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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.

Finally, A Direct Comparison of Smoking and Smokeless Tobacco Use

I have documented how American health authorities refuse to directly compare the health effects of smoking and smokeless tobacco (ST) use.  The results of such an exercise would require them to acknowledge the products’ vast risk differentials.  For years, the American Cancer Society has possessed data that would allow this comparison (here, here, and here), but they refused to run the analysis or provide me with the data (here). I recently explained how FDA officials hid the comparison in a New England Journal of Medicine article (here). I have spent much of the past 25 years trying to correct this information deficit.  Lacking access to the necessary data, the only comparison I could make was indirect (here), which was less than ideal. Now, at last, the data are in full view.  Altria scientists in April published the first-ever follow-up mortality study of cigarette smokers and ST users, using national surveys and the National Death Index, all of which are produced by the U.S. Government and publicly available.  The first author of the impressive study, published in Harm Reduction Journal, is Michael T. Fisher.  The figure at left illustrates the results for all causes of death, all cancers and heart diseases; smokeless tobacco is referenced as SLT.  In each section, hazard ratios – the likelihood of dying compared with never tobacco users – are illustrated for smokersby the first set of black dots/squares in the red circles; former smokers are in the next set; and ST users are in the third set, circled in blue. Smokers are at more than twice the risk of dying from all causes than never tobacco users.  Former smokers’ odds are about 30% to 50% higher than those of never tobacco users (HR = 1.3 – 1.5).  Current ST users who never smoked died at the same rate as never tobacco users. Compared with never users, smokers had even higher odds for dying from cancer, from 2.9 to about 4.2.  Former smokers also had higher odds, varying from 1.6 to 2.4.  Once again, ST users died at the same rate as never tobacco users. Smoking isn’t as big a risk factor for diseases of the heart; other factors, like obesity, diet, physical fitness and diabetes, are also important.  Smokers in this study had odds ranging from 1.2 to 2.2, and not all of these were significant.  ST users had no excess risk. In summary, this analysis of government data confirms that ST use is vastly safer than smoking.  The FDA and CDC not only had this data, but used it in other mortality studies of smokers and cigar users.  By not publishing the results on ST users, federal officials maintained the illusion that ST “is not a safe alternative to cigarettes.”  It is ironic that cigarette industry researchers produced this pivotal analysis.  Stay tuned to this blog for more results. Original author: Brad Rodu
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Smokers: Step Away From the Fire With These Safer Cigarette Substitutes

Most cigarette smokers “say” they want to quit, but that is terribly misleading.  Most smokers answer yes to the quitting question because they know it’s the desired response.  In reality, the vast majority of smokers don’t quit in any given year.  All of them would welcome a healthier lifestyle, but they are unable or unwilling to abandon the immediate benefits of tobacco and nicotine, especially smoking. If you smoke, here’s your guide to vastly safer substitutes that provide nicotine and tobacco satisfaction. E-Cigarettes and Vape Products The best harm reduction options for smokers unable or unwilling to give up nicotine and tobacco are e-cigarettes and vape products.  There are thousands of choices, reflecting the fact that they are the most popular – and most successful – quit-smoking aids.  Vape ShopsSmokers can take the first step away from the fire by visiting local vape shops, which are often staffed by former smokers who are knowledgeable about your best options and dedicated to your success.  These shops sell popular products and also cater to vapers who want advanced hardware and special e-liquid flavors.  To locate nearby shops, check out Vaping 360’s online locator.  The Vapetrotter Directory is another valuable source. For lots of factual information about e-cigarettes and vape products, visit the website operated by Consumer Advocates for Smoke Free Alternatives Association.  And for moral support, visit CASAA’s testimonials webpage containing thousands of success stories.   JUULJUUL has taken the vaping market by storm; it’s making cigarette manufacturers nervous, and for good reason.  JUUL pods contain a satisfying nicotine salt that won’t have you climbing the walls or kicking the dog because you don’t have the nicotine hit you need.  Additionally, the pods are inconspicuous, and easy to use and recharge.  JUUL products are widely available, although the company is only selling tobacco and menthol flavors in convenience and other brick and mortar stores. Its popular flavors -- mango, cucumber, fruit, and crème – are available online. VuseVuse is another family of vaping products that are available in several hardware choices and a wide variety of flavors, including menthol, mint, mixed berry, melon, fruit-and-cream, chai, nectar, tropical fruit and classic tobacco.  Vuse is available onlineand in stores nationwide. Heat-Not-Burn Products IQOSThe FDA recently approved the sale of IQOS heat-not-burn products in the U.S.  They are already available in over 30 other countries, and they have produced an unprecedented decline in cigarette consumption in Japan.  An FDA advisory committee in 2018 concluded that the products significantly reduce smokers’ exposureto toxic chemicals found in cigarette smoke.  I believe IQOS products have the potential to compete with vapor products, as they deliver the tobacco flavor and satisfaction many smokers find lacking in e-cigarettes.  The first U.S. test market for IQOS will be Atlanta, where it will be available at a dedicated Lenox Square store.  Nicotine Pouches             ZYNZYN is a discrete new pouch product from Sweden that contains no tobacco, just nicotine and flavor – spearmint, wintergreen, cool mint, coffee, cinnamon or peppermint.  Also note that there are two strengths, ZYN 3 and ZYN 6 (milligrams).  Originally launched in Western states, ZYN is now available nationwide anywhere cigarettes are sold.  It’s also available from Northerner.com.  On!On! is another nicotine pouch made in Sweden, available in mint, wintergreen, cinnamon, berry, citrus and coffee flavors and in three strengths, 2, 4 and 8 milligrams. These pouches have been in limited distribution here in the U.S., and they are also available at Northerner.com.  However, Altria has just bought a large share of the company, so look for these pouches soon in your local convenience store. Smokeless Tobacco Camel SnusCamel Snus packets come in several flavors: mint, frost (spearmint) and winterchill (wintergreen).  If you prefer more tobacco flavor, try Robust or Mellow.  There are also two sizes, a slim version containing 0.6 gram of tobacco, and a larger pouch with 1.0 gram.  I suggest that smokers start with the small size of their favorite flavor.Camel snus is available nationwide anywhere cigarettes are sold, and online at Northerner.com.  Skoal SnusSkoal Snus packets come in mint and smooth mint.  You can find them nationwide in the smokeless tobacco section of convenience stores, and they are available at Northerner.com. Skoal BanditsIn 1995, when conducting the first-ever smoking cessation clinical trial using smokeless tobacco (abstract here), my research group recommended that smokers switch to Skoal Bandits, the only widely available pouched smokeless tobacco product at that time.  They are still available nationwide in wintergreen and mint flavors.Oliver TwistOliver Twist is the planet’s most discrete smokeless tobacco product.  It consists of mini-rolls of tobacco (smaller than a pencil eraser), which are made in Denmark by rolling whole tobacco leaves into a rope, which is then cut into small pieces.  Flavors include original (tobacco), wintergreen, sunberry and tropical.Oliver Twist can be difficult to find.  Look for stores that sell premium cigars and pipe tobacco, or order it at Northerner.com.      Helpful Tips:First and foremost, place smokeless products inside your UPPER LIP.  That is the key to minimize tobacco juice and the need to spit.  At first it might feel like a cannonball, but it won't be noticeable.There are many options, so don’t be discouraged if one product doesn’t fit your lifestyle or taste.Whatever product you use, get your nicotine buzz, but don’t overdo it. When you inhale cigarette smoke, you get an immediate nicotine kick, and during your smoking career you learned to optimize your buzz. The effect from e-cigarettes or smokeless tobacco may be different, but you’ll learn how to get a similar effect.Stick to the switch. Although some smokers make the transition quickly, smoke-free tobacco products don’t automatically “cure” your desire for another cigarette. These products will make it easier to quit and they’ll make those cravings less intense, but they don’t entirely replace the smoking ritual. If you’ve smoked for years, breaking the habit can still be a challenge.If your ultimate goal is complete nicotine and tobacco abstinence, stepping away from the fire is a critical first step.  Remember that it’s the smoke that kills, so becoming and staying smoke-free, not necessarily nicotine- or tobacco-free, is your first priority.  It’s the key to a longer and healthier life. Original author: Brad Rodu
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Common Sense Legislation Would Limit Teen Tobacco Access

