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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.

Pediatrics Journal Ignores Its Stated Editorial Standards


The journal Pediatricsin March published an article by University of California San Francisco’s Benjamin Chaffee, Shannon Lea Watkins and Stanton Glantz claiming that e-cigarettes lead to smoking. The claim was baseless; the authors ignored subjects’ past smoking activity, as I explained in an earlier blog post (here). On March 15, I submitted a comment to the journal with a re-analysis of Chaffee’s data using the omitted variable and demonstrating the invalidity of Chaffee’s claim.  On the basis of this flaw, I requested retraction of the article.  Our comment was published on the Pediatrics website March 30, along with a response from Chaffee et al. that further validated a retraction (here).  Their response included an attack on my independence, veracity and transparency.  Clive Bates, David Sweanor, David Abrams and Raymond Niaura endorsed our analysis in an April 11 comment, labeling Chaffee’s response “inadequate, disappointing and surprising.”  They pointed out that it was “disappointing because the authors, apparently with the approval of the journal, have resorted to an ad hominem attack on Rodu and without showing any improper conduct or incomplete disclosure.”  I had responded to the attack by Chaffee et al. with an email to the Pediatrics editors on April 9: “Chaffee et al. stated that my ‘financial ties to the tobacco industry are much more extensive than the posted disclosures suggest.’ This is false, defamatory and potentially libelous on two accounts, alleging that I made an inadequate disclosure, and that I have more ‘financial ties.’ My disclosure was accurate and complete. In addition, the website they cited contains no supporting evidence for their allegation, because I have no other financial ties or conflicts of interest. The journal has specific policies prohibiting both defamatory/libelous comments and weblinks. These policies also provide guidance for your immediate attention to this matter.” (here) On or about April 24, Pediatricspublished a revised response from Chaffee et al.  Their fictitious claims about “financial ties” had disappeared, but the revised text carried the same date as the authors’ original comment.  The editors failed to indicate a correction had been made, and that erroneous and disparaging remarks had been removed.  The editors had allowed the libelous statements to remain on the journal site for nearly a month; the offending remarks are still available elsewhere on the Internet (here). The editors violated the journal’s stated policy: “Once a comment has been posted on the website, you will not have the right to have it removed or edited… Be sure to follow all of the consideration criteria below; you will not be able to modify your comment after submission.” (emphasis in original) Compounding this journalistic failure, the editors encouraged Clive Bates and colleagues to edit their published comment and delete language countering Chaffee et al.’s defamatory remarks.  When Bates did not immediately comply, the editors deleted the entire Bates comment.  However, it is still available here. Journal editors Drs. Lewis First (University of Vermont), Alex Kemper (Nationwide Children’s Hospital, Columbus Ohio) and Mark Neuman (Harvard) owe Pediatrics readers full compliance with their journal’s editorial standards, including a detailed correction notice and republication of the full text of the Bates et al. comment. Original author: Brad Rodu
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Poison Control Centers' Data Puts E-Cigarette Exposure Risk in Perspective


The journal Pediatricsrecently reported that “there were more than 8,200 calls to US poison centers regarding exposures to liquid nicotine and e-cigarettes among children younger than 6 years of age from January 2012 through April 2017, averaging 129 calls each month or more than 4 a day.” (here) As I previously noted (here), annual exposures (which were 1,548 according to the Pediatrics article) should be considered in appropriate perspective.  While the journal article acknowledged that e-cigarette exposures “decreased by about 20% from 2015 to 2016,” its senior author called for additional regulation.  If children’s exposure to products should guide regulatory priorities, the following chart from the American Association of Poison Control Centers (2016 report available here) may be instructive..nobr br { display: none } td { text-align: center} Non-Pharmaceutical Exposures Reported To Poison Control Centers in the U.S., 2016Product CategoryNumber Among Children Under 6 YearsNumber Among All AgesDeaths Per 100,000 Exposures*Cosmetics, personal care products136,004180,0653Household cleaners111,445179,82813Foreign bodies65,86490,6671Pesticides33,45877,57322Plants27,56545,15024Arts, crafts, office supplies20,09627,3190Deodorizers17,39821,26614Essential oils (clove, etc.)13,26418,9970Tobacco11,35813,3190Cigarettes6,3316,699--E-Cigarettes2,0752,827--Chewing tobacco1,2201,357--Other1,7322,436--Foods, additives, spoilage10,83933,9099Alcohols9,56222,289117Chemicals9,32833,91080Gasoline, other hydrocarbons8,82127,80776Bites, venom6,70846,98915Paint, strippers6,60112,2380Batteries5,4839,65141Adhesives, glue4,6929,6220Fumes, vapors3,67331,337214Fertilizers2,7594,59080Other35,85994,02444All540,777980,55026* All AgesOf the half million exposures among children under 6 years of age recorded by poison control centers in 2016, 45.8% involved cosmetics, personal care products or household cleaners, while e-cigarettes accounted for just 0.4%.  Looking at product-related deaths per 100,000 exposures, rates were highest for fumes and vapors (which included carbon monoxide) and for alcohols, but there were no deaths recorded for tobacco exposures, including e-cigarettes.Public health generally and children’s health in particular may benefit from regulatory reform that is keyed to demonstrated risk exposure.Original author: Brad Rodu
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The urge to ban: 10 questions to ask first

