Mitch Zeller, director of the FDA Center for Tobacco Products, should stop making false statements about smokeless tobacco. The FDA earlier this week expanded its smokeless tobacco campaign, arranging a series of interviews for Zeller (example here), whose script included two provably false statements. “Every year more then [sic] 2,000 new [mouth or throat] cancer [cases] are diagnosed in the United States solely caused by smokeless tobacco use.” This number is a pure fabrication. No medical authority, including the FDA, has ever produced such a figure, which is more than 50% higher than the agency’s estimate of two years ago (here). Even that number was a gross exaggeration, due to a serious technical error confusing the historical risks of dip and chew (essentially zero) favored by American men with the higher risks of dry powdered snuff preferred by women (here). The Zeller number is further undercut by last year’s American Cancer Society report which omitted smokeless tobacco as a cause of cancer (here). Zeller also produced this false statement in his latest publicity tour: 2. …“a white spot inside your lip or gum that you know if you’re seventeen eighteen years old and you see that and you don't pay any attention to it, it can progress to things like cancer.” A white patch, as I have documented (here), is simply a reaction to the irritating effect of the tobacco, similar to the development of calluses on a worker’s hand. The link between white patches and cancer is virtually zero for dippers and chewers. As director of an FDA center, Zeller has a profound responsibility to enhance public health and adhere to scientific truth. He damages his own credibility and that of his agency by making false statements. Original author: Brad Rodu
And this "Truth" Campaign "Fact" Isn't Even True One of the oft-repeated "facts" being disseminated by the "truth" campaign is that one Juul pod is equal to 20 cigarettes worth of nicotine.More specifically, the "truth" campaign claims, as its #1 most important fact about Juul that: "The amount of nicotine in one JUUL cartridge is roughly equal to the amount of nicotine in a pack of cigarettes."Joining the "truth" campaign in spreading this factual information is the Centers for Disease Control and Prevention (CDC), whose web site currently states that: "a single JUUL pod contains as much nicotine as a pack of 20 regular cigarettes." This "fact" has spread like wildfire. Just as one example, a parenting article in a news magazine writes: "Each JUUL pod contains the approximate equivalent to 1 pack of cigarettes, or 200 puffs. So, if a user goes through one JUUL pod a day, that is the nicotine equivalent of smoking a pack of cigarettes a day."Similarly, the appropriately named "Scary Mommy" web site warns that: "one Juul “pod” contains 20 cigarettes worth of nicotine (that’s a pack of regular cigarettes)."It's not just scary mommy blogs that are disseminating this "critical fact" about Juul. The high tech-site "Inc." has this to say about Juul: "The secret is its uniquely potent formula--a single pod contains roughly as much nicotine as a pack of smokes."I could go on and on with examples. The Chicago Daily Herald reports that: "Most of Juul's single pods contain the same amount of nicotine as a pack of cigarettes." Collegiate Times tells readers that "Engineered to be much more convenient than a cigarette, JUULs are arguably more addictive as one pod is the equivalent of 20 cigarettes (or a typical pack of smokes)...". Vogue magazine reported that even "Dan from Poison Control" apparently informed one concerned caller that the amount of nicotine in a Juul pod is exactly the same as the total amount of nicotine in an entire pack of cigarettes: "Dan from Poison Control called me back to say that a fresh Juul pod has the same amount of nicotine as 20 cigarettes."One respiratory therapist warned that because a single Juul pod contains as much nicotine as a pack of cigarettes, a youth who vapes is in danger of dying from nicotine poisoning: "Juul, which is one of the most popular brands on the market, contains the equivalent of 20 cigarettes. Many times, a bottle of e-liquid can contain the same amount of nicotine as a pack of cigarettes. That means kids, who might like the flavor and puff, puff, puff and go through the entire container, are taking in 20 cigarettes worth of nicotine. This sudden increase in nicotine can lead to nicotine poisoning, a potentially fatal condition."The Rest of the StoryThere are two severe problems with this claim by the "truth" campaign.First, the message that it is sending to kids is that you are better off smoking 19 cigarettes than vaping one Juul pod. This comparison certainly makes it sound like Juuling is a lot worse than smoking. And if that's the case, then the clear message is that you are better off smoking than Juuling.That's clearly the message that the "truth" campaign and other anti-tobacco organizations and health agencies are sending to public health practitioners. For example, the National Center for Health Research