Category: Other Tobacco Products

  • Custom-Made

    Custom-Made

    Lukowa Tobacco has specialized in shisha tobacco from Poland.

    By Stefanie Rossel

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    Originally a centuries-old habit in the Middle East, smoking hookah, also known as a water pipe or shisha, has become a global trend in recent years. While still a niche product compared to combustible cigarettes, it has been growing continuously. According to a 2019 research report, smoking hookah is expected to show an annual compound growth rate of 18 percent over the next five years, reaching a market value of $1.89 billion by 2024, up from $730 million in 2019.

    The tobacco type required for use in water pipes is flue-cured Virginia (FCV) as that cultivated in the southeast of Poland. The leaf comes with a characteristic bright yellow color and a soft tissue. With a value of 0.8 percent to 1.5 percent, the variety is extremely low in nicotine. As manual harvesting prevails, FCV leaf remains largely free from damage associated with mechanical harvesting.

    FCV has a sugar content ranging from 25 percent to 30 percent. The sugar caramelizes during smoking, so it doesn’t hurt the throat, and smoking is “soft.” The sugar also works well as a carrier for molasses and flavors. Moreover, high sugar content ensures a nice puff. In contrast to other tobaccos, the leaf’s “blond” color persists if primary processing and threshing are done properly—even after it has been mixed with honey and flavors, a fact that is of particular importance to shisha smokers.

    Miroslaw Pekala

    Family-owned Lukowa Tobacco has specialized in providing high-quality shisha tobacco, selling only smaller quantities of tobacco for cigarette production. “Actually, we are quite a young company,” says Miroslaw Pekala, Lukowa Tobacco’s CEO. “We started our business in 2013 with only leaf purchasing and trading, but we quickly decided to develop our business and invest in our own factory. In 2015, we launched our primary, and from the very beginning, we started to produce and sell tobacco for shisha.”

    Located in the city of Lukowa in the Bilgorajski district, the company is situated at the heart of Poland’s tobacco country. With 5,000 hectares, the region is the main and largest tobacco growing area in Poland where in total 8,000 hectares are cultivated. Local farmers have longstanding expertise in growing the tobacco types used for water pipe smoking, and they have also established the necessary infrastructure, such as drying barns, to cater to increasing demand.

    “We are happy and lucky to have tobacco in Poland, which is excellent for the shisha industry,” Pekala points out. “As we all know, the cigarette market for factories like ours is going down, but the shisha market is developing from year to year.”

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    Here to stay

    The Polish leaf market was quite different when Lukowa Tobacco entered it. When accessing the European Union (EU) in 2004, the country was cultivating 33,000 tons of tobacco annually. As in the rest of the common market, the Polish tobacco farmers’ community has been shrinking since. Today, it produces around 22,000 tons of tobacco per year.

    By 2015, the number of Polish tobacco companies had risen to more than 300. That year, the Polish government revised existing legislation and introduced new regulations. While some of the novel rules were enacted to make the country’s legislation compliant with EU requirements, others were domestic laws seeking to rationalize its tobacco industry.

    One requirement in particular became a hurdle to many: In order obtain a tobacco trading license, leaf dealing companies have to pay an annual guarantee to the customs office depending on their purchased tobacco volumes. For every 1,000 tons of tobacco traded per year, leaf merchants must pay pln1 million ($257,000)—a significant sum in a business characterized by small margins. As a result, many smaller companies closed or relocated to neighboring countries where legislation was less restrictive. Only 15 legally authorized leaf traders remain on the Polish market, among them the big international players—and Lukowa Tobacco. “We think all new regulation is very useful for serious companies who want to run the tobacco business legally,” Pekala comments.

    The company stands out by being one of only two leaf merchants in Poland that runs its own processing line; a third one has rented a processing facility. Lukowa Tobacco processes most of the tobacco for its own purposes. Third-party services account for only 10 percent of the company’s turnover.

    With its processed shisha tobacco, the company competes on a global level. “90 percent of our volumes are sold abroad,” explains Pekala. “The tobacco world is small; clients usually know the main primary processing factories from different countries and are well orientated with their offers.”

    He adds that high-quality production is a prerequisite to remain competitive in the company’s specialized niche. “Shisha clients to whom we mainly sell are very sensitive with regard to the quality, color and stem content. We must keep high standards of production and quality control. We also put a lot of efforts into cooperation with farmers and the agronomy in order to ensure high-quality leaf produced by farmers.” 

