Category: EVALI

Inside Perspective
The vapor industry makes an economic impact of more than $24 billion in the U.S. The news media is now being more responsible in its reports surrounding lung disease caused by black market THC vapor products. Speaking at TABEXPO, a vapor and tobacco trade show that was held in Amsterdam in November, Maggie Gowen, the executive director of the Global Vaping Standards Association (GVSA), said the e-cigarette and vapor industry in the U.S. is larger than the country’s iron and steel industry and employs nearly as many people as the commercial fishing industry. The industry has produced over 166,000 jobs, and wages and benefits earned are about $8 billion.
Gowen also updated attendees on the recent rash of lung disease caused by black market THC vapor products. “Over the last three months, the U.S. government health agencies have done a terrible job separating nicotine-based vaping products versus illegal black market THC vaping products. And as a result, they have conflated the two issues. The two agencies issued conflicting warnings to the public,” she said.
The U.S. Food and Drug Administration (FDA) was a bit more responsible, warning the public “to stop using THC-containing” vapor products while the U.S. Centers for Disease Control and Prevention (CDC) recommended consumers “stop using e-cigarette products” altogether, said Gowen. “As a result, the media went into a frenzy and began to sensationalize the headlines. Vaping death headlines soared throughout the national news outlets, becoming the top stories in the morning and evening news for weeks. The vaping industry quickly came under attack. And, unfortunately, the CDC did nothing to clarify their warnings. Instead, they choose to continue to lead their reporting with self-reported patient claims.”
Gowen explained that the panic then trickled down to individual states. Some governors used their executive powers to issue statewide emergency bans on nicotine-based vapor products, especially attacking and targeting flavored vapor products. “To counter this, many industry stakeholders are joining forces and filing lawsuits, but as we know, that takes time, and businesses and supply chains are being greatly affected,” she said. “Many vape shops have already closed their doors. Many other businesses are reporting double-digit declines as a result of the issues.”
As of today, the CDC and the media are reporting a little more responsibly, according to Gowen. The latest CDC warning recommends that consumers do not use e-cigarettes or vapor products containing THC. A stark contrast from the organization previously stating not to use e-cigarettes at all. “As a result, the headlines are slowly improving and telling a more realistic story. We are seeing, in my opinion, more responsible reporting,” said Gowen. “THC vaping products are actually in the headlines. Michigan, which was the first state to impose an emergency ban, is now reporting that [a] ‘Michigan resident dies from vaping-related illness as state remains silent about black market THC.’ Other media outlets, such as CNN, are warning consumers to ‘stop using THC vaping products.’ This is a stark contrast to the reporting in September.”
February 25, 2020
Merchants of Doubt

Credit: Pathdoc
In the vaping debate, falsehood flies and the truth comes limping after it
For those of us who support the public health strategy of tobacco harm reduction, it has been a tough few months. Several crises emerged suddenly and the boundaries between them have become blurred: an outbreak of severe lung injuries and deaths, a sharp rise in youth vaping in the United States and the claim that e-liquid flavors are the problem and should be banned.
The satirist Jonathan Swift summed it up pretty well in 1710:
“Falsehood flies and truth comes limping after it so that when men come to be undeceived, it is too late; the jest is over, and the tale hath had its effect; like a man, who hath thought of a good repartee when the discourse is changed, or the company parted; or like a physician, who hath found out an infallible medicine, after the patient is dead.”
What can be done? Falsehood has certainly flown, but could the truth at least break into a jog? Let us examine these crises and try to determine what is true and what is false.
Vaping causes severe lung injury and death: true or false?
As of early December, 2,291 vaping-related lung injury hospitalizations and 48 deaths had been recorded in the United States. Many have assumed nicotine e-liquids are implicated. Because the problem emerged in a specific place (the United States) and at a specific time (from July 2019), it was already clear in July 2019 that this was a specific supply chain problem. It had not affected vaping before and had not affected the millions of vapers in the rest of the world. It soon emerged that the cases were dominated by specialized vapes used for cannabis THC oil. The focus should, at that point, have narrowed to the illicit THC vape suppliers with a clear message exonerating commercial nicotine liquids. Instead, major public health agencies became “merchants of doubt,” maintaining that any vapor product was suspect. However, the chance of a parallel problem occurring in the legal and regulated nicotine e-liquid supply chain at the same time, in the same geography and with the identical symptoms is vanishingly small.
A minority of the users afflicted had denied or refused to confirm use of THC, so there was some doubt. Of course there was doubt! People do not readily admit to using illicit substances because it can get them into trouble with parents, at school or college, or with their employer. Whenever actual tests were done or when users were pressed harder to tell the truth, THC vaping reliably emerged.
The mystery doesn’t end there because THC oil itself is not the issue—there are many THC vapes that do not cause this problem. The investigation narrowed further to identify vitamin E acetate as one likely cause. This is used as a thickener to cut expensive THC oil for economic reasons. This is a lipid, a fatty substance that can have exactly the effect on the lungs that has been seen. There is no question of this being added to nicotine liquids. It is not soluble in nicotine liquids and would serve no purpose as there is no reason to thicken nicotine liquids.
The truth: The lung injuries are a serious problem, but they are nothing at all to do with commercially available nicotine e-liquids. The ultimate problem here is a black market supply chain opportunistically experimenting with novel and untested formulations with no accountability for health consequences. To pretend otherwise is to cause three harms: sending a diluted and contradictory message to THC vapers that may put more lives at direct risk; frightening regular nicotine vapers back to smoking and smokers away from vaping with longer term health consequences; and promoting bad policy responses, like flavor bans, that will tend to increase black market activity and make the problem of adulteration in the supply chain more likely and vaping more risky.
There is a youth vaping epidemic: true or false?
The falsehoods here lie in the interpretation of the headline statistics—what you see if you drill down into the data. First, the headlines. In the United States, vaping among high school students rose from 11.7 percent in 2017 up to 20.8 percent in 2018 and on to 27.5 percent in 2019. A dramatic rise by anyone’s standard and undoubtedly a cause for concern.
But there are three other factors to consider in a drill down. The headline figures refer to any use of an e-cigarette, even a single puff, in the past 30 days, so what is the breakdown between infrequent and frequent use? How many of the frequent vapers also use other tobacco products? For them, vaping may be beneficial. The rise in youth e-cigarette use has been described as an “epidemic of nicotine addiction.” How many show signs of dependence?
The data to address these questions is only available for 2018, but this breakdown of the headline 20.8 percent vaping figure provides a useful illustration:
NYTS 2018 dataPercentage of high school students using e-cigarettes Total = 20.8%High school students No past tobacco use Any past tobacco useFrequent e-cig use: ? 20
days per month0.6%5.2%Infrequent e-cig use: ? 19
days per month4.7%10.3%
First, most adolescent vapers (72 percent) are not frequent users and therefore provide less reason to be concerned. Second, most of the frequent adolescent vapers (90 percent) were already tobacco users. Only 0.6 percent of high school age vapers are both frequent users and have no prior history of tobacco use—and it is also important to recall that smoking is much more harmful than vaping, but in 2018, 13.9 percent had used any combustible product in the past 30 days. Smoking remains the bigger problem.
Turning to the third question of dependence, the analysis of U.S. youth e-cigarette data by epidemiologists Martin Jarvis and colleagues (Epidemic of youth nicotine addiction? What does the National Youth Tobacco Survey reveal about high school e-cigarette use in the USA?) shows little sign of teenage vaping uptake causing nicotine addiction.
“Data from the National Youth Tobacco Survey do not support claims of a new epidemic of nicotine addiction stemming from use of e-cigarettes …. Among current e-cigarette users who had never tried tobacco products, responses consistently pointed to minimal dependence.”
The truth: Many young Americans are trying vaping, but most are not vaping frequently, and it isn’t an especially dangerous youth behavior compared to smoking, using illicit drugs and using alcohol excessively. The frequent or daily vapers are mainly those using other tobacco products. For them, vaping may be a beneficial diversion from smoking. There is reason for concern, but there should not be an overreaction.
The rise in U.S. youth vaping is driven by flavors: true or false?
At one level, it is obvious that e-liquid flavors are important—if vendors could only sell unflavored products, there would be few buyers of any age. E-cigarettes are an inherently flavored product in much the same way that pizza would not be pizza without a topping.
There is much to suggest that flavors form part of the appeal, but they are not the main reason why young people take up vaping. The story is far more complicated: The more credible academic work (e.g., see Nicksic et al. 2019) suggests uptake of vaping is driven by replacing cigarettes and by the “wider social environment.” Flavors are a factor, but they are far from the most important factor. The most recent official analysis of U.S. youth data included reasons for youth vaping uptake (MMWR Table 6). The most important reason given was “I was curious about them,” cited by 56.1 percent of exclusive e-cigarette users. “They are available in flavors, such as mint, candy, fruit or chocolate” came a distant third at 22.3 percent.
The idea of limiting flavors to just tobacco flavor would be like limiting pizza toppings to allow only a simple Marherita. In both cases, it would kill the category and shut down all the vape shops. The likely response would be an uptick in smoking, a black market in flavored products, home flavor mixing and more international internet trade. No one would gain, and many would lose.
The high score for curiosity raises an intriguing question. Has the barrage of breathless media coverage, official school-based anti-vaping campaigns, parent mobilization and political outrage actually been a stimulus for youth curiosity about vaping? Is the reaction part of the cause? We can safely assume that no one involved will fund that research.
The truth: The reasons young people take up vaping are similar to the reasons they take up smoking and can include unpredictable and largely uncontrollable fads and fashions. Vapor products would be nothing without flavors, and banning them would have a range of harmful effects and do little to protect youth from actual harms. If governments want to control flavors, they should focus on flavor descriptors and branded imagery that are aimed at adolescents, not the actual flavors themselves.

Clive Bates
Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
February 18, 2020
Weathering the Storm
Many small vapor businesses have not been able to recover from the EVALI panic caused by the U.S. CDC.
