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Democrats press FDA to proceed with destruction of the vaping market – we respond



June 1st, 2017

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A Smokeless Tobacco-Pancreatic Cancer Claim is Refuted


Snus use is not associated with pancreatic cancer, according to a study published in the International Journal of Cancer (abstract here).  Researchers combined data from nine cohort studies that involved 400,000 men in Sweden.  Compared with never users, the risk for current snus users, after adjustment for smoking, was 0.96 (95% confidence interval = 0.83 – 1.11). The new work was conducted by the Swedish Collaboration on Health Effects of Snus Use, which includes researchers from several Swedish universities.  (In the past, snus research was largely performed by the Karolinska Institute, whose flawed studies I have previously documented here, here, here, and here.)  Their results are almost identical to those in a large study of smokeless use in North America and Europe published six years ago (discussed here), and to findings in another analysis published eight years ago (here). Focus on a purported smokeless tobacco-pancreatic cancer link began after publication of a cherry-picked meta-analysis by Paolo Boffetta in 2008 (discussed here).  Dr. Boffetta contradicted his own finding in a later study (here), and epidemiologist Peter Lee refuted it in his comprehensive analysis in 2009 (here).  The fact is that there is no credible evidence that American or Swedish smokeless tobacco is linked to pancreatic cancer.       Remarkably, the National Cancer Institute persists in asserting a pancreatic cancer link in its smokeless tobacco “fact sheet” (here).  That document also asks what should be a rhetorical question: “Is using smokeless tobacco less hazardous than smoking cigarettes?”  The NCI’s answer is grossly misleading: “all tobacco products are harmful and cause cancer…There is no safe level of tobacco use.”  The agency’s source for this obfuscation is a 31-year-old Surgeon General report that has been eclipsed by three decades of epidemiologic studies.   It should be noted that the U.S. Food & Drug Administration is equally culpable. That agency used the bogus smokeless-pancreatic cancer link as a talking point in last year’s $36 million campaign against smokeless tobacco (here). We already knew that moist snuff and chewing tobacco have no measurable risk for mouth cancer (here).  Now there is scientific evidence that smokeless isn’t linked to pancreatic cancer.    Original author: Brad Rodu
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A Long Journey on Tobacco Road, Vindicated


“Current public health policies offer smokers only two choices: to continue to smoke despite knowledge of adverse health consequences, or to quit, which often proves very difficult. “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.” Brad Rodu DDS, Professor, University of Alabama at Birmingham July 1, 1994  An Alternative Approach to Smoking Control.  American Journal of the Medical SciencesVolume 308: pages 32-34. (here) “Thus, both the 35-year-old non-user of tobacco and the smokeless-tobacco user will live on average to be 80.9 years of age compared with 73.1 years for the smoker.  Only 67% of smokers will be alive at age 70, compared with more than 87% of smokeless-tobacco users and nonusers of tobacco. “…abstinence is not the only approach to reducing tobacco-related mortality: for smokers addicted to nicotine who would not otherwise stop, a permanent switch to smokeless tobacco could be an acceptable alternative to quitting.” Brad Rodu DDS and Philip Cole MD, DrPH, Professors, University of Alabama at Birmingham July 21, 1994 Tobacco-related mortality.  Nature Volume 370: page 184. (here) “Among these and many other opportunities, there’s probably no single intervention, or product we’re likely to create in the near future that can have as profound an impact on reducing illness and death from disease as our ability to increase the rate of decline in smoking.  “We need to redouble efforts to help more smokers become tobacco-free.  And, we need to have the science base to explore the potential to move current smokers – unable or unwilling to quit – to less harmful products, if they can’t quit altogether.” Scott Gottlieb MD, Commissioner, US Food and Drug Administration May 15, 2017 Remarks to FDA Staff (here) Original author: Brad Rodu
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Vaping in the U.K.


Comedian-cum-philosopher Stephen Colbert has opined, “Facts matter not at all. Perception is everything.”  Actual British researchers have gone a step further, finding that, with e-cigarettes and vaping, perception changes behavior. British health authorities have consistently told smokers the truth about vaping since 2011 (here, here, here and here), while American officials, in their pursuit of a “tobacco-free society” or a “tobacco endgame,” have emphasized the negative, or simply perpetuated untruths and urban myths.  Survey data in the U.K. and U.S. demonstrate that truth-telling results in more accurate perceptions about vaping than do obfuscation and scaremongering (here).  Now, a survey from the U.K.’s Action on Smoking and Health (ASH) (here) shows that favorable perception translates into positive behavior. In this case, facts do matter.  The U.K. vaping population has ballooned, from 700,000 in 2012, to 2.9 million this year.  Importantly, the majority (52%) are former smokers – a sharp contrast to American data showing that most vapers are current smokers (here). Within these encouraging U.K. figures are reasons for concern.  First, the prevalence of vaping is currently 5.8%, which is only a 12% increase since 2015.  This suggests that e-cigarette use may be leveling out.  With some nine million Brits smoking today (here), vaping momentum will have to grow in order to drive down smoking. A major barrier to the success of e-cigarettes is misinformation (here).  The ASH report documents that 22% of smokers believe that e-cigarettes are more or equally harmful than cigarettes – a 9% increase from four years ago.  Anti-vaping propaganda, discussed here, may be a contributing factor.  Interestingly, 16% of smokers who tried but don’t use e-cigs said they would try them again if they were sure they were safe to use. The ASH report also documents that e-cigs don’t work for all smokers.  Of smokers who tried but no longer use e-cigarettes, 25% said the devices didn’t feel like smoking, and 20% said they didn’t help with cravings.  Smokers should be given access to a range of safer smoke-free substitutes, including smokeless tobacco and heat-not-burn products, in order to help them quit their deadly smoking habit.            Original author: Brad Rodu
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U.S. E-cigarette Summit Survival Guide