informed its readers that vaping is no safer than smoking. A magazine devoted to asthma and allergies told its readers that e-cigarettes are no safer than cigarettes for kids with asthma.This message is a potentially damaging one from a public health perspective. It undermines the public's appreciation of the severe hazards of smoking and obviously, if any kids end up smoking instead of Juuling because of this information, it could have disastrous consequences.Apparently, I'm not the only one who sees the problem with this message. A number of young people took to Twitter with the same message:"This JUUL thing is so Dumb I wanna smoke 19 Cigarettes.""Hey guys.. time to smoke 19 cigarettes instead of a juul pod cause it’s better for you!!!!" "Okay I’ll just smoke 19 cigarettes instead of my Juul now, thank you for the advice!" "yeah f__k the juul go smoke 19 cigarettes instead."But there's a second, possibly more subtle problem with the claim:It's not true.It doesn't take an advanced math degree to fact-check this claim. We just need two pieces of information:1. The most highly concentrated Juul pod (there are two concentrations) contains 40 mg of nicotine.2. An average cigarette contains about 12 mg of nicotine.Thus, a Juul pod contains the amount of nicotine equivalent to that in about 3 cigarettes (not 20 cigarettes).Moreover, there is nothing terribly unique about the Juul in terms of nicotine content. There are hundreds of varieties of e-liquids on the market that contain 24 mg of nicotine per cartridge, with a cartridge delivering about 200 puffs, similar to a Juul pod. So in reality, the Juul contains less than twice the amount of nicotine present in many other electronic cigarettes.Focusing on the nicotine content obscures a more important factor, one which does actually separate out Juul from most other vaping products. That factor is the rate of absorption of nicotine into the bloodstream. Because of the nicotine formulation used in Juul (i.e., a nicotine salt), it is absorbed rapidly into the bloodstream and the pattern of nicotine levels in the blood over time mimics that of cigarette smoking. This is unlike the pattern for almost every other type of electronic cigarette on the market, which uniformly deliver nicotine quite ineffectively and therefore have a low addiction potential. By focusing on the nicotine content, rather than the formulation, the "truth" campaign and CDC are obscuring the most important information that people need to understand.This commentary is not to minimize the addictive potential of Juul, the fact that there is a high level of nicotine absorption from Juul (much higher than from almost all other e-cigarettes), or that the pattern of nicotine in the bloodstream over time produced by the Juul does mimic that of cigarette smoking. It is just to highlight that there are a lot of exaggerated claims out there and in addition to just being incorrect, some of these claims could actually do public health harm.Note: This post is dedicated to Kimberly Manor, the owner of Moose Jooce vape shops in Michigan: "Kim Shilling Manor smoked 2 1/2 packs of Marlboro reds a day. She smoked even after her husband died of lung cancer and her mother developed lung cancer. Kim quit smoking the FIRST time she tried vaping! It was life changing for her and she opened Moose Jooce so people could see just how easy it was to live smoke free!" It is because of Kimberly, and the literally 2 million other former smokers out there with similar stories, that I continue to try to reveal the "rest of the story."Original author: Michael Siegel
The newly released 2018 Monitoring the Future survey results provide further evidence of a sharp decline in cigarette smoking among high school seniors, coinciding with increased vaping. The rate of current smoking (in the past 30 days) plummeted to 7.6% from 9.7% the year before. Even more impressive, the rate represents a 60% drop from 2011 (18.7%), which is the year that teens started to vape (evidence here). Current vaping (any or no drug) increased in 2018 to 27%, reflecting use of nicotine (21%), marijuana (7.5%) and/or flavors alone (13.5%). Surgeon General Jerome Adams called the increase an “epidemic” and issued a plea for “all hands on deck.” (here). Oddly, federal officials continue to focus more on vaping than on use of intoxicating drugs. High school seniors still used alcohol at a far higher rate than cigarettes (30% versus 7.6%), and over twice as many (18%) reported being drunk in the past month. Marijuana use was 22%; it’s been in this range since 1995. To his credit, most of Dr. Adams’ media comments were evidence-based. That wasn’t the case with the director of the National Institute of Drug Abuse, Dr. Nora Volkow, who said that vaping “might be paving the way for a transition to conventional cigarettes as well as other substances.” (here). I have previously demonstrated that these gateway theories are false and based on fatally flawed research (examples hereand here). The Surgeon General wrongly claimed that nicotine is “very and uniquely