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  • Pakistan Advised to Reject 10-Stick Packs

    Pakistan Advised to Reject 10-Stick Packs

    Photo: Taco Tuinstra

    Health advocates are urging the government of Pakistan to reject an application by Pakistan Tobacco Co. (PTC) for permission to pack cigarettes in cartons of 10 sticks, reports The Nation.

    According to Malik Imran Ahmed, country head of the Campaign for Tobacco-Free Kids, 10-stick packs would undermine efforts to discourage smoking among young people and other at-risk demographics.

    To deter consumption by minors and other at-risk groups, Pakistan law requires tobacco companies to sell cigarettes in packs of at least 20 cigarettes. Sales of individual sticks are permitted, however.

    The rule is placing at risk a large order for PTC to deliver $20.5 million worth of cigarettes to Sudan by mid-May. The contract requires PTC to supply the cigarettes in packs of 10 sticks each. Sudan does not have minimum stick laws, according to PTC officials.

    PTC has requested the government to amend the rules and limit the 10-pack selling restriction to domestic consumption, according to Tribune.

    The Ministry of Health has referred the matter to the Ministry of Foreign Affairs to seek its input on the matter in light of the World Health Organization Framework Convention on Tobacco Control.

    In 2019, PTC also lost an export order due to a lack of clarity on 10-pack cigarette manufacturing. At that time, the Ministry of Commerce gave the go-ahead for exports, but the Ministry of Health objected.

    PTC has been exporting cigarettes since 2019 and has earned $156 million from that business to date. In 2023, the company paid PKR148 billion ($531.35 million) in taxes, making it the country’s second-largest taxpayer after Pakistan State Oil.

  • BAT to Make Smokeless Products in Hungary

    BAT to Make Smokeless Products in Hungary

    Photo: Csak Istvan

    BAT will establish a HUF60 billion ($162.12 billion) factory for smokeless products in Pecs, Hungary, creating 450 new jobs, reports Hungary Today.

    BAT already employs almost 1,000 people. According to Minister of Foreign Affairs and Trade Peter Szijjarto, the project will contribute to the success of two important Hungarian economic policy objectives—to boost exports and protect the environment. The Pecs factory is carbon neutral and will export more than 80 percent of its products, the minister noted.

    The project will also help develop Hungary’s southwestern region, which traditionally has received fewer investments than its western counterparts.

    Usman Zahur, BAT’s regional director for Central Europe, pointed out that the Pecs unit could become a major manufacturing center for smokeless alternatives, building on more than 30 years of cooperation with Hungary.

    “This significant investment is an important step toward a smoke-free world, offering smokers better alternatives to cigarettes,” he was quoted as saying. “The investment further reinforces Hungary’s strategic importance in our long-term plans to have 50 percent of our revenues from new category products by 2035. Our manufacturing capabilities, highlighted by the Pecs center, are key to achieving this goal.”

  • Mariana Islands Fails to Adopt Tobacco Report

    Mariana Islands Fails to Adopt Tobacco Report

    Credit: PVL

    The Senate of the Northern Mariana Islands, a commonwealth of the United States, has failed to adopt its committee report that recommends the passage of its version of a House of Representatives bill.

    That bill aims to increase government revenue by amending the definition of cigarettes to ensure that all tobacco products are properly taxed.

    Four senators voted “yes,” and four senators voted “no” to a motion to adopt the report of the Committee on Fiscal Affairs, but Senate president Edith E. DeLeon Guerrero announced that the report would not be adopted and would no longer exist, according to local media.

    DeLeon Guerrero, Senate vice president Sen. Donald M. Manglona, Sens. Paul A. Manglona, and Celina R. Babauta voted for the committee report’s adoption.

    House Bill No. 23-7 proposes to amend the definition of “cigarette” to include any product that resembles similarities to cigarettes based on its appearance, weight, usage, and packaging, such as “little cigars”, “filtered cigars”, or “roll-your-own.”

  • Maine Lawmakers Change Tobacco Bill to Save Shop

    Maine Lawmakers Change Tobacco Bill to Save Shop

    The Maine House of Representatives passed LD 2157, sponsored by Rep. Matt Moonen of Portland. The bill would prohibit tobacco sales within 300 feet of schools, in an effort to prevent tobacco and nicotine addiction among children.

