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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.

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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Truth Initiative Stumbles in JUUL Study

It’s surprising how many fundamentally flawed e-cigarette studies are aggressively promoted by their authors and allied organizations as grounds for FDA regulatory action.  It is also concerning when authors refuse to acknowledge or respond to honest scientific inquiries about their research.  Here is a representative case involving researchers associated with Truth Initiative, a non-profit anti-tobacco organization. Researchers led by Donna Vallone, Ph.D., recently published a study in Tobacco Control on the “prevalence and correlates of JUUL [e-cigarette] use among a national sample of youth and young adults (here).”  While they reported that the overall prevalence of ever and current (past 30-day) JUUL use was 6.0% and 3.3% respectively, they failed to disclose information about the most important correlate of JUUL use – other e-cigarette use. The authors noted that among underage children (15-17 years), current JUUL use was 6% and current use of combustible tobacco was 7%.  They connected these, finding that children who were currently smoking were five times more likely to use JUUL than non-smokers.  However, 11% of children in that age group currently used e-cigarettes.  They ignored this important correlate in their analyses.  Instead, they inexplicably included e-cig use among other members of the youths’ households. There are other significant problems with this study.  First, youths and young adults were asked: “…on how many days did you smoke a Juul vape?” (emphasis added)  That wording likely confused participants.  Second, the authors didn’t define current use of e-cigarettes, nor did they even give any description of the question in their survey.  Third, the survey flow for JUUL and e-cigarette questions was not provided.  Were separate questions about these products asked of all participants, or did researchers ask first about e-cigarettes, and then only ask current e-cig users if they used JUULs?  Fourth, Vallone et. al. defined JUUL “regular use” as 10-30 days in the past month, and they reported that 25% of youth fell into this category.  That percentage is grossly inflated.  The CDC and other authorities use a more credible “frequent” category of 20+ days (hereand here), which would generate a lower percentage of users at risk.     In summary, Vallone et. al. produced an error-ridden study focused on JUUL “smoking,” while ignoring the effect of other e-cigarette use.  The obvious problems ought to have been resolved in peer review.  Additional questions remain, owing to the fact that the authors used a private dataset.  When Truth Initiative posted the study on the Society for Nicotine and Tobacco Research listserv, I asked the authors to resolve some of these problems; they did not acknowledge my listserv post. Original author: Brad Rodu
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CDC Data Reveal Many Far More Dangerous Teen Behaviors Than Vaping

In the hierarchy of teenage risk behaviors, government data shows that vaping pales compared to drinking-, driving- and weapon-related activities. It is remarkable that public health officials and the media focus so greatly on the former, to the detriment of teen safety and health.A report from the CDC earlier this year (here), based on the 2017 Youth Risk Behavior Survey (YRBS), allows us to put the data in context.The prevalence of past-month e-cigarette use in the 2017 YRBS was 13%.  That rate is higher than those for cigarettes (8.8%), cigars (8.0%) and smokeless tobacco (5.5%).  However, as I discussed recently (here), the vaping rate pales next to those for marijuana (19.8%) and alcohol (29.8%).  In fact, the e-cigarette rate is nearly identical to the rate for binge drinking (4 or 5 drinks within a couple hours). These rates of drug use are troubling, but there is much worse in the federal report for parents and policymakers to be concerned about.  Following is a list of other risky behaviors by high school students in the past 30 days..nobr br { display: none } td { text-align: center} Prevalence (%) of Risky Behaviors Among American High School Students (YRBS, 2017)Past 30 DaysRarely/never wore a seatbelt (as an occupant)5.9%Rode with driver who had been drinking16.5%Drove after drinking5.5%Drove after marijuana use13.0%Texted or emailed while driving39.2%Carried a weapon (e.g. gun, knife, club)15.7%Past 90 DaysHad sexual intercourse28.7%..…and used condom, 53.8% of previousPast YearInvolved in physical fight23.6%Physically bullied on school property19.0%Electronically bullied14.9%Felt sad or hopeless31.5%Considered suicide17.2%Made suicide plan13.6%Attempted suicide7.4%Media coverage of the CDC YRBS report (here) was largely confined to the sensational -- “Fewer teens having sex and using drugs, CDC says.” The absence of focus on the more prevalent and dangerous behaviors in part reflects the FDA-led public health community fixation on vaping.  This may stem from the fact that, of the many greater-risk categories outlined by the CDC, the FDA’s regulatory authority only extends to tobacco. To a federal agency with a hammer, everything is a nail.Original author: Brad Rodu
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Rethinking nicotine: FDA asks six questions about the future of nicotine regulation

