Category: Print Edition

  • A Tough Tobacco

    A Tough Tobacco

    The market for classical oriental tobacco faces many challenges—but this is a hardy business that has survived difficult times before.

    By George Gay

    There seemed at the end of last year to be a consensus among experts in the production and marketing of classical oriental tobaccos (COTs) that demand for this type of leaf is falling and is likely to keep falling. Of course, such a reckoning includes a prediction, and predictions are generally fraught, but I think that what the experts I spoke with were saying is indisputable given that in the future there isn’t some currently inconceivable change in the perceived relationship between tobacco and health.

    At first sight, this forecast seems to provide a grim outlook for COT growers and merchants, but I think it’s too early to get out the mourning bands. The COT industry, focused on the Balkans, has faced many headwinds in the past, and it has survived—sometimes reduced in size, sometimes on a firmer, more predictable footing, but it has innovated and survived. And, from what I have been told, the challenges it faces at the moment seem likely to bring about a decline that will be manageable given that, in any case, the future will almost certainly see a supply side atrophying of tobacco growers and tobacco communities as they turn to other, more modern opportunities and activities.

    The ‘threat’ of vaping

    Currently, the threat to COT demand comes, mainly and not surprisingly, from the fall in consumption of combustible cigarettes that use COT in their blends, a decline that has a number of causes, including greater health awareness among consumers, increasing retail prices caused largely by tax rises and the availability of alternative, less risky tobacco and nicotine products.

    But at this point, the risk posed to the industry becomes almost impossible to assess because of the complexities thrown up by the characteristics of particular markets. For instance, the biggest threat to COT would arise if vaping became acceptable to health advocates and, therefore, governments around the world and to smokers of all stripes. But this is highly unlikely to happen in short order, and, moreover, in certain markets, a switch to vaping would have little effect on demand for COT. You have only to look at the U.K. market to realize that this is true. Vaping is generally supported by the government there and, partly as a consequence of this support, it has had considerable success in switching smokers from combustible cigarettes to electronic cigarettes. But since the sale in the U.K.—a mainly Virginia blend market—of combustible cigarettes that use COT is low, the effect on COT demand has probably been so small as to be unmeasurable.

    If you then turn your attention to the U.S., however, where sales of combustible cigarettes containing COT are high, a major, sustained switch to vaping would have a significant effect on COT demand. But in the U.S., health agencies have consistently delivered inconsistent messages about vaping with the result that the switch to vaping has almost certainly been restrained. In fact, this year has seen vaping take at least a couple steps back in the U.S. as misleading information about the causes of acute lung disease among people using vapor devices has been circulated by officialdom. At the time of writing in the middle of December, it seemed that the rate of switching back from vaping to smoking was falling, but much damage has been done to the vapor industry, and it is likely that the COT industry will have been one beneficiary of this. The likelihood is that this benefit will be short lived, but there is no knowing whether the skittish health agencies in the U.S. might latch on to future vaping scares that will reinvigorate demand for combustible cigarettes.

    It is also possible that the imposition of vapor product taxes will slow the switch to vaping in the U.S. and other countries.

    Around the world, the picture is mixed, with some countries banning or restricting vaping while others support it or at least tolerate it. But the only way to judge the impact of such policies on the consumption of COT is to know whether the market in question is a Virginia blend or an American blend market. I take it that the ban on vaping in India, a largely Virginia blend market, will have a minimal effect on the consumption of COT, but a ban on vaping in the Philippines, a largely American blend market, will help maintain demand for COT and even, in the short term, boost it slightly.

    Another alternative to combustible cigarettes, the heat-not-burn (HnB) cigarette, does not pose the potential long-term existential risk to COT that is posed by e-cigarettes because, as I understand it, COT is a useful ingredient in HnB products—at least in their current iterations. But given the small amount of tobacco used in HnB products, any switch from American blend combustible cigarettes to HnB poses a risk.

    This risk level must have been raised when the U.S. Food and Drug Administration issued one of its rare marketing orders in favor of Philip Morris International’s (PMI) HnB product IQOS. Although it is still to be seen how U.S. consumers will take to this new-to-them product, it must represent one of the issues raising anxiety levels within the COT industry. And the industry must already have been concerned since all the multinational tobacco manufacturers now offer HnB products and especially since PMI has been aggressive in making the point that it wants people to quit combustible cigarettes or, where they are unable to do so, switch to its HnB products. 

    The threat of taxes

    Combustible cigarette tax increases have always posed a threat to consumption that is more acute in respect of the generally more expensive combustible cigarettes that contain higher levels of relatively expensive COT, especially the higher grades of COT. But the industry has tried to ameliorate this situation by modernizing what were highly traditional farming and processing systems and thereby reducing costs. There are limits to what can be done in a short space of time, however. Trials have to be conducted if such changes are to be introduced because it is presumably important to ensure that the special characteristics of COT aren’t destroyed or drastically reduced by whatever changes are made.

    One widely ignored consequence of tax increases is the boost they give to the illegal trade in illicit combustible cigarettes, and one of the experts I spoke with said that this trade was “growing substantially,” mainly in Africa, the Middle East and the Far East in countries where borders were not well controlled.

    It is often said that such illicit cigarettes do not contain the finest ingredients, one of which is COT, so any increase in sales of illicit cigarettes on a world market in decline is likely to negatively affect demand for COT, though this effect is likely to not be as pronounced as it might have been given that the regions mentioned would have markets with substantial, perhaps in some cases majority, sales of Virginia blend cigarettes.

    The question of taxes is further complicated by World Health Organization policies, which on the one hand encourage tax increases on combustible cigarettes, but on the other attempt to “eliminate” the illegal tobacco trade through the employment of track-and-trace systems and undermine the switch by consumers from smoking to vaping.

    Geographic spread

    Another issue that arises in respect of any reduction in demand for COT concerns where the consequent fall in production will occur, assuming that the drop in demand is so big that it cannot be accommodated by the normal season to season volume and quality ups and downs that affect any agricultural product—meaning that contracted volumes have to be systematically reduced.

    It is, of course, impossible to say whether any production cuts that might have to be made would be shared equally across all producing countries, fall more heavily on some countries than on others or affect some varieties more than others. However, looked at from the other direction, currently, the industry in North Macedonia appears to be the most stable production wise, partly because of the popularity among manufacturers of the Prilep variety that it grows but also because growers there receive, on top of the commercial prices paid for their leaf, national subsidies described by one expert as “considerable.”

    Production levels in Turkey tend to be less stable than those in North Macedonia, but Turkey has the advantage of having a relatively big crop made up of a number of sought-after varieties, including the biggest COT crop produced anywhere, Izmir, and taking in the Izmir East variety, which, if I’m not mistaken, might be better described as a semi-oriental tobacco, though one whose price and characteristics make it attractive to some manufacturers.

    Turkey, at the moment, has an advantage because the lira exchange rates against the dollar and euro are helping to make its production competitive. And it has a potential advantage in a proposed law that is apparently being worked on by the Ministry of Agriculture and that is due to be announced soon. The new law would oblige Turkey’s tobacco manufacturers—British American Tobacco, Imperial, Japan Tobacco International, KT&G and PMI—to reach within three to four years a 30 percent inclusion rate of locally produced tobacco within their local market cigarettes. Assuming such inclusion rates are currently below that level, this move would have a positive effect on Turkey’s tobacco industry, which includes COT, flue-cured Virginia and sun-cured Virginia.

    Meanwhile, production levels in Greece tend to go up and down while production levels in Bulgaria seem to be on a generally downward trajectory.

    The 2019 crop of COT was grown under good weather conditions and did not suffer any significant diseases or losses. As a result, the volume was close to the contracted quantities, and qualities are thought to be above average. The one exception seems to have been Turkey’s Samsun crop, which suffered untimely rains and is thought to be of below average quality.

    Overall, however, the 2019 crop of COT is bigger and of better quality than that of 2018, which was badly affected by untimely heavy rain and which one expert described as “disastrous.” For this reason, grade yields were low in respect of 2018 crop tobaccos, which meant reduced profitability for merchants, who will be hoping for, and should be rewarded with, better things from the 2019 crop. Merchants will be hoping too that since the 2019 crop is close to contracted volumes, there will be no or little leftover stock when marketing is completed. In fact, one expert mentioned that it would be an “unpleasant surprise” if significant amounts of 2019 crop COT remained unsold.

