Author: Timothy Donahue

  • 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.

  • Royal College of Physicians Releases New E-cig Report

    Royal College of Physicians Releases New E-cig Report

    Photo: Balint Radu

    E-cigarettes represent a valuable aid in smoking cessation, but more can and should be done to reduce their appeal, availability and affordability to nonsmokers, and reduce environmental harms, according to a new report by the Royal College of Physicians (RCP) in the United Kingdom.

    The results are summarized in over 50 recommendations, which explore trends in combustible tobacco use and vaping products, the differences in health effects of vaping in people who smoke, vape or do neither, ethical dilemmas presented by e-cigarette, environmental damage, and the role of the tobacco industry in the rising use of e-cigarettes.

    The RCP report concludes that:

    • since the 2016 RCP report the evidence of the effectiveness of e-cigarettes as an aid to quitting has become much stronger
    • use of e-cigarettes by young people and nonsmokers has increased substantially in recent years
    • prompt remedial measures are needed to curb youth vaping without undermining use by adult smokers as an aid to quitting
    • the government should commission a series of regular evidence updates on the use and effects of nicotine products to guide policy.

    Regarding the effectiveness of e-cigarettes as a cessation tool, researchers emphasize e-cigarettes should be promoted as an effective means of helping smokers to quit smoking tobacco, particularly focusing on those population groups that could benefit the most, such as patients with mental disorders or those who experience socioeconomic disadvantage and people living in social housing.

    Regarding potential health side effects resulting from vaping product use, researchers carried out a review of biomarkers of exposure to and harm from e-cigarettes using data published between 2021 and 2023 comparing people who vape, people who smoke, people who do both (dual use), and people who do neither.

    Although lower levels of harmful substances were found in vapers compared to smokers for many of the biomarkers analyzed, researchers conclude agreement needs to be reached on the methods for vaping health risks research, including which biomarkers are the most relevant to study regarding the relative and absolute risks of vaping, to draw accurate conclusions. Studies with larger samples are needed both on vapers with a history of smoking and on vapers who have never smoked.

    The RCP report insists on finding a balance between preventing these categories from accessing vaping while not demonizing such products in the eyes of those who use them to quit smoking.

    Regarding youth addiction specifically, RCP researchers concluded that standardized plain packaging combined with reduced flavor and brand descriptions together with retail display bans should be introduced to decrease youth interest in trying vaping.

    E-cigarette price and taxation strategies should reduce the affordability of the cheapest products most commonly used by youth vapers (i.e. disposable e-cigarettes), while ensuring that the products most likely to be used by adults who smoke/quitters (i.e. rechargeable and refillable products), which are also less damaging to the environment, remain affordable.

    The report also proposed to increase prices through the introduction of a consumption tax and a minimum unit price, prohibiting multiple purchases but ensuring that they remain a less expensive option for adults who use them to quit smoking, and limiting promotional materials in retail stores and product visibility, and restricting promotion on social media.

    The authors of the report also urge regulators to prevent cigarette manufacturers from playing a role in the development of national policies.

  • Island Alternatives

    Island Alternatives

    Credit: Solarisys

    Vaping on the island of Sint Maarten is slowly starting to make a dent in combustible cigarettes sales.

    By Timothy S. Donahue

    One in five people smoke combustible cigarettes on the island. There isn’t any wonder why. A carton of the leading super premium brand American Spirits retails for $25. There isn’t much incentive to switch to vaping products when a 3,000-puff disposable vape costs $20 or more. The island of Sint Maarten/Saint Martin (SXM) is duty-free, so traditional tobacco products are cheap. Vaping products, however, can be expensive and limited in choice depending on where you look.

    There are no smoking regulations on Sint Maarten (the Dutch side of the island). However, in Saint Martin (the French side of the island), the rules for smoking are the same as in France. You can smoke or vape pretty much anywhere, though. Research indicates just 1.4 percent of Dutch adults regularly use an e-cigarette, but one in five adults still smokes tobacco. No statistics could be found for the French side.

    Legislation has recently been proposed to ban smoking in all restaurants, bars and casinos; however, smoking is currently allowed inside bars and restaurants in Sint Maarten. Many restaurants do not accept cigar or hookah smoking. Many bars, such as the popular Red Piano in Simpson Bay, encourage the use of e-cigarettes. “You can smoke cigarettes inside. We tried to stop that, but it didn’t work out,” an employee said. “Vaping is strongly encouraged in the smoking section as it is less disturbing for other patrons, staff and entertainers.”

    Kyla Peters (credit: Timothy S. Donahue)

    France’s National Assembly recently unanimously approved a bill to ban disposable e-cigarettes. If that becomes law, and the French side of SXM also bans those products, prices will rise further on the more tourist-heavy Dutch side of the island. Likely, shops on the French side would just keep selling them, however, even if disposables were to be banned technically, according to locals.

