Category: Editor’s Picks

  • A Defining Decade

    A Defining Decade

    Credit: Thomas Trompeter

    The vaping industry has significantly changed in the 10 years since Vapor Voice started publishing.

    By Timothy S. Donahue

    The vaping industry has changed dramatically during the past decade. When Vapor Voice published its first issue in 2014, the e-cigarette industry was about six years old and still in its infancy. Cig-a-likes and tobacco flavors were still popular, but flavors and mods started taking off. In an online article on Dec. 14, 2019, Vapor Voice reported that Clearette was named “Best E-Cigarette and Vapor Line of 2014” in a competition organized by ECig Review Central.

    ECig Review Central gathered 25 leading vapor enthusiasts from around the United States. The judges were blindfolded and sampled 20 prominent e-cigarette brands over six hours. “I liked the bold e-cigs the best,” said one judge. “The throat hit was perfect, and the draw was extremely smooth.”

    Each tester was given a 15-minute to 20-minute break between individual e-cigarettes. Judges rated taste, quality and delivery on a scale of one to 10. In 2014, 21 out of 25 judges rated Clearette’s line as the best tasting. “The entire line was incredible,” stated another judge. “I was thinking it might be a tobacco company’s, but it wasn’t. The vapor tasted just like smoke.” Sadly, like many early vapor companies, Clearette and ECig Review Central are no longer in business.

    These early devices provided little vapor, and battery life was short compared to today’s products. One early industry leader, Njoy, is still producing products, albeit now under the Altria umbrella. The difference between Njoy’s original Daily disposable and its current Daily disposable exemplifies the vapor industry’s technological growth. In addition, Njoy’s Ace pod system is the most technologically advanced vaping product to have received marketing authorization from the U.S. Food and Drug Administration.

    Vapor Voice’s first print edition followed Altria’s announcement to launch its MarkTen e-cigarette nationwide. Altria also purchased Green Smoke for $110 million in cash and up to $20 million in incentive payments. Both the MarkTen and Green Smoke products are no longer on the market. Later that year, Greg Conley started the American Vaping Association, a nonprofit vapor industry advocacy organization that has now become part of the American Vapor Manufacturers Association, and the Oxford English Dictionary voted “vape” as the word of the year. Philip Morris International also launched its heated-tobacco product, IQOS, in Milan, Italy, and Nagoya, Japan.

    In 2014, the U.S. Food and Drug Administration also released its proposed rule for extending its authority to all tobacco products, including e-cigarettes, cigars, hookah and pipe tobacco (“the deeming rule”). The new regulations for electronic nicotine-delivery system (ENDS) products were finalized in 2016. The final deeming regulations were officially published on May 10, 2016, and became effective 90 days later on Aug. 8, 2016.

    The deeming rule changed the vaping industry. Many would say it nearly decimated it. The FDA’s channels for manufacturers and retailers to gain permission to sell their products threatened to put them out of business. According to the Brooklyn Law Review in a 2017 paper, “Through the far-reaching ‘Deeming Rule,’ e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market.”

    The Juul Experience

    Credit: Insurance Journal

    In 2015, we had our first introduction to Juul Labs. During a tobacco industry event in New York, Brian Haynes, with Troutman Pepper, and myself were shown a Juul device by Gal Cohen, Juul Labs’ head of Scientific and Regulatory Affairs. We snuck off into the back corner of a bar together, and he let us both take a few puffs. He wouldn’t let us have one. It blew our minds. We knew then that it was potentially an industry-altering product.

    Juul altered the industry too. Its impact could be summed up as “the good, the bad and the ugly.” The good was that Juul was a technological marvel at the time. The Juul device helped smokers switch to vaping faster than any product before it. Sales began to soar. Juul was the catalyst for the rapid growth of the vaping industry from 2016 to 2019.

    In 2017, Kevin Burns joined Juul Labs as CEO about two years after the company launched Juul. Juul was estimated to make up about 40 percent of the e-cigarette industry at that time. Then, in December 2018, Altria Group invested $12.8 billion in Juul Labs, acquiring a 35 percent interest and valuing the company at $38 billion. Altria claimed Juul Labs would remain a fully independent company.

    Soon after Altria’s investment, Juul Labs began to decline. The company and its advertising practices came under fire. The FDA accused Juul of creating a vaping “epidemic” by hooking youth on vapes, and Burns even went as far as to say he would apologize to parents whose “children were addicted to the company’s products” as concern grew around the teen vaping epidemic.

    There was also the great EVALI scare. The outbreak of “e-cigarette or vaping product use-associated lung injury,” to use the outbreak’s official but misleading name, started in 2019 and was caused by illegal, unregulated cannabis vaping products laced with vitamin E acetate. The U.S. Centers for Disease Control and Prevention, however, wrongly blamed nicotine vaping products. This episode, too, almost ended the e-cigarette industry.

    EVALI and the youth “epidemic” became too much of a burden for Juul Labs. Burns resigned as CEO of the company in September 2019. K.C. Crosthwaite, who was serving as the chief growth officer for Altria, was named his successor. In October 2019, Juul Labs announced it would be laying off about 500 employees by the end of the year. Several Juul Labs executives also moved on from the troubled company that year.

    Stung by Juul’s disappointing performance, Altria announced in October 2019 that it was reducing the value of its investment in Juul by $4.5 billion. In January 2020, the FDA issued a policy prioritizing enforcement against unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. However, the flavor restriction didn’t apply to disposable e-cigarettes. “Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions,” the agency stated.

    Juul subsequently pulled all its flavored pods from the U.S. market except for tobacco and menthol. The impact of the FDA’s rule was devastating for the pod-based Juul and all other pod-based vaping systems. By October 2020, Altria further reduced Juul’s valuation to approximately $10 billion. By March 2021, the valuation was cut to $4.3 billion; by March 2022, it was reduced to $1.6 billion. In July 2022, the valuation of Juul Labs was further cut down to $450 million, which was only 3.5 percent of its original value.

    The fall of Juul may go on to be one of the most significant corporate collapses of this century. Coupled with the FDA’s nonenforcement policy of flavored disposable vaping products, Juul Labs’ downfall caused substantial changes in the vaping industry. No longer were pod systems a dominant force. Instead, sales of disposable vaping products exploded.

    Disposables are King

    Njoy ACE

    The vapor industry has grown dramatically since Vapor Voice started publishing. In 2014, the vaping industry was worth an estimated $7.2 billion, according to Statista. In 2023, its value had grown to more than $23 billion. The global vaping industry is expected to reach more than $26 billion by 2028. The disposable e-cigarette market size was valued at $5.7 billion in 2021 and is poised to grow from $6.8 billion in 2022 to $14.8 billion by 2030, according to SkyQuest Technology.

    While favored by consumers, disposable products present their own issues for the industry. It started with the rise of Puff Bar, which entered the U.S. market in 2019. At the time, it was owned by Cool Clouds Distribution of California. Cool Clouds sold Puff Bar to the brand’s Chinese manufacturer, DS Technology Licensing, in early 2020.