    Nevertheless, according to one estimate, the 2019 crop of COT (including Izmir East tobacco) produced in Turkey, North Macedonia, Greece and Bulgaria stands at 117,000 tons, and three years ago, back-of-the-envelope figures had it that a stable COT crop was about 100,000 tons. Crops of 120,000 tons were said to threaten a buildup of stocks while crops below 100,000 tons were reckoned to threaten scarcity.

    Broken down, the 2019 estimate had it that Turkey had produced about 70,000 tons made up of 50,000 tons of Izmir, 9,000 tons of Izmir East, 5,000 tons of Samsun, 5,000 tons of Basma and 1,000 tons of Prilep. North Macedonia is estimated to have produced a total of 26,000 tons made up entirely of Prilep while Greece is estimated to have grown 16,000 tons made up of 11,000 tons of Basma and 5,000 tons of Katerini, and Bulgaria is estimated to have grown about 5,400 tons comprising 4,600 tons of Krumovgrad, 600 tons of Katerini and 200 tons of Basma.

    From the supply side, production of COT seems assured at the levels now in demand. It would be wrong, as always, to describe growers as happy because, in their eyes at least, input costs will usually be too high, leaf prices too low and labor issues too difficult. But then again, in Turkey, growers are said to be receiving cash advances worth up to 50 percent of the value of their contracted volumes—in essence, interest-free loans at a time when inflation is above 20 percent, loans that can also be used to support the production of other crops. Certainly, there was no suggestion that growers in any of the producing countries were about to down tools.

     

    The author would like to thank the following, listed in alphabetical order, for their help in preparing this story: Nikos Allamanis, president of the board of directors of the Hellenic Association of Tobacco Processing and Trading Industries; Frederick De Cramer, coordinator of Sunel; Dora Gleoudis, managing director of Nicos Gleoudis Kavex; and Nikos Tzoumas, managing director of Missirian and president of the Hellenic Inter-professional Organization.

     

    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.

  • Europe’s Conflicted Stance

    Europe’s Conflicted Stance

    Vaping, yes, snus use, no—the European Union has failed to craft a coherent tobacco harm reduction policy.

    By Stefanie Rossel

    It’s a curious situation: In terms of vaping and snus regulation, the EU is like a distorted reflection of the United States. While in October 2019 the U.S. Food and Drug Administration (FDA) authorized Swedish Match to advertise eight of its General snus smokeless tobacco products as less harmful than cigarettes, the European Court of Justice (ECJ) in December 2018 reaffirmed the EU ban on snus sales, arguing that all tobacco consumption should be reduced and that snus could be a gateway to combustible cigarettes. In the EU, snus can be consumed only in Sweden, which enjoys an exception on cultural grounds.

    In contrast, e-cigarettes are largely tolerated across the EU; in the U.K.—the EU’s largest vapor market—health authorities even actively promote e-cigarettes as quit-smoking aids. In the U.S., meanwhile, vapor products are increasingly demonized following an outbreak of vaping-related deaths and illnesses linked primarily to black market THC products.

    Europe’s vaping landscape appears relaxed by comparison. The EU has thus far been spared the vaping sickness that has caused least 2,400 injuries and 50 deaths in the U.S. Although e-liquids are available throughout the EU in many flavors—including the sweet dessert-like tastes that have been termed “child-appealing” in the U.S.—there seems to be less concern that vaping is a gateway drug luring otherwise uninterested teens into a lifetime of nicotine use.

    Studies published by the German e-cigarette trade association Verband des eZigarettenhandels in June 2019 show that only 0.9 percent of 14-year-old to 17-year-old Germans use e-cigarettes—down from 2.8 percent one year earlier—despite the rapid growth of the segment and the continuously expanding availability of products.

    In the U.K., a mere 1.6 percent of 11-year-olds to 18-year-olds use vapor products more than once a week. Only 0.6 percent use them daily. This compares to 28 percent of high school students in the U.S. who reported using nicotine e-cigarettes in the past 30 days in 2019, up from just over 20 percent in 2018, according to a study published in JAMA in November 2019. Among middle schoolers, that rate rose from 5 percent in 2018 to 11 percent in 2019.

    When U.S. President Donald Trump called for a ban of all nontobacco flavored e-liquids in the wake of the vaping scare, Public Health England (PHE) reiterated its stance on vaping, which it considers to be 95 percent less harmful than traditional smoking, as a cessation tool.

    While the U.K. remains a forerunner in terms of vaping policies, PHE’s approach is nevertheless symbolic of the different attitudes on both sides of the Atlantic. In the U.S., numerous tobacco lawsuits over the past decades have contributed to the perception of e-cigarettes as a potential gateway to smoking combustible cigarettes. Conversely, the EU has embraced vapor products as a tool to discourage smokers from consuming the significantly more hazardous combustible cigarettes. By doing so, the economic community acknowledged the continuum of risk concept. It also drew inspiration from harm reduction initiatives in other areas, such as HIV prevention. Instead of embracing prohibition, many EU countries sought to limit infection by providing drug users with clean needles and sex workers with condoms. 

    Regulated market

    Contrary to the U.S., the EU admitted e-cigarettes to the market under strict regulations. Article 20 of the EU’s Tobacco Products Directive (TPD2) sets safety and quality standards for vapor products and refill containers. Among other things, it restricts the amount of nicotine to 20 mg per mL of e-liquid. By comparison, the most popular vapor product in the U.S., Juul, contains 59 mg per mL of nicotine.

    Furthermore, the TPD2 limits the capacity of e-cigarette tanks to 2 mL and the maximum volume of cartridges to 10 mL. The directive prohibits the use of certain ingredients, including taurine, colorings and caffeine in e-liquids. Vaping liquids that contain THC, the psychoactive constituent of cannabis, or vitamin E acetate, the two substances that have been singled out as likely culprits for the vaping-related illnesses in the U.S., are hard to find in Europe.

    The TPD2 also regulates the packaging and labeling of vapor products. For example, mandatory health warnings advise consumers that they contain nicotine and should not be used by nonsmokers. Packaging must include a list of ingredients and disclose the product’s nicotine content.

    The legal age for purchasing vapor products is 18. E-cigarette advertising in print, on television and radio is limited, and vapor companies are prohibited from targeting teens. Before marketing their products in the EU, manufacturers and importers must register them electronically. In general, it is the responsibility of the producer to ensure that their products comply with the TPD2.

    “Due to the characteristics of e-cigarettes, and in particular their nicotine content, it was deemed appropriate to consider them as tobacco-related products and to include them in the scope of the directive,” says Vivian Loonela, spokesperson of DG Sante, the European Commission’s Directorate-General for Health and Food Safety. “Given the lack of conclusive evidence related to the long-term health effects of e-cigarettes, their use patterns and potential to facilitate smoking cessation, Article 20 of the directive adopts a careful approach to their regulation, allowing these products to remain available to consumers.”

    Thanks in part to this cautious regulatory approach, vaping has become increasingly popular across the EU and contributed to a decline in smoking, most notably in the U.K. According to an annual population survey, smoking prevalence among adults aged 18 and over in England declined by 5.4 percentage points from 2011 to 2018. In 2011, 19.8 percent of adults smoked, falling to 14.4 percent in 2018, equivalent to a drop from 7.7 million smokers in 2011 to 5.9 million in 2018. Action on Smoking and Health (ASH) estimates that around 7.1 percent of Great Britain’s adult population, or 3.6 million people, currently use e-cigarettes. Although the decrease in smoking came at a time when stricter tobacco control measures, such as plain packaging for combustible cigarettes, were implemented, e-cigarettes are believed to have played a significant role in the decline.

    The snus phenomenon

    The European Commission has managed to regulate new nicotine-delivery devices without full scientific evidence about the long-term health effects of the new products. While not claiming that vapor products are harmless, the commission proceeded on the assumption that they were a less hazardous alternative to traditional cigarettes. In this light, the EU’s negative attitude toward snus is difficult to comprehend. Snus is pasteurized oral tobacco that is available as loose products or in small pouches and has been used in Sweden for about 200 years. When Sweden applied for EU membership in 1995, it was exempted from the snus ban on cultural grounds.

    Sweden stands out internationally because of its low smoking rates. According to Statista.com, 7 percent of Swedes smoked in 2016. Across the EU, the figure was 25 percent during that period. Sweden also has remarkably low rates of tobacco-related illnesses among men, low smoking-related mortality rates and the lowest risk of lung cancer among industrial countries—even though the country’s overall tobacco consumption is comparable with that of other European countries.