harmful” to the developing brain, and his web site asserts that vaping can impair learning and memory in those up to age 25 (here). That claim implies that a significant percentage of the 40 million current smokers and even more former smokers, most of whom started as teens and smoked for decades, have brain damage. There is no scientific evidence to support this allegation. In contrast, there is unequivocal evidence linking youth football and other concussion-producing sports activities to chronic traumatic encephalopathy (CTE) (here, for example). If the Surgeon General and others want to protect children’s brains, this would be a more productive area for their focus. Dr. Adams’s statements were embellished by the usual tobacco prohibitionists, including Dr. Josh Sharfstein of Johns Hopkins University, who said, “There’s no more credible or influential voice on nicotine and tobacco than that of the U.S. Surgeon General.” In fact, the current advisory is only the latest in a series of hyperbolic tobacco pronouncements by surgeons general over the past decades, including Dr. Vivek Murthy (here), Dr. Regina Benjamin (here), Dr. Boris Lushniak, Dr. Richard Carmona and Dr. Antonia Novello (here). In 1992 Dr. Novello predicted “an oral cancer epidemic beginning two or three decades from now if the current trends in spit tobacco use continue” (here). That epidemic was not just a fabrication, it was based on a completely false premise. Original author: Brad Rodu
Jonathan Swift 300 years ago observed that “Falsehood flies, and the Truth comes limping after it; so that when Men come to be undeceiv’d, it is too late; the Jest is over, and the Tale has had its Effect.” (here) That is the story of e-cigarettes and vaping today. Billions of dollars have been transferred from tobacco consumers to companies to the FDA in the form of user fees (here). The FDA, via the NIH, has transferred hundreds of millions to fund university research on tobacco use and effects, in order to provide a “scientific basis” for FDA regulations (here). With NIH making no attempt to hide our government’s objective – “a world free of tobacco use” (expressed here) – it is not surprising that much of the funded research and attendant publicity is biased to support the announced policy objective. In March, anti-vaping researchers published a study claiming that metals in e-cigarette vapor are toxic when inhaled. While the media headlined the findings “dangerous” and “alarming”, and termed vape products “brain-damaging,” I explained in this blog that the metal doses delivered by e-cigarette liquids in this study are trivial. I estimated that an e-cigarette user could be exposed to excessive metal levels only by consuming high volumes of vape liquids. For example, vapers would have to use 15.4 liters (nearly four gallons) of liquid per day to achieve exposure to 2 micrograms of cadmium. (here) I worked with Dr. Konstantinos Farsalinos, a prestigious vaping researcher at Greece’s Onassis Cardiac Surgery Center, the University of Patras and the National School of Public Health. The findings of our risk assessment analysis of the metals study were just published in the journal Inhalation Toxicology (abstract here). The original study referenced U.S. Environmental Protection Agency safety limits that apply to 24-hour air exposure, or to workers breathing factory air for 8 to 10 hours. This standard is entirely invalid for e-cigarette analysis, as users do not inhale vapor continuously for such long periods of time. Dr. Farsalinos and I applied more realistic federal standards, such as established regulatory safety limits for inhaled medicines. We calculated total daily exposure to metals by using an average daily vape liquid consumption of 3 to 5 milliliters (e.g., 3 to 5 grams, around 1 teaspoon). The chart demonstrates that vapers would need to consume impossibly large volumes of liquid in order to exceed the safety limits for almost all metals. The one exception is nickel, which requires only 17 grams of liquid, but even that is over three times normal daily consumption. In this case, truth is limping in eight months after widespread false alarms flew about metals in e-cigarette vapor. The Tale has had its Effect, but in the end, as Shakespeare assures us, truth will out. Original author: Brad Rodu
