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  • Council Urges Steep Tobacco Tax Increase

    Council Urges Steep Tobacco Tax Increase

    Photo: Krakenimages.com

    Hong Kong’s anti-smoking watchdog has called for a 75 percent increase in tobacco tax to meet international standards, reports the South China Morning Post.

    If the tax rate is increased by 75 percent, the smoking rate could decrease by 0.7 percentage points to 8.8 percent, according to the Hong Kong Council on Smoking and Health. The council added that other control measures would be necessary to bring the city’s smoking rate down to the 7.8 percent goal by next year.

    The call for a tax increase comes before next month’s budget. Last year, the tax was increased 31.5 percent.

    “Raising tobacco tax should be prioritized for achieving the smoking reduction target,” council chairman Henry Tong Sau-chai said at a press conference.

    “[The increase last year] was insufficient to compensate for the price gap caused by the freezing of the tax rate in the previous eight years.”

    The World Health Organization has stated that the tax should account for at least three-quarters of the retail price of cigarettes, meaning Hong Kong would need an increase of 75 percent.

    “[Hong Kong is] in a really good position to reduce prevalence to the point in getting close to what we call the ‘endgame,’” said Hana Ross, an honorary research associate from the University of Cape Town’s school of economics. 

    Forty-one countries, including France, the United Kingdom and Australia, have reached the WHO’s recommended level of tobacco tax.

  • FEELM Launches Charge-Free Disposable

    FEELM Launches Charge-Free Disposable

    FEELM, a vaping industry leader in closed-system products, has launched the world’s first charge-free vaping system. The new Power Alpha 2.0 solves the problem of needing repeated charging in the large puff vapes currently popular on the market.

    FEELM started developing the charge-free battery technology that can empower large-puff vapes as early as 2022. The previous version of the company’s original Power Alpha technology could only support 6,000 puffs without charging.

    The upgrade more than doubles the count to 15,000 puffs, according to an emailed press release.

    FEELM states that the Power Alpha 2.0 also solves the issues of decaying tastes in cotton mesh coils, realizing consistently true flavors in every puff.

    The Power Alpha 2.0 is equipped with FEELM’s TopPower technology. “Relying on this technology, the energy density of Power Alpha 2.0’s battery cells is 40 percent higher than … products of the same size, making Power Alpha 2.0’s battery cells 40 percent smaller than … products with the same amount of power.

    “The extremely low self-discharge rate is another addition to benefits. A 700 percent lower self-discharge rate compared others on the market, which can lead to a longer shelf life and better support customers’ global market rollout.”

    The Power Alpha 2.0 also uses a unique Mesh constant power solution, leading to a taste that is 300 percent more consistent than other products on the market, according to FEELM.

    “With the substantial increase in the vapor volume and atomization efficiency, Power Alpha 2.0 supports the ability to fully vaporize the e-liquids for richer and fuller flavors, ” the release states. “Experiment data shows that the Power Alpha 2.0 solution’s atomization efficiency has increased by 200 percent along with an increased vapor volume of 49 percent compared to similar products from competitors. The numbers show a very evident advantage.”

  • KT&G Finalizes CEO Candidates Shortlist

    KT&G Finalizes CEO Candidates Shortlist

    Photo: uaPieceofCake

    The governance committee of KT&G Corp. finalized the first shortlist of KT&G CEO candidates on Jan. 31 and recommended the finalized list to the CEO candidate recommendation committee. The first shortlist includes four external candidates and four internal candidates.

    The governance committee held eight meetings since the end of December to oversee the open recruitment for CEO candidates and conduct comprehensive assessments. Subsequently, the committee selected the first shortlist by taking into account impartial and objective opinions from the advisory panel composed of external experts.

    The CEO candidate recommendation committee will now assess the candidates from the first shortlist in order to ensure sufficient candidate validation and select the most suitable candidate for the CEO position. The committee will finalize the second shortlist of three to four individuals by mid-February and disclose the list upon its finalization.

    Then, the CEO candidate recommendation committee will conduct face-to-face interviews with the candidates on the second shortlist to thoroughly review each candidate. Following the assessment, the committee will name the final CEO candidate and report to the board of directors by the end of February. The board of directors will then table the agenda for the annual general meeting of shareholders after resolution, and the CEO will be appointed following the approval at the annual general meeting of shareholders in late March.

    The CEO candidate recommendation committee is composed entirely of outside directors, without the participation of the incumbent CEO, Bok-in Baek.

