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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.

Don't 'Narrow The Off-Ramp' For Smokers Who Want to Quit

On February 13 the Washington Examiner ran my commentary on the FDA Commissioner Scott Gottlieb’s vow to “narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs,” which would be a deadly mistake for many smokers.  Read the article on the Examiner website (here) and below. Smokers need all the help they can get to quit cigarettes. New research reported in the prestigious New England Journal of Medicine (NEJM) confirms that e-cigarettes are significantly more effective than FDA-approved nicotine medicines in helping smokers end their deadly habit. This study is impressive proof of the scientific concept known as tobacco harm reduction, the substitution of vastly safer smoke-free tobacco products – e-cigarettes and smokeless tobacco – by smokers who are unable or unwilling to become nicotine and tobacco abstinent.  Decades of scientific studies document that dipping and chewing tobacco are 98 percent safer than inhaling smoke (here, here, here, here, here), and the prestigious British Royal College of Physicians observed that “vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco.” (here).  The NEJM article describes a British clinical trial in which 886 smokers were given either a refillable e-cigarette and one bottle of liquid, or nicotine medicines (pill, gum or patch).  E-cigarette users were encouraged to experiment with liquids of different strengths and flavors.  Nicotine users selected their preferred products and they were allowed to use them in combination and to switch them up as desired.  After one year, 18 percent of those in the e-cigarette group were not smoking, compared with 9.9 percent in the nicotine medicine group.  That is, e-cigarette users were twice as likely to quit than nicotine medicine users.  Another 13 percent of e-cigarette users reduced their smoking by at least 50 percent, compared to only 7 percent of nicotine medicine users.  This study confirms the results of earlier, smaller clinical trials in Italy (hereand here), New Zealand (here) and Greece (here).  More importantly, it addresses the demand of tobacco control activists for blue ribbon scientific proof.  Among that group are regulators in the FDA.  That agency’s historic mission has been to judge the effectiveness of medicines before making them available to the public.  Their primary assessment tool is the clinical trial – a highly sophisticated and costly experiment, in which doctors control the source and dosing of the medicine and all aspects of patient care. Until now, doctors have considered smoking a disease, to be treated with nicotine medicines, anti-depressives, nicotine blocking agents (like varenicline), and behavioral counseling.  Clinical trials were used to validate such regimens, and success rates have been abysmally low.      Today, e-cigarettes are upsetting the clinical trial cart.  As consumer products, they are widely available to millions of smokers, making it extremely difficult, if not impossible, to conduct controlled clinical trials (here).  Consumers, not doctors, are making the decisions in this environment.  Instead of clinical trials, the best evidence for consumer e-cigarette behavior can be gleaned from surveys.   My university research group’s analysis of government survey data shows that e-cigarettes were among the most commonly used quit aids by American smokers in 2013-2014, and they were the only aid more likely to make one a successful quitter than quitting cold-turkey (here).  Other studies in the U.S. and the United Kingdom have reported similar results, and together provide population-level, real world proof that smokers are quitting with e-cigarettes (here).   In the UK, government officials and most medical societies encourage smokers to switch to vastly safer cigarette alternatives.  It’s time for their U.S. counterparts to provide American smokers with the same lifesaving options (here).  The new British study adds to the argument against FDA Commissioner Scott Gottlieb’s vow to “narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs.”  That would be a deadly mistake for many smokers.  Original author: Brad Rodu
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TPSAC: Copenhagen Has Lower Lung Cancer Risk

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) met on February 6 and 7  to consider smokeless manufacturers’ advertising and marketing claims that their products are safer than cigarettes (making them modified risk tobacco products, or MRTPs). Altria, whose U.S. Smokeless Tobacco Company subsidiary sought MRTP status for its Copenhagen snuff product, was the clear winner, as the committee approved the statement, “Switching completely to this product from cigarettes reduces risk of lung cancer.” (here) Clearly, Altria seeks to underscore the message that their form of smokeless tobacco, which is placed in the mouth and not inhaled, eliminates the risk for lung cancer that is high with cigarette use.  This obvious but important distinction was endorsed 8-0 by the TPSAC panel, with one abstention. Swedish Match, the other company pursuing an MRTP application (that is now almost five years old), was not as fortunate.  The panel rejected their claim that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”  As I commented two months ago, “The term ‘lower risk’ is an understatement, as the risk is almost zero” (here), but the diseases weren’t the problem.  Some TPSAC members thought that approval would send the message to kids that snus was “safe.”  Brian King, a deputy director at the CDC Office on Smoking and Health, expressed concern about future unknowns: “…just because [snus usage] is low now we have to completely dismiss what the relevance could be in the future.” he said. “My response to that is one word: Juul.” (here) King also said that Swedish Match’s “continued absence of any youth data is preposterous to me.”  He seemed to be faulting the company for not surveying teens about snus products, even though, as the company pointed out, such research could run afoul of a ban on teen marketing.  Panel member Ken Warner supported the Swedish Match application.  “I think the health (benefits) are really clear compared to smoking -- more so than for any other smokeless tobacco product.  My sense is that if this is not approved, it might be the death knell for the [MRTP] process because we would be basically saying you can't get anything through this process.” Original author: Brad Rodu
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The War Against Tobacco Flavors Will Fail