    During the summer of 2020, the FDA instructed Puff Bar to stop selling its products. This decision was made because Puff Bar became a popular alternative to Juul after the latter discontinued some of its flavored products. Critics accused Puff Bar of targeting young people. In February 2021, Puff Bar resumed sales with a new design and synthetic nicotine, which, at the time, was not regulated by the FDA. Most disposable makers followed the same playbook. In 2020, U.S. lawmakers asked the FDA to force Puff Bar off the market.

    Puff Bar sales began to decline; however, it wasn’t long before another disposable brand, Elf Bar, took over the market. Founded in 2007, iMiracle Shenzhen Technology was originally an e-commerce firm. In 2018, the company switched to disposable e-cigarettes and launched the Elf Bar brand with synthetic nicotine. In 2022, the FDA said it needed Congress to act to bring synthetic nicotine under its purview.

    Congress closed the loophole last year. Under the new rules, companies were supposed to remove their flavored synthetic vapes from the market and file premarket tobacco product applications with the FDA. New products continued to be launched anyway. Puff Bar and Elf Bar began introducing products under different brand names, and thousands of other manufacturers followed suit.

    This is where the industry stands today. Disposables dominate the market while pod systems continue to trail far behind. However, the FDA has tried to clamp down on the growth of illegal disposables. The agency has issued over 550 warning letters and more than 100 civil money penalty actions to retailers for selling unauthorized e-cigarettes.

    Primarily, the regulatory agency’s actions have proved ineffective. Few retailers responded to the FDA’s actions. This has forced many states to step in. Due to the federal agency’s inability to control illegal flavored products, many state legislatures have introduced premarket tobacco product application (PMTA) registry bills. These bills require retailers only to sell products on a state list filled with products authorized by the FDA (of which there are only 23) and products with a PMTA under review by the regulatory agency. The Consumer Advocates for Smoke-Free Alternatives Association (CASAA) has issued calls to action for several registry bills. Vaping companies are also being sued for selling flavored disposables without authorization.

    Credit: Postmodern Studio

    Altria and BAT subsidiary R.J. Reynolds (the maker of Vuse vaping products) have taken legal action to kill their vape competition. Last October, Altria subsidiary Njoy filed a lawsuit in a federal district court against dozens of manufacturers, distributors and retailers of disposable vapes, including the Breeze, Elf Bar, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar brands. Njoy asked the court to bar imports by the companies and said it would “consider further litigation activity.”

    In January, a U.S. District Court in California dismissed the lawsuit against many of the disposable vape manufacturers, distributors and retailers. The court found that the defendants did not participate in “the same transaction, occurrence or series of transactions or occurrences,” and therefore were improperly joined in the lawsuit. However, the case against iMiracle, the manufacturer of Elf Bar, has not been dismissed. The case is still pending.

    The environmental impact of disposables is also a growing issue. Many companies are moving away from these products as more countries and U.S. states seek to ban them. Martin Miller, Chief Commercial Officer for Plxsur, a company that recently reached $1 billion in consolidated revenues, (see “Keeping Pace,” pg. 18) said safeguarding the environment and delivering safe and innovative products are core to the company’s sustainability agenda.

    “We have worked closely with our partner companies to put in place commercial strategies to migrate consumers away from disposables. Our Italian business, Puff [no relation to Puff Bar], has already successfully migrated many of its consumers using disposables to pod and open devices,” he said. “These alternative products have already outperformed legacy single-use vapes by volume. Adding to this, migration away from disposables is present across our entire group, with Ireland-based Hale having already launched a new pod system and others with an ever-growing portfolio of owned and third-party pod systems.”

    The e-cigarette industry is still growing rapidly. The Federal Trade Commission issued its third report on e-cigarette sales and advertising nationwide in April. The report found that combined sales of cartridge-based and disposable e-cigarette products to U.S. consumers by nine leading manufacturers increased by approximately $370 million between 2020 and 2021. The total topped $2.67 billion. E-cigarette companies spent $90.6 million more advertising and promoting their products in 2021 than in 2020.

    Reported sales of cartridge products increased from $2.133 billion in 2020 to $2.496 billion in 2021; sales of disposable, non-refillable e-cigarette products increased from $261.9 million in 2020 to $267.1 million in 2021. As technology improves and new products come to market, vaping products will continue to save the lives of many combustible tobacco smokers. That’s one thing that isn’t going to change any time soon.

  • Vaping in Ireland

    Vaping in Ireland

    Vaping is beginning to take hold in Ireland’s smaller cities, but combustibles are still king in Dublin.

    By Timothy S. Donahue

    Going on a trip to Ireland, I had expectations. I thought the vaping community would be small and just learning about new products coming to market. No. That wasn’t how it was at all. In Ireland, and I imagine it’s the exact same thing one could witness across the entire European Union, people understand that vaping is better than smoking combustibles. Many former cigarette smokers, an estimated 200,000, have already made the switch.

    According to a 2021 survey from Eurobarometer, Ireland has the highest rate of people who use e-cigarettes in the European Union at, 7 percent, while the EU average is 2 percent. There seemed to be a lot of vapers across Ireland. Media reports suggest that Ireland has a youth vaping problem. When a vape shop owner in Dublin was asked about this, he said that the people who vape are mostly former smokers, but there are youth who would have started smoking combustible cigarettes that instead started vaping.

    This was evident in Killarney, a town of 15,000 in southwest Ireland. It also has about 1.7 million tourists per year. College kids were vaping here. They were also smoking combustible marijuana. They were also drinking at noon on Tuesdays and Wednesdays and so on. It’s Ireland. Drinking is sort of a thing. I asked a few students if they would be smoking combustible cigarettes if vaping didn’t exist. The answer was an overwhelming yes. It’s university; nicotine use is a thing too. Just two years ago, everyone smoked combustibles. 

    Not anymore. Vaping is the way today. Many said they even have their parents, who were two-pack-a-day to three-pack-a-day smokers, vaping now. The older folks like the simplicity of the pods. The younger group likes the flavor varieties in disposables. Walking the streets of downtown, you could witness vapers from a variety of age groups and economic backgrounds. Flavors are also extremely popular.

    “The older folks want the tobacco taste first,” a college student said. “Now, they vape a while, and they don’t want that taste; my mom loves the watermelon now. She’s stopped smoking cigarettes completely and now just vapes. She used to smoke two packs a day.” Watermelon is the favorite flavor in Ireland, followed by Blue Ice, a straw poll of shops in Killarney and Dublin has confirmed.

    Ireland had no age restrictions on the purchase of vaping products until recently. In November of 2022, the country’s minister for health, Stephen Donnelly, and the minister for public health, Frank Feighan, received government approval to introduce additional restrictions on the sale and advertising of nicotine inhaling products, such as e-cigarettes.

    Under the new proposals, the sale of e-cigarettes and related vaping products became prohibited from self-service vending machines, from temporary or mobile premises and at places or events for children. In addition, advertisements for e-cigarettes are now prohibited on public transport, in cinemas and near schools.

    At the time the proposal was announced, Feighan said the legislation was necessary because tobacco smoking continues to kill approximately 4,500 people in the island country each year. “We recognize that nicotine inhaling products are used by some adult smokers to assist them to quit tobacco smoking,” he said. “However, we are clear that these products are of no benefit to our children and young people or to nonsmokers, and that is why we are taking this action.”