    The vaping market is growing in SXM, even with the challenges of cheap combustibles. Kyla Peters, with Don Caribe Souvenirs in Philipsburg, said that many locals are switching to vaping products, but the tourist shops aren’t where they buy them. Residents go to “Chinese grocery stores” (as locals call them) because the products are less expensive and good quality. There have also been a few vape shops that have opened on the island.

    “There are some things locals just won’t buy in the tourism-heavy areas on the island, and vapes are one of those things,” explains Peters. “The difference between buying an Elf Bar, for example, can be $5—or even more than that—less expensive when you start moving further inland.”

    Peters said Elf Bar is the most popular brand that she sells. It is also one of the most popular brands across the island. The most popular flavors are fruit and mint. She also said that the main reason for the higher costs of vaping products on the island is often the cost of shipping. It’s expensive to ship goods to small Caribbean islands. However, that cost is balanced out by the island being duty-free.

    “We don’t have tobacco taxes; there are no customs duties, VAT or other indirect taxes to pay. That is why cigarettes are so cheap. We sell a lot more cigarettes on the island than vapes, but vapes are a growing market,” Peters said. “There are a limited number of vape shops on the island; they are mostly ‘smoke shops’ that sell all types of nicotine products. As the popularity of vaping grows, I do believe the consumer cost of vaping products will come down, and locals, especially, will start to vape more.”

    Stephanne Martin

    Buying vapes at a vape shop is a better alternative than a souvenir shop by a cruise ship port. In February, the Purple Fox Smoke Shop opened in Simpson Bay. The owner, Stephanny Marlin, said that business has been growing steadily. “It’s been great, honestly,” she said. “I would say it’s a mix of both; it’s 50/50, locals and tourists.” She noted that disposables were the most popular items, followed by e-liquids. “We also sell pod systems, but they are not as popular as the other products.”

    The Purple Fox, however, offers a 9,000-puff disposable for $24. That would bring the cost of vaping below even the super low price of combustibles on the island (on a per-puff basis). A former smoker herself, Marlin said many former smokers switched because vapes don’t stink like cigarettes and the cost of vaping has become more reasonable.

    “I quit smoking a while back. But if you buy a pack of cigarettes, maybe it’s $3, $4, and you get, what, 20 cigarettes. But when you’re buying a vape, for example, the ones that I sell, which is 9,000 puffs for $24, you’re getting way more value for your money,” Marlin explains. “So, it’s worth the price. I haven’t had anybody complain about the pricing.”

    The island will likely continue to be a haven for combustible tobacco products. Lawmakers are attempting to enact flavor bans for vaping products, and youth uptake is a concern for the island. However, for an island with such a large number of combustible smokers, the harm reduction potential of vaping on the small island is huge.

  • Playing Whack-a-Mole

    Playing Whack-a-Mole

    Credit: Roman

    The CTP’s inability to apply its enforcement priorities often leaves state regulators and businesses baffled.

    By Rich Hill

    The recent onslaught of vapor registry bills in the United States is creating a lot of anxiety. Proposed registries have brought tension to public hearings and drama on social media. Unfortunately, like most current domestic issues, neither side appears to appreciate the perspective of the other. While only a handful of states have enacted product registries, many legislatures have considered and/or are considering such legislation. Understanding what these registries do, why they are promoted and their consequences is essential for all sides of this debate.

    Rationale for Developing Vapor Product Registries

    At present, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has granted marketing authorization for only a handful of tobacco-flavored vapor products and insists that all other vapor products are illegal. That said, the CTP has communicated its enforcement priorities related to deemed products numerous times. More specifically, the CTP has indicated its intention to prioritize enforcement efforts concerning certain deemed tobacco products (1) not covered by timely filed premarket tobacco product applications (PMTAs), (2) that have been the subject of marketing denial orders or those covered by PMTAs subject to negative determinations, including those rejected on procedural grounds (i.e., refuse-to-accept or refuse-to-file letters), and (3) that raise youth-use concerns.

    Unfortunately, the CTP’s inability to apply these enforcement priorities consistently to the ever-changing and large number of unscrupulous manufacturers often leaves state regulators and businesses baffled about which products are at increased risk of enforcement action.

    In short, this circumstance, with thousands of products remaining the subject of pending PMTAs that fall outside of the scope of the CTP’s enforcement priorities being sold alongside thousands of noncompliant flavored disposable vapor products, many of which fall within the scope of the FDA’s enforcement priorities, creates confusion in the marketplace and for state product regulators. Given the shortfalls in enforcement against vapor products that are not the subject of still-pending PMTAs, state tobacco regulators need a mechanism by which to determine which products should and should not be sold in their states—hence the value of vapor product registries.

