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Some FDA Claims About Teen Vaping Confirmed, Others Evaporate




The Centers for Disease Control and Prevention just released the 2018 data for the National Youth Tobacco Survey (NYTS).  My analysis confirms the FDA claim of a substantial increase in vaping among high school students.  However, I also discovered some information that challenges the FDA commissioner’s narrative (here) that this “threatens to hook an entire generation of kids into a lifetime of addiction.” As seen in the chart at left, current (past 30 days) dual use of combustible and electronic cigarettes rose from 4.2% the year before to 5.7% in 2018.  Exclusive e-cigarette use almost doubled, from 7.6% to 15.1%.  The only good news is that exclusive cigarette use declined from 3.6% to 2.6%.  Frequency of use is seen in the table below, which displays the percentages of the estimated 14.4 million high school students in 2018 who were currently using cigarettes and/or e-cigarettes, by number of days in the past month.  For example, 76.6% of students used neither product (bold text, upper left), an 8 point decline from the year before.  Current users of e-cigarettes are in the red-bordered boxes.  In 2017, 60% of current vapers used the products 5 or fewer days (green text) – the equivalent of trying products at a party.  But in 2018, that percentage dropped to 49%.  In contrast, in 2017 only 20% of current high school vapers used the products 20-30 days (red text), i.e frequent users, which is suggestive of dependence.  That number grew to 28% in 2018.  Slightly over half of those were not currently using cigarettes (bold red text). These worrisome numbers fuel the government’s dire warning that e-cigarettes are creating a new generation of nicotine addicts.  However, these claims require context, which the newly available NYTS data provides.  For example, the FDA emphasized that 28% of high school vapers were frequent users in 2018.  However, only 25% of underage vapers were frequent users, compared with 41% of legal vapers.  Further analysis of frequent vapers according to their underage or legal status shows the following: .nobr br { display: none } td { text-align: center}Table 2. Lifetime Cigarette Consumption of Frequent High School E-Cigarette Users, NYTS 2018Lifetime Cigarette ConsumptionUnderageLegalNot Current SmokersNever smoked43.1%28.2%1 puff to 5 cigarettes35.730.3Half to 1 pack9.417.31-5 packs6.412.65+ packs5.511.6All100%100%Current SmokersNever smoked0%2.8%1 puff to 5 cigarettes16.15.6Half to 1 pack19.725.01-5 packs20.015.85+ packs44.150.8All100%100%The table shows that most frequent e-cigarette users were not virgins with respect to cigarette smoking.  In the underage nonsmoking group, 57% of frequent vapers had smoked in the past.  The percentages were even higher among legal-age and current smokers.  These percentages will likely increase if cigars, smokeless tobacco and other tobacco products are included (as I explained years ago here).  These youths had already smoked, which counters Dr. Gottlieb’s assertion that “e-cigarette use…threatens to hook an entire generation of kids into a lifetime of addiction.”  Simply put, kids who use or try stuff, use or try other stuff.I have noted previously that the FDA’s campaign to eliminate teen vaping has improperly focused on tobacco retailers (hereand here).  The following table from the 2018 NYTS confirms that the dominant sources of e-cigarettes for underage high school users are friends, family and other individuals (71%), while the primary source for legal high school vapers are retailers (64%).  Raising the legal purchase age – Tobacco 21 – remains a viable way to curb underage use. (here).nobr br { display: none } td { text-align: center} .nobr br { display: none } td { text-align: center}Table 3. Source of E-Cigarettes for High School Vapers,* NYTS 2018 UnderageLegalFriend58.0%24.9%Family6.83.2Other person6.68.0Vape shop12.946.8Gas, convenience store6.69.7Internet3.92.0Other store2.31.4Drug store1.12.7Grocery0.90.6Mall kiosk0.90.7All100%100%* Reporting a single source (81% of all)(weighted).I previously said that “The FDA’s Teen E-Cigarette-Addiction Epidemic Doesn’t Add Up” for 2017.  There is no question that e-cigarette use among high school students increased substantially in 2018.  However, analysis of NYTS data documents that the FDA claim that e-cigarettes from retailers are singlehandedly hooking an “entire generation of kids into a lifetime of addiction” is exaggerated and inaccurate.  Original author: Brad Rodu
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Tobacco Sales to Kids Is a Problem For States, Not Retailers