It’s the US E-cigarette Summit …and it’s going to get weird

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Sticking to the Facts On E-Cigarettes & Nicotine Medicines


A dentist colleague notes that the American Dental Association was one of 28 medical societies that signed a letter to the FDA in opposition to a change in the deeming date for e-cigarettes (here):  “Changing this date would significantly weaken FDA’s ability to take prompt action to protect children from thousands of fruit and candy flavored e-cigarettes and cigars, including products in flavors such as cotton candy, gummy bear and fruit punch that clearly appeal to kids.” Ironically, nicotine medicines also come in appealing flavors, like cinnamon surge, fruit chill, fresh mint, spearmint burst and white ice mint (here).  Evidently, marketers of both product categories view flavoring as a necessary and effective device to attract adult smokers. While e-cigarettes are often tagged with groundless or exaggerated claims of health threats, my colleague cites specific health issues associated with nicotine medicines, as reported by a reputable clinical drug information service: Adverse Effects that Occur >10% of the Time: Headache (18% to 26%), Mouth/throat irritation (66%), dyspepsia (18%), cough (32%), rhinitis (23%). Adverse Effects that Occur 1% to 10% of the Time: Acne (3%), Dysmenorrhea (3%), flatulence (4%), gum problems (4%), diarrhea, hiccup, nausea, taste disturbance, tooth abrasions, back pain (6%), arthralgia (5%), jaw/neck pain, nasal burning (nasal spray), sinusitis, withdrawal symptoms Adverse Effects that Occur : Allergy, amnesia, aphasia, bronchitis, bronchospasm, edema, migraine, numbness, pain, purpura, rash, sputum increased, vision abnormalities, xerostomia Adverse Effects For Which the Frequency is Not Defined: Concentration impaired, depression, dizziness, headache, insomnia, nervousness, pain, aphthous stomatitis, constipation, cough, diarrhea, gingival bleeding, glossitis, hiccups, jaw pain, nausea, salivation increased, stomatitis, taste perversion, tooth abrasions, ulcerative stomatitis, xerostomia, rash, application site reaction, local edema, local erythema, Arthralgia, myalgia, paresthesia, sinusitis, allergic reaction, diaphoresis. Any of these adverse effects could be needlessly exaggerated to condemn nicotine medicines, but they aren’t.  Nicotine can be consumed safely in gum, patches or vapor products.Original author: Brad Rodu
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Smokeless Tobacco 101


