advertising code at fault over e-cigarette public health ad ban


This year’s Stoptober campaign encourages smokers to try vaping – bravo!

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Antidote to NEJM Formaldehype Arrives at Last


In January 2015, R. Paul Jensen and colleagues created global headlines with a defective e-cigarette experiment (here).  They claimed in the New England Journal of Medicine that vapor contains “hidden” formaldehyde at far higher levels than cigarettes (here).  Their measurements required overheating or “dry-puffing” e-cigarette liquid, a process that produces such harsh (not hidden) oral sensations that the vapor is intolerable to normal consumers.  As Churchill said, “A lie gets halfway around the world before the truth has a chance to get its pants on.”  The Jensen mischaracterization caused considerable damage, as it encouraged smokers to believe that vaping is more dangerous than smoking.  Last week, the formaldehyde fallacy was laid bare.  Dr. Konstantinos Farsalinos and colleagues reproduced the Jensen experiment and found that “The high levels of formaldehyde emissions that were reported in [the Jensen] study were caused by unrealistic use conditions that create the unpleasant taste of dry puffs to e-cigarette users and are thus avoided.” Their work appears in Food and Chemical Toxicology (abstract here).  Farsalinos’ group painstakingly reproduced the earlier experiment, using the same now-outdated vaping equipment that was prone to dry puffs.  First, they had experienced vapers identify at what settings the “burning” taste of a dry puff was detected: 4.2 volts, 8.0 watts.  They then used Jensen’s methods to measure formaldehyde at various voltage-power settings, seen in the chart (above) adapted from their publication. Vapers detected dry puffs when the formaldehyde level was 100 micrograms (per 10 puffs).  Given that a microgram is one-millionth of a gram, Jensen’s formaldehyde level wasn’t hidden at all; at 380 micrograms, it was much higher than vapers could tolerate.  At lower, normal vaping power, formaldehyde was only 20 micrograms, or two-thirds that of cigarettes. Farsalinos cautions the scientific community: “blindly testing e-cigarettes in the laboratory setting without evaluating realistic use is a serious omission that can result in misleading conclusions about the risk to consumers compared to smoking;” and such conclusions can wrongly imply “that there is little to be gained by switching to e-cigarettes.” In response to the Jensen article in 2015, Clive Bates and Konstantinos Farsalinos published a letter in Addiction calling for its retraction (here); the demand was ignored.  The current publication is a much-needed antidote to Jensen’s seriously flawed and misleading findings. Original author: Brad Rodu
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Do Smokers Quit After Hospital Cessation Trials? Don’t Count on It, or Them


Do smokers lie about quitting?  A new study analyzes smokers’ self-reports of their smoking habits six months after their participation in quit-smoking clinical trials. Several years ago, researchers recruited sick smokers at a group of hospitals – the Consortium of Hospitals Advancing Research on Tobacco, or CHART – and conducted federally-supported smoking cessation trials.  Now Taneisha Scheuermann et al. in the journal Addiction (abstract here) examine the post-trial results, focusing on levels of cotinine, a nicotine breakdown product, in trial participants’ saliva. Hospitals in six cities provided 5,827 smoking patients with a variety of quit-smoking interventions.  Six months later, 4,206 of those subjects completed a survey, with 1,708 reporting that they had not smoked in the past seven days.  Nearly 10% of them reported using pharmaceutical nicotine, e-cigarettes or other tobacco harm reduction products in the past seven days; those subjects were among the 530 excluded from the Scheuermann analysis.  Self-described non-smokers were offered $50 to $100 in exchange for saliva samples, but only 923 participants responded; of those, 822 supplied usable samples. Scheuermann used a standard saliva cotinine cutoff of 10 nanograms per milliliter: participants below this level were considered to be not smoking, while those at or above were still smoking. Of the 822 participants who reported 7-day abstinence, 347 (42.2%) were dissembling, as their saliva cotinine levels indicated they were smoking.  That so many individuals failed to quit evidences a fact that tobacco prohibitionists often ignore: The vast majority of smokers are unable or unwilling to quit.  The 475 verified quitters constituted roughly 8% of the 5,827 patients who started the trials – a percentage that is consistent with the quit rate among the general population.  Also note that these smokers were recruited during a hospitalization, when their focus on health issues might have increased their motivation to quit. Treating smokers as social outcasts may influence their decision to lie about the results of their quit attempts. The CHART study was supported from 2009 to 2014 by five NIH grants costing taxpayers $15.5 million.      Original author: Brad Rodu
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Teen Smoking Unconnected to Cinematic Smoking