Tobacco prohibitionists have objected to tobacco flavors for years.  As I noted nine years ago, “Unflavored smokeless tobacco products are unappealing to many smokers, so the success of tobacco harm reduction is vitally dependent on the availability of substitutes that are satisfying and flavorful. Anti-tobacco extremists know very well that satisfying and flavorful products are now on the American market, so they are using ANY tactic, regardless of its practical or scientific validity, to promote prohibition.” (here) Lately, prohibitionists have turned their focus to vapor products, with FDA Commissioner Scott Gottlieb threatening to ban e-cigarette flavors and menthol (here), while states (here, here, here, here, and here), cities (here) and counties (here) pursue their own initiatives.  The flavor war could permanently affect the vapor market, but its unintended consequences could entirely undermine the bans, driving growth in aftermarket flavor production and sales. Menthol cigarettes.  Although there is little scientific support for flavor regulation (hereand here), Dr. Gottlieb believes menthol is “one of the most common and pernicious routes by which kids initiate on combustible cigarettes” (here).  An FDA menthol ban would generate a robust aftermarket to meet the demand of affected smokers (here).  Scientists at the CDC, Battelle Laboratory and the University of Maryland have published easy-to-follow mentholation instructions (full article pdf here): Crush about a pound of menthol crystals, place them in a stainless steel pan, then spread out 5 packs of cigarettes in a single layer on a 16 X 9 inch rack about 1.5 inches above the menthol.  Cover the apparatus in a large plastic bag and leave at room temperature for about three days. Moist snuff/dip products.  Darcy “Mudjug” Compton and “Outlaw Dipper” Jared offer YouTube videos on adding Mountain Dew to moist snuff (hereand here), and creating a Copenhagen “Hawaiian blend” (here).  Another dipper demonstrates how to add food-grade essential oils to moist snuff (here). E-cigarettes and vapor products.  A flavor ban would not affect vapers who make their own vaping liquids. This segment of the market is already large and will grow; a few examples can be found here, here and here.  A ban might cause the retail market to fracture into two parts: one selling unflavored nicotine liquids, and another selling flavors (google search here).  A high-tax jurisdiction like Chicago, where a prohibitively high per-milliliter tax is imposed on nicotine-containing liquids, provides a template for flavor bans.  Vape shops there sell 30 ml bottles of zero nicotine e-liquids (no tax) and small concentrated bottles of high-strength nicotine (5 ml or less) that are subject to the excise tax.  Flavor bans would simply encourage purchase of flavorless e-liquid and leave consumers to purchase flavors that are widely available in grocery stores and online, such as hereand here. It is worth noting that the only known death attributable to vapor products in the U.S. resulted from a young child ingesting pure nicotine (here), which is used by do-it-yourselfers to create e-liquids.  A flavor ban would likely increase the risk of such accidents.   In closing, imagine if during Prohibition alcohol opponents had banned flavors only; beer, wine and other flavored spirits would have been eliminated, leaving only pure alcohol on retail shelves.  That policy would have been an abject failure, as would any similar ban on tobacco. Note: I would like to thank Brian Fojtik, former Senior Fellow with the Reason Foundation and currently President of Brownstone Communications, LLC, for his help with this post. Original author: Brad Rodu
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Unacceptable Behavior by Tobacco Control Researchers

Dr. Donna Vallone of the tobacco-prohibitionist Truth Initiative was first author last October of a Tobacco Controlarticle on JUUL users (here).  When the publication was promoted on the Society for Nicotine and Tobacco Research (SRNT) listserv, I asked the authors to resolve some problems with their report.  When they failed to respond to my listserv post, I described the flaws in a blog a week later (here), on November 7. The day after my blog post, Dr. Vallone responded on the listserve to all of my concerns, except one: failure to disclose information about the most important correlate of JUUL use – other e-cigarette use.  On November 9 and again on the 30th, I asked on the listserve for Dr. Vallone to provide information about concurrent use of JUULs, other e-cigarettes and cigarettes.  I also sent her private email requests on December 28 and January 18, all to no avail. Dr. Vallone’s failure to provide critical data suggests that the omission in her research article was intentional, designed to support the case for a “JUUL epidemic.” Dr. Vallone’s ignoring of repeated data requests illustrates the insularity and arrogance of much of the tobacco research community.  Manuscripts often are not competently reviewed, results not seriously challenged, and over-the-top policy prescriptions not sufficiently justified.  These behaviors will eventually be deemed unacceptable by the general scientific community.  In the meantime, the Truth Initiative’s findings on JUUL use are incomplete and uninformative. Original author: Brad Rodu
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Think before you sign: a new letter attacking the Foundation for a Smokefree World

WHO Executive Board – will it see beyond the pestering of abstinence-only activists?