  • Pax Labs Files Patent Suit Against Stiizy

    Pax Labs Files Patent Suit Against Stiizy

    Credit: Stiizy

    Pax Labs Inc. has filed a lawsuit against the vape brand Stiiizy Inc. and its manufacturer ALD Group Ltd. for allegedly infringing four patents with vape pens they make and sell.

    Stiiizy and Hong Kong-based ALD make vaporizing devices, including a cartridge and battery, that utilize methods similar to Pax Labs’ patents, according to separate complaints filed Monday in the US District Court for the Central District of California, according to media reports.

    Pax Labs said the companies infringed U.S. Patent Nos. 11,369,756, 11,369,757, 11,766,527, and 11,759,580, which deal with methods for leak-resistant vaporizer cartridges and apparatuses.

    The patents are all labeled as a “Leak-resistant vaporizer device.”

  • Luciano Cigars, Peter James Launch JV

    Luciano Cigars, Peter James Launch JV

    Luciano Cigars and Peter James Co. have announced the launch of Peter James Cigar Co., a new joint venture that will include cigars and accessories released in the near future.

    According to Luciano Meirelles, the new entity is a joint venture equally owned by Peter James Co. and Meirelles and his business partner, Tiago Splitter. The new company will hold the Peter James trademark in the U.S. as well as other trademarks for future products, according to Halfwheel.

    The two are working on a new cigar that will be launched in March, though details about its specifics have not been announced. However, the cigars will be produced at the Luciano Tabacos S.A. factory in Estelí, Nicaragua, and Luciano Cigars will distribute them.

    “This partnership is an extraordinary moment—a fusion of expertise and passion,” said Meirelles in a press release. “My love for the Peter James brand goes beyond their craft and luxury products.

    “There is an intentionality in everything they do: even the smallest details reveal beauty where most people won’t see it. That act of generosity carries beauty and passion into our world. We couldn’t be more excited for what’s to come.”

  • The Potential of Pouches

    The Potential of Pouches

    Photo: Stefanie Rossel

    Some markets have been more receptive to modern oral products than others.

    By Stefanie Rossel

    The modern oral nicotine category continues growing but struggles to reach a wider global audience. Modern oral nicotine products, which are white, pre-portioned little bags comprising a nicotine-containing carrier material, are considered the advanced, cleaner version of Swedish snus, a pasteurized oral tobacco that is available as loose products or pouches and is credited with helping Sweden achieve its record-low smoking prevalence by offering smokers a less harmful way to consume nicotine.

    According to Euromonitor International, global sales of nicotine pouches grew from 17.09 billion units in 2022 to an estimated 20.77 billion units in 2023. The overwhelming majority of sales, however, take place in the U.S., where an estimated 14.97 billion units were sold in 2023 compared to 12.61 billion units in 2022. Sweden ranks second, with 1.8 billion units sold in 2022 and an estimated 2.2 billion units sold in 2023. It is followed by Denmark with a forecast 745.3 million units in 2023 (versus 589.2 million units in 2022), Pakistan and Austria with estimated sales of 695 million units and 477 million units, respectively.

    As far as value is concerned, Euromonitor estimates the category to be worth $10.29 billion globally, up from $8.47 billion in 2022. By 2027, the business intelligence firm expects the segment’s value to reach $15.99 billion. Despite their relentless expansion, modern oral nicotine products remain a niche within a niche—they are a small part of a larger oral tobacco market, which accounted for only around 2 percent of the global nicotine industry in 2022.

    Raphael Moreau

    In the U.S., retail sales of nicotine pouches generated $8.58 billion in 2023 compared to $7.23 billion in the previous year. Raphael Moreau, head analyst at Euromonitor, expects the U.S. modern oral nicotine market to reach $11.03 billion by 2027.

    “The U.S. has benefited from a solid legal framework, with the Food and Drug Administration controlling the market chain, requiring authorization to market, nicotine health warnings and premarket assessment,” Moreau says. “Generally, the U.S. has a strong tradition of oral, i.e., chewing, tobacco. This definitely helped. Nicotine pouches are convenient and discreet to use, and they are taking share from chewing tobacco and Swedish-style snus, which has boosted U.S. sales.”

