Category: This Issue

  • Look Back: Vapor in 2024

    Look Back: Vapor in 2024

    In 2024, regulatory challenges and misinformation continued to test the vaping industry.

    By VV staff

    There is positivity surrounding the nicotine industry. With the Trump administration set to take power in January, many believe it will take a softer stance on flavored nicotine products than the Biden team. The vaping industry continues to survive despite setbacks experienced in 2024, and it continues to grow globally. However, divergent regulatory perspectives on vaping’s harm reduction potential continue to hinder its uptake by cigarette smokers.

    The past 12 months could also be labeled “the year of the registry” as several product registry bills were enacted, the most interesting of which was in Florida. Florida’s governor, Ron DeSantis, signed legislation intended to crack down on the sale of unauthorized vapes that the state deems attractive to children. The new law (HB 1007), however, only targets disposable vaping products not authorized by the U.S. Food and Drug Administration. The rules will be enforced beginning Oct. 1.

    Unlike other state registry lists, Florida is the first state in the U.S. to include a carve-out for refillable pod systems, open-system vaping products, and bottled e-liquids. Florida Smoke Free Association President and entrepreneur Nick Orlando was a driving force behind getting the open-system exemption. In its original form, the bill would have prohibited sales of any vape products that had not yet received FDA approval.

    Orlando said that if any area of the vaping industry genuinely needs reform, it is at the federal level and within the FDA review and approval process. “The FDA’s Center for Tobacco Products [CTP] is supposed to comply with a statutory, 180-day deadline to review new tobacco product applications, many of which are potentially less harmful than combustible cigarettes,” said Orlando. “However, as Florida’s vape manufacturers have experienced, working through this process is often a painstaking, costly and onerous ordeal that has resulted in a backlog of thousands of applications that have sat with the CTP for years.”

    Also this year, the FDA approved menthol vapes for the first time. The regulatory agency authorized four Njoy products through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to Njoy, an Altria subsidiary, for two pods for its Ace closed e-cigarette device, which was authorized in April of 2022, and two disposable e-cigarettes—Njoy Daily Menthol 4.5 percent and Njoy Daily Extra Menthol 2.4 percent.

    The two authorized Ace pods are the Njoy Ace Pod Menthol 2.4 percent and the Njoy Ace Pod Menthol 5 percent. All four of the newly authorized products are prefilled and nonrefillable. The decision is significant because it is the first nontobacco-flavored vapor product to be authorized by the FDA. In his TPL review, Office of Science Director Matthew Farrelly said that Njoy had “demonstrated the potential for these new products to benefit adults who smoke [combustible cigarettes] as compared to those who continue to use [combustible cigarettes] exclusively” and that the company had “also proposed robust marketing plans that include restrictions beyond those required with PMTA authorization.” Farrelly also highlighted data from a longitudinal cohort study that Njoy submitted with its application, which pointed to “robust absolute switching rates” and a higher rate of complete switching than tobacco-flavored Njoy Daily.

    Another pressing issue in 2023 is that critics continue to accuse the vaping industry of avoiding responsibility for the environmental damage caused by disposable vaping products. Federal regulators have failed to pass measures that would make vaping components easier to recycle or more eco-friendly. Some regulations have been proposed to lessen the products’ environmental impact. For example, standards could be put in place requiring them to be reusable or mandating that manufacturers fund collection and recycling programs.

    According to the Centers for Disease Control and Prevention, disposable e-cigarettes account for about 53 percent of the multibillion-dollar U.S. vaping market, which has more than doubled in size since 2020. Several states, including New York and California, have extended product responsibility laws for computers and other electronics, but those rules don’t apply to vaping products. At the federal level, there are no regulations specifically for the disposal of vaping products.

    Some experts say that the devastating environmental impact could last centuries without action. Ultimately, 2024 witnessed significant milestones in combustible smokers making the switch to less risky nicotine-delivery systems. That trend is expected to continue into next year. Looking back on this year, below is a month-by-month recap of the vaping industry’s most prominent headlines of 2024.

    January

    A group of Juul Labs investors challenged a November 2022 financial bailout by directors Nick Pritzker and Riaz Valani, alleging that the deal benefited insiders at the expense of other investors. Jan. 1, 2024, marked the official launch of McKinney Specialty Labs, a scientific organization with expertise in testing nicotine and other aerosolized products.

    On Jan. 3, the U.S. Court of Appeals for the 5th Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States. The Supreme Court of the United States rejected R.J. Reynolds Tobacco Co.’s bid to challenge a voter-approved ban on flavored vaping and other tobacco products in California, the most populous state in the U.S.

    February

    Philip Morris International and BAT settled their ongoing intellectual property disputes relating to heated-tobacco and vapor products. The U.S. Food and Drug Administration continued its de facto flavor ban. It issued marketing denial orders to Fontem US for four Blu disposables and one Myblu brand e-cigarette product. The attorney general for North Carolina announced the launch of an online, searchable public depository containing nearly 4 million documents from the state’s lawsuit against e-cigarette manufacturer Juul Labs.

    R Street Institute released a report that explores how flavors can influence behavior and why well-intentioned efforts to ban flavored tobacco and nicotine products can have unintended consequences. BAT’s Italian division was fined €6 million ($6.4 million) for “misleading advertising of a heated-tobacco product.” Amazon was fined €1 million for the same reason.

    March

    Belarus’ State Committee for Standardization banned 47 types of electronic cigarettes from sale because they contained unlawful levels of nicotine. The highest court in Massachusetts ignored objections from vape shop owners and tobacco retailers and upheld the legality of a novel bylaw in the town of Brookline that bars cigarette sales to anyone born after Jan. 1, 2000. The chairmen of five key Senate committees warned the chief executives of major convenience stores and wholesalers to stop selling illicit flavored vaping products.

    A federal judge approved the final part of a class action settlement with Juul Labs and its parent company Altria, bringing the settlement total to just over $300 million. The Office of the Solicitor General filed a petition for certiorari in the case of the FDA v. Wages and White Lion Investments, asking the Supreme Court to review the U.S. Court of Appeals for the 5th Circuit’s en banc decision concluding that the FDA’s denial of some premarket tobacco product applications was arbitrary and capricious. The global vaping company Plxsur reached its goal of reaching $1 billion in consolidated revenues from its partners in just two years.

    April

    The governor of Vermont, Phil Scott, vetoed legislation banning the sale of flavored vaping and tobacco products in the state. New York City Mayor Eric Adams and New York City Corporation Counsel Sylvia O. Hinds-Radix announced that the city of New York filed a lawsuit against 11 wholesalers for their part in the illegal sale of flavored disposable e-cigarettes.

    Kentucky Governor Andy Beshear signed House Bill 11 into law, making Kentucky the sixth state in the U.S. with a registry law. Lawmakers approved British Prime Minister Rishi Sunak’s plan to ban anyone aged 15 and under from ever buying cigarettes. Kazakhstan’s President Kassym-Jomart Tokayev signed a bill banning the sale and distribution of vaping products.

    The U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California. Florida is the first state in the nation to include a carve-out in vape registry for refillable pod systems, open-system vaping products and bottled e-liquids. The board of directors for the Brazilian Health Surveillance Agency (Anvisa) voted unanimously to maintain a ban on the sale of e-cigarettes and other vaping products.

    May

    The U.S. Drug Enforcement Administration asked the White House for permission to reclassify marijuana as a less dangerous drug. The Oregon Court of Appeals upheld a Washington County ban on flavored tobacco sales. The FDA uploaded the first update to its Searchable Tobacco Products Database, which provides an overview of tobacco and vapor products that may be legally marketed in the United States. Filtrona launched a series of new filters for heated-tobacco products, the Boreas range.

    The FDA filed several modified-risk tobacco product renewal applications submitted by Philip Morris Products for several IQOS products for scientific review. A study published in Thorax found associations between the use of social media platforms and the risk of combustible cigarette smoking and vaping among youth. A judge in Ohio ruled that the state law that prohibits cities from banning flavored tobacco is unconstitutional. The Supreme Court of Justice in Panama ruled unanimously that Panama’s ban on the sale of all vaping products is unconstitutional. The FDA announced that it is seeking civil money penalties from nine brick-and-mortar retailers and one online retailer for selling Elf Bar products.

    June

    The FDA updated its import alert, which includes a “red list” of manufacturers, distributors and brands of vapor products that may be detained “without physical examination.” The FDA reversed a marketing denial order issued to Juul Labs for its vaping products. Governor DeSantis vetoed a bill that aimed to ban delta-8 and other cannabis products. U.S. Senators criticized top health and law enforcement officials for their failure to tame the rapidly growing illicit e-cigarette market.

    The FDA authorized four menthol Njoy products through the PMTA pathway. This was the first time a flavored vaping product was authorized. Romania’s Chamber of Deputies adopted a bill banning advertising of electronic cigarettes and nicotine pouches. Philip Morris International halted sales of Zyn nicotine pouches on its U.S. website as Washington, D.C., officials investigate the company’s compliance with the district’s ban on the sale of flavored tobacco products.

    Altria Group submitted PMTAs to the FDA for its “On! Plus” oral nicotine pouch products. New York state received $112.7 million from a multistate settlement with Juul Labs Inc. due to the vaping company’s involvement in the youth vaping epidemic. The Supreme Court of the United States ruled 6-3 to overturn the “Chevron deference,” a backbone principle for how the federal government keeps corporations in check.

    July

    R.J. Reynolds Vapor Co., an operating company of Reynolds American Inc., the BAT Group’s U.S. subsidiary, announced that it is expanding its vapor portfolio with SENSA, a zero-nicotine vapor product. Australia became the first country to restrict the sale of vapes to pharmacies when its laws surrounding vaping products went into effect. The U.S. Supreme Court agreed to hear the FDA’s defense of the agency’s rejection of Triton Distributing’s PMTAs.

    North Carolina Governor Roy Cooper signed into law a vape registry bill. The U.K.’s Labour government will propose a bill to gradually raise the legal age for purchasing cigarettes and impose restrictions on the sales and promotion of vaping products, as confirmed by King Charles III in a speech. Philip Morris International said that it will invest $600 million in a factory in Aurora, Colorado, to help meet U.S. consumers’ growing appetite for the company’s Zyn nicotine pouches.

    The Italian government placed CBD on the country’s list of narcotic drugs in defiance of a regional administrative court ruling and in contravention of European Union law. The Philippine government halted the sale, advertising and distribution of vape products online. The Cook Islands banned the manufacture, importation, sale, distribution and advertising of cigarette alternatives such as e-cigarettes. PMI postponed the test launch of its IQOS heated-tobacco device in the U.S. to the fourth quarter.

    August

    Costa Rica banned vaping in public places such as restaurants, offices and educational institutions. The Haypp Group, the world’s largest online retailer of nicotine pouches, reported net sales of SEK942.8 million ($89.66 million) for the second quarter of 2024, up 23 percent over the comparable 2023 period. RLX Technology reported net revenues of RMB627.2 million ($86.3 million) in the second quarter of 2024, up 66 percent from the comparable 2023 quarter.

    The FDA and the Department of the Treasury announced a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number ENDS products into the electronic imports system operated by U.S. Customs and Border Protection. New data from Action on Smoking and Health U.K. found that more than half of ex-smokers in Great Britain who quit in the past five years—amounting to 2.7 million adults—used a vape in their last quit attempt. VPR Brands reported revenues of $1.77 million for the second quarter of 2024, down from $1.9 million in the comparable 2023 quarter. Gross profit was $451,469 compared with $1.1 million in the second quarter of 2023.

    Illinois lawmakers decisively passed a law that forbids vaping companies from targeting teens with their advertising, particularly by promoting electronic cigarettes that resemble school supplies such as highlighters, markers or erasers. Smoore International Holdings reported revenue of RMB5.04 billion ($705.4 million) for the six months that ended June 30, down 1.7 percent from the comparable 2023 period.

    An administrative law judge of the International Trade Commission recommended a ban on importing Njoy Ace products into the United States following a patent infringement claim filed by Juul Labs. Philip Morris International’s Swedish Match affiliate announced an investment of $232 million to expand the production capacity of its manufacturing facility in Owensboro, Kentucky. The Kurdistan Regional Government intensified efforts to crack down on the use of e-cigarettes, with both the Ministry of Health and the Ministry of Interior enforcing a decision to ban their import and sale.

    September

    Illinois Senator Dick Durbin condemned top health and law enforcement officials for their, in his eyes, inadequate efforts in combating the surge of illegal disposable e-cigarettes among young people in the U.S. Representatives from PMI began pitching the benefits of its IQOS heated-tobacco device to Nevada state lawmakers. Police in Allen, Texas, secured evidence and marched out business owners in handcuffs for selling what attorneys for the vape shops say were legal cannabis products.