Will no-one rid me of this turbulent molecule? (after Henry II on Sir Thomas Beckett)

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The Answers to FDA’s Tobacco Questions Are Obvious, But Perhaps Unwanted

In his recent Nicotine & Tobacco Research commentary, “The Future of Nicotine Regulation,” FDA Center for Tobacco Products director Mitch Zeller listed five “challenging questions.”  I offer the following answers. 1. How comfortable are we with long-term, or possibly permanent, use of less harmful nicotine delivery mechanisms by adults, if they help keep currently addicted smokers from relapsing to combustible tobacco products? If addicted smokers stay smoke-free by using less harmful smoke-free alternatives, everyone who is not a tobacco prohibitionist is probably comfortable with long-term use.  The harm of permanent nicotine use is of the same magnitude as that of permanent caffeine consumption.  Most are comfortable with chronic consumption of caffeinated drinks, by adults and teens. While the FDA does now acknowledge tobacco harm reduction, the agency still does not adequately distinguish the harm differential between smoke and smoke-free products, nor does it promote smokers’ transition to vastly safer products that have been on the market during the nine years of FDA regulation.  2. How much weight should be placed on diminished interest in quitting nicotine altogether? None. 3. Given the potential health impacts of dual use of tobacco, how acceptable is a short period of dual use while transitioning to less harmful nicotine-containing products? What if many current smokers engage in dual use on a long-term or permanent basis? For smokers trying to quit, dual use of cigarettes and smoke-free products is a common practice which can occur over varying periods of time.  Currently, owing to nonstop campaigning by federal authorities and health organizations, most American smokers believe incorrectly that smokeless tobacco and e-cigarettes are as dangerous as cigarettes (hereand here).  Nine years ago I wrote in this blog: “In 2005, there were 1.4 million American men who were dual users of both cigarettes and ST [smokeless tobacco] products. These men consumed nicotine both from cigarettes and from ST, and the latter clearly resulted in lower consumption of the former. In both 2000 and 2005, every-day smokers who also used ST every day consumed significantly fewer cigarettes on average than exclusive smokers (13 cigarettes per day vs. 20 cigarettes). If these dual users knew that ST products were only 1% as hazardous as cigarettes, it is possible that many would have chosen to use only ST.” (here) 4. Can we revise labeling and indications for medicinal nicotine to increase quitting? Of course, but this question is unrelated to tobacco harm reduction.  Medicinal nicotine is regulated by the FDA Center for Drug Evaluation and Research, not the Center for Tobacco Products, and the former has been futzing and diddling around with medicinal nicotine for decades (here).  In 1995, the Pittsburgh Tribune-Review published my open letter to FDA commissioner David Kessler, urging him to make medicinal nicotine products more available to smokers (here). The FDA did nothing to make them more effective or more affordable. In February 2008, New York State Health Commissioner Richard Daines petitioned the FDA for revised package labeling and sales regulations for nicotine products – changes that would have greatly expanded product availability and consumer awareness. The petition was supported by numerous tobacco research and policy experts and organizations. The FDA failed to issue a response. 5. How might youth initiation be affected by the availability of different nicotine-containing products and how should we account for youth uptake of these products? Teenagers have always been attracted to adult-oriented products and adult behaviors.  Teens are drawn to tobacco and alcohol, which are illegal for those under 21; many teens use marijuana, which is illegal for all or age-restricted in the various states (here).  It is not uncommon for teens to drive cars and have sex, two adult behaviors that can be high-risk. Uniquely, tobacco use is regulated by a federal agency, the FDA, which now asserts that tobacco manufacturers are responsible for teen tobacco use.  Everyone has a role to play in limiting teenage risk-taking, but focusing blame on manufacturers while ignoring other regulatory and information-sharing solutions ill serves the entire population. October 24.  Clive Bates has just published his answers to Mr. Zeller's questions.  Please read them here. Original author: Brad Rodu
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Not All Teen Smokers & Vapers Are Lawbreakers