    This paradox is widely attributed to Swedish tobacco users’ preference for snus over cigarettes. In contrast to the young e-cigarette category where little is known about the long-term risks of vaping, the long-term health effects of snus have been documented by a plethora of epidemiological studies over the past decades. While not risk-free, using snus is associated with lower risks of cardiovascular diseases and cancers than smoking. Studies have shown that the change from combustible cigarettes to snus brings about a drastic decline in health risks and that snus use is not related to oral cancer. According to research, using snus is about 90 percent to 95 percent safer than smoking, which puts the product basically on par with e-cigarettes.

    Incoherent approach

    Despite this scientific evidence and the similarities between the e-cigarettes and snus in terms of their potential for harm reduction, the ECJ endorsed the snus ban last year. “There should be no confusion between use of snus and use of electronic cigarettes,” says Loonela. “With regard to the latter, the commission continuously monitors developments related to e-cigarettes, including emerging scientific evidence. This information will contribute to the implementation report on the directive that the commission is required to submit in 2021.”

    The snus ban, she says, is appropriate considering the directive’s objectives—to facilitate the functioning of the internal market and protect human health. “It is undisputed that oral tobacco is addictive and has adverse health effects,” says Loonela. “The negative health effects of snus and other types of smokeless tobacco were confirmed by the Scientific Committee on Emerging and Newly Identified Health Risks in 2008. The committee concluded that all smokeless tobacco products contain carcinogenic substances, albeit at different levels, and are associated with a number of adverse health effects. It was further concluded that smokeless tobacco in all its forms can cause cancer, increases the risk of death after myocardial infarction and is addictive.”

    That argument is remarkable considering that the sale of combustible cigarettes and other smokeless tobacco products remain legal in the EU. Loonela acknowledges that there is no harmonized EU approach on harm reduction. “The commission has consistently given the message that e-cigarettes pose a risk to health and snus is banned in the EU, with the exception of Sweden,” she says.

    The EU stance on snus resembles the “quit-or-die” attitude advocated by the World Health Organization. In upholding the snus ban, the ECJ followed a line of reasoning strikingly similar to that put forward by proponents of an e-liquid flavor ban in the U.S. The court argued that if snus products were introduced to the EU market, they would be novel compared with already available combustible products and smokeless products, and they would accordingly be attractive to young people.

    By upholding the ban on snus, the EU has missed a chance to implement a consistent tobacco harm reduction policy. A 2017 study by the Swedish Snus Commission found that if every EU member state had the same tobacco-related mortality rate as Sweden, around 355,000 lives would be saved each year.

     

     

     

    Picture of Stefanie Rossel

    Stefanie Rossel

    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.

  • Taking Charge

    Taking Charge

    To prevent a regulatory overreaction, the vapor industry needs to self-regulate its use and marketing of flavors.

    The use of flavors in e-cigarettes is the hottest topic in this disruptive industry. Manufacturers’ use of flavorings in e-cigarettes has come under intense scrutiny and is a piece of ammunition often used by those looking to impose stringent regulation on the industry. As we enter 2020, it is perhaps an opportune time to look back at the tumultuous happenings of the past couple of years to examine where the flavor debate has taken us and what we might expect to see in the future.

    The inclusion of flavors in e-cigarettes poses many challenges for the industry. Broadly speaking, these challenges fall into three categories: the toxicological impact, the effects on vaper behavior and nicotine delivery, and perhaps most importantly, the impact on population level use among different user cohorts. It is the latter that poses an existential threat to the e-cigarette industry and to its ability to provide a reduced harm alternative to deadly combustible cigarettes.

    The potential toxicological impact of flavored e-cigarettes is a relatively simple issue to address. By utilizing robust product stewardship procedures assessing the inclusion of flavor ingredients, utilizing literature and computational approaches to ingredient assessment and utilizing rigorous testing of e-cigarette emissions, manufacturers can easily provide reassurance to consumers that their products are safe. The impact on vaper behavior is another relatively simple issue to consider, and we are now beginning to see scientific evidence showing that flavorings in e-cigarettes can cause differences in nicotine delivery, likely secondary to effects on human puffing behavior (topography).

    The greatest challenge comes with assessing the population level impact of e‑cigarette flavors. It is often stated that flavored e-cigarettes are beneficial in assisting adult smokers who want to quit smoking. There is good evidence for this—for example, research carried out by the Centre for Substance Use Research in U.S. adult vapers concluded that those who have completely switched from smoking cigarettes to using e-cigarettes are increasingly likely to have initiated e-cigarette use with nontobacco flavors and to have transitioned from tobacco to nontobacco flavors over time.1

    More recent longitudinal data from the same group similarly demonstrated that the use of Juul “characterizing” flavors (e.g., mint and mango) was associated with greater odds of quitting combustible cigarette smoking. The U.S. Food and Drug Administration (FDA) acknowledges the support that flavored e-cigarettes provide to smokers; in warning letters sent by the FDA in September 2018 to a number of U.S. manufacturers, the agency describes the “emerging evidence that some adults may potentially use certain flavored tobacco products to transition away from combusted tobacco use.”2 Analyses of the FDA’s own Population Assessment of Tobacco and Health data have shown an association of nontobacco-flavored e-cigarette use with smoking cessation.3

    The concern, though, is not this “off-ramp” for adults, a term used by the former FDA commissioner, Scott Gottlieb, to describe transitioning away from cigarette smoking, but the “on-ramp” for youth use of e-cigarettes and the potential for teens initiating nicotine use through flavored e-cigarettes.4 Action from the FDA on flavored e-cigarette use has arisen due to data from the U.S. National Youth Tobacco Survey (NYTS) showing an escalation of youth use of e-cigarettes, something the FDA terms an “epidemic.” While the use of such a term is perhaps an overstatement of the scale of the issue as recent analyses of NYTS data show very little frequent use of e-cigarettes by teens and particularly by those who have never used other nicotine-containing products,5 it is difficult to argue against the need for action against what is an escalating concern, regardless of its current scale.

    The recent publication of further NYTS data fueled the crisis and has led to stronger calls for regulation of the industry and for the curbing of flavored e-cigarette availability. However, there are no easy solutions, perhaps evidenced by the ever-changing nature of the regulatory measures being discussed and recent data that suggests that even when some flavors are removed from store shelves and online marketplaces, switching to other flavors takes place. Even with the recent U.S. presidential intervention, we still do not have clear sight of what the future marketplace for flavored e-cigarettes will look like or as to what regulatory interventions will take place. And even in the absence of reactionary regulatory measures, the FDA will soon have greater discretion over which flavors are allowed to be sold in the U.S. through its premarket tobacco product application approval procedure.

    Clearly, the industry needs to self-regulate since regulatory action, and especially knee-jerk regulatory action, often comes with unintended consequences that may do more harm than good. Many manufacturers have taken such proactive approaches, but there still remains on sale a vast number of e-cigarettes with flavor names and marketing materials that can be seen as targeted toward youth. If such marketing practices are not curbed by manufacturers themselves, regulators will perform this function for them—and with a potentially poor outcome.

    It is worth noting that the impact of the U.S. flavor debate is being felt elsewhere. Some Canadian provinces, for example, have outlined their proposals to regulate flavored products. Importantly, we must remember that in the European Union, the Tobacco Products Directive (TPD2), a union-wide directive that regulates e-cigarettes, is due for revision soon. As in the U.S., it is expected that regulatory measures in TPD3 could involve restrictions on flavored e-cigarettes.

    Undoubtedly, e-cigarettes have the potential to help reduce the global burden of death and disease caused by combustible tobacco smoking. Further, without doubt, they are a greater tool in helping smokers quit than licensed pharmaceutical products. However, improper regulatory measures may stifle the good that e-cigarettes are doing by limiting smokers’ access to the very products that are helping them quit. But perhaps with some sensible industry self-regulation, as a proactive measure to curb youth use and appease regulators, the widespread reductions in smoking prevalence caused by e-cigarettes will continue for the benefit of smokers and for global public health.

    Picture of Ian Fearon

    Ian Fearon

    Ian Fearon is the director of whatIF? Consulting. He contributed this article on behalf of Broughton Nicotine Services .

  • Correcting the Narrative

    Correcting the Narrative

    The nuances in the vaping debate have been drowned by the media hype.

    By Dan Marchant

    In the past months, vaping has been under an unprecedented attack from the media, politicians and “health professionals.” Headlines have been filled with stories about a deadly lung disease, an “epidemic” of youth vaping and potential bans of flavored e-liquids.