In a July report (here), the CDC Office on Smoking and Health asserted the following about tobacco use in movies: “The Surgeon General has concluded that there is a causal relationship between depictions of smoking in the movies and the initiation of smoking among young persons.” “…the decline in the total number of tobacco incidents [in top-grossing movies] has not progressed since 2010.” “Reducing tobacco incidents that appear in youth-related movies would prevent the initiation of tobacco use among young persons.” “An R rating for movies with tobacco use could potentially reduce the number of teen smokers by 18%...” Responding, Guy Bentley published an excellent commentary noting that any connection between smoking in movies and among teens is illusory (here).  I provide statistical evidence of this by analyzing the CDC report’s numbers together with smoking prevalence rates among high school seniors for the same years.  The resulting chart fails to support any of the above claims.  The number of tobacco incidents per year in top-grossing movies varied from 1,600 to 3,300 over 25 years, 1991-2016, except for a couple years around 2005.  Smoking among high school seniors plummeted continuously after 1996.  There appears to be no connection between the two data sets. The report clearly lacks objectivity.  It was authored by CDC staffer Michael Tynan; Jonathan Polansky, founder of the advocacy firm Onbeyond and creator of the Smokefree Movies campaign (here); Kori Titus and Renata Atayeva from Breathe California Sacramento Region (here), an organization that “…has been fighting for…tobacco-free communities [otherwise known as prohibition] since 1917…”; and Stanton Glantz, faculty member of the University of California, San Francisco, and long-time tobacco opponent.  Polansky, Titus and Glantz acknowledge grant support from the Truth Initiative as their only conflict of interest. Note that the tobacco incident numbers were collected by “Youth volunteers between the ages of 14-22… trained to analyze tobacco content in films…Their data is posted weekly on our sister website SceneSmoking.org and is used by university-level researchers and public health professionals across the globe….”  This underlying data does not appear to be publicly available.  The link to SceneSmoking was not functional and redirected to Breathe California Sacramento.   Original author: Brad Rodu
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Negligible Evidence of Radical Nicotine Reduction Benefit


An August 17 commentary in the New England Journal of Medicine (here) by FDA Commissioner Scott Gottlieb and Center for Tobacco Products Director Mitchell Zeller raises some concern about the agency’s new tobacco regulation strategy. The piece touches on “less harmful tobacco products,” which Commissioner Gottlieb wrote favorably about earlier (here), but it includes descriptors – “potential” (four times) and “conceivable” (once) – that suggest the authors are not convinced that e-cigarettes are truly lower-risk. Smokeless tobacco, already demonstrated to be vastly safer than cigarettes, isn’t mentioned. In their commentary, the FDA officials advocate for radical nicotine reduction (RNR) in cigarettes.  RNR is a variation on a failed concept: supply-side elimination of popular products.  Full-on cigarette prohibition was adopted, then jettisoned, in 12 states from 1899 to 1909 (here). During Prohibition a decade later, brewers tried to market an alcohol-free product called near beer (here).  That bombed just as badly as Vector Group’s RNR cigarettes in 2003 (here).  Any new RNR products will likely be rejected as well, causing smokers to seek out higher-nicotine-level products, licit or otherwise. Despite a significant expenditure of taxpayer dollars on RNR research, this approach has not been demonstrated to reduce adult smoking. For example, a $29 million clinical trial by Dr. Neal Benowitz, reported in 2015, produced dismal results (my review here). The FDA commissioner and his co-author remain optimistic: “A recent 6-week study by Donny et al. showed that cigarettes with lower nicotine content reduced nicotine exposure and dependence, as well as the number of cigarettes smoked, as compared with cigarettes with standard nicotine levels.”  They are referring to another 2015 report (here), but that study’s results were unimpressive as well. Dr. Eric Donny recruited 840 smokers uninterested in quitting, and randomly provided them with one of seven types of cigarettes to use for 6 weeks: their usual brand, a full-nicotine study cigarette and five others with varying low nicotine levels (2% to 33% of the full-nicotine cigarette).  Subjects were paid up to $835 for 10 clinic visits, which probably contributed to a 92% completion rate. While it was not surprising that smokers using reduced nicotine cigarettes had lower nicotine levels in their urine, most of the low-nicotine smokers (73-81%) admitted that they smoked three or four “wildcat” cigarettes (products not distributed as part of the study) on 24-35% of days in the trial. There was little consistency regarding changes in dependence.  On the Wisconsin scale, smokers in all groups had lower scores after six weeks than at baseline, with only one of the reduced nicotine groups significantly lower than the full-nicotine group.  On the Fagerström scale, three low-nicotine groups were significantly lower than the full-nicotine group, but the changes from baseline were not impressive.  In other words, it is not clear if the low-nicotine cigarettes reduced dependence. The number of cigarettes smoked in the Donny study is interesting.  At baseline, every group was smoking about 15 cigarettes per day.  Although Commissioner Gottlieb and Mr. Zeller imply that low-nicotine groups smoked fewer cigarettes at the end of the study, they actually averaged 15-16 cigarettes per day.  Smokers of usual-brand and full-nicotine cigarettes smoked 21-22 per day after six weeks, an increase of 6-7.  Perhaps Donny contributed to this increased consumption by providing full nicotine cigarettes for free. Like the Benowitz study, the Donny study does not prove that reduced-nicotine cigarettes produce meaningful benefits for smokers. It should be noted that the Donny study was supported by $93.3 million in grants from the National Institute on Drug Abuse and the FDA. Original author: Brad Rodu
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Government-Funded Researchers Continue to Misrepresent Smokeless Tobacco Cancer Risks


