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

by Carl V Phillips

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

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

May 15th, 2019

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

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

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

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

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

by Carl V Phillips

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

by Carl V Phillips

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.

Parents of a Florida teenager who became addicted to Juul have sued Juul, Altria, and Philip Morris USA based on a number of claims, including fraud, negligence, and violation of the RICO statute (the compliant is here). Dr. Stan Glantz and Lauren Lempert provide a nice summary of the reasoning behind the lawsuit and the specific claims being made. The case was filed on Monday in the federal district court for the middle district of Florida.The Rest of the StoryAlthough the main complaint is that the company fraudulently provided misinformation about the product, its health risks, and its addictiveness, the complaint itself provides a huge amount of misinformation and distortion of the scientific facts related to vaping and Juul. Here is a sampling of the false or completely unsupported information that is claimed in the complaint:1. Vaping causes chronic obstructive pulmonary disease (COPD): The lawsuit claims that "just like traditional cigarette smoke," vaping causes COPD because it "introduces foreign substances into the lung." There is absolutely no evidence to support this claim. Despite at least 12 years of use and prolonged vaping by millions of Americans, I'm not aware of a single case of COPD that has been documented to be caused by vaping. While vaping does cause acute respiratory irritation, there is no evidence at this point that prolonged exposure to e-cigarette aerosol is extensive enough to cause permanent lung obstruction.2. Nicotine is a carcinogen: The lawsuit claims that "nicotine itself is a carcinogen." The leading, objective, international body that studies carcinogens (the International Agency for Research on Cancer [IARC]) has not declared nicotine to be a carcinogen.3. Juul delivers carcinogens to users: The lawsuit claims that Juul "delivers toxins and carcinogens to users." However, the complaint does not specify exactly what toxins or carcinogens Juul delivers to users. Studies of the aerosol produced by Juuling, to the best of my knowledge, have not demonstrated the presence of detectable levels of carcinogens.4. Juul is designed to transition users to cigarette smoking: The lawsuit claims that Juul is designed to make it "easier for e-cigarette users to transition to conventional cigarettes." The truth is the exact opposite. Juul was designed specifically to transition conventional cigarette smokers to vaping. Juul Labs would be stupid if they designed the product such that its users would transition back to smoking. The company makes no money if its users go back to smoking. In fact, the economic incentive for Juul is to eliminate smoking altogether. The more smokers who switch from conventional cigarettes to Juul, the more money the company makes. There is abundant evidence that Juul has succeeded in transitioning hundreds of thousands of smokers away from conventional cigarette use, but no evidence that Juul has transitioned anyone to cigarette smoking.5. Juul is defectively designed: The lawsuit claims that the Juul e-cigarette is "defectively designed" because it delivers nicotine so effectively. The truth is that this is actually an incredibly effective design because it provides the greatest chance that a smoker will successfully quit smoking by switching to vaping. The problem with most other e-cigarettes is precisely that they do not deliver nicotine effectively. Juul corrected this problem and as a result, it has become the most effective smoking cessation product currently on the market. This is demonstrated by the tremendous market share that Juul holds among adult smokers trying to quit. 6. Juul aggravates nicotine addiction in cigarette smokers: The lawsuit claims that the company knew that Juul "posed a risk of aggravating nicotine addiction in those already addicted to cigarettes." There is no evidence to support this claim and the truth is likely the opposite. While smokers who switch to Juul are obviously still addicted to nicotine, they are no longer addicted to smoking. The behavior of smoking is a huge component of the addiction to nicotine that is observed in cigarette smokers. By eliminating that aspect of the addiction, the overall addiction is almost certainly lessened.7. Juul fails to inform users that its product has not been found to be safe: The lawsuit claims that the company "fails to inform users that its products have not been found to be safe." The truth is that Juul says right on its web site that: "No tobacco-based or nicotine e-liquid product should be considered safe." In addition, Juul informs customers that: "Inhalation of e-vapor from JUUL may aggravate pre-existing respiratory or heart conditions. Additionally, ingestion of nicotine, at any level, may cause other conditions (such as an increase in your heart rate and blood pressure, may cause dizziness, nausea, and stomach pain)." The company also warns users about ingesting the e-liquid, informing them that the product: "Contains nicotine, which is an addictive chemical and can be poisonous. Avoid contact with skin and eyes. Do not drink."8. Juul falsely claimed that it is not affiliated with Big Tobacco: It is true that Juul claimed that it had no affiliation with Big Tobacco. But that was prior to its partial acquisition by Altria. You can hardly blame the company for making a true statement, as long as they no longer make that claim. A Google search revealed that, ironically, the only current internet source of the claim that "Juul Labs is not Big Tobacco" is the lawsuit itself.9. Juul and Altria plan to use Juul as an entry point for youth to start smoking Marlboro cigarettes: Not only is there no evidence to back up this claim, but it is patently ridiculous. You don't get kids addicted to Marlboro by marketing Juul. You get kids addicted to Juul by marketing Juul. Data from the PATH study demonstrate that becoming a regular vaper is a path away from smoking, not towards smoking. In fact, the only kids who currently progress to smoking are those who do not become regular vapers. Why would a company think that by addicting kids to a mango-flavored product, they would suddenly develop a desire for the harsh taste of Marlboro? Altria may have a history of being sinister, but they are not stupid.None of this is to deny the fact that Juul use among youth has become a serious public health problem that needs to be addressed urgently. None of this is to deny that Juul carries some responsibility for having created the problem. However, it doesn't seem fair to file a lawsuit against the company for making false claims by putting false claims into the complaint.Ultimately, I go far beyond nearly all of my colleagues in public health because I believe that the use of nicotine salts is simply not a viable long-term option for a harm reduction strategy that is based on trying to get smokers to switch to vaping. Nevertheless, I don't think it is appropriate to sue the company based on alleged facts that are either completely undocumented or simply untrue.Original author: Michael Siegel

