Category: Uncategorized

  • A Call for Common Sense

    A group of EU citizens is petitioning European regulators to stop treating vapor products as tobacco.

    These are busy days for Dustin Dahlmann. The chairman of the Bundnis fur Tabakfreien Genuss (BfTG), Germany’s only e-cigarette trade association independent of the tobacco industry, has been a sought-after interviewee since the country’s vapor market experienced a dramatic sales drop in October. In a BfTG survey of 600 German e-cigarette retailers, more than half of respondents reported sales declines of 30 percent to 40 percent whereas almost one-fifth related revenue losses of more than 50 percent.

    The market slump occurred in the wake of an outbreak of vaping-related lung injuries and deaths in the U.S. Although regulation is stricter in the European Union (EU) and the main chemicals under suspicion in the U.S., including THC and vitamin E acetate oil, are prohibited in e-cigarettes in the EU, the news has unsettled German consumers, says Dahlmann. “Many customers find themselves in a Catch- 22 situation. We observe that many who would like to quit cigarettes with the help of vape products are returning to combustibles following the events in the U.S.”

    The situation looks similar in France: According to L’Express, sales of e-cigarettes have recently fallen between 10 percent and 40 percent. The downturn in two of the EU’s leading vapor markets comes at a time when an European Citizens’ Initiative (ECI) is calling upon European regulators to take vapor products out of the Tobacco Products Directive (TPD2), differentiate them from pharmaceutical products and create a proportionate and evidence-based regulatory environment.

    Called Vaping is Not Tobacco, the campaign was initiated by eight EU citizens from Germany, France, the U.K., Italy, Belgium, Romania, Ireland and the Czech Republic, among them Dahlmann, who has been registered as its official representative. As its main goals, the initiative lists helping smokers access vapor products that can help them transition out of tobacco, allowing flavored vapor liquids, preventing access by young people to vapor products, reducing risks for vapers by introducing robust product quality, manufacturing and safety standards, and ensuring responsible marketing of vapor products that do not target youth.

    Introduced in the 2007 Treaty of Lisbon, the ECI was designed as a tool to improve democracy by enabling citizens to participate directly in the development of EU policies. If a group of citizens representing at least one quarter of EU member states gathers 1 million signatures supporting their initiative, they can call directly on the European Commission to propose a legal act. The commission then decides on what follow-up action to take. An ECI cannot be submitted by organizations or companies.

    Dahlmann’s petition, which started in late April, has until February 2020 to collect the required signatures. At press time, 47,000 people had signed. “We are grateful for this, but we had expected more support from vapers,” says Dahlmann. “We still have three more months to improve this result, and we will make good use of this time. Each vaper should understand how important a differentiation between e-cigarettes and combustible cigarettes is in legislation and in public awareness.”

    The initiative is using all marketing tools available, from classical tools to social media communication. It also participates in events such as international e-cigarette exhibitions to clarify the differences between tobacco and vapor products. “Besides, a large number of retailers throughout Europe support our campaign and have lists of signatures available,” says Dahlmann.

    A DIFFERENT SITUATION

    According to Dahlmann, the outbreak of vaping-related illnesses in the U.S. and the subsequent crackdown on the sector by regulators has boosted the number of signatures. “In light of the partly very unfair media reporting about the vaping-related illnesses in the states, we have noted a strong alliance of solidarity among consumers and retailers,” says Dahlmann. “Many users are aware that regulated e-cigarettes have nothing to do with the lung injuries and deaths. The issue in the U.S. is about e-joints, illegal products for the consumption of drugs. Only if the public is informed about the true cause of the disease as well as the tremendous advantages of vapor products, a change in thinking can take place again. Everyone who is of the same opinion should support Vaping is Not Tobacco.”

    Apart from the petition, the initiative also includes a campaign to enable European citizens to get in touch with their respective national candidates for the European Elections that took place in May. Dahlmann says that this part of the initiative reached many candidates and members of European Parliament. “The theme is education and motivation towards a clear distinction between tobacco and e-cigarettes. The basic campaign is being used a lot, and we hope for a new political valuation of vaping in Europe.”