Senate Majority Leader Mitch McConnell recently introduced legislation to make 21 the legal age for tobacco sales nationwide.  As he elevated the Tobacco 21 debate to the national stage, McConnell said that stemming teenage vaping was a primary objective. There is no question that vaping is on the rise among teens, but the Food and Drug Administration and other federal agencies have miscast the situation, labeling it an epidemic to provide a rationale for excessive regulations.  Regardless, McConnell’s championing of Tobacco 21 is appropriate, as it would delegitimize tobacco sales to 18-year-old high school students.  While those youths comprise 16% of all high school students, they account for one-quarter of high school smokers and smoker-vapers.     FDA survey data shows that more than 90 percent of teens who use tobacco products obtain them from social sources.  The Population Assessment of Tobacco and Health (PATH) survey collects detailed information about teen tobacco use. It reveals that fewer than 10 percent of current teen e-cigarette users – defined broadly as having taken at least one puff in the past 30 days – “bought them myself.” While the FDA and other government agencies target retailers, the vast majority of underage teens get e-cigarettes from their friends and relatives.  These sources can’t be regulated. The Tobacco 21 debate was reignited recently by a proposed FDA rule requiring retailers to have a separate room for flavored e-cigarette products, accessible only to purchasers of legal age.  This is a nearly impossible requirement for convenience, grocery and drug stores.  The rule might be met by vape and tobacco shops, but that won’t solve the problem. According to a recent study, teens purchased vapor products most frequently online (32%) and from vape (22%) and tobacco (16%) shops.  Convenience, gas and liquor store purchases were less frequent (5.6%), as were grocery, drug and other stores (2.2%).  Thus, the proposed rule would have no impact on the most common sources of teen purchases, but it would likely eliminate vapor sales at stores where teens aren’t buying products.  This would be government regulation at its worst.  While the FDA obsesses over brick-and-mortar retailers, Congress should immediately address online vapor sales.  The 2009 Prevent All Cigarette Trafficking (PACT) Act required online purchasers of cigarettes and smokeless tobacco products to provide proper identification at the point of delivery.  However, the law doesn’t cover e-cigarettes, an omission that would be corrected by the recently introduced Preventing Online Sales of E-Cigarettes to Children Act.  Tackling teen smoking and vaping at the federal level is important.  Passing Tobacco 21 and updating the PACT Act to include e-cigarettes are two easily achievable legislative actions that will be far more successful in decreasing underage teen tobacco use than ill-conceived new restrictions and regulations impacting adult access to e-cigarettes. Original author: Brad Rodu
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How Big Is the So-Called Teen Vaping Epidemic?