    “At 300 feet, this would affect one existing business,” Moonen said on the House floor Tuesday night. “That business is in my district, this business sells tobacco within 26 feet of my school, and I would like that to stop.”

    That business is Fresh Approach, located in Portland’s West End. It’s right across the street from the Reiche Elementary School, according to media reports.

    “I’ve been here for 30 years, and in 30 years, I’ve yet to have a fourth grader come in here and try to buy a pack of cigarettes,” Chet Knights, owner of Fresh Approach, said. “It’s just kind of silly.”

    He says Fresh Approach is primarily a neighborhood grocery store, but some people come in to grab a sandwich and a pack of cigarettes. If he is prohibited from selling tobacco, those customers will go elsewhere.

    “When the construction guys come along, and they want to get a sandwich, a soda, and a pack of Marlboros, and they can’t get a pack of Marlboros, you’re gonna go down the street to the store with the big fancy signs,” Knights said, explaining that he does not advertise for tobacco products at his store. “For me, that business is just gone.”

    On Friday, the Maine state Senate amended that bill, so stores could not obtain a tobacco license within 300 feet of schools, but they could renew a tobacco license if they already had one. This essentially grandfathers Fresh Approach in and allows them to continue to sell tobacco products.

    The bill now goes back to the House.

  • EU Lifts Limits on Cross-Border Cigarette Purchases

    EU Lifts Limits on Cross-Border Cigarette Purchases

    Photo: Richard Villalon

    European Union countries lifted the limit on cigarette purchases from other member states on March 29, in line with EU requirement, reports The Connexion.

    Previously, the limit was one carton (200 cigarettes or 10 packs) per person. It will now be up to member states’ customs officers to determine if the quantity of cigarettes brought in are for personal use or are contraband.

    While customs authorities said the change would make it easier to combat cigarette smuggling, tobacconists in high-tax countries said it would present them with unfair competition from lower-tax jurisdictions.

    In February, French tobacconists and newsagents protested against the planned changes, saying they would cost them business. Cigarettes in neighboring Spain, for example, sell for only half the price of those in France due to lower tax rates.

    Anti-tobacco activists have also criticized the new rules, describing them as “a win for the tobacco lobby.”

    Bertrand Dautzenberg, president of the Paris Sans Tabac association, complained that Europe was prioritizing market freedoms over health.  

    He said that lifting the limit was encouraging consumers buy their cigarettes in a country where they are cheaper. The message, said Dautzenberg, is that “You can now get lung cancer or a heart attack for €7 ($7.54) a day instead of €12.”

    Dautzenberg said that the definition of “personal use” was now too loose because there is no official limit.

    Previously, the EU directive had stated that member states could not set a limit under 800 cigarettes per person.

     Some are now calling for prices to be standardized across the EU.

  • 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.

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
  • 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.

    George Gay, European Editor, Tobacco Reporter

    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.

    George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.
  • Burgeoning Botanicals

    Burgeoning Botanicals

    Photo: nikavera

    Tobacco manufacturers see potential in the herbal heat sticks market.

    By Stefanie Rossel

    Only months after the newly emerged, highly fragmented niche of herbal heated products (HHPs) was deemed important enough to be covered by market analysts, Big Tobacco entered the scene. As it did with vaping, its arrival is expected to change the market significantly.

    At the InterTabac exhibition in September, BAT introduced Veo sticks. The tobacco-free consumables, compatible with the company’s Glo Hyper Series induction heating device, are based on processed rooibos tea substrate that contains 1.6 percent nicotine. They come in five flavor variants, among them two minty and three fruity tastes. The flavor is released through a capsule in the filter. According to BAT, the sticks generate 90 percent less harmful substances than a standard reference cigarette. Veo sticks were first launched in nine European countries, among them Czechia, Germany and Italy. The company plans to roll out the product worldwide.