    All Irish and EU vaping devices and e-liquids are regulated by the Tobacco Products Directive 2. The Tobacco Products Directive regulates nicotine strengths, bottle sizes and ensures that communications about products are factual and clear. The ingredients that make up all Irish regulated vaping products must be provided to the Health Service Executive, with detailed information, including chemical studies and risk assessments.

    These regulations act as an important barrier to any products that do not adhere to EU standards entering the Irish market and can be contrasted sharply with the absence of similar regulations in the U.S. and elsewhere, according to Vape Business Ireland (VBI), the largest vapor industry trade association in Ireland.

    Credit: TS Donahue

    VBI is advocating the Irish government to consider more evidence-based policymaking decisions, which in turn will allow for more evidence-based regulation of vaping products in Ireland. The trade group wants the government to “deliver effective, evidence-based and balanced regulation of vaping products,” according to its leadership.

    There were at least four vape shops in Killarney. None of the owners would speak to me on the record because they said they aren’t “trying to call attention to themselves.” The truth is probably more along the lines of the massive distrust of the media that Ireland has. Owners probably believed I didn’t just want to know about vaping in Ireland and what types of products were popular and that I instead had more dubious plans for this article.

    One shop attendant, Karen, said that most of her customers are college-aged; however, many of them were buying combustibles from her store until vaping became more popular in the country around 2020. She thinks youth are going to experiment with things like drinking, drugs and nicotine and that if there are safer ways to consume these products, government regulations shouldn’t hinder their availability.

    According to the Global State of Tobacco Harm Reduction (GSTHR), the overall smoking prevalence in Ireland has decreased since 2006. More than 23 percent of the adult population in Ireland are current smokers, down from 29 percent in 2006. This means there are now approximately 893,778 smokers in the country. An estimated 26 percent of men still smoke combustibles, and for women, the figure is an estimated 21 percent.

    In Ireland, there are 265,500 vapers in the country, giving an adult vaping prevalence of 6.7 percent, according to the GSTHR. There is a requirement to ensure that vape packaging contains a health warning and vaping devices can be purchased without a prescription. There are no legal restrictions on their use in public places. Heated-tobacco products cannot be marketed, and the situation is “quite complicated” for snus. While it is illegal to import snus for trade or to buy the product online, it is possible to import it for personal use.

    In Dublin, it seemed that combustibles were still king. A short walk around the city, and there are cigarette smokers everywhere. There were also cigarette butts littering the streets everywhere we walked. Places like Temple Bar, an insanely popular tourist neighborhood littered with drinking establishments where few true Dubliners visit anymore, hundreds of people were smoking cigarettes and marijuana openly, and vapers could be seen mixed in the crowd but in much lower numbers.

    There are an estimated 50-plus vape shops in Dublin; however, it seemed like a lot more. Still, no vape shop owner or employee would speak with me on the record. Vaping products could also be found at many discount shops that sold everything from shampoo to clothing throughout Ireland.

    There was even a vape shop in the small fishing village of Howth, a suburb of Dublin. While we only went to see Dublin and various places around County Kerry where Killarney is situated, it wasn’t hard to find vaping products anywhere we visited. One cab driver told me that he was sure everyone in Killarney drank and used nicotine in some form or another and that vaping is definitely more popular than combustible cigarettes in the small town.

    Overall, the rising popularity of vaping in Ireland can’t be denied. The harm reduction benefits of vaping are widely known, and even many cigarette smokers told Vapor Voice they wanted to quit combustibles and have or would try vaping products to try to end their compulsion to smoke cigarettes. It’s quite the contrast to the United States, where many doctors still believe nicotine causes cancer and are skeptical of the harm reduction benefits of vaping.

  • Vape Startup Said to Spread Falsehoods to Promote Product

    Vape Startup Said to Spread Falsehoods to Promote Product

    Respira Technologies is likely using a website to spread misinformation about vaping in order to promote its own product. Jim McDonald of Vaping360 reports that a website promoted by Respira contains false allegations that a scientist commissioned by Public Health England (PHE) and an author of the “vaping is 95 percent safer” than combustible cigarettes study had financial ties to the tobacco industry.

    The California-based company with plans to pursue drug approval for an inhaled nebulizer-style nicotine replacement therapy product has also engaged in a smear campaign suggesting Juul Labs and other vaping product manufacturers may be responsible for causing some of the “EVALI” lung injury cases, and has encouraged the U.S. Food and Drug Administration to adopt standards that would prevent most consumer vapor products from being authorized for sale, according to McDonald.

    Respira links its own website to a site called “Vaping Fact Checker” that attempts to tie nicotine vaping to the 2019 “EVALI” lung injury outbreak. A page on the site titled “EVALI Linked Products” shows Juul, SMOK and Suorin products and implies that they have caused or could cause “EVALI.”

    Under the heading “Myth Busting,” the Vaping Fact Checker website also claims that “one of the authors” of Public Health England’s 2015 e-cigarette evidence review has “financial ties” to tobacco company Philip Morris International.

    British tobacco harm reduction advocate Clive Bates, who has followed and been part of the debate over the 2015 PHE report, is director of Counterfactual Consulting and a former director of Action on Smoking and Health (ASH) in the UK, said that it appears the author of the Vaping Fact Checker claim has (either misinformation or disinformation) confused the PHE review with a separate paper authored by a group of experts led by drug researcher David Nutt.

    “It is both offensive and preposterous to claim that the experts undertaking Public Health England’s evidence reviews were somehow compromised by tobacco industry interests,” Bates told Vaping360. “They are all scientists of the highest standing with no conflicts of interest.”

  • A Costly Failure: How The WHO Lost American Funding

    A Costly Failure: How The WHO Lost American Funding

    By Patrick Basham

    Amid the Covid-19 pandemic, imagine the top global health body instructing governments to shun a particular vaccine should it be found. An unimaginable scenario? Alarmingly, it did happen.

    The rationale for the World Health Organization’s (WHO) April 13 edict was the WHO’s disapproval of the specific industry—tobacco—working to develop the would-be vaccine. A loyal servant of the global anti-tobacco lobby, the WHO clearly abhors Big Tobacco more than it wants to save lives.

    The WHO told governments to have nothing to do with any tobacco-generated vaccine. Nonetheless, the tobacco plant remains a logical vaccine source as it is comprehensively researched and understood, cheaper to grow than animal-based vaccines and faster to scale up than traditional methods, which could yield a large amount of vaccine quickly.

    Consequently, Medicago, a biotech firm partly owned by Philip Morris International, and British American Tobacco are respectively developing potential vaccines grown in tobacco plants. Such a vaccine would enable several billion people to reap technology’s benefits.

    The WHO’s anti-tobacco industry prejudice, epitomized by its illogical Framework Convention on Tobacco Control, should be, but is not, among the reasons for America’s May 29 exit from the WHO. The Trump administration withdrew its $500 million yearly contribution for other interwoven, equally legitimate reasons, namely the WHO’s catastrophic failure on the Covid-19 file and the WHO’s pro-China bias.