    Rich Hill

    How Do Vapor Product Registry Bills Work?

    Vapor product registry bills establish registries requiring companies to submit evidence demonstrating that products that have FDA marketing granted orders are the subject of pending PMTAs filed by specified dates related to PMTA deadlines or are the subject of administrative or judicial reviews. For example, registration in Louisiana requires manufacturers to attest to the marketing granted or still-pending PMTA status of each product and pay a registration fee. Then these products will be placed on a public-facing registry.

    Positive Aspects of Product Registry Bills

    Regardless of one’s position on registry bills, the legislation at least has the potential to create positive change. By way of example, registry bills can:

    • Provide objective criteria. Vapor product registries can theoretically provide objective criteria upon which wholesalers and retailers can rely in making purchasing decisions. While there will be fewer products available, these products may be purchased without the threat of state regulatory enforcement.
    • Supplement CTP enforcement resources. The CTP has limited enforcement resources. While flavored disposable vapor products have been a high enforcement priority for the center, these products still proliferate the retail space. Vapor registries could aid in making up for the CTP’s enforcement limitations.
    • Target youth-friendly products. The 2023 National Youth Tobacco Survey reported that certain flavored disposable vapor products make up the majority of products used by youth. Registries may help in clearing the market of these products that lack pending PMTAs and are the most popular among youth.
    • Generate Revenue. Of course, registries also provide another revenue stream for state governments. With registration fees for each product, the amounts are not insignificant.

    Consequences of Vapor Product Registries

    All legislation and policy decisions invariably come with costs. Vapor product registries are no different. Some examples include:

    • Inhibit harm reduction efforts. Vapor products are harm reduction tools that benefit adult cigarette smokers seeking to quit or reduce their combustible cigarette use. Prohibiting access to such products prohibits access to the tools necessary to reduce combustible cigarette-related mortality and morbidity.
    • May not slow bad actors. Bad actors will continue to be bad actors. If a company violates the rules now, there is little reason to believe that a vapor product registry will prevent such actions.
    • Burden state resources. States are continuing to be required to do more without increased resources. In many instances, state tobacco regulatory enforcement agencies may simply lack the resources to effectively enforce registry requirements.
    • Innovation outpaces regulation. As the industry has observed before, evolution in the space moves more quickly than the regulatory arms can keep up. Innovative products falling outside of the scope of existing regulatory structures undoubtedly will winnow the effectiveness of product registries in the future. Indeed, most recently, innovations such as nicotine analog products are not covered by most registry bills.
    • Prohibitive scope can be too broad. In several instances, products not within the scope of the problem are swept into the “solution.” In a number of cases, modern oral nicotine products—products that sit at the lowest levels of the continuum of risk—are included in these product registry bills, which continues to undercut harm reduction efforts.

    Final Thoughts

    The problems that created the need for product registry legislation will continue. Until federal regulators embrace a harm reduction agenda and provide adult smokers, who will not or cannot quit, the products that have been demonstrated to assist their transition away from combustible cigarettes, the marketplace, whether legitimate or not, will respond by making them available. Vapor product registries, in and of themselves, will not solve the problems in isolation. The policies driving the need for such registries, ineffectual prohibitionist policies, need attention as well. Until the collective vapor product space, including manufacturers, retailers and consumers, aggressively advocates for policy change, new laws and regulations further limiting the ability to serve adult consumers are likely to evolve.

    Richard Hill is senior director of E-Alternative Solutions.

  • The Highs and Lows

    The Highs and Lows

    John Dunne

    The U.K. has been held up as providing the “gold standard” in proportionate vape regulation.

    By John Dunne

    It is astonishing how much ground the vaping industry has covered since Vapor Voice launched in 2014. Back then, the nascent vape industry offered a tantalizing alternative for smokers looking to quit smoking. Cig-a-like devices were the order of the day, but they often leaked, had a limited range of flavors and were rather underpowered. The main thing is that they were not cigarettes and provided a smoking alternative that really worked. It was unclear how e-cigarettes would evolve, but while many dismissed this as a passing fad, budding vaping entrepreneurs were already working on business plans.

    What was clear from the beginning was that a passionate fanbase of devotees emerged, and they spread the word about this new smoking alternative far and wide with evangelical passion. The relatively unsatisfying flavors from these earliest devices turned out to be a massive boon for the fledgling industry as fans made their own e-liquid with readily available ingredients, resulting in an explosion of new flavors being tested on friends and family members.

    These humble beginnings led to the industry that exists today. Many international brands started with someone experimenting with different flavor combinations created in their kitchens or garden sheds, only to discover that they had stumbled upon a product with enormous commercial potential. Technological advances led to more powerful batteries, larger tanks and more efficient heating systems, which excited the growing army of fans.