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

A new study published online ahead of print in the American Journal of Medicine reports that there is no association between vaping and cardiovascular disease among never smokers.Like previous studies of its kind, this was a cross-sectional study that examined the association between current vaping/smoking status and ever having been told that one has cardiovascular disease (including heart attack, coronary artery disease, or stroke). Previous studies used data from the National Health Interview Survey (NHIS) or the Population Assessment of Tobacco and Health (PATH) study; this paper used data from the Behavioral Risk Factor Surveillance Survey (BRFSS).The authors reported no association between current vaping and self-reported cardiovascular disease among never smokers. However, they found that among current dual users there was an increased odds of having ever been told that one has cardiovascular disease.In response to the study, one prominent tobacco control researcher concluded that dual use is causally associated with cardiovascular disease, while dismissing the negative finding that e-cigarette use was not associated with vaping among never smokers. He wrote: "The fact that the authors did not find an effect of e-cigarettes alone may be because they stratified the sample on e-cig and cigarette use, which reduces the sample size for each comparison, and so the power to detect an effect."The Rest of the StoryThis reminds me of what the tobacco industry used to do. If they saw a finding that they liked, they would emphasize that finding, but if they saw a finding that they didn't like, they would just dismiss it. This is sometimes called "cherrypicking." I've never picked cherries, but I assume that when doing so, one only picks the cherries that you like and disregards the ones that you don't.As objective scientists, we can't cherrypick. It allows one to have a pre-conceived conclusion and then to simply publicize findings that support the conclusion while dismissing those that do not. It appears that this is what is going on here.Cherrypicking is becoming more and more common among tobacco control researchers and advocacy groups. Recently I spoke at a conference on vaping, and one of the other speakers on the panel told the audience that there was no evidence vaping can help people quit smoking. The basis of that conclusion was that "there is no clinical trial that shows vaping to be effective ... we need a clinical trial." When I then pointed out that a randomized, clinical trial published last month in the prestigious New England Journal of Medicine found that vaping was twice as effective as nicotine replacement therapy for smoking cessation, they simply dismissed it, saying: "Well I still don't think it's effective." (The same person also did not think there is enough evidence to conclude that vaping is any safer than smoking.)The reality is that many tobacco control researchers and advocates will not be convinced by any amount of data. You could have two clinical trials, both finding that vaping is effective for some smokers, and they would still dismiss the findings. (In fact, we do have two clinical trials -- it's amazing to see how many tobacco control advocates continue to insist that there have not been any clinical trials on the use of vaping for smoking cessation.)Here, a positive finding is accepted and touted, while a negative finding is just dismissed. The reasoning given -- that the study didn't have the power to detect an effect -- doesn't hold water because the sample size of never smoking vapers in the study (15,863) exceeded the number of dual users (12,908).But even the conclusion that dual use is causally associated with cardiovascular disease is unsupported by the evidence presented in the paper. This is a cross-sectional study, so it is entirely possible that the onset of cardiovascular disease preceded the vaping. In fact, this is almost certainly the case for most of the study subjects because e-cigarettes have been popular for only about eight years, and it takes decades for cardiovascular disease to develop.It may actually be that the cardiovascular disease "caused" the vaping because having a heart attack or stroke is a strong stimulus for a smoker to try to quit, and many smokers try to quit by using e-cigarettes.Moreover, dual users are almost certainly a different population from exclusive vapers and one systematic difference between the groups is likely that dual users have a heavier or more intense smoking history, making it more difficult for them to get off of e-cigarettes. If this were the case, it would explain the observed finding that dual use was associated with a higher risk of reporting cardiovascular disease.  The bottom line is that we can't draw causal conclusions from a cross-sectional study like this one, especially one in which it is impossible to determine which came first: the heart attack or the vaping. So to tout the association between dual use and heart disease as a causal finding is bad enough. But cherrypicking findings that support a pre-determined conclusion, while dismissing those which do not support that conclusion, is sinking to the level of the tobacco industry which we once criticized for doing the very same thing.Original author: Michael Siegel

by Carl V Phillips

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

by Carl V Phillips