A draft activist letter to the WHO Executive Board is circulating widely on email networks – so widely that it has even been sent to me. It is a response to an open letter from the Foundation for a Smokefree World to the WHO Executive Board, which is having its annual meeting 24 January – 1 February, 2019.

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Actionable Health Videos for Smokers, Dippers and Chewers

I have been educating tobacco users for 25 years about the differential in risks associated with combustible and smoke-free tobacco products.  I have published dozens of studies in medical and scientific journals (here), authored newspaper op-eds, been quoted in many news stories, penned over 500 blog posts and provided countless radio interviews.  In the face of this fact-driven effort, tobacco prohibitionists in the medical establishment and government have mounted a campaign of exaggerated and even fabricated claims against effective harm reduction tools, including smokeless tobacco, e-cigarettes and heat-not-burn products.  Occasionally, they have subjected me to ad hominem attacks.  With these measures, prohibitionists have dissuaded massive numbers of smokers from acting to reduce their risk and lengthen their lives.  Over these 25 years, 10 million smokers have suffered premature, and for many, preventable early deaths.Of late, vapers have become organized and vocal in challenging these unscientific, unprofessional, and even unethical attacks on tobacco harm reduction, but traditional tobacco users, like smokers, dippers and chewers, have been slower to respond.  One notable exception has been the extremely impactful work of two internet stars.  Darcy Compton joined with two friends in 2005 “to create a product that would fill a need of every smokeless tobacco user in America.  From the humble beginnings of three guys assembling spittoons by hand out of a residential garage, to a full-fledged manufacturing plant based in Southern California, Mud Jug epitomizes the American dream of hard work, honesty, quality and value. Every Mud Jug [portable spittoon] has been, and will continue to be 100% made in the United States of America.” (here)  Darcy is more than a founder and president of Mudjug (here); he’s the star of the wildly popular Mudjug YouTube Series that boasts nearly 200,000 subscribers (here).  In 2012, Darcy published a video review of my book, For Smokers Only (here), which has since drawn over 300,000 views.   Upon learning of the video in 2014, I contacted Darcy and accepted his invitation to record an interview with him, which is available here.  That chat, which has 211,000 views, demonstrates the educational power of social media.     Darcy subsequently introduced me to Jared, aka “Outlaw Dipper,” who recently conducted his own interview with me (here).  Five weeks later, that video has 138,000 views and 1,000 comments.  The FDA insists that the central message of its smokeless tobacco education campaign is “smokeless doesn’t mean harmless,” (here), but the campaign itself is harmful to public health.  The agency claims to “educate rural, male teenagers about risks of dipping,” but it engages in exaggeration, distortion, and even fabrication of minimal or nonexistent risks.  It willfully misleads smokers and dippers, putting their lives in jeopardy.In contrast, the videos from Darcy and Jared are educating hundreds of thousands about the simple, scientific tobacco truth that smoke-free is vastly safer.  Thousands of posted comments prove what surveys have shown (here): that most Americans remain unaware of the differential risks of smoking and dipping.  Darcy’s and Jared’s viewers aren’t just being entertained; many have subsequently switched from cigarettes to smokeless.  Darcy and Jared will never get public health awards for their videos, but they have performed a public health service of incalculable value. Original author: Brad Rodu
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The great American youth vaping epidemic. Really?

But is it really?

Updated: 15 February 2019 to add section 17

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Lynne Dawkins: E-cigarettes – an evidence update

Dr Lynne Dawkins of London South Bank University gives her terrific myth-busting lecture on e-cigarettes – see the YouTube video above. Here are the slides (Slideshare) and here below is Lynne’s summary of the key points.