    While China is culpable for the global pandemic, the WHO is complicit in the attendant public health debacle. Here is a synopsis of the WHO’s documented unpreparedness and the policy mistakes, factual errors and medical misstatements underlying the U.S. decision.

    On Dec. 31, the WHO was informed of China’s coronavirus outbreak. Absent WHO pressure to be transparent, China did not publicly report its first death until Jan. 11.

    Also, on Dec. 31, Taiwan told the WHO about human-to-human transmission of the virus. The WHO did not warn the world about this critical development. Instead, two weeks later, the WHO declared the virus was not contagious as there was “no clear evidence of human-to-human transmission.”

    On Jan. 20, the WHO acknowledged human-to-human transmission was occurring yet assured the world China would contain the virus. But Chinese cities had already exported coronavirus cases to America and Europe. Consequently, the pandemic was unpreventable.

    Chinese laboratories had sequenced the coronavirus genome by the end of last year, but Beijing ordered researchers not to publish their crucial findings. China did not share this data with the world until Jan. 12. Subsequently, the WHO Director General Tedros Adhanom Ghebreyesus publicly praised the speed with which China shared its genome research.

    The WHO endorsed China’s extremely draconian coronavirus response. Centered on a literally brutal quarantine regime, China’s heralded “defeat” of the coronavirus came at an incredibly high human and economic cost. Not having built herd immunity among its population, China was in the throes of a second wave of infections.

    Mid-January found the WHO playing down the rising coronavirus caseload outside China. Hence, at a Jan. 22 emergency committee meeting, the WHO refused to declare the coronavirus—all available evidence to the contrary—a formal public health emergency, which would have better prepared the world in all facets of its response.

    Following the meeting, Tedros visited China. He praised China’s response even as Beijing was persecuting medical whistleblowers, destroying virus samples, expelling foreign journalists and spreading anti-American disinformation about the virus’ origins.

    The next day, the WHO confidently predicted the coronavirus would be less deadly than SARS in 2002–2003, which caused 774 deaths. At the time of writing, Covid-19 had killed 464,000 people.

    On Jan. 30, Tedros advised (and influenced some) governments against introducing travel bans. The next day, the WHO condemned the Trump administration’s new Chinese travel ban, which public health experts credit with saving tens of thousands of American lives. On Feb. 4, the WHO declared that asymptomatic individuals cannot transmit the virus. Again, the world received incorrect information about a crucial medical element.

    In mid-February, the WHO stated that China’s response had bought the rest of the world valuable time to prepare. According to a University of Southampton study, if China had informed the world three weeks sooner, 95 percent of global cases would have been prevented.

    On Feb. 27, the WHO said the virus was “controlled easily” and therefore community spread was not a serious issue. Adding insult to injury, a March 2 WHO publication claimed the stigma emanating from attaching a geographic label (say, “Chinese” or “Wuhan”) to the virus was more dangerous than the virus itself.

    On March 8, after the WHO refused, at China’s behest, to declare the coronavirus a formal pandemic, the Chinese government gifted the WHO $20 million. The WHO finally declared a pandemic on March 11. Without shame, on April 9 the WHO asked member states for an additional billion dollars (the WHO’s annual budget is $2.3 billion) to help fund its Covid-19 campaign.

    Of all global institutions, the WHO should be the least political yet it continues to act as Beijing’s global public health spokesperson. Revealingly, the WHO Goodwill Ambassador Peng Liyuan is Chinese dictator Xi Jinping’s wife.

    The WHO should be renamed the Chinese Health Organization, quipped Japanese Deputy Prime Minister Taro Aso in late March. The WHO’s illogical treatment of Taiwan is Exhibit A.

    From the onset of the pandemic, Taiwan stood out as a model of successful public health policy. Taiwan’s experienced a comparatively low number of Covid-19 cases and suffered few deaths. The island nation’s success is based upon a travel quarantine, massive testing and contact tracing and the mandatory isolation of potential carriers. As such, Taiwan is an important case study for other governments.

    Taiwan is not a U.N. member therefore it cannot be a WHO member. Since 2017, China has blocked Taiwan from receiving observer status at the World Health Assembly (WHA), the WHO’s annual decision-making meeting, a status it previously enjoyed.

    The Trump administration petitioned the WHO to allow Taiwan to gain entry to the WHA held May 18–19 so that the rest of the world could benefit from Taipei’s real-time knowledge and expertise. The brave souls ensconced within the WHO’s Geneva headquarters declined to take a position on whether Taiwan’s participation may be beneficial.

    The WHO’s tragic Covid-19 performance is unsurprising. The WHO’s awful track record on SARS, Ebola and the H1N1 flu is well documented. The rot at the WHO extends beyond and predates an unsavory relationship with Beijing. It involves both mission creep and the misallocation of precious funds.

    In 1948, the WHA inaugurated the WHO with a mandate to control and prevent the spread of epidemic disease and to coordinate the global response to pandemics. This required a “vertical” focus upon specific diseases, which found success in the WHO’s battle against malaria, for example.

    Over time, the WHO’s vertical approach evolved into a “horizontal” approach that attempts to deal with all aspects of health. In 1979, for example, the formal mandate was expanded to “primary care” and “health for all.”

    In a 2009 report, the American Enterprise Institute’s Roger Bate and Karen Porter explained that, “[the] WHO would now promote health ‘development’ more broadly by improving health systems, building infrastructure and fighting chronic diseases. The WHO expanded into many highly political areas where it had less technical ability, managerial competence, or experience, duplicating the efforts of other organizations.”

    The WHO was desperately unprepared for this pandemic. One reason for such inexcusable incompetence is the financial ramification of mission creep. According to the Heritage Foundation’s Brett Schaefer, only 15 percent of the WHO’s $2.3 billion annual budget goes to pandemic response. An Associated Press investigation found that, in 2018, the WHO spent more money on high-end staff travel and personnel junkets than on programs combatting disease.

    The WHO consistently prescribes statist, top-down, anti-market solutions, from government-run healthcare to an ever-expanding menu of politicized “problems,” which now include tobacco, nicotine, obesity, sex education, mental health and domestic violence. Yet, persuasion and policymaking on these topics is the purview of national governments rather than an elitist bureaucratic body.

    This year, the WHO faced its most serious challenge—a once-in-a-century pandemic—and failed miserably. The WHO has been worse than useless; the WHO literally has been a deadly failure. Surely, there must be consequences for its poor performance, argued the Trump administration.

    Cost-benefit analysis informs us that, by allocating its WHO funding to other health organizations, America will receive a better rate of return on its public health investment.

    The WHO needs root-and-branch reform not merely technocratic tweaks. The Wall Street Journal recently concluded, “One way to ensure future pandemics are less deadly: reform or defund the WHO.” Can the WHO be reformed? There are few grounds for optimism that this option can succeed.

    China’s organized and concerted influence over the WHO is paramount. As Beijing holds tremendous sway over many African, Asian and Latin American members, Chinese funding clearly trumps the will to reform.