    The FDA announced a final rule raising the minimum age for certain restrictions on tobacco product sales. A review of evidence by a team of scientists found that e-cigarettes are among the top 3 most effective tools to stop smoking. Accorto Regulatory Solutions joined the Global Institute for Novel Nicotine, an organization dedicated to advancing tobacco harm reduction through supporting the research and development of nonvaporized tobacco alternatives for adult smokers. The Great Smoky Cannabis Dispensary opened in North Carolina for its first recreational marijuana sales for anyone over the age of 21.

    Irish Health Minister Stephen Donnelly proposed bans on nontobacco vape flavors and advertising in nonspecialized shops. The FDA issued six warning letters to manufacturers and retailers for selling or distributing unauthorized e-cigarette products promoted at an industry trade show. PMI recorded a record loss of about £220 million ($198 million) on the sale of its inhaled-therapeutics Vectura Group unit to Molex Asia Holdings in the third quarter.

    Tucker Carlson announced plans to introduce a nicotine pouch brand called ALP in November. U.S. President-elect Donald Trump said he will save flavored e-cigarettes. The European Commission approved France’s bid to ban disposable vapes. The U.S. Department of Health and Human Services updated its regulations to reflect the required annual inflation-related increases to civil money penalties, consistent with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.

    October

    The FDA cleared an Investigational New Drug application for Qnovia’s RespiRx nicotine inhaler (QN-01). According to Qnovia, the RespiRx is the first truly inhalable nicotine-replacement therapy to assist smokers attempting to quit smoking. PMI pulled its IQOS tobacco-heating device from New Zealand store shelves after a new law took effect requiring vaping devices to have removable batteries. French consumer vaping organization SOVAPE announced that it will dissolve. The group had been active since 2016.

    The JT Group completed the acquisition of Vector Group on Oct. 7, following a tender offer. Ispire Technology, a company that develops and commercializes vaping technology products, announced a five-year master distributor agreement with ANDS, a Dubai-based distributor in the Middle East, North Africa region specializing in combustion-free nicotine-delivery solutions. Amazon agreed to pay Vermont $400,000 and improve its vetting practices to settle claims that it failed to stop online vendors from selling e-cigarettes. Jamaica supported an updated strategy to accelerate action to meet tobacco control targets in the Americas region.

    The minister of mental health and addictions says the federal government will ban most vape flavors across Canada. Guam’s governor, Lou Leon Guerrero, vetoed a bill that seeks a 10 percent tax on vaping and electronic nicotine products. Elf Bar and Lost Mary created a board in the U.K. to provide strategic advice for the brands. The Oregon Court of Appeals struck down a law restricting the packaging of vape and cannabis products on the grounds that the legislation unconstitutionally restricts free speech.

    The FDA issued warning letters to nine online retailers and one manufacturer for selling or distributing unauthorized disposable e-cigarettes designed to resemble smart technology, including smartphones and gaming devices. French Health Minister Genevieve Darrieussecq said in an interview with the newspaper Le Parisien that nicotine pouches “are dangerous products because they contain high doses of nicotine” and added that a ban will be announced.

    November

    The U.K. government introduced its Tobacco and Vapes Bill, which involves some of the world’s strictest anti-smoking rules. A jury trial commenced for a lawsuit filed by the state of Alaska against Juul Labs and Altria Group that alleges that the companies played a significant role in the rising use of e-cigarettes among young people. A survey found that one year after Quebec banned nontobacco-flavored vapes, most vapers are buying such products illegal in the province.

    Altria Group beat market expectations for third-quarter revenue and profit as robust demand for its nicotine pouches and vaping products helped soften the blow to its combustible cigarettes category. After a scientific review, the FDA issued a renewal of modified-risk granted orders to Swedish Match for eight General Snus products. A court in The Hague ruled that the Netherlands was allowed to introduce a ban on flavors in e-cigarettes to protect public health. Tobacco stocks rose in the wake of Trump’s victory in the U.S. presidential election.

    Ispire Technology reported revenue of $39.3 million for the first quarter of 2025, down from $42.9 million in the comparable 2024 quarter. Mayor Adams and New York City Acting Corporation Counsel Muriel Goode-Trufant announced that the city of New York filed a federal lawsuit against a major distributor of disposable flavored e-cigarettes. Mexico’s top court ruled that a ban on imports of e-cigarettes and related products was unconstitutional. Tucker Carlson launched his own nicotine pouch brand, ALP, which the conservative American commentator touted as “the first nicotine pouch brand made by and for adults who unapologetically love nicotine.”

    Trump nominated Robert F. Kennedy, Jr. to serve as the new secretary of the Department of Health and Human Services. The Swedish government released data showing that Swedes made history by officially becoming the first country to be “smoke-free.” President Sadyr Japarov signed a law prohibiting the import, circulation and use of electronic cigarettes.

    A report from the CDC Foundation and Truth Initiative showed that from 2019 to 2023, there was a 47 percent increase in e-cigarette unit sales at U.S. retail outlets. The Surgeon General of the United States released a report on health disparities related to tobacco use. Imperial Brands reported a dip in revenue despite double-digit growth in its electronic cigarettes division and growth in its traditional tobacco division. Spain began a public consultation on new rules for vaping devices. A landmark bill in the United Kingdom to ban its younger generation from smoking cleared its first hurdle in the House of Commons.

    December

    (Editor’s Note: This magazine went live in December, so the month may be incomplete.) Tobacco Reporter, after 150 years of nicotine industry news, ended the publishing of its magazine. Vietnam’s National Assembly approved a measure to prohibit the production, sale, import, storage, transportation and use of e-cigarettes starting in 2025. The United States Supreme Court heard oral arguments in FDA v. Wages and White Lion Investments LLC, a pivotal case concerning the FDA’s rejection of applications to market flavored nicotine vaping devices. The U.S. Drug Enforcement Administration began sharing details about its long-anticipated hearings on its cannabis rescheduling publicly.

    A survey by online retailer Nicokick finds more than 86 percent of current U.S. nicotine pouch users say they are likely to switch to Tucker Carlson’s recently launched Alp brand. Smoking rates in Spain dropped to a record low. The FDA issues warning letters to 115 brick-and-mortar retailers for selling unauthorized e-cigarette products. The warning letters cite the sale of disposable e-cigarette products owned by Chinese manufacturers and marketed under popular brand names, including Geek Bar Pulse, Geek Bar Skyview, Geek Bar Platinum, and Elf Bar.

    Looking ahead

    Predicting what the vaping industry will look like by the end of 2025 is impossible. Industry insiders expect regulators to crack down on disposable vaping products, and misinformation will likely continue to run wild. Many in the industry believe Trump will change how the FDA regulates vaping products. The sale and use of single-use disposable vapes will be banned in England from June next year, and many other countries are expected to follow suit.

    From Feb. 2, 2020, to June 16, 2024, U.S. disposable e-cigarette sales increased by 201.3 percent (4.1 million units to 12.3 million units); their unit share increased from 26 percent to 58.1 percent of total e-cigarette sales, according to the CDC Foundation. France began the process of banning disposable vapes in December 2023. The National Assembly and Senate approved the ban in February 2024, and the European Commission approved it in September 2024.

    Additionally, the U.S. will probably see a decline in product variety because the FDA is unlikely to approve many devices. However, the industry should continue to thrive and expand globally, especially in the EU and the U.K. More importantly, innovation should continue to thrive outside the U.S. That could all change, however, as a new president takes office in January in the U.S.

    In September, Tony Abboud, executive director of the Vapor Technology Association (VTA) said he had the opportunity to meet with Trump, where Abboud had a wide-ranging conversation, including praising the then President for taking “two bold and decisive actions” in 2019: preventing a ban on flavored vapes for adults and protecting youth by raising the age to purchase nicotine products to 21.

    “Since then, youth vaping has dropped to an all-time low, and many adults have used flavored vaping to quit smoking. VTA’s meeting with President Trump represents a great day for small businesses across America who fear the Biden-Harris administration’s efforts to shut down small businesses and deprive adults who smoke of their flavored vaping products,” said Abboud. “We are pleased that [Trump] is continuing to fight for vapers.”

    Trump’s nomination of Kennedy to head the Department of Health and Human Services, which oversees the FDA, which regulates vaping, nicotine pouches, and all other nicotine and tobacco products through its Center for Tobacco Products, is also a wild card for the nicotine industry. Kennedy’s position on vaping, nicotine, and tobacco harm reduction remains unknown, making anything a possibility in 2025.

  • The Golden Age

    The Golden Age

    Killing THCa will end a renaissance of cannabis reform, access and business opportunity.

    By Rod Kight

    As I write this, I sit in the Charlotte airport awaiting a flight to Las Vegas, where I will speak at MJBizCon on a panel about rescheduling.

    As I prepare for the panel and think about the implications of rescheduling, it’s impossible to ignore a fundamental reality, namely that “cannabis” is already mostly descheduled. Cannabis and all its cannabinoids, including delta-9 THC in concentrations up to 0.3 percent by dry weight, were completely descheduled at the end of 2018, when the current Farm Bill was enacted.

    In other words, we simultaneously watch the Drug Enforcement Agency (DEA) rescheduling saga play out in the hope that marijuana and its cannabinoids will eventually be downgraded to schedule 3, while we live in a world where cannabis and all its cannabinoids were removed from the Controlled Substances Act (CSA) six years ago. Of course, I’m referring to hemp.

    We Are Living in a Cannabis ‘Golden Age’

    Amidst the high drama of the “cannabis civil war,” it is easy to overlook the fact that we are living in a cannabis “Golden Age”—a renaissance of cannabis reform, access and business opportunity. There’s never been a time in history when you could legally order cannabis flower to your front door (not to mention a host of other cannabis products, including THC beverages, gummies and vapes).

    It’s been almost 100 years since an individual or a small company could legally grow, manufacture and/or sell cannabis and cannabis products across state and international lines. Today, cannabis consumers have a wealth of product choices that are sold by a wide array of distribution outlets, from dispensaries to grocery stores and consumption lounges to e-commerce websites. At the same time, cannabis entrepreneurs have more options to enter the industry than ever before.

    Over the past six years, cannabis rapidly expanded across the country, resulting in normalization in ways most people did not anticipate. This trend continues to grow.

    Killing THCa Ends This Golden Era

    Killing THCa ends this Golden Era. As most people who read my blog know, “THCa flower” is just “cannabis flower” that complies with the Farm Bill’s current legal definition. It’s not new. It’s not synthetic. It’s the same thing we’ve been smoking for thousands of years, and, as I write this, it is still federally lawful.

    Despite all the amazing cannabis form factors to which we have access, flower remains “ground zero,” the mother of every cannabis product. For many, smoking or vaping cannabis flower is the go-to method of use. If we kill THCa, we effectively “reschedule” cannabis and eliminate billions of dollars of legal cannabis flower from the market.

    Closing this so-called “loophole” in the next Farm Bill ends an unprecedented era of massive cannabis reform, normalization, business growth and consumer choice. The idea of rescheduling cannabis that was legalized in 2018 should be sinful to anyone who truly believes in and cares about the plant. Regardless of Congressional intent, the 2018 Farm Bill is unambiguous. It offered an opportunity to the cannabis industry.

    Rather than working to undo this windfall based on presumptions about what Congress did or did not want, we should embrace and expand on it. This is particularly important as we watch the DEA drag its feet by simply moving marijuana to schedule 3, a move that is important but not nearly as powerful as saving THCa and preserving the definition of “hemp.” Even better, we should expand the definition of “hemp” as proposed in Rand Paul’s hemp bill, which increases the delta-9 THC limit to 1 percent without any reference to THCa.

    Let’s Regulate Hemp Properly

    I’ll close this article by stating the obvious—hemp needs to be regulated properly. This is not the article to discuss regulatory issues, but those who were involved in the early days of cannabis reform remember that it took time to get regulations worked out. (Most people would argue that California and many other states went overboard in their efforts, but that’s also better suited to another article.) The point is that the hemp industry is young, and regulating any new industry takes time.

    Importantly, though, the hemp industry is actively pushing to be better regulated. I contend we need a structure focused on the “Three Pillars”: age-gating, safe manufacturing and standardized labeling. To that end, the U.S. Hemp Authority expanded its certification program to include intoxicating hemp products, and other organizations, such as the American Healthy Alternatives Association, lobby for reasonable regulations. The National Cannabis Industry Association has made positive moves for hemp. It will take some time, but rather than throwing the baby out with the bathwater, we should focus on working out proper regulations.

    Conclusion

    Killing THCa will end the cannabis Golden Age, will set cannabis reform back in a way that may take decades to recover from, will push billions of dollars of cannabis back onto the black market and will restrict access to millions of people. Let’s not do that.

    Rod Kight is an international cannabis lawyer who represents businesses throughout the cannabis industry.

  • Don’t be Alarmed

    Don’t be Alarmed

    Media outlets often decry vaping while promoting other unhealthy activities.

    By George Gay

    The Guardian newspaper on Oct. 3 pressed ahead with its apparent campaign to undermine vaping whenever possible with a story headlined “Alarm at rise in vaping among nonsmokers.” This is the first paragraph from Health Editor Andrew Gregory:“One million people in England now vape despite never having been regular smokers, a sevenfold increase in just three years, according to research that has alarmed health experts.”

