(828) 698-5795 

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.

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
  767 Hits
  0 Comments

Looking back, but forwards too – guest posting by Louise Ross


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

Continue reading
  566 Hits
  0 Comments

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
  662 Hits
  0 Comments

Public health experts rally to support US legislative initiative on vaping


March 13th, 2018

Continue reading
  610 Hits
  0 Comments

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
  824 Hits
  0 Comments

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

Continue reading
  758 Hits
  0 Comments

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.

Continue reading
  610 Hits
  0 Comments

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
  728 Hits
  0 Comments

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
  639 Hits
  0 Comments

Tobacco Harm Reduction Research & Funding Draw Ad Hominem Attack


The influential journal Sciencerecently posted on its website an article (here) on the Foundation for a Smoke-Free World, an organization funded by a pledge of almost $1 billion from Philip Morris International.  The Foundation supports tobacco harm reduction research with a stated goal of “end[ing] the production and use of combustible cigarettes and help[ing] smokers switch to less dangerous alternatives.”  Asking, should scientists take the funding, the article clearly leans toward “no”. The only affirmative comments included in the piece are from the Foundation’s director and me, with my response truncated by the author to this: “But public funding to help settle those questions is in short supply, says Brad Rodu, a harm reduction advocate at the University of Louisville in Kentucky who for years has relied on tobacco money.” As I have written, government funding, predominantly from the National Institutes of Health, keeps academic research aligned with a vision of a tobacco-free society (here).  NIH’s opposition to tobacco harm reduction dates back to the mid-1990s, as seen in the agency’s efforts to undermine my research and reputation (detailed in Jacob Sullum’s book, For Your Own Good, here). The Science writer casts me as “a harm reduction advocate…who for years has relied on tobacco money,” despite my record of 65 published professional articles (available here, with PubMed links) and 24 years of scientific endeavor, 19 of which were supported by unrestricted grants from tobacco companies to, and administered by, two universities. Elsewhere in the story, an individual with half as many published articles is respectfully described as a “tobacco control researcher” as he terms the Foundation a “scam”. I support academic freedom, including the right to use research funding from any lawful source, accompanied by total transparency and full disclosure.  Research ought to be judged on its merits, using objective standards of quality and accuracy.        The Foundation director is, regrettably, prescient in anticipating “harassment of grantees and staff” and “ad hominem attacks”.  Such behavior is, as he notes, unacceptable. Original author: Brad Rodu
  725 Hits
  0 Comments

American Smokers’ Misperception of E-Cigarettes’ Relative Harm: A National Disgrace


Clive Bates recently commented on Americans’ perception of the relative harm of e-cigarettes versus cigarettes, as measured by the National Cancer Institute’s Health Information National Trends Survey (HINTS).  After looking at numbers from 2013 and 2017 (available here), he asked: “So what difference did four years of better products, academic studies, journal articles and commentaries, conferences and publicly funded risk communication make? Yes, it caused a deterioration in these already very bad numbers…those incorrectly believing e-cigs were just as harmful or worse than cigarettes had risen from 39.8% to 55.4%.” These numbers, while unfortunate, pale in comparison to growing misperception among American smokers.  These are the people whose lives will be shortened if they don’t quit.  In the chart I summarize a disheartening trend. In 2012, 38% of smokers correctly believed that vaping was safer than smoking (the green zone on the chart); the percentage increased to 57% a year later.  In contrast, about 37% and 34% of smokers thought e-cigs were equally or more harmful in those years (the red zone).  A slight decrease in accurate perceptions (green, at 55%) was seen in 2014, while those with misperceptions grew to 41% (red).  HINTS did not survey smokers again about the comparison until 2017; at that time, accuracy dropped to 38% (green), and misperception rose to 53% (red).        The sharp increase in misperceptions coincides with a sharp decline in smokers who vaped, from 6.3 million in 2014 to 4.1 million in 2016, according data from the CDC (here).       This is a national disgrace, driven by hundreds of millions of taxpayer dollars spent on anti-tobacco, anti-tobacco-harm-reduction research (here), with fawning complicity by the media and ill-advised endorsement by public health officials and major medical organizations.  Smokers are the unfortunate victims of this irresponsible crusade. Original author: Brad Rodu
  769 Hits
  0 Comments