    Recently, he adds, numerous measures had been taken to educate the public with regard to vaping, with many of them being highly successful. Together with other trade organizations, the BfTG has been educating the European media about the events in the U.S.

    WELL ORGANIZED

    The petition for smarter vaping regulation is not the first attempt at influencing e-cigarette legislation in Europe. In contrast to its predecessors—none of which succeeded—the current initiative has been meticulously planned. With all of the petitioners representing vapor companies and organizations, including the Czech Vaping Association and the organizers of Vapitaly, a leading Italian trade fair, the initiative has financial support. However, critics have seized on the fact that €10,000 ($11,077) of the €35,000 in donations collected so far came from Imperial Brands.

    For Dahlmann, it is irrelevant. “Like many others, Imperial Brands has supported the campaign financially,” he says. “All participants have jointly developed the wording of the campaign, not only Imperial. That’s why we are 100 percent behind the initiative. The committee members are the only ones to take on official responsibility and decide on the execution of the campaign. Imperial doesn’t have any control of it. It’s an initiative for e-cigarettes and hence the exact opposite of a tobacco campaign. Otherwise, the BfTG as a tobacco-free association would not have supported the campaign.”

    HIGHLIGHTING THE ISSUE

    Collecting 1 million signatures by February seems ambitious. Even if it is achieved, the EU can still object to considering the initiative. Nevertheless, Dahlmann remains confident. “The initiative is about to find as many supporters as possible so that the necessity of the campaign becomes obvious. Achieving that would be a success for us. If we don’t reach our goal of 1 million signatures, we will continue with our political work to draw attention to the urgency of this issue. If the required number of signatures is gathered, the European Commission is not obliged to submit a proposal for a legislative act. However, it has to meet with the initiators so that they can elucidate the topics covered by the initiative. Furthermore, the organizers have the opportunity to present their initiative in a public hearing at the European Parliament.”

    Even if the petition succeeds, the desired legislation would still be a long way off. “If the commission decides to submit a proposal for a legal act, the regular legislative process will get started,” explains Dahlmann. “The commission’s proposal will be presented to the legislator, which usually is the European Parliament and the European Council—in some cases only the latter. If the proposal is adopted, it will become law.”

    Picture of Stefanie Rossel

    Stefanie Rossel

  • Cloudy Perspective

    President Trump’s listening session on vapor products provided a much needed forum for the vapor industry.

    It was a contentious situation. Groups both for and against flavored vapor products spoke passionately about their position during a listening session with U.S. President Donald Trump. Held in late November, the roundtable discussion centered on e-liquid flavors and youth vaping. Overall, Trump seemed to have softened his opinion of an outright ban on all flavored vapor products except tobacco.

    During the meeting, Trump announced that the federal rule for purchasing tobacco products will be raised from age 18 to 21. “We’re going to be doing that. Twenty-one, we’re going to be doing that,” Trump said. While whether he favors a flavor ban is clouded in uncertainty, Trump did show concern that an all-out flavor ban could push consumers toward the black market and counterfeit products. Trump stated that a decision on the flavor ban “would be coming soon.”

    “This is a very big subject, and it’s a very complex subject. Probably a little bit less complex than some people think. But I’m here to listen, and I have very divergent views,” said Trump. “We’re going to be announcing very soon. We did have an instinct, but we’ll be announcing, and we’re going to continue this meeting for a little while.”

    Only the first hour of the meeting was open to the media. Held at the White House, the session included vapor industry leaders, public health advocates, politicians, regulatory officials and others to address a surge in underage vaping and what would happen to the industry if flavored e-liquids were to be banned. It became heated at times as both sides tried to convince the president of their point of view. A Washington Post columnist likened the ordeal to a public policy version of the reality TV show The Apprentice as industry and government representatives randomly shouted at each other in hopes of swaying Trump.

    Ryan Nivakoff, CEO at NJoy, for example, stated that a hundred thousand Americans were going to lose their jobs (if flavors were banned), adding that it’s not disputed by anybody in the public health sector. Tony Abboud, executive director for the Vapor Technology Association (VTA), which recently released an independent economic impact study that puts the number of jobs lost at over 150,000 (see “Significant Impact”), stated, “Actually, the number is higher, Mr. President.” Senator Mitt Romney, sitting at the right hand of the president, then stated, “[It’s actually] much lower.”