    The Vaper Expo U.K.—now one of Europe’s most essential vape events—came to the U.K. in May 2015 and saw thousands of vape fans queueing for hours to be among the first into the arena. The interest in vaping was astonishing, and things began to move very quickly. Former smokers morphed into passionate advocates for this new technology. Expos featured spinoff cloud-chasing contests and performances from talented individuals who found they could make a living by producing intricate patterns from exhaled vapor clouds.

    Specialist vape shops sprung up to meet the demand of former smokers and hobbyist vapers while flavor names from these early days were often exotic and fantastical. Names like “Beach Bum,” “Eye of the Tiger,” “Flaming Hot Tamale,” “Dragon’s Crown,” “Vamp Toes” and “German Chocolate Beefcake” dominated.

    E-liquid came in glass bottles of various colors with pipette droppers, and branding often featured the most complex and colorful designs, which would not have looked out of place in a modern art graduate’s portfolio. Many early adopters abandoned their careers to invest their life savings in producing their own e-liquids. As vaping became more popular and moved from niche to mainstream, politicians took notice, and regulation changed everything.

    The European Union updated its 2001 Tobacco Products Directive to include e-cigarettes in 2014 and, after a two-year grace period, the U.K. began enforcing regulations covering product safety, vapor emissions testing and new limits on tank and bottle sizes and nicotine strength. This saw the demise of many hobbyist e-liquid creators who had supplemented their incomes with home-grown e-liquids they sold locally or online, but it also paved the way for the serious players to grow and flourish.

    The U.K. Vaping Industry Association (UKVIA) was formed in 2016 to “support, develop and promote” the vape industry and promote the public health benefits of this reduced-risk alternative to smoking. It was immediately clear that there was a lot of opposition to overcome.

    Just like we have seen in the U.S., the mainstream media in the U.K. found it could generate huge numbers of clicks and views by stirring up a new moral panic around vaping. Scare stories misrepresented already dubious scientific research, and baseless articles linking vaping with cancer, lung disease and heart disease flourished. The press demonized a product that was allowing smokers to quit and quietly ignored the enormous death toll caused by cigarettes.

    I have never been in more demand from national TV, radio and newspapers to speak about vaping. Media interviews can range from productive to utterly frustrating. Some presenters want me on their shows just to shout at me, and others have their minds made up and refuse to listen to reason, but some want a balanced discussion about vaping and its role in harm reduction.

    Emotive subjects, such as environmental concerns and youth access, are staple interview topics, and I am happy to get up at the crack of dawn for the first segment of the morning TV breakfast show or appear live in the studio for a late-night current affairs debate to promote the benefits of the vaping industry.

    The U.K. has been held up as providing the “gold standard” in proportionate vape regulation for the rest of the world to follow. Although not perfect, our regulations have generally offered the right level of public protection while allowing the industry to flourish by offering adult smokers a far less harmful alternative to cigarettes.

    In recent years, that has started to change, with the U.K. poised to ban disposable devices next year on the grounds of environmental and youth access concerns. These concerns are important, but there are better ways to tackle youth vaping. For four years, we have been calling for the government to introduce a vape retail licensing scheme, similar to the way alcohol is licensed, with fines of up to £10,000 ($12,453) per instance for those who sell illegal products or sell to anyone underage. This scheme would fund a national enforcement campaign backed by regular inspections and test purchasing to ensure retailers comply with the law or face losing their license and their ability to trade.

    Vape Club, one of our UKVIA members, has already drafted the framework for such a scheme, yet the government insists it has no plans to introduce such a system. Back in 2016, I could hardly have imagined a future where the vape industry would be proposing more robust and more effective legislation to a government that seems unable or unwilling to do so, yet that is exactly how things turned out.

    We currently have proposed legislation making its way through Parliament that would give the government unprecedented new powers to restrict flavors, point-of-sale displays and packaging. The government accepts that bringing in new restrictions could cause current vapers to resume smoking but, astonishingly, has not conducted a risk assessment to determine the health harms this may bring.

    The evolution of the vape industry in the past decade has brought many challenges and has been far from smooth. The industry started with disposable devices, moved to refillable tank systems, witnessed a recent renaissance in disposables and is moving back to refillable tank systems once again. E-liquid flavors, absolutely vital to help adult smokers quit, will continue to evolve to meet changing consumer demand, but I can’t see a return to the days of “Flaming Hot Tamale,” “Dragon’s Crown” and “Vamp Toes” flavors—and that is not a bad thing.

    We have achieved so much in a decade, and I am convinced we can eventually win over a skeptical media. Until that happens, I will patiently explain why vaping does not cause popcorn lung and how nicotine does not cause cancer.