    The research was attributed to a Lancet study led by University College London (UCL) and published in The Lancet Public Health journal.

    The first point to make is a minor one but one that is worth mentioning because it crops up in a lot of news stories that would claim to be objective in reporting only the facts but in my view are not. Indeed, The Guardian is published under a banner stating that comment is free while facts are sacred—so what is the word “just” doing in that first paragraph? To my way of thinking, it introduces an opinion into the sentence; it says that the writer believes three years is a short period, but, just in case the reader has different ideas, this “just” is just to put the record straight.

    Another point to bear in mind is that we are not told in the story how a vaper is defined, though the study no doubt does give such a definition. In the story, the closest we come to a definition is where it is said that “most [my emphasis] of the people now using e-cigarettes who had never been regular smokers were vaping daily and over a sustained period.” So, insofar as the story is presented, it could be the case that almost half of the 1,006,000 who have taken up vaping after not having been regular smokers might vape once every two days, once every week, once every month ….

    More importantly, I read the article and was unable to detect a sense of alarm in what was said by the health experts quoted. Indeed, what is striking about the story is that all the health experts take the opportunity to mention the good that vaping has done in helping smokers quit their habit. One of those experts, Nick Hopkinson, a respiratory physician and chair of Action on Smoking and Health, was quoted as saying also that high levels of vaping among young people and the growing use of vaping among never-smokers was a “concern,” but concern doesn’t come close to alarm in my book. I would feel concern if I had invited four people over for dinner and found at the last minute that I might not have provided enough food for that number. I would feel alarm, however, if I realized that the food I had provided had been contaminated with an emetic, especially if there were only one bathroom in the house.

    Beyond that, eagled-eyed readers will have noticed that whereas Hopkinson talks of “never smokers,” the writer is concerned with people who have never been “regular smokers.” These categories are clearly not the same. Indeed, given what we are told about smoking, it is difficult to understand how there could exist smokers who do not indulge their habit regularly. We are told that smoking comprises an addiction so overwhelming that it is more compelling than taking heroin, so how could it be that people can smoke or not smoke as their fancy takes them?

    The next thing to note is that the writer is claiming that alarm is being raised over vaping, something that has not, as far as I am aware, killed anybody in England and raises only potential risks at this stage. In what seemed to me to be a fair and balanced statement, the study’s lead author, Sarah Jackson, of the UCL Institute of Epidemiology and Health Care, was quoted, in part, as saying that vaping regularly over a sustained period posed more risk than not vaping. Fair enough, but then crossing the road regularly over a sustained period poses more risk than not crossing the road, and regularly eating sticky buns over a sustained period poses more risk than not eating them, etc., etc.

    But let’s look at this another way. The Guardian, which claims to offer a high level of journalism and often does, has for a long time campaigned against vaping while promoting alcohol. Indeed, it has railed in tabloid-type pieces against the use of cartoons on vaping products as being a lure to those underage while on one occasion devoting three quarters of a page to the promotion of a wine that boasts a cartoon character on its label. And it has railed in badly presented stories against the uptake of vaping by the young but has promoted the launch of a wine especially aimed at the young. It promotes alcoholic drinks in its weekly food supplement and runs advertisements for alcoholic drinks.

    And while The Guardian raises alarm about people coming to vaping for the first time, it is not alarmed at people who don’t usually drink alcohol getting into it in a big way. On Oct. 16, it ran a story that, for all intents and purposes, was an advertisement for a supermarket wine. Hannah Crosbie wrote in part that the wine was so sweet that she thought it would appeal to people who didn’t particularly like wine. And this was not a story about “sensible drinking,” the usual cop-out used by people in favor of alcohol consumption but against tobacco or nicotine consumption. She promoted the idea of guzzling the wine without thinking about it too much, and later, she asked a question about whether the taste of the wine needed to offer complexity when it was £6.50 ($8.25) a bottle: “Ask me again after my fourth glass,” she signed off.

    So I suppose I shouldn’t be surprised that I cannot remember ever having seen in The Guardian a story about alarm being raised about the number of people in England who previously didn’t drink alcohol but now do. And yet, 40 percent of adults in England drink more than 14 units of alcohol a week when previously they drank no alcohol. That’s about 16 million people while the figures for those who drink at all are about 80 percent and 32 million.

    So, alarm is being raised over 1 million people who have taken to a habit that poses a potential risk whereas no alarm is being raised about 16 million people who have taken to drinking alcohol that poses risks known to be serious. According to the Alcohol Change U.K. website, alcohol is a causal factor in more than 60 medical conditions, including mouth, throat, stomach, liver and breast cancers, high blood pressure, cirrhosis of the liver and depression. Alcohol misuse is the biggest risk factor for death, ill-health and disability among 15-year-olds to 49-year-olds in the U.K.*

    And according to the Drink Aware website, in 2022, 16 percent of U.K.* adults (about 6.4 million), defined as those older than 16 years of age, reported binge drinking in the previous week while 19 percent (about 7.6 million) did not drink alcohol.

    One of those 6.4 million is likely to have been the U.K.’s secretary for health and social care, Wes Streeting, who, in 2023, told The Guardian during an interview: “If I’m going out, I’m a binge drinker—terrible messaging for the shadow health secretary [as he was at that time]!” This was typical of the jokey blokey way in which alcohol is portrayed generally in the U.K. But it is inconceivable that Streeting would have said, or The Guardian would have reported, that he binge smoked or binge vaped during a night out.

    But then binge smoking or binge vaping are of course impossible, and, anyway, smoking or vaping doesn’t lead to all those fun memories of alcohol-induced assaults, vomiting in the street, vehicle accidents, arrests, visits to the accident and emergency departments of under-pressure hospitals and the beating of partners and children on arriving home. Memories for those who still have recollections the following day and those who make it home, of course.

    Streeting is said to be keen on preventing ill-health as a way of reducing the burden on the U.K.’s National Health Service, though while he seems bent on targeting vaping, I have not seen any move on his part to reduce the level of alcohol consumption, which many people believe would be a good idea. According to Alcohol Change, from 2009 to 2019, the price of alcohol decreased by five percent relative to retail prices and became 13 percent more affordable than in 2008. Alcohol is 74 percent more affordable than it was in 1987.

    In relation to the prevention of ill-health, on Oct. 15, there was an excellent debate on the BBC’s Today news program in which two well-informed people who were clearly concerned with doing the right thing spoke about his suggestion that obese people should be given weight reduction injections to help them and help them back into the workforce.

    One of those debating this idea mentioned, almost in passing, that while such an idea had merit, it might raise ethical issues. Immediately, the presenter interrupted with a question about why it would raise such issues, which I found strange. You don’t have to be a philosopher—and I am not—to know that one of the basic principles of ethics is that you should treat other people as ends in themselves, not as a means to an end. Providing people who wish to lose weight for the good of their health with the means to do so safely is right and proper, but we surely cross an ethical line when we do so to make them into more productive work units. And a few seconds’ thought about what use weight-loss injections and other medical interventions might be put to, and possibly are being put to, in one of the world’s increasing number of authoritarian regimes is enough to set alarm bells ringing.

    And yet we in the U.K. long ago started to move in this direction, in line with neoliberal capitalist ideas. For instance, many years ago, people were redefined as human resources with little pushback. And one of the “problems” with smoking has often been defined as a problem with productivity loss, real or invented by the fevered imaginations of those who simply oppose smoking.

    But I digress. I wrote above that Jackson had delivered what I thought was a fair and balanced statement, and this is what else she was quoted as saying: “The public health impact of this substantial rise in vaping among people who have never regularly smoked will depend on what these people would otherwise be doing. It is likely that some would have smoked if vaping were not an available option. In this case, vaping is clearly less harmful.”

    And you can take this idea further. Might they, for instance, have taken to drink if not to vaping? Gregory says in his story that, according to the researchers, the “dramatic increase” has been largely driven by young adults, with one in seven 18-year-olds to 24-year-olds (14 percent) in England who had never regularly smoked now using e-cigarettes. It might be coincidental, but anecdotal data seems to indicate that young people are drinking less alcohol than previous generations of young people.

    If there is a correlation here, I think it is to be welcomed. In my opinion, the cause of ill-health prevention will be better served if younger generations take to vaping rather than drinking. The message I would take from all this is don’t panic, don’t be alarmed. Try to keep an open mind and seek out the facts.

    *I realize that using figures for England and the U.K. is not entirely satisfactory, but it proved impossible to obtain all the figures used only for England. I have mitigated against this problem by not directly comparing figures for England and the U.K. England accounts for about 85 percent of the U.K.’s adult population of about 40 million.

  • Routine Failure

    Routine Failure

    The US Supreme Court to decide if a failed routine drug test amounts to racketeering.

    By Timothy S. Donahue

    The U.S. Supreme Court has been busy this session. The court has heard several cases dealing with the nicotine and cannabis industries. Among them is the case of a truck driver who was fired from his job after a CBD wellness product marketed as THC-free caused him to fail a routine drug test. Douglas Horn sued the maker of the CBD product he took for chronic pain under a federal racketeering law for economic harm.

    A decision in the case, expected next year, could determine the ability of Americans to collect substantial damages under an anti-mob law if they lose their job after being injured by consumer products.

    The companies that manufacture the product argued to the justices that Horn’s injuries were personal rather than related to any harm to his business or property. Therefore, they contended that his case did not fall under the Racketeer Influenced and Corrupt Organizations Act (RICO). This federal law, originally enacted to combat organized crime, establishes the right for individuals who suffer injuries to their business or property due to racketeering activity to seek triple damages.

    A longtime trucker, Horn had an unblemished record over his decades of service. Like many truckers, Horn’s job required frequent drug testing to ensure compliance with federal regulations, particularly given the risks associated with operating heavy machinery on the nation’s highways. A single failed drug test could cost him his commercial driver’s license and, consequently, his livelihood.

    In 2020, Horn began experiencing chronic pain due to the physical demands of his job. After researching various treatments, he turned to CBD products for relief. CBD, or cannabidiol, is a nonpsychoactive compound derived from the cannabis plant and is widely marketed for its potential therapeutic benefits, such as pain relief and reduced anxiety. Significantly for Horn, the CBD products he chose were advertised as containing no THC—the compound in cannabis that is responsible for its intoxicating effects.

    Relying on these assurances, Horn began using CBD products regularly. While CBD is entirely legal, THC remains illegal in certain contexts. However, during a routine drug test, he tested positive for THC. Despite his protests that he had only used CBD products labeled as THC-free, Horn was promptly suspended and later terminated from his job. Unable to find another position due to the failed drug test, Horn faced financial ruin.

    Horn filed a lawsuit, claiming that the producers of Dixie X committed mail and wire fraud that resulted in harm to his “business or property.” A federal district court ruled against Horn, but the New York-based 2nd U.S. Circuit Court of Appeals allowed his suit to move forward. The company appealed to the Supreme Court a year ago, arguing in part that the RICO Act never contemplated “garden-variety products-liability” suits. The justices agreed to hear the case, recognizing its broader implications not only for the CBD industry but also for the interpretation of federal law and consumer protection standards.

    The CBD companies argued that they were operating within the bounds of federal law, particularly under the 2018 Farm Bill, which legalized hemp-derived CBD products with THC levels below 0.3 percent. They contended that any trace amounts of THC in their products were legal and that they had not intentionally deceived consumers. The companies also asserted that RICO was not the appropriate vehicle for this type of claim, arguing that it was intended to address criminal enterprises, not businesses engaged in legal commerce.

    However, Horn’s legal team countered that the companies’ actions constituted a pattern of fraudulent activity, directly causing harm to consumers like Horn. They argued that RICO could be applied in this case because the companies knowingly misled consumers about the contents of their products, thereby violating federal laws and causing tangible damages.

    Lisa Blatt, representing the manufacturers, stated during the hearing that Horn’s unwanted ingestion of THC constituted an injury to his body—essentially a “personal” injury—and not an injury to his “business or property.” She argued that Horn’s economic losses were the “damages he sustained” due to that injury.

    Easha Anand, representing Horn, argued that the lost employment is an injury to “business” that should bring the case within the wheelhouse of RICO. The lower court agreed with Horn, permitting his suit to proceed before the companies took the case to the Supreme Court. The American Association for Justice agreed with Anand and urged the Supreme Court to side with the trucker.

    Unlike its criminal counterpart, the companies contend that the civil RICO statute explicitly states that a plaintiff must be “injured in his business or property.” They argued that this wording indicates an intent to exclude the other primary type of injury recognized by the law —injury to the person—typically the basis for hiring “personal injury” lawyers.