Huffington Post has published a discussion Joel Nitzkin and I had with psychotherapist Robi Ludwig (here).  HuffPo was not able to use the large number of resource links we provided, so I am republishing the article with the full complement, below. Two Doctors on A Mission to Set the Record Straight about Smokeless Tobacco and Its Impact on Public Safety By Robi Ludwig, PsyD, Contributor The historical roots of tobacco go way back to almost the beginning of time. Some date it as early as 1 B.C. when the American Indians used it for religious and medicinal practices. Given what we know about tobacco today it’s almost impossible to believe tobacco was ever thought of as a cure-all for everything from dressing wounds to the standard go-to painkiller. By the 1600’s tobacco was so popular that it was even used almost as frequently as money. Some even referred to it “as good as gold”. But some of the dangerous effects of smoking tobacco was starting to become apparent during this time, too. Sir Francis Bacon, the 1st Viscount St Alban, an English philosopher, statesman, scientist, jurist, orator, and author, who served both as Attorney General and as Lord Chancellor of England, admitted to having a very hard time quitting his tobacco use and found it to be an impossible “bad” habit to break. When we fast forward historically to the 1960’s, this is when the Surgeon General reported the various dangers of smoking to our health. And by 1971 Commercial Ads for cigarettes were taken off the air in the United States as an attempt to curb this dangerous and growing habit. Even today, with everything we know about the dangers of smoking, there are still some misperceptions out there about tobacco use, which could negatively impact up to 8 million adult American Smokers, but not if two prominent doctors have their way. Now Dr. Rodu and Dr. Nitzkin are trying to influence the public about Tobacco use by setting the record straight. Dr. Brad Rodu, who has studied the science behind tobacco harm-reduction strategies and has been appointed the first holder of the endowed chair in tobacco harm reduction research at the University’s James Graham Brown Cancer Center and Dr. Joel Nitzkin, public health physician, who is board certified in preventive medicine and has been involved in tobacco control activities since the late 1970’s, have made it their professional mission to reduce tobacco-related illnesses. Dr. Rodu and Dr. Nitzkin strongly believe that smokers who are unable or unwilling to quit cold turkey should be informed about much lower risk smokeless tobacco or e-cigarettes. I spoke with both doctors to find out how they believe adult smokers can potentially be spared from life-threatening smoking-related illnesses. Here’s more about what they both had to say on this topic. Dr. Robi: What exactly is smokeless tobacco, why was it created? Dr. Rodu and Dr. Nitzkin: Anthropologists and historians believe that tobacco has been used by humans for thousands of years.  The plant originated in the New World and was completely unknown outside the Americas until 1492, when Columbus first encountered native Americans using tobacco for ceremonial and medicinal purposes.  They smoked and chewed tobacco, the latter serving as the provenance of modern smokeless tobacco products. Smokeless tobacco dominated the American market prior to the 20th Century, because a day’s supply could be carried and conveniently used in both industrial and agricultural work settings.  In contrast, smoking was uncommon because producing cigars, cigarettes and pipes was labor-intensive and expensive.  In addition, smoking was very inconvenient before a safe and portable source of fire was readily available, which didn’t happen until the widespread use of safety matches in the late 1800s.   Dr. Robi: What are the different kinds of smokeless tobacco? Dr. Rodu and Dr. Nitzkin: In the U.S. there are two main kinds of smokeless tobacco.  Loose leaf chewing tobacco (“chew”) consists of shredded tobacco leaves and stems packaged in foil pouches.  Chew is also heavily sweetened and flavored.  It is used in fairly large quantities, which produces the typical swollen cheek appearance and generates a lot of juice. Moist snuff, also called dip tobacco, is the most popular smokeless product in the U.S.  It is manufactured from dark, fire-cured tobaccos grown in western Kentucky and Tennessee, fermented and ground to the consistency of finely chopped parsley.  Multiple flavors are available, but moist snuff does not contain sweeteners.  It is used in small amounts, generally as much as can be grasped between the thumb and forefinger in a “pinch.”  The tobacco is then placed inside the lower lip between the cheek and gum. Moist snuff is hard to contain in one spot, so manufacturers have packaged pinch-sized portions in small tea-bag type paper pouches.  The pouches are no larger than a piece of chewing gum or a breath mint, making them virtually invisible to place and use.  They also don't disintegrate, which makes the tobacco easy to remove after use. Since 2005 a Swedish version of moist snuff, called snus, has become more popular in the U.S.  Rather than fermented, the tobacco is treated by a pasteurization process that gives it a different flavor than American dip, and somewhat lower levels of unwanted contaminants.  Snus is also marketed in many flavors and small pouches. Americans place moist snuff in the lower lip, where it generates juice and spitting.  In contrast, Swedes don’t have to spit when they use snus, mainly because they place it inside the upper lip. Nicotine is absorbed from all smokeless tobacco products through the lining of the mouth, giving the user a “buzz” very similar to, but with a slower onset than that achieved by smoking a cigarette.  Nicotine is not the major cause of any disease; it is no more harmful than caffeine, which is also addictive but safely consumed in coffee, tea and cola drinks.    Dr. Robi: Are different kinds of smokeless tobacco better for you than others? Dr. Rodu and Dr. Nitzkin: No tobacco product is absolutely safe.  All contain traces of unwanted contaminants in addition to nicotine.  But it’s been known for two decades that, by avoiding smoke, chewers, dippers and snusers eliminate about 98% of the health risks associated with smoking.  The risks are so small that even large epidemiologic studies with hundreds of thousands of users cannot provide indisputable evidence that smokeless tobacco causes any disease.  With risks that small, it is not possible to prove that one kind of dip, chew or snus is safer than the other. Dr. Robi: Why is there so much confusion about smokeless tobacco and if this is a healthy alternative to regular cigarettes? Dr. Rodu and Dr. Nitzkin: Decades of scientific studies document that smokeless tobacco use is vastly safer than smoking with respect to cancer, heart attacks and strokes and many other diseases.  There is no confusion about smokeless tobacco among tobacco research and policy experts.  In 2002 a report by the British Royal College of Physicians, one of the world’s oldest and most prestigious medical societies, stated “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.”  The Royal College issued another report in 2007 concluding “…that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.  In 2008 the American Association of Public Health Physicians became the first medical organization in the U.S. to formally adopt a policy of “…encouraging and enabling smokers to reduce their risk of tobacco-related illness and death by switching to less hazardous smokeless tobacco products.”    Cigarettes are so popular that tobacco controllers incorrectly use the terms “smoking” and “tobacco use” as if they were synonyms, and they have become obsessed with the notion of a tobacco-free society.  They have transformed a legitimate war on smoking into a moral crusade against all tobacco products, a mistake that was tragically made with alcohol almost 100 years ago. When a federal survey asked in 2015 if smokeless tobacco products are less hazardous than cigarettes, only 11% correctly answered “yes”; 67% responded “no” and 22% didn’t know.  In other words, 89% of Americans have no clue that dipping, chewing and snusing are 98% safer than smoking.  They are confused because they have been misinformed for decades by government agencies and medical organizations that all tobacco products are equally harmful.  Misinformation from public health officials should no longer be tolerated.  Recently, two internationally renowned tobacco policy experts, 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, urged the FDA to end a $36 million campaign against smokeless tobacco “that fails to directly warn about the much greater harms from smoked tobacco (predominantly cigarettes).”  They concluded that “Public health agencies have an obligation to correct the current dramatic level of consumer misinformation on relative risks that they have fostered.”  Dr. Robi: Why do you think the FDA has not informed the public about the whole truth about smokeless tobacco? Dr. Rodu and Dr. Nitzkin: Obsessed with the notion of a tobacco-free society, the FDA so far has taken a hard line, falsely claiming that “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.”  In other words, no tobacco product is absolutely safe.  The agency is defying a key element of its stated mission – “to provide the American public with factual and accurate information about tobacco products.”  And Congress in 2009 prohibited tobacco companies from any communication with smokers regarding safer smokeless alternatives without the express approval of the FDA.  The FDA has refused to acknowledge that its smokeless warnings are inaccurate.  Even worse, some of its regulations threaten to remove large numbers of smokeless and vapor products from the market.  In some cases the regulations require companies to conduct dozens of unnecessary studies on minute product details and human effects, which could take a decade or more. This is regulatory fundamentalism, a bureaucratic maze that condemns smokeless tobacco products and e-cigarettes, and therefore tobacco harm reduction, to purgatory. With this delay, cigarettes will continue to dominate the American tobacco market, and 440,000 Americans will die from smoking-related disease every year. Dr. Robi: How many adult smokers use smokeless tobacco as a way to quit smoking altogether? Dr. Rodu and Dr. Nitzkin: Federal surveys are usually used to count current, former and never tobacco users.  The surveys generally don’t ask former smokers if they switched, but there was one exception.  In 2000, the National Health Interview Survey asked former smokers if they had quit by switching to smokeless; some 260,000 men said yes, providing the first population-level evidence that smokeless is a viable cigarette substitute.  The 2015 NHIS documented that there were 5.1 million current smokeless tobacco users that year.  Unfortunately, the survey didn’t ask former smokers specifically about switching, but about 1.6 million smokeless users were former smokers, meaning they had switched to safer products like dip, chew or snus.  Almost 1.4 million smokeless users were current smokers; if they were made aware that smokeless was 98% safer, they might have fully switched. Dr. Robi: How many smokers die every year from smoking cigarettes? How about from smokeless tobacco? Dr. Rodu and Dr. Nitzkin: According to the CDC, the annual death toll among smokers is 440,000.  Despite the fact that smoking rates have been plummeting for three decades, the CDC death toll hasn’t changed for nearly 20 years.  In 2013, an FDA scientist concluded that the CDC estimate is too high. One might assume that the CDC tracks smoking deaths throughout the year, but that’s not the case.  Instead, they estimate the number of smokers in the U.S., then they apply secret mathematical formulas based on comparisons between current, former and never smokers.  A reporter years ago tried unsuccessfully to crack the black-box formulas.  Here is her summary: “The computer is fed raw data and... employs various complex  mathematical  formulas  to  determine  how  many people in various age groups, locations, and heaven knows what other categories are likely to get sick or die from what diseases and how many of these can be assumed to be smoking related.” The CDC provides death counts among smokers with single-digit precision (the current number is 439,033), but when it comes to deaths from smokeless use, the agency claims it can’t be done.  In fact, the CDC has the necessary data; its disinclination is likely due to the very low number that would result.  British researchers are not so inhibited; they reported in 2015 that there were no cancer deaths due to smokeless tobacco in the U.S. and Canada.  Last year, U.S. government-sponsored research revealed that the number of mouth cancer deaths among men who use dip or chew is zero.         Dr. Robi: What is the “Swedish Experience” and how does it connect to tobacco harm reduction? Dr. Rodu and Dr. Nitzkin: In virtually all developed countries, cigarette smoking has been the dominant form of tobacco consumption for over 100 years.  Sweden is a remarkable exception.  Smoking rates among men in Sweden have always been lower than in any other developed country, resulting in the lowest rates of lung cancer – indeed, of all smoking-related deaths.  The reason is that, instead of smoking, Swedes enjoy nicotine and tobacco by using snus, a 200-year old smokeless product. A study published in the Scandinavian Journal of Public Health examined lung cancer – the sentinel disease of smoking – among men and women in all European Union countries.  It concluded “that snus use is inversely correlated with cigarette consumption among men in Sweden, resulting in the lowest [lung cancer mortality rates] in Europe for most of the past 50 years.”  Numerous published studies have documented that male smokers in Sweden have used snus as a gateway to a smoke-free life, but that is only part of the story.  Snus use has also played a valuable role in steering tobacco initiators away from cigarettes.  Any tobacco use among children should be discouraged, but Swedish boys who experiment with tobacco choose snus, the product their fathers use.  This fact is well-received by tobacco research and policy experts who focus on eliminating deaths from smoking, not on eliminating tobacco. With respect to tobacco, Sweden is unique in the 28-country EU, which bans snus everywhere else.  The effect of this prohibition is profound.  If men in all EU countries had the smoking rate of Swedish men, nearly 300,000 deaths from smoking could be avoided each year.     The Swedish experience also has implications for its neighbors Norway and Finland.  In 1995, when Sweden and Finland joined the EU, Sweden applied for and received a waiver on the EU’s existing snus prohibition, thereby allowing Swedes to continue producing and selling within the country.  Finland adopted the ban, and since Norway never joined the EU, snus remained available there. Norwegian tobacco research experts have documented that snus suppressed smoking rates there.  In Finland, the decline in smoking levelled off after the 1995 snus ban, while the decline in Sweden continued. The Swedish experience wasn’t launched as a government program or anti-tobacco campaign.  It arose organically as tobacco users in Sweden made rational choices to use snus instead of cigarettes.  Dr. Robi: If you had to state a clear message to the public about smokeless tobacco, what would it be? Dr. Rodu and Dr. Nitzkin: The Swedish experience exemplifies harm reduction: consumers making rational choices to use smokeless instead of cigarettes, based on accurate perceptions and preferences.  The 40-50 million Americans who consume tobacco deserve truthful information from government and health organizations about vastly safer smokeless tobacco, e-cigarettes and vapor.  Millions of them could make the switch from combustible to smoke-free and lead longer and healthier lives.  How Swede it could be.    Original author: Brad Rodu
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CDC: E-Cigarettes More Popular Than FDA-Approved Quitting Aids


