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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.

Australian medicines regulator intends to continue to protect the cigarette trade – we challenge its bizarre reasoning

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Solid as a rock?  The TGA justification for banning e-liquids certainly isn’t

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Complicated Models Can’t Alter the Data - Part 2: Youth Smoking Is Way Down


As reported here last week, University of California San Francisco researchers Lauren Dutra and Stanton Glantz tortured data from the National Youth Tobacco Survey (NYTS) to support a purported “lack of a demonstrable acceleration in the long-term rate of decline” in youth smoking after 2009.  This was despite the fact the survey data showed that smoking among high school students declined from almost 16% in 2011 to 9% in 2014 – a reduction of 43% in just three years (here).  The “untortured” NYTS findings can be confirmed by charting data from another federal survey: the National Survey on Drug Use and Health (NSDUH), which I have used for smoking research for many years (discussed here). Once again, I used 2010 as the anchor year for equal intervals before widespread e-cigarette use (2006-2010) and after (2010-2014, the latest year for public access of NSDUH data).  I tallied smoking rates among boys and girls age 14-18 years, which is comparable to high school students in the NYTS.  The definition of a current smoker is also the same in the two surveys: anyone who smoked on at least one day in the past 30. The accompanying chart clearly illustrates that smoking declined among boys (-13%) and girls (-20%) from 2006 to 2010.  However, during the next four years, the rate of decline doubled – to   -31% for boys and -41% for girls. Findings from both federal surveys are consistent: The decline in smoking among high school students accelerated as demonstrably safer (here) e-cigarette use increases.  Original author: Brad Rodu
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Complicated Models Can’t Alter the Data: Smoking Among Youth and Young Adults Is Way Down


Smoking among high school students declined from almost 16% in 2011 to 9% in 2014 – a reduction of 43% in just three years.  That is according to data from the National Youth Tobacco Survey (NYTS) that I recently published (here).  Now two researchers at the University of California San Francisco, Lauren Dutra and Stanton Glantz, torture the NYTS data to support a perceived “lack of a demonstrable acceleration in the long-term rate of decline” in youth smoking after 2009.  Dutra and Glantz analyzed smoking among children from 2004 to 2014.  They used a complicated model to determine the rate of decline from 2004 to 2009, then compared that to the 2011-2014 rate, when e-cigarette use was increasing among youths.  The UCSF publicity statement on their work (here) states: “E-cigarettes …are actually attracting a new population of adolescents who might not otherwise have smoked tobacco products…”  Professor Glantz is quoted: “E-cigarettes are encouraging, not discouraging, youth to smoke and to consume nicotine, and are expanding the tobacco market.”  This resulted in headlines such as “Vaping encouraging youth to smoke” (here) and “E-cigarettes are creating a brand new generation of cigarette smokers” (here). If Dutra-Glantz’s claims are true, we should see evidence of the “new generation” in the young adult population, particularly in current smoking rates among 18- to19-year-olds.  I used the CDC’s annual National Health Interview Survey to analyze two five-year periods: first, when e-cig use was minimal to nonexistent (2005-10), and then when e-cigs were in wide and growing use (2010-15).  I used the standard definition of current smokers: those who had smoked at least 100 cigarettes in their lifetime and smoke every day or some days. The accompanying chart clearly illustrates that smoking declined among 18- to 19-year-olds during the first five years.  However, from 2010 to 2015 the rate dropped by over half among 18-19 year-old males, and by nearly two-thirds among females. One fact is crystal clear: The decline of smoking in young adults is accelerating. Original author: Brad Rodu
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Vaping and tobacco harm reduction in Ireland – consultation response in five quotes

The report is out for public consultation until the 3rd February 2017.  The consultation page allows for a free-form response.  You can put in whatever information you think will assist the review team.   Here is my response, framed around five quotes from the Royal College of Physicians:

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Experts to FDA: End the Smokeless Tobacco Misinformation Campaign