    But why the sudden media furor?

    Last August, stories began to emerge from the U.S. regarding a mysterious lung disease that had started to affect multiple people. Information was sparse, but fairly quickly, both the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) began to warn that this disease, which had by now killed more than one victim, was in some way vaping related. They advised that all vaping should cease—and thus the touch paper was lit.

    However, it became clear early in these investigations that there was a conflation between vaping as an alternative to smoking and vaping as a delivery mechanism for illicit drugs. Many experts had already identified black market THC (the psychoactive ingredient in marijuana) vapor products as the likely culprit, specifically products that contained a substance called vitamin E acetate.

    Yet both the FDA and the CDC continued to warn against the use of all vapor products because not all the patients had reported using THC. At this stage, something like 70 percent to 80 percent had admitted drug use, but many had not.

    What could have stopped this confusion? It would be normal in such circumstances for the CDC to advise medical practitioners to take a urine sample from all the cases, allowing them to determine beyond a doubt whether patients had been using THC (or other drugs). But for some reason, this was not done, and they had to rely on people, who for many reasons may not be forthcoming, being honest.

    As time went by, unfortunately, growing numbers of people were hospitalized with the illness, and the death toll was rising. By Sept. 11, President Donald Trump gave a speech in which he combined concerns about this outbreak with concerns about the much-reported youth vaping “epidemic” in the U.S. He said that his administration was worried about vaping and would consider a nationwide ban on vapor flavors to “protect the children.”

    So now vaping was doubly under attack; both the mysterious vaping illness and the teen vaping problem were front page news, and the U.S. vapor market suffered a huge decline. Some reports estimate it to be down by 80 percent to 90 percent, putting thousands of small businesses at risk. Even the U.K. vapor business declined by an estimated 30 percent despite the fact that it didn’t experience a spike in youth vaping or an outbreak of vaping-related illnesses.

    As the story unfolded, evidence piled up that black market THC products were behind the outbreak of lung disease. The illicit products contained vitamin E acetate, which is used to “cut” the product so that it vaporizes more easily and requires less THC distillate. Unfortunately, vitamin E acetate has oil-like properties and when inhaled, it can cause lipoid pneumonia. Oil deposits in the lungs and impairs their function, which can be fatal.

    To the outside world, it was clear that this was a U.S. problem; no cases of this illness were reported outside of America. If the injuries were caused by legitimate vapor products used by consumers as a less harmful alternative to cigarettes, then vapers would have been falling ill all over the world—but they haven’t been.

    By Oct. 4, the FDA realized the same and updated its warnings to say that consumers should avoid THC vapes. But the CDC waited to update its advice until December. Now both organizations are suggesting that consumers who vape as an alternative to smoking should continue—but it’s too little, too late. The damage has been done, and the headlines have moved on before health experts could correct the narrative.

    Unfortunately, the U.S. seems to have a big problem with youth access to vaping. The situation in the U.K. is quite different. The latest statistics from Action on Smoking and Health show that just 1.6 percent of 11-year-olds to 18-year-olds vape regularly (once a week or more) and 1.5 percent were previously smokers. And note that these figures include 18-year-olds, who are legally allowed to buy and use the products in the U.K.

    In the U.S., by contrast, 20.8 percent of U.S. high school students are classified as “current” e-cigarette users. The U.S. figures cannot be compared directly to those of the U.K., however. For starters, the FDA defines a “current” user as somebody who has vaped in the past 30 days. It is also rumored that the U.S. statistics include any type of vaping, including that of THC, so there could be some confusion on the actual numbers. Nonetheless, there has clearly been a much bigger uptake of vaping in the U.S. than in the U.K. But why?

    The answer is regulations. The U.K. and the U.S. have very different rules for vapor products. The U.K. implemented the EU Tobacco Products Directive in 2016, and this brought strict regulations for electronic cigarettes. These laws ensure the quality and safety of the nicotine-containing products on the market. They ensure that devices and e-liquids are tested for safe emissions, do not contain banned ingredients (ones we know could be harmful) and impose nicotine limits.

    The U.S. does not have anywhere near the same level of regulations. In August 2016, the country implemented its “deeming regulations” on vapor products. This meant no new product could be brought to market after Aug. 8, 2016, but those already available could continue to be sold until May 2020, by which time they must submit to the FDA a premarket tobacco product application. As of June 2019, all products on the market should have submitted information such as ingredients listings. However, there is as yet no list of banned ingredients or any testing requirements.

    Most importantly, the U.S. does not restrict the amount of nicotine in vapor products. The EU and the U.K., by contrast, limit nicotine to 20 mg per mL of liquid. While some have argued that this may be too low to help the heaviest smokers switch from combustible cigarettes, the limit ensures that consumers don’t receive too much nicotine in one go.

    In the U.S., there has also been a huge rise in the popularity of small “USB stick” devices, which use pre-filled pods containing 50 mg to 60 mg of nicotine per mL. This is too much for many adults, let alone for a teenager with smaller body mass who has not built up nicotine tolerance. Such a dosage essentially gives them a brief high. And this is a major contributing factor toward the youth access issues in the U.S.

    Another big problem is caused by retailers who illegally sell these products to minors. It is right to be outraged by so many youngsters getting their hands on vapor devices, but the outrage should be directed at the illegal sellers not the products. After all, vapor products have saved the lives of millions of adults who would otherwise have succumbed to one of the many smoking-related illnesses that kill 50 percent of all smokers.

    It’s been a hard year for the vapor industry and its customers. What’s worse, amid the media hype and confusion, many vapers have returned to smoking combustible cigarettes; 2019 might be the first year in decades that smoking rates have increased in the U.K. Needless to say, this is a disaster for public health and for tobacco control.

    On the bright side, throughout the uproar, Public Health England has maintained its stance that vaping is 95 percent less harmful than smoking. It has defended flavors as playing a vital role in helping people switch from smoking combustible cigarettes, and it has cited regulations as a reason that the U.K. has been spared an outbreak of vaping-related illnesses.

    This gets little coverage, unfortunately. We need the media to help get this message out to the hundreds of thousands of vapers who have been scared by these stories and reassure them that vaping is still far less harmful than smoking.

    Picture of Dan Marchant

    Dan Marchant

    Dan Marchant is the owner of Vape Club and a founding member of the U.K. Vaping Industry Association

  • Merchants of Doubt

    Merchants of Doubt

    Photo: Airdone – Dreamstime.com

    In the vaping debate, falsehood flies and the truth comes limping after it

    For those of us who support the public health strategy of tobacco harm reduction, it has been a tough few months. Several crises emerged suddenly and the boundaries between them have become blurred: an outbreak of severe lung injuries and deaths, a sharp rise in youth vaping in the United States and the claim that e-liquid flavors are the problem and should be banned.

    The satirist Jonathan Swift summed it up pretty well in 1710:

    “Falsehood flies and truth comes limping after it so that when men come to be undeceived, it is too late; the jest is over, and the tale hath had its effect; like a man, who hath thought of a good repartee when the discourse is changed, or the company parted; or like a physician, who hath found out an infallible medicine, after the patient is dead.”

    What can be done? Falsehood has certainly flown, but could the truth at least break into a jog? Let us examine these crises and try to determine what is true and what is false.

    Vaping causes severe lung injury and death: true or false?

    As of early December, 2,291 vaping-related lung injury hospitalizations and 48 deaths had been recorded in the United States. Many have assumed nicotine e-liquids are implicated. Because the problem emerged in a specific place (the United States) and at a specific time (from July 2019), it was already clear in July 2019 that this was a specific supply chain problem. It had not affected vaping before and had not affected the millions of vapers in the rest of the world. It soon emerged that the cases were dominated by specialized vapes used for cannabis THC oil. The focus should, at that point, have narrowed to the illicit THC vape suppliers with a clear message exonerating commercial nicotine liquids. Instead, major public health agencies became “merchants of doubt,” maintaining that any vapor product was suspect. However, the chance of a parallel problem occurring in the legal and regulated nicotine e-liquid supply chain at the same time, in the same geography and with the identical symptoms is vanishingly small. 

    A minority of the users afflicted had denied or refused to confirm use of THC, so there was some doubt. Of course there was doubt! People do not readily admit to using illicit substances because it can get them into trouble with parents, at school or college, or with their employer. Whenever actual tests were done or when users were pressed harder to tell the truth, THC vaping reliably emerged.