    I am also heartened to see just how far the vaping industry has come in one decade, and I am intrigued to see what incredible advances will occur between now and 2034.

    John Dunne is the director general of the U.K. Vaping Industry Association.

  • Insider Info Allegations Lead Chill Brands to Suspend CEO

    Insider Info Allegations Lead Chill Brands to Suspend CEO

    The UK-based vape maker Chill Brands said on Monday that Callum Sommerton had been suspended as its CEO after allegations were raised around the company’s use of inside information.

    The company said law firm Fieldfisher had been appointed to investigate the allegations, but it added that Sommerton’s suspension did not imply that he was guilty of misconduct.

    Chill Brands’ share price plunged as much as 31 percent in Monday morning trading after the announcement, according to media reports.

    “This suspension does not constitute disciplinary action or a disciplinary penalty and does not imply any assumption that Mr Sommerton is guilty of any misconduct or that any decision has been made,” Chill Brands stated in a release.

    The company added that it will engage with the Financial Conduct Authority over the investigation, and the findings will be reported “in due course.”

  • Closing the Space

    Closing the Space

    Cape Town, South Africa (Credit: Deyan)

    At the current rate, tobacco harm reduction is likely to remain a fantasy in South Africa.

    By Asanda Gcoyi

    Like other countries around the world, South Africans have taken to vaping in great numbers over the past 10 years. What started as a small community of smokers seeking out less harmful alternatives to cigarettes has now morphed into a massive industry that is growing in leaps and bounds.

    Since 2013, vaping devices in South Africa have become a ubiquitous sight, with many a smoker giving up their deadly habit in favor of vaping. For the past decade, vaping has remained outside the regulatory net while tobacco has been regulated through the Tobacco Products Control Act, 83, 1993. While hailed in its initial days, the act has failed to reduce South Africa’s smoking rates successfully.

    This is reflected in recent statistics, which show that South Africa’s smoking rate has increased from about 18 percent in 2018 to over 25 percent in 2022. This is a result of lax law enforcement and the proliferation of cheap illicit tobacco products that are reported to account for over 60 percent of the South African smoked tobacco market.

    For a time, harm reduction advocates were hopeful that vaping would make a significant contribution toward reducing smoking in the country. There was even a faint hope that regulators would embrace the vaping industry in the spirit of reducing the harm that smokers are exposed to and hopefully also reduce the external costs of smoking, which are borne mainly by the poorly performing public health system.

    Not so. Over the past two years, the South African government has succumbed to pressure from the anti-smoking lobby, which relies on misinformation and disinformation to discredit tobacco harm reduction. In part, the antipathy toward vaping has arisen out of fears that young people were taking up vaping in droves.

    Except, there is minimal evidence for this contention. The research that has been done is limited in scope and reach, and its conclusions cannot be generalized to the rest of the South African youth. No doubt, young people are curious and are trying out vaping. However, there is no evidence that large numbers are regular vapers or that they are progressing to smoking cigarettes, as has been claimed by those in favor of strict regulations of vaping.

    Asanda Gcoyi

    What is beyond any doubt is that a significant number of young people are smokers due to the accessibility and low prices of illicit tobacco. In its rush to be seen to be doing something about the manufactured crisis of youth vaping, the government has embarked on two processes: the introduction of a vaping tax and the amendment of the country’s tobacco control laws to include vaping.

    After a two-year public consultation charade, the government started levying an excise duty on vaping liquids on June 1, 2023. This immediately made refillable vapes unaffordable for your average vaper, as the price of a 100 mL bottle more than doubled overnight. At ZAR2.90 ($0.16) per milliliter, South Africa’s rate is on the steep side and has made smoking more attractive from a price point of view.

    Perversely, the excise duty has made disposable vapes much cheaper than refillable vapes. Up to the introduction of the tax, refillable vapes had been the preferred choice for smokers who were using vaping as a harm-reduced alternative to smoking. Common wisdom has it that disposable vapes are the most preferred option for young adults and teenagers.

    In introducing the steep rate, the government has failed to deter the people who should not vape from doing so while forcing many former smokers and dual users to vape higher nicotine disposables and revert to smoking due to price.

    Parallel to the tax’s introduction, Parliament has been processing the Tobacco Products and Electronic Delivery Systems Control Bill, which was introduced in December 2022. This anti-harm reduction draft law dismisses the possibility that vaping is less harmful than smoking and that there should be a differentiation in law between how the two are treated.

    It conflates vaping and smoking and extends draconian regulations to vaping, some of which will virtually wipe out any communication about vaping as a harm-reduced alternative to smoking. In the process, it will confirm smoking’s importance as the only viable form of nicotine delivery for the millions of nicotine addicts who do not know enough about vaping or believe the disinformation that vaping is as harmful, if not more so, than smoking.