    As consumers become more familiar with the product, Moreau anticipates the market to continue growing rapidly. In 2023, just under 3 percent of the U.S. adult population consumed modern oral nicotine products. “Over the next five years, we will see an increase because of more awareness of the brands,” he says. “There is a wide flavor selection, which appeals to consumers who can’t use flavored vape products anymore as they are banned. The return to office work after the Covid pandemic will also contribute to the category’s growth: When working from home, people were more likely to vape. At the office, pouches are more convenient. Besides, the products are used as a cessation aid away from cigarettes and other combustibles.”

    Moreau suspects that the majority of modern oral nicotine is used in combination with other tobacco products. “This also has caveats because potentially, consumers may just try them and not become regular users, so prediction is difficult,” he says.

    With a 77 percent category retail value share in the third quarter of 2023, Zyn remains the U.S. market leader.
    (Photo: Swedish Match)

    Zyn Pulls Further Ahead

    With a 77 percent category retail value share in the third quarter of 2023, Zyn is the U.S. market leader by a large margin. Shipment volume of Zyn nicotine pouches amounted to 104.5 million cans during that period, a 65.7 percent increase compared to the third quarter of 2022, according to Philip Morris International. PMI became the owner of the Zyn brand through its acquisition of Swedish Match for $16 billion in late 2022. The move has given PMI a comfortable lead in the U.S. nicotine pouch market, where it previously had no presence to speak of, and will help the company to achieve its goal of becoming substantially smoke-free by 2023.

    At PMI’s Investor Day Conference in September 2023, Lars Dahlgren, president of smoke-free oral products and CEO of Swedish Match, forecast “stellar growth” for the product also because Zyn is cheaper than cigarettes, retailing at $5 per can compared to a price of $8 for a pack of cigarettes. According to news platform Seeking Alpha, the brand is popular among Generation Z, which has otherwise been a hard market for traditional tobacco companies to crack.

    In addition to Zyn, some other brands have made gains recently, according to Moreau. With a retail volume of 15.4 million units and a value share of 11 percent in 2022, Altria’s On! Brand ranks second behind the market leader, followed by Swisher International Group’s Rogue nicotine pouches, with 7.9 million units sold during that period.

    The “attractive category dynamics” in the highly competitive U.S. nicotine pouch market also holds potential for new players. In June 2023, ITG Brands acquired a range of nicotine pouches from Canada-based TJP Labs in order to facilitate its entry into the U.S. modern oral market. Following further consumer testing, ITG Brands plans to launch 14 pouch product variants in 2024.

    “The category still is very young, so there is no strong brand loyalty, and consumers are likely to try new brands,” comments Moreau. “This makes the market attractive to new entrants. And there’s quite a lot of room for them, as the category is growing very fast.”

    Regulation Required

    Except for the Nordic countries, where consumers have been familiar with snus for two centuries, the modern oral category is still underdeveloped in the rest of the world.

    Japan Tobacco International, present in the segment with its brand Nordic Spirit, sees vast untapped potential. Nordic Spirit was developed in Sweden and has rapidly grown since its launch in 2018. The product is available in the U.K., Ireland, the Philippines and Switzerland. “While the tobacco-free nicotine pouches category is still in its infancy, we already see that many adult tobacco and nicotine consumers globally will be interested in trying the product, helping the new category to grow significantly over the coming years,” says a JTI spokesperson. “For example, smoke-free nicotine pouches have become increasingly popular in the U.K. Responding to this growing trend, the Nordic Spirit brand has witnessed growth and increased its market share to around 45 percent.”

    According to Euromonitor, U.K. consumers bought 92.1 million nicotine pouches in 2022. In 2023, the category there grew 54.6 percent.

    Pakistan, however, was the country with the largest year-on-year growth rate, with sales in 2023 expected to be 70.7 percent, up from the 127.8 million units sold in 2022. In Pakistan, an estimated 10 million people use smokeless tobacco, which corresponds to more than 40 percent of the country’s total tobacco market. In December 2022, BAT announced that its modern oral nicotine brand Velo, which it had launched in Pakistan in early 2020, had achieved a monthly volume of more than 40 million pouches in the country, making it the company’s third-largest market for nicotine pouches.

    Most growth in the category will come from Asia-Pacific and Eastern Europe, according to Moreau. In Poland, for instance, the category increased by 69.5 percent in 2023. “The Czech Republic is also interesting because it had quite strong demand in 2022 and 2023,” Moreau says. “This is likely to stay [this way], particularly since nicotine pouches are regulated in the country now.”

    In May 2023, Czechia’s Ministry of Health issued a decree, modeled on tobacco and e-cigarette legislation, which regulates the composition, appearance, quality and characteristics of nicotine sachets. It also defines the legal age for sale and requires manufacturers and importers of nicotine sachets to register their products with the Ministry of Health. The legislation entered into force on July 1, 2023.