FDA Advisory Committee: Heat-Not-Burn is Lower Exposure Than Smoke





The FDA Tobacco Products Scientific Advisory Committee (TPSAC) on January 25 unanimously endorsed a claim by Philip Morris International that switching completely from cigarettes to its heat-not-burn IQOS system significantly reduces smokers’ exposure to harmful and potentially harmful chemicals (here).  The committee, however, denied two other claims, that switchers “can reduce the risks of tobacco-related diseases” (8 against, 1 abstention) and that switching “presents less risk of harm” than continued smoking (5-4 against).  PMI published numerous short-term studies documenting that toxicant levels from IQOS aerosols were substantially lower than those in smoke, and demonstrating the biologic and medical impact of these differences in cells, animals and humans.  The committee’s denial of the diseases claim was understandable: risks manifest after three or four decades of steady smoke exposure, so risk reduction from switching to IQOS “can” occur over longer time periods.  However, TPSAC’s close vote rejecting the reduced harm claim is problematic.     In 2012, the FDA published a list of 93 Harmful and Potentially Harmful Constituents (HPHC) in Tobacco Products and Tobacco Smoke (hereand here).  The agency declared that the HPHCs variously posed health hazards as carcinogens, respiratory toxicants, cardiovascular toxicants, reproductive or developmental toxicants, and/or addictive agents.  The agency provided no guidance for the levels of exposure that constitute harm.  This is important, as seen in the case of formaldehyde, a weak carcinogen to which nearly everyone is exposed, but smokers significantly more so (discussed here).TPSAC rejected impressive evidence of HPHCs reduction in IQOS vapor.  I collected the following information from Appendix C of the FDA Briefing Materials (available here), which standardized toxins in IQOS aerosol and smoke according to nicotine intake.      On average, the reduction in the level of all potential and proven carcinogens (n=29) in IQOS aerosol was 90%.  For the most important carcinogens (n=9), the reduction was 96%.  Average reductions in respiratory (n=18) and cardiovascular (n=8) toxicants were 91% and 93% respectively.  The reductions for all of these individual agents are illustrated in the charts that follow.  The substantial reductions in all tested HPHCs support the claim that switching completely to IQOS “presents less risk of harm” than continuing to smoke.  There is adequate justification for the FDA to set aside TPSAC’s narrow 5-4 rejection of this claim. The two-day hearing raised no significant roadblocks to FDA market authorization for IQOS, which would allow U.S. sales.  Given the significant relative health benefits of this smoke-free product, market authorization is the appropriate action.   Original author: Brad Rodu
  1178 Hits
  0 Comments

Japan’s IQOS Experience Suggests Product Could Reduce U.S. Cigarette Consumption


An FDA advisory committee this week will vote whether to recommend that the FDA grants modified risk status to Philip Morris International’s IQOS heat-not-burn tobacco product (here).  A positive vote would acknowledge that the product poses a lower risk and/or lower exposure to toxins than cigarettes. The committee’s activity is garnering considerable media attention, but the larger issue is: Will the FDA permit IQOS sales in the U.S.?  In order for that to happen, the agency must approve the company’s premarket tobacco application (PMTA). IQOS is already available in 31 countries, with Japanese sales initiated in 2016.  The chart at left shows that Japanese consumption of IQOS heat sticks (green) in 2017 coincided with a 14% annual decline in cigarette consumption (red), compared with 2-3% decline in cigarette sales over the previous 5 years. The Japanese experience suggests that IQOS MRTP designation by the FDA could have a significant downward effect on American cigarette consumption. Original author: Brad Rodu
  898 Hits
  0 Comments