Cigarette smokers prefer e-cigarettes to FDA-approved quit methods, according to a research brief authored by the CDC Office on Smoking and Health, RTI International and the University of North Carolina (here).Using a nationally representative online survey of 15,943 adult smokers who tried to quit during the past three months, they found that 75% used one or more methods to quit, and 25% used only one method, as shown below..nobr br { display: none } td { text-align: center} Weighted Prevalence (%) of Methods Used By 15,943 Adult Smokers Who Attempted to Quit in Past 3 MonthsQuit MethodOne Method OnlyMultiple MethodsGave up cigarettes all at once14.7%65%Gradually cut back6.662Partially substituted e-cigarettes1.135Switched completely to e-cigarettes1.125Used nicotine gum or patch0.825Used Zyban or Chantix0.412Switched to “mild” cigarettes0.320Sought help – health professional0.215Sought help – websiteless than 0.17Sought help – telephone quitlineless than 0.17All methods25.375E-cigarettes were far more popular single quit aids for partial or complete substitution (2.2%), compared with nicotine patches/gum (0.8%) or other prescription medicines (0.4%).  They were also more popular when more than one aid was used.Of note, telephone quitlines were rarely used.  The government has poured millions of dollars into this mini-industry, yet quitlines were used by a mere 0.02% (unweighted, n=3) of smokers as single quit aids in this study.Participants here were current smokers.  A similar analysis performed on former smokers will show even more impressive effects from vaping. Despite the current study’s evidence of vaping’s popularity among smokers, the authors’ summation was understated: “Given that our data show that e-cigarettes are more commonly used for quit attempts than FDA-approved medications, further research is warranted on the safety and effectiveness of using e-cigarettes to quit smoking.”The fact is that the CDC has documented with real-world data that e-cigarettes are preferred smoking cessation aids, negating the argument that evidence is merely “anecdotal” (here).  Our government should adopt the UK Royal College of Physicians’ position that “the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco.” (here).  In Britain e-cigs have been the leading quit-smoking aid since 2013 (here, page 46).Original author: Brad Rodu
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Age Restrictions on Smoking, Drinking and Driving