Sixteen percent of high school exclusive vapers in the 2017 National Youth Tobacco Survey (NYTS), or 184,000 out of 1.15 million, were 18 years of age or older, meaning that they could buy tobacco products legally.   Legal-age students also constituted one-quarter of high school smokers and 23% of dual users, according to the NYTS and shown on the chart at left.Legal-age students are themselves the most common source for e-cigarettes among underage students, as the following table shows.  The majority of underage students (74%) obtained e-cigarettes from family members, friends and others.  The next biggest source was vape shops (12%).  The Internet, which was singled out by FDA Commissioner Gottlieb in his recent announcement, was the source for fewer than 5% of underage vapers.   .nobr br { display: none } td { text-align: center} E-Cigarettes Sources for Underage High School Users, 2017SourceFriend64.0%Family member5.8%Other person4.0%Vape shop11.8%Internet4.7%Other retail3.6%Gas station/convenience store3.4%Mall kiosk1.4%Drugstore1.2%Grocery storeUnder 1%  Retailers must stop selling e-cigarettes to underage youths, and the FDA is responsible for enforcing that rule.  However, it is critical that regulators and the public address the fact that friends and family are the biggest contributors to underage use. N.B.  Thanks to Bill Godshall for suggesting this assessment.Original author: Brad Rodu
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The FDA’s Teen E-Cigarette-Addiction Epidemic Doesn’t Add Up

Commissioner Scott Gottlieb on September 12 announced an agency initiative to “address [the] epidemic of youth e-cigarette use” (here) and a teen-vaping-related “epidemic of addiction.”  He promised to use the FDA’s “civil and criminal enforcement tools” to reign in e-cigarette marketers. Dr. Gottlieb based his assessment on non-public data, but publicly available data from the 2017 National Youth Tobacco Survey (NYTS) does not show an epidemic.  The table at left displays the percentages of the estimated 14.9 million high school students who were “currently” using cigarettes and e-cigarettes, by number of days in the past month.  The numbers in each box represent the percentages of all high school students.  For example, 84.3% of students used neither product (boldtext, upper left).  Current users of e-cigarettes are in the red-bordered boxes.  The majority (60%) of current vapers used the products 5 or fewer days (green text) – the equivalent of trying products at a party.  In contrast, a minority (20%) of vapers used them 20-30 days (red text), which is suggestive of dependence.  Half of those were not using cigarettes (bold red text).  This means that in 2017, only 184,000 high schoolers (1.24% of 14.9 million) constituted the FDA’s e-cigarette-addiction epidemic. Original author: Brad Rodu
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Over 70 experts call on WHO to embrace technology innovation in the fight against diseases caused by smoking

October 1st, 2018

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FDA’s New Anti-Vaping Campaign Is a Misguided Clone of “Reefer Madness”

FDA Commissioner Scott Gottlieb on September 12 announced an FDA initiative to “address [the] epidemic of youth e-cigarette use.” (here)  Dr. Gottlieb misbranded teen vaping an “epidemic of addiction.”  The commissioner asked manufacturers of JUUL, Vuse, MarkTen, blu and Logic e-cigarettes to respond “to the FDA in 60 days with robust plans on how they’ll convincingly address the widespread use of their products by minors, or we’ll revisit the FDA’s exercise of enforcement discretion for products currently on the market.” Dr. Gottlieb added: “Let me be clear: Everything is on the table. This includes the resources of our civil and criminal enforcement tools.” The commissioner’s rationale and targeting for the threatened enforcement action appear to be grossly flawed. Dr. Gottlieb said he used “the word epidemic with great care,” but his statement that teen e-cigarette use is “almost ubiquitous” is simply wrong.  The chart at left, based on University of Michigan Monitoring the Future data, shows that e-cigarette use among high school seniors is only marginally higher than cigarette use, which has been declining for decades.  E-cigarette use pales in comparison with marijuana and alcohol, which are far more dangerous (hereand here). In his remarks, the commissioner used the word “danger” three times to describe teen nicotine and e-cigarette use.  This characterization is reminiscent of the “reefer madness” propaganda of the 1930s and beyond, which is well-chronicled in Mark Hay’s article, “A Brief, Paranoid History of Anti-Weed PSAs” (here).  Dr. Gottlieb’s attack on the four e-cigarette marketers may be misdirected, as FDA data show that only 10% of current teen users purchased e-cigarettes for themselves; the vast majority obtained them from social sources (here) – older siblings, friends and parents.  While elimination of underage tobacco use is an important objective, focusing the full force of the agency’s civil and criminal enforcement tools on manufacturers and retailers misses the target almost entirely. Original author: Brad Rodu
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“Third-Hand Vapor” Precautions Are Not Justified. Guest Post by Dr. Roberto Sussman