    Supported by Bloomberg Foundation-funded organizations, the bill is a clear demonstration of the deep-seated disdain that the South African government has for the smoking public. In countless public hearings, the ruling party and its fellow travelers in the anti-tobacco campaign loudly proclaimed their contrived belief that harm reduction is a ruse.

    They have used every opportunity to talk up the dangers of youth vaping while completely ignoring the plight of the more than 10 million smokers in South Africa. In their telling, smokers should just quit because vaping is as bad, if not worse, than smoking. In one hearing, they were even proud to display a poster showing the diseased body of a vaper, science notwithstanding.

    While there is always a chance that the new government to be elected on May 29 will revisit the draft Bill submitted to Parliament, there is little hope among tobacco harm reduction experts of any change in direction. It has become clear that the South African government has lost its ability to make public health policy guided by its unique circumstances. It is content to defer to the ideological prescripts of the World Health Organization and the Framework Convention on Tobacco Control, even when it clearly goes against its own interests as a country.

    This is a disheartening and anti-democratic exercise in policy capture, which, left unchecked, will prejudice South African smokers by foreclosing the possibility of switching to less harmful alternatives. At the current rate, tobacco harm reduction is likely to remain a pipe dream rather than a reality.

    Asanda Gcoyi is CEO of the Vapour Products Association of South Africa.

  • Significant Shifts

    Significant Shifts

    Credit: Nightman

    The vaping industry continues to overcome regulatory challenges and false narratives.

    By Greg Conley

    Over the past decade, Vapor Voice has closely tracked the vaping industry’s turbulent evolution from niche interest to a subject of global attention. These years have been marked by significant shifts due to technological advancements, evolving regulatory landscapes and changing public health views. As a longtime advocate for safer nicotine alternatives, I’ve observed the industry’s struggle for legitimacy and its ongoing battle against misinformation.

    In the early days of the vapor industry, doubts and skepticism were rampant. I had a memorable encounter in 2011 at a conference filled with tobacco industry executives. There, an executive remarked to me, “Enjoy this while it lasts. You’ve got about a year left before the U.S. Food and Drug Administration crushes you.” There was no malice or ill will in his voice but rather a resigned acknowledgement of the regulatory hurdles that lay ahead, courtesy of the FDA’s Center for Tobacco Products (CTP) and the 2009 Family Smoking Prevention and Tobacco Control Act. This insight foretold the imminent regulatory challenges we were about to face.

    Greg Conley

    Initially, certain industry players were confident in their ability to satisfy CTP requirements. Despite the plain text of the Tobacco Control Act, some manufacturers still believed that the CTP would not outright reject flavored products. A stark reality check was dealt when the CTP’s original deeming proposal was leaked online in 2015. Had the Office of Management and Budget at former President Barack Obama’s White House not intervened to object to a provision that would have immediately pulled flavored products from the market, the industry could be radically different today.

    The appointment of Scott Gottlieb as FDA commissioner during former President Donald Trump’s administration was initially met with cheers. This ignited industry hopes for a science-based approach to the impending deadlines for submitting premarket tobacco product applications (PMTAs). Yet, Juul’s skyrocketing popularity and the associated increase in youth vaping quickly became a major point of contention, halting any progress toward streamlining the PMTA process.

    A profound nadir of the last decade was undoubtedly the summer 2019 e-cigarette or vaping product use-associated lung injury (EVALI) crisis. Even as the evidence grew linking the illnesses and deaths to illicit THC products, the legal nicotine vaping industry was unjustly blamed and the subject of sensationalist media coverage. Worse still, several of the nation’s top health officials spearheaded efforts to cloud the true cause of EVALI.

    Notably, one health official who played a central role in the U.S. Centers for Disease Control and Prevention’s mishandling of the EVALI situation now holds a significant role in shaping the future of vaping—Brian King, who heads the CTP. It is deeply ironic that King, who helped add fuel to the fire that caused a remarkable decline in public perception of nicotine vaping, now oversees the CTP’s purported efforts to rectify misconceptions about smoke-free nicotine products.

    As the industry emerged from the doldrums of the EVALI crisis, it faced the longstanding regulatory challenges that advocates had been cautioning about for years. Following numerous delays, the submission deadline for PMTAs for tobacco-derived nicotine vaping products finally arrived in September 2020. Amid the global focus on Covid-19 and the impending presidential election, the media was uninterested in stories about small business concerns with the CTP’s flawed system.

    September 2020 was not an easy month for CTP employees. When it proposed the deeming regulation, the CTP predicted that it would receive fewer than 3,000 PMTAs. However, the vapor industry firmly stood its ground. Through an effort spearheaded by the founding members of the American Vapor Manufacturers Association, over 200 manufacturers inundated the CTP with several million PMTAs.