State legislatures have been lobbied in a coordinated effort, called Tobacco 21 (here), to raise the minimum age for tobacco sales from 18 to 21 years.  Hawaii, California and the District of Columbia have adopted the higher age limit, but numerous city and county ordinances have been passed.As an advocate of tobacco harm reduction, I strongly oppose any tobacco use by teenagers.  However, I am unconvinced that implementing a smoking ban for those under 21 is an effective strategy. One of the arguments for Tobacco 21 is that the same age limit has reduced teenage drinking.  The National Minimum Drinking Age Act was passed in 1984.  By 1988, all states prohibited alcohol purchase by those under 21.  The impact on underage drinking is debatable.  It has been on the decline for many years, but rates remain disturbingly high (here).  The chart above shows past-month (i.e., current) cigarette smoking, marijuana use, alcohol consumption and binge drinking (5 or more drinks on one occasion) among 16-17, 18-20 and 21-25 year olds in the 2014 National Survey on Drug Use and Health.  Despite almost 30 years of Alcohol 21 across the county, nearly a quarter of 16-17 year-olds and 44% of 18-20 year-olds were currently drinking, compared with 11% and 24% who were smoking.  In addition, a majority of drinkers were binging.  In 2014, recreational marijuana wasn’t legal for anyone, yet 15% of 16-17 year-olds and 21% of 18-20 year-olds were using that drug.  We can also compare these figures with those from 10 years earlier.  Here are the changes in current use from 2004:.nobr br { display: none } td { text-align: center} Percentage Change From 2004 to 2014 in Prevalence of Youth and Young Adults Who Currently Smoke, Toke, Drink or Binge DrinkAge (yrs)SmokeToke(%)DrinkBinge Drink16-17-51+6-28-4118-20-36+17-14-2321-25-25+25+4-1With Alcohol 21 in force for almost 30 years, drinking and binge drinking declined moderately among 16-17 year olds.  But smoking saw the steepest declines in all age groups, even in the absence of a ban for 18-20 year-olds.Alcohol 21 and Tobacco 21 laws are promoted to save lives.  In the case of smoking, the lives saved are far in the future, as smoking generally takes a toll in advanced age.  With alcohol, the lives saved are primarily from traffic accidents.  With or without alcohol, traffic accidents are the number one killer of youth and young adults (age 16-24 years), with about 7,000 deaths each year (here).  Legislators seeking immediate life-saving impact should consider further age-restricted driving licenses.  Original author: Brad Rodu
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In cheap publicity stunt Royal Society of Public Health sounds a fake alarm about a non-problem

Today the Royal Society of Public Health is pitching its ‘undercover investigation’ into vape shops selling stuff to adults who don’t smoke. Naturally, the primary purpose of this exercise has little to do with public health but is a publicity stunt for an ailing organisation in a declining field that offers ever less to the public or to health.

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The Human Toll of Anti-Tobacco Extremism


This is a tale of two tobacco users and the very different medical advice they received. In 2005, two physicians and a dentist published a report in the American Journal of Psychiatry(reference here): “Ms. A, a 52-year-old woman with schizoaffective disorder, bipolar type, started smoking shortly after her first psychotic episode at age 19 and, on average, smoked about 1½ packs per day for 33 years. She had attempted to quit using pharmacotherapy, nicotine gum, or patches in combination with cessation classes. Both gum and patch treatments were ineffective since they did not control her craving for cigarettes. “Her motivation to quit was strong because of the sequelae of smoking: bronchitis, isolation from others, and destabilization of her psychiatric illness from frequently awakening to smoke. Her brother with a bipolar disorder had experienced severe burns over most of his body and died secondary to a fire caused by his smoking. For her, smoking had become a constant reminder of his suffering, which led to nightmares and further isolation. She was afraid to jeopardize the health and safety of others. “One year ago, she was cross-titrated over a 1-week period to oral pouches. Since that time, she has not resumed smoking, and her psychiatric and medical symptoms have stabilized. Before her cessation of smoking, she lived an isolated existence. Now she resides with and cares for her parents. For Ms. A, ceasing to smoke was a life-changing event.”  A disabled veteran with post-traumatic stress disorder sent me this email: “My doctor has been pounding me regarding mouth cancer and me dipping. I have good oral hygiene, but she insists I will get cancer. I now find myself worrying sick every time I have a wrinkled gum, or cut from a chip....etc. “Please give me advice. “Should I be concerned and quit dipping and switch to a vape or gum??  It is about to drive my wife nuts, it seems I’m always looking at my mouth now, and the doctor has her convinced too that I’m at a 4 times more likely [to get mouth cancer] than a non dipper.  Your input to ease my mind please.  I do not have a laptop, but saw your book.  Can’t read it on the phone.  So thought I’d ask.  My grandfather, right here in Kentucky smoked Pall Mall nonfilter cigs for 65 years...he died from a bleeding stomach ulcer caused by aspirin... I NEED TRUTH AND PEACE OF MIND. So I don’t become ocd more than I am since she gave my wife all these statistics.  I’d rather hear the blunt truth. “Should I be worried? “I’m 41, dip a can in a day and half, have dipped for 17 years since I went in the Army. I have high BP...(according to them) 140/84.. “Appreciate it very much if you would kindly respond.” I asked the writer to put me in contact with his physician, so that I could provide her with factual information and resources for the benefit of all her patients. These stories are polar opposites, but equally poignant.  Doctors in 2005 successfully switched a patient with severe mental problems from cigarettes to smokeless tobacco, citing two of my studies (here and here) as the scientific basis for their humane and “life-changing” guidance.  In 2017, a misinformed physician tormented a disabled veteran about smokeless tobacco’s negligible mouth cancer risk (here).      Too many doctors cause unnecessary suffering among tobacco users and their families.  Their actions are influenced by the misguided crusade against smokeless tobacco conducted by many government agencies and prohibitionist organizations.  This harmful disinformation effort must end. Original author: Brad Rodu
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Problems Multiply for Proposed FDA Smokeless Tobacco Rule