    Horn’s premise—that civil RICO is available if the “personal” injury leads to “business or property” damages—would have sweeping implications, the companies argued, making RICO available to any tort plaintiff who can produce a receipt for lost wages or other economic loss. And the Clayton Act, a critical antitrust statute, Blatt told the justices, limits private suits to plaintiffs with injuries to “business or property,” for which the Supreme Court routinely has rejected personal injury claims. The same result, she argued, should apply here.

    For Horn, though, “injured” is the same thing as “harmed,” and the harm he suffered to his business (loss of employment) is a classic injury to business of the type that the civil RICO statute reaches. Anand also emphasized that in RICO, Congress made clear that the act “shall be liberally construed to effectuate its remedial purposes.” That rule of construction, she said, suggests that in the event of any doubt, the court should permit Horn’s suit to proceed.

    After more than an hour of argument, it appeared that the case could divide the court’s conservative justices, some of whom seemed sympathetic to Horn’s position and others wary of opening up the ability for people to seek significant awards for run-of-the-mill injury claims. During Anand’s presentation, Chief Justice John Roberts stated that the limitation on “business or property” is intended to be a significant constraint on the scope of RICO, which he views as central to the law’s purpose. He suggested that Anand’s position could undermine this important limitation.

    Justice Brett Kavanaugh was even more pointed, criticizing the idea that Horn could “get around that limitation … by characterizing the lost wages or medical expenses as separate injuries to your business or property.” And Horn’s position, Kavanaugh warned, would create “a dramatic, really radical shift in how tort suits are brought throughout the United States.”

    Justice Elena Kagan challenged Blatt’s reading of the text. Kagan pushed Blatt to assist her in figuring out “the most normal, natural reading” of the statutory language.

    “If you’re harmed when you lose a job, then you’ve been injured in your business, haven’t you?” Kagan asked the lawyer for the companies. The law, Kagan said, “just says if you’ve been injured by a RICO violation in your business, which includes your employment, then you’re entitled to threefold damages.”

    The Supreme Court’s decision in the Horn case could significantly impact both the trucking and cannabis industries. If the court rules in favor of Horn, it may lead to an increase in lawsuits against CBD companies, potentially changing the legal landscape for the industry, according to legal experts. Furthermore, such a ruling could prompt Congress to reconsider the 2018 Farm Bill and related legislation to establish clearer CBD product guidelines.

    If the court rules in favor of the CBD companies, it may enhance the current regulatory framework and limit the use of RICO in cases involving cannabis products that are legal under state law. This outcome could provide some reassurance to the cannabis industry, which has frequently encountered legal uncertainty due to the conflicting laws between federal and state regulations.

    The case not only affects the parties directly involved but could also establish a precedent for how courts manage disputes in industries where state and federal laws conflict. Additionally, it may shape how companies address advertising and product labeling in sectors with new and changing regulatory frameworks.

    Consumer protection advocates have also commented on the case, arguing that companies should be held accountable for their claims, particularly in industries where health and safety are at stake. They see the case as a critical test of whether existing laws are sufficient to protect consumers in the rapidly evolving cannabis market.

    The Horn case touches on fundamental issues of federalism, consumer protection and the intersection of law and commerce in a rapidly changing industry. For Horn, the case represents a fight for justice after a devastating blow to his career. For the CBD companies, it is a battle to protect their business practices and the legitimacy of an entire industry.

    Regardless of the outcome, the decision will likely have a lasting impact on the legal and regulatory landscape for CBD products, the trucking industry, and beyond. The Supreme Court’s ruling will not only decide the fate of one trucker but could also shape how emerging industries are regulated and held accountable under U.S. law.

  • Licensed to Sell

    Licensed to Sell

    The 2024 UKVIA forum focused on the UK’s proposed Tobacco and Vapes Bill.

    By George Gay

    As many people have noted, it seems odd that after decades of handwringing over the negative health consequences of tobacco smoking, the health community has been at best lukewarm and at worse fundamentally opposed to the introduction of new-generation nicotine products. After all, these products are significantly less risky than combustible cigarettes, and they have been more effective at helping smokers quit their habit than any of the products or strategies previously used. The health community seems to have been intent, and largely successful, on reviving the tobacco wars as the nicotine wars—this time, with it comprising the bad guys.

    The health community has obstructed the introduction of these new products, which it generally recognizes as being less risky than cigarettes, partly on the grounds that, since they are relatively new, it is not known what negative health effects they might cause in the future, after prolonged use. This, of course, is to misapply the precautionary principle given that the new products are being used to replace combustible cigarettes, which the health community likes to describe as comprising a consumer product that will kill you when used in the way it is designed to be used. Since humans are unable to predict the future with certainty, such an approach comprises an ideology that rules out change, including progress, of any kind.

    The health community has resisted the introduction of less risky products also on the grounds that they are used by those too young to buy them legally. Consumption by those underage is often described as comprising an epidemic, but this is hyperbole, often used, apparently unashamedly, by people who put themselves forward as scientists. It has also been used by U.K. politicians who, while saying that nobody wants children to come to harm, vote against providing meals to young people from financially impoverished families.

    It seems that many in the health community and many politicians prefer to stick their heads in the sand when it comes to the rising level of child poverty in the U.K. and prefer to remain in that rather uncomfortable—not to say undignified—position rather than admit that many underage vapers are the risk-takers who, if they had not been vaping, would have been smoking.

    Nevertheless, it cannot be denied that if some of those who are too young to buy vapes legally are vaping regularly, then somewhere along the line, the law has probably been broken, and this law-breaking should not be allowed to continue to happen with impunity. Indeed, this is something the U.K. Vaping Industry Association (UKVIA) has recognized for a long time. For years, it has called for the introduction of a retail licensing scheme that would allow sanctions to be imposed on retailers who sold vapes to the underaged and indulged in other illegal activities.

    And from this point of view, one provision of the U.K. government’s much-trailed Tobacco and Vapes Bill (T&V) 2024, which was published 10 days before the UKVIA held its annual forum in London on Nov. 15, drew a cautious welcome from participants. In part, the bill provides for the introduction of a licensing scheme* for the retail sale of vapes and nicotine products as well as tobacco products, herbal smoking products and, somewhat bizarrely, cigarette papers (but not cigarette lighters). The welcome was cautious because a few flies could drop into the ointment, one of which could be a lack of enforcement, a problem that was given a new-to-me angle during the forum.

    In the past, it has been said that government austerity measures had left Trading Standards (TS) with inadequate resources to fully carry out its responsibilities, which, among many others, include enforcing compliance with retail laws as they apply to tobacco and nicotine products. But a forum presentation by Kate Price, the lead officer for vaping at the Chartered Trading Standards Institute, seemed to cast doubt on whether this lack of TS funding was the most significant issue and, therefore, on whether an increase in funding would make a great deal of difference.

    The forum was told that TS teams worked for local authorities that also had seen their funding slashed, leaving them needing to control their budgets tightly. The implication seemed to be that these authorities, with responsibilities that include the protection of vulnerable children and older people, might not see retail offenses as a high priority for prosecution through the courts, which anyway were suffering from backlogs caused by their own funding issues.

    Neither, it seemed, would it make much difference if, as some have suggested, the revenue from licensing fees were to be ringfenced for use by TS because, presumably, this would do nothing to relieve the bottlenecks further down the line that lead to court appearances. One other provision in the T&V bill might be more positive in that, if enacted, it would give TS powers to issue on-the-spot fines, but the industry seems to believe, not without justification, that the level of fines being discussed would not present much of a deterrent given the profits that can be made by retailers who sell illicit products and/or licit and illicit products to those underage.

    I shouldn’t give the impression that Price is against further funding for TS; she isn’t. In fact, she made the point that it was difficult for TS to cover the 60,000 premises from which vapes are sold, and, because of this, she asked industry players to report whenever they came across rogue retailers. This was all well and good and in line with the industry’s desire to work closely with TS, but later in the forum, retail representatives seemed to suggest that many reports were made, but few seemed to be acted upon. It was said that there were few prosecutions, and those prosecutions attracted low penalties.

    It was said too that the system of enforcement needed to move from reactive to proactive, using, among other things, a system of regular test purchases, and I got the impression that there was a need for a complete rethink because the whole system of retail oversight and enforcement seemed far too cumbersome to produce timely prosecutions. The industry is aware that this is the most important issue that it needs to address because the retail sale of illicit products and the sale of all products to the underaged are two big sticks with which its opponents can keep beating it. On the positive side, the government says that it intends to strengthen enforcement activity to support the implementation of the measures outlined in the T&V, but, with government coffers hardly overflowing, the industry would be unwise to hold its breath on this one.

    Price’s presentation, informative and useful as it was, rather put me in mind of some of the wise words of the late JJ Cale on his Grasshopper album, where he laments that “Prop up the front, the back falls down.” In fact, come to think of it, those words might comprise a suitable theme for the 2025 UKVIA forum.

    This year’s forum, which was held under the theme “The Changing Vaping Environment— Succeeding in a New Policy Landscape,” comprised a packed program of practical presentations and panel discussions that, along with a modest exhibition space, embraced nicotine pouches as well as vapes.

    In opening remarks, forum participants were told that the vaping industry faced an unprecedented period of change but that it could succeed and even thrive in the new policy landscape. The industry, the government, regulators and the public health community could work together to ensure that vaping could achieve its full potential—a smoke-free U.K. and the health benefits that would flow from such an outcome.

    John Dunne, the director of the UKVIA, said, however, that the industry had to deal with the issue of youth uptake and, in this regard, he expressed delight that the government had reintroduced its T&V bill and added a provision to include a vaping licensing scheme. The industry supported evidence-based and well-balanced regulation aimed at addressing the issues of packaging, product design and flavor descriptions that young people might find overly appealing, he added. But he issued a word of warning in asking the government to oppose any measures that could equate vaping with smoking because far too many people still believed that vaping was as harmful or more harmful than smoking.

    I’m afraid this is a plea destined to fall on deaf ears. In fact, if the T&V bill goes through in anything close to its present form, which seems likely, I think the equating horse will have already bolted. You only have to look at the name of the bill to see that smoking and vaping are being lumped together, and many of the bill’s provisions, as they stand, give the idea that cigarettes and vapes need to be dealt with in lockstep. Unfortunately, smokers are likely to interpret this as meaning that there is no point in switching.

    The only way in which it would be possible to view this bill as having been put together by people who intended to engage the full potential of vaping to reduce the incidence of smoking would be to assume they were suffering from a nasty case of cognitive dissonance. I think the bill indicates that the U.K. is on the cusp of throwing away its previous positive approach to tobacco harm reduction.

    How else is it possible to explain how a country that has stated officially that vaping is 95 percent less risky than smoking and that has been operating a “swap (vapes for cigarettes) to stop” scheme is now proposing that the advertising and sponsorship of nicotine products be banned, putting them into the same basket as cigarettes? In a bill factsheet, the government states unequivocally that its intention is to equate nicotine products with tobacco products in this respect. “The bill will ban the advertising and sponsorship of all vapes and other nicotine products (such as nicotine pouches), mirroring impactful restrictions on tobacco [my emphasis],” it says. This seems to me to be the exact opposite of what is needed, which is the vigorous promotion of the advantages of smokers switching to vapes and other nicotine products.

    There is much more that is of concern too. “The bill also provides powers to make places vape-free and heated-tobacco-free, insofar as they are smoke-free places,” the factsheet states. “Vape usage is already prohibited in many places, and, as with smoke-free places, proposals for any restrictions will be subject to full public consultation.” Once again, the government is implying that there is no difference between smoking and vaping, without having rescinded its 95 percent less risky stance. This is cognitive dissonance on stilts.

    Although it is not necessarily relevant here, it is worthwhile examining the government’s thinking on tobacco smoke in outdoor settings. “Secondhand smoking poses a risk to your health even outdoors,” it states in the “Rationale for Intervention” section of its factsheet. “It is particularly dangerous for vulnerable people like children, pregnant women and those with preexisting but usually invisible health conditions such as asthma and heart disease.

    In some public settings, exposure can be high—if you can smell smoke, you are inhaling it.” Of course, it could have added: If you can smell e-cigarette vapor, you are inhaling it. And it could have further added for those who enjoy being frightfully continental and sitting at pavement cafes with diesel traffic chugging by that the opposite is not true, so you can inhale a busload of toxic fumes that your olfactory system has not warned you about. The truth is that you can get up and move away from tobacco smoke, which, like e-cigarette vapor, is also visible, but even if you detected it, you would have to move to the Outer Hebrides to get away from vehicle pollution. But then who is interested in the truth when half-truths and hypocrisy will win the argument?

    The bill will also provide ministers with powers to regulate the flavors, packaging and display of all vapes and other nicotine products, which, as Dunne indicated, are not issues that would necessarily concern the industry. But the sweeping powers are surely of concern, if for no other reason than that they leave the industry at the mercy of the whims of ministers, who come and go. This is a difficult position in which to leave an industry that runs on costly innovation and therefore needs stability.

    As was said often during the forum, the devil is in the detail, which is currently out for “consultation.” The trouble here is that there are consultations and consultations, and if the tobacco industry’s experience is anything to go by, this consultation will be between the government and those who support the government’s position or want its interventions to be more draconian than those proposed.