    The mystery doesn’t end there because THC oil itself is not the issue—there are many THC vapes that do not cause this problem. The investigation narrowed further to identify vitamin E acetate as one likely cause. This is used as a thickener to cut expensive THC oil for economic reasons. This is a lipid, a fatty substance that can have exactly the effect on the lungs that has been seen. There is no question of this being added to nicotine liquids. It is not soluble in nicotine liquids and would serve no purpose as there is no reason to thicken nicotine liquids.

    The truth: The lung injuries are a serious problem, but they are nothing at all to do with commercially available nicotine e-liquids. The ultimate problem here is a black market supply chain opportunistically experimenting with novel and untested formulations with no accountability for health consequences. To pretend otherwise is to cause three harms: sending a diluted and contradictory message to THC vapers that may put more lives at direct risk; frightening regular nicotine vapers back to smoking and smokers away from vaping with longer term health consequences; and promoting bad policy responses, like flavor bans, that will tend to increase black market activity and make the problem of adulteration in the supply chain more likely and vaping more risky.

    There is a youth vaping epidemic: true or false?

    The falsehoods here lie in the interpretation of the headline statistics—what you see if you drill down into the data. First, the headlines. In the United States, vaping among high school students rose from 11.7 percent in 2017 up to 20.8 percent in 2018 and on to 27.5 percent in 2019. A dramatic rise by anyone’s standard and undoubtedly a cause for concern.

    But there are three other factors to consider in a drill down. The headline figures refer to any use of an e-cigarette, even a single puff, in the past 30 days, so what is the breakdown between infrequent and frequent use? How many of the frequent vapers also use other tobacco products? For them, vaping may be beneficial. The rise in youth e-cigarette use has been described as an “epidemic of nicotine addiction.” How many show signs of dependence?

    The data to address these questions is only available for 2018, but this breakdown of the headline 20.8 percent vaping figure provides a useful illustration:

    NYTS 2018 data

    Percentage of high school students using e-cigarettes Total = 20.8%

    High school students

    No past tobacco use

    Any past tobacco use

    Frequent e-cig use: ≥ 20

    days per month

    0.6%

    5.2%

    Infrequent e-cig use: ≤ 19

    days per month

    4.7%

    10.3%

    First, most adolescent vapers (72 percent) are not frequent users and therefore provide less reason to be concerned. Second, most of the frequent adolescent vapers (90 percent) were already tobacco users. Only 0.6 percent of high school age vapers are both frequent users and have no prior history of tobacco use—and it is also important to recall that smoking is much more harmful than vaping, but in 2018, 13.9 percent had used any combustible product in the past 30 days. Smoking remains the bigger problem.

    Turning to the third question of dependence, the analysis of U.S. youth e-cigarette data by epidemiologists Martin Jarvis and colleagues (Epidemic of youth nicotine addiction? What does the National Youth Tobacco Survey reveal about high school e-cigarette use in the USA?) shows little sign of teenage vaping uptake causing nicotine addiction.

    “Data from the National Youth Tobacco Survey do not support claims of a new epidemic of nicotine addiction stemming from use of e-cigarettes …. Among current e-cigarette users who had never tried tobacco products, responses consistently pointed to minimal dependence.”

    The truth: Many young Americans are trying vaping, but most are not vaping frequently, and it isn’t an especially dangerous youth behavior compared to smoking, using illicit drugs and using alcohol excessively. The frequent or daily vapers are mainly those using other tobacco products. For them, vaping may be a beneficial diversion from smoking. There is reason for concern, but there should not be an overreaction.

    The rise in U.S. youth vaping is driven by flavors: true or false?

    At one level, it is obvious that e-liquid flavors are important—if vendors could only sell unflavored products, there would be few buyers of any age. E-cigarettes are an inherently flavored product in much the same way that pizza would not be pizza without a topping.

    There is much to suggest that flavors form part of the appeal, but they are not the main reason why young people take up vaping. The story is far more complicated: The more credible academic work (e.g., see Nicksic et al. 2019) suggests uptake of vaping is driven by replacing cigarettes and by the “wider social environment.” Flavors are a factor, but they are far from the most important factor. The most recent official analysis of U.S. youth data included reasons for youth vaping uptake (MMWR Table 6). The most important reason given was “I was curious about them,” cited by 56.1 percent of exclusive e-cigarette users. “They are available in flavors, such as mint, candy, fruit or chocolate” came a distant third at 22.3 percent.

    The idea of limiting flavors to just tobacco flavor would be like limiting pizza toppings to allow only a simple Marherita. In both cases, it would kill the category and shut down all the vape shops. The likely response would be an uptick in smoking, a black market in flavored products, home flavor mixing and more international internet trade. No one would gain, and many would lose.

    The high score for curiosity raises an intriguing question. Has the barrage of breathless media coverage, official school-based anti-vaping campaigns, parent mobilization and political outrage actually been a stimulus for youth curiosity about vaping? Is the reaction part of the cause? We can safely assume that no one involved will fund that research.

    The truth: The reasons young people take up vaping are similar to the reasons they take up smoking and can include unpredictable and largely uncontrollable fads and fashions. Vapor products would be nothing without flavors, and banning them would have a range of harmful effects and do little to protect youth from actual harms. If governments want to control flavors, they should focus on flavor descriptors and branded imagery that are aimed at adolescents, not the actual flavors themselves.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Hauni’s Astonishingly Flexible Filter Maker

    Hauni’s Astonishingly Flexible Filter Maker

    Hauni has just released an astonishingly flexible multifilter maker.

    By George Gay

    Somebody whose knowledge of packaging ranges across a lot of fast-moving consumer goods told me recently that tobacco manufacturers were good at coming up with new ideas for tobacco packs, and this seemed like quite a compliment given the restrictive regulations under which these manufacturers often operate.

    But there is another sector of the industry where, arguably, you can see even more inventiveness and variety coming through, and that is the filters sector. The evolution of the multisegment filter has reached a point where the large numbers of segments, or base rods, that can be combined and included on one cigarette, the variety of the base rods available and the various orders in which they can be brought together mean that the number of different filters that can be produced is simply enormous.

    And not only can these multifilters be produced, but they are being produced—in ever growing numbers. Cigarettes with multifilters no longer comprise a market niche; they are mainstream.

    So it is timely that Hauni’s multifilter maker, the KDF 6MF LEAD, which made its debut in November 2016 at a company exhibition and which was first sold a little over a year ago, has just been released for general sale—for sale with all its specifications to all customers.

    The “6” in the name designates its maximum capacity of 600 meters per minute, but perhaps the most important piece of information is conveyed by the “LEAD” designation. To say that LEAD stands for length and diameter, as it does, is to underplay its significance because this acronym more broadly stands for flexibility—a higher level of flexibility that Hauni is rolling out as it redesigns the machinery across its portfolio to LEAD standards.

    Klaus Masuch, who heads a department of product placement managers and who heads two of the department’s divisions, filter making and logistics, told me that such flexibility manifested itself in two distinct ways in the 6MF LEAD. First, the machine could be supplied with up to four modules, meaning that it could be used to produce a filter comprising up to four completely different base rods. And second, a three-dimensional conversion involving base-rod length, diameter and segmentation could be carried out on a three-module machine in less than six hours. To put that into perspective, a simple conversion of an early generation filter maker apparently took up to two weeks.

    Did I hear somebody ask, “A quadruple filter?” Well, I posed the same question, and yes, there are apparently at least two brands of traditional cigarettes on the market with quadruple filters. But, as Masuch explained, demand for such filters is very much being driven by the evolution of heat-not-burn (HnB) products, all of which apparently use at least triple filters and most of which use quadruple filters. In fact, he said that the 6MF LEAD could be considered to be a main component of an HnB production line. Hauni had developed a specific multisegment maker for HnB production—one that combined the tobacco rod as well as the filter base rods.

    For companies looking to control their investments but expand their portfolios of products, the 6MF LEAD can be used on the one hand to produce multifilters for regular cigarettes while on the other hand to produce multifilter components for HnB production.

    Masuch makes no bones about the fact that there is a considerable investment to be made in taking on multifilter production. It adds to production complexity by adding another step, with its accompanying logistics and increased footprint, between filter-rod production units and cigarette makers. In the case of a four module 6MF LEAD, it could be that it would be necessary to include four KDF6 base-rod makers. However, the KDF6 can be equipped with a Flexport system whereby a basic monoacetate module can be replaced with others capable of producing just about all of the base-rods currently available, including, for instance, those with charcoal, capsules, threads and channel ventilation.