By John Castle
Any small business is liable to face obstacles, including financial, logistical and bureaucratic issues. A small business in an industry centered on disruptive technology also faces not only those obstacles but outright hostility from their well-entrenched and well-funded legacy industry competitors. Add on various levels of government dependent on the revenue generated by those legacy competitors and going into business can, in a sense, mean going to war.
By now, we all know what happened in the late summer of 2019. To give the following its proper context, however, perhaps a very brief recap is in order. Beginning in July and progressing into August, adolescents began arriving at local hospitals with symptoms similar to those of acute lipoid pneumonia. Each patient said they had been vaping (either THC, nicotine or both).
On Aug. 23, the first reported death related to this phenomenon emerged from Illinois health officials. It would not be until December 2019 that the U.S. Centers for Disease Control and Prevention (CDC) would conclusively state that the culprit behind the illnesses and deaths was not nicotine vaping but the use of black market THC products adulterated with vitamin E acetate. By then, the damage caused by their ambiguous reporting and the ensuing media firestorm was unrepairable.
Many small businesses faced devastation and even closure as a result of lost sales that were driven both by consumer fears and regulatory overreaction. States like Massachusetts and New York enacted bans, amplifying a trend that had previously been seen only at the municipal and county levels in states such as California. The panic caused by what the CDC has labeled e-cigarette or vaping-associated lung injury (EVALI) was so powerful that it reached the United Kingdom.
Andy Brown, an employee at a vape shop in Mildenhall, England, for the past three years, came into the business prior to the establishment of the European Tobacco Products Directive (TPD). With a small-town shop surrounded by three American military bases, most of Brown’s customers were American service members.
Brown explained that shortly after the crisis began in the U.S., British wholesalers and others in the trade stated that average sales were down 30 percent to 50 percent across the country. “The subsequent news articles around the world have since undone so much hard work in harm reduction. People that had switched from smoking to vaping were returning to cigarettes believing that it was the safer option,” Brown said. “This has been an issue worldwide, and despite the truth eventually coming out about the real cause of the illnesses and in the U.K. Public Health England and the Royal College of Physicians standing by their well-researched claims that vaping remains at least 95 percent safer than using combustible tobacco, the media had already done so much damage.”
Back in the U.S., Jennifer Madsen of Dripped Out Vapers in Palm Bay, Florida, said she saw her business sales decimated, and the effects have been far-reaching. While noting that she can only speak directly about her business, she added that she knows the entire state’s vapor industry felt the impact. “I think that people not involved in vaping don’t understand the community. Vape shops aren’t just retail shops that supply a product,” Madsen said. “For a lot of people, we become a club, a place to make friends, to vent about your job and family, to be heard and to be accepted. I’ve had customers come to me and ask if they can meet a blind date at my shop (we have beer and wine) because they feel safe there. I’ve had customers bring their new boyfriends/girlfriends to meet me because we’ve become a family; we’ve become part of each other’s lives.”
For many like Lisa Talarico of Exotic Vapors in Buffalo, New York, and Elizabeth Robinson Pharis of Underground Vapor Lounge in Rusk, Texas, financially crippled businesses have already meant lost employees and lost jobs that may or may not return. “I own a vape shop in New York [and] my sales are down over 50 percent [with] some days even as high as 80 percent,” said Talarico. “I am working seven days a week now because I had to lay my employee off.”
Pharis said she understands the issues Talarico has been facing. She explains that her business saw a significant drop in sales too. “We are the only vape shop in town; we still weren’t safe from the hype. Business dropped 70 percent and we’re still not beginning to recover. We let go of all of our employees, and my daughter had to drop out of college; we just couldn’t afford it,” she said. “I still wake up every morning waiting for the bomb to go off and hear an announcement that flavors are now gone. I just wish there was a definitive answer.”
The effects of the CDC’s and the media’s reporting weren’t confined to vape shops. Even comparatively large businesses such as manufacturers and distributors were crippled. Chris Weidlich, a former employee of Purebacco USA, said the ban cost him his livelihood. “I have been an employee with Purebacco USA where we manufactured for Akston Hughes, FlavorZ and Namberjuice e-liquid brands,” he said. “A Michigan flavor ban enacted by the governor set in motion a series of events that have led to the permanent closing of a legacy manufacturing company and the unemployment of many employees, including my own imminent loss of employment at the end of [2019].”
Some businesses have begun to see some recovery. However, the uncertainty of the industry still haunts them. Andrew Simpson with Tri Guys Vapor in Salem, Missouri, said the EVALI panic hit his business with full force. “A month after the ‘outbreak’ started, I had to take my employees down to part time. We survived like that for a while. Then Trump announced that he was going to ban flavors. The next day, I wrote my employees a month’s wage check each and told them that they deserve to have a chance to find a job because I [knew] I wouldn’t be able to afford to pay them the next month due to sales continuing to drop,” explained Simpson. “For the first time in my life, and before my child was born, I was petrified that I couldn’t give my family the life that I promised my wife when I married her. I was scared we weren’t going to have a home for my child. I was scared he wasn’t going to have clothes. I was scared he would go hungry. I was just plain scared.”
Simpson said he quit his job as an emergency medical technician so he could give his undivided attention to his vape shop. “I cut all of my costs down to nothing. I hunkered down and budgeted and prepared the shop to be able to stay open for four months without making a dime (I’m thankful it never had to come to that),” he said. “But we had to radically change our lives to prepare for the worst. We looked at options and were prepared to go completely bankrupt. But I wasn’t ready to give up on my business and customers. We were already in debt … and were looking at bankruptcy anyway; what does it matter if we’re completely broke when we closed.”
While Tri Guys has recovered to a level Simpson describes as “only down about 20 percent from our average before all the propaganda happened,” he says the fear and sense of betrayal remain. “It really showed me how corrupt and broken our system is. This known and proven life-saving technology is going to be ripped off the market because of money,” he said. “They genuinely don’t care about the American people. They don’t care that 440,000 people die so they can get a paycheck. They don’t care about me or my family like I thought they did growing up. I’ve never felt so betrayed.”
The vapor industry doesn’t seem optimistic about vaping’s prospects in 2020 either. However, there are a lot of fighters still not ready to call it quits. Many of the owners who are still in the fight say that a fight is exactly what this is. Brown could only offer a call to action. “The truth needs to be shared far and wide. Be under no illusion that if nothing is happening in your country that affects vaping [then] nothing will. Don’t be the, ‘I’m all right, Jack’ person,” Brown said. “Share your experiences with people, tell the truth about life-saving vapor products and harm reduction, and advocate until you are blue in the face. If we don’t fight to keep our vapor products, we will lose them.”

February 18, 2020
Expert Advice
In their response to the recent vaping scare, health authorities may have done the public a disservice.
By George Gay
After listening to a few presentations given at the 2019 Global Tobacco & Nicotine Forum (GTNF), I started to wonder anew about the word “expert,” though I should make it plain that I am not questioning the expertise of the presenters.
The presentations suggested, among other things, that experts in the U.S. were reacting irrationally to health issues recently raised in respect of the use of vapor devices; that some vaping policies developed by U.S. experts were, to say the least, unhelpful; that people were broadcasting on U.S. television information about vaping that appeared to be expert but that was simply wrong; and that any number of governments outside the U.S., presumably advised by experts, were making irrational decisions in respect of vaping.
If it is true that experts are causing so many mismoves, what, you might ask, is an “expert”? Good question. Just after the U.K.—or parts thereof—voted in 2016 to leave the EU, a prominent politician and leave campaigner caused some disquiet when, in refusing to name any economists who backed the country’s exit from the EU, he was reliably quoted as saying that “people in this country have had enough of experts.”
He was clearly talking about expert economists, but his statement was condemned widely, including by one popular scientist whose television programs reach a wide audience. The gist of the responses was that if people shut their ears to the opinions of experts, chaos and anarchy would descend upon the world.
This has a ring of truth about it, but I suppose some might retort that chaos, in the form of environmental breakdown, is being given a clear run even with any number of experts in place. But again, while this retort would have a ring of truth about it, it would sidestep the uncomfortable fact that environmental experts are not in control of the environment. They must compete with experts at plundering our natural resources in the name of making money for the ear of politicians, who, while democracy still stands, have the final say. Like it or not, politicians are the experts of last resort.
One way of getting around the issue of experts failing in their chosen fields is to assume that there is no such thing as an expert. All you must do is extrapolate to all fields of endeavor what William Goldman said about the motion picture business: “Nobody knows anything.” And while that might sound a mite dismissive, it is much less so when you consider that he went on to qualify that remark with, “Every time out it’s a guess and, if you’re lucky, an educated one.”
That raises another issue. What part of being an expert is played by education and intelligence, two concepts that I have to admit I would struggle to define and the latter of which I would have no idea how to measure? Still, such lack of knowledge does not stop me from wondering whether an expert necessarily must be well educated and intelligent. Indeed, are education and intelligence inextricably linked? I would suggest not. Clearly, many people are intelligent without being educated while many well-educated people are not what I would judge to be intelligent because they lack attributes such as common sense, creativity and natural wit.
Nowhere is it better demonstrated that a lack of education and intelligence need not be a bar to be an expert than in the U.K.’s Houses of Parliament. Votes form the only qualification necessary for being a representative of the people in the House of Commons, given that one meets certain criteria to do with such things as age, citizenship and the ability to stump up a nonrefundable deposit, while membership of the House of Lords is down to a complex form of Buggins’ turn that doesn’t bear too much scrutiny much of the time.
That’s worth thinking about. The people who are voting on issues that will affect everybody in the land and some of those overseas, and who might plunge us into war, need not be educated or intelligent, and they need not be what many people would consider to be an expert. Indeed, a person with little education and the wit of a paving slab could become a Member of Parliament and be elevated to a high office of state, depending on just how far she is willing to go in towing the party line or on what Homer Stokes would describe as the state of cronyism, nepotism and rascalism within the system.
But, of course, you don’t have to be thick as a brick to be a politician, and many are highly educated and intelligent. Recently in the U.K., a prominent politician implied that his superior intelligence or common sense would have allowed him to escape from a tragic event in which many people were killed. The politician is, without question, well-educated and intelligent, but, judged only on this comment, you would think him otherwise.