Two internationally renowned tobacco policy experts are urging “the FDA and like campaigns and health information websites” to “follow established ethical principles and accepted communication methods to inform the public of less-harmful tobacco/nicotine products as well as the greater harms of smoking.” Lynn Kozlowski, professor at the University of Buffalo School of Public Health and Health Professions, and David Sweanor, adjunct professor of law at the University of Ottawa, published their commentary online in Addictive Behaviors (open access, here).  Their focus is a $36 million FDA campaign against smokeless tobacco “that fails to directly warn about the much greater harms from smoked tobacco (predominantly cigarettes).”  Shortly after the campaign’s launch in April 2016, I produced a detailed analysis showing that it was based “on population cancer estimates derived from unreliable and inappropriate relative risks” (here).  I insisted that “the FDA should publish an honest estimate of the risks and consequences of smoking and smokeless use, and issue public messages that inform rather than mislead.  The current campaign wastes taxpayer resources, obfuscates the truth about smokeless tobacco and, ultimately, denies smokers information that could save their lives.” Kozlowski and Sweanor echo my criticism of the FDA’s war on smokeless, noting that “consumers and potential consumers have a fundamental right (based on the principles of autonomy, health communication, and health literacy) to be well aware of the dramatic differential harms from the various products they are already or might consider using (reference here).”  Consumers don’t have that information, and the authors blame “…health authorities [that] have failed to provide accurate differential risk information on tobacco products” for decades.  They highlight misinformation from the Mayo Clinic, which I have criticized for 12 years (here), and former U.S. Surgeon General Richard Carmona’s congressional testimony of  2003, which, as I noted at the time (here), ignored decades of published research and the findings of Britain’s esteemed Royal College of Physicians. Kozlowski and Sweanor offer clear policy prescriptions: “The public and especially users of multiple tobacco/nicotine products need to be provided accurate and actionable information on major differential tobacco/nicotine product risk. “This recommendation applies equally to youth who are using prohibited products and adults who are using legal products. “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.” The Kozlowski/Sweanor commentary mirrors my 23-year science-based argument that government and other health authorities must stop lying about vastly safer tobacco products.  “Health-focused agencies,” they write, “need to regain some credibility in communicating about tobacco/nicotine product risks and work to place it responsibly in the context of comprehensive public health activities.” Original author: Brad Rodu
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Reshaping American tobacco policy: eight proposals for the Trump administration

Welcome to a new report written by me, Clive Bates, with David Sweanor of Ottawa University, and Eli Lehrer, President of the R Street Institute. The fully designed report is available at R Street with press notice.

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Federal Studies: ZERO Mouth Cancer Deaths Among Men Who Dip or Chew Tobacco