    Romney later stated that there are approximately 10,000 vape shops in the U.S. with an average of four employees and conceded the “flavors” segment of the industry only accounted for about “50,000” jobs and that not all those jobs would be lost if flavors were banned. Romney did not include in his assessment employees at e-liquid manufacturing companies or flavor houses that also serve the industry as well as numerous other ancillary players in the market.

    “They will lose their jobs, sir. They sell—I’d like to finish [Romney was trying to speak over Nivakoff]. [Vape shops]
    sell exclusively flavors. So … I don’t think we need to argue the virtue of youth not using these products,” said Nivakoff. “We all agree that they shouldn’t.”

    Overall, the vapor industry represented itself well. As one of the first speakers, Greg Conley, president of the American Vaping Association, explained to Trump that unlike on Sept. 11, when he initially announced his intent to ban flavors, Trump now knows the U.S. Centers for Disease Control and Prevention (CDC) was wrong in saying nicotine vapor products were killing people. “But now we know from the CDC that their main focus of their investigation, it’s not store-bought nicotine products,” said Conley. “It’s not the companies that Tony Abboud represents. It was illicit THC oil cartridges.”

    Conley explained that he agreed with Trump’s decision to raise the age to purchase tobacco products to 21, but more can be done. “We need bulk sales purchase limits. We need marketing restrictions. And also, most importantly, there is—in May of 2020, every single vaping product on the market has to go through what’s known as a premarket review,” explained Conley. “That’s going to cost several million dollars per product. So even if we solved this crisis today—which I hope we do—in five, six months, we’re back where we started with potentially only the largest multibillion-dollar companies being able to survive … and all these small businesses, they’re the ones that are employing people—70,000, 80,000 direct jobs, 70,000 indirect jobs.”

    Regarding the flavor ban, Trump asked members of the meeting if banning flavors would lead to any negative consequences for the consumer. “Isn’t that going to be just sold, you know, illegally, or somebody is going to open up a shop in China and ship it in with flavors and you don’t know what standard you’re getting? Isn’t that a problem?” Trump asked. Most members of the industry agreed. “In New York City, if you go to a bodega to buy the Juul pods, you can buy 15 different versions of Juul mango, which have been off the market since September,” Nivakoff explained.

    Abboud explained to Trump that this is a complex problem, so it needs a sophisticated plan. “A flavor ban will not work. And you’ve articulated one critical reason why it will not work: People will just go to the black market. And that’s because adults are demanding these flavors,” said Abboud. “And I think the better approach would be to raise the age to 21, put severe restrictions on how you market the product. Then, on top of that, you have to increase penalties for retailers because our retailers are fine with the increasing penalties because they do know that they are age-gating and keeping these products out of the hands of kids.”

    Additionally, Abboud said his organization supports a “three strikes and you’re out” rule for sales violations to underage customers. “Today, the FDA can allow you to have seven strikes before you’re actually told to stop selling tobacco products. That’s unacceptable,” he said. “On top of that: age verification. We are in the day, age, of technology. And that is what this is; this is a technology product that is helping people quit smoking.”

    Trump likened the situation to the prohibition of alcohol. “You watch prohibition, you look at—you know, with the alcohol—you look at cigarettes, you look at [it] all—if you don’t give it to them, it’s going to come here illegally, OK? They’re going to make it,” Trump said. “But instead of Reynolds or Juul or, you know, legitimate companies, good companies, making something that’s safe, they’re going to be selling stuff on a street corner that could be horrible. That’s the one problem I can’t seem to forget. I mean, I’ve seen it. You just have to look—you have to look at the history of it. And now, instead of having a flavor that’s at least safe, they’re going to be having a flavor that’s—that’s poison.That’s a big problem.”