    Gizelle Baker

    Also in September, Philip Morris International CEO Jacez Olczak presented his company’s new Levia product. Levia uses cellulose as its carrier material, a natural plant fiber that is also found in tobacco leaves. As Gizelle Baker, PMI’s vice president of global scientific engagement, explained in an interview, the product does not contain tobacco but contains nicotine and propylene glycol, thus creating an aerosolized nicotine similar to e-cigarettes. PMI claims that Levia emits on average 99 percent fewer harmful chemicals than combustible cigarettes—less even than e-cigarettes, which are said to be 95 percent less harmful than traditional smokes. The product has been designed for use with IQOS Iluma, a heated-tobacco device that uses induction technology to heat tobacco-based Terea consumables. Baker said that after an update of its firmware, the device is able to recognize the consumable used and adjust the settings to give users the best experience for that product. She added that the company would start to conduct “people usage” studies once Levia was put on the market.

    According to eliquids.ie, Levia was introduced in the Czech Republic in November, with a retail price of €4.90 ($5.32) per pack—the same price as Terea. The product was initially available only in online shops and dedicated IQOS stores. It is marketed in two flavor variants in Czechia—“Electro Rouge,” a combination of blueberries, flower and menthol, and “Island Beat,” which the website describes as a creamy menthol and peppermint taste.

    In November, Imperial Brands launched iSenzia heat sticks, which are formulated from Oolong and green tea leaves infused with nicotine and have been developed for the company’s Pulze 2.0 heating device. The product, which also features capsule technology, was introduced to the Czech market in four fruity flavors and one menthol flavor at a price of €4.30 per pack, according to Tobacco Insider.

    Preserving Flavor Options

    Eva Antal

    HHPs gained momentum ahead of the EU’s Oct. 23, 2023, ban on flavored heated-tobacco products (HTPs) (see “Teatime,” Tobacco Reporter, August 2023). Many observers expected the market to be short-lived. The entry of the leading tobacco companies surprised some, given the lengthy and costly process of product development that went into HTPs, says Eva Antal, director of market analysis at Tamarind Intelligence, parent of market research firm TobaccoIntelligence, which in November launched an Herbal Heated Sticks Tracker. “We don’t have information on how long these products were in the pipeline, but it is surprising how little information has been shared at launch about the scientific background of health impacts of HHPs,” she says. “Manufacturers’ motivation was to continue their offer of flavored products.”

    Before the product launches by BAT, PMI and IB, all HHPs were targeting non-Iluma IQOS users and therefore were also compatible with KT&G’s Lil and IB’s Pulze devices. “No HHPs targeted Glo devices, as IQOS had and still has the highest market share in EU markets,” says Antal. “At that time, our estimate was that between 1 percent and 9 percent of heated-tobacco users were regularly using such products—mostly along with other tobacco-containing sticks—which was relatively low still. We observed an increasing offer in nicotine-containing HHPs in the past year as products not containing nicotine had been the main shortcoming of the category. With the main players launching their HHPs, this segment is bound for fast growth mainly driven by the fact that only these consumables will be able to have flavors and large companies’ distribution advantage to make these products widely available in their regular HTP sales channels.”

    While many EU countries are starting to regulate the category, plenty of opportunity remains. “Eastern European markets with strong HTP markets are attractive due to a lower price point and consumers’ predilection of flavors,” says Antal. “Asia, where herbal smoking products have a long history, is strong, especially Japan.”

    Amended Tax Laws

    HHPs became popular not only due to their flavors but also because they initially avoided the taxes levied on their tobacco-containing counterparts. In the meantime, however, several countries have expanded their fiscal definitions to include HHPs. In December 2023, Greece changed its laws to fiscally equate tobacco-free electrically heated products with tobacco products. In Germany, tobacco-free Veo sticks are sold with a tax stamp stating, “heated tobacco” because it is being taxed as such.

    Its price hasn’t changed, though. Since its introduction in Germany, a pack of Veo sticks has retailed for €5.80, the same price as BAT’s tobacco-based Neo sticks. “Large companies’ HHPs were launched on the same price as their tobacco-containing counterparts even in countries where they were not taxed,” explains Antal. “This was probably to avoid the cannibalization of tobacco sticks of the company. The price differential may not solely come from the tax. Price of raw materials, manufacturing costs and other margins may play into it as well, which is probably why we still see smaller companies’ HHPs being cheaper than HTPs even in countries with tax.”