Yesterday, the first recreational marijuana facility opened in Massachusetts. Out of curiosity, I decided to check out its menu of offerings. Although I thought that this ballot initiative was all about allowing adults to use marijuana for recreational purposes, I was surprised to find a menu that is certain to appeal to youth.The Rest of the StoryHere are some menu items - tell me that they are not going to be appealing to teenagers:Strawberry-flavored chewy bitesLarge, citrus gummy bearsDelectable Belgian dark chocolate bars Assorted fruit-flavored chewsAssorted fruit-flavored cubesRaspberry flavored confectionRaspberry flavored lozengesChewy, cocoa caramel bite-sized treats Raspberry & watermelon flavored lozenges Chocolate-chip brownies.”My point here is that we are in complete hysteria because youth are using flavored e-cigarettes and health agencies want to ban e-cigarettes because they attract youth with gummy bear and cotton candy flavors, yet we are practically encouraging youth to enjoy kid-friendly flavors and varieties of marijuana, doing nothing to address the access of youth to real cigarettes in retail stores, and allowing the unfettered sale and marketing of flavored alcohol products which are used by more high school students than use the Juul and other e-cigarettes combined.I can drive to a store within 10 miles and get flavored alcoholic beverages, menthol cigarettes, and chewy, cocoa caramel marijuana, but I can't buy a Juul flavor multi-pack to help me quit smoking?This is public health in 2018?Original author: Michael Siegel
Tomorrow, the FDA is expected to announce the strictest regulation of cigarettes sales in decades. Spurred by the data showing that nearly 8% of high school students are current cigarette smokers, the FDA will announce that from now on, with just a few exceptions, cigarettes may not be sold in any convenience store or gas station. Online sales of cigarettes will still be allowed, but it will be subject to advanced age verification procedures. The only stores that will be allowed to sell cigarettes without restriction will be those which are only open to adults (or which establish an area that is only open to adults).The FDA said it was forced to take this drastic action because it has evidence that: "a new generation is being addicted to nicotine, and we can’t tolerate that."The tobacco companies intentionally make cigarettes more addictive by adding ammonia to the product, which enhances nicotine absorption. Cigarettes are the most effective known product to deliver nicotine in a pattern that is capable of quickly initiating and then sustaining addiction.According to the CDC, every day more than 3,200 youth smoke their first cigarette. It has been estimated that it only takes four to five cigarettes for a youth to become addicted to smoking. One out of every two long-term addicted smokers will die prematurely, primarily from lung cancer, lung disease, heart disease, stroke, or other cancers. The Rest of the StoryActually, I got it wrong.The FDA is not banning the sale of most cigarettes at convenience stores; it is banning the sale of most fake (electronic) cigarettes at convenience stores.Convenience stores and gas stations can continue to sell real cigarettes - which, despite lower smoking rates, continue to addict a new generation to nicotine - but they will no longer be able to sell electronic cigarettes (with only minor exceptions).Somehow, we have completely lost all sense of public health perspective. Every argument that the FDA is making in justifying a ban on the sale of electronic cigarettes in convenience stores and gas stations applies even more strongly for real tobacco cigarettes: you know, the ones that kill hundreds of thousands of Americans each year. Something is terribly wrong with our sense of perspective when we take the fake cigarettes off the shelf but allow the real ones to remain.So let me attempt to correct this skewed perspective.First, we need to recognize that the problem of youth addiction to electronic cigarettes is not a broad problem of youth becoming addicted to e-cigarettes; it is a very specific and narrow problem of youth becoming addicted to Juul. It is one specific product that is causing the problem.Other than Juul, all other closed system electronic cigarettes do not have high addiction potential because they are actually quite poor at delivering nicotine. Specifically, there is no nicotine spike in the blood, and the nicotine level drops off quite slowly. In contrast, the Juul uses a specially formulated nicotine salt that is absorbed much more rapidly into the bloodstream, and the pattern of blood nicotine levels from Juuling mimics that of a real cigarette. Youth are becoming addicted to nicotine not because they are vaping generally, but because there is an epidemic of Juul use occurring in middle schools and high schools across the nation.However, just four days ago, Juul announced that it would voluntarily stop selling flavored Juul products in all convenience stores and gas stations. In fact, Juul has agreed to stop selling flavored Juul products in any brick-and-mortar establishment. These products will only be available online and with age verification procedures.So this sweeping action by the FDA is not necessary. It will not result in the elimination of flavored Juul sales from convenience stores because that is already occurring.So the rest of the story is that what the FDA's action is doing is to make it much more difficult for adults who have quit smoking to continue to stay smoke-free using their favorite brands of electronic cigarettes, which will be taken off the shelves. Youth will not be able to purchase flavored Juul products from stores, but that was going to happen anyway. The other e-cigarettes that are being sold at these