    The anti-vapor groups never acknowledged the black market growth potential. They did, however, talk about the rise in youth vaping and their position that flavors don’t help smokers quit. “Mr. President, we have 5.3 million kids who are addicted, and it’s separate from the lung disease— 5.3 million kids. A million kids a day are using these products repetitively with addiction,” said the Campaign for Tobacco- Free Kids’ president, Matt Myers. “Since the flavors have been introduced, we have seen a meteoric rise in use by kids. We have seen no increase whatsoever before flavors were marketed so heavily … the No. 1 flavor of e-cigarette on the market was tobacco flavor.” Romney agreed with Myers, adding that “most adults are not using flavors.”

    No Nielsen data or any other study could be found that showed tobacco flavor was once a market leader. However, several studies and all available Nielsen data shows nontobacco flavors to be the most popular in every market. Nivakoff said that “92 percent of my revenue is flavors, and I had 1.2 percent of [the] U.S. [market].”

    Sally Goza, president of the American Lung Association, called the situation of youth vaping “a crisis.” She suggested to Trump that she represented “the nation’s doctors … and we’re all of the same message—that we need to take all flavors off the market, pending FDA investigation of that. And then we are worried that if we leave one flavor on the market—even menthol—that the children will go to that because they’re going to want something to help—they’re going to want something. And that’s why action is so desperately needed here.”

    However, when asked by Trump what she would do about the potential problem of a black market and the public health issues that could arise (similar to the black market THC deaths), she had no answer. “I’m looking at Secretary Azar and hoping he has the great solution for that,” she said. “Well, it’s the problem,” replied Trump. “I think you have the same [black market] problem with drugs and everything else.”

    Robin Koval, CEO and president of the Truth Initiative, said that the black market isn’t a problem; addicted kids will just quit. “If I may, on the counterfeit issue: We know, actually, that many of these kids want to quit. They need help quitting,” she said. “We asked kids, ‘What would you do if all the flavors were taken off the market, including menthol?’ Sixty percent—the No. 1 answer was ‘quit.’”

    Toward the end of the open session, Abboud explained to Trump that the vapor industry is a new industry that’s—for the first time—competing for the cigarette smoker with a less harmful product. “You have a new industry that’s competing … trying to yank [cigarette smokers] off of that cigarette. And so, we have to do both things. There is no reason we can’t do both things in this country [have vapor products and combustible cigarettes],” said Abboud. “But if you eliminate flavors … because flavors make up about 85 [percent] to 90 percent of their sales … [many small businesses] will go out of business. There is no question about that because no small-business owner could take that kind of hit to their revenue.”

    “It’ll destroy the business,” replied the president.

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • Juul withdraws support of ballot to reverse San Fran vapor ban

    Juul withdraws support of ballot to reverse San Fran vapor ban

    Juul Labs will end its support for a ballot measure that would roll back San Francisco, California’s, ban on e-cigarettes.

    In a statement released on Monday, Juul Labs said it “recently announced a broad review of the company’s policies in order to responsibly lead the industry.”

    “As we continue that review, the company announced it will cease active support of Prop C in San Francisco.”

    Prop C would repeal the e-cigarette sales restrictions that were passed unanimously by the city’s board of supervisors.

    In June, San Francisco became the first U.S. city to ban e-cigarettes in response to what officials described as an “epidemic” of youth e-cigarette use. The ordinance prohibits the sale and distribution of e-cigarettes in San Francisco unless that product has undergone premarket review by the U.S. Food and Drug Administration.

    No e-cigarette has done so yet.

    Juul Labs’ announcement follows a leadership change. Last week, the company named K.C. Crosthwaite as its new CEO, replacing Kevin Burns.

    Previously, Crosthwaite was chief growth officer at Altria, which owns 35 percent of Juul Labs.

  • Maryland passes law to prevent nicotine sales to youth amid vaping concerns

    Maryland passes law to prevent nicotine sales to youth amid vaping concerns

    Nearly all teenagers will be barred from buying e-cigarettes or their analog counterparts in Maryland after Tuesday, when a law raising the age to purchase tobacco products takes effect.

    Maryland joins the District and 14 other states that restrict nicotine sales in an effort to curb an alarming surge in teen vaping. Approved in the spring, Maryland’s law takes effect amid nationwide concern about the safety of vaping both nicotine and marijuana products, according to an article in the Washington Post.