Apart from the fact that his remark was crass, hurtful and politically dumb, he had failed to discern that what divided him from the people who died was not intelligence but the availability of information. He was viewing the tragedy from the safety of his armchair and with benefit of hindsight. Those who died were caught up in fast-moving events and were acting in line with official advice—advice provided by experts.
But I digress. To me, the post-referendum brouhaha about experts in the U.K. came down to the fact that people see things differently. A specialist’s view of an expert is different to that of the person in the street. To the specialist, an expert is somebody learned in their field, though not necessarily somebody the specialist would agree with, while to the person in the street, an expert is somebody who gets things right, and those two attributes don’t always go hand in hand.
Within the field of science, however, these two definitions of what constitutes an expert should not cause so much conflict as in some other fields because, in theory, science is a dynamic process in which theories are raised, confirmed or refuted and then, in either case, used to develop new ideas. This does not necessarily work in the same way in other fields, such as economics, as our post-2008 world amply demonstrates. In the field of economics, I would suggest, expert opinion is like art and philosophy—it is basically whatever you can get away with.
There is a further complication, however, and that is between what I would roughly describe as “big science” and “small science.” We can all watch a television program about Heisenberg’s uncertainty principle and nod off to sleep happy in the knowledge that if we don’t catch the end of the program, we are not going to be put at any direct disadvantage, no matter how important the principle is to quantum theory.
Nod off, however, during a program on the damage done by the consumption of a certain foodstuff, and you could be shortening your life by a year or whatever. Or perhaps not, depending on whether the scientific experts on the program have got it right—indeed, in the terms of the lay person, whether those scientists are experts.
This is important, in my view, because the person in the street is being asked increasingly often to make judgments when “experts” disagree or rather when there might be broad agreement among experts but there are also loud, dissenting views also from experts—economists in the case of Brexit and globalization, say, public health professionals in the case of vaping and vaccinations, and scientists in the case of climate change and quantum theory.
So how is it possible for nonspecialists to make those calls? Well, there are strategies we can all employ depending on how much time we have. Common sense often helps but is not 100 percent reliable. We can ask ourselves why we think the expert is saying what she is saying—especially, who is funding her research and does she or a close relative or friend have a vested interest in what she is saying?
We can investigate her previous research and intercessions, we can try to chase down her credentials, keeping in mind that her qualifications might have been bought online, and we can investigate what her peers say about her, bearing in mind that we really ought firstly to check out just where they’re coming from. And if we’re retired and have some long winter evenings to fill, we can even try our hand at reading, without nodding off, the scientific literature, and we can revisit all of the information we have gathered to see how much of it has come from sources where lying is seen as part of the great rough and tumble of life.
But all of this gets thrown out of the window when the person in the street has little time to make what appears to be a life-affecting decision quickly and the advice being given out by normally reliable institutions conflicts with some other expert advice and common sense. This is what happened, in fact, when, earlier this year, there was an outbreak in the U.S. of acute pulmonary illness among a relatively small number of vapor device users.
The initial advice from the U.S. Centers for Disease Control and Prevention (CDC) was for people to stop using vapor devices with THC oil or nicotine liquids. Common sense indicated, however, that whereas it seemed plausible that the inhalation of THC oil, especially black market THC oil, which was a relatively recent activity, could be the cause of the outbreak, it was implausible that nicotine liquids, which had been consumed in this way around the world for about 10 years, were the cause of the problems. This seemed like a case of science, in the form of scientific experts at the CDC, getting it wrong.
At the time of writing, the CDC seems to have come around to a position closer to that dictated by common sense—an approach, by the way, that had the backing of some healthcare professionals. The problem, however, is that much damage has been done already. The fear raised in the minds of the public slowed the conversion of smokers to vapers and caused some converts to relapse.
It is worrying that this development seems to support the idea that “good” vaping science is always going to be playing catch-up with “bad” vaping science and that sometimes it is never going to catch up. What I mean by this is that the shock-horror headline on page one might be overturned the next month but only with a piece at the bottom of page 32. One of the presentations at the GTNF, which was held in Washington, D.C., in September, included a number of clips from a television program. One of these clips implied that vaping with nicotine liquids could reduce the IQs of young people by 10–15 points from what they might have otherwise been. It was then pointed out that measuring such IQ deficits was difficult, something that could probably be accurately interpreted as being impossible and therefore never having been done.
But as the GTNF presenter pointed out, even though there were only a few seconds between the statements being made, the damage had surely been done. Most viewers, especially those with children still at school, were going to remember the 10–15 point IQ deficit because it was aimed at the heart and because it would later be in 72-point type on page one while few were going to remember the retraction, which was aimed at the head and was bound for an 18-point presentation on page 32.
There is a further problem here. Once those viewers who watched the program and who absorbed the 10–15 point statement passed this information on to their friends at the school gate, they were probably well on their way to becoming experts. Their friends would ensure this in quoting them while passing on the information to others.
Perhaps we are all bound to become experts for 15 minutes. What a frightening thought.

George Gay
December 23, 2019
Irrational hysteria
The sudden outbreak of lung illnesses and deaths have made headline news. But painting these adverse events as “vaping-related” is vague and inaccurate.
By Maria Verven
The headlines would make anyone swear off of vaping forever. A sudden rash of “vaping-related” illnesses and deaths—12 as of this writing—has made the front pages of almost every major news outlet.
But get past the headlines and you’ll find that these adverse events are not related to vaping legal e-cigarette products. The overwhelming majority of cases have been tied to vaping cartridges containing THC wax or oils. And most were purchased illegally on the black market.
Saying someone died from “vaping” is akin to saying someone died from “drinking” without specifying that they accidentally drank something poisonous.
In short, news stories that blame deaths on vaping are painting the story with an extremely large brush way outside the lines of reason.
Just apply the laws of epidemiology
Konstantinos Farsalinos, a cardiologist, clinical researcher and expert on e-cigarettes, says we need only apply the simple rules of epidemiology to understand the recent turn of events.
E-cigarettes have been on the global market for more than 10 years. Today, approximately 11 million people in the U.S. and millions more worldwide vape regularly. The typical adult vaper in the U.S. is around 40 years old, and many have been vaping daily for several years.
Up until this summer, no reports of respiratory diseases or deaths were reported anywhere in the world.
Then suddenly, we witness hundreds of acute cases but only in the U.S. and primarily among young adults—and all bearing a remarkable resemblance.
It absolutely defies the laws of epidemiology that these cases could be related to the long-term use of e-cigarettes that have been on the market for years, used by millions of consumers, according to Farsalinos.
Applying simple logic, he explained that these cases are not indicative of a disease related to vaping but rather poisoning from either a new product, a new raw ingredient or a new practice in the manufacturing process. Only this explains the timing of the outbreak, he says.
Indeed, all signs are pointing to an emulsifier called vitamin E acetate, a product that hasn’t been used in store-bought e-liquids.
“The emotional, irrational hysteria against e-cigarettes needs to stop as soon as possible,” Farsalinos said. “Yet I wonder if the passionate statements made by the media, scientists and authorities will ever be corrected once the exact cause of this outbreak has been firmly established?”
So what exactly is vitamin E acetate?
Found naturally in foods such as olive oil and almonds, vitamin E sounds completely innocuous as does the oil, vitamin E acetate, that’s derived from it. Vitamin E acetate is commonly used in skin creams and as a nutritional supplement—but ingesting it is far different than inhaling it. Its oil-like property could well account for the types of respiratory issues—shortness of breath, chest pain, etc.—reported by sickened patients.
After noting that the majority of the bootleg THC cartridges patients used tested positive for vitamin E acetate, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) launched a full-scale investigation.
New York Governor Andrew Cuomo also served subpoenas to three companies that sell thickening agents containing vitamin E acetate, ordering them to help with the FDA investigation.
Notably, the FDA told New York state officials that its lab tests found nothing unusual in the nicotine products it collected from sick patients. While some victims maintained that they only vaped nicotine products, it only stands to reason that patients in states where cannabis is not yet legal may not readily admit using illegally purchased THC vape cartridges.
The three companies at the heart of the investigation are Mass Terpenes, a Massachusetts-based company that sells Pure Diluent; Honey Cut, a California-based company that sells Honey Cut Diluting Agent; and Floraplex Terpenes, a Michigan-based manufacturer that sells Uber Thick. All three companies quickly removed their products from the market. The Honey Cut website is now gone while the website for Mass Terpenes has this notice on its front page:
“We are alarmed by recent reports linking vape ingredients containing vitamin E acetate to serious lung problems of consumers …. We have never sold a product without assurances of safety from the leading terpene suppliers and have taken steps to ensure that absolutely NO products on this site contain vitamin E acetate.”
The FDA has said it’s too soon in the investigation to determine whether vitamin E acetate is the sole culprit behind these events. “No one substance, including vitamin E acetate, has been identified in all of the samples tested. Importantly, identifying any compounds that are present in the samples will be one piece of the puzzle but will not necessarily answer questions about causality,” said an FDA spokesperson.
Yet we are clearly learning about the health risks of inhaling vitamin E acetate—at the very least, it appears to cause lipoid pneumonitis, which results from inhaling fat particles into the lungs. Chest pain, coughing and difficulty breathing were among the symptoms that were reported by patients who said they’d recently used black market THC cartridges.
In fact, safety instructions for vitamin E acetate specifically advise suppliers to avoid marketing vitamin E acetate for anything other than topical use, warning users to “keep away from heat and sources of ignition” and to “not ingest/do not breathe gas/fumes/vapor/spray.”
Aaron Riley, CEO at CannaSafe, the largest cannabis testing laboratory in California, says odorless, tasteless diluting agents such as Honey Cut are commonly used in the majority of black market vapes as a way to thicken vape oil and make it look more legitimate. “It looks like cannabis oil. It has the same color; it’s odorless. It was considered the best cutting agent,” he told Rolling Stone.
Protection is simple: Don’t buy THC vape juice illegally
The FDA’s public statement cautions consumers against buying “street” products: “Since consumers cannot be sure whether any THC vaping products may contain vitamin E acetate, consumers are urged to avoid buying vaping products on the street and to refrain from using THC oil or modifying/adding any substances to products purchased in stores.”