    On a more general level, the 6MF LEAD, along with other Hauni machinery, has been designed to operate with maximum efficiency, which means, in part, minimum energy usage. In fact, during the past few years, energy consumption per unit output is said to have come down by something like 20 percent to 25 percent. Part of this reduction will no doubt be down to the changes that have been made so as to move to machines that use no oil, a move that has the added benefit of reducing noise levels considerably.

    Talking with Masuch, I got the impression that filter makers and combiners were becoming increasingly important to Hauni’s business, and I asked him whether he was confident about the future for such machines. Absolutely, he said. With the introduction of the 6MF LEAD, the Hauni filter equipment portfolio had been rounded off and now ran from a standard, low-investment base-rod making unit up to the LEAD family of machines. This equipment allowed manufacturers to produce almost every specification of filter at different speeds, in different volumes and at different costs.

     

    Hauni’s portal comes with comprehensive features to support customers in their daily work

    With the launch of its new customer platform myPORTAL, German tobacco equipment manufacturer Hauni says it offers registered clients a new user experience in the procurement process and beyond. The portal will replace the company’s webshop, which had been live for more than two decades.

    “The biggest difference between the two platforms is that our former webshop focused on the spare and wear parts business, whereas myPORTAL is an online experience platform with an integrated webshop,” says Elena Enns, marketing communications manager at Hauni, who has been involved with the development of the new solution from the outset.

    “The target group of our old web shop was mainly purchasing managers. Now we can also address maintenance managers, project engineers, corporate functions as well as operators with relevant topics. They all will find solutions that are pertinent to their work.”

    The platform enables closer collaboration by ensuring transparency over joint projects with Hauni. A new project space allows project members to exchange documents with other members throughout the company, to create milestones and to archive projects after completion.

    Far more than a webshop

    The portal focuses on several topics—machine information, spare parts management and convenient shopping. In addition to equipment information such as serial number, delivery date and warranty status, the machinery and assets section provides users with more than 100 of Hauni’s technical improvement programs (TIPs) for the appropriate machine type and a direct link to the latest software information for specific machines. In the future, the company says, it will also offer downloads of updated machine software. A direct linkage to machine’s documentation enables users to identify spare parts from the technical documentation and load them directly into their shopping carts.

    The platform’s spare parts management service supports customers in avoiding obsolescence issues. It contains a sophisticated analysis feature that can identify obsolete electrical and electronic spare parts and their successor products. A “where used” function shows users in which machines the obsolete part is still installed.

    The webshop offers a convenient shopping experience. Beyond price, availability and customs information it allows users to compare formats with a few clicks and load up to 150 articles into their shopping cart at once. When utilizing the webshop customers receive a 2 percent discount over regular orders.

    A detailed product page instantly shows whether the part can be repaired. If repair is possible, users can initiate the process with a repair request from the platform. For customers seeking spare parts with a longer service life, the search function will indicate availability of premium versions.

    The platform also features explanatory videos, a manual and personal support.

    “This is procurement convenience at its best—beyond price and availability information, product comparison, usage of customer-specific article numbers,” says Enns. “The topics the portal covers interlock and facilitate working with Hauni machines for our customers. An intuitive and state-of-the-art user guidance leads clients through complex themes. Single-source information as well as collaboration have been completely redesigned and implemented in myPORTAL. As far as we know, such a convenient touchpoint is unique in the tobacco industry.”

     

     

     

  • Plain Packaging for RYO

    Plain Packaging for RYO

    Christian Hinz and Lisa Esser evaluate the impact of new plain packaging requirements for RYO paper packaging.

    By Stefanie Rossel

    Christian Hinz

    Plain cigarettes packaging has been around for almost eight years now. Recently, Canada and Israel took the concept to a new level, requiring, for the first time, that the packaging of roll-your-own (RYO) papers be marketed only in a standardized design. In both markets, legislators have chosen a drab brown-green color for all packaging and a predetermined typeface for the brand names. Designs or logos aren’t permitted anywhere on the package. Israel also requires a health warning in Hebrew on RYO paper booklets.

    Tobacco Reporter spoke with Christian Hinz, managing director, and Lisa Esser, head of corporate affairs and business development, at Gizeh Raucherbedarf, a German manufacturer of RYO and make-your-own (MYO) papers, about the implications of the extended legislative requirements on their business.

    Lisa Esser

    Founded in 1920, the company has 600 employees and is best known for its brands Gizeh and Mascotte. Gizeh, which is present in more than 80 markets, is the only company in the RYO/MYO papers sector that has its own printing plant as the company puts a lot of emphasis on the sophisticated, appealing packaging of its products.

    The state-of-the-art print shop at Gizeh’s headquarters in Gummersbach is equipped with three die cutters to produce the elaborate packaging designs of the company’s products, including the firm’s well-known magnetic lock booklet. Packaging development takes place either in-house or in collaboration with specialized agencies.

    Tobacco Reporter: In which of the two countries is it easier for manufacturers to implement the new packaging requirements?

    Christian Hinz: Definitely for Canada. Health Canada defined 24 months ago that rolling papers, although they don’t contain any tobacco, are tobacco products. Since Nov. 9, 2019, manufacturers and distributors have not been allowed to produce, sell and distribute noncompliant products and packaging. There is, however, a transitional period of two years. Besides, the new rules have been communicated clearly by the Canadian government.

    Israel, by contrast, passed its plain packaging law in January 2019. To make their products compliant, manufacturers to date only have a nonauthorized English translation of the Hebrew legal text, which they received at a very late point. The new legislation will enter into force on Jan. 8, 2020. If any merchandise with noncompliant packaging is found at a shop after that date, both the retailer and the manufacturer will be fined up to €50,000 ($55,137). There is no grace period. We have stopped delivering noncompliant products to Israel as retailers cannot guarantee the complete sell-off by the due date.

    What does it mean for your product portfolios in these markets?

    Hinz: We are only present with one variant of our rolling papers in Canada, but in Israel, we have been selling three qualities of rolling papers in four versions until now. With standardized packaging, you cannot communicate the differences between the individual variants anymore. Therefore, we will have to reduce our offer in Israel to only one product from January since consumers won’t have a chance to differentiate. This is annoying.

    Lisa Esser: We first had the idea to include some explanations inside the booklets, which would have reached consumers after they had bought the product, but even that is not permitted, which is incomprehensible to me.

    Which implications do regulations like these have on the overall market?

    Esser: It will lead to the multinationals taking over an ever-greater share of the market as already is the case in the foodstuff industry. As a result, the selection of different products will decrease. Transferred to tobacco products in, for example, Israel, it means that manufacturers who until now had, let’s say, 20 different products on the market will drastically reduce their portfolio because it’s not economically viable to offer so many variants.

    Price will become the only determinant for retail sales figures. This might lead to the formation of an oligopoly that goes straight down the supply chain. Only those manufacturers that can sell their products at a low price and also have a functioning distribution system will be successful.

    What about the consumer?

    Hinz: The consumer won’t have much of a choice anymore. It is, in a way, an incapacitation of the consumer. We expect a slow process in which the consumer starts to downtrade, following the argument that if there is no difference between the products on offer anymore, they could also buy the cheapest one. The entire process will lead to a deterioration of product quality in the market—at the expense of the consumer.

    What do these plain packaging laws mean for you as a manufacturer?

    Esser: It’s basically an expropriation of the brand owner as it deprives manufacturers of their intellectual property rights. I still cannot comprehend how constitutional states can permit such regulation. There’s a whole range of implications: We cannot communicate innovations to consumers anymore. It also won’t be possible to launch a small volume of a new product that has proven successful in another country to test it in such a market.

    We will probably have to restrict our geographical radius of market activities if there was a domino effect of plain packaging being extended to rolling papers in more markets. There would definitely be a limitation of our product portfolio in countries with plain packaging and/or warning requirements. In the worst case, we would have to launch a dedicated plain packaging variant for each country—just think of the individual health warnings required in the national languages. We expect each market to develop its own standards for such regulation. This would imply a strong individualization and customization of our products, restrict our portfolio, lead to smaller volumes and higher cost.

    What effects do you expect the measures to have on counterfeiting?