    Maryland’s law increases the buying age for tobacco from 18 to 21 for everyone except active-duty members of the military.

    The chief architect of the statute, House Economic Matters Committee Chairman Dereck E. Davis (D-Prince George’s), plans to introduce legislation in January to completely ban flavored vaping products, according to the story.

  • Walmart stops e-cig sales

    Walmart stops e-cig sales

    Walmart, the world’s largest retailer, will end sales of e-cigarettes at its locations in the United States, reports The New York Times

    The announcement was made on Friday in response to rising concerns about sicknesses and deaths seemingly linked to vaping.

    “Given the growing federal, state and local regulatory complexity and uncertainty regarding e-cigarettes, we plan to discontinue the sale of electronic nicotine-delivery products,” Walmart said in a statement.

    The company will continue selling the devices until its current inventory of e-cigarettes is exhausted.

    Earlier this year, Walmart raised the minimum age to purchase tobacco products from 18 to 21. In May, it announced that it would no longer sell fruit-flavored and dessert-flavored electronic nicotine-delivery systems.

  • PMTA rule proposed

    PMTA rule proposed

    On Sept. 20, the U.S. Food and Drug Administration (FDA) issued a proposed rule to set forth requirements related to the content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs).

    “Our review of premarket product applications will help evaluate the public health benefits and harms of a tobacco product to ensure that those authorized for marketing are appropriate for the protection of public health,” said Acting FDA Commissioner Ned Sharpless.

    The proposed rule follows the FDA’s mid-September vow to clear the market of unauthorized, non-tobacco-flavored e-cigarette products

    In July, a U.S. District Court judge in Maryland issued an order requiring that manufacturers submit premarket applications by May 12, 2020, for deemed tobacco products, including e-cigarette products, that were on the market as of Aug. 8, 2016.

    The proposed rule will be open for public comments for 60 days through Nov. 25, 2019.

    Read the FDA’s full statement announcing the proposed rule here.

  • Criminal probe launched

    Criminal probe launched

    zeller
    Mitch Zeller

    The U.S. Food and Drug Administration has launched a criminal probe into the vaping-related deaths and illnesses that have plagued the United States in recent weeks.

    The U.S. Food and Drug Administration has launched a criminal probe into the vaping-related deaths and illnesses that have plagued the United States in recent weeks, reports USA Today.

    “We are in desperate need of facts,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

    The investigation will focus on the products, where they were purchased and how they are being used.

    As of Sept. 20, the Centers for Disease Control and Prevention (CDC) was aware of 530 cases of lung injury and seven deaths.

    The cause of the outbreak remains a mystery. No consistent product, substance or brand has been identified in all cases, CDC said. Most, but not all, patients reported a history of using e-cigarette products containing THC, a psychoactive chemical found in cannabis.

    The FDA has collected more than 150 vaping product samples for forensic analysis, and the agency is testing them for traces of nicotine, THC, opioids, cutting agents, additives, pesticides, poisons, toxins and other substances.

  • Study: majority of respiratory diseases in vapers linked to illegal THC products

    Study: majority of respiratory diseases in vapers linked to illegal THC products

    Patients in Illinois and Wisconsin finds that 83 percent of them who experienced severe respiratory illnesses after vaping admitted using black-market cannabis products. The remaining 17 percent claim to have used only nicotine products, however, some of them may have been reluctant to admit using illegal drugs, according to the study.

    These findings cast further doubt on the wisdom of general warnings about “vaping” and “e-cigarettes,” which imply that legal nicotine products are implicated in these cases, according to an article on Reason.com. Such warnings may encourage former smokers who are now vaping to start smoking again, a decision that exposes them to much greater health risks.

    The new study, reported Friday in The New England Journal of Medicine, focused on 53 patients who had vaped within 90 days of their symptoms, typically within the previous week, according to the story.

    Their median age was 19, and nearly a third were younger than 18. Among the 41 patients who were “extensively interviewed,” 80 percent reported using THC products, 7 percent mentioned CBD products, and 17 percent said they had vaped nicotine only, according to the story. The authors note that “information on product use is based on reports by the patients, and patients may be reluctant to report illicit drug use.”