    Tobacco companies have designed their herbal offerings to work with their existing tobacco heating equipment. | Photo: BAT

    Distribution and Scale

    She predicts further growth in nicotine-containing HHPs, a category that started from zero nicotine options only, as well as a widening flavor offer. “PMI only launched HHP for IIuma, which is probably forward thinking as PMI is replacing heritage models with Iluma in an increasing number of markets,” she says. “But there are still a lot of users of heritage models that use Heets, which in the short term could be an opportunity for smaller companies. Imperial Brands’ Pulze HHP iSenzia is compatible with IQOS. Will there be a HHP launched for Fiit, which is the Lil consumable? PMI has a distribution relationship with KT&G, and their consumables are compatible with their devices. A Lil-compatible HHP may cannibalize PMI’s tobacco-containing Heets consumables, so this probably is not likely to be favored by PMI.”

    The question, according to Antal, is whether these large company HHPs will remain in EU Tobacco Products Directive (TPD) markets or whether they will become part of a larger strategic change in direction away from tobacco.

    Small players could be more agile to develop new products and respond quicker to consumer feedback. “However, they are not likely to have a huge advantage, as distribution and scale is key where larger players are better positioned,” says Antal. “Probably not a lot of questions will be asked by consumers if an HHP is made by the same company they know from their tobacco-containing consumables is displayed in the same place as their old product and has a flavor they like or are used to.”

    She thinks that the Big Tobacco takeovers that happened in the vapor business are unlikely to occur in the HHP category. “As the HHP phenomenon started with zero nicotine, it has not become very popular before large companies launched, and smaller manufacturers did not have enough time to build significant market share. There is not a large amount of technical IP going into these products; they are easy to manufacture, and there currently is no brand with significant market share or brand strength, so I don’t see any acquisitions unfolding in this space.” 

    Observers agree that it is only a matter of time before governments start regulating HHPs. “The basis of such regulation could be that these products are used in a similar way or for a similar purpose to a tobacco product, hence they imitate the consumption of tobacco products or replace tobacco products, but this is subject to the existing definitions of individual countries,” says Antal. “HHPs are expected to be part of the revised TPD3, if not before.”

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • Growers Worried About South African Tobacco Bill

    Growers Worried About South African Tobacco Bill

    Photo: poco_bw

    Small-scale tobacco growers in South Africa raised concerns about the impact of proposed legislation during public hearings in the Eastern Cape province.

    To strengthen public health protection measures, lawmakers are considering a bill that would ban smoking in all indoor public places and certain outdoor areas; prohibit cigarettes sales in vending machines; require standardized tobacco packaging and ban the display of tobacco product at points of sale. The bill would also regulate electronic nicotine delivery systems and non-nicotine delivery systems.

    During the Eastern Cape gathering, tobacco growers described the relative wealth that tobacco cultivation had afforded them in an area suffering from unemployment and poverty.

    “When we were producing vegetables, me and my family were staying in a one-roomed mud house but immediately when we started producing tobacco leaf, I was able to build myself a beautiful six-roomed house, Nomfusi Kotsele, a member of the Katala cooperative in Butterworth, was quoted as saying in a report by South Africa’s Parliament. “I was also able to take my children to school so that they can have a better future than I had.”

    Participants in the meeting also cautioned against the unintended consequences of overregulation. They pointed to South Africa’s thriving illicit cigarette trade, which exploded in the wake of a Covid-19 prohibition on tobacco sales and has remained above pre-pandemic levels long after the ban ended.

    The hearings are part of a nationwide public participation process to garner citizens’ views on the bill. Similar consultations have already taken place in North West, Mpumalanga, Limpopo, Free State and Gauteng.

  • Disposables Ban Could Thwart Cessation: Study

    Disposables Ban Could Thwart Cessation: Study

    Image: Viktoria Ostroushko

    A ban on disposable vapes, currently being considered by the U.K. government, could discourage the use of e-cigarettes among people who are trying to quit smoking, according to a new study led by researchers from University College London (UCL) and funded by Cancer Research U.K.

    Published in the journal Public Health, the study looked at survey responses from 69,973 adults in England, Wales and Scotland between January 2021 and August 2023.

    The researchers found the proportion of adults using disposable e-cigarettes rose from 0.1 percent to 4.9 percent during that period. The increase was particularly pronounced among 18- to 24-year-olds, with 14.4 percent using disposable vapes in 2023, as well as among smokers (16.3 percent) and people who had stopped smoking in the past year (18.2 percent).