BR note.  Readers of this blog know that anti-tobacco activists greatly exaggerated the risks of second-hand smoke (here and here). Unfortunately, the scaremongering has expanded to include third-hand smoke (discussed here), third-hand smokeless (here) and third-hand vapor (here).   Two weeks ago another exaggerated “third-hand vapor” study was published by University of California activists.  For a perspective on this study, I am happy to introduce Dr. Roberto Sussman, a scientist (physics) in the Institute for Nuclear Research at the National Autonomous University of Mexico. Dr Sussman is also the director of Pro-Vapeo México AC, an all consumer non-profit association representing Mexican vapers and consumers of non-combustible nicotine delivery products, and an active member of INNCO.“Third-Hand Vapor” Precautions Are Not JustifiedBy Dr. Roberto Sussman  A recently published article (abstract here) seems to suggest potential health hazards from what could be called “third-hand vapor” in parallel to analogous studies on third-hand smoke. Specifically: the estimated exposure to electronic cigarette exhaled aerosol residues (ECEAR) deposited on surfaces and fabrics in rooms that are adjacent to a vape shop.   While it is worrying that the study of such extremely minute potential exposures to vapor residues may contribute to justify extensive vaping bans, the present comment only deals with strictly scientific (not political or activist) issues. Specifically, the following three issues are worth commenting: (1) E-cigarette vapor vs PM2.5.The article provides some background on possible health hazards from e-cig vapor. The following texts appear in the introductory section: Significant amounts of 1,2-propanediol, glycerin, nicotine and PM2.5 particles were present indoors during 2 hours of vaping. Moreover, an indoor air quality study showed that a large room with active EC users contained PM2.5 at concentrations that were higher than in hookah cafes and bars that allow cigarette smoking. .   The text conveys a sense of alarm, as it alludes to “PM2.5”  (particulate matter of diameters smaller than 2.5 microns) allegedly present in the e-cigarette aerosol. These particles are found in aerosols produced by combustion mechanisms, for example in air pollution or tobacco smoke. However, the text quoted above hints the existence of an equivalent concern on health effects from exposure to PM2.5found in environmental e-cigarette vapor.  This seems to be completely unwarranted, since the “particles” in electronic cigarette exhaled aerosol are liquid droplets, not proper particulate matter, even if “particle” counts and diameters are of the same order of magnitude as in environmental tobacco smoke. This is clearly stated in various reliable sources (for example, “Public Health Consequences of E-Cigarettes: a Consensus Report”,  National Academies of Sciences Engineering and Medicine, see page 72 of the report here.) I wonder why an article whose task is to look at potential exposures to pollutants in electronic cigarette vapor does not mention, as relevant background information for the readers, the fact that “particles” in the EC aerosol are chemically distinct (liquid droplets) from solid PM2.5 found in second hand smoke. It is an important fact, yet it is omitted.  (2) Accumulated fabric exposures are not realistic exposures in humans. The article mentions the possibility of potential exposure to toxicants by ingestion or dermic contact with ECEAR (electronic cigarette exhaled aerosol residues) deposited in cotton towels, paper towels and air filters.  However, no actual human exposures are measured or even estimated; only short and long term accumulated concentrations of deposited ECEAR in fabrics and filters placed in various fixed positions that can be in the path for continuous ECEAR deposition, for short and long term periods specified in Table 1. The results of this accumulated deposition are given in figures 2 and 3 in terms of dimensionless  quantities proportional to “1 ng (nanogram = 10-9 gm) per 1 gm of a fabric”, analogous to ppb (particle per billion) figures for concentrations in a gaseous medium.  To estimate actual human exposures to ECEAR, it would be necessary to estimate the time and fabric surface area in which human subjects are actually exposed (under realistic assumptions) to these accumulated concentrations. Under normal circumstances exposure times to pollutants by dermic manipulation or ingestion of these items is not continuous nor prolonged: people may ingest or dermically manipulate these items for brief intermittent time periods and along reduced mouth or skin contact surfaces.  The accumulated deposits of nicotine, alkaloids and nitrosamines can only be translated into actual human exposures under the extreme maximalist assumption of continued ingestion or dermic interaction for the same period in which the toxicants accumulated in the filters and fabrics that were placed to collect the substances in fixed spots. Realistic total human exposure will be much less because the actual ingestion or dermic interaction is short timed and intermittent and contact or mouthed surfaces contain few grams of fabric.  