The best way to protect yourself from unsafe THC products is to purchase products from licensed dispensaries, Riley advised. “Dispensaries have a responsibility to protect consumer safety. If you’re not going in a dispensary, then the product you’re buying is not legitimate.”
“These unfortunate incidents reinforce the need for greater regulation, standardization and oversight of the cannabis market—principles which NORML has consistently called for in the cannabis space,” said NORML deputy director Paul Armentano in a prepared statement. “Consumers must be aware that quality control testing is critical and only exists in the legally regulated marketplace.”
Unfortunately, we may only be seeing the tip of this iceberg since purchasing illicit THC products is common in states where cannabis is illegal. Yet the legal cannabis industry may only account for a small portion (some estimate 22 percent) of the nation’s $52 billion cannabis market. Do the math, and 78 percent of the cannabis products are coming from a completely unregulated supply chain where profits rule the game.
The cannabis site Leafly estimates that as many as 50 million tainted carts may currently be circulating in the U.S. These carts likely originated in Shenzhen, China, where most carts are produced and where millions of people work long hours but rarely, if ever, partake in the products they make. And then these products are shipped in large pallets to Los Angeles, California, and Long Beach, California, where they quickly find their way into the illicit cart market.
Until this year, the health effects of street-purchased vape cartridges went largely unnoticed. It’s not clear whether that’s because doctors didn’t spot earlier vaping-related lung irregularities or if something dramatically changed in the vape oil itself in the past few months. All we know is that somehow, within the last year, a new additive entered the street THC vape cart supply.
Hysteria and overreactions
The sudden surge in cases prompted the CDC to activate its emergency operations center, which allows the CDC to assign additional staff and resources to aid in the investigation.
“[The] CDC has made it a priority to find out what is causing this outbreak of e-cigarette or vaping-related injuries and deaths,” Robert Redfield, the CDC’s director, said in a statement.
Meanwhile, the CDC also issued a broader advisory against using e-cigarettes and vapor devices, especially those “bought off the street,” implicating both nicotine and THC products.
Yet according to Michael Siegel, a Boston University School of Public Health professor who has 32 years’ experience in tobacco control including two years at the CDC’s Office on Smoking and Health, the CDC has irresponsibly botched its investigation of these vaping-related illnesses and deaths.
By continuing to state that they have no idea what’s causing this “mystery illness” and that “no single product” explains all of the cases, the CDC has confused policy makers and the public while putting the entire nation at risk, Siegel wrote on his blog, The rest of the story. These statements violate basic principles of epidemiological outbreak investigations, he said.
“Like all outbreak investigations, [this epidemic] is going to be solved by identifying a type of product that is common to an overwhelming majority of patients,” Siegel wrote. “Frankly, we already have that, and it’s called marijuana. There is just far too high a proportion of case patients who have admitted to using THC or CBD oils for this to be merely a coincidence.”
By demanding that clinicians test patients’ urine for evidence of THC, the CDC would easily be able to issue appropriate recommendations to the public that would curtail this epidemic of life-threatening respiratory failure.
Indeed, without knowing the true source of this outbreak, policymakers are moving to ban large segments of the e-cigarette market. The Trump administration announced plans to ban nontobacco-flavored e-cigarettes. Michigan was the first state to prohibit sales of most flavored e-cigarettes in its effort to curb underage vaping. And the governors of California and New York also recently announced emergency plans to ban the sale of flavored e-cigarettes.
“We know that nicotine vaping products are far less hazardous than smoking,” said Greg Conley, the American Vaping Association president. “Even the FDA notes that they can be very helpful and a great benefit to [the] public health of adult smokers who switch [from combustible cigarettes to vapor products]. Going straight to prohibition is a bad idea.”
“The most popular flavors among adult switchers are not tobacco or menthol. It’s fruit and sweet flavors. So Governor Cuomo is actually banning the most successful products at getting smokers off of cigarettes,” Conley said. “We need to keep these products available to smokers so they can use them to quit.”
“The CDC itself admits that about 80 percent of the outbreak patients admit to using THC oils. My count puts that figure closer to 90 percent. Apparently, it’s 100 percent before the CDC takes the appropriate actions and enables health authorities to put an end to the tremendous morbidity and mortality this outbreak is causing,” said Siegel.
“This is like reporting deaths from eating romaine lettuce and advising people to immediately stop eating all lettuce and cabbage—except it’s a lot worse because [there is] no harm when people stop eating cabbage.
“Severe harm is already resulting from ex-smokers stopping vaping and returning to smoking or to the black market,” he said.
Hysteria and overreactions
The sudden surge in cases prompted the CDC to activate its emergency operations center, which allows the CDC to assign additional staff and resources to aid in the investigation.
“[The] CDC has made it a priority to find out what is causing this outbreak of e-cigarette or vaping-related injuries and deaths,” Robert Redfield, the CDC’s director, said in a statement.
Meanwhile, the CDC also issued a broader advisory against using e-cigarettes and vapor devices, especially those “bought off the street,” implicating both nicotine and THC products.
Yet according to Michael Siegel, a Boston University School of Public Health professor who has 32 years’ experience in tobacco control including two years at the CDC’s Office on Smoking and Health, the CDC has irresponsibly botched its investigation of these vaping-related illnesses and deaths.
By continuing to state that they have no idea what’s causing this “mystery illness” and that “no single product” explains all of the cases, the CDC has confused policy makers and the public while putting the entire nation at risk, Siegel wrote on his blog, The rest of the story. These statements violate basic principles of epidemiological outbreak investigations, he said.
“Like all outbreak investigations, [this epidemic] is going to be solved by identifying a type of product that is common to an overwhelming majority of patients,” Siegel wrote. “Frankly, we already have that, and it’s called marijuana. There is just far too high a proportion of case patients who have admitted to using THC or CBD oils for this to be merely a coincidence.”
By demanding that clinicians test patients’ urine for evidence of THC, the CDC would easily be able to issue appropriate recommendations to the public that would curtail this epidemic of life-threatening respiratory failure.
Indeed, without knowing the true source of this outbreak, policymakers are moving to ban large segments of the e-cigarette market. The Trump administration announced plans to ban nontobacco-flavored e-cigarettes. Michigan was the first state to prohibit sales of most flavored e-cigarettes in its effort to curb underage vaping. And the governors of California and New York also recently announced emergency plans to ban the sale of flavored e-cigarettes.
“We know that nicotine vaping products are far less hazardous than smoking,” said Greg Conley, the American Vaping Association president. “Even the FDA notes that they can be very helpful and a great benefit to [the] public health of adult smokers who switch [from combustible cigarettes to vapor products]. Going straight to prohibition is a bad idea.”
“The most popular flavors among adult switchers are not tobacco or menthol. It’s fruit and sweet flavors. So Governor Cuomo is actually banning the most successful products at getting smokers off of cigarettes,” Conley said. “We need to keep these products available to smokers so they can use them to quit.”
“The CDC itself admits that about 80 percent of the outbreak patients admit to using THC oils. My count puts that figure closer to 90 percent. Apparently, it’s 100 percent before the CDC takes the appropriate actions and enables health authorities to put an end to the tremendous morbidity and mortality this outbreak is causing,” said Siegel.
“This is like reporting deaths from eating romaine lettuce and advising people to immediately stop eating all lettuce and cabbage—except it’s a lot worse because [there is] no harm when people stop eating cabbage.
“Severe harm is already resulting from ex-smokers stopping vaping and returning to smoking or to the black market,” he said.

September 1, 2019
Afraid of ghosts
AFRAID OF GHOSTS
Common sense doesn’t seem to be on the agenda when it comes to the U.S. regulatory response to recent THC-related vaping illnesses.
By George Gay
By the end of the U.S.-held Global Tobacco & Nicotine Forum (GTNF) in September, I was in a state of confusion, though to be fair and to put that into context, I should point out that a state of confusion is my spiritual home. One of the messages that came across loud and clear at the forum—and that I have no reason to doubt—was that a huge amount of great science has been carried out into vaping and vapor devices.
In the case of the U.S. Food and Drug Administration (FDA) and its contractors, such research presumably dates back to at least August 2016 when vapor devices were “deemed” by the FDA to be tobacco products and part of its remit while in the case of the vapor industry, it dates back considerably further. So far, so good.
But the other dominant message to emerge was that the vaping environment in the U.S. was in utter chaos. Now, unless you’re the sort of person who believes that great science causes utter chaos—an idea that is not as outrageous as it might seem—it is rather difficult to square these two messages.
The more I thought about this while dozing my way back to the U.K., the more I wondered whether the chaos might be caused not by the great science but by a surfeit of great science. I know, I know—the forum was told that you can never have too much data, too much science, but taken to its logical conclusion, such an idea is patently silly unless you have an unending supply of scientists to interpret that data and an endless amount of time in which to interpret it, which is not the case here.
Let me describe how science can be overcooked using a modified joke from a book by Thomas Cathcart and Daniel Klein titled Plato and a Platypus. A couple who both lecture at the same university are driving home together through the countryside when the woman, who is employed by the philosophy department, says, “I see they’ve shorn the sheep” to which her husband, a scientist, replies, “On this side.” When I imagine this scene, I see the FDA as the scientist stopping the car, getting out, donning rain boots and trudging across the field to look at the other side of the sheep, indifferent to the fact that they are meanwhile dying of exposure.
While common sense can lead you astray at times, it can be useful, and it was worrying to see that it had been almost expunged from the thinking processes of those who are in the driving seat of vapor policy. The FDA has been rightly praised for attending forums such as the GTNF, but there has to be more to such interaction than mellifluous words about the future.
In his poem, “Autumn Journal,” which was written between August and December 1938, Louis MacNeice described international negotiators as “Eating dinner in the name of peace and progress.” MacNeice knew that such dinner meetings were going to deliver not peace and progress but simply form an agreeable-for-the-diners prologue to death and destruction. The words need to be put into positive action that transcends mastication.