    The description of the vapes used by the patients indicates that most were black-market products represented as containing cannabis extracts. “Patients reported using 14 distinct brands of THC products and 13 brands of nicotine products in a wide range of flavors,” the researchers say. “The most common THC product that was reported was marketed under the ‘Dank Vape’ label (reported by 24 of 41 interviewed patients [59%]). Patients reported use of a number of different e-cigarette devices to aerosolize these products,” the article states.

    It’s not clear whether any of the products in the THC-only cases were closed-system devices such as Juul, as opposed to refillable vaporizers, according to the story. Nor is it clear whether the cartridges or e-liquids used in the devices were legally produced, illegal knockoffs, DIY solutions, or mystery fluids concocted by third-party suppliers.

    At last count, the U.S. Centers for Disease Control and Prevention had identified “over 450 possible cases,” including five fatalities, in which pulmonary diseases may have been caused by vaping. Data from California and New Mexico, like the Illinois and Wisconsin cases analyzed in the NEJM study, point to THC products as the main issue, according to the story.

    E-cigarettes have been in wide use for years, while these cases have cropped up only recently. It therefore seems likely that the agents responsible for the symptoms are relatively new.

    The theory currently favored by public health officials investigating lung diseases among vapers, The New York Times notes, is that “some dangerous chemical or combination of chemicals has been introduced into the pipeline of vaping products.” Investigators “believe that when people vape this noxious cocktail, it sets off a dangerous, even lethal, reaction inside the lungs.” They “have said repeatedly that they do not yet know which substance or device may be causing this reaction, and that is the subject of their urgent investigation.”

    One possible culprit, identified in most samples of cannabis extracts tested by the Food and Drug Administration (FDA) and health officials in New York, is vitamin E acetate, an oil-based nutritional supplement that may be dangerous when inhaled. “Legally sold nicotine based e-cigs are not harmless,” former FDA chief Scott Gottlieb said on Twitter last week, according to the story.

    “But most of these severe cases, so far, appear to be symptoms that can occur when either oils or lipid-containing substances enter lungs. This points to illegal products that are being cut with dangerous chemicals as a culprit.” He added that “legitimate e-liquids are generally based on chemicals that are water soluble, not oils that can cause acute lung injury.”

  • Snowdon: US public-health fanatics are spreading unfounded fears about vaping

    Snowdon: US public-health fanatics are spreading unfounded fears about vaping

    Vaping ordinary water-based nicotine-containing liquids did not suddenly become extremely dangerous after having been used safely by millions of people for more than a decade, according to Christopher Snowdon, director of lifestyle economics at the U.K. Institute of Economic Affairs.

    Writing in Spiked, Snowdon takes issue with what he describes as “the great American vaping panic” in which American public health activists are spreading unfounded fears about vaping.

    While the recent vaping-associated hospitalizations and deaths in the U.S. are regrettable, Snowdon points out that in nearly all the cases, the victims had been vaping unregulated street drugs instead of standard vape juices.

    Snowdon attributes the panic to “a mendacious coalition of anti-smoking groups, quackademics and government institutions” spreading fear and disinformation.

  • Utah state lawmaker says 84% of vapor products in Salt Lake County tested positive for opioids

    Utah state lawmaker says 84% of vapor products in Salt Lake County tested positive for opioids

    According to a story on fox13now.com, 84 percent of e-cigarette liquid sold in Salt Lake County vape shops tested positive for opioids and other illegal drugs, according to Utah State Rep. Paul Ray.

    The Davis County Republican said Wednesday the samples were purchased from the shelves of Salt Lake County vape shops and that they tested positive for opioids and other illegal drugs in laboratory tests, the story states.

    He called the findings a “health emergency” and called a 4 p.m. news conference to discuss a potential ban on the sale of e-cigarette products in Utah.

    Drug Enforcement Administration District Agent in Charge for Utah, Brian Besser, will join Ray at the news conference to answer questions and discuss black market sales, according to the story.