    In the production of hookah tobacco, Poland directly competes with France and Germany, which both have similarly favorable climates for the cultivation of Virginia leaf. Pekala says that his company also uses German and French seeds. “The tobacco is basically the same from those countries. Of course, it may vary because of the impact of weather conditions during the cultivation season. For sure, the advantage [of Polish shisha tobacco] is price because our farmers get lower prices for tobacco [compared] to France or Germany. It has the main impact on the final price and competition. However, Polish tobacco is not [as] well recognized all over the world like German or French [tobacco]. We still have a lot to do with the marketing of Polish tobacco. This is the mission of our company.”

  • Ahead of Their Time

    Ahead of Their Time

    Shifts in consumer sentiment are giving some traditional products a remarkable modern edge.

    By George Gay

    Going back a while, I was regularly told during visits to India that the country’s tobacco consumers would in time move away from traditional products, such as chewing tobacco and bidis, and toward (combustible) cigarettes, which were frequently described as representing the “modern” form of tobacco consumption. Thinking about this now, I suppose a post-modernist would have described such a suggestion as representing the ideology of an elite group trying to establish, in its own interests, the cigarette as the cultural norm. And that post-modernist wouldn’t have been too far from the truth, though she needn’t have worried unduly, especially in relation to the Indian market. Even though globally, though not in India, combustible cigarettes represent far and away the most common form of tobacco consumption today, they are in decline, and, I think, few people would describe them as modern.

    The sorts of products that might today be described as modern would be, for instance, heat-not-burn (HnB) devices, which are sleek in form and technically advanced in function, delivering nicotine to the consumer without the need to set fire to the tobacco they contain. But our post-modernist might raise the same objection in relation to these products as she did in relation to the idea that combustible cigarettes were modern. That is, the promotion of HnB products is merely an attempt by the more or less same elite group to establish these devices as the cultural norm, though the group could reasonably argue that, in this case, such promotion is also in the interests of the smoking, and perhaps the wider, population.

    But our post-modernist would have a hard job making such a complaint about Oliver Twist, though the question that would arise with this tobacco product is: Is it modern? I would argue that it is modern, though I also know that it isn’t. Let me explain.

    To be sure, Oliver Twist, which has been owned by Swedish Match since April 2018 when it bought House of Oliver Twist, does not have the look of a modern product, being devoid of lights, buttons and programmable devices. It is an oral tobacco product that today is manufactured in what is described on the product’s website as a process that uses advanced technology alongside the same types and levels of craftmanship that were employed when it was first produced in 1805. This “spun” tobacco product is described as comprising “tobacco bits,” a phrase that does not seem to have tripped off the tongue of a modern corporate marketing guru, and it is sold in tins that inevitably have a retro look.

    But in many important ways, this is a modern product. For instance, it can be used as a harm reduction device. Most people who have studied such things in an objective way agree that the consumption of oral tobacco products is generally less harmful than the consumption of combustible cigarettes, and in the case of some oral products, this becomes far less harmful. These tobacco bits—about 1 cm long and 0.5 cm in diameter—can simply be enjoyed or, as in the case of electronic cigarettes, used to quit smoking. They are discreet in use, so they can be used almost anywhere.

    But perhaps one of their greatest claims to modernity is that, in an age of concerns about the environment, their positive credentials are indisputable. The product comprises bits of tobacco made from manually harvested leaves and flavors that are sold in tins. In addition, the product is manufactured in Odense, Denmark, close to its major markets in Scandinavia.

    Also underlining Oliver Twist’s claim to modernity must be its seemingly bright future. After all, demand must be an important guide to what is modern. The company said in an emailed reply to questions that the future would see a “growing demand for smokeless tobacco in general and … a growing demand for a quality product like Oliver Twist.” This seems to add up. There is a growing market for oral tobacco in Scandinavia, and Oliver Twist is already sold elsewhere in Europe and the U.S. Restrictions on the use of other tobacco and nicotine products must at least give it a boost in other markets, especially those with a tradition of oral tobacco use.

    Mixing tradition and modernity

    Oliver Twist

    Other tobacco products (OTP), by which, for the purposes of this story, I mean tobacco products that fall outside the cigarette and RYO/MYO categories, tend to have relatively good environmental credentials. Poschl Tabak’s snuff, for instance, comprises only ground tobacco moistened with essential oils of various flavors and paraffin, and one of the keys to the product’s quality is simply time—allowing the moisturized ground tobacco to undergo a cold fermentation process.