The U.S. Food & Drug Administration (FDA) on January 23, 2017 published a proposed smokeless tobacco (ST) regulation (here) that is based on erroneous calculations of ST risks. The agency would require a radical reduction in N-nitrosonornicotine (NNN), a tobacco-specific nitrosamine, in smokeless tobacco (ST) products.  Most American ST products today have very low NNN levels: about 2-10 millionths of a gram per gram of product – that is, 2-10 parts per million (ppm), while a limited number of products contain 10-15 ppm (here).  The FDA proposes to limit the NNN level in ST products to one ppm or lower.  As is typical with FDA action on ST (here and here), this proposal is based on obscure calculations and flawed assumptions and interpretation.  Here is a summary of the FDA logic: Compared with never users, ST users have an excess risk of mouth and throat cancer (Relative risk, RR = 2.16). ST use causes 276 deaths from mouth and throat cancer in the U.S. each year (this number was rounded to 300 in the proposed rule) – 268 men and 8 women. ST products contain NNN, a human carcinogen that causes mouth and throat cancer. Reducing NNN levels to no more than 1 ppm will reduce the number of deaths by about 115 per year.While the latter two statements are by no means scientific certainties, in this post I will focus on the demonstrably inaccurate first assertion, which is the flawed basis for the FDA’s calculation of “300” deaths due to ST use. The FDA’s use of an RR of 2.16 is in error. The figure, based on a 2008 report (abstract here), combines radically different RRs for men and women.  In 2002, I documented (here) that men, who generally use moist snuff (also called dip) or chew, do not have significantly elevated risk for mouth and throat cancer (RR ~ 1).  In contrast, women, who primarily use powdered dry snuff, have significantly elevated risk (RR ~ 4-6).  My research is in general agreement with risk estimates published last year by the National Institute of Environmental Health Sciences’ Annah Wyss and colleagues at the National Cancer Institute and over a dozen universities and health centers in the U.S. and beyond (abstract here).  They determined odds ratios (ORs, interpreted the same as RRs) among snuff and chew users for head and neck cancer – which includes voicebox cancer in addition to mouth and throat, but the risk estimates are applicable.  The combined OR among snuff users, men and women combined, was 3.0, which is similar to the FDA estimate.  However, the OR among men was 0.86, while the OR among women was 8.89.  The ORs for chewing tobacco were not significantly elevated for men or women.  I will use the Wyss ORs to show how the application of risks specific to men and women change the FDA estimates.  First, the following table (adapted from Table 5 in the FDA’s proposed rule) summarizes the data the FDA used (ST prevalence, RRs and total numbers of deaths from mouth-throat cancer in the U.S.) and the agency’s estimates for deaths attributable to ST (last column).  The FDA erred in applying a single RR (2.16) for men and women when, in fact the RR is 0.86 for men and 8.89 for women. .nobr br { display: none } td { text-align: center} Table 1. FDA Estimate of Annual Deaths from Mouth and Throat Cancer Attributable to Smokeless Tobacco (ST), Men and Women in the U.S.Prevalence of ST Use (%)Relative RiskAll Mouth/Throat Cancer DeathsPercentage Attributable to STNumber Attributable to STMenAge 35-64 years4.62.162,7705.1140Age 65+ years3.92.162,9974.3128WomenAge 35-64 years0.22.168320.32Age 65+ years0.32.161,6990.36All8,298276 In the next table I illustrate how the death estimates change if the specific ORs for men (0.86) and women (8.89) from the Wyss study are used.  .nobr br { display: none } td { text-align: center} Table 2. Revised Estimate of Annual Deaths from Mouth and Throat Cancer Attributable to Snuff Use, Men and Women in the U.S.Prevalence of ST Use (%)Relative RiskAll Mouth/Throat Cancer DeathsPercentage Attributable to STNumber Attributable to STMenAge 35-64 years4.60.862,77000Age 65+ years3.90.862,99700WomenAge 35-64 years0.28.898321.5613Age 65+ years0.38.891,6992.3139All8,29852As noted earlier, my revised estimates are specific to snuff use – powdered dry snuff for women and moist snuff for men.  However, the risks for chewing tobacco in the Wyss study are not significantly elevated for men or women, so that product would add zero deaths.  In summary, the FDA failed to use RRs specific to men and women, resulting in overestimation of cancer deaths in the former and underestimation in the latter.  Using the same FDA formula and assigning the proper risks, I estimate that 52 women using powdered dry snuff die each year from mouth-throat cancer, but the number of deaths among men who use dip or chew is zero.  The proposed regulation is therefore unjustified for dip and chew products. Original author: Brad Rodu
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New WHO/NCI Report Falsely Conflates Smoking & Tobacco