    On April 14, President Trump placed American funding on a 60 day to 90 day hold dependent upon the WHO’s willingness to reform itself. The WHO chose to ignore the threat, with last month’s WHA enacting no reform measures. The U.S. concluded that, as reform would not occur, America should stop hitting its head against this bureaucratic wall.

    Financial threats do not work because the WHO possesses a Bank of China ATM card. American funds will be replaced by a commensurate increase in China’s contribution.

    The WHO resembles too many peer organizations: anachronistic, complacent and incompetent. The WHO’s predicament is part of a pattern of decline among international institutions from the United Nations to the European Union to the World Trade Organization.

    National governments need to choose between supporting public health or politicized institutions. Defunding the WHO is a down payment on the public health side of the ledger.

  • Mountain Service Distributors: Vapor Growing in C-stores

    Mountain Service Distributors: Vapor Growing in C-stores

    Mountain Service Distributors owner says vapor product sales continue to rise in convenience stores.

    By Timothy S. Donahue

    Refrigerators didn’t exist when Mountain Service Distributors (MSD) began operating in 1929. Situated in the Catskill Mountains of upstate New York, USA, the family-owned distributing company started as an ice delivery service that added candy sales to its portfolio by pure happenstance. Located near where the famous Woodstock Music Festival was held in 1969, Stephen Altman’s—MSD’s current president—father was operating an ice delivery company when a candy manufacturer in Brooklyn, New York, asked the older Altman if he would sell candy along with the ice.

    The business was doing well. Then refrigerators started appearing in homes, and no one needed ice deliveries. Candy became the company’s new cash cow. The company kept adding on more and more products such as chips and soft drinks. MSD’s history reads much like the history of convenience stores themselves. As cars became more reliable, gas stations were closing their repair shops, and MSD started using the empty space to sell supplies to travelers and the local community. As the c-store market grew, so did MSD. Stores needed greater varieties of product, so MSD began to increase the number of SKUs it could deliver.

    Stephen Altman

    “When I was a kid, we sold candy and tobacco and a lot of potato chips. We also had an ice cream business that when my father passed away, his brother, who was a junior partner, had to make a decision [about] because we had all these insulated iceboxes that we would sell ice cream and dry ice [from]. Now he had to replace 500 iceboxes, and he didn’t want to invest in compressor-driven refrigeration for ice cream. He sold the ice cream business,” says Altman. “Twenty or so years later, I became a Slush Puppie distributor. And now I had to buy hundreds and hundreds of machines that made slush. So, it was an interesting turnaround.”

    During the TMA digital conference “Unsteady Ground: Shifting Landscapes,” Altman discussed the c-store industry today and how vapor products have become best sellers.

    Vapor Voice: How has Mountain Service Distributors faired during the Covid-19 pandemic?

    Steve Altman: We’re a convenience store supplier; the reason is not the tobacco element, but we’re able to stay open because we supply groceries to convenience stores. We have had a few issues. Some of the stores that are customers of ours are not allowed to be open, and we have an [accounts receivable] problem where they closed up and didn’t pay their bills. And we’re working through that issue as well.

    What we find interesting is that the c-stores that are open—and most of them are open because they carry food—they’re doing very well because a lot of shoppers are afraid to have their bodies in crowded supermarkets. So, they’re buying a lot of groceries in convenience stores where they never did that before.

    What has the growth of Mountain Service Distribution been like?

    Well, when I started out here full time in 1962, we didn’t do a million dollars in sales a year … There’s only three ways for my kind of business to grow, and it’s probably [the same] for many other businesses. You either get your customers to sell more product, which is very difficult to do, or you obtain new customers. But the biggest growth comes from when you can buy out another distributor and hope to obtain 75 percent of the business. Over [a] period of years, nothing lately, I’ve bought out seven other distributors.

    Looking back, was acquisition the proper way to go about your growth?

    Oh, absolutely. Some of these were competitors of ours that we always had a high, I guess, business ethics with each other. We didn’t cut each other’s prices. I gained their trust through keeping to that way of doing business … I just bought their inventory, and I helped them collect their accounts receivable. I hired their people.

    How large is the complex where MSD is headquartered?

    The complex is, at this time, about 100,000 square feet, with 30-foot ceilings, with forklifts and driving around. When I started, it was an icehouse. The walls were a foot thick, filled with sawdust. It was 40 feet by 100 feet, so, that’s what? 4,000 square feet. Now, it’s 100,000 square feet. We [are now doing approximately over $100 million in sales]. It’s not a lot. I am a medium distributor, but we have … one of the highest percentages of bottom line profits there is in the industry. Most distributors’ bottom line isn’t even 1 percent, and ours is over 3 percent.

    How many different types of products do you distribute? How many different pieces?

    Well, I think we have about 12,000 SKUs. Cigarettes and tobacco, and confectionery, and health and beauty aids, and sundries, and frozen beverage products and coffee products. And we sure sell a lot of water, which I’m not a fan of because retaining and getting drivers with CDL licenses is very difficult. And I don’t like breaking their back with heavy products like water.

    We’re really heavy in electronic cigarettes. We have customers all over the country that my son has created because he’s become an expert in the category. And they range from wholesalers and vape shops and even retail chains. Those chains who buy from mega distributors, they don’t pay attention to the category and help the retailer grow it.

    Are you only servicing c-stores and other traditional-type brick-and-mortar retailers?

    We do prisons. We do vape shops. We do gift shops. We do pizza parlors. We do beach stores when it comes to frozen beverage. And we have six or seven wholesalers that are steady customers. And as I mentioned earlier, we have some chains, and I try to stay away from chains. I can never figure out how to make a profit on them. But we have some chains. We also serve the four casinos that are in the state of New York, not the Indian casinos, but the casinos that were licensed by the state of New York.

    What is the state of the tobacco business in c-stores from your experience?

    Well, starting with cigarettes, it’s been declining for years, as you are aware. The electronic cigarettes helped the decline. Lately, in the last few months since the pandemic, we’re selling more cigarettes and less vape. But different [rules] of the states we do business with has precluded the vape business a little bit because of the elimination of flavors … Overall, our vape business is up. Our tobacco business started growing a few years ago [when] roll-your-own became popular as the taxes in the Northeast went up dramatically. That’s still alive and doing well. So, overall, in the last 10 years, tobacco was 80 percent of our business; 80 percent of sales, not 80 percent of the profit. Today, it’s about 70 percent.

    What types of vapor products are you selling?

    We do very little e-liquid. We were selling both open and closed [systems], but now the closed systems have come under the eyes of legislators, and you know what happened with that. In New York state, it’s about to kick in [a flavor ban] on the 17th of May that only allows tobacco flavors. We found that even when we lost the Juul flavors of creme brulee … I had it take them off the market. I guess the steadfast consumer just switched to those [tobacco flavors]. They didn’t give up Juul. They just switched.

    Have you seen an increase in sales of other salt nicotine closed systems, such as Leap and Njoy?

    We carry them all. Juul has lost some market clout so to speak, but our Juul business is up because my son has created new Juul customers across the country. So, sometimes something happens in the country that doesn’t affect me, such as the flavor ban.

    What are the challenges with distributing vapor products?