The FDA on January 23 published a proposed smokeless tobacco (ST) regulation that would require a radical reduction in levels of N-nitrosonornicotine (NNN), a tobacco-specific nitrosamine.  I documented (here) that the rule is based on erroneous calculations of ST risks; others have since raised additional concerns. Scott Ballin, Health Policy Advisor to the University of Virginia’s Morven Dialogues, observes that the FDA ignored its statutory requirement, when setting product standards, to “invite appropriate participation though joint conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, agricultural or consumer organizations who in the Secretary's judgment can make a significant contribution.” Brian Fojtik, Senior Fellow at the Reason Foundation, notes (here) that the FDA invited participation from selected stakeholders: “Within hours of publication in the [Federal] Register, a comment was filed by a coalition of interest groups collaboratively (American Academy of Pediatrics, Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco Free Kids and Truth Initiative) . . . a reasonable person is left wondering how six large organizations could possibly have each reviewed a highly technical, 50-page rule, reached conclusions on the rule’s specific merits and crafted a collaborative response that all agreed to sign within hours of the rule’s publication in the Register.  Even in the most forgiving of lights, the appearance is unseemly and should necessitate the withdrawal of the proposed rule.” Another major error in the FDA’s proposed rule-making process was identified by Altria in a March 3 comment submission.  The agency filed a regulatory impact analysis (here) for the rule, estimating that 30% of moist snuff products currently meet the 1 ppm dry-weight limit (Table 3, panel A).  However, FDA miscalculated the wet-weight to dry-weight conversion, invalidating the estimate.  Moist snuff is about 50% water; when it is dried, the level of any agent in the remaining tobacco will double.  The FDA did the reverse, calculating that a product with 2 ppm NNN wet-weight would have 1 ppm dry weight.  The correct conversion is 0.5 ppm wet-weight to 1.0 ppm dry weight.  Almost no moist snuff products on the U.S. market are at 0.5 ppm wet weight. Altria urged the FDA to withdraw the proposed rule because it “would fail to provide a scientifically valid formula for manufacturers to measure and maintain records of NNN levels on a dry weight basis in order to demonstrate compliance with the product standard.” Original author: Brad Rodu
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Educating Air Force Generals About Tobacco Use & Risks


The Military Health System and the Defense Health Agency last November published a grossly misleading article on their website titled, “Quit the spit: Smokeless tobacco no better than lit” (archived article here).  After I educated Air Force officials, the article was removed.  Here is the story.  The piece wrongly asserted that smokeless tobacco (ST) use is equally harmful as smoking: “…putting in a dip or a chew can cause as much harm as lighting up cigarettes... ‘A lot of the effects smoking has on the body – causing blood vessels to narrow raising blood pressure and causing several cancers – are the same for smokeless tobacco,’ said Air Force Col. Thomas Moore, a preventive medicine doctor and in charge of health promotions for the Air Force Medical Support Agency... ‘You’re really not gaining anything by giving up cigarettes just to put in a load of chew,’ said Moore.” (emphasis added) In a November 18 email I advised Colonel Moore of the article’s numerous errors: “These passages send the clear, unmistakable and completely false message to military personnel that smokeless tobacco use is just as dangerous as smoking.  Numerous scientific studies published over the past twenty years provide indisputable evidence that smokeless tobacco use is vastly safer than smoking.  For example, a 2002 report by the British Royal College of Physicians (here), one of the world’s oldest and most prestigious medical societies, stated ‘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.’ “Your just-as-dangerous message may be considered a breach of medical ethics.  A 2004 study (here) authored by a panel of international tobacco research and policy experts concluded: ‘…[smokeless] products pose a substantially lower risk to the user than do conventional cigarettes.  This finding raises ethical questions concerning whether it is inappropriate and misleading for government officials or public health experts to characterize smokeless tobacco products as comparably dangerous with cigarette smoking.’ “Members of our armed forces put their lives on the line every day.  The Military Health System and the Defense Health Agency should show them respect by giving them truthful information about tobacco use.  There is a lot at stake.  In another 2007 report (here) the Royal College concluded ‘...that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.’ “I urge you to promptly retract the article or issue a substantial revision to reflect the indisputable evidence that smokeless tobacco use is vastly safer than smoking.  Please let me know if I can provide any additional information to facilitate this action.  I appreciate your prompt response to my request.” In the absence of a response, I sent a similar email to U.S. Air Force Surgeon General Mark Ediger.  This generated a reply from Major General Roosevelt Allen, Jr., Director of Medical Operations & Research in the Office of the Surgeon General.  He wrote that I was “correct in stating that current scientific evidence clearly delineates different levels of health risk associated with the various forms of tobacco use,” and he promised “to see if it is possible to post a clarification of the article on the Health.mil site.” At General Allen’s request, I supplied a portfolio of published medical articles on ST and tobacco harm reduction.  Sometime in February, the offending article was removed from the military website.  It is evident that senior Air Force health officials recognized that the Defense Health Agency’s article was indefensible, given the vast difference in risks involved in smoking and ST use.  I am hopeful that this awareness will translate into a rational tobacco policy at the Department of Defense and beyond. Original author: Brad Rodu
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Department of Defense Anti-Smokeless Campaign Is “50” Shades Darker