The World Health Organization and the U.S. National Cancer Institute recently published a 700-page report on the economic consequences of smoking, tobacco use, or both (here).  The dozens of tobacco experts who contributed failed to distinguish between tobacco and smoke.  This is especially disappointing, since one of the two editors, University of Illinois at Chicago professor Frank Chaloupka, previously acknowledged the difference (here). The report’s summary conclusions, which are mainly about smoking and not tobacco, follow, with smoke highlighted in red and tobacco highlighted in green.1.  There are about 1.1 billion smokers in the world, and about 4 in 5 smokers live in low- and middle-income countries. Nearly two-thirds of the world’s smokerslive in 13 countries.2.  Substantial progress has been made in reducing tobacco smoking in most regions, especially in high-income countries. Overall smoking prevalence is decreasing at the global level, but the total number of smokersworldwide is still not declining, largely due to population growth. Unless stronger action is taken, it is unlikely the world will reach the WHO Member States’ 30% global reduction target by 2025.3.  Globally, more than 80% of the world’s smokers are men.  Differences in prevalence between male and female smokers are particularly high in the South-East Asia and Western Pacific Regions and in low- and middle-income countries.4.  Globalization and population migration are contributing to a changing tobacco landscape, and non-traditional products are beginning to emerge within regions and populations where their use had not previously been a concern.5.  An estimated 25 million youth currently smoke cigarettes.  Although cigarette smoking rates are higher among boys than girls, the difference in smoking rates between boys and girls is narrower than that between men and women. Smoking rates among girls approach or even surpass rates among women in all world regions.6.  Worldwide, an estimated 13 million youth and 346 million adults use smokeless tobacco products.  The large majority of smokeless tobacco users live in the WHO South-East Asia Region.  Smokeless tobacco use may be undercounted globally due to scarcity of data.7.  Secondhand smoke exposure remains a major problem. In most countries, an estimated 15%–50% of the population is exposed to secondhand smoke; in some countries secondhand smokeexposure affects as much as 70% of the population.8.  Annually, around 6 million people die from diseases caused by tobacco use, including about 600,000 from secondhand smokeexposure. The burden of disease from tobacco is increasingly concentrated in low- and middle-income countries.In the last item, the substitution of tobacco for smoke is obvious.  In fact, most of the report is distorted by this bogus substitution.   The sham synonym tactic reflects the anti-tobacco posture of the report’s sponsors, NCI and WHO.  Officials at those organizations supplied two prefaces, totaling 2,700 words. “Tobacco” appears 128 times, while “smoke” is used only 14 times.Decades of scientific studies document that tobacco is not synonymous with smoke (here and here).  The deliberate conflation of terms by anti-tobacco forces would not be tolerated in any other serious scientific or medical debate.  Original author: Brad Rodu
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CDC Omitted Important Findings in Report on 2015 National Youth Tobacco Survey


The U.S. Centers for Disease Control and Prevention released selected information from the 2015 National Youth Tobacco Survey in April 2016 (here).  The agency cherry-picked numbers from previous surveys to portray e-cigarettes as a threat to teens, while ignoring sharp declines in teen smoking (here, here and here).Last month, the CDC released the underlying 2015 NYTS data, ending an eight-month embargo that prevented analysis by independent investigators.  The agency traditionally reports current smoking and vaping numbers separately, ignoring dual use and wrongly suggesting that the numbers are independent.  In contrast, here I report exclusive users of these products as well as dual users.  I also add important findings that the CDC omitted.The chart shows current use (that is, on one or more days in the past 30) of cigarettes and e-cigarettes among middle and high school students over the four-year period.  The CDC emphasized the large increase in e-cig use from 2011 to 2015.  As I noted earlier (here), the large spike from 2013 to 2014 was likely due to a change in the NYTS questions.  It is clear that the increase slowed during the last year, but prevalence of exclusive e-cig use among high schoolers still  increased from 8.2 to 10.6%; dual use declined marginally from 5.2 to 5.0%.  The prevalence of exclusive smoking among high school students was flat at 4.0%.  Given that the CDC has relentlessly asserted that e-cigarettes are a gateway to smoking, it is unsurprising that the agency did not publicize responses to two questions in the 2015 survey that focused on which products students used first.  I report here for the first time how high school students answered these questions, comparing two groups of current smokers: those who only smoked cigarettes and dual users of cigarettes and e-cigs.The question, “Which of the following tobacco products did you try first?” produced these results:.nobr br { display: none } td { text-align: center} Table 1. Percentage of High School Current Exclusive Smokers and Dual Users Who Tried Various Tobacco Products First, NYTS 2015ProductExclusive SmokersDual UsersCigarettes60.2%66.8%Cigars11.36.0E-cigarettes6.58.7Smokeless tobacco9.17.6Hookah4.56.7Other products1.12.6Not sure2.91.3Never tried any product4.40.3All100%100%Percentages in bold: Exclusive smokers significantly different than dual users. The table shows that there were no significant differences between exclusive smokers and dual users in the product first used.  Most had tried cigarettes first (60% and 67% respectively); the rest had chosen cigars, smokeless, e-cigs and other products.  There is little evidence here for the CDC’s claim that e-cigarettes are a gateway to smoking.A question about initiation further exposed the relationship between cigarette and e-cigarette use.  Here is how current exclusive smokers and current dual users responded:.nobr br { display: none } td { text-align: center} Table 2. Relationship of Cigarette and E-Cigarette Use Among High School Current Exclusive Smokers and Dual Users, NYTS 2015ResponseExclusive SmokersDual UsersNever tried cigs or e-cigs16.4%1.8%Only tried cigs19.82.7Only tried e-cigs0.51.9Tried cigs before ever tried e-cigs48.777.2Tried e-cigs before ever tried cigs 14.616.4All100%100%Percentages in bold: Exclusive smokers significantly different than dual users. This table shows that large majorities of high school current exclusive smokers and dual users started with cigarettes.  Only 15-16% of these students are even eligible to be considered gateway cases, in which users moved from vaping to smoking.There are troubling inconsistencies in these tables.  For example, 16% of current exclusive smokers – who only used cigarettes in the past 30 days – responded that they never tried cigarettes (Table 2).  Four percent of exclusive smokers responded that they had never used any tobacco product (Table 1). The “Y” in NYTS stands for youth, and responses from these surveys are known to be inconsistent.  In working with the data, if one eliminates participants who gave inconsistent responses, there would be considerably fewer valid participants.  I discussed this problem in 2015 (here), when I called on the CDC to “issue a comprehensive report on the internal consistency and relative validity of the NYTS data.” The agency appears to have ignored that issue.Original author: Brad Rodu
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Confirmed: Snus Use Protective for Parkinson’s Disease