    We constantly debate with United Parcel Service (UPS) that doesn’t like us shipping these things. Of course, they talk about the suit they’ve lost … but that was about cigarette sales to consumers. We don’t ship to consumers. So, we always have an issue with UPS constantly beating us over the head that we can’t be doing this. And we keep telling them we’re not shipping to consumers and blah, blah, blah. We only ship to people that have licenses to carry and sell the product. We are also having supply chain issues with products coming from China.

    What have you seen or what do you believe is the issue with the supply chain? Is it mostly shipping?

    Well, I think it’s [because of] the [Covid-19 pandemic] that some of these factories had to close up. But, to tell you the truth, Tim, I don’t worry about it. There’s no lack of some kind of product or a plethora of different brand products in my customers’ stores. There’s no shortage at retail. If they’re out of one brand’s orange, then they could a buy something else orange.

    Vapor products are starting to overtake your tobacco products business, is that correct?

    Oh, oh, it has. Well, when it started out—when Altria and RJ Reynolds went to [a large distribution company] and said, “We’re coming out with these things. What do you need for margin?” that fixed the margin on their products for us [too]. Of course, [the large distribution company] doesn’t have the expenses of most of the distributors. They have no sales force. They don’t have the expense of taking returns from retailers. But [the profit margins on vapor products] were better than tobacco items.

    What is the current state of sales growth for vapor products in c-stores?

    Other than the customers we have that we ship [to via] UPS Freight or UPS Ground in other states, I think, in my core, where my salesmen call on customers, it’s flat. There’s no decline. There’s no growth. Listen, different consumers get their news in different sources. And this business that happened a number of months ago where vape gets accused of poisoning kids, [the] recent lung disease outbreak found [it] to be caused by black market THC products when it turned out to be illicit home-packed marijuana sticks. The public got turned off. You know what I mean? They read about the problem, but they didn’t read about what the real problem was. Now you have a lot of apprehensive, potential users of electronic cigarettes that won’t go near them because they still think they’re poison.

    How are you looking at future growth?

    We are also improving [our technology]. If you get the retailer to put his order in with our app on his phone, then the salesman has more time to consult with him, right? And that’s worked. Half our customers place their own orders on our app on their smartphone, and we’re able to show them how to make more money, and then we become more valuable to them.

  • CTFK Wants Vape Shops Labeled as Non-Essential

    CTFK Wants Vape Shops Labeled as Non-Essential

    Chakrapong Worathat | Dreamstime.com

    The Campaign for Tobacco-Free Kids (CTFK) is sending out email blasts urging for a “Call to Action” to pressure U.S. President Donald Trump to label vape shops as non-essential businesses.

    “In a new low, vape shops are lobbying the Trump Administration to be declared “essential businesses” so they can stay open during the COVID-19 crisis. This is ludicrous and we need your help to stop it,” the email begins. “It is the height of disgrace for the vaping industry to argue that e-cigarettes, which damage the lungs, should be considered essential during a lung disease pandemic. It has never been more urgent for us to protect our kids and their health, not vape shops.”

    Some states have labeled vape shops as non-essential businesses. In states such as Ohio, vapor advocacy groups such as the Ohio Vapor Technology Association (OHVTA) have asked its members to close their doors during the pandemic. Ohio, however, allows online sales. Many US states do not.

    Gas stations and convenience stores, where the majority of combustible cigarettes are purchased, are labeled essential businesses. CTFK does not make any mention of asking for businesses that sell deadly cigarettes to be closed.

  • U.S. FDA to Announce Sept. 9 PMTA Deadline

    U.S. FDA to Announce Sept. 9 PMTA Deadline

    While not yet official, the deadline for submitting premarket tobacco product authorizations (PMTA) to the U.S. Food and Drug Administration (FDA) is one step closer to being delayed from May 12, 2020 to Sept. 9, 2020 due to the Covid-19 pandemic.

    Judge Paul Grimm of the U.S. District Court for the District of Maryland issued an “indicative ruling” granting the FDA’s request to delay the deadline by 120 days.

    The ruling is not yet final, however, due to procedural issues that are expected to be resolved expeditiously. Due to appeals filed by several organizations, including the Vapor Technology Association and the FDA itself, Grimm no longer has the authority to modify his original ruling which moved the deadline to May 2020. That power now lies with the U.S. Court of Appeals for the Fourth Circuit.

    For the ruling to become valid, the Fourth Circuit must remand the case back to Grimm’s court where Grimm says he would modify the order to allow the FDA to delay the change. The FDA will then need to update its regulations to move the PMTA date to Sept. 9, 2020.

  • Vype Debuts Week-Long Virtual Music Series

    Vype Debuts Week-Long Virtual Music Series

    Credit: Acantha Lang Music

    As a growing list of music gigs are being cancelled or postponed, musicians are still eager to connect with their fans. British American Tobacco’s (BAT) Vype brand has launched a week-long, live music series from musician’s homes.

    Each performance will feature intimate conversations with up-and-coming musicians about how they find inspiration at home along with a one of a kind live music shows, according to a Vype press note. Playing songs of resilience and hope, this free musical series is designed to inspire creative ways to connect while at home. The series will take place on Tuesday, Thursday and Friday and will be streamed on Vype_worldwide Instagram page.

    “We are committed to bringing inspiration to as many of our adult consumers as we can across the globe,” says Elly Criticou, Vapour Category Director, British American Tobacco. “We are excited to continue to offer unique experiences that encourage people to find different ways to stay in touch with each other.”

    The music series will kick-off this week with New Orleans-born Acantha Lang on Tuesday 31st March at 5pm GMT; followed by composer and pianist Okiem on Thursday April 2nd at 5pm GMT and finishing the week with singer Lil Rice on Friday April 3rd at 5pm GMT.  Performances will feature a range of musical genres including blues and soul, cinematic classical and country rock.

  • Staying Vigilant

    Staying Vigilant

    STAYING VIGILANT

    The effectiveness of the White House’s flavor ban remains to be seen, but it is time to adapt.

    By Mike Huml

    After months of speculation and anxiety, the Trump administration has finally released its final ruling on the fate of vaping. In a tepid compromise, refillable vapor products are to be left alone for the moment while closed pod systems will be restricted to tobacco and menthol flavors only.

    While some in the vaping community are willing to take the win, others are hesitant to be optimistic. On one hand, many vapers hold a negative view of Juul, which accounts for a large portion of the vapor market. Juul sparked the popularity of the modern pod system and played a large role in building demand for nicotine salt e-liquid. On the other hand, the attributes that made the Juul popular among adults also found appeal among youth, and many believe that Juul’s availability, unassuming appearance and discreetness contributed to a surge in teen nicotine addiction.

    The effectiveness of the White House’s decision remains to be seen, but one thing is certain: It’s time to adapt. Juul catches a lot of flak for many reasons. Juul Labs is partially owned by a major tobacco company, the Juul doesn’t offer any options for users to lower their nicotine strength (other than selling a 30 percent nicotine strength online) and many view the company’s marketing strategies as questionable. However, it’s important not to forget a time before the Juul.