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Original linkOriginal author: Clive Bates
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FDA Blocks Consumer Access to New Smokeless Products


When Congress gave the FDA regulatory authority over tobacco in 2009, it specified that manufacturers wanting to sell a new product must get a “substantial equivalence” (SE) order demonstrating to the FDA that the product has the “same characteristics as a predicate tobacco product [i.e. on the market before February 15, 2007]; or has different characteristics than the predicate tobacco product but…does not raise different questions of public health.” (here) Copenhagen brand moist snuff has been available in the U.S. since 1822.  The U.S. Tobacco Company (UST) had 17 different styles of the brand, including 5 pouches and 4 with wintergreen flavoring on the market in 2007. It's worth examining UST's SE application submitted on November 13, 2015 for a variant to be called Copenhagen Bold Wintergreen Pouches.  According to the Troutman Sanders law firm blog (here): “The Copenhagen Bold [WG Pouches] SE submission compared the new product, a portioned smokeless tobacco in pouches with a grandfathered product in the same format (pouched smokeless tobacco) but containing different tobacco.  UST had considered using a different grandfathered product – a loose tobacco product with the exact same blend and formula as Copenhagen Bold – but the FDA discouraged UST from doing so because the grandfathered product was in a different format.  At the FDA’s suggestion, UST designated the grandfathered loose tobacco product with the exact same tobacco blend and formula as Copenhagen Bold as a ‘surrogate’ product.” Despite the company’s acquiescence in using its loose wintergreen snuff as the predicate product, the FDA denied the SE on July 13, 2017.  UST’s appeal of that decision was denied by the agency on January 2, 2018. The company sued the FDA on February 2, seeking to overturn the agency’s action. The filing is available here. This lengthy, so far futile attempt to gain marketing approval for a simple variation of a moist snuff product that is associated with nearly zero health risks underscores the broken state of the FDA review process. To be clear, my criticism of FDA is not intended to further the interests of any company, but rather to advance the health interests of American smokers who should be encouraged to switch to safer smoke-free cigarette substitutes. Limiting the market entry of potentially attractive cigarette alternatives reduces the chance that smokers will give up their dangerous habit. Original author: Brad Rodu
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FDA Is Targeting E-Cigarette Retailers, But They’re Not Teens’ Primary E-Cigarette Source


FDA Commissioner Scott Gottlieb reportedlytestified at a House Appropriations subcommittee April 17 about “excessive use of e-cigarettes among youths…Gottlieb said the FDA will crack down on youths' use of e-cigarettes in the coming weeks.  ‘We are going to take some vigorous enforcement steps to try to perceive what we see is inappropriate use by youth,’ Gottlieb said, refusing to elaborate on when the action will happen.  The agency has several avenues for targeting retailers that are selling to minors.  Those include a warning letter, massive fines, or banning the retailer from selling any tobacco or e-cigarettes.”A common theme among e-cigarette prohibitionists is that the protection of children justifies all forms of regulation.  Beyond that, the commissioner’s remarks are undercut by the fact that only a small percentage of children have tried e-cigarettes, and only a tiny fraction of those youths bought c-cigarettes from retailers.  Support for this is seen in the FDA’s Population Assessment of Tobacco and Health (PATH) survey.  The PATH youth survey collected detailed information about tobacco use from 13,628 participants age 12-17 years in 2013-2014.  Based on the survey’s sophisticated weighting formula, the figures below are estimates for 25 million teens across the U.S.The data reveal that about 2.6 million teens had ever used an e-cigarette in 2013-14.  Of these, about 771,000 had used e-cigarettes in the past 30 days – the widely accepted definition of “current” use among youth and consistent with another federal survey of teen tobacco use (discussed here).  This means that there were far fewer current e-cig users in PATH than currently used alcohol (1.83 million) or marijuana (1.24 million), which is also consistent with other federal surveys (discussed here).Current e-cig users were asked: “In the past 30 days, how did you usually get your own e-cigarettes/cartridges and e-liquid?”  Here are the results:.nobr br { display: none } td { text-align: center} PATH Survey: How Did You Get Your E-Cigarettes?HowNumber of teensPercentageSomeone offered me one353,70046%Gave someone else money to buy them126,50016%Bought them myself75,7009.9%Asked someone to give me one73,7009.7%Got them some other way52,5006.9%Took them from a store or another person31,6004.1%Bought them from another person24,7003.2%Don’t know, refused to answer32,4004.2%All770,800100%The table shows that only 10% of current teen users, about 76,000, bought e-cigarettes for themselves.  In other words, while the FDA and other government agencies pursue vaping manufacturers and retailers, the vast majority of teens get e-cigarettes from unregulated sources.  Of course, even more teens use alcohol, which is only sold to adults age 21+ years, and marijuana, the sale of which is legal to adults only in limited states.Original author: Brad Rodu
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Another UC San Francisco E-Cigarette Gateway Claim, Based on Tiny Numbers