Investigators in Sweden, Italy and the United States report that “non-smoking men who used snus had a substantially reduced risk of Parkinson’s disease…” The research, published in the International Journal of Epidemiology (abstract here), combined data from seven Swedish cohort studies involving nearly 350,000 men.  Subjects were classified according to tobacco use and diagnosis of Parkinson’s disease (an illness of the nervous system affecting movement) over an average 16 years of follow-up. The principal results are impressive: “Among never-tobacco smokers, Parkinson’s disease risk in ever-snus users was lower than in never-users (pooled [hazard ratio, similar to relative risk] HR = 0.41, 95% [confidence interval] CI 0.28-0.61, for the fully-adjusted model).  Current-snus use was associated with a lower Parkinson’s disease risk than former use.  In addition, there was evidence of dose-response relationships such that moderate-heavy amount (pooled HR 0.41, 95% CI 0.19-0.90) and long-term current-snus users (pooled HR 0.44, 95% CI 0.24-0.83) had the lowest Parkinson’s disease risks.” The bottom line: Current snus use, not former use, was strongly protective against Parkinson’s disease, with more protection from heavier and long-term use. This is not the first such finding.  In 2009, I discussed (here) research from the American Cancer Society showing a similar strong protective effect (Relative risk, RR = 0.22, CI = 0.07 – 0.67) (abstract here).  Further, Parkinson’s may not be the only nerve illness for which smokeless tobacco and/or nicotine use is protective.  Snus users have a significantly lower risk for multiple sclerosis than nonusers of tobacco (here).  Nicotine has been found to improve performance in people with mild cognitive impairment, and it may also benefit those with Alzheimer’s disease (discussed here). The current study represents a new era in Swedish snus research.  It was conducted by the Swedish Collaboration on Health Effects of Snus Use, “which brought together Swedish prospective cohort studies with detailed information on tobacco smoking and snus use.” In the past, the snus research field was dominated by investigators at the Karolinska Institute; they published a series of studies that featured obvious technical problems and contradictions, and routinely found significant, small risks.  I documented these flawed studies in professional journals and in my blog (here, here, here, and here). It is my hope that the Swedish Collaboration, with investigators from multiple universities in Sweden and beyond, will produce valuable, unbiased research on the health impact of snus use.Original author: Brad Rodu
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Sacramento Bee Errs Twice with Fake News on E-Cigarettes