    Other countries, by contrast, have been less accommodating, with the Netherlands and Belgium banning modern oral products in April 2023 and October 2023, respectively. The European Commission, too, is reportedly mulling a ban on nicotine pouches for the common market. The products are also prohibited in Australia and New Zealand.

    “History has repeatedly shown that bans of legal products often do not lead to their intended goals and instead encourage criminal gangs to increase supply of illegal products to make up for the shortfalls,” warns JTI’s spokesperson. “Instead of an outright ban, we should aim for an evidence-based regulatory framework that acknowledges the potential of nicotine pouches to reduce the risks associated with smoking. At the same time, we must ensure that oral nicotine products aren’t marketed or sold to minors under any circumstances.”

    In Germany, modern oral tobacco continues to operate in a regulatory gray area. Nicotine pouches are classified as food in the country, which makes them subject to European food law. Because the EU has not approved nicotine as a food or food ingredient, this means that nicotine pouches cannot be legally traded in Germany.

    Despite the German Federal Institute for Risk Assessment’s October 2022 acknowledgement that tobacco-free nicotine pouches could reduce the health risks compared to smoking, the products’ legal status remains unchanged. “It will only change after a decision at EU level,” says Moreau. “Germany is a typical case where an uncertain or hostile landscape and a lack of familiarity with the products are two negative factors that are feeding each other. Whenever the legal status is unclear, not exactly defined or restrictive, retailers will basically avoid selling them. Therefore, consumers will not be aware of the products, and they will not trust them. In Germany, nicotine pouches are still available online, but the products are obviously now not as widespread as [they would have been] if they were sold in stores.”

  • Registration Opens for 2024 Habano Festival

    Registration Opens for 2024 Habano Festival

    Registration for the 2024 Habano Festival is now available through an online accreditation system at https://registrations.habanos.com. Those hopeful to attend can review all activities and make a payment online with a credit card.

    Typically, registration for the event happens in November of the previous year. This year, registration was delayed by approximately two months. No reason was given by Habanos for the delay.

    The registration period for the Habano Festival will be open from January 30th to February 12th or until the slots available are exhausted.

    “Once payment has been made, you will receive an email with a QR code which you may present it per activity, either on your phone or printed, along with the physical invitation given to you at Palco Hotel, Convention Center, Havana,” the release states. “Thank you for your interest; we look forward to seeing you at the most important Premium tobacco event in the world: the Habano Festival.”

    The events and costs are:

    • Welcome Evening — €530 ($574) — Event commemorating the 30th anniversary of Habanos S.A. to be held at Club Havana;
    • Visit to Plantations in the Pinar del Río region — €170 ($184)
    • International Seminar — €425 ($460);
    • Mid-week Evening — €745 ($807)— Event celebrating 50th anniversary of Quai D’Orsay brand to be held at the El Laguito Protocol Room;
    • Visit to Habanos Factories — €200 ($216);
    • Gala Evening — €1,325 ($1,436) — Dedicated to the 55th anniversary of the Trinidad brand to be held at Pabexpo.

    The exclusive cigar event is to be held in Havana from Feb. 26 – to March 1, 2024.

    Payments in Cuba can also be placed through Havanatur, according to Habanos. For further information, email Havanatur at eventos@havanatur.cu

    Habanos, S.A., the state-run distributor of global Cuban cigars, said in a release that its annual event is “in an international and exclusive atmosphere,” and it will include a wide-ranging program of activities combining the knowledge of the Habano and the exciting culture, including the ending final evening gala dinner and famed humidor auction.

    “In this XXIV Edition, the best specialists, distributors and aficionados will enjoy all the activities that, along with the best gastronomy and music, have made this famous event: visits to renowned Habanos factories, plantations, seminars with interesting lectures, exclusives pairings, contests and three very special nights where they will get a sneak preview of the latest Habanos, S.A. novelties,” the release states.

    Habanos, S.A. is already “working to make this event memorable for the expectations of aficionados with the passion and magic they have come to expect from each new edition.”

  • Sunak Asked to Reconsider Ban

    Sunak Asked to Reconsider Ban

    Photo: Lumos sp

    The U.K. Vaping Industry Association sent a letter to U.K. Prime Minister Rishi Sunak to “express profound dismay and disappointment” that the government decided to proceed with a disposable vape ban.