1.7 Million High Schoolers Vaped in 2016, As Both Vaping and Smoking Declined



The Centers for Disease Control and Prevention 2016 National Youth Tobacco Survey (NYTS) shows that 1.08 million (7.2%) American high school students used e-cigarettes in the past 30 days, 580,000 (3.9%) smoked, and 660,000 (4.4%) used both products. Compared with 2015, smoking declined by about 14% and vaping by 28%.The apparent spike in e-cigarette use from 2013 to 2014 was partially due to what scientific researchers refer to as an artifact, as it stemmed from a change in the survey design.  Questions about e-cigarette use were bundled with those for other rarely used tobacco products until 2014, when they appeared in a separate section.  The NYTS also collected information on how many days e-cigarettes were used in the past month.  The chart below shows that 7 out of 10 students who vaped but did not smoke used e-cigarettes five days or fewer.  This is basically “party” or “weekend” vaping, rather than regular use.  While half of high school students who vaped and smoked used e-cigs five or fewer days, 22% used them all 30 days.Last June, the CDC published selected information from the 2016 NYTS (here), listing smoking and vaping rates separately, effectively double-counting the 660,000 high-schoolers who vaped and smoked.  The CDC only released the full NYTS data set earlier this month (here).    The federal data confirm that e-cigarette experimentation by youth since 2011 has not produced an epidemic of smoking.  In fact, the decline in youth smoking accelerated to a record low rate.Original author: Brad Rodu
  1148 Hits
  0 Comments

Trials and Tribulations of Reduced Risk Tobacco Products


When Congress gave the FDA regulatory authority over tobacco in 2009, it provided a pathway for companies to obtain approval for “modified risk tobacco products (MRTPs)…, sold or distributed for use to reduce harm or the risk of tobacco-related disease…” (here).  While decades of epidemiologic studies prove that non-combustible tobacco products are vastly safer than those involving inhaled smoke laced with thousands of toxins, the legislation required proof from manufacturers that MRTPs must “benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.” (here)  In other words, MRTPs must benefit the 60 million Americans who smoke as well as 250 million American non-smokers.Despite this challenge, tobacco manufacturers have made credible efforts to seek MRTP status.  Swedish Match in 2014 started down this pathway (here) to remedy inaccurate warning labels that are required on their smokeless tobacco products and marketing materials (here).  The FDA denied the company’s application in 2016 (here).In November of that year, Philip Morris International (PMI) requested MRTP status for its IQOS heat-not-burn tobacco (here).  IQOS is already available in 31 other countries.  However, since it is an entirely new product, the company must also pursue an FDA premarket tobacco application (PMTA) before it can be sold in the U.S. PMI seeks MRTP approval for any one of three messages: “Switching completely from cigarettes to the IQOS system can reduce the risks of tobacco-related diseases.”“Switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes.” “Switching completely from cigarettes to the IQOS system significantly reduces your body’s exposure to harmful and potentially harmful chemicals.”Another manufacturer, R.J. Reynolds, filed an MRTP application in March 2017 for its Camel Snus products (here).  They, too, submitted three messages, 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.”Despite a wealth of evidence to support such statements, FDA took two and a half years to reject the Swedish Match MRTP application (here), as can be seen in the following table..nobr br { display: none } td { text-align: center} Key Dates for General Snus, IQOS and Camel Snus MRTP ApplicationsEventGeneral Snus (Swedish Match)IQOS (PMI)Camel Snus (R.J. Reynolds)Submission DateJune 6, 2014November 18, 2016March 31, 2017Time to next step2 months6 months9 monthsFDA AcceptanceAugust 27, 2014May 24, 2017December 18, 2017Time to next step8 months8 months---TPSAC MeetingApril 8, 2015January 24, 2018---Time to next step20 months------FDA DecisionDecember 14, 2016------ In the 30 months it took the FDA to analyze and reject the first MRTP application, 1.2 million Americans died from smoking.  The agency must move faster in its evaluation of obviously lower-risk smoke-free tobacco products and give them MRTP status. Original author: Brad Rodu
  590 Hits
  0 Comments