As an example, the article reports that “After 35 days in the field site, a cotton towel collected 4.571 micrograms of nicotine. If a toddler mouthed on 0.3 m2 [squared meters] or about 1 squared feet of cotton fabric from suite #1, they [sic]would be exposed to 81.26 mg [micrograms]of nicotine”.  From Table 1 and figure 2B this corresponds to sample SF35D, the quantity in the figure is 4571 ng per fabric gram, though 0.3 m2 is not a square foot but 3 square feet (3000 cm2). The reported area of 1 gm of cotton towel is 13.4 X 12.5 = 168.75 cm2, so that 3000 cm2 corresponds to 3000/168.75 = 17.8 gm of fabric, which multiplied times 4.571 mg per fabric gram yields the reported 81.25 mg of exposure to nicotine. However, this estimation is extremely unrealistic:  a toddler does not mouth a cotton towel for a long time, and 3 square feet is a huge fabric surface for a toddler to mouth! To understand how the authors obtained this quantity, we assume a constant deposition rate for 35 days in which the fabric sample SF35D was exposed to ECEAR. This means 135 ng per 1 gm of fabric per day, hence the total deposition for 0.3 m2 is 2.314 mg per day, and thus 81.25 mg of nicotine just exactly corresponds to 81.25/2.314 = 35.11 days of exposure to a continuous 35 days of ECEAR deposition. Hence, the authors assume that the 81.25 mg exposure to nicotine by a toddler mouthing 3 square feet is equivalent to a continuous 35 days exposure to nicotine by a 3 square feet surface area of the cotton fabric. This is wholly unrealistic and highly exaggerated; toddlers don’t mouth cotton fabric in this manner.    If we follow the authors’ estimate of nicotine exposure but apply more realistic toddler-mouthing times and fabric surface area, we get far smaller exposure figures. For example, a toddler mouthing only 1 gm of fabric (168.75 cm2) for one hour per day – still a gross exaggeration – is exposed to 5.41 ng of nicotine (130 ng per day/24). For 35 days we get 189.35 ng, not the suggested 81,250 ng.  Moreover, the assumption of one hour contact with 1 gm of fabric every day during for 35 days is still unrealistic. Under normal conditions the exposed items (towels and filters) do not sit statically in homes, shops and offices for such extended time periods, and their chemistry will change by interaction with multiple external agents, necessarily altering the deposited ECEAR amounts.  Filters are designed to trap pollutants, thus it is not surprising that they contain more ECEAR, but are touched and manipulated only for maintenance or for normal control/replacement operation (which takes seconds). Paper towels are disposable and cotton towels are periodically washed, so 81.25 mg of nicotine will never accumulate. As far as I am aware, the tobacco-specific nitrosamines (TSNAs) are the most worrying compounds in ECEAR, yet the detected exposure by fabrics and filters collecting ECEAR is really minute. Even long term, it is below 15 ng per 1 gm of cotton fabric, or about 0.42 ng per day. Assuming daily exposure comparable to this deposition rate and one hour of dermic manipulation of the towel yields a very minute exposure to TSNAs of 0.0175 ng.  I doubt that such a small hazard signal can be separated from the background noise.     (3) Does exhalation of large clouds release more nicotine?. The article states that 94-99% of nicotine is retained by the vaper (citing reliable sources), yet the authors mention that  “... the extent of nicotine exhalation depends on the user’s propensity to produce clouds of aerosol. In our real world study, nicotine generated by vape shop occupants reached suite #1 and contributed to ECEAR"    It is not evident that exhaling larger clouds releases more nicotine into the environment. True, a large cloud contains more mass of aerosol, and thus more nicotine, but exhaling large clouds also requires deeper inhalation, which would likely produce larger nicotine deposition in the respiratory system. It is not obvious that this could compensate the larger mass of exhaled aerosol + gas phase.   Excessive usage of the precautionary principle. The article concludes with this statement: “Building codes will need to be developed and enforced to protect those who do not wish to be exposed to ECEAR. Vape shop air quality is not currently regulated nor has it been thoroughly studied. Regulatory agencies should exercise authority over malls to ensure that employees and tenants do not receive unwanted exposure to EC aerosols and its residues”. The results and actual measurements in this report were from exposures to static fabrics and filters, not realistic exposures to real people.  So the authors’ recommended regulations are excessive and unfounded.Original author: Brad Rodu
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