    Before pod systems, many e-cigarettes, including starter kits, required some instruction. Vaping required, at the very least, a passing interest in vapor technology. This alienated a large portion of smokers. Many tobacco users don’t give smoking a second thought. They stop by a gas station after work, pick up a pack of smokes and a lighter and they go on about their days. If any considered a switch to vaping, there were two options: disposables or proper vape starter kits.

    While the learning curve to get into vaping wasn’t steep, the disposable option was much more appealing. Many disposables were and continue to be sold alongside analog cigarettes in convenience stores. So, the routine of buying cigarettes remained unchanged. Even though a large number of smokers tried to make the switch to vaping by using disposables, these products just didn’t satisfy in the same way that cigarettes could.

    This poor experience turned many people off ofvaping since many smokers just don’t have the same interest in vaping as the hobbyist community. As such, one bad experience from a poor product, typically a disposable cigalike, cast a harsh shadow over the entire vapor industry. This all changed with Juul’s introduction to the market.

    Juul offered a much better product that was convenient and satisfying. It was so popular that even mainstream vapor manufacturers tried to duplicate Juul’s success, leading to the boom in pod systems that’s been seen over the past several years. Unfortunately, this jump in quality and convenience also made vaping more accessible to minors, and while teen smoking is at an all-time low, vaping among youth has increased, according to the U.S. Centers for Disease Control and Prevention (CDC). This is where the idealist versus realist schism occurs.

    Nobody wants teens to use nicotine, and while it’s not a good thing that kids are vaping, one side is pushing for the complete absence of nicotine use among youth while the other side views vaping as the lesser of two evils. However, for people who have never smoked, vaping can only increase the risk of health issues, even by a marginal amount, according to several studies. It’s difficult to determine how many vapers who have never smoked would have smoked had it not been for vaping. So, it almost becomes a philosophical question: For both youth and adults, should the end goal be to eliminate nicotine addiction completely or to accept that people will always seek out vices and to mitigate the associated risk as much as possible?

    Some say this is the only true question as every issue will materialize two sides to the argument until the industry can agree on the true goal of vaping. As such, regulation and legislation will be nearly impossible to implement and enforce effectively while this issue remains so divisive. For now, the government seems to want to take the path of least resistance. It needs to show that it’s taking action after the bizarre lung injuries associated with black market THC cartridges, but it also can’t be seen crippling an entire industry in one fell swoop.

    So, the ban on flavored pods is supposed to target youth in particular. The perception is that youth are attracted only to flavors, and by banning flavors in regard to the most popular vapor product among youth, the hope is that teen vaping will plummet. Only time will tell if this strategy will be effective. In all likelihood, kids will continue to vape whatever is easy to acquire, and a number of adult vapers will either seek alternatives or return to smoking. After all, underage vaping and drinking are also prohibited, but youth find a way.

    What does this mean for vapor businesses? Well, it completely depends on the consumer. For stores that are more hobbyist focused, this ban may well mean absolutely nothing. These stores likely carry few, if any, closed pod systems, and certainly most don’t carry Juul. Other stores may focus more on attracting new vapers and primarily stock pod systems, starter kits and possibly a few mods or intermediate items, and this transition may prove to be more impactful.

    Convenience stores may not want to deal with any of this and simply stop carrying vapor products altogether. The cumulative result of this flavor ban will likely be a net negative for vaping and public health. The selection of products just became smaller, which means there will be people who can’t find the product that kept them from smoking. Youth who developed an addiction or dependence on nicotine will now either have to stop vaping (unlikely), find another vapor product that’s easy to acquire or switch to smoking combustible cigarettes to satisfy their cravings, which would be ironically disappointing.

    All hope is not lost. As a result of the closed system flavor ban, there is an obvious workaround: Make refillable pods an option. There is nothing stopping Juul or any other manufacturer from simply introducing a refillable pod and offering e-liquid as a separate purchase.

    Of course, this adds an extra step of complexity to the vaping process, but this wouldn’t alienate nearly as many adult vapers compared to how many would need to find different options completely if these companies don’t adapt and start offering refillable pods. Business owners should keep their collective ears to the ground and take notice of any pod system manufacturers that start offering conversion kits or even new products. Alternatively, instead of, or in addition to, waiting for new refillable options from the current manufacturers, store owners can start stocking any of the myriad refillable pods that are already available.

    In the short term, those who adapt to this change will be the most successful, and it shouldn’t be viewed as the “vapocalypse” just yet. The industry still must contend with the U.S. Food and Drug Administration’s upcoming premarket tobacco product application deadline (May 12) and possibly even more regulation. When this closed system flavor ban fails, smoking rates rise and the teen vaping “epidemic” continues, will regulators reconsider their approach to vaping regulation or double down and start banning more flavor-atomizer combinations? Only time will tell. For now, stay informed, stay vigilant and adapt.

  • No More Mr. Nice Guy

    No More Mr. Nice Guy

    The FDA and CDC often seem to act absurd in their regulations and explanations of vapor products.

    By George Gay

    Have you heard the joke about the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the smoker looking to switch to vaping? No? Don’t worry; it’s probably just as well. It isn’t very funny, especially if you’re a smoker. In fact, it’s more of a shaggy dog story than a joke, so it goes on and on for so long—3 1/2 years and counting—that you need a pooper-scooper and a good supply of bags to clean up the mess created.

    The FDA and the CDC have for a long time made a dog’s breakfast of vaping in the U.S. and, in recent times, have acted in a manner that comes close to being absurd as was well illustrated during the second half of last year when the CDC went off half-cocked over the lung disease affair, which has been well covered in these pages previously.

    But most of the running has been made by the FDA through its Center for Tobacco Products, and it got off to a great and well-trailed start in 2020. On Jan. 2, it issued a release titled, “FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.” The release was subtitled with a threat, or, as some would see it, a promise: “Companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.”

    The headings reflect the rambling, repetitive nature of the release—1,700 words of what should have been a mea culpa but what was made to look like a bold move by an agency on top of its game. The subtitled threat is repeated more or less verbatim for the second sentence as if the companies referred to had been flagrantly breaking the law.

    It is not until the sixth paragraph, about halfway through the release, that the reader learns that all of the electronic nicotine-delivery systems (ENDS) currently on the U.S. market are unauthorized for sale there—and that they are unauthorized because the FDA has used its discretion to allow them to be marketed without authorization.

    In fairness to the FDA, the owners of these products could have sought authorization by putting their products through the agency’s premarket tobacco product application (PMTA) process, but it would have been unreasonable to expect them to go through such an involved and expensive procedure while the discretionary principle was being applied.

    As most of the readers of this magazine will already know, the FDA’s Jan. 2 release marked the end of the FDA’s discretionary approach and the start of a “no more Mr. Nice Guy” stance. Or some such. There will still be some discretion but not in the case of certain products. The FDA said it was “focusing on the following groups of products that do not have premarket authorization:

    • Any flavored, cartridge-based ENDS product (other than a tobacco-[flavored] or menthol-flavored ENDS product);
    • All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
    • Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.”