    “This decision jeopardizes the significant progress made in reducing smoking rates in the U.K. and poses a threat to the well-being of millions of adults who have successfully quit smoking with the help of vaping,” the letter reads.

    “We urge the government to reconsider the ban on disposable vapes and adopt a more balanced approach that prioritizes effective enforcement over draconian bans,” the letter says. “A distributor and retailer licensing scheme, as proposed to government repeatedly by the UKVIA, would achieve such an outcome without any cost to the taxpayer.”

  • Not For The Birds

    Not For The Birds

    Will the 5th Circuit’s recent ruling allow manufacturers of flavored e-cigarettes to secure their hitherto elusive market authorizations? | Photo: Dean Collins

    The impact of the 5th Circuit’s recent ruling against the FDA on tobacco harm reduction

    By Cheryl K. Olson

    Willie McKinney

    “Over several years, the Food and Drug Administration sent manufacturers of flavored e-cigarette products on a wild goose chase.” So reads the first line in this long-awaited Jan. 3 en banc decision by the U.S. Court of Appeals for the 5th Circuit. We can infer that the judges’ sympathies do not lie with the FDA.

    The entire decision makes for entertaining and informative reading. In exhaustive detail, the court covers the history of the 2009 Tobacco Control Act and the evolution of the FDA’s approach to premarket tobacco product applications (PMTAs). It then states: “Never in this long, winding and byzantine regulatory process of meetings, PowerPoint decks, proposed rules, comment periods, guidance documents and enforcement priorities did FDA ever say that it was contemplating an across-the-board ban on flavored products.”

    In short, the court ruled against the FDA and its reasons for rejecting the flavored e-liquids of Wages and White Lion Investments (dba Triton Distribution).

    “These judges confirmed what so many nicotine product manufacturers have been saying: ‘We’re not being treated fairly,’” says Willie McKinney of McKinney Regulatory Science Advisors. “The FDA has been moving the target and putting people out of business.”

    For those of us driven to help people find lifesaving alternatives to cigarettes, what does this 10-6 legal decision mean? Does the FDA have to do anything different? 

    What happens next on the legal side? Might this go to the Supreme Court? Most importantly, what can we do during this period of ongoing uncertainty?

    Below, legal and regulatory experts share their impressions and best guesses.

    ‘Surprise Switcheroo’

    If you thought the 5th Circuit had ruled on this case already, you’re correct. That court has had three bites at this apple. Here’s a rapid refresher.

    As required, Triton submitted PMTAs for its existing products to the FDA before the September 2020 deadline. When the FDA issued marketing denial orders (MDOs), Triton petitioned the 5th Circuit for review. In October 2021, a three-judge panel unanimously granted a stay. This was the famous “surprise switcheroo” ruling.

    In July 2022, a separate panel, not unanimous, upheld the FDA’s rejection of Triton. In January 2023, to resolve differences in rulings by this and other courts, the en banc 5th Circuit (all the judges together) agreed to hear the case.

    Bryan Haynes

    What led up to this? “The FDA in 2021 came up with this new standard for flavored ENDS [electronic nicotine-delivery systems] that effectively had two components,” says Bryan M. Haynes, a partner at the Troutman Pepper law firm. For one, contrary to previous guidance, the FDA now required expensive studies: randomized controlled trials or longitudinal cohort studies.

    “Two, what was even more surprising: The outcome of those studies had to show that the flavored ENDS had reduced smoking at a greater rate than a tobacco[-flavored] variant,” adds Haynes. “There was nothing like that in any FDA guidance.”

    Unsurprisingly, multiple companies sued. All of the cases had effectively the same issue: Was it appropriate for the FDA to do this?

    Some courts of appeal had sided with the FDA, showing what Haynes called extreme deference to the FDA’s decision-making. “The 5th Circuit is the first one to substantively, quite emphatically, rule that FDA’s standard was unlawful for a variety of reasons.”

    A 2022 decision by the 11th Circuit Court of Appeals in favor of Bidi Vapor and five other companies ruled that the FDA’s behavior was arbitrary and capricious. However, Haynes notes, “This ruling focused on a fairly narrow issue: The FDA had suggested that companies show that their marketing plans would deter youth use, and then refused to consider those plans.”

    By contrast, “The en banc decision in Wages and White Lion was much broader. It attacked head-on FDA’s so-called ‘fatal flaw’ standard requiring comparative smoking cessation or reduction.”