Last week I called for retraction of a flawed study by University of California San Francisco’s Benjamin W. Chaffee, Shannon Lea Watkins and Stanton A. Glantz that appeared in the journal Pediatrics (hereand here).  Once again using the FDA Population Assessment of Tobacco and Health (PATH) survey, the same authors exaggerated the gateway effect of e-cigarettes, hookah and smokeless tobacco in a January JAMA Pediatrics article (here).  I criticized at that time the omission of information that would have provided context for their findings (here).  The exaggerations were amplified in the media.In an interview with National Public Radio (here), Dr. Watkins failed to note the minuscule numbers used in her study to support the gateway claim.  I have inserted those numbers in bold in her quote, here:“We found that kids who tried e-cigarettes [n=11] or hookah [n=8] or smokeless tobacco [n=3]or cigars [n=7] – any noncigarette tobacco product – were all twice as likely to try cigarettes a year later compared to kids who hadn’t used any of those other tobacco products [n=175].  Kids who were using two or more noncigarette products [n=15] were four times as likely to report using cigarettes a year later.” (I have confirmed these numbers in the FDA data; they are in the table below)Dr. Watkins added the extraordinary claim that trying one tobacco product changes one’s perception of cigarettes: “Using these products might change a kid’s perception of the harm of cigarettes, and so they are perceived as less dangerous and they get used to using tobacco and so using conventional cigarettes is not so scary or ‘bad’.”In her view, trying a tobacco product causes one to change friends: “It will expose them to different kinds of kids, maybe kids that are already using conventional cigarettes, and then they might go on to try them.”Instead of sharing her conjecture on how e-cigarettes led 11 children to begin smoking, Dr. Watkins should have focused on the fact that 80% of the 219 new smokers [n=175] in her study had not previously used any tobacco product..nobr br { display: none } td { text-align: center} Odds Ratios And Numbers of Teens Smoking Cigarettes After One Year, According to Ever Tobacco Status at BaselineEver Tobacco Status- Baseline (n)Odds RatioNumber Smoking At One Year (%)Never tobacco use (9,058)Referent175 (79.9)E-cigarettes (255)2.1211 (5.0)Hookah (189)2.158 (3.7)Other combustible (114)3.087 (3.2)Smokeless tobacco (93)1.533 (1.4)Two or more products (200)3.8115 (6.8)All (9,909)219 (100)Original author: Brad Rodu
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The US media is losing its mind over vaping and Juul – the questions a credible journalist should ask


April 9th, 2018

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Ten perverse intellectual contortions: a guide to the sophistry of anti-vaping activists







This puts it nicely:

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UC San Francisco Authors Inadvertently Validate Our Call for Retraction