    As anticipated, chaos ensued. The FDA’s system was completely overwhelmed. The agency was at a loss on how to proceed with the PMTAs. The indecision ended after an April 2021 legislative hearing, during which FDA Acting Commissioner Janet Woodcock was harangued by House Democrats who wanted to see all PMTAs for flavored vaping products immediately denied. She returned to the FDA and mandated that the CTP create a new system to expedite the denial of the backlog of vapor product PMTAs.

    The FDA’s infamous “fatal flaw” memo resulted in the banning of millions of nicotine vaping products. These bans were not based on any direct public health risk posed by the products. Rather, they were implemented because, well, after the PMTA submission deadline had passed, the FDA decided it would not review PMTAs for flavored vaping products without a specific clinical trial or longitudinal study. As a result of ongoing litigation, which could potentially reach the Supreme Court in the next year, many of the PMTAs submitted in 2020 are still pending resolution.

    As a testament to the industry’s dynamic nature, the products caught up in court fights have fallen out of favor with adult consumers. Since 2020, the explosion in popularity of flavored disposable vapes, fueled by ambiguous regulations and enforcement regarding synthetic nicotine, has significantly reshaped the industry. This shift has happened amid steep declines in youth usage and steady increases in adult usage.

    The ongoing legislative and legal battles surrounding disposable vaping products signal the onset of a struggle that will likely shape the next decade of vaping. Approximately 10 million adults in the U.S. use flavored disposables, with a significant portion turning to these products as a complete replacement for combustible tobacco products. In our interconnected society and in a country growing more skeptical about government interference with the private choices of adults, preventing adults from accessing flavored vaping products will prove to be no simple feat.

    Looking back at the evolution of the vaping industry over the last decade, the road has been both rocky and rewarding. From regulatory challenges to breakthroughs in harm reduction, the narrative is rich with lessons learned and battles fought. Amid these uncertainties, one thing is clear: Our journey is far from over.

    Greg Conley is the director of legislative and external affairs for the American Vapor Manufacturers Association.

  • Elfbar ‘Equipped to Pivot’ Around UK Disposable Ban

    Elfbar ‘Equipped to Pivot’ Around UK Disposable Ban

    Credit: Profit Image

    The company behind two of the UK’s most popular vape brands says new reusable versions leave it “well-equipped” to deal with the upcoming ban on disposables, despite concerns over producers exploiting “loopholes.”

    Elfbar and Lost Mary have already launched reusable versions of their popular disposable vapes.

    Elfbar said it was “addressing demand” for a tool to help smokers quit.

    But critics say the vapes will not achieve the ban’s environmental aims, reports the BBC.

    Councils have also warned that the UK government should not let producers exploit “loopholes” in the ban.

    Green Fun Alliance is one of the main distributors in the UK of Elfbar and Lost Mary, which account for nearly half of the British market.

    It is owned by low-profile Chinese entrepreneur Shengwei Zhang, 51, who also controls the companies that make Elfbar and Lost Mary vapes.

    The latest accounts for Green Fun Alliance show that its sales have skyrocketed as disposable vapes gained popularity—almost tripling to £117.3m for the year ending January 31, 2023.

    In a filing with Companies House, Green Fun Alliance noted the government’s plans to ban them from next April “will have a detrimental effect on sales and profitability.”

    “However, management have been preparing for this and are well equipped to pivot their business to the exclusive sale of non-disposable vapes and related products,” it said.

  • Vaping in Malaysia: Taxes Likely Coming Soon

    Vaping in Malaysia: Taxes Likely Coming Soon

    It remains to be seen whether Malaysia will remain as tolerant of vaping as it is today.

    By Norm Bour

    Over the past four months, I have been in four different Asian countries. Each has its own currency, language, food and culture. They also all have their own vape markets, which differ based on regulations, cost of purchase (compared to income) and, in many cases, religious restrictions.

    In Malaysia, my current homestay, the dominant religion is Islam, and I have seen more women wearing hajibs than in previously visited countries. What is fascinating is the exceptionally high number of young female vapers walking in the malls and on the streets. In a country so devout, I asked a vape shop clerks how religious leaders feel about vaping, especially among women.

    “Cigarette and tobacco usage is very high within the Muslim community,” said one of the counter girls from Vape VG, which is located in a mall. “And even though most of us realize it’s an unhealthy habit, there is no opinion on it from our religious leaders.” She did not address the female perspective.

    When I followed up and asked her which were the most popular products, she said (as many shopkeepers globally do), “flavors of all kinds, especially fruity [ones].”