FDA Commissioner Scott Gottlieb recently threatened that “some flavored e-cigarette products will no longer be sold at all…other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access…” (here) Dr. Gottlieb blames the so-called youth vaping “epidemic” on illegal retail sales and “kid-friendly marketing.” (here)  Focusing so heavily on retailers, he ignores the fact that underage sales rates are extremely low in many states – Georgia (2.2%), Montana (2.7%), Hawaii (3.0%) and California (4.2%) for example, according to 2018 FDA inspection data – while violation rates in others is extremely high -- North Dakota, Michigan, Ohio and Nevada are close to 23% (here). In order to explore the connection between retailers’ violations and state enforcement efforts, I downloaded FDA information on 26,000 inspections conducted in 2018 at national retail chain stores – Walgreens, Walmart, Rite Aid, Shell, Family Dollar, Dollar General, Circle K and 7-Eleven.  I calculated the rate of violations for these chains’ stores in each state (excluding Nevada and North Dakota, with very low numbers of inspections).    The chart shows the combined results for these retailers.  Note that the x axis is the state rate, based on 146,000 inspections, and the y axis is the retailers’ rate, based on 26,000 inspections.  There is a strong correlation between violations in these chain stores and the state in which they were located (correlation coefficient, CC = +0.77).  The correlation is also seen with individual companies.  For example, Walgreens’ violation rate was 2.2% in Georgia (based on 46 inspections) and 17% in Ohio (with 229 inspections).  Note that nearly all of the retailers’ rates are below the green diagonal line, showing that they were lower than the state rates in all jurisdictions except DC, Connecticut, Oregon, Minnesota, Alaska and Hawaii. The FDA blames retailers for selling tobacco products to children, but it ignores the significant differences in violation rates among states.  Youths in Georgia, Montana, Hawaii and California can seldom buy tobacco products, suggesting that those states’ enforcement efforts are far more effective than the other 46 states. The simplest route to obtaining age restriction compliance seems to be FDA pressure for stronger state enforcement, rather than agency action against retailers or product categories. Original author: Brad Rodu
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FDA’s Campaign Against Tobacco Retailers Doesn’t Hold Up to Inspection



Today Dr. Scott Gottlieb announced a draft compliance policy predicting that ““some flavored e-cigarette products will no longer be sold at all…other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access…” (here)Gottlieb has blamed a so-called youth vaping “epidemic” on illegal retail sales and “kid-friendly marketing.” (here)  Last week he spotlighted Walgreens, saying that 22% of its stores had illegal sales of tobacco products to minors “since the inception of the FDA’s retailer compliance check inspection program in 2010.”  He also listed 14 other national retail chains that had violation rates of 15% to 44%.  These shocking numbers are, in fact, inflated through the use of cumulative math covering a nine-year period. I reported on public FDA inspection data just after the program started (here) and again in 2016 (here).  In response to current FDA news, I have now analyzed the data from 2018 (available here), the year Dr. Gottlieb said youth vaping skyrocketed, based on still unpublished data from the National Youth Tobacco survey.  My findings on the 2018 FDA inspection data are illuminating.FDA contractors conducted over 146,000 retailer inspections in 2018, resulting in a national average violation rate of 12%, just one percent higher than in 2015-16 (here).  The following table contrasts the cumulative violation rate (range) reported by Dr. Gottlieb with the actual rate in 2018..nobr br { display: none } td { text-align: center} National Retailers’ Tobacco Sales Violations: “Cumulative” Versus 2018 RatesRetailerGottlieb “Cumulative” Rate (%)Actual 2018 Rate (%)Walmart15-246Walgreens15-249Family Dollar15-2411Circle K15-2412Kroger15-2413Casey’s General Stores25-34117-Eleven25-3414Shell25-3419Chevron25-3419Marathon35-4426Citgo35-4419Exxon35-4420Mobil35-4420Sunoco35-4421BP35-4424Dr. Gottlieb did not need to use inflated cumulative numbers to demonstrate that national retail chains, especially those with gas stations, are still selling tobacco products to underage youth.  Additionally, his focus on Walgreens, with a 2018 violation rate of 9%, three points lower than the national average, seems inappropriate.  Other key data points were omitted from Dr. Gottlieb’s remarks.  First, there is a large variation in state violation rates, from Georgia (2.2%), Montana (2.7%), Hawaii (3.0%) and California (4.2%) all the way to North Dakota and Michigan at 22.5%; Ohio and Nevada at 22.9%.  Retailers’ state rates were similarly diverse. For example, Walgreens and Walmarts in Georgia had much lower rates than those in Ohio.  This doesn’t absolve retailers of responsibility.  Rather, it indicates that state policies and attitudes may be contributing as significantly to underage sales as retailers.While Dr. Gottlieb’s regulatory effort is aimed ostensibly at combatting youth access to e-cigarettes, only 19% of the cited 17,500 violations in 2018 involved those products.  Cigars were the most frequent culprit (44%), followed by cigarettes (33%), with smokeless tobacco at a mere 4%.There is no excuse for a national tobacco sales violation rate of 12%; retailers everywhere must stop selling to underage youth.  Still, the federal government’s own survey data shows that more than 90% of teens who use tobacco products obtain them from social sources, such as friends or family.  Only 10% of current teen vapers buy their own e-cigs (here).  Given these facts, the FDA can’t hold retailers entirely responsible for teen e-cigarette use.Original author: Brad Rodu
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Federally Funded Authors Promote Misperceptions of Smoke-Free Tobacco Products