    This is not to suggest that the industry and its supporters should not interact with the consultation, especially if they are the sorts of people who find comfort in whistling Dixie. But my guess would be that many of the most popular flavors among adult consumers will be junked. And in further measures that will emphasize in the minds of consumers the idea that smoking and vaping are the same, packaging will be tightly regulated, possibly with the inclusion of unfounded health warnings, and vapes will be regulated out of sight in retail outlets.

    What is probably the standout provision of the T&V will make it an offense to sell tobacco products, herbal smoking products and cigarette papers—what has the government got against small pieces of paper?—to anyone born on or after Jan. 1, 2009. This provision seems to be supported by the vaping industry, but for the life of me, I cannot see why. In the unlikely event that this measure is made to work, and the industry sticks to its position that vapes should be used only by cigarette smokers to quit their habit, all the generational tobacco sales ban will do is ensure that the industry runs out of potential customers faster than it would do otherwise.

    In addition, you have to wonder whether the industry really believes that, having been successful with its generational tobacco sales ban, a future government won’t turn its sights on a generational nicotine ban. The signs are there for those who look, not the least of which is the fact that heat-not-burn products are to be included in the tobacco sales ban. The best way to encourage smokers to quit their habit is to offer them a range of alternative low-risk products, and heat-not-burn systems have proved that they should be part of the range. The government should take cognizance of the fact that while you can kick logic out the door, it will come back at you through the window.

    Surely, a better industry approach would be for it to oppose the generational tobacco sales ban on the grounds that, since so-called smoking-related diseases take decades to manifest themselves, such an ungainly policy will take far too long to show any significant effects. It could argue, rightly, that a much faster route to a healthier population is available and is one that will not involve the government in spending huge sums on enforcement, that will not require it possibly getting bogged down in issues of identity cards and that will not involve it getting into a fight with libertarians and others concerned with individual rights.

    All the government has to do is bring in an effective vaping product registration scheme, which anyway is one of the provisions of the T&V, stop equating vaping with smoking and start promoting the health benefits of smokers switching to vaping. What is a highly innovative industry will do the rest.

    Innovation was to the fore during the forum, and one session looked at “How vape technologies are evolving as we approach a post-disposables future and a new era of responsible vaping.” Although what was an interesting but shortened session ranged much wider than the title suggests, it is to be welcomed, I think, that the title, with its “new era of responsible vaping,” seemed to suggest that the industry has come to terms with the ban on disposables that will come into effect at the beginning of April next year. There are some fights worth engaging in, but they don’t include those that are difficult to win because they are ethically suspect at a time of environmental breakdown.

    Of course, some will say that the ban won’t work. The phrase “bans have never worked and never will work,” rang out often at the forum. But this simply isn’t true. There are a huge number of bans that work under any reasonable definition of the word “work” in this context, car speed limits comprising one. Only if you apply to the word “work” the unreasonable definition that brooks no or few contraventions can it be claimed that bans don’t work. This is not to say that all bans are a good idea, of course.

    In fact, there is widespread tacit approval of bans within the vaping industry, though these industry-friendly bans are supported because they operate under the cover of being positive developments, as well they might be, rather than negative ones. Look at the title of this session: “From licensing to product and regulatory compliance—killing the black market, not the consumers.”

    The licensing scheme referred to here will ban all those who cannot obtain a license for selling vapes while the regulatory compliance scheme will ban any product that doesn’t conform. And, of course, it goes without saying that the black market is banned. Those who don’t believe in bans should come out against the licensing proposal, they should come out against the regulatory compliance proposal, and, in fact, they should agitate to make everything legal. Such a position, if enacted, would at least save a fortune on enforcement.

    And such a position would save another fortune on lawyers. But for the time being, at least they are involved, as was made obvious by an informative presentation on“A case for vaping —What legal recourse does the industry have against misinformation, infringement, bad regulation and the illicit market?”This was an interesting presentation in line with the UKVIA forum’s emphasis on the practical, including as it did a look at patent infringements and anti-competitive practices, among other topics.

    Meanwhile, there were presentations on “Politics in the spotlight—Working with a new government and understanding the vaping products duty.” The latter presentation was interesting, not least because it highlighted a measure brought in by the new government that clearly is another way in which smokers might be persuaded that the consumption of vapes is as harmful as smoking. Looked at in a more positive light, however, Price mentioned in her piece that the application of duty would drag into the vapes enforcement arena bodies with more powers than TS has—HMRC (revenue and customs) and Border Force.

    It is worth mentioning that the duty issue comprised a positive example of the industry’s being able to use the consultation process. It wasn’t able to dissuade the government from applying a duty, but it was able to persuade it to bring in a flat rate rather than the tiered system that had been proposed. In fact, the forum was told that the Labour government had proved more approachable and receptive than the previous Conservative government had proved more approachable and receptive. The industry had been able to have a good level of engagement with the government, TS and HMRC.

    The forum included a couple of sessions focused on the truth, or lack of it, within the vaping sphere: “Closing the trust gap—How public education campaigns can be critical to correcting the vape narrative” and “Taste of truth—Understanding the key role of flavors in harm reduction.” One session looked at “The balancing act—What is the best route to further unlock vaping’s potential to improve harm reduction while also protecting young people?,” and the final session gave the floor to consumers by “Adding consumers to the conversation—A live focus group with the industry’s biggest stakeholders.”

    *Health issues are generally the responsibility of the U.K.’s devolved governments and administrations in Northern Ireland, Scotland and Wales, but, in this instance, the licensing scheme will apply in England, Wales and Northern Ireland while the bill will expand the scope of Scotland’s existing retail register to include herbal smoking products and nicotine products.

  • Gateway to THR

    Gateway to THR

    The Middle East Vape Show will hold their next event in Bahrain in January.

    By Norm Bour

    Over the past year, I’ve shared insights to the vape markets in Southeast Asia, including Indonesia, Vietnam, the Philippines, Thailand and Malaysia. Though some of them are separated by just a few feet, the differences between their vape markets—if they even exist—can be a numbing chasm of uncertainty.

    Though the vape market started in China, it took off more quickly in the West, and the U.S. and Europe jumped on trend with a vengeance. Asia took longer, limited by religion, government restrictions and customs as much as anything, and even though these countries are still muddled and unpredictable, the Middle Eastern market is also trying to compete with the Western world and has matured impressively over the last few years.

    In 2021, I was fortunate to be a speaker in Dubai at the World Vape Expo, and as the Covid pandemic was finally allowing the world to return to “normal,” the exhibitors and attendees seemed impressed at the Middle Eastern presence.

    Now, three years later, the region’s vape market is slowly transitioning from a sinful (and unlawful) replacement to tobacco, to a viable (and profitable) alternative to cigarettes, and the Middle East Vape Show, MEVS 360, will demonstrate that at its Jan. 15–17, 2025, event in Bahrain. Last year, post-Covid, the organizers restarted their event in Cairo. The event will alternate between several locations, including Kuwait and Jordan.

    But, as this article was being written, there are even more changes in the works.

    This event, launched in 2019, has been recently purchased by Dallah Promotions, one of the biggest event management companies in Bahrain and Saudi Arabia. Dallah promotes everything from Comic Con to Ferrari Night, so it must see potential in the vape market, and since they specifically focus on B2C, that would be an enhancement to the show. With this new ownership, the old name, MEVS 360, will be replaced with International Vape Con (IVC) at the Bahrain show, which will be held at the beautiful Exhibition World Bahrain venue.

    The new owners recognize the growth trend of vaping throughout the Middle East, and their biggest targets are Saudi Arabia and Kuwait. As a member of the Gulf Cooperation Council (GCC), Bahrain charges a 100 percent tax on tobacco, vape products and energy drinks. Bahrain’s excise tax law was ratified in 2017 and is intended to equalize tobacco taxes and reduce the affordability of tobacco and improve public health. Even with the high tax rates (paid upon import), finding exhibitors for the MEVS 360 show has not been a problem, though the numbers are down from prior years.

    Arya Hakim, senior media and production manager with the organization, said it clearly: “The mostly Middle Eastern buyers want quality and are willing to pay for it. They like the disposables, won’t buy ‘junk,’ and they want innovation. This puts pressure to the Chinese exhibitors to bring their ‘best game’ and leave their knockoffs at home.”

    Due to restrictions, the IVC will showcase only vape-related products and e-liquids but no tobacco, hookah, shisha, etc. The relatively small show brings in fewer than 100 exhibitors. Its main problem is that the Middle East is still viewed as a small market. The competing World Vape Show in Dubai is the exhibition’s biggest competition in the region.

    Smoking is still a big business in the Middle East. Vapers account for almost 20 percent of Egypt’s 112 million population. Home to just 1.5 million people, Bahrain reported a share of about 15 percent in in 2020. In between is the affluent Saudia Arabian market of 37 million people, of which 10 percent are smokers.

    “Arabs love to smoke!” joked Hakim.

    But Bahrain does have a unique competitive edge in the Middle East. It is one of several countries that have a Free Trade Agreement with the U.S., primarily driven by the mutually beneficial military and naval presence there. Hardware is duty-free for Americans, but tobacco and vape liquids are not.

    Another positive change in the show is the partnership with Ecigclick, an independent testing organization that offers advice on the best vape products to buy, along with industry news. Since 2010, the organization has been a leader in the vape space and annually hosts its Ecigclick Vape Awards, which is judged by public vote. Also part of this new collaboration will be 2FIRSTS, a China-based vaping industry media outlet and consultancy, and Rifbar, a newer disposable supplier that has been very hot.

    No question, over the years, new collaborations, buyouts and mergers have fueled the growth of the vape industry, creating larger and larger entities, controlled by fewer players. This was predicted a decade ago, and that trend should continue going forward.

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

  • Thoughtful Progress

    Thoughtful Progress

    GTNF 2024
    Credit: TS Donahue

    At the recent GTNF in Athens, stakeholders debated how to responsibly advance innovation.

    By Taco Tuinstra

    For a decade and a half now, the Global Tobacco and Nicotine Forum (GTNF) has nurtured engagement worldwide, fostering lively and constructive discussions among its participants. The GTNF’s most recent gathering, Sept. 24–26 in Athens, was no exception. For three days, the Divani Apollon Hotel served as a modern-day Greek agora, the ancient public space where people exchanged ideas and engaged in philosophical discussions with both friends and adversaries. Paying tribute to the host nation’s famous philosophers, the GTNF delegates asked probing questions, contemplated opposing viewpoints and displayed the courage to doubt themselves.

    But even as Athens upheld the tradition of spirited discourse, one of the conference’s most powerful moments was strikingly quiet. On day three of the forum, Carolyn Beaumont, a general practitioner and tobacco harm reduction educator from Australia, concluded her presentation with silence. She then chimed a bell every time a person would have succumbed to tobacco-related disease during that time span. Mindful of the conference’s full agenda, Beaumont played the recording for only a brief period. Had she let it run for the duration of the one-hour panel discussion she took part in, the bell would have tolled 900 times. That’s the equivalent of one death every four seconds, or 8 million deaths—nearly the population of Switzerland—every year.

    The staggering numbers underlined the urgency for the industry to help reduce the harm inflicted by smoking, and how to best achieve that goal was a major focus of this year’s GTNF. The task, of course, is formidable. Smoking is a notoriously difficult habit to kick, witness the fact that 60 years after the U.S. Surgeon General’s landmark report on smoking and health, and following decades of anti-smoking campaigns around the globe, more than 1 billion people continue to light up.

    Credit: TS Donahue

    Much of that is due to the properties of nicotine. The chemical’s uncanny ability to simultaneously stimulate and relax keeps many users coming back despite the widely known health risks of smoking. Illustrating the tenacity of nicotine addiction, another GTNF speaker, the cardio-endocrine physician Rohan Savio Sequeira, shared an anecdote of a patient who woke up from bypass surgery and immediately asked for a cigarette. “That’s the challenge we’re up against,” Sequeira said.

    But while addictive, nicotine is not the compound that causes the most serious smoking-related diseases. Nicotine may elevate blood pressure and heart rate, but the more significant risks presented by cigarettes, including cancer and chronic obstructive pulmonary disease, stem from combustion. Several GTNF speakers compared the rewards and risks presented by nicotine to those of caffeine. But unlike the most popular method for taking caffeine—drinking coffee—the most common nicotine consumption method—setting fire to dried tobacco leaves and inhaling the smoke—exposes its user to thousands of harmful chemicals.

    While the obvious solution would seem to be for smokers to consume only the nicotine, through patches, for example, the low success rate of nicotine-replacement therapies in cessation suggests there are additional factors that keep people reaching for cigarettes. As multiple speakers pointed out during the GTNF, smoking is about more than self-administering nicotine. Many aspects of the ritual are difficult to replicate. “Pouch and blow me a smoke ring,” Rae Maile, managing director of research at the U.K. investment bank Panmure Liberum, challenged his intellectual sparring partner, Erik Bloomquist, during a GTNF “fireside chat” about the financial side of the nicotine business.