What is it in the makeup of humans that allows us to identify the road that needs to be taken but not to take it? Much of the talk at the GTNF was about peace and progress but not peace and progress now—later, seemingly after the death and destruction has been allowed to run its course. But we can have it now. We can cut down our scientific workload by relying on our experience. As Cathcart and Klein pointed out, we don’t need to inspect the other side of the sheep. Farmers don’t shear sheep on one side only, and even if they did, not all of the sheep could be made to stand with their shorn side to the road. It’s common sense—in fact, it’s science.
OK, to be fair, the current situation is not entirely the fault of the FDA but of the law that dumped tobacco into its lap. And there was qualified support for the FDA from some forum participants who argued that it was necessary to work with the FDA since it was the only game in town. According to my observations, there was a continuum of FDA policy acceptance with the major manufacturers with the most U.S. exposure at the high acceptance end and smaller manufacturers with exclusive U.S. exposure at the other.
This is not news, and it shouldn’t be surprising because the major companies that manufacture both tobacco and nicotine products can afford to work with the FDA both financially and time-wise given that, in large part, what they lose on the nicotine swings they gain back on the tobacco roundabouts, which is not the case with smaller nicotine-only players.
In fact, the forum exuded what I perceived as a higher than usual undercurrent of industry division with allegations that the major manufacturers were reasonably happy with the current situation because the direction of travel was such that small manufacturers were likely to be overtaken and ground underfoot by the FDA’s complex, expensive and late-to-market (it still wasn’t finalized at the time of this article’s writing) premarket tobacco product application (PMTA) process. Indeed, a representative of one major manufacturer said that he understood why these allegations arose in the U.S. and suggested that the system could well end in wiping out smaller players.
Although the GTNF is an international forum, the focus this year was very much on the U.S., in no small part because it was held (Sept. 24–26) in Washington, D.C., but also because three major threats were converging on the local vapor industry: the long-running issues raised by the use of flavors in e-liquids, the uptake of vaping among young people and the then-recent issue of pulmonary illness that had occurred among a relatively small number of vapers.
Those opposed to vaping were trying to connect these issues in various ways with dubious to ludicrously low levels of justification, often using the sort of extreme language worked up during the early days of Juul so that we now have an “epidemic” or “explosion” of vaping among young people and a “plague” of pulmonary illness.
And the FDA, feeding on a panic that it started and that has now been supported by the Trump administration, is planning, in effect, to ban the use of most flavors in vapor devices. In fact, the FDA would protest that it is not planning such a ban, but it is in all but name. The FDA’s acting commissioner, Norman E. “Ned” Sharpless, told a U.S. House Energy and Commerce subcommittee in September that based on the fact that “youth” e-cigarette users had cited fruit and menthol/mint flavors as being the most popular, it intended “to enforce existing law that limits the marketing of such products. [The] FDA intends to prioritize enforcement action such that flavored e-cigarette products will be expected to exit the market unless and until manufacturers of these products provide scientific evidence demonstrating that marketing their products is appropriate for the protection of the public health,” he said.
What Sharpless didn’t say was that the scientific evidence required is beyond the scope of most manufacturers and that the timeline for supplying such evidence is derisory. One forum participant brought up an important but mostly overlooked aspect of the U.S.’ long-running young people vaping saga by pointing out how official press notes often lacked age definitions when talking about young people. “Kids,” she said, could sometimes encompass people who were one day short of their 21st birthdays.
Indeed, official press notes often conflate “kids” with “youth,” it is not unusual to see “teens” used to refer to people not all of whom are teenagers, and “children,” though thankfully not yet “babies,” like “kids” can seemingly be used to take in what most people would call young adults.
Meanwhile, another young people issue derives from the oft-stated—at the forum and elsewhere—idea that, put in various ways, everybody agrees that young people should not vape. We shall never lift the confusion if we insist on making claims that are comforting but wrong.
If everybody agreed that young people should not vape, they would not vape because even the young people concerned would be in agreement. Since vaping began, there have been people who have been making money out of getting vapor devices into the hands of young people and others who have been indifferent to whether this trade happens or not.
With the pulmonary illness issue, however, we have entered new territory. At the time of the forum, hundreds of people had taken ill and 12 had died as a result of this illness. Information was sketchy at that time, and I’m not even sure that it is right to refer to a single illness or whether what was on display was a number of similar illnesses, but it seemed that one factor linking those who had fallen ill was vaping.
At this point, the moral panic that was worked up by the FDA in its contacts with the media over Juul was re-engaged and, it would seem, moved up into passing gear by the U.S. Centers for Disease Control and Prevention (CDC). The first victim of this panic was great science, which was quickly abandoned and replaced by the sort of conjecture that should have been quickly dismissed by everybody who didn’t also believe in ghosts.
But this should not be allowed to underestimate the damage caused by such conjecture. As the freethinker Madame du Deffand apparently once said when asked whether she believed in ghosts, “No, but I’m afraid of them.”
Despite the fact that huge numbers of people in the U.S. and elsewhere have been vaping with nicotine for more than a decade with, as far as I am aware, few serious ill effects outside those caused by exploding batteries, the CDC apparently came to the conclusion that this outbreak of acute illness that had occurred only in the U.S. and Canada (one case) could be due to vaping with nicotine alone.
The first item on its list of advice concerning the illness was that people should “consider refraining from using e-cigarette or vaping products, particularly those containing THC [tetrahydrocannabinol]. If you are an adult who used e-cigarettes containing nicotine to quit cigarette smoking, do not return to smoking cigarettes,” was the second bit of advice.
This advice was based on legitimate concerns, but, in my view, it went too far in including nicotine-containing devices that have helped millions of smokers quit combustible cigarettes, which, we are told, cause more than 400,000 deaths in the U.S. annually. And neither was the advice justified by adding that former smokers should not return to smoking cigarettes.
I’m certain that the CDC believes that nicotine is addictive, so how does it expect vapers to give up their vapor devices without going back to cigarettes or at least some tobacco product? Perhaps it would point to nicotine replacement products as the way out, but only if it inhabits a parallel universe.
At the time of this article’s writing, the CDC was saying that about 77 percent of people who had contracted the illness had reported using products containing THC and that about 36 percent had reported exclusive use of THC-containing products. About 57 percent had reported using nicotine-containing products and about 16 percent had reported exclusive use of nicotine-containing products.
Now given that these figures are based largely on self-reporting by people who are seriously ill and, in some cases, perhaps not wanting to divulge what they bought and consumed, common sense has to suggest that the problem would seem to lie with the THC-containing products.
But unfortunately, the CDC’s approach is to stop the car, get out, put on the rain boots and go trudging across the field to check the sheep’s underbellies. OK, few people would probably mind that this is how it chooses to spend its time but for the fact that in the meantime, it has stopped and perhaps reversed the clock ticking away the switch from smoking to vaping with nicotine.

George Gay
George Gay is Vapor Voice’s European editor, but his territory spans the globe.
Based in London, George has covered the vapor and tobacco industries since 1982.
George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Vapor Voice’s readers.
September 1, 2019
Questioning accuracy
The director of the FDA’s CTP, Mitch Zeller, says the accuracy of self-reporting in respiratory cases should be questioned.
By Timothy S. Donahue
Things are still quite unclear. However, vaping is less risky than smoking combustible cigarettes, according to Mitch Zeller, director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP). He told more than 300 attendees of the Global Tobacco & Nicotine Forum (GTNF) that “if you are an addicted cigarette smoker and you have been able to successfully transition to e-cigarettes, the last thing [the FDA] would want to see is someone going back to a combustible product.”
He reminded the packed audience of British psychologist and tobacco harm reduction expert Michael Russell’s adage that people smoke for the nicotine but die from the tar. “Nicotine does not cause the cancer, lung disease and heart disease; the nicotine gets you hooked to a product that … with each puff of smoke, you are inhaling the chemicals associated with those diseases,” he said. “There is a public health opportunity to move smokers down the continuum [of risk].”
Most of those in attendance wanted to hear Zeller’s understanding of the current pulmonary illnesses that have caused, as of this writing, 18 deaths in 15 states. The FDA and Drug Enforcement Administration (DEA) have opened a criminal probe into the vaping-related illnesses. “We are working very closely with our colleagues at the CDC and the [U.S. states where illnesses have occurred] as we try to get to the bottom of … how many cases are we talking about?” he explained. “The numbers that you see … are only going one direction and that is up. The CDC will be revising the numbers shortly.”
Hours after Zeller’s keynote address, the CDC released new figures stating that 1,080 lung injury cases associated with using e-cigarette or vaping products had been reported to the CDC from 48 states and one U.S. territory. “Most patients report a history of using THC-containing products,” the CDC release states. “The latest national and regional findings suggest products containing THC play a role in the outbreak.”
The role of the FDA in the pulmonary cases is to work in a complementary role with the CDC and other necessary federal organizations, such as the DEA, Zeller said. “When states have collected product samples and have made the decision to share them with [the FDA] then those samples go to our forensic chemistry center—these are expert analytical chemists—as we try to understand what is in these products,” he said. “The challenge we are all facing is [that] there is no common thread … there is no common thread in these self-reports from patients who have informed state officials in the first place.”
Attendees were told that it is “certainly looking like many of the cases involve” THC-based vapor products. However, there were also cases of CBD and nicotine, and some patients claimed to use more than one product, according to Zeller, who added that all of reports were done on a voluntary basis. This means results may not be accurate. For example, a self-reporter may live in a state where THC products are illegal and doesn’t want to disclose THC use for fear of prosecution.
“We maybe might want to question the accuracy of the self-report, but some of the self-reports are [from] individuals claiming the only product they used was a nicotine-containing product,” he said. “This is a challenge for everyone involved in this … investigation, but the right level of coordination exists between federal agencies and with the state health departments that are more boots on the ground for this. We are always looking for any information for any adverse effect for any tobacco product, including e-cigarettes, to be reported to the FDA.”