In their recent journal article, “U.S. adult perceptions of the harmfulness of tobacco products” (abstract here), a group of researchers from the FDA, other federal agencies, Canadian and American universities suppress important information about safer tobacco products.  G.T. Fong and 11 co-authors used federal funds to analyze the FDA Population Assessment of Tobacco and Health (PATH) Survey with respect to perceptions of eight non-cigarette tobacco products’ relative harms.  While their roughly 5,000-word treatise included three large tables, one figure, two supplemental tables, and 40 references, they included not a word about how these perceptions match up with reality.  The only time they used the word “misperception” was to suggest that Americans who view non-cigarette products as less harmful should be educated with “new information”. The authors found that “40.7% of adults believed that electronic cigarettes were less harmful than cigarettes.” In their view, “These results point to the potential value of enhancing knowledge, within the U.S. population, of the harm of tobacco products to prevent tobacco use and to encourage tobacco users to quit, through providing new information about the harms that may not be widely known and/or through countering misperceptions that may exist.” Readers of this blog know that numerous published studies document that smokeless tobacco use is vastly safer than smoking, and that the British Royal College of Physicians affirms that vaping is at least 95% less hazardous than smoking.  It is appalling that 12 government-funded researchers have published a lengthy screed without acknowledging that smoke-free products are less harmful.  Original author: Brad Rodu
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Vaping research priorities – my top ten


Following up on the guest post by Louise Ross: What are the vaping research priorities? Have your say… I have now had my say and wanted to share my top 10 priorities.

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Anti-vaping activists pitch unscientific fringe positions to a national newspaper





Some veterans of the tobacco control establishment have found the public health opportunity of vaping hard to come to terms with

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What are the vaping research priorities? Have your say…




Vaping: what do we need to know?

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The American Cancer Society: For and Against Tobacco 21