    Brian King (Credit: TS Donahue)

    But innovation is changing the equation. Over the past decade or so, breakthroughs in battery and atomization technologies have allowed manufacturers to construct devices that not only deliver nicotine without the harmful products of combustion but also closely mimic aspects of smoking that many consumers find so appealing—the “throat hit,” the hand-to-mouth motion and, yes, even the ability to blow rings. BAT Group Head of Global Policy Flora Okereke likened the nicotine business’ rapid technological leap to the progress that had played out over a much longer timespan in the automobile business: from Ford’s Model-T to today’s self-driving cars. While not risk-free, these tools, which include e-cigarettes and devices that heat rather than burn tobacco, offer an opportunity to satisfy people’s cravings at a fraction of the risk presented by traditional cigarettes. In 2015, Public Health England memorably announced that vaping was 95 percent less risky than smoking.

    Yet despite their considerable potential, such next-generation nicotine products have not been universally welcomed, with many regulators and health groups, including the influential World Health Organization, more attuned to the risk of attracting new nicotine users than the promise of transitioning adult smokers from deadly cigarettes to less risky consumption tools. Electronic nicotine-delivery systems have also come under fire for generating e-waste and creating fire hazards.

    Much of the Athens GTNF revolved around this conundrum: How can society reap the benefits of cigarette alternatives without attracting consumers who shouldn’t be using those products and without creating other unintended side effects, such as environmental pollution? As suggested by the 2024 conference theme, at least part of the answer lies in “Advancing Responsible Innovation.”

    Elaine Round (Credit: TS Donahue)

    Acknowledging the fact that tackling the challenges will require the involvement of stakeholders from all parts of society, the conference hosted a whopping 79 speakers, including 30 women, from various professional walks of life. In addition to industry officials, regulators and analysts, the lineup featured health activists, politicians and consumer advocates. There were returning headliners such as the director of the U.S. Food and Drug Administration’s Center for Tobacco Products, Brian King, and numerous first-time contributors, such as Greek Health Minister Adonis Georgiadis, who in a video message encouraged delegates to educate governments so that they could provide their citizens with accurate information about the relative risks of nicotine products.

    Other participating politicians included Morgana Daniele, a member of Lithuania’s Parliament and chair of that nation’s Commission for Addiction Prevention, and Pietro Fiocchi, a member of the European Parliament and vice-chair of the Committee on the Environment, Public Health and Food Safety. The retail sector was represented by Henry Armour, president and CEO of NACS in the U.S., and Panos Panayiotopoulos, general manager and director of the Greek retail association, among other speakers.

    Perhaps the GTNF’s biggest “coup” this year was the participation of Kathy Crosby, president and CEO of The Truth Initiative, a U.S. anti-tobacco group established after the 1998 landmark Master Settlement Agreement between leading tobacco companies and American states seeking to recover the cost of treating sick smokers. The Truth Initiative has been highly skeptical of e-cigarettes, especially because of their uptake by underage consumers. But Crosby courageously elected to engage rather than demonize the industry—a decision that will surely have raised eyebrows among the more uncompromising members of the public health establishment.

    Yet Crosby did not dilute her message. Even as she acknowledged the need for less harmful solutions for smokers who are not ready to leave nicotine behind, she was adamant such products should leave behind their youth appeal. With unauthorized sales accounting for the overwhelming majority of U.S. e-cigarette sales, she urged retailers to remove illegal products from their store shelves immediately. Doing so, she said, would create goodwill and pave the way for constructive dialogue with the public health community. Industry representatives at the GTNF eagerly accepted the olive branch. “The ball is now in our court,” said Jose Luis Murillo, chief regulatory advisor to Juul Labs’ CEO.

    Joe Murrilo (Credit: TS Donahue)

    Encouragingly, each link of the supply chain represented at GTNF appeared eager to address underage access. While preventing sales to minors is a legal requirement in many markets, NACS’ chief, Armour, stressed that his organization’s members are motivated not by fear of penalties but because they feel a responsibility toward the communities they serve.

    Of course, that doesn’t mean it’s easy. Sketching the size of challenge, Armour noted that half of the U.S. population—some 165 people—comes to a convenience store every day, with 40 percent of their inventory comprising age-restricted products such as tobacco, alcohol and lottery tickets. Fortunately, technology, such as digital age verification platforms, are increasingly alleviating the burden.

    While the desire to prevent youth access is widely shared among stakeholders, opinions differ on the best way to achieve that objective. Around the world, lawmakers are increasingly resorting to prohibition, banning vape flavors or single-use products, for example—or outlawing new nicotine products altogether.

    That is not the approach favored by most GTNF speakers. Counterfactual Director Clive Bates reminded his audience that people have been using nicotine for at least 12,000 years. “Demand will persist because nicotine provides psychoactive rewards,” he predicted. Banning it, Bates noted, will simply shift demand from legitimate suppliers to law-evading ones, as happened in the U.S., where an onerous product authorization system combined with halfhearted enforcement has handed nearly the entire vaping business to the black market. Dave Dobbins, former chief operating officer of the American Legacy Foundation and now a consultant to Altria Group, cited the example of Bhutan, which in 2004 declared a nationwide ban on sales of tobacco products but was later forced to abandon its experiment under pressure from the illicit market (see “Bhutan’s Tryst with Health Imperialism,” Tobacco Reporter, June 2024).

    Instead of betting on unworkable bans, many GTNF attendees were hopeful that the same innovation that had brought the world less harmful nicotine products would help tackle challenges such as underage consumption. Elaine Round, group head of life sciences at BAT, took the opportunity introduce the GTNF audience to her company’s recently launched Omni platform, an evidence-based, accessible and dynamic resource that shows how science and innovation can combine to achieve a smokeless world. The potential of such innovations was clearly demonstrated in three “big pitch” presentations, a new GTNF event during which companies outlined their solutions to some of the business’ most vexing problems, and answered questions from an expert panel.

    Rhodri James, chief sales officer at Yoti, a digital identity company, described a technology that verifies buyers’ ages by scanning customers’ faces and measuring their skin tone. As people age, James explained, the pigment of their skin changes. Wrinkles, for example, have a different tone than smoother parts of the skin. By determining the differences, Yoti’s technology is able to determine a potential buyer’s age with an almost uncanny accuracy. In tests, the platform performed much better than human store clerks. In addition to speeding up checkouts—and thus reducing “friction” in store transactions—the platform helps defuse what James described as “challenges to the challenge.” Confronted with a customer incensed about being denied a sale, the salesclerk can simply blame the computer. Asked about privacy, James noted that facial age estimation is not facial recognition. The platform, he said, cannot tell who you are—only how old you are.

    Greenbutts presented a filter that it claims is biodegradable without compromising performance and taste (see “A Future Without Plastics,” Tobacco Reporter, March 2023). The product addresses a colossal challenge indeed. With 11 billion cigarettes discarded daily, filters are the single most littered item on the planet. As indoor smoking bans have forced consumers outdoors, the problem has only become worse; butts that were previously deposited in ashtrays are now ending up in the environment. Made with cellulose acetate, current filters degrade into nanoplastics, which not only pollute but also end up in the food chain.

    Founded in 2010, Greenbutts has developed a plastic-free, plant based product that is 100 percent dissolvable in water. Importantly, the filter delivers the same sensorial experience as cellulose acetate products at a comparable cost, according to the company. In blind tests performed at trade exhibitions, many smokers chose Greenbutt’s filter, said Chief Strategy Officer Luis Sanches, who added that production could be scaled up easily.

    Greentank shared a solution that offers vapers a more consistent user experience while lowering the risk of creating undesirable compounds during the heating process. In many currently available vapes, the flavor tends to wane as the pod empties. In tests, the Quantum Vape technology delivered 1,000 puffs with virtually unchanged flavor intensity. According to President and Chief Operating Officer Corey Koffler, Greentank was able to achieve this through “cleanroom chip manufacturing technology combined with physics at nanoscale.” Instead of relying on wicks and coils or ceramics, Quantum Vape comprises thousands of microscopic heating tubes on a chip. The system allows Greentank to precisely control both the location and the duration of the heating, thus eliminating hot spots and avoiding the risk of negative chemical reactions.

    The 2024 GTNF highlighted many more examples of such remarkable innovations, which perhaps isn’t surprising considering the amount of money invested. In a discussion among prominent suppliers of vaping hardware, e-liquids and nicotine pouches, company representatives revealed how much their employers spend on research and development. For example, Smoore International Holdings, a leading e-cigarette manufacturer headquartered in China, directs a whopping 10 percent of its revenue to R&D, according to Executive Director Eve Wang.

    While celebrating innovation, GTNF speakers lamented the hurdles preventing society from reaping the full benefits of new technologies. Misguided regulation featured prominently among the delegates’ gripes. According to Health Diplomats President Delon Human, 34 countries ban tobacco harm reduction products outright, leaving the market to combustible cigarettes. In the rest of the world, manufacturers must contend with everything from no regulations to very strict frameworks. Many words were devoted to the burdensome product authorization process in the U.S., which has left law-abiding American consumers with only a handful of outdated products and a thriving black market. The European Union’s continuing ban of snus, too, elicited repeated groans, as did the rapid spread of bans on nicotine pouches.

    Speakers also despaired at increasing restrictions on vape flavors. Konstantinos Farsalinos, senior  researcher at the School of Public Health at the Universities of Patras and West Attica, said that in the name of protecting youth, regulators aimed to make tobacco harm reduction products unpleasant and difficult to access. “But harm reduction will not work if you substitute cigarettes with a product that the smoker does not enjoy,” he warned.

    Misinformation was also mentioned as a challenge by many GTNF delegates. The World Economic Forum lists it as the biggest threat to humanity after climate change, noted Tikki Pang, former director of research policy and cooperation at the WHO. In the nicotine business, misinformation is widespread not only among consumers, many of whom now mistakenly believe that vapes are more harmful than cigarettes, but also among people who should know better: doctors. What medical schools teach their students about nicotine is abysmal, noted Jasjit Ahluwalia, a professor of behavioral and social sciences and professor of medicine at the Brown University School of Public Health and Alpert School of Medicine. In a recent survey, 80 percent of U.S. physicians erroneously indicated that nicotine causes cancer. Speakers agreed that education would be key to help correct misperceptions, although they acknowledged that any such effort by nicotine-related companies would likely backfire due to the industry’s enduring reputational challenge.

    The Athens GTNF also devoted much attention to a key but often overlooked stakeholder in the debate: the consumer. Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates, emphasized the need to humanize the consumers, who she said are too often treated as mere data points. “We are more than statistics,” said Loucas, after sharing her personal story of transitioning away from smoking with the help of e-cigarettes.

    Acknowledging the people that make up the market, tobacco companies appear to be increasingly receptive to that message, as became clear during a keynote by Imperial Brands’ Paola Pocci, whose very title—chief consumer officer—underscores the central role of nicotine users in the manufacturers’ operations. While consumers are similar in their desire for better health, Imperial Brands’ research also revealed that one size does not fit all; they need a variety of product categories to choose from, depending on local regulations and personal preferences, which may vary even depending on the time of day.

    To facilitate the transition to lower-risk products, devices must also be easy to use. As multiple panelists observed, innovation is useless if consumers don’t want the product. Bells and whistles that excite product designers also complicate operations, which in turn could deter users. The success of disposables is a case in point. Single-use vapes have become popular largely due to their ease of use; there are no buttons to push, batteries to charge or apps to pair. All the user has to do is puff—just like with a conventional cigarette.

    Despite the tremendous technological developments of recent years, GTNF panelists agreed that much work remains. Because no player has yet managed to develop a perfect cigarette substitute, the industry must continue to listen to consumers and address their pain points, said Pocci. The fact that cigarettes are still the most popular nicotine product suggests that the industry has not done enough to reduce the harms of smoking, echoed Marina Murphy, senior director of scientific affairs at the Haypp Group—although she also noted that it had done much better than the pharmaceutical sector, which failed to appreciate that people smoke not only to satisfy their nicotine cravings but also for the sensory aspects.

    Even as regulatory frameworks tighten and misinformation persists, the 2024 GTNF once again underlined the industry’s strong commitment to tobacco harm reduction and continued innovation. While the combination of regulatory and societal challenges will keep nicotine companies on their toes, it will also ensure another trove of compelling discussion topics when the GTNF reconvenes at a yet-to-be-announced location in 2025.

  • Cognitive Dissonance

    Cognitive Dissonance

    Credit: Good Ideas

    Regulators often run a campaign of hypocrisy when confronting vaping.

    By George Gay

    “However, it is vital that we do not sit and wait for this data [on the long-term health impacts of using nicotine-containing products] and action is taken now to prevent any potential harms caused by vapes.”

    “However, it is crucial that any proposed regulations [on vaping] are based on robust evidence, ensuring they are effective as possible, and implemented without delay.”