The American Journal of Epidemiology in October 2016 published a report by Annah Wyss of the National Institute of Environment Health Science and 20 government-funded coauthors.  It revealed that American men had ZERO mouth cancers associated with dipping or chewing tobacco (Odds Ratio, OR = 0.9), while women, who mainly use powdered dry snuff, had a 9-fold elevated risk (here).  After trying for several months to correspond with the authors, I wrote to the journal editor.  My letter was accepted, and the authors were invited to reply.  The journal published both items on August 4 (here). Here is my letter.  Because the references are important, I provide links to the sources. “In the article… Wyss et al. omit key information that would likely yield critical insights about their most important result. “Wyss et al. reported that ever use of snuff among never cigarette smokers was associated with head and neck cancer (OR = 1.71, [95% Confidence Interval] CI: 1.08, 2.70), based on 44 exposed cases and 62 exposed controls.  The OR among women ever snuff users (8.89, CI: 3.59, 22.0, based on 20 exposed cases and 12 controls) was an order of magnitude higher than that in men (0.86, CI: 0.49, 1.51, based on 24 exposed cases and 50 controls).  “The striking difference between women and men reflects completely different snuff exposures.  It is widely known that in the southern U.S. women primarily use powdered dry snuff, whereas men throughout the U.S. use moist snuff.  Powdered dry snuff use is associated with excess oral cancer risk in four previous studies (Reference 2), all of which were cited by Wyss (3, 4, 5, 6).  In contrast, moist snuff is associated with minimal to no risk in eight previous studies (2). “Wyss and colleagues are knowledgeable about the use of powdered dry snuff by women and its cancer risk; one was first author of a 1981 study reporting that “[t]he relative risk [for oral and pharyngeal cancer] associated with snuff dipping among white [women] nonsmokers [in North Carolina] was 4.2 (95 per cent confidence limits, 2.6 to 6.7).” (4)  Subjects in that study had exclusively used powdered dry snuff.   “Wyss et al. used pooled data from 11 US case-control studies located throughout the U.S.  They have information to confirm that the 20 female [powdered dry] snuff users with cancer were from study sites in the Southern U.S., whereas the 24 male [moist] snuff users were from more diverse locations.  This information is not available from the 12 publications cited by Wyss et al. as data sources.  Six publications had insufficient information about exposed and unexposed cases and controls (i.e. no specificity with respect to smokeless tobacco type, gender, and/or smoking), three reported no results related to any smokeless tobacco product and three did not mention smokeless tobacco at all. “Wyss et al. should provide in tabular form the number of exposed and unexposed cases and controls separately for never smoking men and women from each of the 11 source studies.  This information is routinely provided in publications of pooled analyses, and it is available in the existing data and results files.” In their response, Dr. Wyss and her coauthors provided additional results, per my request.  While they confirmed no risks among men who dip, their conclusion about women was grossly inaccurate: “Snuff use was strongly associated with elevated [head and neck cancer] risk in both Southern women…and non-Southern women.” In Southern women, the risk was quite high (OR = 11.25) and statistically significant, but with a wide 95% confidence interval (2.14 – 59.07), owing to the fact that the OR was based on only 26 cases.  In non-Southern women, the OR was even higher, at 15.91, but this was based on a mere 6 cases.  While statistically significant from a technical perspective (CI = 1.20 – 211.43), the CI is so large and unstable that the estimate is virtually meaningless. Dr. Deborah Winn of the National Cancer Institute knows that powdered dry snuff is the only smokeless product with mouth cancer risk (evidence here, here, hereand here); she published a study in 1981 that falsely implicated dip and chew.  Even though Dr. Winn co-authored the new report, the authors’ only comment on powdered dry snuff was, “we cannot comment on whether snuff users – female or male, Southern or non-Southern – in our analysis used dry or moist snuff.” To be clear, numerous studies since 1981 have demonstrated that the huge difference in mouth cancer risk between women and men is attributable to powdered dry and moist snuff.  Yet federally funded researchers continue to misrepresent these established facts in order to sustain the fiction that all smokeless products are hazardous.   Original author: Brad Rodu
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E-Cigarettes: The Case for Regulatory Restraint