February is a popular month for tobacco prohibitionists to attack smokeless tobacco (ST).  A year ago, this blog refuted seven false claims (here) from county health departments.  This year, the U.S. Department of Defense (DOD) escalated the attack. Thanks to David Sweanor of the University of Ottawa Centre for Health Law, Policy & Ethics, we became aware of an outrageous DOD website called UCanQuit.  Sweanor, who has a long history of fighting cigarette company malfeasance, coauthored a commentary last month labeling an FDA ST misinformation campaign unethical (here).  The DOD site prompts users to engage in chat sessions to obtain quitting advice.  The apparently scripted responses from human agents are filled with false information, such as these from Sweanor’s session:“Chewers are 50 times more likely than nonusers to get cancer of the cheek, gums, and inner surface of the lips… long-term users have a 50% greater risk of developing oral cancers than non-users.”A “50 times” risk is a boldface lie (here), as the proven risk is nearly nil (here).  While the American Cancer Society in 2010 told the Wall Street Journal that it would no longer use the 50 number (here), DOD perpetuates that falsehood, even as it makes a contradictory misstatement about a 50% increased risk. DOD chats are numbingly focused on ST nicotine levels.  In Sweanor’s 12-minute session, the subject came up 16 times: “[ST users] are hooked on nicotine, a highly addictive drug…[ST] products deliver substantial doses of nicotine along with powerful cancer-causing chemicals… nicotine from [ST] is absorbed through the mouth…nicotine obtained from smokeless tobacco is comparable to that of cigarettes… One can of snuff gives you as much nicotine as 60 cigarettes. Nicotine gives you the ‘buzz’ but is highly addictive… [ST] contains MORE nicotine than cigarettes! Using snuff or chewing tobacco may give you three to four times as much nicotine as from smoking a cigarette. And the nicotine stays in the bloodstream longer. Use two cans a week and you'll get the same amount of nicotine as smoking a pack and a half a day…” When Sweanor inquired, “any difference in relative risks? Is using snus safer than smoking cigarettes for someone addicted to nicotine?”, the response was only more of the same: “one can of snuff gives you as much nicotine as 60 cigarettes…Smokeless tobacco contains MORE nicotine than cigarettes! Using snuff or chewing tobacco may give you three to four times as much nicotine as from smoking a cigarette. And the nicotine stays in the bloodstream longer. Use two cans a week and you'll get the same amount of nicotine as smoking a pack and a half a day.” Other experts subsequently visited the DOD site to engage in chats, with similar results.  My 12-minute session yielded 14 nicotine mentions, plus one particularly bizarre exchange. This list appeared suddenly and without context: “1. Cadmium: used in car batteries 2. Formaldehyde: embalming fluid 3. Lead: a poison 4. Nicotine: an addictive drug 5. N-Nitrosamines: cancer-causing chemical 6. Polonium 210: nuclear waste 7. Acetaldehyde: irritant 8. Hydrazine: toxic chemical 9. Benzopyrene: cancer-causing chemical 10. Uranium 235: used in nuclear weapons 11. Sodium: salt, can cause high blood pressure 12. Sugar: can cause cavities 13. Fiberglass and Sand: abrasive” The implication was that these are deadly constituents of ST.  I have previously noted that such lists are meaningless, as everything we consume contains trace amounts of contaminants (here).  Chew and dip are no exceptions, but the contaminants at trace levels pose zero risks (here). Because tobacco prohibitionists often imply that such trace contaminants are added to ST, I asked my chat correspondent: “I don't understand the answer starting with cadmium. Do you mean that those things are added to dip and chew?”Chat operator:  “Yes they are.”I asked: “How do dip and chew makers get access to uranium?” Chat operator: “I have no idea.”Finally, an honest answer.  DOD has gone to the dark side with their taxpayer-funded, unfactual, anti-smokeless website. It should be taken down. Original author: Brad Rodu
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E-Cigarette Toxic Chemical Exposure Is Same as for Nonsmokers