Tobacco Gateway Report Omits Important Information


Here we go again.  Another federally funded study from the University of California, San Francisco, claims that “Nonsmoking adolescents who use e-cigarettes, smokeless tobacco or tobacco water pipes are more likely to start smoking conventional cigarettes within a year.” (UCSF press release here)  Researchers analyzed data on some 10,400 teens enrolled in the Population Assessment of Tobacco and Health (PATH) Survey in 2013-2014, then followed up with the subjects one year later. “We found that teens who experimented with tobacco in any form were at greater risk of future smoking,” said senior author Dr. Benjamin W. Chaffee; his study appears in JAMA Pediatrics. The researchers report that teens who had ever used e-cigarettes, hookah, other combustible products or smokeless tobacco at the baseline survey were two or three times as likely to be smoking cigarettes (in the past-30 days) one year later than those who had not tried any tobacco product.  Those who had tried two or more products were 3.8 times more likely to be smoking.The authors used a sophisticated analysis to arrive at these results, but news stories describing this as evidence of a gateway to teen smoking (examples hereand here) are inaccurate.Chaffee and his colleagues, including anti-tobacco crusader Stanton Glantz, omitted information that is critical to putting their findings in perspective.  Although teens trying other tobacco products were more likely to smoke, the majority of new smokers after one year came from the group that had not tried tobacco at baseline.  I offer the following calculations based on obscure information in the published article..nobr br { display: none } td { text-align: center} Odds Ratios (ORs) And Numbers of Teens Smoking Cigarettes After One Year, According to Ever Tobacco Status at BaselineEver Tobacco Status- Baseline (n)OR (95% Confidence Interval)Number 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)After one year, 219 teens had smoked a cigarette in the past 30 days, and 175 of those (80%) had never used any tobacco product at baseline.  Even though the odds of smoking were higher among youth who had tried other products, the number of smokers contributed by each of these groups was minuscule.  (While actual survey numbers may vary slightly, the relative contributions of the groups will not change.)The Chaffee article emphasizes odds ratios but omits or obscures important contextual information.  While teens who try one tobacco product are more likely to try another, the dominant gateway in the PATH survey was from no previous tobacco use to cigarettes.No underage tobacco initiation is acceptable; neither is misdirection by researchers.Original author: Brad Rodu
  741 Hits
  0 Comments

Regulating e-liquid flavors – could the U.S. regulator do more harm than good and how would it know?

Assessing potential harms and benefits arising from flavors in nicotine products

Following the 28 July announcement of FDA’s new nicotine strategy, publication of several Advanced Notices of Proposed Rulemaking (ANPRMs) is expected within months. These will provide a more detailed articulation of the strategy This memo discusses significant issues for consideration in the drafting of the forthcoming ANPRM on the role of flavored tobacco/nicotine products in attracting youth.