The Sacramento Beeon January 21 published a column written by a hearing aids company executive.  Titled “E-cigarettes may also cause hearing loss” (here), the piece asserted that “damage to inner ear of teen [sic] is an overlooked potential health risk to vaping” and that “nicotine – regardless of whether it is inhaled in smoke or in vapor – presents a significant risk to hearing.” These claims are fallacious.  On January 27, the newspaper published my correction online: “There is virtually no scientific evidence to support Dave Fabry's claim.  I conducted a search of Medline, which contains journal citations and abstracts for biomedical literature from around the world for the period 1946-2016.  Nicotine is identified as a topic in 22,218 medical publications, and hearing loss is identified in 11,984 articles.  There are only two articles matching both terms: a 1956 article on vitamin therapy of chronic deafness published in Italian, and a 1964 article entitled "Are You Smoking More But Hearing Less?"  It is almost impossible for Dave Fabry's claim to be valid if these two articles are the only relevant scientific publications in the world's biomedical literature for the past 70 years.” Days later, the Beedeleted the correction but left other comments.  Reader Jim McDonald observed: “Why did you delete Dr. Rodu's comments? He did a search for studies on this topic, going back to 1946 and found nothing to support Mr. Fabry's claim. Dr. Rodu is a professor at the School of Medicine at the University of Louisville. That seems relevant. “You also deleted mine from earlier today. I was not disrespectful. “If you print opinions and offer a place for comment, you should expect opposing points of view.” Nicotine has nothing to do with hearing loss, but smoking might worsen age-related impairment (here, here and here) via damage to small blood vessels in the ear. Kudos to Mr. McDonald and another reader who brought the deletion to my attention.  The newspaper erred in publishing fake news, then compounded its mistake by suppressing truthful corrective responses. Original author: Brad Rodu
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FDA Rejects Plea to Correct Smokeless Tobacco Warnings; A Closer Look at Flawed Interpretations


After two and a half years’ review, the FDA Center for Tobacco Products rejected Swedish Match’s request to eliminate or revise the 30-year-old, egregiously inaccurate warnings that are required to appear on snus products sold in the United States.  In 2014, Swedish Match sought to: ·         Remove the warning, “This product can cause gum disease and tooth loss”; ·         Remove the warning, “This product can cause mouth cancer”; and, ·         Replace the warning, “This product is not a safe alternative to cigarettes” with this text: “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” I explored this issue earlier (here). The FDA justified its rejections in a six-page letter to the company (here) in a 115-page supporting document (here), and subsequently in an announcement proclaiming, “FDA Issues Science-Based Decisions on First MRTP Applications.”  Science-based?  Following is my review of the FDA’s tortured interpretation of the scientific evidence in its decisions on the gum disease/tooth loss and mouth cancer warnings.  Gum Disease/Tooth Loss Warning Decision The agency interpreted removal of a warning as a marketing claim, obligating Swedish Match to prove that snus was entirely without risk – a virtually impossible task.  The FDA advised, for example, that “Omission of [the gum disease tooth loss warning] from a subset of smokeless tobacco products indicates that unlike other smokeless tobacco products, the eight General Snus products cannot cause gum disease or tooth loss.” (emphasis in original). For this decision, the agency reviewed published studies of “dental conditions (e.g., plaque, caries, tooth wear or tooth loss), gingivitis, gingival recession and periodontal disease” that it claimed were related.  Here are the conclusions for each of these, with the FDA findings in bold: ·         Dental conditions: “Overall, the dental conditions data included no studies that evaluated tooth loss over time…The results on caries were mixed, and the only study to examine the association between Swedish snus and tooth wear found an association. No association was seen between Swedish snus and plaque…” ·         Gingivitis: “Overall the results of the studies on gingivitis were mixed.” ·         Gum recession: “Overall, the only adjusted study of gingival recession to include non-users found a significant positive association between Swedish snus and gingival recession, and several unadjusted studies found significant associations between Swedish snus and gingival recession, although the direction of the association was mixed.” ·         Periodontal disease: “Overall, nearly all of the studies which examine the association between Swedish snus and indicators of periodontal disease (plaque, pocket depth, attachment loss, bone loss) found no association…” Note the repeated finding of “mixed,” suggesting that some studies showed a positive association while others showed no association or a negative one.  For periodontal, or gum, disease, there was no association.  Despite these equivocal or nil findings, the FDA concluded: “Overall, the totality of the evidence demonstrates that the eight General snus products can cause gum disease and tooth loss, and, correspondingly, does not support the removal of the warning that these products can cause gum disease and tooth loss.”  The FDA's decision is entirely unsupported by the "totality of evidence." Mouth Cancer Warning Decision The FDA decision on mouth cancer is based on an improper analysis of six published studies.  Peter Lee in 2010 published a formal meta-analysis of these studies and one more (abstract here).  Here are his findings for mouth cancer: “No overall association is seen for oropharyngeal cancer, the most studied cancer type.  For the whole population, an increase (RR 3.1, 95% CI 1.5–6.6) seen in the Uppsala county study (Roosaar et al., 2008), based on 11 cases, contrasts with six studies showing no increase, the overall estimate being 0.97 (0.68–1.37). The never smoker estimate, 1.01 (0.71–1.45), based on four studies, is also null. These results are supported by long-term follow-up of 1115 individuals with ‘‘snuff-dippers lesion’’ (Axéll et al., 1976), which observed no oral cancers at the sites of lesions seen initially (Roosaar et al., 2006).” When Lee included Roosaar with the other studies in his analysis, there was no association of snus and mouth cancer.  The FDA basically agreed with Lee that Roosaar was the lone work that was positive for snus and mouth cancer, but it cited this study as the sole reason for maintaining the warning.  In fact, the FDA is saying it will ignore the broad consensus of scientific research (i.e. the "totality of evidence") if any one study reports a positive finding. Having set this impossibly high bar for safer tobacco products, the FDA went further by focusing on tobacco-specific nitrosamines in snus.  Research documents that TSNAs exist in vanishingly small concentrations in snus – about two parts per million or lower (here), and there is no scientific evidence directly linking TSNAs to mouth cancer.  Still, the FDA cited “the presence of nitrosamines in the products that are the subject of these applications, the lack of a threshold dose for mouth cancer” as additional reasons to sustain the warning.  The FDA is effectively saying that TSNAs must be reduced to zero for the warning to be removed. The FDA closed the door on the gum disease tooth loss warning, but it gave Swedish Match the option of submitting a revised application for the other warnings.  It appears that the agency’s revision/amendment pathway is designed to defeat all the but wealthiest and most determined applicants, leaving millions of smokers and future smokers with demonstrably false warnings against the use of safer smoke-free products. Original author: Brad Rodu
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The Surgeon General’s Misguided Report on E-Cigarettes