Federal authorities insist upon the existence of a teen vaping epidemic, based on results of the 2018 National Youth Tobacco Survey (NYTS).  They claim that current (past-30-day) use of e-cigarettes surged 78% in 2018, resulting in over three million high school vapers.   Federal officials ignore two other 2018 estimates from a commercial online panel that are representative of the U.S. population.   It’s called KnowledgePanel, and it’s a product of the German firm GfK (Growth from Knowledge).  While both of these published studies focus on JUUL use, I will examine only their e-cigarette estimates. The first KnowledgePanel survey was analyzed by Donna Vallone and colleagues at the Truth Initiative, a rabidly anti-tobacco non-profit organization.  I have previously detailed major technical problems with their Juul results, and noted that the authors refused to respond to my questions in a professional forum.  However, it is unlikely that Dr. Vallone underestimated the prevalence of current e-cigarette use, which she reported as 11% among 15-17 year-olds in 2018. The second KnowledgePanel survey was analyzed by Neil McKeganey and Christopher Russell at the Centre for Substance Use Research in the U.K.  Under contract with JUUL Labs to research the population impact of e-cigarettes, they recently published a study in the American Journal of Health Behavior reporting that current vaping among 15-17 year-olds in the U.S. was 8.7% in 2018. The chart above presents the prevalence and population estimates from these three surveys.  In summary, the epidemic of vaping among 15-17 year-olds in 2018 involved either 2.3 million, 1.2 million or 952,000 youths. Federal officials, politicians and tobacco prohibitionists are calling for drastic measures to curtail a teen vaping epidemic.  Their first priority should be to produce accurate estimates justifying both the existence of such an epidemic and any remedial program.Original author: Brad Rodu
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Tackling Tobacco 21 Objections

In his recent commentary, Ramesh Ponnuru asserts that “there’s no…justification [unlike alcohol] for raising the age to buy tobacco products” from 18 to 21.  While more thoughtful than some opponents, Ponnuru echoes a familiar refrain: “If you’re old enough to vote, serve on a jury, marry or fight in a war, you should be considered old enough to light up, too.” The logic of this argument quickly fails under examination. While one may cherish voting or marriage, they are still considered privileges that are subject to qualifications.  One of these is age, which is not permanently set in stone but determined by historical and cultural customs.  For example, the Preventing Tobacco Addiction Foundation notes that “For 600 years of English common law and throughout most of U.S. legal history, the age of 21 was regarded as the age of full adult status.”  Serving on a jury is required by law (Title 28, U.S. Code, Sections 1861-1878), and as such, the current age of 18 years is subject to revision.  The most common objection to both Alcohol and Tobacco 21 contrasts eligibility for military service at age 18 with prohibition of drinking or smoking.  This argument is meaningful only if military service is compulsory, a policy that ended in 1973.  Eighteen-year-old men and women may choose to join the armed forces, but that choice is unrelated to the privilege of being able to purchase and consume alcohol or tobacco, unless society decides otherwise. Fourteen states have raised the age of tobacco sales to 21 years, and there are bipartisan bills in the U.S. Congress that would make Tobacco 21 the law of the land.    In his commentary, Ponnuru enumerates the reasons for Tobacco 21: delay or reduce tobacco uptake; reduce smoking-related health effects, medical care and insurance costs; and achieve other so-called paternalistic objectives.  But Ponnuru omits the most direct and compelling reason to enact Tobacco 21: to delegitimize tobacco sales to 18-year-old high school students.  In 2018, 16% of all high school students could legally purchase tobacco, and they accounted for one-quarter of high school smokers and smoker-vapers (here).  Government survey data confirms that legal buyers – not manufacturers or retailers – are the primary source for tobacco products used by underage high schoolers (here). Complaints about paternalism as the rationale for Tobacco 21 are irrelevant.  Tobacco 21 simply provides the best opportunity to defeat the informal black market that supplies tobacco products to the nation’s underage high school students.  Ponnuru objects that Tobacco 21 advocates “don’t provide any good reason to treat young adults as though they were minors.”  But there is one very good reason: to be treated as an adult, one must act responsibly with respect to children.  Those high schoolers who are the primary suppliers of tobacco to their underage friends are clearly acting irresponsibly.  This is a compelling justification for Tobacco 21.   Original author: Brad Rodu
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Tobacco 21 is Unstoppable, But U-Turns Are Unacceptable