    So again, this is a centuries-old product that can make claims to modernity through its environmental credentials but also because it is discreet to use, so it transcends most modern anti-tobacco laws.

    According to Poschl, snuff is the oldest tobacco consumer product in the world—one that has been popular for many centuries in Asia, Africa, America and particularly in Europe. But, at the same time, Poschl says, its snuff tobaccos—English menthol snuff—are in rising demand, which stakes another claim to its modernity. “Apart from Europe, our focus is directed to Africa where we recently inaugurated our newest subsidiary company, Poschl Tobacco South Africa PTY Ltd., and launched a new product called NKWE,” which was specially developed for that market, the company said in an emailed reply to questions from Tobacco Reporter.

    Again, there is a mix of tradition and modernity. Poschl’s classic Bavarian Schmalzler snuff, described as dark in color, medium-fine grained and relatively moist, takes its name from the fact that it used to be refined with clarified butter: Butterschmalz. But, admittedly outside of the OTP category as defined above (and falling outside the German tobacco tax law), Poschl also offers a tobacco-free snuff powder.

    Poschl, which is headquartered in Geisenhausen, Germany, also offers the OTP products pipe tobacco and chewing tobacco along with additive-free cigarettes and RYO and MYO tobaccos. Although it already has a presence in about 100 countries, it is in an expansionary mood, believing that the trend toward additive-free tobaccos will continue. “[W]hile the main focus has been on Europe so far, we were recently able to generate new growth in South America and will work to make use of the strong potential of the Asian market in the future,” Poschl said. “We have only been active in the duty-free business for a few years now and delivered to about 100 airports worldwide already last year.”

    The slow movement

    Pipe tobacco is an interesting OTP in that its environmental credentials are good, especially where it is sold in tins. But it has yet another claim to being modern in that it can be seen as being part of the slow movement. According to Wikipedia, the slow movement began with Carlo Petrini’s protest against the opening of a McDonald’s restaurant in Piazza di Spagna, Rome, in 1986, which initially sparked the creation of the slow food movement. Over time, this developed into a subculture of movements in areas beyond food. Indeed, given the long history of the consumption of pipe tobacco, it could be seen as being part of the slow movement even before anybody realized there was a need for such a thing.

    Of course, partly because it is not an organized undertaking, the slow movement is little in the media’s eye, though it is keen on running endless features on how to avoid the rat race. So people are generally still laboring under the impression, put about by those modernists with equity in such matters, that speed is all the go. The aim is to have 5G—whatever that is—available around the world so that even those sitting in the most remote cove can livestream on their smart phones rubbish entertainment in garish colors while doing stress level raising banking, updating their Facebook pages and uploading never-to-be-viewed-again pictures to computer clouds, the maintenance of which is contributing significantly and increasingly to climate change.

    Such activities are seen these days as normal while a person sitting stress free in that same cove watching the waves and enjoying a pipeful of tobacco (assuming he was allowed to do so) would be seen as rather odd. But if we are going to solve the world’s problems, it is going to happen through this sort of quiet reflection. Rushing about is the problem not the answer.

    Cigars can be seen in a similar light. They come in all sorts of shapes, sizes and packaging, but, generally, I think, they are sound on an environmental level. And, especially the bigger format cigars, like pipe tobacco, they provide space for reflection.

    Of course, reflection shouldn’t be an end in itself. If you reflect for hours, you possibly have a decision-making disorder, so it is probably the case that the founder of Joh. Wilh. von Eicken, Johann Wilhelm, had it about right when, according to the company’s website, he decided “to create tobacco products that give people moments of enjoyment and a pronounced sense of joie de vivre.”

    Von Eicken offers both pipe tobacco and, since its 1991 takeover of the German tobacco manufacturer Dingelstadt, machine-made small and large cigars as well as cigarettes and RYO/MYO tobacco. It manufactures its products at factories in Lubeck and Dingelstadt, Germany, while offering them on every continent in more than 100 markets.

    The company said in an emailed reply to questions that while it was a small player within the global tobacco industry, it had the potential to grow. Asked about the future demand trend of its OTP products, the company said that quality would continue to be important. Quality at a fair price would be the key to success, it said. Furthermore, von Eicken’s customers valued its flexibility in developing products for individual markets.

    In this regard, von Eicken has recently launched Pipers Club Cigar, which it describes as being “a completely new approach in the cigar world as this product offers an unbeatable price quality ratio.” In addition, with the recent launch of Chapman Super Slim and King Size Little Cigars, it says it has introduced a flavor hybrid product that is specially designed for Eastern Europe and Asia.