Teen smoking declined to record-low levels in 2016, according to the latest University of Michigan annual Monitoring the Future Study, which examines youth tobacco, alcohol and drug use (data tables here).  The figure at left shows the percentage of high school seniors using alcohol, marijuana, cigarettes and e-cigarettes in the past 30 days over the period 1990-2016. Cigarette smoking among high school seniors plummeted from 19.2% in 2010 to 10.5% this year.  That is, the smoking rate was cut almost in half after e-cigarettes became readily available.  E-cigarette use also dropped over the past two years.  Days ago, U.S. Surgeon General Vivek Murthy issued a report asserting that e-cigarette use among youth is “a major public health concern.”  The report recycles dire warnings about vaping that have been issued by FDA tobacco director Mitch Zeller and CDC director Tom Frieden, despite the lack of evidence of significant health risks associated with e-cigarettes. The report is ostensibly a full review of scientific literature relevant to e-cigarettes and smoking among youth.  But as Case Western University law professor Jonathan Adler pointed out in the Washington Post (here), “there are now several studies that look at the effect of restricting teen access to vaping products showing that such measures increase teen smoking (including among pregnant women). I’ll say that again: Reducing youth access to e-cigarettes appears to increase youth smoking rates…Despite their relevance, these studies are completely ignored by the surgeon general. They’re not even listed in the report’s references.”  Those studies were discussed in this blog (here and here).  Their omission in the Surgeon General’s report is inexcusable. Why does the government focus on youth as it wars against e-cigarettes?  These products are responsible for virtually no health problems and certainly no deaths among youth and young adults.  In contrast, the MTF survey documents that alcohol is by far youth’s drug of choice.  In 2016, one-third of high school seniors had an alcoholic drink in the past 30 days, and one in five had been drunk, despite laws against underage sales and consumption.  Young Americans die from alcohol consumption and abuse.  From 2007 to 2014, CDC data (here) shows that accidental alcohol poisoning killed 930 people age 15-24 years.  And alcohol also contributes to traffic fatalities.  With the exception of the elderly, this age group (15-24 years) suffers the highest death rates due to auto accidents.  Comprising just 14% of the U.S. population, this young cohort accounts for 25% of auto deaths (1,544 in 2014). The Surgeon General’s report is the latest in a series of misleading and unsupported tobacco diatribes (here and here).  The public would be better served if government committed its limited resources based on the relative impact of a substance on children’s health.  Tobacco products should not be ignored, but Dr. Murthy’s report wrongly damns a safer and satisfying product that is currently helping 2.5 million former smokers (here) become or remain smoke-free.Original author: Brad Rodu
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Bad science, poor insights and likely to do harm – rapid reaction to the Surgeon General’s terrible e-cigarette report