    You could be forgiven for assuming that these two quotes have been taken from statements by people or organizations on different sides of the vaping debate because, on the one hand, it is said to be “vital” that action must predate the collection of data while, on the other hand, it is said to be “crucial” that the collection of data must predate action. But you would be wrong.

    The first is from the final paragraph of the Executive Summary of the August-published report from the British Medical Association (BMA: the trade union and professional body for doctors and medical students in the U.K.) titled Taking Your Breath Away: Why We Need Stronger Regulation of Vapes. The second is taken from the final paragraph of the full report.

    Would I be rude in suggesting that the BMA authors might be suffering from cognitive dissonance and that they should try healing themselves before handing out advice willy-nilly? After all, the authors, if not doctors themselves, are representatives of the U.K.’s doctors, people whose opinions those of us of the outer dark tend to accept without question in respect of matters of health.

    And this level of trust, I think, is perfectly reasonable when it comes to face-to-face consultations involving doctors and individual patients. But once doctors become involved in wider concerns, I think it is necessary to take a more jaundiced view of what they have to say.

    Once doctors stop seeing people as individuals and view them only as groups marking points on a graph, they lose that which makes them special, as when they pay more attention to your “body mass index” than to your body. At a populations level, their pronouncements are little more than opinions based not on their medical knowledge but, as in the case of the rest of us, largely on ideologies and prejudices. They become part of the “tyranny of experts.”

    In other words, it is important to keep in mind that once doctors step outside the surgery, they can be just as irrational as you or me—or you at least; let’s keep me out of this. Indeed, some time ago, I was at an event where, at the end of the evening, a person who I knew to be a senior medical doctor was doing the rounds, pouring any remaining wine from the bottles on the tables into his glass and drinking it. The event had attracted a wide range of people, from those in their early 20s to those in their 80s, and even a few teenagers.

    Sitting at a table watching this person, I started to wonder about him. Was he, for instance, an alcoholic or somebody who usually drank in moderation but was on this occasion letting his hair down? Did he understand, care, or was he too far gone to think about the example he was setting to the younger people present?

    Surely, I thought, he must be aware that any level of alcohol consumption creates health risks. Was he a hypocrite who would have been offended if I had smoked or vaped in front of the young people; was he dimmer than his qualifications would have me believe; or was he as heavily into cognitive dissonance as he seemed to be into drinking?

    I often think of this occasion when I read of medical professionals making pronouncements on smoking and vaping (but rarely on drinking). And I thought of it again when I read the BMA report, which should have been called the “however” report. You might have noticed that the two report quotes with which I started this piece both opened with the word “however.”

    Basically, the report could be summed up as one that reluctantly admits the important role that vapes can play in helping smokers quit their habit but then de facto goes on to say, “however,” we don’t like these products and therefore we are calling for them to be debased by regulation to the point where they will not appeal to anybody and smokers will return to smoking. After all, you know where you are with smoking because people have been doing it for a long time.

    The word “however” appears 16 times in the BMA report, whose text takes up only 12 pages. How many times have we seen doctors and researchers put their names to such “however” reports? Reports that purportedly aim at striking a balance between the need to keep vapes appealing enough to smokers so that they are encouraged to give up smoking while not appealing to young people but that, “however,” always come down in support of protecting from themselves a few misbehaving students from well-off families at the expense of trying to help financially impoverished smokers?

    Reports that complain about how smoking is the major cause of premature death worldwide but wind up unable to support the use of the one product that has come along that could make a real dent in the toll caused by smoking because the authors are ideologically opposed to people enjoying using nicotine.

    The authors of such reports like to sex them up by talking of an “epidemic” of vaping that is in part harming “children.” You can imagine them wringing their hands in anguish at what is happening to these middle-class, mischievous students while ignoring the fact that hundreds of thousands of children from financially impoverished families live in poverty, meaning they are undernourished, with all the negative impacts on their life chances that that entails.

    On Dec. 22, just three days before the major feast of Christmas, The Guardian newspaper led with a story titled “Revealed: huge rise in hospital admissions with malnutrition” while on page six it ran with “‘Heartbreaking’: Teachers tell of children with bowed legs and no winter coat.” The latter story, by Jessica Murray, quoted a headteacher as saying some children at her school had bowed legs because they were so deficient in vitamins.

    “We’ve had children so malnourished they’ve had heart murmurs,” the headteacher said. “It’s heartbreaking. It’s not how it should be. It’s the worst I’ve ever seen it. We’ve got two-year-olds coming in and trying to eat sand because they’re so hungry.”

    As the lead story pointed out, such deficiencies can interfere with brain and bone development and cause health problems in later life. But, despite this, there has been little follow-up of these issues since then, with space being given over rather to numerous negative stories about vaping. 

    The BMA reports on health problems visited on children by vaping but set against the damage caused by malnutrition (or any number of other causes, such as ketamine addiction), these problems are minuscule. “The NHS revealed that in 2023, 50 children were admitted to hospital with vaping-related disorders,” the report states “The U.K. has a population of more than 12 million children defined as those 0 years old to 17 years old, so 50 represents 0.0004 percent].

    “This is up from just 11 children three years previously, demonstrating the significant growth in prevalence of vaping in this age group. Vaping-related disorders can range from lung damage to worsening asthma symptoms, which include wheezing, coughing and chest tightness.”

    These numbers are tiny, and, in any case, I wonder if even they can be put down to vaping in the way that malnutrition can be put down to vitamin deficiencies. After all, we are not told how many of the children said to be suffering from the effects of vaping live in our highly polluted cities and/or in the many houses afflicted with damp and mold that are inhabited by impoverished families, but perhaps the doctors assumed that vaping children would live in comfortable houses in leafy suburbs.

    In any case, I don’t wish to sound cynical, but aren’t children suffering from asthma rather asking for trouble if they vape? After all, children who are intolerant or allergic to certain foods are taught to avoid them. We don’t seek to regulate such foods so they become unpalatable to children and adults alike.

    Why is there so much emphasis on children vaping but so little on their going hungry? There are a number of reasons, but, in my opinion, the main one has to do with the fact that coming down on vapers and smokers allows those involved to do some virtue signaling at little or no cost whereas making sure that children are properly fed needs an effort by those responsible that comes with a price tag that most are not willing to pay.

    In fact, the BMA’s report came out at a rather bad time in respect of its attitude to at least some children. The day after publication, The Guardian newspaper ran a story under the heading “BMA accused of witch hunt after transgender care leak.”

    The piece, by health policy editor Denis Campbell, described how the BMA had been heavily criticized by key medical figures since it voted on July 17 for, in effect, rejecting a report by Hilary Cass on transgender care, which put it in the position of being the only medical organization in the U.K. not to accept, and to find fault with, her findings, findings that were accepted by the previous right-of-center government and its left-of-center successor.

    Campbell wrote that the Academy of Medical Royal Colleges, which represents all U.K. doctors professionally, had criticized the BMA’s refusal to accept “the validity of the evidence and consequently the findings of the independent Cass review of gender identity services for children and young people.”

    And ignoring the rule that when in a hole, the best idea is to stop digging, the BMA allegedly undertook a “witch hunt” to try to identify which senior figure leaked that it was set to oppose the Cass review. According to Campbell, critics described the BMA’s action in this regard as “disgraceful” and “Orwellian.”

    None of this will make the slightest difference, of course. Nor will the fact that, in my opinion, the BMA report is largely a rehash of stuff that has gone before many times over because the likelihood is that the government, like the general media, will merely read and relay the recommendations, not the thinking or lack of thinking behind them. They will probably not notice that though the report’s 99 references suggest a scientific accountability, in places it reads more like an essay in that it throws out unreferenced and vague statements such as “there are concerns that,” “there is no doubt,” “many health organizations” and “can also influence belief.”

    Some of what is said seems not to be supported by evidence and amounts to little more than urban myths while some is based on the lazy idea that what happens in the future will be the same as or similar to what happened in the past unless an intervention is made.

    And how does the BMA come up with a sentence such as this: “Novel products such as nicotine pouches are a growing class of noncombustible nicotine product that pose similar public health risks as [those posed by] vapes yet are not sufficiently regulated.” One would have hoped that doctors or their representatives would have figured out that the risks must be different. One activity involves inhalation while the other does not.

    The BMA report, like many such reports in the past, comes with a helping of emotional blackmail. The word “children” is used 55 times, and the phrase “young people” is used 23 times, but while these are not used as synonyms (on 16 occasions on which each of these terms are used, they are used in combination as “children and young people”), we are not told what the difference is between them, so we can assume only that “young people” refers to those people who are 18 years of age or older but who are not middle-aged or old. The word “youth” is used 15 times and the word “adolescent” four times.

    We are also treated to “people under 18” (the usual definition of a child in the U.K., though the National Health Service sometimes refers to children as those under 16), “children 11–17,” “young fashionable models” and even the impersonal “younger market.”

    And what of the “growing epidemic” mentioned in the first sentence of the Executive Summary? Well, this is what is said in the rest of the first paragraph: “Vape use by adults has risen significantly over recent years, but more worryingly, by children and young people. 7.6 percent of 11[-year-olds to] 17-year-olds are now vaping, either regularly or occasionally, compared to 1.3 percent in 2014.”

    I’m reluctant to go to bat against the BMA on the question of an “epidemic,” but what the hey? If the “epidemic” is supposed to refer to children as well as to adults (it’s unclear), under 8 percent seems a little short of a “widespread” outbreak, which is how my dictionary in part defines an epidemic. And this is especially so when you start to pull apart that 7.6 percent figure, which is from Action on Smoking and Health (ASH).

    It is made up of 4.6 percent of “regular” vapers, who, inexplicably, in my view,* are defined as those vaping more than once a week, and 3.1 percent of occasional vapers, defined as those who vape “less than once a week,” which means, I assume, they could vape only once a month, once a year or once a millennium. (*Imagine the reaction of your doctor when, on asking you whether you had regular bowel movements, you said, “Oh yes, more than once a week!”) 

    The truth of the matter is that, as part of this “epidemic,” “ever vaping” (a category it is safe to assume includes even those children who once looked sideways at a vape) fell between 2023 and 2024 in respect of all age groups examined. Of course, this is true only if the figures are correct. I guess the ASH figures are based on “self-reporting,” and it often puzzles me how those collecting data will accept the word of people, some of whom are breaking rules.

    The report seems to me to be poorly written. Take this sentence from the Executive Summary: “The availability of disposable vapes is clearly linked to the sharp rise in child use.” It seems that the BMA is mixing up cause and effect. According to it, the rise in the use of disposable vapes by children has caused the availability of disposable vapes. Well, not caused, because it clearly cannot state that, so it uses the word “linked,” which it hopes will do the same job as “cause” in the minds of the readers. Like I can say my bed is linked to my sleeping, and my knife and fork are linked to my eating.

    This linking business seems to be linked to an ASH graph that appears under the title “Rapid rise in youth vaping 2021–2023 associated with [not linked to, but associated with] growth in use of disposables.” But the graph seems to show nothing of the sort. Rather, as a subheading indicates, it graphs the “Proportion of vapers of all ages who mainly use disposable vapes, by age.” And the BMA does not mention that between 2023 and 2024, the proportion of 11-year-old to 17-year-old vapers who mainly used disposable vapes fell from 69 percent to 54 percent.

    This might come as a surprise, but I am on the same page as the BMA when it comes to one issue: the need, from an environmental perspective, to ban disposable vapes. Companies and consumers have proved time and time again that they are unwilling or unable to dispose of these and other consumer products and their packagings in a manner that does the minimum damage to the environment. They, like much of the rest of the population, seem to be so dim that they cannot absorb the simple but vital environmental message so eloquently expressed about another matter in the film Moonstruck: Don’t shit where you eat.

    Where I diverge from the BMA’s stance is at the point at which it is not willing to accept those products that have been designed by parts of the vaping industry to address these environmental concerns while still offering the positive usage characteristics of disposables.

    In fact, the report’s first recommendation is that the U.K. government bans “the manufacture for commercial sale and the commercial sale of all disposable vapes ….” I’m not sure how far the BMA imagines the U.K. government’s writ runs in such matters, but I would assume that at least a number of China-based manufacturers would be somewhat bemused by such an idea.

    But the BMA, while it is ready with its vaping advice, seems to be rather lost when it comes to the world of vaping. It bemoans the fact that the “nicotine contained in one disposable vape can be equal to [that in] two packs of cigarettes.”

    What is the problem here? It is not the quantity of nicotine in a device that counts but the amount of nicotine delivered to the user, and the amount of nicotine delivered is controlled by the vaper. And surely, if the BMA were really concerned about the environmental consequences of disposables, it would welcome bigger nicotine reservoirs.

    Bizarrely, the BMA also talks of vapes not containing tar. Well, no, but then neither do cigarettes; the tar is a product of the combustion process after a cigarette’s tobacco is set alight. And there is no tobacco in a vape and no combustion process.