    Again, what is on show here are traditional, established products with good claims to being modern, and these are from von Eicken, a company established in Germany in 1770 that is now celebrating its 250th anniversary.

    The writer would like to thank the following, listed in alphabetical order, for their help in preparing this story: Thomas Nellemose, area sales manager for the House of Oliver Twist; Rafal Rembowski, head of export for Poschl Tabak; and Peter Witzke, head of export for Joh. Wilh. von Eicken.

    Picture of George Gay

    George Gay

    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.

  • MRTP for General Snus: Small Step or Giant Leap?

    MRTP for General Snus: Small Step or Giant Leap?

    While a victory for tobacco harm reduction, the impact of the U.S. Food and Drug Administration’s recent nod to General snus should not be overstated.

    By George Gay

    A number of people have made the point, one way or another, that it is often unpalatable to find yourself in agreement with a majority opinion. And a few seconds’ thought will provide numerous examples of when and where this would have been true. Though, in some cases and for some people, the truth might have become obvious only in retrospect. Many of those examples, however, will also demonstrate that it can be uncomfortable, even dangerous, to challenge majority views.

    But even when there is no danger involved, most people don’t like to be the odd one out, as numerous experiments have shown. If you ask somebody to measure the length of a stick and then ask her to pick the length she measured from a multiple-choice answer, she will almost always come up with the right answer. But conduct the same experiment with the same person and six others primed to pick and declare out loud before she does one of the other answers, and the subject of the experiment is highly likely to fall in with the answer given by the others, no matter that the answer might not bear a close resemblance to the length of the stick. The thinking seems to be better wrong than different.

    I find this attitude difficult to accept, and so I find myself partly at odds with a development that many have found inspiring. In October, the U.S. Food and Drug Administration (FDA) announced that it had, for the first time, authorized the marketing of products through its modified-risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA (SMUSA) snus smokeless tobacco products sold under the General brand name, the FDA said in a statement published on Oct. 22.

    At first glance, this seemed all very positive, but the more I read, the more it struck me that the press note and some of the commentary attached to it did not warrant the sound of triumph that emerged—the idea that what happened represented a major victory for the future of tobacco harm reduction. On close reading, while the announcement was to be welcomed as a tiny step in the right direction, it carried so much baggage that the step was unsteady.

    The “for the first time” phrase used in the first sentence of the press note presented an impressive front, but the reality is much different. The FDA’s first-time decision and announcement had taken more than five years—an unconscionable length of time given that traditional cigarettes continued throughout that period to take the lives of more than 400,000 smokers a year. And it wasn’t as if the latest application had been the first. Three years ago, the FDA, in effect, turned down three reasonable requests from SMUSA in relation to health warnings that were required to be applied to all smokeless products, including General snus, condemning the U.S. to another three years at 400,000 deaths a year.

    It would be absurd, of course, to say that 2 million people’s lives could have been saved over those five years if the MRTP had been granted in reasonable time, but the chances are that many lives would have been saved and that the momentum behind switching from combustibles to Swedish-style snus would by now have built a solid foundation.

    Nudge, nudge, wink, wink

    As it is, SMUSA has to start from now, and still has a mountain to climb in changing attitudes to its authorized products, in part because official information on the health implications of using snus has been misleading and because, even now, the October FDA announcement is nothing if not equivocal. And it couldn’t be otherwise simply because it is based on what is termed a “modified risk.” What is the woman in the street to make of a “modified risk”? Hey, they think they can save my right leg, but apparently my left arm might drop off.

    True, the FDA decision allows SMUSA to market the products in question by saying, “Using General snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” But, according to the press note, this is just a “claim.” And just to underline this, the third paragraph states, “While today’s decision permits the eight General brand snus smokeless tobacco products to be sold in the U.S. with a modified-risk claim, it does not mean these products are safe or ‘FDA approved.’ All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from their use. The modified-risk orders are product specific and limited to five years.”

    Again, what is the woman in the street to make of this? Nudge, nudge, wink, wink—don’t touch this stuff with a bargepole?

    And if you didn’t get that hint, perhaps you picked up the one in the previous paragraph: “In an effort to help prevent youth access and exposure, the agency has also placed stringent advertising and promotion restrictions on the products, including a requirement to restrict advertising to adults. In addition, the products’ packaging and advertising must also bear the warning statements required for all smokeless tobacco products.”