In the previous post I described fatal flaws in a study by University of California San Francisco’s Benjamin W. Chaffee, Shannon Lea Watkins and Stanton A. Glantz in the journal Pediatrics(here).  Their published response (here) validates my criticism. Chaffee et al. correctly observed that I have frequently challenged flawed research, and they kindly provided three examples of my published letters to editors of scientific and medical journals.  My professional blog is replete with fact checks of published claims by federal officials (here, here, here, here, here, here) and government-funded researchers (here, here, here, here, here, herehere, here) that e-cigarettes are a gateway to teen smoking.  My criticism has extended to research published by UCSF faculty (here, here, and here) The recent Pediatricsanalysis by Chaffee et al. showed that teen e-cigarette users in the Wave 1 FDA Population Assessment of Tobacco and Health (PATH) survey had higher odds of consuming 100+ cigarettes or past 30-day smoking one year later at follow-up.  I noted that the authors ignored important information about lifetime cigarette consumption (LCC), from as little as “1 puff but never a whole cigarette” all the way to having smoked 99 cigarettes.  When my research team applied LCC data to Dr. Chaffee’s analysis, his positive results for an e-cigarette “gateway” essentially disappeared.  In response, Chaffee et al. called our addition of the LCC information a “statistical trick.”  By using that term, it appears that they believe, incorrectly, that the LCC variable is an outcome rather than a confounding factor.  Inexplicably, they described our analysis as “akin to suggesting that a study of hypertension should adjust for confounding by systolic blood pressure.”  In this, Chaffee et al. prove our case.  Let’s say we are studying the effect of dietary salt consumption on development of hypertension (systolic blood pressure, bp >140 mm) after one year of follow-up among participants who were not hypertensive at baseline (that is, they had a systolic bp = 90 to 139 mm).  If someone has a baseline bp of 139 mm, it is much more likely that they will have a bp of >140 mm after one year, compared to a person who had a baseline bp of 90.  It would be negligent to blame salt for causing hypertension while completely ignoring baseline systolic bp values in this example.  The same principle applies to Dr. Chaffee’s e-cigarette study.  The chart below clearly illustrates the large differences in LCC that Chaffee et al. ignored between never e-cigarette users and past 30 day users or triers. It is negligent to ignore cigarette consumption at baseline while placing all the blame for smoking one year later on e-cigarette use.  The Chafee article must be retracted.  Original author: Brad Rodu
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Retract the UC San Francisco E-Cigarette “Gateway” Study


Some published articles are so flawed that they deserve retraction.   A case in point is the Pediatrics article by University of California San Francisco's Benjamin W. Chaffee, Shannon Lea Watkins, and Stanton A. Glantz (here) that features a totally baseless claim: “Among adolescent cigarette experimenters, using e-cigarettes was positively and independently associated with progression to current established smoking.”  Using Wave 1 of the FDA Population Assessment of Tobacco and Health (PATH) survey, Chaffee et al. define teen experimental smokers as having smoked “in your entire life” anywhere from “1 or more puffs but never a whole cigarette” up to 99 cigarettes.  They divide experimental smokers into three groups according to e-cigarette use: never users, past 30-day users and ever triers.  In their analysis, controlling for numerous variables, e-cigarette users at Wave 1 had higher odds of having consumed 100+ cigarettes or having smoked in the past 30 days at follow-up one year later. The findings and the claim are false. In their analysis, the authors ignore the fact that their study group consisted entirely of experimental smokers with widely varied experience – one or more puffs but never a whole cigarette, one cigarette, 2-10, 11-20, 21-50 and 51-99 cigarettes.  Using the PATH data, my research team reproduced Chaffee’s analysis and Pediatrics published our results online (here).  The table we submitted to the journal was published in an unreadable fashion, so we offer it here..nobr br { display: none } td { text-align: center}Odds Ratios (95% Confidence Interval) for Smoking Outcomes in the Wave 2 PATH Survey, According to E-Cigarette Use at Wave 1MetalChaffee’s ResultsBR-NPBR-NP + Wave 1 LCCOutcome: Smoked 100+ CigarettesNever E-CigReferentReferentReferentE-Cig Past 30 Days2.56 (1.58 – 4.14)2.60 (1.61 – 4.19)1.21 (0.69 – 2.13)E-Cig Trier2.13 (1.43 – 3.18)2.16 (1.46 – 3.22)1.45 (0.88 – 2.38)Outcome: Smoked Past 30 DaysNever E-CigReferentReferentReferentE-Cig Past 30 Days2.29 (1.64 – 3.19)2.12 (1.52 – 2.96)1.41 (0.998 – 2.00)E-Cig Trier1.56 (1.15 – 2.12)1.43 (1.05 – 1.95)1.09 (0.78 – 1.52)Outcome: Smoked 100+ Cigarettes and Smoked Past 30 DaysNever E-CigReferentReferentReferentE-Cig Past 30 Days2.56 (1.52 – 4.32)2.55 (1.51 – 4.31)1.32 (0.75 – 2.30)E-Cig Trier2.41 (1.46 – 3.97)2.45 (1.49 – 4.03)1.70 (0.96 – 3.01)BR-NP, Rodu-Plurphanswat reproduction of Chaffee et al. odds ratios  When we added lifetime cigarette consumption (LCC), the positive results for e-cigarettes essentially disappeared, negating Chaffee’s core claim.  It is well established that past smoking (in this case, LCC at Wave 1) predicts future smoking (one year later).  Chaffee, Watkins and Glantz ignored this information in order to claim that e-cigarettes are a gateway to smoking.  Their study should be retracted.   I will review in my next post Chafee’s published response to our comment. Original author: Brad Rodu
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Instead of Greenlighting IQOS Sales, FDA Continues to Slow-Walk Safer Cigarette Substitutes