    Use among people who had never regularly smoked was relatively rare (1.5 percent) but was higher among 18- to 24-year-olds, of whom 7.1 percent used disposable e-cigarettes and had never regularly smoked tobacco.

    “Our study suggests a ban on disposable e-cigarettes would affect an estimated 2.6 million people in England, Wales and Scotland,” said lead author Sarah Jackson, of the UCL Institute of Epidemiology & Health Care, in a statement.

    “This group includes about 316,000 18- to 24-year-olds who currently use disposables but who have never regularly smoked tobacco. However, it also includes 1.2 million people who currently smoke and would benefit from switching to e-cigarettes completely, and a further 744,000 who previously smoked and may be at risk of relapse.

    “While banning disposables might seem like a straightforward solution to reduce youth vaping, it could have substantial unintended consequences for people who smoke.

    “In the event of a ban, it would be important to encourage current and ex-smokers who use disposables to switch to other types of e-cigarettes rather than going back to just smoking tobacco.

    “In addition, we found disposable use to be particularly prevalent among recent ex-smokers with a history of mental health conditions. This group may require targeted support to help them avoid relapse.”

    While banning disposables might seem like a straightforward solution to reduce youth vaping, it could have substantial unintended consequences for people who smoke.

    Lead author Sarah Jackson, UCL Institute of Epidemiology & Health Care

    The research team used data from the Smoking Toolkit Study, in which a different sample of 2,450 adults in Great Britain (who are representative of the general population) are interviewed each month.

    They found disposable e-cigarette use was significantly higher among adults living in England than Wales or Scotland (5.3 percent vs. 2 percent and 2.8 percent at the end of the study period) and among those from less (vs. more) advantaged social grades (6.1 percent vs. 4.0 percent), those with (vs. without) children (6.4 percent vs. 4.4 percent), and those with (vs. without) a history of mental health conditions (9.3 percent vs. 3.1 percent).

    Until recently, the researchers noted, very few adult vapers in Great Britain used disposables, but in 2021 new disposable e-cigarettes entered the market with designs and branding that appealed to young people, causing use of disposables to quickly rise in the U.K. and elsewhere. These products are available widely, for instance in corner shops, and are sometimes promoted via colorful in-store displays.

    While they are convenient to use, with a very low upfront cost, they have also become an environmental problem, with millions of the devices reportedly thrown away in the U.K. each week.

    A ban may discourage use of e-cigarettes among people trying to quit smoking and may induce relapse among those who have already used disposables to quit.

    Senior author Jamie Brown, UCL Institute of Epidemiology & Health Care

    “There is a need for action to reduce disposable vaping among young people who have never smoked,” said senior author Jamie Brown, a professor at the UCL Institute of Epidemiology & Health Care. “However, trade-offs need to be carefully considered. A ban may discourage use of e-cigarettes among people trying to quit smoking and may induce relapse among those who have already used disposables to quit. Cigarettes are far more harmful to our health and are not currently banned and a ban on disposable e-cigarettes may signal to large numbers of people that these products are worse for our health or that their harm is comparable to that caused by smoking tobacco. I favor a range of alternative policies, in the first instance, allied with rapid evaluation to judge whether these are sufficient to achieve reductions in youth vaping.”

    In the paper, the researchers outlined other measures to strengthen the regulation of disposable vapes that had a reduced risk of unintended consequences, such as causing relapse among ex-smokers.

    These included prohibiting branding with appeal to children (e.g., bright colors, sweet names and cartoon characters), prohibiting promotion of e-cigarettes in shops, putting e-cigarettes out of sight and reach of children, and putting an excise tax on disposables to raise the price to the same level as the cheapest reusable e-cigarettes. Defining disposables may prove problematic so a minimum unit price may be more a straightforward alternative to reduce their affordability and is something that could be implemented quickly.

    The researchers noted that their data might underestimate prevalence of disposable vape use. This is because survey respondents were asked which type of e-cigarette they mainly used, so people who used disposables as a secondary product were not captured.

    In addition to Cancer Research UK, the study received support from the U.K. Prevention Research Partnership.