    And what are those warnings? This product can cause mouth cancer, and this product can cause gum disease and tooth loss. In other words, the FDA is hedging its bets. Yes, it seems to be saying, these General snus products are demonstrably different to others on the market and that is why the agency has issued an MRTP, but, on the other hand, they aren’t different and that is why they have to carry the same warnings as other smokeless products.

    And just in case you’re particularly dumb and still didn’t quite get the message, the same points that are laid out in the second paragraph are repeated in the fourth. The FDA has cloaked itself in so many layers of the cautionary principle that it is unable to move. After five years of examining what must be close to the most benign tobacco product ever to be devised, it was unable to issue an unqualified statement saying the consumption of these eight products is way less risky than smoking.

    Quoting acting FDA Commissioner Ned Sharpless, the FDA’s press note states, “Today’s action demonstrates the viability of the pathway for companies to market specific tobacco products as less harmful to consumers but only following a thorough scientific evaluation by the FDA. Our team of scientific experts examined these applications to ensure that the tobacco products meet the public health standards in the law.”

    Of course, this is true, up to a point, but it hides some other uncomfortable truths. Yes, it is the case that the recently issued MRTP has proved that, 10 years after the enactment of the Family Smoking Prevention and Tobacco Control Act, one company has found a way to convince the FDA to equivocate on the health implications of eight of its products. But that is an awfully long time and an awful lot of resources to not get very far. And even that limited achievement is not set in stone. As Sharpless was quoted in the press note, “Should any information lead us to determine that the marketing of these products as posing less risk no longer benefits the health of the population as a whole, the agency would consider withdrawing this authorization.” It is worth noting that when Sharpless talks of “any information,” he is including information undoubtedly already being prepared by the legions of quit-or-die advocates circling the courts.

    A viable pathway for who?

    You have to ask yourself, what does it mean for Sharpless to say that this is a viable pathway for “companies to market specific tobacco products as less harmful to consumers”? Let’s be aware of the import of this. He cannot possibly be talking about any old company; he has to be talking about companies with big pockets. No ordinary company could afford to allocate to such an uncertain undertaking five years’ worth of the sorts of resources necessary to put together and present the results of the detailed research demanded by the FDA.

    The investment does not stop with the granting of the MRTP. The press note points out, “With the authorization of these products, the company is required to conduct post-market studies to determine the impact of modified-risk tobacco product orders on consumer perception, behavior and health …. The company is required to report regularly to the FDA with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.” It is to be hoped that quit-or-die advocates will be held to the same standards.

    Later, the note adds, “To continuously market these same products with the same modified-risk information beyond the five-year limit would require the company to submit a request for renewal and receive renewal authorization from the FDA before the current orders expire.” Of course, it should add that companies can continue to market traditional cigarettes regardless.

    And what of the “specific tobacco products” that Sharpless talks about? Are we somehow to believe that the issuing of an MRTP in the case of eight General snus products indicates that other types of tobacco products might soon be in the pipeline? I don’t think so—not in this millennium. Even other snus products might struggle. Take a look at what the FDA has to say: “In addition to these lower risks relative to cigarette smoking, the FDA previously determined that the levels of two potent carcinogens in smokeless tobacco products called NNN and NNK [both tobacco-specific nitrosamines] are lower in these General snus products than [in] the vast majority of smokeless tobacco products on the U.S. market. In addition, the evidence showed [that] when used exclusively instead of other smokeless tobacco products, the General snus products offer the potential for reductions in oral cancer risk.”

    Focus on the negative

    The FDA, it seems to me, tends to be drawn to the negative rather than the positive. In its press note, the agency makes the point that as part of its assessments, it has to take into account both users of tobacco products and persons who do not currently use tobacco products. “In making this assessment, the agency must consider, among other things, whether those who do not use tobacco products would start using the product and whether existing tobacco users who would have otherwise quit would switch to the modified-risk product instead,” it said. Why this example, you might ask? Why not the positive example of taking into account the effect on nontobacco users of tobacco users switching to a product generating no secondhand smoke?

    With such a negative approach, the agency seems to work to undermine the evidence that it apparently accepts. Few would say the FDA should look at this issue through rose-colored glasses. But in making the announcement, it should have emphasized the positive. There are real positives down in paragraph six, for example: “The FDA’s review determined that the claim proposed by the company in its application is supported by scientific evidence, that consumers understand the claim and appropriately perceive the relative risk of these products compared to cigarettes, and that the modified-risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.”