Continue reading
  495 Hits
  0 Comments

Tobacco Truth Top Ten


During the holidays we celebrate this blog’s eight years of factual reporting and critical analysis of science and policy surrounding tobacco and tobacco harm reduction.  We’ve strived to satisfy the curiosity and technical interests of health professionals, while couching our message in terms that are comprehensible to the lay consumer as well.  We are proud to note that Tobacco Truth has some 450 posts, with over 2.8 million pageviews.  We sincerely hope this translates into a significant number of lives extended and improved. Based on pageviews, here are the Top Ten Tobacco Truths, with notable quotes from each.     I’m a Smokeless Tobacco User – Will I Get Mouth Cancer?  2012  “Harm reduction doesn’t allow us to enjoy risk-free lives. It does give us valuable information to manage the risks of the activities that make life enjoyable.”     Nicotine Levels in American Smokeless Tobacco Products  2012  “The broad range of free nicotine levels among these products is good news for smokers.  They should look for a smokeless substitute that satisfies them.”     The Proven Positive Effects of Nicotine and Tobacco  2010  “It’s time to be honest with the 50 million Americans, and hundreds of millions around the world, who use tobacco. The benefits they get from tobacco are very real, not imaginary or just the periodic elimination of withdrawal. It’s time to abandon the myth that tobacco is devoid of benefits, and to focus on how we can help smokers continue to derive those benefits with a safer delivery system.”     Tobacco Trick or Treat by Florida’s Surgeon General  2012  “The availability of flavored tobacco products is important for tobacco harm reduction among adults who smoke…it is important that these individuals have access to appealing, vastly safer smoke-free alternatives to cigarettes…Banning tobacco flavoring is no more logical than banning flavored beer, wine and mixed drinks on the grounds that those products appeal to youth.”     More Evidence That Smokeless Tobacco Products in the U.S. Have Low TSNA Levels  2012  “this study shows that TSNAs are present in tiny concentrations.  As discussed in a previous post (here), there is virtually no evidence that current TSNA levels are associated with any measurable cancer risks.”     Nebraska Legislature Passes Tobacco Harm Reduction Resolution  2012  “The Nebraska legislature on March 27 [2012] passed resolution LR 499 to ‘recognize the importance of tobacco harm reduction strategies as an additional choice to assist cigarette smokers in quitting.’ ”     The Health Risks of Cigar Smoking  2012  “Cigars, the data show, have few health effects when used in moderation.”  Also see this popular post in 2016.      Regulatory Purgatory: Tobacco Harm Reduction at Risk  2012  “The FDA should abandon regulatory fundamentalism that condemns safer product development to a purgatory of red tape.”      Cancer Risks From Smokeless Tobacco Use: Next To Nil  2009  “The clear implication is that the deaths each year of 103,635 male smokers in the U.S. could be avoided if public health leaders shared the truth about safer smokeless tobacco, and if tobacco manufacturers were allowed and encouraged to urge smokers to switch.”     E-Cigarettes – No Toxic Effects from Inhaled Propylene Glycol Aerosol  2011  “First, even high concentrations of PG vapor don’t have any measurable harmful effects, which is fully consistent with its designation by the FDA as “generally recognized as safe” as a food additive for all food categories up to 2% (here). Just as important, there will be no impact on bystanders from “second-hand” exposure to e-cigarette vapor, if it occurs at all.” The following posts from the past year have been very popular as well. E-Cigarette Toxic Chemical Exposure Is Same as for Nonsmokers  “The fact that vapers’ [volatile organic compound] exposures are similar to those of nonsmokers is headline-worthy.” Federal Studies: ZERO Mouth Cancer Deaths Among Men Who Dip or Chew Tobacco  “The U.S. Food & Drug Administration (FDA) on January 23, 2017 published a proposed smokeless tobacco (ST) regulation that is based on erroneous calculations of ST risks.” FDA Tobacco Director Ignores 2.5 Million “Anecdotal Reports” About E-Cigarettes  “The FDA’s refusal to acknowledge population data on e-cigarettes facilitates its effort to impose industry-killing regulations on the vapor market.  The chief federal regulator of tobacco products should acknowledge government survey data showing that e-cigarettes have helped as many as 2.5 million Americans quit smoking and/or stay smoke-free.” We approach the new year with a renewed commitment to elevate global public discourse on the science of tobacco harm reduction. Original author: Brad Rodu
  727 Hits
  0 Comments