    Of course, the above could take in every product but was widely interpreted as meaning that the sorts of flavored e-liquids used with open systems would not be the subject of the 30-day enforcement meted out to the cartridge-style products, provided that e-liquid manufacturers took stringent steps to ensure that their products weren’t getting into the hands of those who had not yet reached adulthood, which I think Congress was poised to set at 57 years of age by the time this story was published. But the FDA is set to prioritize its enforcement policies against all ENDS products for which manufacturers have not submitted a PMTA by May 12 this year.

    This latest farrago is based on the idea that young people, who should not be vaping, prefer cartridge systems to open systems whereas the opposite is true in the case of adult smokers looking to quit their habit using electronic cigarettes. But, clearly, the scene is set for a quick crackdown on open systems because, following the logic of the FDA, young people, strung out on nicotine and deprived of their fruit-flavored and mint-flavored cartridges, will be driven slavishly into the arms of the open systems. Although, I need to add a caveat here because the question must arise as to whether young people would prefer menthol in a cartridge or mint in an open system. Tricky.

    At this point, there is probably a need to explain something to people not used to FDA speak. Most people, I think, probably carry around in their heads rough distinctions between such terms as children, kids, adolescents, students, young people and minors, though they might be pushed to articulate them. But the FDA applies no such distinctions. The heading of the release uses the word “children,” but the first sentence alone refers to youth, children and kids. Sad person that I am, I counted 42 instances of the use of “youth,” “children,” “kids,” “minors” and “students”—that’s one instance every 40 words.

    Of course, the FDA is right in a way. People in the U.S. up to one day short of their 21st birthdays have been declared by Congress as children, or kids, or youth, who, though able to marry, drive and fight for their country, are unable, under legislation signed into law at the end of last year, to obtain tobacco products legally.

    This is in a country that allows what I would call children to work in tobacco fields (but won’t buy tobacco from countries in Africa that do likewise), that protects the rights of people to bear arms against students and that is seemingly indifferent to its subclass of young people who go to bed malnourished at the end of every day. 

    But never mind all that. The FDA is busying itself fighting the good fight—protecting the better-off young people from the tyranny of cartridge-type ENDS products—though with the exception of those running menthol and tobacco flavors. It has long interested me that authorities around the world are keen to protect individuals from things they can control for themselves, such as the consumption of tobacco, alcohol and fatty foods, but don’t like to get involved in those things that individuals have little or no control over, such as pollution, poverty, an incoming avian influenza and munitions.

    The FDA’s release, which to my mind contains a number of questionable claims, opens by saying, “Amid the epidemic levels of youth use of e-cigarettes …” The idea of an epidemic has been dismissed by many commentators, and I simply don’t believe it, partly because it is an idea that the FDA and others, with the aid of a gullible media, seem overly keen in planting in the minds of people. The word epidemic appears in the first line of each of the first three paragraphs of the FDA’s release.

    But its release is not convincing on the subject. It says that the 2019 National Youth Tobacco Survey (NYTS) results on e-cigarette use show that more than 5 million U.S. middle school and high school students are current e-cigarette users, which it defines as those having used such products within the last 30 days (presumably even just once), with a majority reporting cartridge-based products as their usual brand.

    “The NYTS survey, which is conducted annually by the FDA in conjunction with the Centers for Disease Control and Prevention, also shows that of current youth e-cigarette users in 2019, approximately 1.6 million were using the product frequently (use on 20 days or more in a 30-day period), with nearly 1 million using e-cigarettes daily,” the release said in part.

    Where do these figures fit with the addiction of young people that the FDA wrings its hands about throughout its release? I mean, using an e-cigarette once or twice in 30 days hardly demonstrates addiction, and, I would suggest, even using a device 20 times in 30 days is not addiction. Okay, you might argue that people admitting below-daily use are just trainee addicts. But this would be trying to have your cake and eat it too.

    We are told that just one dose of nicotine can cause addiction, so our e-cigarette trainees would be hooked from day one, and that would mean that a single survey count of less-than-daily users would surely throw up a very low number—not the 4 million implied here.

    Is this an epidemic? Is it enough to justify taking fruit-flavored cartridge-type products off the market when they are probably the preferred choice of many young adult consumers who have quit smoking, who do not want to return to smoking and who find open systems difficult to use? Of course, the FDA says that companies can apply to have their flavored cartridge products authorized, but if the past is a predictor of the future, the young adults who use them will be muttering incoherently in old folks’ homes, and Congress will have raised the age of consent to 104 before that comes to fruition.

    There is another thing that worries me about the rush to ban flavors that the FDA says appeal to “kids.” Even if one takes what the FDA says at face value, surely the fact that “kids” prefer fruit and mint flavors to tobacco and menthol flavors does not mean that these people vape because of the availability of fruit and mint flavors. There could well be something else at work here. The FDA seems to be in danger of addressing the symptoms, not the cause of its self-styled epidemic.

    At least some of the big tobacco manufacturers reportedly welcomed the FDA’s announcement, claiming that it brought clarity to the situation. But they would, wouldn’t they? The complexities and the costs associated with making PMTAs is going to put off most of the competition, leaving the field clear for the major tobacco companies.

    But this was to be expected because the FDA seems to favor tobacco-containing products—lit or heated (but not oral, of course)—over other types of products, especially ENDS, as was demonstrated recently by the PMTAs granted to Philip Morris International’s IQOS heated-tobacco device and to 22nd Century’s low-nicotine combustible cigarettes Moonlight and Moonlight Menthol.

    But I guess the FDA’s preference for playing with fire simply reflects a wider picture where little effort is made to stop people smoking and, in fact, encouragement, in the form of decriminalization, is given to people to take up smoking marijuana. Perhaps the thinking is that if somebody is going to draw toxic fumes into their lungs, it’s best that they are properly toxic, along the lines of the air in major cities.

    Now don’t get me wrong. I am happy for people, properly—that means truthfully—informed, to smoke tobacco or any other legal substance as long as they don’t interfere unduly with the lives of others. But a society that takes a laissez faire attitude to tobacco and marijuana while coming down hard on vaping seems to be a society that has lost its sense of direction.

    Of course, as is stated above, the FDA tries to explain this away with talk of a youth epidemic, but this is nonsense. The only epidemic in evidence is that concerning the moral panic among adults, who are so worked up about vaping among young people that, without FDA-approved antidepressants and opioids, they would probably be tipped over the edge.

    Having said all this, I have to admit to having some considerable sympathy for the FDA. When it was launched into the murky waters of tobacco in 2009, the FDA, like the Titanic before it, was seen as unsinkable, built as it was on the steely structures of solid science. And it well might have sailed on effectively but for the fact that it cannot set its own course, which is at the mercy of politicians with one eye on the media and the next round of elections, and of special interest organizations ranging from libertarian groups that would have discounted cigarettes sold at school canteens and liberticides who want total control of people’s lives, especially those bits where they try to have fun.

    Somehow, and I have no idea what processes would be necessary to achieve this, the FDA needs to be set free so that it can follow the science, cushioned by common sense but unencumbered by the stifling interference and bureaucracy under which it now seems to operate. But it especially shouldn’t be at the beck and call of lunatic groups complaining about such things as “kids” being put at risk because gummy bears, having escaped from e-liquids, are freely defecating in the woods.

    Picture of George Gay

    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.