    In addition, paragraph eight says, “The available evidence does not demonstrate significant youth initiation of these products, and evidence submitted by the company also found low levels of intentions to buy the product among nonusers of tobacco (including young adults) and, importantly, found that the inclusion of the modified-risk claim did not affect these intentions.”

    My views on the MRTP announcement might not chime with the majority view of what has happened, but I would suggest that those who have welcomed these MRTP authorizations with open arms should consider how, in doing so, they might be helping to lower the ambitions of tobacco harm reduction.

  • MRTP for General Snus

    MRTP for General Snus

    Photo: Swedish Match

    The U.S. Food and Drug Administration (FDA) has authorized Swedish Match U.S. division’s amended modified-risk tobacco product (MRTP) applications for eight varieties of General Snus, making it the first tobacco product to secure the modified-risk designation and right to market the product as a less harmful alternative to cigarettes.

    “Today’s decision is a huge accomplishment for public health in the U.S. and another step toward realizing our vision of a world without cigarettes,” said Gerry Roerty, vice president and general counsel for Swedish Match.

    “There are nearly 35 million adult smokers in the U.S., all of which have been led to believe the only way to reduce tobacco risk is complete abstinence. We now have the opportunity and responsibility to inform cigarette users who cannot abstain that General Snus can be a risk-reducing alternative. If that’s enough to make even a percentage of them switch, we’ve made progress.”

    The modified-risk status classifies General Snus as a tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. The FDA also cleared Swedish Match’s claim that using General Snus instead of cigarettes puts users at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.

    In a statement, Swedish Match said the authorized claim allows it to begin working to reduce misperceptions related to the risk of General Snus. According to the National Young Adult Health Survey, only 10 percent of respondents believed snus was less risky than cigarettes.

    Snus has already been tied to progressing the reduction of cigarette use in other countries. In Sweden, widespread use of snus in place of cigarettes is believed to have helped the country achieve the lowest lung and oral cancer rates in men in Europe. In Norway, snus rates among young women increased to 13 percent since its legalization in 2002. Smoking rates among young women dropped from 30 percent in 2001 to 1 percent in almost the exact same time span.

    In announcing the first-ever modified-risk orders for a tobacco product, the FDA said its decision does not mean General Snus is safe or “FDA approved.” Acting FDA Commissioner Ned Sharpless said, “While we are authorizing these specific modified-risk tobacco products, it’s important for the public to understand that all tobacco products—including these—pose risk.”

    The market authorization is valid for five years and requires Swedish Match to conduct postmarket studies to determine the impact of MRTPs on consumer perception, behavior and health.

    Bonnie Herzog of Wells Fargo Securities described the ability to make a modified-risk claim in tobacco/nicotine as a game changer—”not just from a consumer perception point of view but also in terms of potential tax favorability down the line since it’s logical that a tobacco product that is less harmful to public health should be taxed less onerously than a higher risk product,” she wrote.

    “We view this as very good news for the broader tobacco/nicotine industry as it demonstrates the FDA’s commitment to a ‘continuum of risk’ strategy and provides a viable pathway/process for manufacturers,” she added.

  • Myblu performing well

    Myblu performing well

    Imperial Brands said today that its myblu vaping device was performing well, with increased investment driving brand awareness among smokers and vapers and significant year on year revenue growth.

    Under a Next Generation Products heading within a trading update posted on its website, Imperial said it had built strong retail share positions in Europe and in Japan. ‘In the USA, we have achieved good year-on-year revenue growth, despite some constraints due to market uncertainty following statements by the US Food & Drug Administration.’

    In its update issued ahead of its close period on April 1, Imperial confirmed it was on track to meet constant currency net revenue and earnings expectations for the full year, with group net revenue growth at, or above, the upper end of its 1-4 percent revenue growth range and EPS growth within its 4-8 percent guidance range.

    Imperial said it was on track to deliver modest revenue growth in tobacco, with growth weighted to the second half more than offsetting a slight decline in the first half. Price/mix continued to be strong, while volume trends were slightly behind those of the second half of last year, impacted by the phasing of trade inventories, including in the US following a recent Imperial price increase.

    ‘Operating profit in the first half reflects continued underlying growth in tobacco profits albeit more than offset by increased investment in blu of £100 million, as highlighted in November,’ Imperial said.

    ‘First half earnings per share will also be impacted by the reduction of our Logista stake and last year’s divestment of our Other Tobacco Products business.