Last week the Inside Sources published my commentary on Tobacco 21.  Read it here or on the Inside Sources website. Walmart added momentum to the Tobacco 21 movement by announcing on May 8 that it would raise the minimum age for tobacco sales in July.  So far this year the number of T-21 states has doubled to twelve, and Senate Majority Leader Mitch McConnell has called for congressional action to implement the policy across the U.S. However, everyone is not in favor of curbing underage access, sort of.  Anti-tobacco crusaders who campaigned for years to increase the legal age for tobacco purchases made a sudden U-turn, calling T-21 a Trojan horse for the tobacco industry. The T-21 turnaround has been seen multiple times in state legislative battles across the country. In fact, it’s clear that some anti-vaping crusaders never really cared about changing age restrictions as a means of keeping e-cigarettes out of the hands of underage users; rather, as soon as there’s an opportunity to enact a T-21 law, they tack to opposition, pushing for even more extensive controls like flavor bans and increased taxes. Crusaders trade on fear, not facts. The facts tell us that smoking continues to kill nearly 500,000 Americans each year, according to the Centers for Disease Control. E-cigarettes and other non-combustible alternatives may not be perfect, but researchers now consider vaping to be 95 percent safer than smoking. E-cigarettes provide a safer alternative for adult smokers and science shows that e-cigarettes are more effective at helping smokers quit than other nicotine replacement therapies. Still, there has been a rise in teen vaping. And while e-cigarettes are a better alternative for adult smokers, we don’t want a new generation getting hooked on nicotine unnecessarily. That’s why, just last week a bipartisan Tobacco 21 bill was announced by U.S. Senators Brian Schatz (D-HI), Todd Young (R-IN), Dick Durbin (D-IL), and Mitt Romney (R-Utah). But this isn’t a partisan issue. Many organizations, such as the American Cancer Society, the American Heart Association, and the Campaign For Tobacco-Free Kids support the new legislation. These groups had originally endorsed Tobacco 21, then opposed it in several states, and now support it again. Some anti-tobacco crusaders, however, continue to swim against the current, now insisting that Tobacco 21 legislation is a farce. Ohio State Professor Robert Crane, president of the Preventing Tobacco Addiction Foundation, said of the federal Tobacco 21 bill, “the hair on the back of my neck stood up and I said, ‘This is really terrible.’” Ironic, since Dr. Crane’s foundation hosts the Tobacco 21 advocacy website with a long list of major medical organization endorsements. Prohibitionists ostensibly support Tobacco 21, but they are capitalizing on the visibility McConnell brings to the issue to launch a thinly veiled attack on all safer products, even those still blocked by the FDA. IQOS, Philip Morris International’s new heat-not-burn product, has been available in 45 countries and has decimated cigarette sales in Japan, but the FDA just got around to approving it last week (after two years, or 1 million smoker deaths). We’re still waiting to see if the FDA acknowledges the unanimous findings of its scientific advisory committee and allows PMI to market IQOS as less harmful and likely to reduce risk of disease. U.S. cigarette sales are declining as the market develops safer, satisfying alternative products.  But this is what is driving crusading prohibitionists crazy. For decades, they invoked burdensome legislation, litigation, taxation and regulation that failed to curtail the annual toll of dead smokers. Now, despite their latest efforts to promote the exaggerated, distortedand even imaginarydangers of e-cigarettes and teen epidemics, vapor products have become the most popular and most effective quitting aidsfor American smokers.  The fact is that while smoke routinely kills, tobacco and nicotine rarely do. Instead of supporting safer, smoke-free cigarette substitutes that help smokers step away from the fire, anti-tobacco crusaders promote policies that sustain the cigarette market, and its deadly consequences.  We have to keep all tobacco products away from underage teens while providing vastly safer smoke-free cigarette substitutes to their parents and grandparents. Tobacco 21 will help accomplish both of these public health priorities. Original author: Brad Rodu
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The 2018 American Teen Vaping Epidemic, Recalculated

Former FDA Commissioner Scott Gottlieb and other government officials have repeatedly asserted that the U.S. is in the midst of a teen vaping epidemic (example here).  Their claim is based on last year’s National Youth Tobacco Survey, the full contents of which was finally released six weeks ago by the Centers for Disease Control and Prevention.  With that data in hand, I have confirmed some of the assertions made by anti-vapers but easily put the lie to others (here).Federal officials claim there were over three million high school vapers in 2018.  Let’s take a look at the actual numbers.  Each table below lists the number of high school students who used e-cigarettes 0, 1-5, 6-19 or 20-30 days in the past month, according to whether they were underage or of legal age (18+ years).   Table 1 shows that 3.13 million high schoolers vaped, with 877,500 using the products 20-30 days in the past month..nobr br { display: none } td { text-align: center} Table 1. Number of High School Students in 2018 Who Vaped in the Past Month, According to Age Days VapedLess than 18 years18+ yearsAll1-51,303,366200,2641,503,6306-19602,392150,841753,23320-30630,490247,000877,490All2,536,248598,1053,143,353Next, let’s remove any high school students who ever tried CIGARETTE SMOKING.  As shown in Table 2, that leaves 1.36 million, with 198,000 using the products 20-30 days in the past month..nobr br { display: none } td { text-align: center} Table 2. Number of High School Students in 2018 Who Vaped in the Past Month But Never Tried Cigarette Smoking, According to Age Days VapedLess than 18 years18+ yearsAll1-5762,02392,035854,0586-19259,45043,231302,68120-30151,17647,150198,326All1,172,649182,4161,355,065Removing students who ever tried CIGARS, the total drops to 978,000, with 132,500 using the products 20-30 days in the past month (Table 3)..nobr br { display: none } td { text-align: center} Table 3. Number of High School Students in 2018 Who Vaped in the Past Month But Never Tried Cigarette or Cigar Smoking, According to Age Days VapedLess than 18 years18+ yearsAll1-5607,89450,784658,6786-19163,69922,841186,54020-30109,12323,392132,515All880,71697,017977,703Finally, subtracting students who ever tried SMOKELESS TOBACCO, Table 4 reveals that the vaping epidemic consists of 897,000individuals, with 116,000 using the products 20-30 days in the past month.  Of those, 95,316 were underage..nobr br { display: none } td { text-align: center} Table 3. Number of High School Students in 2018 Who Vaped in the Past Month But Never Tried Cigarette or Cigar Smoking or Smokeless Tobacco, According to Age Days VapedLess than 18 years18+ yearsAll1-5572,09147,539619,6306-19139,88120,942160,82320-3095,31621,053116,369All807,28889,534896,822For comparison, I conducted the same analysis on the 2017 NYTS, which yielded 26,660 underage teens who vaped 20-30 days in the past month but never used other products.  That was less than 0.2% of all high school students.  It is true that frequent vaping among underage high school teens increased substantially from 26,660 in 2017 to 95,316 in 2018.  These numbers translate into an increase from less than 0.2 to 0.6% of all high school students.In summary, the oft-cited teen vaping epidemic involves not three million youths, but rather 95,000 underage teens who vaped frequently but never used other tobacco products – or 0.6% of the nation’s 14.8 million high school students.     Original author: Brad Rodu
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Rethinking tobacco and nicotine – a Twitter chat