The introduction of heat-not-burn cigarette substitutes in Japan has led to a precipitous reduction in cigarette consumption.   Tobacco industry analyst Michael Livery of Piper Jaffray recently issued a report on the Japanese market, citing 2017 sales data. The chart at left suggests that Philip Morris International’s IQOS heat sticks (green) and BAT’s Glo products (blue) caused a 13% decline in cigarette consumption for the year.  Livery deliberately underestimated the number of heat sticks sold because of evidence that up “to 20% (4th Quarter 2017) of iQOS HeatStick volumes…is getting re-sold in China, Thailand, and Hong Kong, and likely other parts of Asia.” I suggested (here) that a similar result could be possible in the U.S., if the FDA grants marketing approval for such products. The agency, however, appears to be in no rush to make a decision. Philip Morris submitted a premarket tobacco application (PMTA) to the FDA on March 31, 2017; it has been pending ever since. According to the FDA (here), if a PMTA is accepted and found to be complete, the agency will file it and begin substantive review.  “After completing its review, FDA intends to issue an order within 180 days after receipt of the Premarket Tobacco Application that the new product may or may not be introduced or delivered for introduction to consumers.” (emphasis added) The FDA took eight months to grant Swedish Match a PMTA for eight snus products in 2015 (here).  This week marks the twelfth month of FDA consideration of the IQOS PMTA submitted March 31, 2017. It is often said that regulation is a slow, deliberate process.  But in this instance the FDA is in apparent violation of its own procedural guidelines.  The FDA simply slow walks any decision on safer options for smokers: it took 2.5 years (here) and 4 years (here) to reject requests to correct inaccurate smokeless tobacco warnings.  All of these are examples of regulatory purgatory that I warned about six years ago (here).  Our country’s smokers and their loved ones deserve better.Original author: Brad Rodu
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Kentucky Tobacco Taxes: The Rest of the Story