    Hinz: The black market for rolling papers is likely to thrive under such conditions, similar to what happened to the cigarette markets in countries that introduced standardized packaging. This is disadvantageous for all stakeholders in a market. Legislation doesn’t take issues like that into account at all. Forging of rolling papers already is a big problem, but currently the hurdles are high for counterfeiters—if you as a manufacturer continuously launch paper and packaging innovations, counterfeiters’ work gets more difficult. Lawmakers implementing plain packaging lower that hurdle considerably.

    How large are the Canadian and the Israeli markets for rolling papers, and what developments do you anticipate for your business following the introduction of plain packaging for RYO paper products?

    Esser: The legislative changes in both countries have quite an impact on our business. It’s still too early to say how the situation will develop, though. Assessing the true market size for rolling papers in Canada is very difficult because most of the tobacco cultivation for RYO and MYO takes place in the Native American reservations between Canada and the U.S., which are exempt from taxation. The latter is the basis for a determination of market sizes. In Israel, evaluation of the market is similarly difficult.

    What’s your view of current regulation of tobacco products in general?

    Hinz: Principally, we have to deal with a lot of poorly crafted regulation today. Take Belgium and France as an example where legislation demands that cigarette paper needs to be matte white. What did lawmakers want to say? Cigarette paper is not permitted to come in colors. If you look at unbleached paper, though, it is gray. Legislative statements like this create uncertainty instead of clarity.

     

     

     

     

  • Congress Tackles Challenges and Opportunities

    Congress Tackles Challenges and Opportunities

    The TABEXPO congress tackled the challenges and opportunities in a rapidly evolving industry.

    By Arpi Shively

    From production automation advances to digital packaging that talks and from building trust to tobacco company transformation, the TABEXPO 2019 congress in Amsterdam (Nov. 12–14) looked at the challenges and changes taking place in today’s tobacco and nicotine businesses.

    “Businesses need to balance the brave new world of emerging products and the familiar world of tobacco,” said congress master of ceremonies Simon Clark, director of Forest and advocate for the right to enjoy smoking and vaping. The first morning focused on tobacco and emerging products, hearing from those involved in the supply chain.

    Jeroen Slobbe, a board member of ITM Group, reviewed trends and developments in tobacco and nicotine production automation. He highlighted the need to partner more closely with customers and to pursue ever more stringent quality standards for pharmaceutical level reporting requirements to comply with tightening regulations. ITM Group is betting on a modular approach in creating new equipment that meets fast-changing customer needs. Slobbe used the analogy of Lego bricks, each with individual capabilities that can be bolted together to provide maximum flexibility.

    Speaking for the Indonesian paper and packaging manufacturer BMJ, business development director Liem Khe Phung echoed the need to respond to customization requirements with ingenuity and at speed. He unveiled BMJ’s digital printing solution. It dispenses with the need to produce and store dyes, is environmentally friendly and can accommodate last minute changes with its quick machine setup. Design and specifications can all be conducted online, including a 3D preview of the finished packaging. Actions that used to take seven days from concept to object can now be done in eight hours.

    Anna Ostergren, personal communications expert at Armatos, took up the theme of trust, which has become more important than ever as change speeds up. Ostergren shared the subtle physical and linguistic ways in which manufacturers and suppliers can convey confidence in their businesses and products.

    Creating trust was also an important thread in the Supplier Focus panel at the end of the first morning. Moderator Christopher Greer, president and CEO of TMA, quizzed panelists on current concerns and future plans. Linda Crumpler of Cerulean said that innovation in e-cigarettes and vaping has almost outpaced the technology. There was consensus that though change is unavoidable and accelerating, measurement technology and results must remain stable and reliable. Dora Gleoudis of Nicos Gleoudis Kavex spoke of the challenges facing farmers in balancing social responsibility and regulatory demands in a shrinking market. Victor Dixon of tobacco packaging experts LLFlex emphasized the need to anticipate “the new,” even beyond tobacco, and help customers to reinvent at speed. All agreed that suppliers must become trusted solution providers.

    James Millard of NDC Technologies spoke of the need for leaf suppliers and next-generation product manufacturers to switch from a tech-driven focus to a market-driven focus and to partner with tech companies earlier in the product cycle. Asked to identify the positives of living through “interesting times,” all spoke of change providing the impetus to step out of their comfort zones—a movement that often resulted in improved products and performance.

    The second morning of the congress was devoted to next-generation products and the associated global challenges. Michiel Reerink, vice president of global regulatory strategy at Japan Tobacco International, looked ahead to the ninth Conference of the Parties (COP9) of the World Health Organization’s (WHO) Framework Convention on Tobacco Control (FCTC), scheduled to convene in the Netherlands in May 2020. The FCTC continues to drive regulation worldwide. According to Reerink, plain packaging continues to spread slowly, though the measure has yet to prove itself effective as a tool to reduce smoking.

    Even as stakeholders are still evaluating the impact of the 2014 revised EU Tobacco Product Directive (TPD2), TPD3 is already taking shape. The new directive will cover e-cigarettes for the first time, and the full impact of TPD3 will become clear by 2022–2024. Will EU countries follow the lead of the U.K. with its relative tolerance of e-cigarette use or that of the U.S., which has been imposing restrictions on alternative products, good, bad and ugly alike?

    Stavroula Anastasopoulou, senior market analyst for ECigIntelligence, depicted a highly fragmented EU e-cigarette market worth €3.8 billion ($4.15 billion) in 2019. It is led by the U.K., which at €1.2 billion a year in revenues accounts for more than one-third of this market, far ahead of France, Italy, Germany and Poland. The most recent consumer surveys in these latter countries reveals that quitting smoking is still the No. 1 reason people use e-cigarettes.

    Vape stores have suffered from the recent negative publicity around e-cigarettes in the U.S., with U.K. stores reporting around 25 percent less revenue in October. Online channels, currently responsible for 35 percent of distribution, are predicted to shrink as regulation bites while convenience stores, now doing just 15 percent of the sales, are set to grow as pod and e-liquid brands enter this channel. In fact, open pods and pod devices hold a promise of future growth, according to Anastasopoulou.

    From statistics to science, Sarah Cooney, head of scientific collaboration and communication at British American Tobacco (BAT), outlined how BAT is embracing the nicotine-delivery revolution, using consumer-driven and technology-driven disruption to transform the nicotine marketplace. BAT is working on new technologies, including a new smokeless product called Epok, and a way of extracting flavor directly from the tobacco leaf. Consumer safety is keeping pace with innovation: Scientific data from BAT’s Vype device offers the single largest data set for any e-cigarette product, paving the way for it to be demonstrated as potentially reduced risk, according to Cooney.

    These are exciting developments, although the next speaker sounded a note of caution with regard to the U.S. regulatory framework. Maggie Gowen, executive director of the Global Vaping Standards Association (GVSA), spoke of a difficult environment for the U.S. vapor industry, intensified in recent months by the THC vaping crisis. When the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) failed to make a clear distinction between THC and all other vapor products, the resulting media frenzy resulted in statewide flavor bans and a hardening of negative sentiment around the products. The impact has bitten fast and bitten deep: In Ohio, more than 20 percent of vape stores have already closed, according to Gowen. Not before time, the CDC has clarified THC as the harmful element, and it remains to be seen if consumer confidence returns.

    Youth usage is another issue creating negative headlines, said Gowen. Uptake is rising with more than 5.3 million teens reporting using e-cigarettes in the U.S. Flavors are not the only contributing factor. High nicotine content, relative lack of age controls for purchasers and the cool image promoted by some advertisers all play into the surge in younger vapers. The GVSA promotes “smart and reasonable standards” and focuses on “safety first” to address these concerns.

    “Follow the money,” urged Delon Human in a bracing presentation looking at vested interests by the pharmaceutical industry and governments in the discussion about vaping. He warned against vapor companies accepting blame too readily, especially at the upcoming COP9 meeting in 2020 and urged the sharing of facts and rich data with regulators. Human likened knee-jerk bans on flavors and vaping to banning peanuts worldwide because a few people are highly allergic to them. He called the bans a tragic development for adults who want to quit smoking or switch from combustible products. Instead, he urged evidence-based debate and peer-reviewed data leading to clear, science-based risk evaluation and guidelines.

    Yushu Zhu, director of Ruvian Technology, explored new fields to conquer in his presentation on reconstituted hemp in traditional products, e-cigarette products and vapor products. Over the past 20 years, process and product have been refined to create better aroma and flavor and raise the overall performance of hemp cigarettes and slow-release heated products, he noted.

    Global nicotine and tobacco investment consultant Erik Bloomquist pointed out that there were no longer any certainties in the tobacco space. He cited slowing growth in key markets for vapor and heated-tobacco products and a gloomy outlook for the vapor market in particular.