May 15th, 2019

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About Sensationalist Science and Rhetoric on E-Cigarettes

Last week the Louisville Courier-Journal published my plea to stop confusing the public with sensationalist rhetoric on e-cigarettes.  Read it here or on the Courier-Journal website. The problem of misinformation is widespread. The public constantly receives alarmist misrepresentations about vaccinations, the food they eat, the household products they use, and now e-cigarettes and vaping. But hysterical rhetoric has consequences, because people act on what they are told. And health officials at all levels of government are misinforming Americans that e-cigarettes are as dangerous as cigarettes and pose an existential threat to their children. Unfortunately, this misinformation can be deadly. Production of tobacco misinformation follows a formula, originating in “user fees” (read: taxes) Congress established in 2009, giving the FDA regulatory authority over tobacco (here).  Every year tobacco manufacturers consumers pony up over $700 million dollars in user fees to the FDA, which then transfers a big chunk of that money to the National Institutes of Health, which distributes it to thousands of researchers at the nation’s universities to study tobacco products.  This system, which has been operating for several years, isn’t set up to discover the truth about tobacco.  Instead, it generates only what the NIH, and others in the federal government, wants: bad news about all tobacco products.  Including tobacco-free, smoke-free, and vastly safer e-cigarettes.    This bad news is then amplified by university media departments and our brave new world of social media, which makes it hard to see what’s true, and what’s exaggeration, distortion or pure fiction. Americans are exposed to a tsunami of fictitious “dangers” from vaping and of an e-cigarette “epidemic” that will put a generation of youth in danger. Of course, no policy measure is too strong when our kids are at risk. But the result of this misinformation cycle is significant. A study last month in JAMA Network Open found that the percentage of American adults who perceive e-cigarettes as equally harmful as cigarettes more than tripled from 11.5 percent in 2012 to more than 36 percent in 2017; those who perceive e-cigarettes as more harmful also tripled from 1.3 percent to over 4 percent. In short, Americans are listening to the alarmism about the “dangers” of e-cigarettes and the teen vaping “epidemic.”  They deserve better from our lawmakers and public health officials. The FDA knows that nicotine is the reason people smoke but it is not the reason that smokers die. Yet officials have not actively communicated this message to the public. Even worse, the FDA has exaggerated the teen vaping problem by manipulating data and incorrectly blaming retailers, in order to justify onerous regulations that will give consumers fewer healthier choices. Meanwhile, the real risks are forgotten. Smoking continues to prematurely kill 500,000 Americans every year, and smoking-related healthcare costs are nearly $300 billion. According to the CDC, more than 16 million people live with a smoking-attributable disease. In recent decades, anti-tobacco crusaders have tried everything to kill cigarettes, including litigation, legislation, taxation and regulation. But their crusade lost its direction when it started to target all tobacco products – even those that don’t contain tobacco.  Officials in international health organizations and national governments know that “tobacco” is not synonymous with “smoking,” yet they purposefullyconflate them.  In desperation, they have tried to kill e-cigarettes and vaping, an innovative, satisfying and vastly safer cigarette substitute. Ironically and tragically, their actions are sustaining and extending the cigarette market.  E-cigarettes contain nicotine – which is addictive – but they lack the toxins in smoke that cause lung cancer, heart disease and other maladies. This substantial difference is what led prestigious British medical organizations like the Royal College of Physicians and Public Health England to deem e-cigarettes at least 95 percent safer than combustible cigarettes.  In fact, the British government’s Department of Health helps smokers switch from combustibles to vapor. The good news is that even though misinformation is rampant, American smokers are still using e-cigarettes more frequently – and more successfully – than FDA-approved medicines to help them quit, according to a population-level studyusing the FDA’s national survey.  In February, British researchers reported in The New England Journal of Medicine that e-cigarettes are nearly twice as effective in helping smokers quit as FDA-approved nicotine medicines like patches and gum. Free and open conversation about truthful information is essential to a healthy democracy. But it’s also critical to establishing sound public health policy. It’s time for Americans to have all the facts about e-cigarettes, so they can make educated choices in order to enjoy longer and healthier lives. Original author: Brad Rodu
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CDC Quit-Smoking Ads Lack Real-World Solutions