My op-ed about Virginia’s adoption of Tobacco 21 was published in the Richmond Times-Dispatch (available at Richmond.com hereand below).  As I have documented before (here), the American Cancer Society is out of touch with American smokers and their need for reasonable and rational ways to quit.  Further evidence is seen in the Society’s U-turn from supporting to opposing Tobacco 21 in Virginia (below) and Utah (here).  The Society complained in both states that “the devil’s in the details,” but there are no details: states simply want to move the legal age for tobacco sales from 18 to 21.  The Society should advocate for the health, and respect the rights, of American teens and smokers._______________________________________________________ Virginia has raised the minimum age for buying all nicotine products, including e-cigarettes, from 18 to 21. The bill had widespread support from state medical societies and Gov. Ralph Northam, a pediatric neurologist; and it is part of a national trend in which states are responding to the growing number of adolescents choosing to vape. But some in the public health community tried to make the perfect the enemy of the good by standing in the way of a sensible regulation that has the potential to curtail teen nicotine use, without making it harder for adult smokers to access healthier alternatives. It’s true there has been an increase in teen vaping — a problem exacerbated, in part, by older students legally buying tobacco products and selling them to their younger classmates. Raising the age from 18 to 21 will delegitimize tobacco sales to 18-year-olds and potentially disrupt high school “black markets.” Eighteen-year-olds make up 14 percent of all American high school students, but they account for one-quarter of high school smokers and smoker-vapers. Legal buyers — not manufacturers and retailers — are the primary source for tobacco products used by underage high schoolers. So Virginia’s Tobacco 21 law could make a big impact in limiting access to youth. The problem comes from the growing contingent of “anti-tobacco” activists who won’t be happy until there is simply no tobacco — or nicotine — for sale at all. Specifically, the American Cancer Society needs to start acknowledging scientific facts and abandon its “tobacco-prohibition” stance. The society opposed the sensible Tobacco 21 bill in the Virginia legislature, despite the fact that the ACS’s lobbying arm, the Cancer Action Network (CAN), endorses Tobacco 21 at the national level. CAN spokesman Brian Donohue insists, “the devil is in the details.” Similarly, the American Heart Association also supports Tobacco 21 in theory, but has been critical of the Virginia legislation. AHA spokesperson Ashley Bell said — somewhat incoherently — that youth access laws “may not be strong enough to support the current age … are not strong enough to support the enforcement of raising the age.” ACS-CAN’s Donohue added that Tobacco 21 “is a great goal, but it’s backwards.” The only thing backwards is the public health community’s flip-flopping on support for Tobacco 21. ACS-CAN is critical of the bill’s focus on youth — rather than retailers — and is insisting additional changes ought to be made such as the elimination of fines for teen buyers (currently $100 for the first violation, $250 after that), and increased fines for retailers (currently set at $500 for the first violation and up to $2,500 subsequently). But the reality is, they don’t intend to settle halfway because they want the complete elimination of nicotine and tobacco products. Efforts to stem the use of tobacco and vaping products through Tobacco 21 laws — like the one signed into law in Virginia — are growing. Hawaii, California, New Jersey, Oregon, Maine, and Massachusetts have already raised the purchase age to 21, and Alabama, Alaska, and Utah bumped it to 19. The leadership at organizations like ACS-CAN and the AHA know that the FDA punishes retailers who sell tobacco to anyone under 18. E-cigarette companies have implemented stringent age verification systems online to support these measures. No tobacco product is perfectly safe, but vaping is considered 95 percent safer than smoking. E-cigarettes not only provide a safer alternative for adult smokers; but, as the New England Journal of Medicine just confirmed, they are used more often by smokers, and they are more effective than medicinal nicotine in helping smokers quit. Each year more than 16 million Americans live with, and almost half a million die from, smoking-attributable illnesses; the total economic cost is more than $300 billion. We can’t afford to let politics interfere with sensible policies. Kudos to Governor Northam for ignoring tobacco policy u-turners in order to remove legal tobacco consumers from Virginia high schools. Original author: Brad Rodu
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Teen Smoking-to-Vaping Is More Frequent Than Vaping-to-Smoking, Says Data in New Study