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It’s Time for Tobacco 21

A December 19 “teen vaping epidemic” presentation by U.S. Surgeon General Jerome Adams at the University of Texas MD Anderson Cancer Center was particularly noteworthy for one passage (here):  “We want the science to be an important part of that policy discussion.  I think the science is clear that raising the age of which youth can purchase these tobacco products to 21 has clear public health benefits.  There’s no doubt about that.  The science part of this policy equation is clear: Tobacco 21 works.” To my knowledge, this is the first time the Surgeon General has publicly supported Tobacco 21.  Perhaps his landmark endorsement will prompt Congress to legislate that the minimum age for tobacco purchase match that for alcohol. There are compelling reasons to make Tobacco 21 the law of the land.  First and foremost, it would delegitimize tobacco sales to 18-year-old high school students.  While they constitute 14% of all high school students, they account for one-quarter of high school smokers and smoker-vapers (here).  Legal buyers – not manufacturers and retailers – are the primary source for tobacco products used by underage high schoolers (here). Another argument for Tobacco 21 is the track record of Alcohol 21, which was adopted by all states by 1988 (here).  There is no doubt this law has played an important role in the decline of high school drinking and binge-drinking (trend here), even though current prevalence is far from optimal. I have to acknowledge my discomfort with treating 18-20-year-olds as children, but the Tobacco 21 website provides this persuasive information: “For 600 years of English common law and throughout most of U.S. legal history, the age of 21 was regarded as the age of full adult status.  Until 1971 the legal minimum voting age was 21 and many states maintained age 21 as their legal drinking age.  It was not until the Vietnam War with the unpopular, forcible draft of disenfranchised 18-year-olds, that the age to vote in the U.S. was shifted downward to 18 by the 26th Amendment to the U.S. Constitution.  During that period 25 states also moved to reduce the age to purchase and consume alcoholic beverages.  The result was a dramatic increase in highway crashes, injuries and deaths caused by intoxicated drivers in the 16-20 age group.” Data from the National Highway Traffic Safety Administration reveals that in 1988 there were 10,200 drivers age 16-20 years involved in a fatal accident, and 25% of them had a blood alcohol concentration (BAC) of 0.08% or higher (here).  By 2016 the number of drivers in that age group involved in fatal accidents was 4,400, and 15% had a BAC of 0.08% or higher.  Alcohol 21 is only one of many factors that contributed to that reduction, and those numbers are still unacceptably high, but the trend suggests that Tobacco 21 will result in a reduction in teen tobacco use. Tobacco 21 has been endorsed by most major medical organizations (here), and it has been adopted by six states: Hawaii (2015), California (2016), New Jersey (2017), Oregon (2017), Maine (2017) and Massachusetts (2018) (here).  While the remaining states could adopt Tobacco 21 at will, congressional action would have a more immediate, profound effect in limiting high school students’ access to tobacco products. Original author: Brad Rodu
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Intolerable False Statements by FDA’s Mitch Zeller

Mitch Zeller, director of the FDA Center for Tobacco Products, should stop making false statements about smokeless tobacco. The FDA earlier this week expanded its smokeless tobacco campaign, arranging a series of interviews for Zeller (example here), whose script included two provably false statements.    “Every year more then [sic] 2,000 new [mouth or throat] cancer [cases] are diagnosed in the United States solely caused by smokeless tobacco use.” This number is a pure fabrication.  No medical authority, including the FDA, has ever produced such a figure, which is more than 50% higher than the agency’s estimate of two years ago (here). Even that number was a gross exaggeration, due to a serious technical error confusing the historical risks of dip and chew (essentially zero) favored by American men with the higher risks of dry powdered snuff preferred by women (here). The Zeller number is further undercut by last year’s American Cancer Society report which omitted smokeless tobacco as a cause of cancer (here).    Zeller also produced this false statement in his latest publicity tour: 2.     …“a white spot inside your lip or gum that you know if you’re seventeen eighteen years old and you see that and you don't pay any attention to it, it can progress to things like cancer.” A white patch, as I have documented (here), is simply a reaction to the irritating effect of the tobacco, similar to the development of calluses on a worker’s hand.  The link between white patches and cancer is virtually zero for dippers and chewers. As director of an FDA center, Zeller has a profound responsibility to enhance public health and adhere to scientific truth.  He damages his own credibility and that of his agency by making false statements.  Original author: Brad Rodu
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The War Against Vaping: Déjà Vu All Over Again

A document in the University of California San Francisco tobacco industry archives describes the hostile reaction in 1995 to my smokeless tobacco harm reduction strategy for smokers (here).  Opponents used messaging they would later redeploy against e-cigarettes: (1) all tobacco is dangerous, (2) medicines work, so substitutes aren’t needed, and (3) the children. In a CNN “Your Health” segment on October 21, 1995, correspondent Loretta Lepore “met a doctor who actually prescribes tobacco pouches as a way to satisfy the craving for nicotine without lighting up.” Lepore: “One, two, the count climbs to forty-six million U.S. smokers.  Charles Mayfield, a genetic cancer researcher was one, until his toddler demonstrated the error of his way.” Mayfield: “He used to walk around with a piece of paper rolled up like a cigarette…And, I mean, that had a devastating effect on me and my conscience.” Lepore: “Mayfield quit smoking, but he hasn’t overcome his nicotine addiction.  Now he gets his fix from smokeless tobacco.” Dr. Brad Rodu: “It’s a discreet, paper pouch that fits invisibly between the cheek and gum.” Lepore: “Oral pathologist Brad Rodu recommends all smokers make the switch.  He says it’s the smoke that causes fatal lung and heart disease.” Mayfield: “I’m using smokeless tobacco right now, and no one can even tell.” Lepore: “While the use of smokeless tobacco socially acceptable to some, many view Rodu’s approach as medically unacceptable.” Dr. Scott Tomar (CDC): “To recommend to smokers that they switch to smokeless tobacco is simply maintaining their addiction.” Lepore: “Instead, Tomar recommends an already approved nicotine replacement therapy.” Tomar: “Nicotine patch and gum, both have been found to be effective in treating nicotine addiction.” Rodu: “Nicotine patch and gum don’t provide nearly the same level, or nearly the same spike that smokers crave, and so are not effective for many smokers [Note: “ineffective” is more accurate, hereand here] Lepore: “And there’s another concern.” Dr. Clark Heath (American Cancer Society): “Smokeless tobacco carries with it a sharply increased risk of cancer.” [Totally wrong with respect to dip and chew here] Lepore: “A four to five fold increase over non-smokers.  Aside from health concerns, Dr. Rodu’s critics are also raising ethical questions about his approach.  Mainly, should doctors be advising patients to choose another addiction?  And if a patient gets sick from smokeless tobacco, is the doctor legally responsible?” Rodu: “Since when is it unethical to reduce the smoker’s risk for all tobacco-related diseases, including oral cancer?” Lepore: “A 1981 study published in the New England Journal of Medicine says 26 out of 100,000 smokeless tobacco users contract oral cancer each year.  The five-year survival rate for oral cancer is 50 percent.  In part, because it’s easier to detect than lung and other forms of cancer.  So according to Dr. Rodu’s theory, if all smokers switch to smokeless tobacco, the United States would see 6,000 cancer deaths each year [Note: this was a gross overestimate, based on falsified research, hereand here], versus 420,000 smoking-related deaths reported annually.” Lepore: “Dr. Donald Miller, an oncologist and Rodu colleague at the University of Alabama at Birmingham.” Miller: “I have wondered many times why I didn’t think of this.  It is an outstanding idea that really has the opportunity to change the way society thinks about cancer risk.” Lepore: “Critics say there’s also the risk non-smokers, especially teenagers, will start using smokeless tobacco, perceiving it to be safe.  But Dr. Rodu stresses his approach is for smokers only.” This transcript was circulated by Vincent Gierer, Chairman of the Board and CEO of US Tobacco, to employees of the world’s largest smokeless tobacco company in 1995.  Gierer challenged the baseless claims that my research was an industry ploy: “Obviously, Dr. Rodu’s thesis may cause considerable controversy, since some people may view his advice as favorable to our Company and our products.  Whatever your personal opinion of his thesis may be, I want to make clear the Company’s position regarding Dr. Rodu’s [book] publication.  The Company’s longstanding policy is not to make health claims about its products, nor to comment on health claims regarding other tobacco products.”Original author: Brad Rodu
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Vaping Is Not the Real Health & Safety Threat in Kentucky High Schools