People regularly ask me why I’ve spent the last 25 years researching and advocating for tobacco harm reduction and related products.  While it’s difficult to provide a succinct answer, a powerful ad campaign from the Centers for Disease Control and Prevention illustrates why I am dedicated to helping smokers. The campaign is called “Tips from Former Smokers”. For the first 15 years of my career, I was on clinical staff at the Comprehensive Cancer Center of the University of Alabama at Birmingham.  As an oral pathologist I made microscopic diagnoses of hundreds of cancers.  But as a clinician and member of a multidisciplinary team treating countless patients with mouth, throat and lung cancer, leukemia and other serious smoking-related diseases, I was compelled to search for practical quitting options for smokers just like Terrie, the patient in the CDC public service ad above.  Click hereto watch the entire ad. Those smokers reminded me always of my maternal grandfather.  He had smoked for most of his 65 years, despite the onset of heart disease that led to his early retirement from operating a dragline excavatorin the coal strip mines of Western Pennsylvania.  I remember my great-grandfather, an underground coal miner who chewed tobacco until he passed away at age 99, pleading with him: “Worthy, every cigarette is another nail in your coffin.”  My grandfather never quit, and in 1965 he suffered a stroke that left him hospitalized for months before he died.  Every night, my parents drove us 25 miles to visit him. One memory from that sad period is still with me: my grandfather, on oxygen and barely able to move or talk, begging his nurse for a cigarette. For many tobacco opponents, patients like these are only an abstraction, numbers to be wielded in a fight for absolute prohibition.  Most extremists have never worked with smokers suffering from a devastating disease.  If they had, they would care enough to ensure that smokers are offered every option to quit before it’s too late. That’s the frustrating thing about the CDC advertising.  It doesn’t endorse the most frequently used, and most frequently successful quitting aids: e-cigarettes.  Instead, the CDC pitches telephone quit-lines and gives smokers trite advice: “keep your mouth busy…do something else…go for a walk or a jog…take slow deep breaths.”  These tips are worthless for most of those who are desperate for their next cigarette.  What about children?  After my lectures, I am often asked by parents, “What if my child learns about you and your ideas, then starts using smokeless tobacco or e-cigarettes?” My answer: “What if, despite all of your good intentions and nurturing, your child becomes a smoker?  And what if, after 10 or 15 years, they are unable or unwilling to quit?  As a parent, wouldn’t you want your child to know about safer tobacco products?” We have to keep tobacco out of the hands of children, but safer cigarette alternatives must not be regulated out of reach of their parents and grandparents, whose smoking habit leaves them desperate to avoid fatal illness.Original author: Brad Rodu
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The California Crusade Against Tobacco Flavors: From Foolish to Dangerous

Today the California Globe published my oped on the foolish and dangerous legislative effort to ban flavored tobacco products.  Read it here or on the Globe website. “Crusades typically start out by being admirable, proceed to being foolish, and end by being dangerous.” Russell Baker used these words in a 1994 New York Times column describing the anti-tobacco crusade, noting that the holy war was entering the last stage. Now, 25 years later, California legislators are fighting their own crusade—against the so-called teen vaping “epidemic”—with a proposed ban on flavored tobacco products. First, let’s examine the “epidemic.” Authorities generously define “current use” of any drug by children as at least once in the past month. The FDA, using this definition in a national survey, reported that vaping among American high school students increased substantially in 2018. The FDA was only telling part of the story; about half of those kids had vaped five or fewer days, the equivalent of trying products at a party. And most frequent e-cigarette users are not virgins with respect to cigarette smoking; most of them have smoked in the past. Drug use by underage children is a serious matter. That makes it entirely baffling that California legislators ignore higher rates of alcohol and marijuana use among high schoolers, facts that have been known for decades. These behaviors have nothing to do with flavors, but instead demonstrate that kids are attracted to adult behaviors and products. The FDA promotes the myth that a teen vaping epidemic is caused by unscrupulous manufacturers and retailers. This isn’t true, especially in California, where the violation rate in FDA inspections was only 4% in 2018, one of the lowest in the country (here and here). Since retailers aren’t the problem in California, a ban on flavored tobacco products isn’t the solution. This is harassment without reason. Even advocates of alcohol prohibition 100 years ago didn’t try to ban flavors. A flavor ban is supposed to stop kids from using nicotine, but is that a worthwhile objective? Nicotine, while addictive, is not the cause of any diseases associated with smoking. It is as safe to consume as caffeine, another addictive drug used daily by millions of adults and teens. Because nicotine is so safe, prohibitionists fabricate hazards. One frequent claim is that nicotine can harm teenage brains. That may be a legitimate argument – for laboratory mice. If it was true for humans, then 40 million current smokers – and even more former smokers – who started as teens and smoked for decades would have demonstrable brain damage. There is no scientific evidence of such injury, nor to support the claim of youth brain risk. If California legislators want to protect children’s brains, they should ban football, as there is unequivocal evidence linking concussion-producing sports activities to chronic traumatic encephalopathy (here, for example). A flavor ban will not affect vapers who make their own vaping liquids. This segment of the market is already large and growing; a few examples can be found here, here and here. A ban might cause the current retail market to fracture in two: one segment selling concentrated, unflavored nicotine liquids, and another selling flavors. A high-tax jurisdiction like Chicago, where a prohibitively high per-milliliter tax is imposed on nicotine liquids, demonstrates what happens when the market is bifurcated.  Vape shops there sell 30 ml bottles of zero-nicotine e-liquids (no tax) and small concentrated bottles of high-strength nicotine that are taxed.  Flavor bans will simply encourage consumers to purchase flavorless e-liquids, and then buy flavoring that is widely available in grocery stores and online, such as here and here. Unintended Consequences A flavor ban would create unintended consequences. Flavors would no longer be supplied by legitimate companies. Instead, do-it-yourselfers would be adding flavors with unknown chemistry to concentrated nicotine solutions. It is worth noting that the only known death attributable to vapor products in the U.S. resulted from a young child accidentally ingesting pure nicotine. Politicians routinely ignore another basic economic fact: bans drive black markets. Economists and legal scholars use the terms “bootleggers” (black market retailers) and “Baptists” (legislators and other misguided do-gooders), calling them “unlikely allies from the tobacco wars [who] try to fight off a game-changer [e-cigarettes].” Two years ago, California was already the sixth biggest cigarette black-market state. Legislators should not create a bootlegger paradise for flavored tobacco, when they haven’t even solved the bootleg marijuana problem. The legislature legalized cannabis in 2016, but retained high taxes; the black market is now worth $3.7 billion, four times the legal market. The same rush to stigmatize vaping will doubtlessly create a black market in this category, as well. The California crusade to ban flavors isn’t just foolish, it’s dangerous. With the exception of menthol, the ban will have the least impact on sales of cigarettes, the deadliest tobacco products. But it will remove from retail shelves many more smoke-free products – including e-cigarette liquids, dip, chew and snus. These products are vastly less hazardous than cigarettes. Imagine if alcohol opponents had only banned flavors during Prohibition. Beer, wine and other flavored spirits would have been eliminated, leaving only pure alcohol on retail shelves. That policy would have been an abject failure, as would any similar ban on flavored tobacco products.Original author: Brad Rodu
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Broad Tobacco-Related Insurance Premiums Are Unjustified & Injurious