FDA Commissioner Gottlieb on February 10 tweeted, “Now, a new study, published in the Journal of the American Medical Association (JAMA), further demonstrates what we’ve seen from other data: Teens who vape are more likely to start smoking cigarettes.” (Tweet here)  The study (here), by Kaitlyn Berry at Boston University and colleagues there and at the Universities of Louisville and Southern California, appeared in JAMA Network Open.Berry et al. examined the FDA Population Assessment of Tobacco and Health (PATH) survey involving youth, which started in 2013-14 and had two follow-ups, one and two years later.  The researchers identified 6,123 youths age 12-15 years who had not used a tobacco product at enrollment.  Some of the participants first tried a tobacco product over the next two years.  Berry et al. assessed whether first use of a particular product resulted in youth ever or current (past 30 days) cigarette smoking.  They concluded that “e-cigarette use is associated with increased risk for cigarette initiation and use.”Taking a closer look at the study, New York University professors David Abrams and Ray Niaura and I produced a comment, which has been published in the journal, making the following important observations.While Berry et al., and Commissioner Gottlieb, emphasized the 4.0% probability of current smoking among e-cigarette first users, we found a reverse result buried in a supplemental table: The probability of current e-cigarette use at follow up among cigarette first users was 8.3%.  This means that twice as many first-smoking teens currently used e-cigarettes at follow-up than first-vaping teens who currently used cigarettes.  We also noted that 527 teens first used e-cigarettes during follow-up, 202 used cigarettes first, and 306 used other products.  The table shows that out of 130 current smokers at follow-up, the relative impact is 25% for first e-cigarette use and 75% for all others. .nobr br { display: none } td { text-align: center} First Use of Tobacco Products By Teens in the PATH Survey and Current Smoking at Follow-upFirst Product Used (n)Percentage Currently Smoking at Follow-up (n)E-cigarette (527)5.9% (31)Other Tobacco (306)8.2% (25)Cigarette* (202)None* (5,088)1.4% (74)All (6,123)2.1% (130)*First cigarette users were combined with nonusers by Berry et al.This is entirely relevant to the FDA public health standard.  The absolute population impact (API) can be calculated using the full denominator of 6,123 teens. This reveals that e-cigarette first use resulted in 31/6,123 or about 0.5% API, contrasted with 25+74 = 99 /6123 or 1.6 % for teens without any first e-cigarette use.  In short, the API for teens without e-cigarette first use was triple that for teens with first e-cigarette use.Drs. Abrams, Niaura and I concluded:“Even with this small impact [0.5% API], e-cigarette first use cannot be causally linked to current smoking two years later, because plausible shared liability factors have not been ruled out. As a result of the issues we raise, scientists, journalists, regulators, policymakers and the public may be misled into thinking that e-cigarette first use is a unidirectional gateway into smoking. When information about API and the opposite gateway to smoking cessation are included, a much more complete picture emerges.”We look forward to a response from Ms. Berry and her colleagues.Original author: Brad Rodu
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Twitter Caught Up In This Year’s Annual Through With Chew Misinformation Orgy



Smokeless tobacco users are in for harassment this week, the 30th iteration of the annual Through With Chew orgy of smokeless tobacco misinformation.  Dippers and chewers will be demonized and the real science about the relative safety of their favored products will be twisted into fear-inspiring untruths. Consider this Tweet, for example, from the U.S. Department of Defense @ucanquit2 account on February 11: “Smokeless tobacco users are 50x more likely to get cheek, gum & mouth cancer than nonusers.”  The DoD made the same bogus claim two years ago (here).  I responded to this blatant fabrication with a Tweet of my own on February 15: “Your 50 claim is a complete fabrication by a staffer @theNCI. Here is the explanation: https://tinyurl.com/yxjsnugd . Furthermore, a large federally-funded study documented that men who dip/chew had ZERO excess risk for mouth cancer. ZERO. http://tinyurl.com/hd8nd49” After my Tweet was liked by 24 people and retweeted by 13, a strange chain of events occurred.  The Twitter accounts of many of the above were suspended.  The affected individuals pleaded with @TwitterSupport to make amends.  On February 16, I also asked for a correction: “To @TwitterSupport, Pls restore me/others. I am a scientist, 25 years published in this field. My tweet was professional and credible. In 2010 @CarlBialik at @WSJ investigated ‘50’ number and reported it was a fabrication used by @AmericanCancer, others http://tinyurl.com/y6a7ox8a.” That’s right.  Carl Bialik, “The Numbers Guy”, published a weekly column in the Wall Street Journal.  When Carl exposed the “50” myth (here) the American Cancer Society promised to stop using it: “Dr. Thomas Glynn, director of cancer science and trends for the American Cancer Society, said this week that his organization will no longer use the statistic citing a 50-fold increase in risk.” Yet still today, the Cancer Society and other tobacco prohibitionists tout the 50 number.       This week’s Twitter account suspensions likely resulted from a complaint by an authoritative anti-tobacco figure or agency.  While I understand that Twitter aims to protect the integrity of the information on its platform, in this case they sanctioned the wrong party. Note: As I post this on February 19, the suspended accounts have not been restored.   February 22: Today Jacob Sullum authored an article on the Reason Hit and Run Blog, "Did Twitter Punish Criticism of Government Propaganda About Smokeless Tobacco. (here).  A few hours later affected users reported that their accounts were returned to normal functioning. Original author: Brad Rodu
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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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