Kentucky’s tobacco opponents are furious.  Their coalition crusaded for big tax increases on all tobacco products, but the State House of Representatives instead passed a 50-cent tax increase on cigarettes and left chew/dip products and e-cigarettes alone.  That is in keeping with the rational tax plan (here) authored by me, released by the Pegasus Institute last Fall and supported by 16 tobacco research and policy experts from Kentucky and across the U.S. Coalition member Al Cross objected in a March 2 commentary in the Louisville Courier-Journal that we “didn’t know or tell the whole story.”  He is wrong, and here’s why. Cross implied that our proposal was linked to tobacco companies, alleging, “It appears that tobacco companies ‘came out with the 50-cent proposal to kind of blunt the effort to go to a dollar or higher,’ said Ben Chandler, president of the Foundation for a Healthy Kentucky.” This is false.  Tobacco companies had nothing to do with our proposal; it was the result of years of work in the field of tobacco harm reduction and health economics.  I first described this approach in the Tallahassee Democrat15 years ago (here).  We based our current Kentucky tax plan on a 2015 article in the New England Journal of Medicine written by three prestigious tobacco policy experts.  Two of them supported our proposal, along with fourteen other experts.  Cross’s article contained inconsistent statements.  He claimed that “50 cents more a pack wouldn’t be a big hit for most smokers,” but then wrote, “The big hit would be felt by lower-income people, who are more likely to be smokers.”  Chandler was even more insensitive: “you’ve got to have the sticker shock…”    Indeed.  We acknowledged that even a 50-cent increase “could present a severe financial challenge to Kentucky smokers, many of whom have only limited resources.”  We made it clear that we are not interested in punishing smokers; our cigarette tax increase is not meant to force them to quit.  Instead, we “encourage and incentivize smokers to quit or switch to less expensive and vastly safer smoke-free tobacco products” like smokeless tobacco and e-cigarettes.  Decades of epidemiologic studies document that the health risks of dipping and chewing tobacco are, at most, a mere two percent of those of smoking.  Unlike cigarettes, smokeless tobacco does not cause lung cancer, heart and circulatory diseases or emphysema.  A recent government-funded study conducted by federal researchers and experienced epidemiologists found that men who dip or chew tobacco have no excess risk for mouth cancer (here).     Kentucky men will be especially interested in this information.  Federal survey data shows that 226,000 dip or chew tobacco, 90,000 of whom also smoke.  These dual users don’t know that smokeless is vastly safer; our proposal gives them information and a financial incentive to escape the smoke.  Tax policy should encourage smokers to switch to e-cigarettes, which already are among the most common – and the most successful – quit aids in the U.S. (here).  While federal health agencies demonize these devices, United Kingdom government and health organizations endorse them based on solid science.  The prestigious British Royal College of Physicians has stated, “…the hazard to health arising from long-term vapour inhalation from the e-cigarettes available today is unlikely to exceed 5% of the harm from smoking tobacco.”  Britain’s Department of Health last year formally endorsed the substitution of e-cigarettes by smokers. Cross wrote that “Smoking-related health costs in the state are near $2 billion a year.”  We address that concern: “Federal and state spending for Medicaid in Kentucky for fiscal year 2016 was $9.66 billion; smoking was responsible for $1.47 billion. The only way for the Commonwealth to lower these high costs is to provide every option for smoking cessation, including vastly safer cigarette substitutes.” Cross mentioned “retailers along the state’s border who sell lots of cigarettes to people from states where the taxes are higher.”  We addressed that by trying to “correct cross-border discrepancies in cigarette excise taxes affecting large populations across the Ohio and Indiana borders, and avoid creating other significant cross-border discrepancies.” (emphasis added) It is well documented that traditional quit-smoking methods, which strive for complete nicotine and tobacco abstinence, fail to help over 90% of smokers.  Kentucky Medicaid currently spends millions on expensive and failure-prone FDA-approved stop-smoking medicines (nicotine patches, gum, lozenges, bupropion, varenicline, and nasal spray and inhalers).     Our tax proposal offers a superior approach, at no additional cost to the commonwealth.  It incentivizes smokers to switch to smokeless tobacco or e-cigarettes.  The Senate should have acknowledged the substantial health risk differentials between combustible and smoke-free tobacco products, and endorsed the House bill.  Smokers who switch will spend less, and live longer, healthier lives.  Original author: Brad Rodu
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Looking back, but forwards too – guest posting by Louise Ross


Out there, on your side – Louise Ross puts the public back into public health

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Smokers Deserve Improved FDA E-Cigarette Regulation: Pass Cole-Bishop


It’s no secret: E-cigarettes are vastly safer, increasingly popular and successful substitutes for traditional tobacco cigarettes.  More and more smokers are replacing combustible tobacco with vapor technology to reduce their health risks (here), or even to ultimately eliminate their nicotine consumption.  This is a particularly important development for my home state Kentucky, where smoking and lung cancer rates are among the highest in the country. Unfortunately, government bureaucrats, dreaming of a tobacco-free society (read: prohibition), are trying to condemn the emerging e-cigarette industry to regulatory purgatory. The FDA’s plan to retroactively enforce cigarette-style regulations on vapor could decimate e-cigarettes, which are cigarettes’ greatest potential adversary.  Cigarettes burn tobacco, creating smoke that contains thousands of harmful toxins. Vaping products, on the other hand, heat e-liquid into an aerosol.  They eliminate combustion, which significantly reduces toxic byproducts.  Many e-cigarettes don’t even contain nicotine.   E-cigarettes barely existed in 2009 when Congress passed the tobacco legislation that the FDA is trying to retro-fit to vapor.  Furthermore, the agency interpreted the law to require that any e-cigarette or vapor product not on the market in February 2007 – in other words, every product on the market today – pass an onerous, expensive and time-consuming review.  Similar regulatory hurdles would apply even when a manufacturer only wants to upgrade a battery, develop a new e-liquid or make even minor improvements.  E-cigarettes are among Americans’ most commonly used quit-smoking aids. In fact, they are the only aid more likely to make one a former smoker (that is, a successful quitter) than quitting cold-turkey, according to an analysis I recently published using FDA survey data (here and here).  Without these products, smokers face a difficult choice: try FDA-approved smoking cessation products that have a documented 93% failure rate, go cold turkey, or remain a smoker.  FDA regulation should not subject smokers to such a quit-or-die predicament when alternatives like e-cigarettes are available. Congress must intervene in the interest of public health, by passing the Cole-Bishop Amendment, which contains provisions to ensure that smokers across the U.S. continue to have access to safer cigarette substitutes.    The Cole-Bishop Amendment would grandfather products that are already on the market.  It supports consumer safeguards such as manufacturing standards and accurate product labeling. Bottom line: Cole-Bishop provisions recognize the scientific and technological differences between vapor and smoke and the significant differences in their risk profiles.  It has broad consumer support, including a coalition of sixteen center-right public policy organizations and think tanks (here) and all major vaping groups. Vapor products represent a vital “fire escape” for millions of inveterate smokers. FDA regulations should not make it more difficult for people to stop smoking, and stay smoke-free.  Original author: Brad Rodu
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Public health experts rally to support US legislative initiative on vaping