Foundation for a Healthy Kentucky (FHK) and Kentucky Youth Advocates (KYA) recently launched a campaign to discourage e-cigarette use by youth (here).  KYA executive director Dr. Terry Brooks predicted that “unless we as a commonwealth treat e-cigs as the health threat it is — in terms of now and in the future — then in 2038, Kentucky will still be the cancer capital of the nation.”  According to Ben Chandler, FHK chairman and CEO, “the fact that youth e-cig use is often a gateway to cigarette smoking makes immediate action imperative.” Does evidence support the claim that e-cigarettes are a gateway to cigarettes? No.  Since the campaign cites the biennial Kentucky Youth Risk Behavior Survey, I have used KYRBS data to illustrate smoking and vaping among high school students in the Commonwealth from 2005 to 2017. The chart at left shows that current (past-30-day) smoking declined from 26% in 2005, to 24% in 2011.  E-cigarettes were not widely available during that period.  In contrast, during the e-cigarette era (2011 to 2017), current smoking dropped from 24% to 14%.  The prevalence of current vaping, collected only in the latter two years, was 23% and 14% respectively.  With the data showing show an unprecedented decline in smoking rates, there is no e-cigarette crisis among Kentucky high schoolers.  KYA asserts that they “are laser-like in our efforts to…protect kids from abuse and neglect,…help kids grow up healthy and strong…” (here)  If that’s the case, they shouldn’t ignore behaviors that are far more dangerous than vaping.  For example, 27% of Kentucky high schoolers were current drinkers, 13% were current binge drinkers, and 16% were current marijuana users.  Additionally: .nobr br { display: none } td { text-align: center}Prevalence (%) of Risky Behaviors Among Kentucky High School Students (KYRBS, 2017)Past 30 DaysRarely/never wore a seatbelt (as an occupant)9%Rode with driver who had been drinking14%Drove after drinking4%Texted or emailed while driving35%Carried a weapon (e.g. gun, knife, club)21%Past 90 DaysHad sexual intercourse29%..…and used condom, 51% of previousPast YearInvolved in physical fight21%Physically bullied on school property21%Electronically bullied18%Felt sad or hopeless29%Considered suicide15%Made suicide plan13%Attempted suicide8% Kentucky health organizations should stop obsessing about a mythical high school vaping crisis and focus instead on stopping other behaviors and activities that State data define as immediate health and safety threats.   Original author: Brad Rodu
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Federal Officials Obsessed By Teen Vaping, But Ignore Teen Drinking and Toking