    ‘Calvinball’

    Importantly, administrative agencies can’t make statements that people will rely on, then pull a surprise switcheroo. As this latest ruling says, “All that matters here is that the agency unquestionably changed its position and then pretended otherwise.”

    David Dobbins

    “This court’s not going to let the FDA play Calvinball,” says Dave Dobbins, an independent consultant working with Altria and former chief operating officer of the Legacy Foundation/Truth Initiative. As described in the classic comic strip “Calvin and Hobbes,” that sport’s only rule is that the rules always change.

    “You should have a priori rules that people can understand,” says Dobbins. He describes the FDA’s approach as, “We’ll authorize you if you have what we think is good science. And we’re not going to tell you what that is or which results would compel us to issue an authorization.”

    Dobbins notes how drastically the FDA Center for Tobacco Products’ (CTP) approach differs from that of other regulators, such as the Environmental Protection Agency. “EPA has real interaction with companies. They have standards you can understand,” he says. “If you’re building a power plant, the EPA doesn’t say, ‘We don’t want it to pollute that much.’ Then show up and say you can’t use it after you’ve spent a bajillion dollars.”

    In contrast to the PMTA process for new products, the CTP does have quantitative guidelines for its substantial equivalence approval pathway. Embarrassingly, the CTP does far better at approving sales of new cigarettes than of novel reduced-harm products. “Just 23 e-cigarettes have been authorized. And few are ones people actually use,” says Dobbins. “It’s nuts that it’s easier to authorize a cigarette.”

    Topping off this unpredictable process is the CTP’s repeated failure to meet deadlines for product review. U.S. Senator Richard Durbin’s frustration is clear from the heading of his Jan. 16 letter to FDA Commissioner Robert Califf: “Another Durbin vaping letter for you to ignore.” He castigates the agency for being 28 months past the court-ordered deadline “to complete reviews of e-cigarettes with the largest market share and youth appeal.”

    Where Next?

    Might the Supreme Court weigh in? Haynes notes that the clear split among circuits, with the 5th and 11th evaluating the FDA’s actions differently from others, gives this case a good shot.

    “That kind of situation is untenable for obvious reasons,” he says. “You shouldn’t have rules that fundamentally differ depending on where you are in the country.” He thinks the court might agree to hear the case this year, with a decision issued in 2025.

    In the meantime, what to do if the FDA issues an MDO? For manufacturers who previously submitted PMTAs and meet guidelines for enforcement discretion, the path is now marked. Based on court precedents, Haynes says, “If a denied applicant could join forces with a retailer in the 5th Circuit who sells their products, they could get venue to challenge an MDO.”

    Haynes sees no rapid end to the uncertainty. “I’m not so sure FDA is going to act on a lot of PMTAs, given the existing division between circuits.” He noted that the recent Smok decision did not involve a consumable product, only a device system. If the FDA continues to issue decisions based on the “fatal flaw” standard, “It’s highly likely the applicant goes to the 5th Circuit. If it’s on that narrow ground, the applicant is likely to find success.”

    McKinney feels guardedly optimistic about the potential effects of the 5th Circuit decision. For clues to change, he suggests watching what the FDA does with products still in the review queue: those at the low end of the risk continuum, such as pouches and gums, that are not currently appealing to youth. 

    “If a lot of those products get refused-to-file or marketing denial orders, then nothing has changed at the agency,” he says. “If they start making it through, it suggests there are opportunities.”

    To conserve resources, companies seeking to bring new reduced-risk nicotine products to the U.S. market might follow “a cautious, stepwise approach,” he advises. “Spend a little money to generate minimal data for an initial PMTA. But have plans and protocols on the shelf ready to execute” when greater clarity inevitably emerges and competition heats up.

    What About APPH?

    This frustration and confusion was not inevitable. The wording of the Tobacco Control Act provides a path for authorization of reduced-harm products that will be appropriate for the protection of public health (APPH). “It’s the agency’s obligation to give content to those words,” says Dobbins. “And they’ve never done it. And that is why this is off the rails. They’ve never given guidance on what APPH actually means to them.”

    “If you look at the FDA’s recently issued five-year plan, there’s almost nothing said about encouraging innovation toward reduced-harm products,” says Agustin E. Rodriguez, a partner at Troutman Pepper. “There seems to be much more focus on outright quitting of products. I worry that this is unrealistic in terms of historical consumer approach to the tobacco and nicotine space.”

    “There are a billion smokers worldwide,” Dobbins reminds us. “People want nicotine. Someone is going to deliver it.” Public health benefits from a regulated industry that works within the law to deliver the least harmful products possible.