Population-Level Proof: E-Cigarettes Are Popular & Successful Quit-Smoking Aids


Tobacco harm reduction opponents have belittled reported use of e-cigarettes as smoking cessation aids, dismissing case studies as mere “anecdotes” (here) and claiming a lack of population evidence to support a quit-smoking claim.  Now that evidence exists.In a just published study, my colleague Nantaporn Plurphanswat and I use federal government data to demonstrate that e-cigarettes were one of the most commonly used quit aids by American smokers in 2013-2014, and that they were the only aid more likely to make one a former smoker (i.e., a successful quitter) than quitting cold-turkey.  Our study, appearing in the International Journal of Environmental Research and Public Health(open access, available here), analyzed data in the Population Assessment of Tobacco and Health (PATH) Survey, a combined project of the U.S. Food and Drug Administration and the National Institutes of Health.  The PATH survey asked current smokers which aids they used when they tried to quit, and former smokers which aids they used to quit, in the past 12 months.  Participants could pick from the following: (1) no aid, (2) support from friends and family, (3) other aids (counseling, quit line, books, pamphlets, videos, clinic, class, web program), (4) e-cigarettes, (5) other combustible tobacco (cigars, cigarillos, filtered cigars, pipe tobacco, hookah), (6) smokeless tobacco (dip, chew, or snuff, and dissolvable tobacco), (7) pharmaceutical nicotine (NRT: patch, gum, inhaler, nasal spray, lozenge or pill), and (8) prescription drugs (Chantix, varenicline, Wellbutrin, Zyban, or bupropion).Here is a summary of the results for smokers using a single quit aid:.nobr br { display: none } td { text-align: center} Single Quit Aids Used By American Smokers, 2013-2014AidCurrent Smokers*Former Smokers*All*% FormerOdds Ratio** (95% Confidence IntervalNo aid5,546,0001,429,0006,975,00020.5ReferentSupport, friends family1,992,000446,0002,438,00018.30.98 (0.75-1.28)Other aids139,00037,000176,00021.00.89 (0.36-2.17)E-cigarettes1,652,000540,0002,192,00024.61.43 (1.12-1.83)Other combustible91,00024,000115,00020.91.43 (0.78-2.63)***Smokeless tobacco92,00032,000124,00025.81.43 (0.78-2.63)***NRT1,190,000284,0001,474,00019.30.89 (0.61-1.28)Prescription drug347,00070,000417,00016.80.97 (0.55-1.71)All aids11,049,0002,862,00013,911,00020.6*estimated from PATH survey weighting.  Some numbers do not appear in the peer-reviewed publication.**Odds ratio of being a former smoker, adjusted for number of quit attempts, age, sex, race/ethnicity, education, income and region***categories combined to produce a single OR Overall, nearly 14 million smokers tried to or did quit using a single quit aid in 2013-2014.  As we note, “E-cigarettes were used…by 2.2 million smokers…, NRT by 1.47 million, prescription drugs by 418,000 and smokeless tobacco by 124,000.”  While NRT and prescription drugs, combined, helped some 354,000 smokers quit, it was e-cigarettes, which are routinely condemned by many public health institutions, that produced the greater success, helping 540,000 smokers quit.  Given the government’s own evidence, it’s time to acknowledge the scientific legitimacy, value and benefit of e-cigarettes with respect to the health of the population. Original author: Brad Rodu
  593 Hits
  0 Comments

FDA Releases More Positive Results for IQOS; British Medical Association Supports E-Cigs