The newly released 2018 Monitoring the Future survey results provide further evidence of a sharp decline in cigarette smoking among high school seniors, coinciding with increased vaping.  The rate of current smoking (in the past 30 days) plummeted to 7.6% from 9.7% the year before.  Even more impressive, the rate represents a 60% drop from 2011 (18.7%), which is the year that teens started to vape (evidence here). Current vaping (any or no drug) increased in 2018 to 27%, reflecting use of nicotine (21%), marijuana (7.5%) and/or flavors alone (13.5%).  Surgeon General Jerome Adams called the increase an “epidemic” and issued a plea for “all hands on deck.” (here).  Oddly, federal officials continue to focus more on vaping than on use of intoxicating drugs. High school seniors still used alcohol at a far higher rate than cigarettes (30% versus 7.6%), and over twice as many (18%) reported being drunk in the past month.  Marijuana use was 22%; it’s been in this range since 1995. To his credit, most of Dr. Adams’ media comments were evidence-based.  That wasn’t the case with the director of the National Institute of Drug Abuse, Dr. Nora Volkow, who said that vaping “might be paving the way for a transition to conventional cigarettes as well as other substances.” (here).  I have previously demonstrated that these gateway theories are false and based on fatally flawed research (examples hereand here).    The Surgeon General wrongly claimed that nicotine is “very and uniquely harmful” to the developing brain, and his web site asserts that vaping can impair learning and memory in those up to age 25 (here).  That claim implies that a significant percentage of the 40 million current smokers and even more former smokers, most of whom started as teens and smoked for decades, have brain damage.  There is no scientific evidence to support this allegation. In contrast, there is unequivocal evidence linking youth football and other concussion-producing sports activities to chronic traumatic encephalopathy (CTE) (here, for example).  If the Surgeon General and others want to protect children’s brains, this would be a more productive area for their focus. Dr. Adams’s statements were embellished by the usual tobacco prohibitionists, including Dr. Josh Sharfstein of Johns Hopkins University, who said, “There’s no more credible or influential voice on nicotine and tobacco than that of the U.S. Surgeon General.”  In fact, the current advisory is only the latest in a series of hyperbolic tobacco pronouncements by surgeons general over the past decades, including Dr. Vivek Murthy (here), Dr. Regina Benjamin (here), Dr. Boris Lushniak, Dr. Richard Carmona and Dr. Antonia Novello (here).  In 1992 Dr. Novello predicted “an oral cancer epidemic beginning two or three decades from now if the current trends in spit tobacco use continue” (here).  That epidemic was not just a fabrication, it was based on a completely false premise.      Original author: Brad Rodu
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Safer Tobacco Product Marathon: An Update

Smokers who are interested in vastly safer alternatives to cigarettes need to know that companies have filed four FDA applications seeking approval for advertising or marketing claims that their products are safer than cigarettes.  Technically, the companies are seeking “modified risk tobacco product”, or MRTP, approval.  Here are status updates on the applications. General Snus Swedish Match submitted the first MRTP application for General Snus four and a half years ago, asking to change grossly inaccurate but federally mandated warning labels on its smokeless products (here).  The FDA rejected the application in December 2016, using flawed regulatory interpretations (here).  In September 2018, Swedish Match requested approval of this language: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” The term “lower risk” is an understatement, as the risk is almost zero. The FDA scientific advisory committee will consider this application on February 6, 2019. IQOS Philip Morris International (PMI) filed an MRTP application for its IQOS heat-not-burn tobacco more than two years ago.  The FDA scientific advisory committee met in January and agreed that “Switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful and potentially harmful chemicals.” (here)  However, the FDA hasn’t reached a decision about allowing this factually correct statement to appear.  Even worse, the FDA has yet to act on a separate PMI application to put IQOS on the market in the U.S., even though its availability in Japan and other markets are decimating cigarette sales (here).  Based on predictions from industry analysts, it appears that the agency is slow-walking the application (here).  Camel Snus R.J. Reynolds filed an MRTP application in March 2017 for its Camel Snus products (here).  They requested approval for three statements, this being the most comprehensive: “Smokers who switch completely from cigarettes to Camel Snus can significantly reduce their risk of lung cancer, oral cancer, respiratory disease, and heart disease.”  The FDA’s scientific advisory committee reviewed the application in September; formal release of their recommendation is pending. Copenhagen Moist Snuff The U.S. Smokeless Tobacco Company in March this year submitted an MRTP application for Copenhagen fine cut snuff.  The company sought approval for a simple statement: “Switching completely to this product from cigarettes reduces risk of lung cancer.”  The FDA scientific advisory committee will consider this matter on February 6, 2019.  The wheels of regulation grind slowly.  The months and years go by, and smokers continue to die. .nobr br { display: none } td { text-align: center} Key Dates for General Snus, IQOS, Camel Snus and Copenhagen MRTP Applications EventGeneral Snus (Swedish Match)IQOS (PMI)Camel Snus (R.J. Reynolds)Copenhagen (US Smokeless Tobacco)Submission DateJune 6, 2014November 18, 2016March 31, 2017March 20, 2018Time to:2 months6 months9 months6 monthsFDA FilingAugust 27, 2014May 24, 2017December 18, 2017September 14, 2018Cumulative time to:10 months14 months18 months11 monthsTPSAC MeetingApril 8, 2015January 24, 2018September 13, 2018February 6, 2019Cumulative time to:30 months25 months and counting21 months and countingFDA DecisionDecember 14, 2016------Cumulative time to:51 monthsAmendment FiledSeptember 17, 2018Cumulative time to:56 monthsTPSAC MeetingFebruary 6, 2019Original author: Brad Rodu
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Who Smokes Menthol Cigarettes?