stores (i.e., products other than Juul) have low nicotine addiction potential. It makes no sense to take them off the shelves but to allow real cigarettes, which have extremely high addiction potential, to remain available for sale and distribution to the 3,200 youth who try these products every day.I believe this action will have a net negative impact on the public's health because it will almost certainly result in many ex-smokers returning to smoking as their products disappear from convenience store shelves.What the FDA should have done is to deal directly with Juul and demand that they voluntarily remove their flavored products from the shelf and bolster their age verification procedures for online purchases. But since Juul has already agreed to this, there is no need for this drastic regulation, especially because cigarette sales are being left unencumbered.One might argue that the reason that Juul agreed to remove their flavored products from the shelf is that they anticipated this FDA regulation. If that is the case, then perhaps the threat of regulation was successful in achieving this result. But now that Juul has agreed to take most of their products off the shelves, the FDA should not proceed with the regulation. Unless it is sincerely concerned about youth becoming addicted to nicotine, in which case it should ban all cigarette sales in brick-and-mortar establishments that are not restricted to adults.Original author: Michael Siegel
Recently a special issue of the journal Tobacco Control offered 22 articles on Philip Morris International’s (PMI) IQOS heat-not-burn tobacco product (here), aiming to dissuade the FDA from allowing IQOS sales as reduced risk products for smokers. In the words of editor Stanton Glantz: “Policy makers should give greater weight to the advice provided by public health scientists than to submissions from industry when it comes to regulating tobacco products such as heated tobacco products.” Dr. Glantz’s advice has been inaccurate in the past. A year ago, when he argued that “PMI’s own data fails to support a modified risk claim in people who are actually using [IQOS],” I detailed the errors in his analysis (here). This new collection of anti-IQOS articles deserves the same scrutiny. One treatise, by UCSF’s Gideon St. Helen and colleagues, acknowledges that “All substances in PMI’s list of 58 constituents (PMI-58) were lower in IQOS emissions compared with mainstream smoke of reference cigarettes.” That accurate statement is followed by the suggestion that PMI ignored that “levels of 56 other constituents, which are not included in the PMI-58 list or FDA’s list of [harmful and potentially harmful constituents], were higher in IQOS emissions.” The authors criticize PMI for not undertaking “non-targeted chemical analysis” to identify these compounds. Dr. St. Helen et al. are mistaken. The chart above, taken from PMI’s presentation to the FDA advisory committee last January (here), documents that the company performed that analysis. PMI’s extensive investigation of “other” substances is confirmed on the FDA website, where a chart labeled “non-targeted screening” appears in a document submitted by PMI on December 8, 2017, and published by FDA on January 12, 2018 (here). The December filing acknowledged that “80 compounds were found to be of higher concentration or new in [IQOS] aerosols…compared to cigarette smoke. A toxicological assessment was performed and identified 68 of those that do not present specific toxicological concern. 8 compounds present potential genotoxic concerns based on structure-activity computational alerts and 4 compounds are classified mutagens/carcinogens.” PMI scientists did not dismiss the findings: “Although a minor subset of compounds identified in this study show intrinsic (potential) toxicological hazards, overall toxicity of the THS generated aerosol was lower compared to cigarette [smoke]. In vitro studies demonstrated a marked decreased biological activity of [IQOS] aerosol compared to smoke. An in vivo 90 days inhalation study showed in general a lower biological activity of the mainstream aerosol from [IQOS] when compared to mainstream smoke.” Importantly, PMI is undertaking more research: “Additional investigations are ongoing to further characterize the impact of the [mutagens/carcinogens] on the overall toxicity of [IQOS] products.” Original author: Brad Rodu