    ‘We continue to expect to realise £50-100 million of other gains this year which will benefit the second half.

    ‘Translation FX at current rate of exchange is expected to benefit first half earnings by c. 2 percent and be flat for the full year.’

  • FDA final guidance

    FDA final guidance

    US vape shops that modify a product so that it is deemed by the US Food and Drug Administration to be a ‘new tobacco product’ are required to comply with the agency’s premarket authorization requirements, according to a final FDA guidance.

    In a note issued through its Center for Tobacco Products, the FDA said it had posted a notice in the Federal Register announcing the publication of the final guidance, Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops. This guidance was said to finalize the draft guidance of the same title, which was available for public comment on January 17, 2017.

    ‘Under section 903(a)(2)(C) of the Food, Drug, and Cosmetic Act [FD&C], a tobacco product in package form is misbranded if its label does not include an accurate statement of the percentage of tobacco used in the product that is foreign-grown and domestic-grown,’ the note said. ‘This guidance clarifies FDA’s interpretation of this as applying only to tobacco products that are made or derived from tobacco. Tobacco products (such as components, parts, and accessories) that are not made or derived from tobacco would not be required to bear the statement.

    ‘Additionally, at this time, FDA does not intend to enforce this requirement for certain products, including tobacco-derived liquid nicotine, e-liquid made or derived from tobacco, cigars, smokeless tobacco, and waterpipe tobacco. FDA is providing this compliance policy as the agency recognizes the current scientific and technical difficulties of quantifying the percentage of foreign and domestic tobacco used in these products.

    ‘The guidance also clarifies [that] vape shops that are tobacco product manufacturers are subject to the requirements in section 904(a) and (c) of the FD&C Act, including the requirements to provide ingredient listings, report harmful and potentially harmful constituents, and submit health documents. Those vape shops that modify a product so that it is a new tobacco product are required to comply with the premarket authorization requirements. Vape shops that are engaged in the manufacture, preparation, compounding, or processing of tobacco products are required to comply with the establishment registration and product listing requirements in section 905 of the FD&C Act.

    ‘The final guidance explains certain activities which modify a product, and which would subject the vape shop to the requirements of the Act that apply to manufacturers and includes a compliance policy for limited circumstances for which FDA does not intend to enforce these requirements…’

  • Problem cannot be patched

    Problem cannot be patched

    Taxpayers in the state of South Australia will pay for nicotine substitutes for prisoners as the state moves to make its jails smoke-free, according to a story by Rebecca Puddy at abc.net.au.

    The Department for Correctional Services has estimated that 80 percent of South Australia’s 2,800 prisoner-population comprises smokers, with 75 percent smoking daily.

    Under the current smoking rules, prisoners can buy their own cigarettes and tobacco from canteens.

    A $2 million bill for nicotine patches and lozenges will form part of the $6.2 million cost to taxpayers of keeping cigarettes out of the state’s prisons in the years to 2022, with additional funding set aside for health and security measures, staff costs and quit support.

    The smoking ban has received bipartisan support and strong backing from Cancer Council SA and the Public Service Association, the union representing the state’s prison guards.

    Under the current structure, SA Health pays for NRT in prisons that have not enacted a smoking ban but will hand over this cost to the Department for Correctional Services when the ban is introduced at the end of the year.

    Under the rules to be introduced as prisons become smoke-free, taxpayers will foot the bill for the first six weeks of a nicotine replacement program, with prisoners required to pay one quarter of the cost for the next three weeks, and 50 percent of the cost for the final three weeks.

    Cancer Council SA spokeswoman Alana Sparrow said the Government had worked with stakeholders to develop a “good evidence-based approach”, learning from the experiences of other states.

    “We have looked at evaluations in different states and territories – in some it has worked extremely well but we are also learning from the experiences in other states like Victoria,” she said.

    A 2018 study of former prisoners in Queensland found 94 percent relapsed to smoking within two months of their release, with 72 percent doing so on the day of their release

  • Looking for change

    Looking for change

    Knowledge∙Action∙Change (KAC), a private sector public health agency based in the UK, has called for action to prevent the dramatic rises in smoking rates in Africa that have been predicted by the World Health Organization.

    In a note issued through PRNewswire, KAC said that while globally smoking rates were decreasing, in many lower- and middle-income countries, African nations among them, rates were increasing. WHO data showed a steep rise in smoking in many African countries, with many five-year projected increases at five percent and more.