When asked whether consumers using nicotine-based pod systems should be concerned about pulmonary illness, Zeller said the FDA is still “trying to get around this on a case-by-case basis,” and some of the self-reports do claim to have only used nicotine-containing products. “When we are doing the analytical chemistry, obviously we are not talking to the person and are not asking questions about what products they used,” he said. “In some of these cases, there are multiple products being said they are being used with each case … many of these cases appear to be THC related … it’s complicated; it’s challenging.”
An attendee also asked Zeller if the FDA was concerned that current users may be switching back to combustible cigarettes. Zeller said that the FDA is a science-based agency that follows the science when it comes to this set of products (e-cigarettes). “Our point is that [electronic nicotine-delivery systems (ENDS)] are illegal and remain on the market through enforcement. Removing all vaping products from the market would be like pressing a reset button …. I want smokers to quit smoking or switch to less harmful products. The door is open for pre-submission meetings. The door is open for the companies to come in. The burden should be on companies to show the FDA that the products meet the burden of being for the protection of public health.”
Confronting other issues
Zeller told attendees that the FDA’s vision for the future of tobacco remains unchanged since the introduction of the regulatory agency’s Comprehensive Plan for Tobacco and Nicotine in July of 2017. “We still envision a world where cigarettes as we know them would no longer create or sustain addiction, and adults that are still [seeking to use nicotine] can get it from alternative and less harmful sources,” he said. “Even at this acute moment in time—as we are dealing with the vaping illnesses, as we are dealing with the epidemic use of e-cigarettes by kids in the United States—it’s still an opportunity to pause and acknowledge that the continuum exists.”
Products containing nicotine pose different levels of health risks to adult users with combustible products—like cigarettes with their toxic mix of more than 7,000 chemicals and efficient delivery of nicotine to maximize addiction potential—being the most harmful, nicotine replacement therapies (NRTs) being the least harmful and noncombustible products, such as ENDS products, falling somewhere in between, according to Zeller. “The public health return on this policy is generational,” he said.
The FDA is committed to protecting the public health of all Americans while regulating an addictive product that carries with it health risks, according to Zeller. To this end, the agency is conducting ongoing research on potentially less harmful forms of nicotine delivery for adults, such as ENDS products or e-cigarettes. “Though more research on both individual and population health effects is needed, many studies suggest e-cigarettes may be less harmful than combustible cigarettes,” Zeller said.
While ENDS products may be less risky than combustible products, Zeller said that recent proposals by the FDA to ban or restrict flavored tobacco products have been driven by an increase in use of ENDS products by youth. Zeller noted previously reported statistics from the 2018 National Youth Tobacco Survey (NYTS), which found that e-cigarette use among high schoolers had increased by 78 percent from 2017–2018.
“Think of it as a public health balancing act that has been made more challenging with the very disturbing 2019 NYTS results—more of which we will be sharing at a later date—where we saw the preliminary 2019 data showing more than 25 percent of high school students are current e-cigarette users. There will be more to come in [the] form of a paper [that] will be published,” Zeller said. “The reality is that not one of these products is lawfully on the market … not one of them—they have remained on the market since we gained regulatory authority in 2016 through regulatory enforcement. This balancing act by law requires us [to figure out] what’s going and what are the impacts on users and what are the impacts on nonusers … or what are the positive and negative impacts on initiation and the positive and negative impacts on cessation.”
There has been a lot of press lately surrounding teen use of Juul products because the device uses nicotine salts (in high concentrations), its small nature and how the product has been marketed. Zeller said that it is not just the Juul brand as there are numerous similar products on the market. “One of the real problems of concern are products that resemble USB flash drives,” said Zeller. “The product Juul has gotten most of the attention, but there are other products like Juul.”
In September of 2018, the FDA issued more than 1,300 warning letters and fines to numerous retailers for selling tobacco products to minors. Zeller said that what is more concerning is retailers who continue to sell products to youth despite warnings and fines from the FDA. In March, the FDA sent letters to 15 retailers for allegedly selling tobacco products to minors. These retailers include Walgreens, Walmart, Kroger, 7-Eleven, Family Dollar, BP and Citgo. The agency also requested information from more than 40 e-cigarette companies the agency thinks may have illegally introduced new products onto the market.
Concerning the premarket tobacco product application (PMTA) process, Zeller explained that the agency would soon release quality control requirements and considerations for tobacco-related good manufacturing practices (GMPs) or tobacco product manufacturing practices (TPMPs). Zeller could not comment on when the industry can expect this Foundational Rule and Guidance for TPMPs to be issued by the FDA; however, he did stress that the rule, along with the other foundational rules and guidances, is a priority for the CTP. “We take very seriously the commitment to making the process as efficient and transparent as possible,” he explained.
The FDA has already issued three advance notices of proposed rulemaking (ANPRMs) that have the potential to reframe the tobacco landscape. Zeller explained that the ANPRMs focus on “the role that flavors—including menthol—play in initiation, use and cessation of tobacco products.”
Input on these issues will assist in the consideration of the most impactful regulatory options the FDA could pursue to achieve the greatest public health benefit, according to Zeller. “We’re proceeding in a science-based fashion, building a strong administrative record by securing more information about the potential positives and negatives of flavors in both youth initiation and in getting adult smokers to quit or transition to potentially less harmful products,” Zeller stated in a press release about the ANPRMs.
Zeller also briefly discussed the PMTA authorization for the marketing of IQOS, a heat-not-burn device manufactured by Philip Morris. Following a rigorous science-based review through the 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 FDA has placed stringent marketing restrictions on the products in an effort to prevent youth access and exposure,” said Zeller. “This was an application that got through the PMTA pathway because, at the end of the day, we were able to conclude that the marketing of this product would be appropriate for the protection of public health.”
Also speaking at the GTNF, Matthew Holman, the director of the CTP’s Office of Science, reiterated many of Zeller’s points. Holman said the FDA needs as much scientific data as it can possibly gather from numerous sources, and that is still a work in progress. Holman added that there was a “critical” need to share as much information as possible to work on regulations on new products of the tobacco industry that are less harmful for consumption. “Our goal is to be world leaders in understanding these products and regulations,” said Holman. “It is important to work in all disciplines, observing behavior, addiction, toxicity and many others, and not focus on a single point.”

Timothy Donahue
Timothy S. Donahue is the co-founder and managing editor of Vapor Voice.
Tim spends much of his time on the road, attending conferences and interviewing industry representatives.
His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
September 1, 2019
Reacting to roadblocks
During a recent Vapor Technology Association event, several experts discussed the major obstacles for the ENDS industry.
By Timothy S. Donahue
The e-cigarette is on the ropes. Over the last 18 months, especially the last four, three major developments have forced the vapor industry into an outright battle for its existence. These events have several states and even the U.S. government using the issues to either ban flavors in e-liquids or ban all vapor products entirely. Several industry experts say that an outright flavor ban (except tobacco flavor) would force thousands of businesses to close, eliminate nearly 200,000 jobs and cost tens of billions of dollars in negative economic impact.
First came a large increase in youth use, and later, the U.S. Food and Drug Administration (FDA) was forced to ramp up its premarket tobacco product application (PMTA) deadline, then the lung illnesses started happening. In early June, the U.S. Centers for Disease Control and Prevention (CDC) and the FDA began to receive reports surrounding an outbreak of respiratory illnesses linked to what the FDA and CDC claim were “vapor and e-cigarette” products (see “Irrational Hysteria,” page 18). In response to the epidemic, several states, the FDA and even President Trump himself have called for a ban on all flavored e-cigarette products.
At least four states, New York, California, Michigan, Rhode Island and Massachusetts, have enacted some type of vapor ban. Vapor Technology Association (VTA) Executive Director Tony Abboud, in response to the flavor bans, said his organization is “going to make it clear that this is the wrong approach, that it will literally cut down an entire industry that has grown up, with 166,000 jobs, to challenge the tobacco industry, and they are mostly small businesses.”
The industry is also struggling to get PMTAs submitted to the FDA by a court-ordered deadline. On July 12, Judge Paul Grimm of the U.S. District Court for Maryland ruled in a lawsuit filed by anti-tobacco groups that the regulatory agency had exceeded its authority in allowing electronic nicotine-delivery systems (ENDS) to remain on the market until 2022 before companies applied for regulatory approval. Grimm subsequently ordered vapor companies to submit costly PMTAs to the FDA by May 12, 2020, or remove the lifesaving products from the market. The FDA would then have one year to approve or deny those submissions.
The possibility does exist that the deadline could be moved, however. Several vapor organizations, including the VTA, have been granted a motion to Iitervene exclusively for the limited purpose of filing an appeal of the Memorandum Opinion and Order and the Remedy Order that forced vapor companies to submit PMTAs to the FDA by the new deadline. “The vapor associations have no other opportunity to provide their views on the deadline imposed in the Remedy Order, and the government’s objectives appear to have diverged from the interests of the vapor associations that seek to intervene,” Grimm wrote in his ruling.
The judge denied a motion to stay the order. “I also will deny the vapor associations’ motion to stay because, as noted, the Remedy Order does not impose immediate deadlines, and the vapor associations have not shown that ‘a pressing need exists,’” Grimm wrote.
Lawyers with the law office of Keller and Heckman (KH), a Washington, D.C., law firm that represents the VTA and other vapor industry stakeholders, filed motions to intervene and stay with the U.S. District Court for the District of Maryland pending appeal of the July 12, 2019, Memorandum Opinion and Order (Remedies Order) on behalf of several vapor trade associations. KH also filed a notice of appeal with the United States Court of Appeals for the Fourth Circuit on July 30, informing the appellate court of its intent to appeal the District Court’s order denying the trade associations’ initial attempt to intervene in the case on the remedies issue.
During the VTA’s fourth annual Vape & the FDA event, these topics were at the forefront of discussion as the more than 270 attendees from 42 U.S. states and four countries fretted over the future of the U.S. vapor industry. Combating youth initiation, fighting to keep flavors legal and forcing the FDA and the CDC to be truthful about the causes of the lung illnesses are primary goals of the VTA’s more than 90 members, including 26 state vapor advocacy organizations.