I recently received this email: “I am a 29 year old male from Upper Michigan, married with 3 kids.  My wife and I recently signed on with [company name redacted] as this was one of the only affordable health care options for our family and I like most all of their ‘principles’ or values. “Only 1 problem; they require that you don't use any drugs, drink, smoke, chew, nothing.  I consider myself a healthy individual as I'm 6'3", 200 lbs and fit. I haven't seen a doctor in years, frankly because I haven't a need.  I don't use drugs, drink, or smoke. However, I've chewed Copenhagen snuff for about 15 years and never had a problem with it. I was the one who had 2, maybe 3 small dips each day, a can would last me a week. It was never excessive and never a problem. “For the sake of [company] I quit chewing snuff a few months ago. Since I quit, I've noticed I'm short tempered with my wife and kids.  My performance at work has decreased, and I started gaining weight, and losing sleep. I think about it every day, and I feel no better without it. I feel like [company]'s penalty is harsh for dipping.  And they penalize the same for smoking or other hardcore drugs that I'd never do.  “I found you online, and I admire your courage to speak the truth about smoking and chewing.“Please let me know if you can help educate my health ‘insurance’ company on the truth about chewing tobacco. Any help is appreciated.”______________________________________________________________________________This narrative is not unusual; over the years, I have received numerous similar complaints.  Many smoke-free tobacco users are pioneers; my research group published a study about them in 1995, and I have also told their stories in this blog.   Unfortunately, smoke-free tobacco users continue to suffer from policies that consider all tobacco products – even medicinal nicotine – as equally dangerous, and all tobacco/nicotine users as high-risk.  This conflation of risks improperly raises premium costs, limits employment opportunities and degrades the quality of smoke-free tobacco users’ lives.  It also provides a financial windfall for insurers.  The federal government and health organizations often promote this conflation, and Obamacare legislation codified it, defining“smoking” as “using any tobacco producton average four or more times per week in the past six months.” (emphasis added)  It may be justifiable to charge smokers higher premiums, because they are at risk for many diseases that health insurance must cover and, on average, their lives will be shortened by 8-10 years, justifying higher life insurance premiums.  But use of smoke-free tobacco products which are associated with minimal or no added health risks should not incur such punitive premium treatment.  Many tobacco consumers avoid higher premiums by lying about their lifestyle choice.  Research shows that “tobacco users may be decreasingly likely to report their tobacco use status accurately to avoid surcharges” when enrolling in Healthcare.gov exchanges.  The problem for these individuals is that insurers and employers commonly require urine tests, which readily detect nicotine as long as three to four weeks after use. However, these tests do not distinguish how nicotine entered the body – via smoking or the use of smoke-free tobacco or medicinal nicotine.  As a health professional, I do not condone deliberate misreporting of tobacco use on insurance applications.  However, I do oppose the degradation of smoke-free tobacco users’ quality of life for no legitimate reason. Original author: Brad Rodu
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FDA Approves PMI’s IQOS Heat-Not-Burn Tobacco For U.S. Sales

Today the FDA approved Philip Morris International’s heat-not-burn tobacco system for sale in the U.S., saying in an agency press release: “Following a rigorous science-based review through the premarket tobacco product application (PMTA) pathway, the agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes. The products authorized for sale include the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks.” The FDA approval was issued two years (alternatively, 1 million smoker deaths) after PMI’s application, which is about a year and a half past the agency’s own deadline.  IQOS is only the second product approved under the PMTA pathway.  The first was in 2015 for eight General snus products from Swedish Match.  The FDA action is both good and bad news for e-cigarette and vapor manufacturers and retailers.  The good news is that the PMTA process works.  The bad news is that it took years, and hundreds of millions of research dollars, for PMI to obtain this approval.  By 2022 manufacturers and retailers, who already sell tens of thousands of e-cigarettes and vapor products but don’t have the resources of PMI, will be required to submit PMTAs to the FDA, or risk having them ordered off the market.  Original author: Brad Rodu
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FDA Holds IQOS Heat-Not-Burn Hostage, As Market Forces & Smoke-Free Products Slash Japan Cigarette Sales