It’s surprising how many fundamentally flawed e-cigarette studies are aggressively promoted by their authors and allied organizations as grounds for FDA regulatory action. It is also concerning when authors refuse to acknowledge or respond to honest scientific inquiries about their research. Here is a representative case involving researchers associated with Truth Initiative, a non-profit anti-tobacco organization. Researchers led by Donna Vallone, Ph.D., recently published a study in Tobacco Control on the “prevalence and correlates of JUUL [e-cigarette] use among a national sample of youth and young adults (here).” While they reported that the overall prevalence of ever and current (past 30-day) JUUL use was 6.0% and 3.3% respectively, they failed to disclose information about the most important correlate of JUUL use – other e-cigarette use. The authors noted that among underage children (15-17 years), current JUUL use was 6% and current use of combustible tobacco was 7%. They connected these, finding that children who were currently smoking were five times more likely to use JUUL than non-smokers. However, 11% of children in that age group currently used e-cigarettes. They ignored this important correlate in their analyses. Instead, they inexplicably included e-cig use among other members of the youths’ households. There are other significant problems with this study. First, youths and young adults were asked: “…on how many days did you smoke a Juul vape?” (emphasis added) That wording likely confused participants. Second, the authors didn’t define current use of e-cigarettes, nor did they even give any description of the question in their survey. Third, the survey flow for JUUL and e-cigarette questions was not provided. Were separate questions about these products asked of all participants, or did researchers ask first about e-cigarettes, and then only ask current e-cig users if they used JUULs? Fourth, Vallone et. al. defined JUUL “regular use” as 10-30 days in the past month, and they reported that 25% of youth fell into this category. That percentage is grossly inflated. The CDC and other authorities use a more credible “frequent” category of 20+ days (hereand here), which would generate a lower percentage of users at risk. In summary, Vallone et. al. produced an error-ridden study focused on JUUL “smoking,” while ignoring the effect of other e-cigarette use. The obvious problems ought to have been resolved in peer review. Additional questions remain, owing to the fact that the authors used a private dataset. When Truth Initiative posted the study on the Society for Nicotine and Tobacco Research listserv, I asked the authors to resolve some of these problems; they did not acknowledge my listserv post. Original author: Brad Rodu
In the hierarchy of teenage risk behaviors, government data shows that vaping pales compared to drinking-, driving- and weapon-related activities. It is remarkable that public health officials and the media focus so greatly on the former, to the detriment of teen safety and health.A report from the CDC earlier this year (here), based on the 2017 Youth Risk Behavior Survey (YRBS), allows us to put the data in context.The prevalence of past-month e-cigarette use in the 2017 YRBS was 13%. That rate is higher than those for cigarettes (8.8%), cigars (8.0%) and smokeless tobacco (5.5%). However, as I discussed recently (here), the vaping rate pales next to those for marijuana (19.8%) and alcohol (29.8%). In fact, the e-cigarette rate is nearly identical to the rate for binge drinking (4 or 5 drinks within a couple hours). These rates of drug use are troubling, but there is much worse in the federal report for parents and policymakers to be concerned about. Following is a list of other risky behaviors by high school students in the past 30 days..nobr br { display: none } td { text-align: center} Prevalence (%) of Risky Behaviors Among American High School Students (YRBS, 2017)Past 30 DaysRarely/never wore a seatbelt (as an occupant)5.9%Rode with driver who had been drinking16.5%Drove after drinking5.5%Drove after marijuana use13.0%Texted or emailed while driving39.2%Carried a weapon (e.g. gun, knife, club)15.7%Past 90 DaysHad sexual intercourse28.7%..…and used condom, 53.8% of previousPast YearInvolved in physical fight23.6%Physically bullied on school property19.0%Electronically bullied14.9%Felt sad or hopeless31.5%Considered suicide17.2%Made suicide plan13.6%Attempted suicide7.4%Media coverage of the CDC YRBS report (here) was largely confined to the sensational -- “Fewer teens having sex and using drugs, CDC says.” The absence of focus on the more prevalent and dangerous behaviors in part reflects the FDA-led public health community fixation on vaping. This may stem from the fact that, of the many greater-risk categories outlined by the CDC, the FDA’s regulatory authority only extends to tobacco. To a federal agency with a hammer, everything is a nail.Original author: Brad Rodu
In his recent Nicotine & Tobacco Research commentary, “The Future of Nicotine Regulation,” FDA Center for Tobacco Products director Mitch Zeller listed five “challenging questions.” I offer the following answers. 1. How comfortable are we with long-term, or possibly permanent, use of less harmful nicotine delivery mechanisms by adults, if they help keep currently addicted smokers from relapsing to combustible tobacco products? If addicted smokers stay smoke-free by using less harmful smoke-free alternatives, everyone who is not a tobacco prohibitionist is probably comfortable with long-term use. The harm of permanent nicotine use is of the same magnitude as that of permanent caffeine consumption. Most are comfortable with chronic consumption of caffeinated drinks, by adults and teens. While the FDA does now acknowledge tobacco harm reduction, the agency still does not adequately distinguish the harm differential between smoke and smoke-free products, nor does it promote smokers’ transition to vastly safer products that have been on the market during the nine years of FDA regulation. 