FDA Commissioner Scott Gottlieb recently said, “I’m deeply concerned about the availability of menthol-flavored cigarettes.”  He noted that menthol represents “one of the most common and pernicious routes by which kids initiate on combustible cigarettes” and “menthol products disproportionately and adversely affect underserved communities. And as a matter of public health, they exacerbate troubling disparities in health related to race and socioeconomic status that are a major concern of mine…we need to address the impact that menthol in cigarettes has on the public health.” (here) In a similar vein, the Truth Initiative’s latest menthol screed suggests that menthol smokers are primarily teens, females, minorities and those with mental illness (here).  Is that accurate? The answer for adults can be found in the National Health Interview Survey, the main instrument used by the CDC to track smoking in the U.S.  The NHIS collects information on menthol about every five years.  The chart at left presents the characteristics of menthol smokers in 2015, the most recent year for which NHIS data is available.  Of the 36.5 million American adult smokers, about 10.7 million reported that they smoked menthol cigarettes (22.4 million preferred plain cigarettes and the rest were uncommitted).  Women outnumbered men by a small margin, and menthol smokers were broadly distributed across the age spectrum.  Racial distribution figures stand out.  Although Black/African American smokers overwhelmingly favored menthol cigarettes, they were far outnumbered by White menthol smokers. Sixty-one percent of menthol smokers and 55% of plain cigarette smokers were in the lowest income group.  Any difference in income distribution between menthol and plain cigarette smokers may be explained by differences in age, sex or race.  The claim that menthol use reflects a socioeconomic disparity is not valid without further investigation. Last year I published research showing that smoking may contribute to depression, anxiety, or emotional problems (here).  But the association has nothing to do with menthol.  In the 2015 NHIS 11% of menthol smokers reported difficulty with activities because of these conditions.  The rate was the same among plain cigarette smokers. Five years ago I noted in this blog that an “FDA preliminary evaluation – reflecting data from numerous studies – does not provide evidence of any significant differences between menthol and regular cigarettes with respect to smoking initiation, addiction to nicotine or cessation.  There is no justification for an evidence-based decision by the FDA to ban or otherwise restrict the menthol content in cigarettes.” (here)   It is not clear that a stronger scientific rationale for FDA action on e-cigarettes presently exists.  If action is taken, this blog post has described the characteristics of the 10.7 million smokers it will affect. Original author: Brad Rodu
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Pediatrics Journal Wants to Rectify Teen “Inaccurate Beliefs” About Smoke-Free Tobacco Hazards

In the journal Pediatrics, University of Vermont’s Maria Parker, Ph.D., and 11 coauthors from four other institutions report that “Youth [age 12-17 years] who believed that noncombustible tobacco products posed ‘no or little harm’ at [wave 1 of the FDA Population Assessment of Tobacco and Health Study, PATH] were more likely to have tried those products at wave 2.” (here) This finding is not particularly surprising.  It shows that, despite a relentless campaign against vastly safer smoke-free tobacco products, some youth recognize the truth: It’s the smoke that’s harmful.  Dr. Parker found that 85% of youth thought cigarettes conferred “a lot of harm,” while only 27% thought the same of e-cigarettes.  On the other hand, only 51% thought e-cigarettes were less harmful than cigarettes, 44% assessed them as equally harmful, and 5% believed them to be more harmful. Skewing their findings against smoke-free products, Parker et. al. used “ever trying” the products between survey waves as their outcomes.  This is much less meaningful than “currently using”, which was not reported and might have produced negligible results.   The take-away from the article is that youth who [correctly] believe that smoke-free tobacco products are less harmful than cigarettes are more likely to try the former.  Parker et al. imply that trying can be prevented by disabusing teens of their “inaccurate beliefs.” Even though the study's findings are inconsequential, its 12 authors use them to justify aggressive intervention by authorities “across local, state, and national levels…to convey accurate information on and address inaccurate beliefs about the absolute and relative harms of tobacco products in an effort to reduce youth tobacco use.”  They highlight the FDA’s Real Cost Campaign, which conveys “accurate information” by depicting e-cigarette worms invading teen brains and bodies (here). Speaking of real costs, this study was supported by $62.3 million in NIH grants.     The article’s recommendation was endorsed by the journal’s editor (here), who previously acted contrary to editorial standards for professional medical journals after publishing a flawed e-cigarette gateway study (hereand here).     Original author: Brad Rodu
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More heat than light – new US statistics on youth vaping provide no basis for FDA policy

What’s going on in their lives?