    And finally, the BMA notes that “[a]s more young people are using disposable vapes and using them more frequently, there are concerns that they are at significant risk of addiction to nicotine.” Here the risk is probably being exaggerated. According to ASH figures, more 11-year-olds to 17-year-olds (9.5 percent) try vaping only once or twice than go on to become either regular or occasional users (7.6 percent), and 1.3 percent are classed as having been vapers but having quit.

    The question should at least be asked about how this 1.3 percent threw off this appalling addiction. Perhaps they returned to smoking, or did they just get bored with vaping? Young people get bored with things quite easily. That’s the main difference between old people and young folk. The former hang onto the past with a vice-like grip because they cannot compete in the present while the latter want to move on; they are hungry for the future. You can see this reflected in the charts of ASH and the dark forebodings of the BMA that are issued even as the young are moving on, beyond last year’s concerns.

    The report’s second recommendation and the one that has attracted most criticism calls for a ban on all nontobacco vape flavors. The BMA is clearly against vaping, and here at least the organization nails its colors to the mast but not without hitting its thumb in the process.

    Look at this sentence from the report, bearing in mind that the report is supposed to be a serious attempt at influencing government policy and presumably was read by any number of people before being loosed on the world: “However, like children, fruit flavors are the most popular with adults.” Hmm.

    Recommendation three, if implemented, would degrade the aesthetics of vaping devices and their packaging, which would make them less appealing to smokers, a move that would be simply vindictive since the BMA also wants, according to recommendation four, for these products to be kept out of sight at retailers.

    And just in case there were any doubt that the BMA is against vaping full stop, part of recommendation five calls for a government-funded and government-delivered “education campaign”—read propaganda—to warn the public “on the dangers of vapes to reduce appeal.” Again, an awful phrase, but we can figure out what is meant.

    Recommendation five includes some sensible ideas about policing the retail environment, but these are measures that the industry, at least in the form of the U.K. Vaping Industry Association, has been calling for for years. In fact, the recommendations do not go as far as the UKVIA has suggested, though there are signs that the government might be starting to favor the suggestion about licensing retailers that sell vapes.

    This is sensible. Most of the problems that vaping throws up have been caused by 14-years-and-counting of austerity under which the authorities responsible for overseeing retailing have been starved of funds so that checking the import, compliance and retail sale of these products has been nowhere near as vigorous as it should have been.

    But somehow, it is the smoker and the vaper who must be punished for these failures. Children are being naughty in using these products, manufacturers are putting noncompliant products on the market, retailers are selling vapes illegally, the authorities are failing in their duty to stop this abuse, but it is the people who are not doing anything wrong, the smokers and vapers, who are to be made to suffer.

    Recommendation six merely expands the report’s ideas, if you can call them that, to other nicotine products but not to traditional tobacco products.

    I think that one of the problems identified above is that the opinions of doctors should not be given too much credence when they are based on issues that go beyond their individual patients. We know that a lot of medical doctors still believe erroneously that nicotine causes cancer.

    And in a letter to The Guardian at the beginning of September in response to a government proposal to ban smoking in beer gardens, James Scott wrote, in part, “Tobacco is unique among the substances that humans use: When used exactly as intended by the manufacturer, it will harm and eventually kill its consumers. It is categorically different from alcohol and other drugs humans use and needs to be treated as such.”

    This completely ignores recent findings that drinking alcohol also harms and eventually kills its consumers when used exactly as intended. Writing in The Guardian on Aug. 21, Devi Shridhar, chair of global public health at the University of Edinburgh, pointed out that the World Health Organization had stated in January 2023 that there was no safe level of drinking. “The agency highlighted that alcohol causes at least seven types of cancer and that ethanol (alcohol) directly causes cancer when our cells break it down,” Sridhar wrote.

    But of course, it goes so much further than the direct harm caused by consumption. Smokers, unlike drinkers, do not go home and assault their partners just because they have been smoking. They do not start fights in the street just because they have been smoking, and they do not cause vehicle “accidents” just because they have been smoking.

    The problem is that you must have a wide view of society to see things clearly, in the round. On the same day that Scott’s letter was published about the proposed ban on smoking in beer gardens, there was a letter from Robert Lee, the contents of which anybody who has been involved in magistrate court proceedings would recognize as being right on the money.

    “The government’s almost evangelical crackdown on smoking contrasts sharply with its attitude to alcohol, which is responsible for more problems,” Lee wrote. “I sat as a magistrate for many years, and a huge proportion of offenses were directly or indirectly linked to alcohol. But I never heard a defense lawyer plead in mitigation that their client had smoked too many cigarettes.”

    And I cannot imagine that excessive vaping will ever be cited as mitigation in such proceedings. There is only one reason why smoking tobacco and vaping nicotine are under constant attack by all and sundry while drinking ethanol is not, and that is because the U.K. runs on hypocrisy. Let them eat sand.

  • Tools to Quit

    Tools to Quit

    Credit: Qnovia

    The RespiRx, the first inhalable nicotine-replacement therapy, gains IND clearance.

    By VV staff

    A Virginia-based pharmaceutical company is developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform. Qnovia announced that its RespiRxNicotine Inhaler (QN-01) received clearance for its Investigational New Drug (IND) application by the U.S. Food and Drug Administration.

    The company will initiate a Phase 1, randomized, crossover, open-label trial in the U.S. to determine the pharmacokinetics, safety and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes, according to Brian Quigley, CEO of Qnovia.

    “The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company. Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine-replacement therapies [NRTs],” said Quigley. “The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison.

    “We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the U.K. to support an MAA submission to the MHRA [Medicines and Healthcare products Regulatory Agency] in 2026.”

    Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing QN-01 in the U.K., according to Mitch Zeller, the former director of the FDA’s Center for Tobacco Products, who is now serving as Qnovia’s policy and regulatory strategy advisor.

    “There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit ‘cold turkey’ remains the most popular method of quitting smoking,” said Zeller. “There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit.”

    Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, Quigley told Vapor Voice last year (“Licensed to Thrive,” Issue 1, 2023, page ?). Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG.

    RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal by-products.

    RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product.

    Credit: Qnovia

    “The nebulizing unit (cartridge) gets replaced by the patient every one [day] to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”

    Mario Danek, Qnovia’s founder and chief technical officer, agrees that eliminating the cleaning requirement was a priority. “The idea was to create a technology that emulates the form factor of a successful high-adoption consumer product but that is imbued with technologies that would pass CDER’s [Center for Drug Evaluation and Research] stringent standard for safety—combined with Qnovia’s purposeful design features, it should bring patient adherence and quit rates to new highs, which historically have been found lacking in NRT,” he said. “Additionally, from a drug delivery platform perspective, those CDER-aligned device safety requirements are just as imperative to Qnovia’s API expansion strategy into other indication areas.”

    RespiRx is a “step-down” therapy, like many NRT products. However, instead of buying different pods with varying levels of nicotine, Qnovia’s device has a dosage-monitoring system programmed into the device. Uniquely, the use regimen is determined based on how much a smoker is smoking, said Quigley. For example, a one-pack-a-day smoker would start with 20 doses per day. The two-pack-a-day smoker would start with 40 doses per day.

    “Then the device will, over the 12 weeks, gradually reduce the available number of doses to that patient. It is a much more manageable step-down over the 12 weeks, unlike currently available cessation methods. And the device itself will prevent the patient from using more than they’re supposed to use,” said Quigley. “Patients would also have the on-device LCD screen interface to help them understand how to use their doses. That, too, is another benefit of our product versus the existing smoking cessation therapies.”

    Danek said the company is proud to lead the charge in encouraging the innovation and development of safe and effective pharmacotherapies to help the millions of smokers who are trying to quit smoking.

    “We believe our proprietary drug delivery platform has the potential to be a highly differentiated treatment option not only for treatment of nicotine dependence but for a wide variety of treatments that would benefit from inhaled drug delivery,” said Danek.

  • Myriad Issues

    Myriad Issues

    Credit: Phaisarnwong2517

    Industry experts explain why vaping regulations vary throughout Southeast Asia.

    By Norm Bour

    After living in Southeast Asia for the past year, I don’t have much more clarity about the vaping laws here than when I arrived. There is no commonality and no correlation between countries. And in many cases, there is no common sense either.

    In the U.S., England and other large countries, there is usually just one regulatory agency in control, the proverbial Goliath to be fought by the Davids out there. The U.S. Food and Drug Administration has been the American tormentor for the dozen years I have been in the vaping industry, and even though some states—and in some cases cities—have instituted their own guidelines (thank you, San Francisco, for your 2018 flavor ban), at least the “enemy” is understood.

    To get a better feel of what I might be missing, I contacted highly regarded and well-known Ecigintelligence and its parent company, Tamarind, which has offices in Barcelona, London and New York. They were kind enough to get thoughts from several of their team members.

    Legal analyst Sergi Riudalbas Clemente identified Malaysia and Indonesia as being the furthest along regarding specific regulations for vaping in their countries.

    “Malaysia and Indonesia have wanted to regulate these products for a long time, and they have finally decided to do so. This entails a comprehensive regulatory framework, in contrast to what other Asian countries have decided to do, which is to ban these products,” said Clemente, and I agree with those directions since they are attempting to control rather than ban the products, as they do in Thailand, one of the most draconian markets.

    One of the biggest problems Clemente identified is that “harm reduction is never acknowledged, thus vaping is treated equally to tobacco products,” which is a misstep.

    Freddie Dawson, who has also spent a decade in the industry, serves as managing editor at Tamarind Intelligence. According to him, one of the biggest culprits pushing the anti-vape message is the World Health Organization, which has historically focused on scare tactics like “accidental poisoning, youth corruption and unexpected consequences and side effects.”

    Of the four Asian countries I have lived in since last year, just one, Malaysia, seems to take a commonsense and open-minded look at the vape scene. Dawson sees Malaysia following that same direction on the one “good” hand but Thailand staying the course on the other “bad” hand.

    Another Tamarind employee, legal analyst Fernanda Tucunduva, cited a scary statistic from Vietnam. “Data from the authorities show that the use rate of e-cigarettes by young people (13–15) increased from 3.5 percent to 8 percent in one year,” Tucunduva said. “This is a big jump and seems to reflect a shifting preference among younger populations toward vaping and other nicotine alternatives.”

    According to Statista, in Southeast Asia, the revenue generated in the e-cigarette market is projected to reach $700 million in 2024. The market is anticipated to experience a compound annual growth rate of 1.85 percent between 2024 and 2029. Compared globally, the United States leads in revenue generation, with an estimated $8.83 billion in 2024. Considering the total population figures, the per-person revenue in Southeast Asia is expected to be $1.25 in 2024. In Singapore, the strict regulations on e-cigarettes have led to a decrease in popularity and limited market growth.

    As much as disposables have been a double-edged sword—convenient on the one hand, easily concealable on the other—it’s hard not to point at them as a catalyst to underage vaping. With such low price points and various options, there is something to suit anyone’s tastes.

    Overall, in Asia, as well as the rest of the world, two enormous problems are limiting the vape market: education and the enforceability of the laws. Eva Antal, the group’s director of market analysis, shared her thoughts about the youth market in Vietnam and addressed the youths’tendencies to follow the crowd.

    “It is true that younger age groups are more likely to experiment and that disposables are very easy to use, but it’s very hard to prove if that person would have started smoking if vapes were not around, and sad as that is, it is extraordinarily accurate,” she said. “Cigarettes have appealed to the youth market as long as kids looked for ways to rebel against their parents, authorities and society as a whole.

    “Decades ago, before cigarettes were identified as being the cancer-causing vehicles they are, most parents discouraged their kids from doing it, but since they probably did it themselves, they didn’t want to appear hypocritical.”

    In developing nations, cigarettes are too prevalent and familiar, and seeing construction workers and vendors smoking in the streets is an everyday situation. When I wrote in an earlier article about Vietnamese cigarettes being crazy cheap at a price of $1.33 (second only to Nigeria), I was reminded that that price was a significant percentage of their gross income.

    Dawson reiterates the enforceability issue as significant in Asia and elsewhere. Vapers more often do not make their own vaping devices; they buy them somewhere.

    He writes, “In the American market, 99 percent of the products currently being sold are technically illegal as they do not have a PMTA [premarket tobacco product application] market authorization.” Whether we are critical of the entire PMTA process or just its convoluted nature, these two wrongs do not make a right.

    “In Australia, Uber drivers were, until recently at least, openly advertising the sale of e-cigarettes despite there being a prohibition in place,” stated Dawson.

    Malaysia may be at the forefront of regulation in Southeast Asia with its Generational Endgame provision, which was part of the Control of Smoking Products for Public Health Act 2024.

    It appears that industry pressure from various places has kept this regulation off the table. It would have prohibited the sale of vaping and tobacco products to anyone born after Jan. 1, 2007, and two different Tamarind persons indicated that there seem to be political and financial motives to keep things at the status quo.

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