Several speakers told attendees about various segments of the vapor industry. Chris Howard, vice president, general counsel and chief compliance office for E-Alternative Solutions, discussed the history of the vapor industry and the oddball way the FDA has attempted to regulate it. “The deeming rule, PMTA process, flavors, speculation … it has been a crazy ride,” says Howard.
Brad Rodu, endowed chair in tobacco harm reduction at the University of Louisville, said vaping is driving smoking rates down as e-cigarette use rises. Studies like the FDA’s National Youth Tobacco Survey (NYTS) are intentionally misinterpreted in order to give the vapor industry a black eye. He says that laws that ban flavors just aren’t going to work, but more importantly, “federal agencies aren’t accountable to anyone.” This is why the rash of lung-related illnesses has been placed at the feet of the vapor industry instead of the marijuana industry where it belongs.
Factual distortion
As of Oct. 1, more than 1,000 people had been hospitalized for a serious respiratory illness, and at least 18 deaths had been possibly attributed to a thickening agent, vitamin E acetate, that only recently began to be used in THC-containing cartomizers, according to data from the CDC and the FDA. Several vapor industry experts have accused both the FDA and the CDC of intentionally misleading the public as to the circumstances surrounding the outbreak and accused the government agencies of wrongly placing some of the blame on nicotine-based vapor products.
During the VTA event, Michael Siegel, a professor with the Boston University School of Public Health, told attendees that CDC protocols for outbreak investigations are being ignored by the agency itself. Siegel trained with the CDC for two years in how to properly respond to an epidemiological outbreak. “They are telling you to ignore the facts. This is completely against the CDC’s protocol for outbreak investigations,” says Siegel. “I was trained by the CDC to conduct these investigations. You never find a single exposure in any outbreak. That’s not the way the world works; it’s not the way data works.”
A major issue the CDC, the FDA and even the Department of Health and Human Services (HHS) have is that none of the organizations recommend that clinicians test for THC in the patients with lung illnesses, according to Siegel. He says that tells him that the organizations do not want to know or be forced to tell the public that this is a THC problem and not a nicotine problem.
“I believe they are not telling clinicians to do THC testing because they know the majority [would test positive]. That would completely destroy their ability to blame this on e-cigarettes, and I believe that is what they want to do. They saw this as an incredible opportunity,” he says. “They have been against e-cigarettes since the beginning, and nothing bad has been happening. Then you have this [outbreak of lung illnesses,] and they wanted to be able to say, ‘I told you so. We told you how bad e-cigarettes were.’ Even the secretary of HHS says to stop using e-cigarettes and doesn’t mention THC on their website.”
Siegel goes on to say that this is an inexcusable public health practice. He even goes as far as to label the actions by the CDC and the FDA as public health malpractice. “Could you imagine if we had an outbreak of e-coli from contaminated lettuce and the CDC put out a statement that didn’t mention the word lettuce anywhere? That would be completely irresponsible,” he says. “Even if they didn’t know for sure … it would be inexcusable. It isn’t just the CDC; it’s every major health organization that deals with the anti-tobacco groups [spreading vaping illness misinformation].”
When trying to determine the cause of an outbreak, Siegel says the CDC must look at the data. The CDC trains epidemiologists to look at certain characteristics such as age, sex, race, location and timing. When looking at the timing of the lung illness outbreak, it was around May of 2019 that there was a sharp spike in vaping-related illnesses. “Why did it start now? Any explanation must explain that,” said Siegel. Second is looking at the distribution of cases. “If it were a nationally sold product, why would entire states be spared completely, at least early on,” he says.
Siegel goes on to explain that the majority of patients were aged between 16–53 with a median age of 19. This means a full half of these cases are between the ages of 16–19. There are twice as many adult vapers between the ages of 25 and 44. The number of people under the age of 20 that use e-cigarettes is very low, according to Siegel. “It doesn’t fit the pattern,” he says. “It doesn’t make sense that this is electronic cigarettes.”
By his estimates, Siegel says that 90 percent of cases reported using black market THC vaping cartridges. In New York state, every THC cartridge tested was found to contain the thickening agent vitamin E acetate. He stated that in New York state, every patient used THC products. There were also no abnormalities in any of the e-liquids tested.
“So put all this together … because of the timing we know this is not any electronic cigarette or e-liquid. Then, what youth is going to readily admit to using marijuana?” Siegel asks. “The most important thing is that the CDC is not recommending patients be tested for THC. This is a striking revelation. There is no way to tell if a youth is using marijuana without testing. This is something the CDC should be recommending …. The CDC conclusion is … it’s electronic cigarettes. There is no way that could be the case. Even without looking at the data, we knew that wasn’t the case. The CDC recommendation was don’t use e-cigarettes. Kids are dying from buying black market THC cartridges, and the CDC is telling them to stop using e-cigarettes.”
Unfortunately, this transfers into public policy, Siegel explains. The president has said he is going to ban flavored e-cigarettes. The FDA is saying they will ban flavored e-cigarettes. The pieces are starting to come together. “What is happening is the CDC, the FDA, the Trump administration and all the anti-tobacco groups are saying ‘we have a THC cartridge problem.’ So, we should ban all e-cigarettes,” Siegel says. “It’s a complete disconnect. They are using a crisis in one industry to attack another.”
Power push
The FDA does not have the authority to do anything about marijuana-based products. Federal law prohibits the federal sale of marijuana, so it makes it very difficult to regulate, according to Siegel. He says it is also the opinion of many people, including former FDA Commissioner Scott Gottlieb, that the FDA could be given a limited amount of authority over these products through Congress. States, however, have the power to regulate THC products.
“There is nothing to stop states from their own enforcement. If states were really concerned about this outbreak, what they should be doing is spending less time demonizing e-cigarettes and spending more time trying to find the illicit distribution channels for these illicit THC vaping carts,” Siegel says. “E-cigarettes are becoming the scapegoat for a situation that has nothing to do with nicotine. In 2007, when vaping products first hit the market, I was adamantly opposed to them. Everything you hear the FDA, [the] CDC and anti-vaping groups saying now, I was saying in 2007.”
Siegel says he then did something that none of these anti-tobacco groups has done in the last 12 years: He started to talk to some human beings who were actual vapers to try to figure out what these products were and how they helped people quit smoking cigarettes.
“When I found out the truth, that completely changed my point of view. That is not what’s happening. These anti-tobacco groups state their position, stake their ground and confirm to their preexisting [beliefs] to the point that when they have information which directly contradicts their preexisting conclusion, they are twisting it in a certain way and are really going through great lengths of desperation to try and twist it to make it fit even though it doesn’t.”
Seigel says another issue that continues to plague the vapor industry is the term “e-cigarettes.” He says that what you call something has incredible implications. “I think it is unfortunate that e-cigarettes took on the term ‘e-cigarettes’ from the very beginning because that just fed right into the anti-smoking groups propaganda that this is just another form of smoking,” he said. “I think it is very critical that we make the difference [between e-cigarettes and e-joints clear]. We need to come up with terms that make the two very different.”
The VTA has been an active voice in the vapor industry over the past several years. It has also been doing its part to help get the word out that THC products, not nicotine, are at the center of the lung illness epidemic. Abboud says that the VTA has “applauded government when it acts responsibly. We have been holding our decision makers accountable when they are not acting responsibly. Because we represent all the different sectors of this industry, we are able to speak clearly to our leaders in terms of a rational comprehensive policy around this industry segment.”
He’s right. The VTA has fought anti-vaping bills in nearly every U.S. state and has prevented the industry from becoming regulated out of existence. That’s pretty positive since the vapor industry makes an enormous economic impact of $24.5 billion on the U.S. economy, according to the VTA. It provides over $7.9 billion in wages alone. He believes that flavors aren’t the real problem, but the real problem is what companies name those flavors and how they market those products.
Abboud says that vape shops should not have flavors banned because they are better at verifying age than a traditional gas station or convenience store. “Vape shops are a place of community, and this [is] why they are better able to protect youth from getting these products. We need to remind people all the time that all of these products have flavors, and even tobacco is a flavor,” he says. “The real issue is marketing not flavors. Flavors are needed to make these products consumable. Banning flavors is too simplistic of an argument. We need to look at all the marketing issues that exist. Unicorn puke, cotton candy—news flash, these are not flavors, they are marketing gimmicks. The real issue is how do we control these things.”
There have been several studies as well as an enormous amount of survey data that have found that flavors are helping people quit smoking cigarettes, according to Abboud. He says that what most anti-vaping groups are really concerned about is the argument that vaping is a gateway to smoking. Siegel agreed with Abboud that the gateway does not exist, but anti-vapor groups misconstrue data to argue that it does.
Both agree that vapor products are safer than smoking cigarettes. “No serious person says that e-cigarettes aren’t at the lower end of the risk continuum,” says Abboud. “If flavors are banned, what will happen is the mass market exit of the vapor product. People will start smoking again, and that is a bad thing.”

The flavor ban caravan
In early September, Michigan became the first state to proclaim its intent to limit sales of vapor products. Governor Gretchen Whitmer later issued an emergency ban on the online and retail sale of nicotine vapor products in any flavor except tobacco for at least 180 days. On Sept. 17, New York became the first state to implement a statewide ban on most flavored nicotine vapor products, just days after Governor Andrew Cuomo called for emergency action.
The worst ban came on Sept. 24 when Massachusetts Governor Charlie Baker declared a public health emergency due to the then more than 500 vaping-related lung illnesses and at least seven deaths reported to the CDC. Five of those illnesses occurred in Massachusetts. Baker enacted the country’s strictest vaping prohibition: a four-month statewide ban on online and retail sales of all marijuana and tobacco vapor products (not only flavored products). According to a press release, Massachusetts lawmakers chose to ban both marijuana and nicotine products due to continuing uncertainty over what is causing the respiratory illnesses.
The day after the announcement for Massachusetts’ ban, Rhode Island Governor Gina Raimondo signed an executive order banning the sale of flavored e-cigarettes in the state for at least 120 days. Raimondo called vaping a “public health crisis” for youth, adding that she is assembling a group of medical experts to advise her on the best ways to combat the problem. Washington became the fourth state to ban flavored vapor products when its state Board of Health issued an emergency rule that bans the sale of flavored vaping products In mid-Oct. The ban lasts 120 days, according to the Washington State Board of Health. The ban will apply to products containing nicotine as well as THC.