    “If FDA believes that what they’re doing will be upheld by the Supreme Court, they should be anxious to get its imprimatur. If they are wrong, they should be anxious to fix their processes, so they can administer the law in a way that will survive court review,” Dobbins concludes.

  • Give Them A Break

    Give Them A Break

    Photo: Syda Productions

    Smokers suffer a greater degree of ostracization than those engaging in other risky activities.

    By George Gay

    Although some people will probably complain that I am being irresponsible, I want to present a piece about tobacco smoking and smokers that puts them in a more favorable light than the one under which they usually appear—a piece that, especially, questions why combustible tobacco products and their consumers are treated as villains, justifiably subjected to massive sanctions, when other risky products and their consumers are not. After all, this is a tobacco magazine.

    In recent times, the promoters of new generation devices have been allowed largely to shape the smoking debate by reconfiguring the narrative of tobacco control with the inclusion of substitute products. It has been a no-contest with, on one side of the debate, the almost voiceless smoker, and on the other, the highly vocal public health officials, tobacco harm reduction advocates and politicians, many of whom make a comfortable living around the dubious claim that tobacco smoking is the major cause of preventable diseases and death and endlessly squabbling about how to go about preventing these outcomes. This is all very well up to a point because most of these interventionists would claim to have the best of intentions, but it puts me in mind of what Mark Twain supposedly once said: “Whenever you find yourself on the side of the majority, it is time to pause and reflect.” So I shall.

    But before doing so, I should make the point that I would discourage anybody from taking up cigarette smoking if they value their health. I should add, too, that I think it is perfectly legitimate for interventionists to try to encourage cigarette smokers to quit their habit, provided they treat smokers with respect—provided they treat smokers as ends in themselves, not as means to a profitable end. And provided they stick to the facts. They should not allow their mission to become tainted with, for instance, the automatic parroting of smoking myths and unproven and clearly questionable smoking statistics.

    ‘Preventable Deaths’

    I have long been fascinated by the idea alluded to above of “preventable deaths,” which is often applied to deaths attributed to tobacco smoking, though it could be applied to any number of causes. Of course, death cannot be prevented once life has started. What is meant, I think, is that there is the potential for life to be prolonged by various interventions, including, but not confined to, giving up smoking and other risky habits and activities. But the question that is rarely asked concerns whether prolonging life is a good thing, and the reason it is not asked, I suspect, is that, generally, those who promote prolonging lives through such interventions as quitting smoking live much more comfortably than those who smoke. Why wouldn’t these smokers want to live longer, the interventionists might ask? To which I would reply: Use your imagination, or reference Thomas Hobbes.

    Let’s take that a little further by asking why smokers would not heed the seemingly sensible advice of the interventionists and give up their risky habit. Well, one reason, I suspect, is that having been lied to continuously, smokers do not necessarily trust what the interventionists have to say. One clear example of this continuing deceit is the way in which interventionists claim to be attacking tobacco smoking on behalf of “children,” a word that is usually not clearly defined. Of course, at best, these interventionists are trying to protect the adults that children become, not the children. Although the interventionists try to lay at the door of smoking responsibility for damage done to children, that responsibility lies elsewhere—often where the interventionists, in this case mainly politicians, find it inconvenient to intervene. If the protection of children is paramount, why is tobacco smoking, which I imagine has caused the death of a small number of children, singled out when the death toll among young people is down mostly to infectious diseases in the case of the very young, and mostly to violence, including road traffic accidents, in the case of older young people?

    One of the most spiteful regulations pointlessly controls the delivery levels of cigarettes, which means that the smoker is presented with a degraded product while tobacco manufacturers are presented with a potential for increased profits.

    One of Many Risky Activities

    Tobacco smoking and smokers seem to be the subject of discrimination here, presumably because smoking is a minority activity while driving is close to being ubiquitous in many parts of the world. In general, the interventionists are happy to show how keen they are to protect children by coming down heavily on smoking and smokers, something that will have no effect, but are less keen in respect of taking the necessary actions in respect of driving and drivers. Such hypocrisy is even further to the front when it comes to attitudes toward smoking and drinking. Smoking, like drinking, might lead to your death, but of the two, only drinking is likely to lead to your death at a young age, and only drinking is likely to seriously disrupt your life in the interim. According to a Dec. 30 story in The Guardian, alcohol is reckoned to play a part in “about 39 percent of all violent crime in the U.K.” This was a story whose focus was a recent rise in “offenders” being fitted with “sobriety tags” that can tell probation officers if the offenders have been drinking, potentially landing them back in jail.