2. How much weight should be placed on diminished interest in quitting nicotine altogether? None. 3. Given the potential health impacts of dual use of tobacco, how acceptable is a short period of dual use while transitioning to less harmful nicotine-containing products? What if many current smokers engage in dual use on a long-term or permanent basis? For smokers trying to quit, dual use of cigarettes and smoke-free products is a common practice which can occur over varying periods of time. Currently, owing to nonstop campaigning by federal authorities and health organizations, most American smokers believe incorrectly that smokeless tobacco and e-cigarettes are as dangerous as cigarettes (hereand here). Nine years ago I wrote in this blog: “In 2005, there were 1.4 million American men who were dual users of both cigarettes and ST [smokeless tobacco] products. These men consumed nicotine both from cigarettes and from ST, and the latter clearly resulted in lower consumption of the former. In both 2000 and 2005, every-day smokers who also used ST every day consumed significantly fewer cigarettes on average than exclusive smokers (13 cigarettes per day vs. 20 cigarettes). If these dual users knew that ST products were only 1% as hazardous as cigarettes, it is possible that many would have chosen to use only ST.” (here) 4. Can we revise labeling and indications for medicinal nicotine to increase quitting? Of course, but this question is unrelated to tobacco harm reduction. Medicinal nicotine is regulated by the FDA Center for Drug Evaluation and Research, not the Center for Tobacco Products, and the former has been futzing and diddling around with medicinal nicotine for decades (here). In 1995, the Pittsburgh Tribune-Review published my open letter to FDA commissioner David Kessler, urging him to make medicinal nicotine products more available to smokers (here). The FDA did nothing to make them more effective or more affordable. In February 2008, New York State Health Commissioner Richard Daines petitioned the FDA for revised package labeling and sales regulations for nicotine products – changes that would have greatly expanded product availability and consumer awareness. The petition was supported by numerous tobacco research and policy experts and organizations. The FDA failed to issue a response. 5. How might youth initiation be affected by the availability of different nicotine-containing products and how should we account for youth uptake of these products? Teenagers have always been attracted to adult-oriented products and adult behaviors. Teens are drawn to tobacco and alcohol, which are illegal for those under 21; many teens use marijuana, which is illegal for all or age-restricted in the various states (here). It is not uncommon for teens to drive cars and have sex, two adult behaviors that can be high-risk. Uniquely, tobacco use is regulated by a federal agency, the FDA, which now asserts that tobacco manufacturers are responsible for teen tobacco use. Everyone has a role to play in limiting teenage risk-taking, but focusing blame on manufacturers while ignoring other regulatory and information-sharing solutions ill serves the entire population. October 24. Clive Bates has just published his answers to Mr. Zeller's questions. Please read them here. Original author: Brad Rodu
Sixteen percent of high school exclusive vapers in the 2017 National Youth Tobacco Survey (NYTS), or 184,000 out of 1.15 million, were 18 years of age or older, meaning that they could buy tobacco products legally. Legal-age students also constituted one-quarter of high school smokers and 23% of dual users, according to the NYTS and shown on the chart at left.Legal-age students are themselves the most common source for e-cigarettes among underage students, as the following table shows. The majority of underage students (74%) obtained e-cigarettes from family members, friends and others. The next biggest source was vape shops (12%). The Internet, which was singled out by FDA Commissioner Gottlieb in his recent announcement, was the source for fewer than 5% of underage vapers. .nobr br { display: none } td { text-align: center} E-Cigarettes Sources for Underage High School Users, 2017SourceFriend64.0%Family member5.8%Other person4.0%Vape shop11.8%Internet4.7%Other retail3.6%Gas station/convenience store3.4%Mall kiosk1.4%Drugstore1.2%Grocery storeUnder 1% Retailers must stop selling e-cigarettes to underage youths, and the FDA is responsible for enforcing that rule. However, it is critical that regulators and the public address the fact that friends and family are the biggest contributors to underage use. N.B. Thanks to Bill Godshall for suggesting this assessment.Original author: Brad Rodu