In California, Governor Gavin Newsom took a less heavy-handed approach. On Sept. 16, he issued an executive order aimed at curtailing the state’s youth vaping epidemic by allocating at least $20 million for a “vaping awareness campaign” and asked state agencies to help end sales to anyone under 21 years old and end illegal and counterfeit vapor product sales entirely.

Timothy Donahue
Timothy S. Donahue is the co-founder and managing editor of Vapor Voice.
Tim spends much of his time on the road, attending conferences and interviewing industry representatives.
His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
September 1, 2019
Collective effort
A recently released white paper aims to motivate U.S. Congress, the FDA and the CDC to confront the two major issues facing the vapor industry.
By Timothy S. Donahue
The industry is starting to get organized. Two major concerns facing vapor companies have brought together a varied group of 70 industry stakeholders hoping to get the U.S. Congress to confront both youth initiation and the recent outbreak of acute pulmonary disease, which has caused several deaths. Each of these concerns will have significant public and economic impacts, according to a recently released white paper by the group that represents multiple domestic and foreign vapor hardware and e-liquid manufacturers as well as more than 600 vapor retail stores covering 35 states.
“Although state health departments and the FDA have continued to link recent respiratory illnesses with illegal THC use, the [U.S. Centers for Disease Control and Prevention] CDC reports did not adequately differentiate between THC and nicotine vape even though they are completely different industries,” said Sam Salaymeh, president of AMV Holdings, one of the largest U.S. vapor retailers. “The failure of the CDC to demand THC screening of patients who refuse to admit to such use is irresponsible and dangerous. This oversight has caused widespread panic among consumers and government policymakers and negatively impacted public health.”
Salaymeh says that some vapers are going back to smoking traditional cigarettes, and there is a significant reduction in the rate of smokers who adopt nicotine vaping for harm reduction. The nicotine vapor industry is suffering “severe economic hardship,” according to Salaymeh. “We have had to shut down many stores and lay off more than 15 percent of our workforce due to the actions of drug dealers selling contaminated THC cartridges. That should not happen in a country founded on freedom and justice.”
These significant negative impacts with respect to public health are sending people back to smoking and black markets as well as the loss of potentially 80,000-plus jobs and $24 billion in industry economic output and direct political impacts, according to the paper. The group’s members collectively serve approximately one million customers a year, of which over 85 percent have used vaping to quit or substantially reduce smoking combustible cigarettes, according to the paper. Of these former smokers, the paper claims that 97.8 percent say vaping has improved their lives. None of these operators are owned by major tobacco companies.
“The consequences of the political action taken in response to these two fabrications have not been duly taken into consideration,” the paper states. “There is no evidence that [the U.S. Food and Drug Administration] FDA-regulated vapor products have resulted in any of the recent pulmonary disease-related deaths, and the overwhelming majority of the patients suffering from respiratory illness have reported the use of only THC vaping products with or without nicotine. The CDC has failed to properly distinguish illegal black market THC vaping cartridges from legally purchased nicotine-containing e-cigarettes. This oversight has caused significant consumer confusion resulting in customers returning to cigarettes and economic hardship for vape retail store operators.”
In confronting the issue of youth initiation, which the FDA claims is driven by flavored electronic nicotine-delivery system (ENDS) products, the paper states that “flavored ENDS products have existed worldwide for more than a decade. The acceleration of youth consumption only became an epidemic in the last two years along with the increased popularity of high-nicotine closed pod systems.” The paper states that Juul Labs’, the nation’s largest e-cigarette brand, growth and market penetration follow youth initiation growth patterns, and flavors are not the fundamental cause of the increase in youth uptake,.
“From a product standpoint, we believe there is ample evidence that the underlying cause for youth initiation is a combination of nicotine salts that contain high levels of nicotine and discreet devices,” the paper states. “The least important factor is nontobacco flavors. Lastly, we believe that the distribution channels of c-stores and online purchases drives youth initiation rather than the vape store channel.”
According to the paper, the group makes three data-driven, risk-based policy recommendations for regulators in response to helping curb youth initiation:
Limit flavors to lower nicotine products sold through adult-only age-verified retailers. “Our research shows flavors are not the underlying cause of the ‘youth epidemic.’ However, flavors combined with high nicotine strengths and discreet devices can increase youth initiation. We recommend limiting flavors to lower nicotine concentrations (30 mg [per] mL and below) sold through adult-only age-verified retailers.”
Examine nicotine strength and risk profiles. “The acceleration of youth vaping is highly correlated to the growing popularity of high nicotine concentration products, particularly 50 mg [per] mL. A nicotine level restriction has proven lower youth adoption rates in other countries where nontobacco flavors remain available. The FDA should recognize this heightened risk profile with respect to the distribution and marketing of all ENDS [products].”
Encourage manufacturers to build age verification tools into all hardware. “Discreet devices are a powerful tool for adult consumers; however, when combined with high nicotine concentrations, they also have the youngest customer age demographic. For hardware devices commercially marketed prior to Aug. 8, 2016, we recommend the FDA waive enforcement action to allow for the addition of age verification tools. Additionally, we recommend [the] FDA waive enforcement action for pre-Aug. 8, 2016, closed pod systems marketed with a high nicotine concentration in order for the manufacturer to reduce the nicotine level. These devices should only be sold in adult-only age-verified retailer establishments.”
The CDC has not stated outright that nicotine vapor products are not the cause of the recent pulmonary health issues. However, in early October, the FDA stated that the majority of samples tested by the states or by the FDA “related to this investigation have been identified as vaping products containing THC. Through this investigation, we have also found most of the patients impacted by these illnesses reported using THC-containing products, suggesting THC vaping products play a role in the outbreak. As this complex investigation continues, we urge consumers to take heed of our warning and stop using THC vaping products and to not use vaping products of any kind that are purchased off the street or from unknown sources.”
The claim that nicotine-based ENDS products have anything to do with the pulmonary disease issue is being widely published by the national media and is supported by statements made by the CDC, which has been vague at best, according to the paper. “This claim does not differentiate between regulated nicotine vapor products and black market THC vape cartridges. It has become overwhelmingly clear that the acute pulmonary diseases and multiple fatalities are the results of vaping illegal THC cartridges and other illicit products not FDA-regulated nicotine-containing products,” the paper states. “E-cigarettes have been widely used for more than a decade, and the current cases are focused on a very narrow epidemic, both in time and geography. This suggests that these respiratory illnesses are caused by specific batches of tainted black market products and not FDA-regulated vapor products.”
As far back as August, Brian King, deputy director of research translation at the Office on Smoking and Health at the CDC, said that potential irritants include “ultrafine particulates, some heavy metals, such as lead,” and, he said, there “are also concerns about some flavorings …. We haven’t specifically linked any of those ingredients to specific cases.”
On Sept. 5, 2019, the New York Department of Health (NYDH) released an update on the pulmonary cases of New York patients. They stated that lab results found extremely high levels of vitamin E acetate in nearly all cannabis-containing samples tested as part of the investigation. “At least one vitamin E acetate-containing vape product has been linked to each patient who submitted a product for testing,” NYDH stated in a release.
In Minnesota, the Department of Health’s news release on Sept. 6, 2019, stated that of the 32 cases of reported lung illnesses under investigation, those who were interviewed all disclosed that they were vaping illicit THC products. According to the recent New England Journal of Medicine report, 85 percent of patients’ lung illness incidences were tied to black market drugs. This study delved deeper into 53 pulmonary illness cases in Illinois and Wisconsin. Of those patients, 41 were extensively interviewed, and 80 percent reported using THC products.
“By linking nicotine-based vaping and illegal black market THC vaping, the CDC has caused widespread panic among consumers who have used vaping to quit smoking cigarettes. Further, they have discouraged current smokers from transitioning to the less harmful alternative of e-cigarettes,” according to the paper.
In order to help rectify the misinformation, the group suggests that the CDC should “immediately release a public announcement further clarifying FDA-regulated vapor products are not the cause of the respiratory illnesses and deaths that it is investigating.” They also ask that the CDC publicly acknowledge Public Health England’s statement that e-cigarettes are 95 percent safer than combustible cigarettes.
Consequences of misinformation
Claiming that nicotine-based vapor products cause pulmonary illness and youth use is motivated by nontobacco flavors has caused consumer confusion and poor policy implementation, according to the paper. This has also lead to a negative public health impact and the potential loss of 80,000 jobs.
Because the CDC has refused to differentiate between nicotine vaping and THC-based vaping, the agency has created massive confusion and panic among the 13 million consumers who vape nicotine-containing e-liquids, the paper states. In addition, the CDC statement has emboldened knee-jerk state action, which will be detrimental to public health.
As for flavors, President Trump, Health and Human Services Secretary Alex Azar and acting FDA Commissioner Ned Sharpless announced the intention of the Trump administration/FDA to take action against flavored e-products in early September. In a separate announcement soon after, Sharpless announced that in the “coming weeks,” the FDA’s Center for Tobacco Products would look to clear the market of flavored e-liquid via market authorization requirements based on preliminary results from the National Youth Tobacco Survey showing continued utilization of flavored e-products by youth.
Former FDA Commissioner Scott Gottlieb stated last year that “e-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine-delivery products that may not have the same level of risks associated with them.”
Both Gottlieb and the FDA’s director of the Center for Tobacco Products, Mitch Zeller, have stated that if they can take every adult smoker and fully switch them to e-cigarettes, it would be good for public health. Since the public health announcement, daily sales for vape retail stores have decreased compared to the previous month’s sales, according to Salaymeh. “Sadly, numerous consumers have informed us that they will return to smoking cigarettes as it is now viewed as a ‘safer alternative,’” he says.

Timothy Donahue
Timothy S. Donahue is the co-founder and managing editor of Vapor Voice.
Tim spends much of his time on the road, attending conferences and interviewing industry representatives.
His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
September 1, 2019