Debate over FDA regulation of e-cigarettes often degenerates into bitter argument and ad hominem attack.  In contrast, a point/counterpoint presentation in the Journal of Policy Analysis and Managementis calm, thoughtful and enlightening. The case for stringent FDA regulation (citations here and here) is presented by Kurt Ribisl, a professor at the University of North Carolina, along with graduate students Andrew Seidenberg and Elizabeth Orlan (hereafter RSO).  Cornell University Professor Donald Kenkel makes the case for light regulation (here and here). Describing the problem – “Smoking is estimated to result in 480,000 deaths per year in the United States” – Kenkel underscores a death toll that has not changed in 20 years, despite increasingly harsh anti-smoking policies.  Tobacco prohibitionists frequently cite this horrid data, but they rarely support vastly safer alternative products like e-cigarettes, referred to by Kenkel as “perhaps the most revolutionary product innovation in the market…” Kenkel puts the risk differences in striking contrast.  He notes that if Britain’s health authorities are correct that vaping is no more than 5% as hazardous as smoking, then a world in which all smokers vape would suffer only 24,000 deaths attributable to e-cigarettes, compared to 480,000 actual deaths due to smoking.  This projection is similar to that in my 1994 publication (here), where I estimated 6,000 deaths among an imagined 46 million smokeless tobacco users – a mere 2% of the 419,000 actual deaths from smoking. RSO acknowledge that vaping is less risky than smoking, but they reject the 5% estimate, arguing that it “lacks empirical basis, as it came from a multicriteria decision analysis model developed from one meeting of 12 people. This type of expert opinion is at the bottom rung of the evidence hierarchy…”  That is true, but the North Carolinians offer no counter-estimate.  Kenkel suggests that even if the e-cigarette risk was as high as 10% as that of smoking – which is highly implausible, the result “would still be a revolutionary public health gain.” RSO “supports regulating e-cigarettes less stringently than combustible tobacco products,” however that position is not fully reflected in their policy recommendations.  As Kenkel notes, they still call for “restrictions on flavors, advertising and marketing restrictions, taxes, bans on indoor vaping, and mandatory product warnings.”  Using “the conceptual framework of economics,” Kenkel brings a refreshing perspective to e-cigarette use: “the key question is whether vaping and smoking are substitutes or complements… if they are complements, a policy that encourages vaping will increase smoking… If they are substitutes, a policy that encourages vaping will cause consumers to substitute vaping products for combustible cigarettes and thus reduce smoking.” Kenkel finds that “Accumulating evidence suggests that vaping is a substitute for smoking,” and he concludes: “Policies to encourage vaping could facilitate such a revolutionary change in the U.S. market for tobacco products.” Government and insurance incentives are worth considering, says Kenkel: “the benefits of reducing smoking could also justify a more activist policy approach. Taxing cigarettes and subsidizing a substitute good are alternative approaches to correct market and individual failures in the cigarette market. Many private and public health insurance plans provide generous coverage for one class of substitute goods—nicotine replacement products approved as smoking cessation aids. The same rationale might support subsidies for vaping products.” Observing that vaping is “an existential threat to the market for combustible cigarettes, unless their spread is restricted by government regulation,” Kenkel seems to be in sync with new FDA Commissioner Scott Gottlieb, who has signaled a lighter approach toward e-cigarette regulation. Original author: Brad Rodu
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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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Huge FDA announcement on future tobacco and nicotine strategy


July 28th, 2017

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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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Challenging the prohibitionists – submissions to Australian parliamentary inquiry into e-cigarettes


July 21st, 2017

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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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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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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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