March 13th, 2018

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Beyond the Headlines: Trace Toxins, Present in All Teens, Improperly Blamed on E-Cigarettes


The University of California San Francisco publicized a study on March 5, asserting that “Adolescents who smoke e-cigarettes are exposed to significant levels of potentially cancer-causing chemicals.” (here)  The study’s lead author, Mark Rubinstein, M.D., said, “Teenagers need to be warned that the vapor produced by e-cigarettes…actually contains some of the same toxic chemicals found in smoke from traditional cigarettes.”This led to messaging that vaping is just as dangerous as smoking -- “Teens Using E-Cigarette Have the Same Toxic Chemicals Found in Smokers” (here), “E-Cigarette Users Ingest High Levels of Cancer-Causing Chemicals” (here).In fact, the research, published in Pediatrics, analyzed urine, not vapor.  The study reports the presence of minute amounts of volatile organic compounds (VOCs) in the urine of teens who didn’t smoke or vape (i.e., controls), e-cigarette users, and dual users of e-cigarettes and cigarettes. Here are the study results:.nobr br { display: none } td { text-align: center} Median VOC Levels (ng/mg*) in the Urine of Controls, E-Cig Users and Dual UsersParent CompoundControlsE-Cig UsersDual UsersBenzene000.2Butadiene000Ethylene Oxide1.30.51.0Acrylonitrile01.359Acrolein193254440Propylene Oxide152940Acrylamide3567236Crotonaldehyde100149185*ng/mg = parts per MILLION (creatinine)Significantly, there were no cigarette smokers in the study.  Existing research tells us that their VOC levels would have been far higher, undercutting the UCSF anti-e-cigarette narrative. Note that there are no alarming elevations in benzene or butadiene, and levels of ethylene oxide were actually lower among users than controls.  This data indicates that teens virtually no exposure to these chemicals.While levels of other agents are higher in e-cigarette users and especially in dual users, levels in controls are not zero.  The authors are on shaky ground in their attribution of higher toxin levels among e-cigarette users to the vapor.  A previous study (co-authored by one of the current authors, here) that they cite failed to find any acrolein and crotonaldehyde in vapor from 12 e-cigarettes.  A Centers for Disease Control and Prevention study (here) found that nonsmokers’ urine had up to 245 ng/g of acrolein and up to 158 ng/g of propylene oxide (smokers had far higher levels of both).  Thus, toxin levels seen in e-cigarette users in the new UCSF report are not necessarily due to vapor.The UCSF research ignores a possible alternative source of these contaminants: recent marijuana smoking, as shown in a CDC study that identified elevated VOC levels among tokers (here).  As I recently noted (here), marijuana use is more prevalent among teens than vaping or cigarette smoking; data from one federal survey shows that about 40% of teen vapers are current marijuana users.  These findings increase the odds that toking impacted results in the new study.The UCSF research was supported by four grants totaling some $32 million from the National Institutes of Health to authors Rubenstein, Neal Benowitz and Stanton Glantz.  Original author: Brad Rodu
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Foundation for a Smoke-Free World and the mindless mob behaviour of tobacco control



An update from the World Conference on Tobacco or Health, Cape Town

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Tobacco control and the tobacco industry – a failure of understanding and imagination



What about the war on disease and premature death? They just aren’t the same thing.

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Beyond the Headlines, E-Cigarette Vapor Has Only Trace Amounts of Metals