The media has been silent about an unprecedented decline in cigarette consumption.  Japan Tobacco International reports (here) that cigarette sales in Japan declined 12% in 2018, largely due to sales of reduced-risk products.  The dominant reduced-risk product in Japan is Philip Morris International’s IQOS heat-not-burn HeatStick. David Sweanor, a veteran tobacco harm reduction advocate in Canada, observed: “Japan provides a great lesson in how tobacco control groups ‘doing nothing’ and ‘staying out of the way’ has led to outperformance in reducing cigarette smoking.  A key question is what could be accomplished if these groups actively facilitated transitions away from combustibles.  Japan has reduced cigarette sales dramatically in just three years, Iceland reduced prevalence of cigarette smoking by 40% in three years, Norway reduced the cigarette market by half in a decade, Sweden achieved by far the lowest rates of smoking in Europe, and the U.S. appears to have tripled the rate of decline in cigarettes sales. All this largely despite, not because, of, actions by mainstream tobacco control. That should be a wake-up call.” Clive Bates, another veteran THR advocate from the U.K., remarked: “The only mystery is why the skies over Tokyo are not dark with chartered planes bringing officials from WHO, FDA, Truth Initiative, the Campaign for Tobacco-Free Kids, the European Commission and others on an emergency mission to learn about this most extraordinary shift.  What is the secret they would find? ‘Do nothing, stay out of the way....’  There was very little involvement from tobacco control – the demise of cigarettes in Japan has been driven by the market and consumer preference.”  Meanwhile, in the U.S., smokers can’t buy IQOS because the FDA has not approved PMI’s marketing application (known as an PMTA), which was submitted in March 2017.  Approval requires the company to demonstrate “that the new tobacco product is beneficial to the population as a whole.”  Nothing benefits a population more than the rapid deterioration of cigarette sales, as seen in Japan. An FDA official recently indicated that a decision on IQOS will be issued by the end of this year.  That would mark the passing of 2.75 years from submission, and the untimely deaths of 1.3 million American smokers. The FDA took eight months (335,000 dead smokers) to grant Swedish Match a PMTA for eight snus products in 2015 (here).  What will happen in 2022, when the FDA receives thousands of PMTAs from vapor manufacturers and retailers? Original author: Brad Rodu
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Bizarre FDA vaping retail restrictions more likely to do harm than good

Caught in its auto-induced moral panic about the teen vaping epidemic, the FDA has decided that it would be better if certain vaping products were harder to get hold of than cigarettes, and the ones that were easiest to get hold of should be the ones most like cigarettes – tobacco and menthol flavour. This seems entirely mad to me and riddled with the potential for unintended consequences that would increase smoking in both adults and adolescents.

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Premium Cigars Threatened by Pending FDA Regulations, with Negligible Public Health Benefit

Chairman Marco Rubio convened a field hearing of the Senate Committee on Small Business & Entrepreneurship on April 5 in Tampa, Florida.  The focus was on proposed FDA regulations’ likely effect on premium cigar production and marketing.  I was invited to testify on the health effects of cigar smoking.  In addition to submitting formal testimony, available here, I made the following remarks at the hearing. As an oral pathologist at a major cancer center 25 years ago, I discovered that Americans, including doctors, are grossly misinformed about the high health risks of cigarettes versus the vastly lower risks of dip and chew.  This launched my tobacco research program that has produced 70 publications in the peer-reviewed medical literature. My research established that smokeless tobacco use is 98% less hazardous than smoking, and that extends to the risk for mouth cancer.   This was confirmed by a large recent study from federal and federally-funded investigators; they found that men who dipped or chewed tobacco had no excess risk for mouth cancer. Zero.   Differences in health effects are also well documented for combustible products.  First, some basic principles.  When you burn tobacco, you release nicotine and about 7,000 other chemicals.  Twenty to 30 years of 10 deep puffs on 20 to 30 cigarettes per day builds high risks for cancers, circulatory diseases and emphysema… leading to a high death toll.  Cigars also involve burning tobacco, but patterns of use are completely different.  The FDA knows that the cigar category encompasses a wide spectrum of products.  On one end are premium cigars; the rest of the category largely consists of machine-made, mass-produced cigarillos, little cigars and filtered cigars. I will reference the latter group as “little cigars”.  In 2014 FDA staff estimated that less than one percent of Americans smoked premium cigars; most light up infrequently.  Consumers of little cigars smoke a lot more often, and they also tend to smoke cigarettes. Premium cigar smokers fit another FDA label, primary (they never smoked cigarettes), as opposed to former smokers and dual users of both products.  This is important because adding cigarettes adds risk.  In my submitted testimony I present detailed information from a published FDA analysis of 22 epidemiologic studies of the causes of death among cigar smokers, most of whom are men.    The FDA study listed many diseases associated with cigarette smoking; the biggest killers are cancers, heart diseases, strokes and emphysema.  Consumption of one or two cigars per day was not associated with significantly increased deaths from any of these.  To be clear, puffing or inhaling the smoke of burning tobacco is not a healthy activity.  But the FDA researchers misstated the facts when they concluded that “…cigar smoking carries many of the same health risks as cigarette smoking.” All tobacco consumers deserve truthful information and guidance.  The sweeping FDA indictment ignores scientific evidence and misleads cigar smokers.  The following facts are indisputable: (1) in the U.S. the prevalence of cigar use, especially premium cigars, is very low; (2) premium products are used infrequently and in small numbers; and (3) they are puffed, not inhaled.  Low prevalence, infrequent use and reduced exposure translates into minimal harm at the population level.  Conflation of cigarette smoking with dip and chew, vaping, cigar and pipe smoking falsely informs consumers that all tobacco products are equally dangerous.  When Congress gave the FDA regulation of tobacco products 10 years ago, it did not direct the agency to treat all tobacco products as equally hazardous.  Unfortunately, the FDA’s regulatory actions have done just that. The FDA’s current posture wastes government resources, undermines public health and does nothing to address the 500,000 annual deaths caused by cigarette smoking. Original author: Brad Rodu
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Some FDA Claims About Teen Vaping Confirmed, Others Evaporate

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

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

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

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