I earlier reported (here) that Stanton Glantz, a University of California, San Francisco professor, urged the FDA to deny Philip Morris International’s application to market its IQOS heat-not-burn cigarette as a modified risk tobacco product, based on his comparison of lab results for IQOS users versus continuing smokers.  I noted that Glantz ignored data for IQOS users versus complete quitters, although that statistical comparison was not in the documents released by the FDA.Additional data released by the FDA yesterday shows that PMI had submitted considerably more information from its Japanese study.  PMI reported data on exposure to carcinogens, carbon monoxide and nicotine, and, importantly, analyses for all of these results, including IQOS versus smoking, and IQOS versus quitting.The following table shows all results after three months.  Differences in the table are described positively with respect to health (e.g., IQOS significantly lower).  “NS” indicates no significant difference between groups for that test.  The primary carcinogens are listed, with lengthy chemical metabolites abbreviated in parentheses.   IQOS users were not significantly different than quitters with respect to inflammation, oxidative stress, blood pressure, lung function and carbon monoxide levels.  Compared with continuing smokers, IQOS users had significantly lower levels of 15 out of 16 carcinogen markers after 90 days of use.  There were no differences between IQOS and quitting for 13 of 16 markers.My previous blog post was based on partial results released by FDA.  The agency’s latest release provides further evidence that toxin levels three months after switching to IQOS look more like complete quitting.No one is claiming that IQOS is perfectly safe.  However, exposure to toxic agents among IQOS users is substantially lower than exposure among smokers, and very close to that associated with complete quitting. In breaking news, the British Medical Association Board of Science has just issued a positive report on e-cigarettes (here).  Their findings, which likely apply to IQOS, appear below verbatim.Is it safe to use an e-cigarette in the long-term?In the absence of long-term studies it is not possible to be certain about the long-term health risks, but there is growing consensus that use of e-cigarettes is significantly safer than smoking.Unlike cigarette smoking, e-cigarette use does not expose users to the products of combustion, and most of the toxicants causing smoking-related disease are absent or significantly reduced in e-cigarette vapour.Indications to date are that complete switching can lead to improvements in the levels of toxins and carcinogens in urine similar to that in smokers who switch completely to NRT (nicotine replacement therapies)..nobr br { display: none } td { text-align: center} Comparison of Laboratory Values: IQOS Users Versus Continuing Smokers and Versus Complete Quitters After 3 MonthsLab MarkerIQOS Versus SmokingIQOS Versus Complete Quitting*InflammationWhite blood cell countIQOS significantly lowerNSC-reactive proteinNSNSSoluble ICAMIQOS significantly lowerNSFibrinogenNSNSOxidative StressProstaglandin F2 alphaIQOS significantly lowerNS11-DTX-B2NSNSCholesterol, TriglyceridesHigh density lipoproteinIQOS significantly higherNSLow density lipoproteinNSNSTotal cholesterolNSNSTriglyceridesNSIQOS significantly lowerBlood pressureSystolicNSNSDiastolicNSNSLung functionForced expiratory vol, 1 sec.NSNSCarbon monoxideIQOS significantly lowerNSCarboxyhemoglobinIQOS significantly lowerNSNicotineNS*IQOS significantly higherCarcinogens**Nicotine-derived nitrosamine ketone (NNK)IQOS significantly lowerQuitting significantly lowerButadiene (MHBMA)IQOS significantly lowerNSAcrolein (3-HPMA)IQOS significantly lowerQuitting significantly lowerAcrolein (HMPMA)IQOS significantly lowerNSBenzene (S-PMA)IQOS significantly lowerNSPolycyclic aromatic hydrocarbons (1-OHP)IQOS significantly lowerNSPolycyclic aromatic hydrocarbons (CYP 1A2)IQOS significantly lowerNSN-nitrosonornicotineIQOS significantly lowerQuitting significantly lower4-aminobiphenylIQOS significantly lowerNS1-aminonaphthaleneIQOS significantly lowerNS2-aminonaphthaleneIQOS significantly lowerNSo-toluidineIQOS significantly lowerNSAcrylonitrile (CEMA)IQOS significantly lowerNSStyrene (HEMA)IQOS significantly lowerNSBenzo(a)pyreneIQOS significantly lowerNSToluene (S-BMA)NSNSNS, No significant difference* IQOS results in nicotine levels that are similar to smoking** carcinogen (chemical metabolites)Original author: Brad Rodu
  1187 Hits
  0 Comments

Five Flavor Review

Featured Review

Video Tour of Lab