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Warning: The Surgeon General has crossed the boundary between science and propaganda

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Smokers: It’s Never Too Late to Quit or Switch to Smoke-Free


A new study from researchers at the National Cancer Institute and the National Institute on Aging finds that even smokers in their 60s who quit can reduce their chances of dying early.  In 1995, 160,000 people age 50-71 years were enrolled in the study; data on their smoking and quitting was collected in 2004-2005.  Researchers documented causes of death and calculated rates through 2011 among never, current and former smokers, with adjustment for other risk factors.  The study appears in the American Journal of Preventive Medicine (abstract here). Current smokers were three times as likely to die during the study as never smokers.  Compared with current smokers, former smokers had significantly lower death rates; the magnitude of the reduction correlated with the age when they quit.  For example, smokers who quit in their 30s had a death rate that was 57% lower, while those who quit in their 50s had a 36% lower rate.  Even smokers who quit in their 60s had a 23% lower rate.This study should give hope to smokers of all ages, but this is not new information.  In 1996, Dr. Philip Cole and I published similar research in the journal Epidemiology (here).  We estimated how long never and current smokers of various ages would live on average.  In addition, we estimated remaining years for quitters and switchers.  Here are our results: .nobr br { display: none } td { text-align: center} Average Years of Life Remaining According to Tobacco Use and AgeSex and Age (years)Never SmokerContinuing SmokerQuitterSwitcherMen404234414150322530306023171818Women404440444450353135356026222424The good news: No matter what age, smokers can improve their life expectancy if they quit or switch.  It’s never too late to move to a smoke-free substitute.Original author: Brad Rodu
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Five questions to put to the US Surgeon General on e-cigarette science

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Will he get the thumbs up for his e-cigarette report?

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The critic’s guide to bad vaping science

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“Full of sound and fury but signifying nothing” – Shakespeare

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Bad science, accountability and courage – speech by AG Tom Miller

Iowa Attorney General Tom Miller
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Tom Miller: “public policy through facts and science rather than ideology”

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Exploding E-Cigarette? Maybe Not.


“A worker at a wine store in Grand Central Terminal suffered burns to his hand and leg after an e-cigarette caught fire in his pocket,” according to a November 23rd ABC news story (here).  This incident requires context.  Christopher E. Lalonde, a psychology professor at the University of Victoria in Canada with expertise on e-cigarette hardware, made the following comments: “The device appears to be a Reuleaux RS200 model... It has various safety features designed to protect against such incidents: reverse battery protection, overheating/auto cut-off, battery venting, etc…Not foolproof by any means, but ‘e-cigs’ and ‘cellphones’ don’t explode, batteries do. “The Reuleaux requires three 18650 batteries to operate. There appear to be six batteries in the photo — along with an assortment of metal coins. “The three seemingly intact brown coloured batteries (far left, far right, and one remaining in the device) are likely LG 18650s that are recommended for use with this model. “…I suspect the three silver coloured charred batteries are likely the cause of the explosion. If they were carried along with loose coins in the victim’s pocket, then the “e-cig” didn’t explode — the loose batteries did.” (my emphasis) Professor Lalonde, while noting that he has “every sympathy for the unfortunate victim of this incident,” provided valuable insight by suggesting that, based on the photographic evidence, batteries interacting with pocket change was the likely cause of this explosion.  Lithium ion batteries are essential for a wide range of electronic devices.  Consumers should use, charge and store them with care. Original author: Brad Rodu
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To tax or not to tax? Response to EU on taxing vaping and other reduced risk products

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December 1st, 2016

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Five Flavor Review

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