    With this in mind, public health experts from KAC had this week visited Lilongwe, Malawi, and Nairobi, Kenya, to launch No Fire, No Smoke – The Global State of Tobacco Harm Reduction 2018 (GSTHR), ‘a landmark report on the worldwide availability, regulation, and use of lower-risk alternatives to tobacco, such as e-cigarettes (vapes), heat-not-burn devices, and Swedish snus (pasteurized oral tobacco)’.

    ‘A proven public health strategy, harm reduction refers to policies, regulations, and actions that reduce health risks by providing safer forms of hazardous products or encouraging less risky behaviors, rather than simply banning them,’ the note said.

    ‘Independent evidence from the UK Government’s leading public health body demonstrated recently that vaping is at least 95 percent safer than smoking tobacco. Yet despite the WHO Framework Convention on Tobacco Control (FCTC) of 2003 citing harm reduction as one of its main tactics, the WHO has been persistently negative about e-cigarettes, has called for their ban or strict regulation, and sees them as a threat, rather than as a public health opportunity.

    ‘Partnering with the information dissemination project, Tobacco Harm Reduction Malawi, and the newly launched Campaign for Safer Alternatives based in Kenya, the GSTHR report’s publishers presented global findings on tobacco harm reduction, showing that many smokers have switched to safer products and dramatically reduced the risks associated with smoking.’

    “We need to halt the dramatic rises in smoking rates in Africa which are predicted by WHO,” Professor Gerry Stimson, director of KAC and Emeritus Professor at Imperial College London, was quoted as saying. “Most smokers want to quit smoking, but they find it hard to stop using nicotine. Around the world, millions of lives depend on both consumer and government acceptance of safer alternatives to smoking.”

    Meanwhile, Chimwemwe Ngoma, project manager, Tobacco Harm Reduction Malawi and holder of a Global Tobacco Harm Reduction Scholarship, said that Tobacco Harm Reduction Malawi believed that all citizens of Malawi should be informed of the health consequences, addictive nature, and mortal threat posed by tobacco consumption and exposure to tobacco smoke. “Malawians should be able to make more informed public and personal choices, including having access to safer nicotine products, to enable them to live longer and healthier lives,” he said.

    And Joseph Magero, chair of the Campaign for Safer Alternatives and holder of a Global Tobacco Harm Reduction Scholarship, said society’s relationship with tobacco and nicotine was changing due to technical developments in vaping devices and other safer nicotine products. “The Campaign for Safer Alternatives has formally launched this week to ensure more people across East Africa receive accurate information on alternatives to smoking,” he said. “By arming people with information, we can finally begin to curb the tobacco epidemic.”

  • Speakers named

    Speakers named

    The organizers of the 2019 Global Forum on Nicotine have announced the names of 16 of the speakers who are due to take part in the conference.

    The conference, whose theme is, It’s time to talk about nicotine, will be held at the Marriott Hotel, Warsaw, Poland, on June 13-15.

    It is due to include plenary sessions, symposia, panel discussions, poster presentations, and satellite sessions.

    In an earlier announcement, the organizers said the program committee would use selected abstracts to construct themed sessions.

    The names of other speakers and the draft program are due to be posted on line shortly.

    Meanwhile, the organizers said that abstracts for poster presentation could be submitted until March 31.

    Abstracts should be submitted on-line, via the conference registration system at: https://gfn.net.co/programme/submit.

    Registration for the conference is open.

  • Dust-up in Bangladesh

    Dust-up in Bangladesh

    At least 20 ‘tobacco dust factories’ in the Kaliganj and Aditmari upazilas (sub-districts) of Bangladesh have been in operation for years, without official permission and posing ‘serious health hazards’ to thousands of locals, according to a story in The Daily Star.

    The factories apparently process the tobacco dust into smokeless tobacco products such as jarda and gul.

    The story reported that, on the roadside at Baninagar village in the Kaliganj upazila, five such ‘illegal’ factories have been in operation for the past eight years.

    The factories have been set up in the vicinity of homes, a primary school and a village market.

    Locals said that though they had complained repeatedly to the appropriate authorities, the factories had not been closed. They did not know why.

    A student was quoted as saying that he and his fellow students had to hold their noses while passing the factories on their way to and from school so as to protect themselves from the wretched smell.

    And a local shopkeeper said that whenever the dust factories were in operation, he was unable to stay for long at his shop.

    But an owner of one of the tobacco dust factories at Baninagar village said tobacco dust did not pollute the environment and that the factories provided employment opportunities for many locals.