    I asked a group of several female vapers if they felt out of place or self-conscious about vaping in public or even in private. They said they had no problem doing it on the streets, but some felt uncomfortable doing it in their parents’ presence—even if their parents smoked.

    Regardless, there is still a strong motivation in the country to increase tobacco taxation. In its February 2024 budget meeting, the government proposed to impose an excise duty on liquids or gels containing nicotine used for e-cigarettes or vaping devices—but that is as far as it got.

    And Malaysia’s current excise duty on e-cigs and liquids with nicotine applies to just a few manufacturers. Meanwhile, the taxation on traditional cigarettes has not changed since 2017.

    So far, the vape market in Malaysia is prolific and in the open. You don’t need to go very far to find a vape shop. Ironically, we saw more vape shops than tobacco stores, as my wife had difficulty finding the clove cigarettes she enjoys sometimes. The vape stores range from tiny kiosks, like Action Vape, within the walkways connecting buildings to small units of just a few square feet to the larger outlets, like Brain Freeze Vape, which claims to be the largest in the country.

    With a population of just under 2 million, Malaysia’s capital, Kuala Lumpur, provides valuable insights into the country’s vaping market.

    Considering that vaping is banned in neighboring Thailand, Singapore and Brunei, plus nearby Cambodia and Laos, it’s refreshing to see an open market. One shop owner confirmed that his store gets a lot of tourists from abroad, especially from countries where vaping is outlawed.

    Malaysia, too, came close to banning vapes under its “Generational Endgame” bill. Proposed in 2022, this legislation would have prohibited anyone born in 2007 or later from buying and using cigarettes or vaping products in Malaysia, in effect gradually raising the legal age until it covered the entire population. The bill never passed, however; it was abandoned in November 2023, officially due to concerns about its constitutionality. Critics, however, blamed the U-turn on industry lobbying.

    With that said, Malaysia still restricts underage sales. The law prohibits sales to those under the age of 18, but loopholes make that restriction toothless, according to critics. Health advocates complain that leading tobacco companies such Philip Morris International, BAT and Japan Tobacco International wield considerable influence in Malaysia.

    Last year, the government exempted liquid nicotine and gels from its Poisons Act, effectively legalizing vaping as of last April. The move angered many people. Currently, the Control of Smoking Products for Public Health Bill 2023 prohibits the advertising and sponsorship of e-cigarettes or vape products.

    Many businesses see potential in the Malaysian vaping market. At the end of March, Airscream U.K. announced plans to invest myr100 million ($21.12 million) in its operations over the next five years and move its headquarters to Malaysia, according to media reports. The company has already established administrative, sales and marketing operations and a showroom in Shah Alam. It has close to 40 employees locally and 100 globally.

    Airscream founder and CEO Sam Ong cited a robust market and vaping industry ecosystem as reasons for the company’s decision. Over the past decade, Malaysia’s vaping industry has grown into a myr3 billion business, employing more than 30,000 Malaysians, according to the Malaysian Vape Chamber of Commerce.

    Ong believes the market is poised for further growth, potentially driving more foreign direct investments into the country and bolstering job creation. “We are also encouraged by the passing of the Control of Smoking Products for Public Health Bill 2023, which brings Malaysia on par with other countries around the world, including the U.K., Australia, Thailand and Singapore, which have standalone legislation on tobacco and vape,” Ong said.

    Additionally, China-based Ispire Technology received ISO9001: 2015 Quality Management System, ISO14001: 2015 Environmental Management System and ISO13485: 2016 Quality Management System Medical Device certifications for its 31,000-square-foot manufacturing facility in Malaysia earlier this year. Company leadership announced previously that Malaysia offers more business-friendly tariff rules than some other Asian countries.

    “Earning three ISO certifications at our Malaysian manufacturing facility is a testament to our team’s ability to quickly bring the facility up to some of the highest standards in the industry, allowing us to expand our gross margins, geopolitically de-risk our production and service other businesses who need manufacturing for their vape hardware,” said Ispire’s Co-CEO, Michael Wang. “As the facility ramps up production, our gross margin is expected to increase due to the lack of a tariff when assembling products in Malaysia and then shipping them to the U.S.

    “This is in contrast to the 25 percent tariff incurred when shipping finished products from China.”

    The vaping and smoking trends in Malaysia seem contrary to those in many other countries. E-cigarette use among Malaysian youths aged 13–17 rose from 9.8 percent in 2017 to 14.9 percent in 2022, according to the National Health and Morbidity Survey. During the same period, cigarette smoking rates dropped from 13.8 percent to 6.2 percent.

    With organizations such as the Southeast Asia Tobacco Control Alliance pressuring countries in the region to crack down on vaping, it remains to be seen whether Malaysia will remain as tolerant of vaping as it is today.

    Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.