The new finding from British and U.S. e-cigarette researchers understated the good news for vapers. “Long-term NRT-only and e-cigarette-only use…is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes,” reported scientists at the University College London; King's College, London; the Roswell Park Cancer Institute in Buffalo, New York; and the U.S. Centers for Disease Control and Prevention (CDC). Their work, with Lion Shahab as lead author, appeared in the Annals of Internal Medicine last month (abstract here).  “The observed carcinogens and toxins” were a group of volatile organic compounds (VOCs), including acrolein, acrylamide, acrylonitrile, butadiene and a combination of ethylene oxide, acrylonitrile and vinyl chloride.  The researchers actually measured metabolites – products formed when the body breaks down the VOCs – in the urine.The finding is good news for vapers, who avoid the thousands of toxins in smoke.  But the study and associated media coverage gave the impression that e-cigarette use also resulted in excess exposure to the VOCs.  That may not be true.People are exposed every day to these VOCs, in the air and in our food and drinks.  Research published by K. Udeni Alwis et al. in 2012 (abstract here) showed that nonsmokers have measurable levels of these chemicals.    Here are compared results from the Shahab and Alwis studies.  The former did not report absolute levels of the VOC metabolites; rather, it designated smokers as the referent group, and reported levels in vapers as a percentage of levels in smokers.  The Alwis study reported actual levels in smokers and nonsmokers, allowing me to calculate the percentages.       .nobr br { display: none } td { text-align: center} Percentage Exposures to VOCs in Vapers (Shahab) and NonSmokers (Alwis), Compared to SmokersVOCPercentage in VapersPercentage in NonSmokersAcrolein33%26%Acrylamide43%42%Acrylonitrile2.9%2.5%Butadiene11%18%Combination*44%35%*ethylene oxide, acrylonitrile and vinyl chlorideThe table shows that VOC exposures in vapers were similar to exposures in nonsmokers.  For example, in the Shahab study, vapers’ exposure to acrylamide was 43% of the exposure among smokers, whereas nonsmokers’ exposure was 42% of smokers in the Alwis study.The authors of the Shahab report, particularly Dr. Alwis (who is at the CDC), should have made the connection between the results of the two studies.  The fact that vapers’ VOC exposures are similar to those of nonsmokers is headline-worthy.Original author: Brad Rodu
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Challenging the proposed e-cigarette prohibition in Taiwan

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March 4th, 2017

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Heavy Snus Use: Possible Link to Type 2 Diabetes


A Swedish research study finds that heavy consumption of snus is associated with type 2 diabetes (abstract here).  Analyzing data from six groups of Swedish men, researchers found no risk of type 2 diabetes in all snus users combined, but they reported a modest elevated risk with higher levels of consumption, at 5-6 cans per week (Relative risk, RR = 1.42, 95% Confidence Interval, CI = 1.07 – 1.87) or 7+ cans per week (RR = 1.68, CI = 1.17 – 2.41).In a Karolinska Institute press release (here), lead research author Sofia Carlsson said, “We can confirm earlier suspicions that snus-users have a higher risk of type 2 diabetes.”  In fact, the new study confirmed only one “earlier suspicion”, as Carlsson’s is only the second study to show an association at higher consumption levels.  Here are the results from the four studies that have been published to date: .nobr br { display: none } td { text-align: center}Studies of Snus Use and Type 2 Diabetes in SwedenAuthor, Year, Snus UsersRelative Risk (95% CI)Eliasson et al., 2004Current snus users (prevalent diabetes)1.06 (0.43 – 2.64)Current snus users (follow-up diabetes)No casesӦstenson et al., 2012Current snus users1.1 (0.6 – 2.0)1-5 cans per week0.6 (0.2 – 1.4)6+ cans per week3.3 (1.4 – 8.1)Rasouli et al., 2017A. Current snus users0.96 (0.67 – 1.37)A. Ever snus usersLess than 5 boxes per week0.78 (0.56 – 1.09)5+ boxes per week0.95 (0.57 – 1.58)B. Ever snus users0.91 (0.75 – 1.10)Less than 3 boxes per week0.88 (0.72 – 1.08)3 + boxes per week0.92 (0.46 – 1.83)Carlsson et al., 2017Current snus users1.15 (1.00 – 1.32)1-2 boxes per week1.14 (0.86 – 1.50)3-4 boxes per week1.03 (0.82 – 1.29)5-6 boxes per week1.42 (1.07 – 1.87)7+ boxes per week1.68 (1.17 – 2.41)A.    Swedish snus usersB.    Norwegian snus users    Significantly elevated RRsWhile those two studies suggest that high snus consumption is associated with type 2 diabetes, more research is needed to confirm a link. Many other factors are known to contribute to this type of diabetes (here), including age, overweight or obesity, inactive lifestyle, smoking (here), family history, high blood pressure and high blood cholesterol levels.  Research and analysis must fully account for these factors in order to confirm or refute a snus link.Original author: Brad Rodu
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Are e-liquid flavours really ‘hooking another generation of kids’?

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Attraction to vaping? Or attraction from smoking? Or just a consumer preference?

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Nicotine, Smokeless Tobacco & Tourette Syndrome


A man with Tourette Syndrome, a nerve disorder developing in childhood and involving muscle tics (repetitive involuntary movement) and voice problems (here), recently posted online his experience with smokeless tobacco.  Diagnosed at age six, he was treated unsuccessfully with numerous drugs.  At ten, he experimented with dipping and discovered that it controlled his symptoms.  His doctor “was not happy that i was dipping but he under stood [sic] and told me the reason for that [alleviation of symptoms] was the nicotine…”  The doctor prescribed nicotine lozenges, which worked.  Later, the man resumed dipping. Youth initiation of tobacco use is wrong, but this individual’s experience is worth noting.  Tourette is a challenging and frustrating disorder for which medicines are not always effective. A search of the medical and scientific literature reveals that nicotine has been used with mixed results to treat the symptoms of Tourette, mainly as a supplement to other medicines (here, here, here, here, here, and here ).  Researchers have primarily tested nicotine gum and patches, which deliver very low, non-addictive doses.  These medicines have been shown to be less than ideal quit-smoking aids (here); perhaps their low nicotine levels limited their effectiveness with Tourette as well.  Moist snuff, in contrast, delivers a higher dose of nicotine for several hours, which may account for the symptom relief in the case described above.    There is growing evidence that tobacco and nicotine may play a role in preventing and/or managing nerve disorders such as Parkinson’s disease, multiple sclerosis and Alzheimer’s disease (here).  Unfortunately, nicotine and smoke-free tobacco have been so demonized by prohibitionists that researchers are reluctant to fully investigate the benefits of these products.Original author: Brad Rodu
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Hold the Mayo

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Once again the Mayo Clinic indulges in unethical and misleading risk communications in the form of a new article on e-cigarettes,  promoting fear and confusion and dissuading smokers from trying them.

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