    Is it surprising, therefore, that drinking causes a greater societal burden and, therefore, a greater economic burden on the U.K. than smoking? And yet it is only smokers who are penalized to any extent, even though whatever health issues smoking causes are largely confined to the smoker while those caused by drivers and drinkers reach out to embrace their victims. There are no graphic health warnings on cars or bottles of wine, at least in England, where I live, and people are not forced to buy a car or a bottle of wine without seeing it first, from behind closed doors, as is the case with cigarettes.

    And it is not as if the authorities are unaware that these differing attitudes to smoking and drinking are not justifiable. According to another Dec. 30 story in The Guardian, in France, Olivier Cottencin, the head of the national body of university professors in addiction studies who coordinated a recent letter calling on the French state to promote a month of abstinence from alcohol, said it was surprising that the government backed a tobacco-free month every November, but not an alcohol-free month. Later in the story, it was said that a government-backed campaign in January 2023 had shown people clinking their glasses and saying, “sante” followed by the question, “Isn’t it a bit absurd to wish someone good health with alcohol?” 

    It is also interesting to compare the different treatments meted out to the products consumed and used by smokers, drinkers and drivers. The manufacturers of cars and alcohol are allowed to change and glamorize their products to make them more appealing and to advertise their new products. But, in many parts of the world, tobacco manufacturers have been forced to make cigarettes as unappealing as is possible through regulations aimed at limiting ingredients and controlling almost all aspects of packaging. And it goes without saying that tobacco cannot be advertised. One of the most spiteful regulations in force in some places pointlessly controls the delivery levels of cigarettes, which, the regulators must know, means that the smoker is presented with a degraded product while tobacco manufacturers, whom the regulators profess to hold in contempt, are presented with a potential for increased profits.

    Yes, even tobacco manufacturers receive a better deal than smokers, especially when it comes to financial incentives and disincentives. It is often said that smokers tend to be some of the most financially impoverished within societies because they smoke. This must be one of the most absurd ideas ever to come out of the mouths of the interventionists, and there have been some corkers. Are these people saying quitting smoking is guaranteed to lift a person out of poverty? Surely not. Many smokers in the U.K. have been dealt an almost unplayable hand that has meant they have been born into financially struggling families, been allowed, as children, to go undernourished by an uncaring government, been poorly educated and therefore been unable to find well-paying work. And, just to rub it in, those who have been dealt a better hand call constantly for the price of cigarettes, though not that of alcohol, to be increased. In his Nov. 22, 2023, Autumn Statement, the U.K. Chancellor, Jeremy Hunt, who was not born into poverty and who was privately educated, increased the duty on hand-rolling tobacco by 12 percent with immediate effect while freezing the duty on alcohol until August this year. Hand-rolling tobacco is generally consumed by the most impoverished smokers while alcohol is supped by relatively well-off politicians, their advisers and guests at bars within the parliamentary estate.

    While smoking being seen as a root cause of poverty is absurd, another idea put forward by interventionists must take the cake: the denormalization of smoking. The upshot of this is that, by default, drinking alcohol, which can quickly lead to people losing mental and physical faculties, is regarded as normal while smoking, which does not cause such upset, is not regarded as normal. So the person walking down the street after smoking a cigarette is regarded as having indulged in an activity that is not normal while the person with a few drinks inside him, clothing disheveled, staggering down the same street, unable to articulate the few thoughts in his head and in danger of stepping into the path of a moving vehicle, is seen as having partaken in a normal activity. To whom does this make sense?  

    Surely, the time is well overdue to give smokers, and I am talking about committed smokers, a break in the form of a better deal. They should not be given a special deal, just a deal that echoes the one drinkers are given in most parts of the world. Especially, smokers should be able to buy at reasonable prices a wide range of products from a wide range of manufacturers, big and small, that are not intentionally degraded and to enjoy them while receiving only the same level of warnings as are directed at drinkers.

    I know it is unfashionable to think this way, but it is possible that some tobacco smokers have done a risk/benefit assessment of their habit, factoring in the pollution that will anyway surround them, and decided that they want to continue to smoke. This must be especially true in the case of pipe and cigar smokers. And it is further possible that some of these smokers have done an environmental audit and decided that, for the sake of future generations, they will continue to smoke rather than switch to vapes.