    As for combustible cigarettes, Bloomquist revealed eroding support from traditional allies, such as labor unions and even tobacco farmers, against a background of increasing tax burdens and regulation. He warned that the FDA was likely to enforce premarket tobacco product application (PMTA) requirements immediately for all flavors except tobacco and menthol (even the latter could be revisited and disallowed) and to go with the prohibitionist drive of the WHO and influential nongovernmental organizations such as Bloomberg. With few but the largest companies able and ready to comply with PMTA requirements, smaller vapor businesses would be pushed out of the picture, according to Bloomquist.

    To close the second morning, Marcus Navin Jones, a partner in the specialist law firm Keller & Heckman, reviewed the main challenges facing the EU vapor industry in terms of emerging TPD regulations, such as enhanced product safety, quality, packing and labeling, and reporting requirements. Member states have discretion to impose elements of the regulations—and bear commensurate responsibility.

    The third and final day of the TABEXPO congress was more upbeat with Patrick Basham asking, “How high can the tobacco and nicotine industries get?” regarding the rapidly growing legal cannabis market. Basham believes that tobacco-derived expertise in areas like compliance, supply chain management and track-and-trace technology means that tobacco and nicotine companies are well-placed to seize this golden opportunity.

    Finally, another kind of industry transformation was presented by the Foundation for a Smoke-Free World. The foundation’s Tobacco Transformation Index will evaluate 15 of the world’s leading tobacco companies, tracking their progress toward a smoke-free world. Working with market research expert Euromonitor and advisory firm SustainAbility, their first report will be published in 2020 with regular updates thereafter. The index will also review actions of around 36 countries to assess their contribution to the smoke-free world the foundation is aiming for “within this generation.”

    Simon Clark summed up the congress content as a reflection of tobacco and nicotine engaging with tightening regulation, accelerating innovation and, in some cases, sheer survival. He ended on a positive note, citing the industries’ resilience and ability to adapt. Will these qualities be even more in evidence at the next TABEXPO congress? Those exhibiting at and attending that event will be doing their best to ensure that they are.

     

     

     

     

     

     

     

  • Petitioners Call for Common-Sense Regulation

    Petitioners Call for Common-Sense Regulation

    A group of EU citizens is petitioning European regulators to stop treating vapor products as tobacco.

    By Stefanie Rossel

    Dustin Dahlmann

    These are busy days for Dustin Dahlmann. The chairman of the Bundnis fur Tabakfreien Genuss (BfTG), Germany’s only e-cigarette trade association independent of the tobacco industry, has been a sought-after interviewee since the country’s vapor market experienced a dramatic sales drop in October. In a BfTG survey of 600 German e-cigarette retailers, more than half of respondents reported sales declines of 30 percent to 40 percent whereas almost one-fifth related revenue losses of more than 50 percent.

    The market slump occurred in the wake of an outbreak of vaping-related lung injuries and deaths in the U.S. Although regulation is stricter in the European Union (EU) and the main chemicals under suspicion in the U.S., including THC and vitamin E acetate oil, are prohibited in e-cigarettes in the EU, the news has unsettled German consumers, says Dahlmann. “Many customers find themselves in a Catch-22 situation. We observe that many who would like to quit cigarettes with the help of vape products are returning to combustibles following the events in the U.S.”

    The situation looks similar in France: According to L’Express, sales of e-cigarettes have recently fallen between 10 percent and 40 percent. The downturn in two of the EU’s leading vapor markets comes at a time when an European Citizens’ Initiative (ECI) is calling upon European regulators to take vapor products out of the Tobacco Products Directive (TPD2), differentiate them from pharmaceutical products and create a proportionate and evidence-based regulatory environment.

    Called “Vaping is not tobacco,” the campaign was initiated by eight EU citizens from Germany, France, the U.K., Italy, Belgium, Romania, Ireland and the Czech Republic, among them Dahlmann, who has been registered as its official representative. As its main goals, the initiative lists helping smokers access vapor products that can help them transition out of tobacco, allowing flavored vapor liquids, preventing access by young people to vapor products, reducing risks for vapers by introducing robust product quality, manufacturing and safety standards, and ensuring responsible marketing of vapor products that do not target youth.

    Introduced in the 2007 Treaty of Lisbon, the ECI was designed as a tool to improve democracy by enabling citizens to participate directly in the development of EU policies. If a group of citizens representing at least one quarter of EU member states gathers 1 million signatures supporting their initiative, they can call directly on the European Commission to propose a legal act. The commission then decides on what follow-up action to take. An ECI cannot be submitted by organizations or companies.

    Dahlmann’s petition, which started in late April, has until February 2020 to collect the required signatures. At press time, 47,000 people had signed. “We are grateful for this, but we had expected more support from vapers,” says Dahlmann. “We still have three more months to improve this result, and we will make good use of this time. Each vaper should understand how important a differentiation between e-cigarettes and combustible cigarettes is in legislation and in public awareness.”

    The initiative is using all marketing tools available, from classical tools to social media communication. It also participates in events such as international e-cigarette exhibitions to clarify the differences between tobacco and vapor products. “Besides, a large number of retailers throughout Europe support our campaign and have lists of signatures available,” says Dahlmann.

    A different situation

    According to Dahlmann, the outbreak of vaping-related illnesses in the U.S. and the subsequent crackdown on the sector by regulators has boosted the number of signatures. “In light of the partly very unfair media reporting about the vaping-related illnesses in the states, we have noted a strong alliance of solidarity among consumers and retailers,” says Dahlmann. “Many users are aware that regulated e-cigarettes have nothing to do with the lung injuries and deaths. The issue in the U.S. is about e-joints, illegal products for the consumption of drugs. Only if the public is informed about the true cause of the disease as well as the tremendous advantages of vapor products, a change in thinking can take place again. Everyone who is of the same opinion should support ‘Vaping is not tobacco.’”

    Apart from the petition, the initiative also includes a campaign to enable European citizens to get in touch with their respective national candidates for the European Elections that took place in May. Dahlmann says that this part of the initiative reached many candidates and members of European Parliament. “The theme is education and motivation towards a clear distinction between tobacco and e-cigarettes. The basic campaign is being used a lot, and we hope for a new political valuation of vaping in Europe.”

    Recently, he adds, numerous measures had been taken to educate the public with regard to vaping, with many of them being highly successful. Together with other trade organizations, the BfTG has been educating the European media about the events in the U.S.

    Well organized

    The petition for smarter vaping regulation is not the first attempt at influencing e-cigarette legislation in Europe. In contrast to its predecessors—none of which succeeded—the current initiative has been meticulously planned. With all of the petitioners representing vapor companies and organizations, including the Czech Vaping Association and the organizers of Vapitaly, a leading Italian trade fair, the initiative has financial support. However, critics have seized on the fact that €10,000 ($11,077) of the €35,000 in donations collected so far came from Imperial Brands.

    For Dahlmann, it is irrelevant. “Like many others, Imperial Brands has supported the campaign financially,” he says. “All participants have jointly developed the wording of the campaign, not only Imperial. That’s why we are 100 percent behind the initiative. The committee members are the only ones to take on official responsibility and decide on the execution of the campaign. Imperial doesn’t have any control of it. It’s an initiative for e-cigarettes and hence the exact opposite of a tobacco campaign. Otherwise, the BfTG as a tobacco-free association would not have supported the campaign.”

    Highlighting the issue

    Collecting 1 million signatures by February seems ambitious. Even if it is achieved, the EU can still object to considering the initiative. Nevertheless, Dahlmann remains confident. “The initiative is about to find as many supporters as possible so that the necessity of the campaign becomes obvious. Achieving that would be a success for us. If we don’t reach our goal of 1 million signatures, we will continue with our political work to draw attention to the urgency of this issue. If the required number of signatures is gathered, the European Commission is not obliged to submit a proposal for a legislative act. However, it has to meet with the initiators so that they can elucidate the topics covered by the initiative. Furthermore, the organizers have the opportunity to present their initiative in a public hearing at the European Parliament.”

    Even if the petition succeeds, the desired legislation would still be a long way off. “If the commission decides to submit a proposal for a legal act, the regular legislative process will get started,” explains Dahlmann. “The commission’s proposal will be presented to the legislator, which usually is the European Parliament and the European Council—in some cases only the latter. If the proposal is adopted, it will become law.”

  • 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.