The American media have been obsessed with a new study (here)claiming that “e-cigarettes are a potential source of exposure to toxic metals (chromium, nickel, and lead), and to metals that are toxic when inhaled (manganese and zinc).” The headlines misrepresent or overdramatize the facts:       “E-Cig Vapors May Contain Brain-Damaging Toxic Metals, Says New Study” Tech Times “E-Cigarette Vapor Filled With Dangerous Toxins Like Lead, Study Finds” Newsweek “E-cigarettes leak toxic metals, study finds” Medical News Today “Are E-Cigarettes Safe? Alarming Levels Of Metal Found In Its Heating Coils” International Business Times The research, published in the journal Environmental Health Perspectives, was authored by faculty at Johns Hopkins University, Columbia University, and the Universities of Granada (Spain) and Graz (Austria).  They reported the metals’ median levels and range (from the 25th to the 75th percentile) in 56 e-cigarette devices’ aerosols.  All values are in micrograms (ug, one-millionth of a gram) of metal per kilogram (kg, one thousand grams) of vape aerosol.  For reference, there are 454 grams in a pound.  The following table shows how much liquid an e-cigarette user must vape per day to exceed either the FDA’s daily exposure limit for inhaled medicines (here), or the CDC’s minimal risk levels (MRLs) for workplace inhalation (here).  I used the upper level (75thpercentile) of the range, so the results below are not underestimates.  .nobr br { display: none } td { text-align: center}Maximum Levels of Metals in E-Cigarette Vapors, and Amount of Liquid Used Daily to Exceed FDA Maximum Levels for Inhaled Medicines And/Or CDC Minimal Risk Levels (MRLs)MetalMaximum Vapor Level (ug/kg)Daily FDA Maximum or CDC MRL* (ug)Volume of Vaping Liquid Exceeding FDA Max or CDC MRL*Aluminum22.2NA--Cadmium0.13215.4 LITERS0.136*1.1 LITER*Chromium43.9368 millilitersCopper51.030588 millilitersIron23.6NA--Manganese9.564.08*427 milliliters*Nickel289517.3 millilitersLead37.15135 milliliters30*808 milliliters*Antimony1.932010.4 LITERSTin19.4603.1 LITERSZinc809NA-- NA, not available One thing is crystal clear: an e-cig 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.  Nickel is an outlier because at a high 75thpercentile value (289 ug/kg), the exposure limit is 17 milliliters (the typical vaper uses 10 milliliters or less daily).  However, the median value for nickel in all samples was much lower (6 ug/kg), meaning that users could consume 800 milliliters before reaching the recommended exposure limit. The authors emphasize that some of these metals, notably cadmium, chromium, nickel and lead, are toxic.  However, they fail to mention that toxicity is proportional to dose and duration.  The metal doses delivered by e-cigarette liquids in this study are trivial. Note: Thanks to Dr. Konstantinos Farsalinos, a researcher at the Onassis Cardiac Surgery Center, the University of Patras and the National School of Public Health in Greece, for his expert assistance with this entry. Original author: Brad Rodu
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Federal Officials, Please Pay Attention to Federal Surveys: E-Cigarettes Are Not Gateway Products


I noted in 2013 that the CDC director’s claim – that “many kids are starting out with e-cigarettes and then going on to smoke conventional cigarettes” – was pure gateway speculation (here).  Youth surveys had just started collecting information that teens were using e-cigarettes, but there was zero evidence that they were “going on to smoke.” In January I presented data from the CDC’s National Youth Tobacco Survey showing that e-cigarette experimentation since 2011 did not produce an epidemic of teen smoking (here).  The 2017 Monitoring the Future survey, illustrated in the chart at left, provides further evidence of a steady decline in cigarette smoking among high school seniors.  In 2017, the smoking rate in MTF dropped below 10% for the first time in history.  At 9.7%, the rate is almost half that of 2011 (18.7%), while the vaping rate remained at 16-17%.  Meanwhile, high school seniors used alcohol and marijuana at far higher rates than cigarettes (33% and 23% respectively).  Nineteen percent of seniors reported being drunk in the past month. MTF vaping data in 2014-2016 didn’t specify the liquids used; in 2017 MTF collected information on non-specific vaping and vaping nicotine and marijuana in the past month.  Nonspecific vaping, illustrated by the green line in the chart, was around 16%, nicotine vaping was 11%, and marijuana vaping was 4.9% in the past month. Federal officials are still obsessed with the vape-to-smoke gateway, despite virtually no evidence.  FDA Commissioner Scott Gottlieb recently tweeted a warning: “The [e-cigarette] industry isn’t sustainable if it leads to a whole generation of youth initiation on tobacco.” (here)  I tweeted a reply urging Dr. Gottlieb to look at his agency’s data from the “…PATH survey of 9,909 never-smoking teens. One year later, 219 (2.2%) had smoked in past 30 days. All awful, but 175 (80%) had no prior tobacco product use; only 11 had used e-cigs. FDA data shows vaping not major gateway to teen smoking [here].” (emphasis added) Federal officials should stop claiming that vaping is a gateway to smoking, because evidence is absent in all federal surveys. Original author: Brad Rodu
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