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Detoxing the Heavy Metal Vape Scare

Jonathan Swift 300 years ago observed that “Falsehood flies, and the Truth comes limping after it; so that when Men come to be undeceiv’d, it is too late; the Jest is over, and the Tale has had its Effect.” (here)  That is the story of e-cigarettes and vaping today.  Billions of dollars have been transferred from tobacco consumers to companies to the FDA in the form of user fees (here).  The FDA, via the NIH, has transferred hundreds of millions to fund university research on tobacco use and effects, in order to provide a “scientific basis” for FDA regulations (here).  With NIH making no attempt to hide our government’s objective – “a world free of tobacco use” (expressed here) – it is not surprising that much of the funded research and attendant publicity is biased to support the announced policy objective. In March, anti-vaping researchers published a study claiming that metals in e-cigarette vapor are toxic when inhaled.  While the media headlined the findings “dangerous” and “alarming”, and termed vape products “brain-damaging,” I explained in this blog that the metal doses delivered by e-cigarette liquids in this study are trivial.  I estimated that an e-cigarette user could be exposed to excessive metal levels only by consuming high volumes of vape liquids.  For example, vapers would have to use 15.4 liters (nearly four gallons) of liquid per day to achieve exposure to 2 micrograms of cadmium. (here)  I worked with Dr. Konstantinos Farsalinos, a prestigious vaping researcher at Greece’s Onassis Cardiac Surgery Center, the University of Patras and the National School of Public Health.  The findings of our risk assessment analysis of the metals study were just published in the journal Inhalation Toxicology (abstract here). The original study referenced U.S. Environmental Protection Agency safety limits that apply to 24-hour air exposure, or to workers breathing factory air for 8 to 10 hours.  This standard is entirely invalid for e-cigarette analysis, as users do not inhale vapor continuously for such long periods of time.  Dr. Farsalinos and I applied more realistic federal standards, such as established regulatory safety limits for inhaled medicines.  We calculated total daily exposure to metals by using an average daily vape liquid consumption of 3 to 5 milliliters (e.g., 3 to 5 grams, around 1 teaspoon). The chart demonstrates that vapers would need to consume impossibly large volumes of liquid in order to exceed the safety limits for almost all metals.  The one exception is nickel, which requires only 17 grams of liquid, but even that is over three times normal daily consumption. In this case, truth is limping in eight months after widespread false alarms flew about metals in e-cigarette vapor.  The Tale has had its Effect, but in the end, as Shakespeare assures us, truth will out. Original author: Brad Rodu
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Youth vaping and the dangers of over-reaction – a letter to the FDA

Letter from Iowa Attorney General Miller and others, including me, to Scott Gottlieb, FDA Commissioner. See PDF at the link below:

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Tobacco Control Special Issue Yields Smoke But No Hazard for IQOS Aerosol

Recently a special issue of the journal Tobacco Control offered 22 articles on Philip Morris International’s (PMI) IQOS heat-not-burn tobacco product (here), aiming to dissuade the FDA from allowing IQOS sales as reduced risk products for smokers.  In the words of editor Stanton Glantz: “Policy makers should give greater weight to the advice provided by public health scientists than to submissions from industry when it comes to regulating tobacco products such as heated tobacco products.” Dr. Glantz’s advice has been inaccurate in the past. A year ago, when he argued that “PMI’s own data fails to support a modified risk claim in people who are actually using [IQOS],”  I detailed the errors in his analysis (here).  This new collection of anti-IQOS articles deserves the same scrutiny. One treatise, by UCSF’s Gideon St. Helen and colleagues, acknowledges that “All substances in PMI’s list of 58 constituents (PMI-58) were lower in IQOS emissions compared with mainstream smoke of reference cigarettes.”  That accurate statement is followed by the suggestion that PMI ignored that “levels of 56 other constituents, which are not included in the PMI-58 list or FDA’s list of [harmful and potentially harmful constituents], were higher in IQOS emissions.”  The authors criticize PMI for not undertaking “non-targeted chemical analysis” to identify these compounds. Dr. St. Helen et al. are mistaken.  The chart above, taken from PMI’s presentation to the FDA advisory committee last January (here), documents that the company performed that analysis.  PMI’s extensive investigation of “other” substances is confirmed on the FDA website, where a chart labeled “non-targeted screening” appears in a document submitted by PMI on December 8, 2017, and published by FDA on January 12, 2018 (here).  The December filing acknowledged that “80 compounds were found to be of higher concentration or new in [IQOS] aerosols…compared to cigarette smoke.  A toxicological assessment was performed and identified 68 of those that do not present specific toxicological concern. 8 compounds present potential genotoxic concerns based on structure-activity computational alerts and 4 compounds are classified mutagens/carcinogens.”  PMI scientists did not dismiss the findings: “Although a minor subset of compounds identified in this study show intrinsic (potential) toxicological hazards, overall toxicity of the THS generated aerosol was lower compared to cigarette [smoke]. In vitro studies demonstrated a marked decreased biological activity of [IQOS] aerosol compared to smoke. An in vivo 90 days inhalation study showed in general a lower biological activity of the mainstream aerosol from [IQOS] when compared to mainstream smoke.” Importantly, PMI is undertaking more research: “Additional investigations are ongoing to further characterize the impact of the [mutagens/carcinogens] on the overall toxicity of [IQOS] products.”        Original author: Brad Rodu
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