Category: Print Edition

  • The quest continues

    The quest continues

    BAT’s Chris Proctor shares his views on the current state and future direction of tobacco research.

    By George Gay

    In recent years, British American Tobacco (BAT) has invested a huge amount of money in increasingly advanced scientific research into tobacco products and, more latterly, alternative products. Firstly, it concentrated on investigating whether tobacco cigarettes could be modified so as to make their consumption significantly and demonstrably less risky than is the consumption of unmodified products. And then it moved the focus of its attention toward vapor products, which deliver nicotine without the compounds generated by burning tobacco.

    Partly because they have found acceptance with many smokers and former smokers, these vapor products seem to offer a public health advantage that is immediately realizable and far higher than could be expected from any combustible cigarette, no matter how skillfully it were modified.

    The question seems to arise, therefore, as to whether there is any point in continuing with research into combustible products. And after running into BAT’s chief scientific officer and head of scientific product stewardship, Chris Proctor, at the Global Forum on Nicotine in Warsaw, Poland, in June, Tobacco Reporter had the opportunity of posing, in an email exchange, a number of questions about the current state and direction of travel of tobacco research.

    Tobacco Reporter: Is BAT still involved in research and development in respect of traditional tobacco cigarettes.
    Chris Proctor
    : Yes. While it may not be possible to measurably reduce the inherent risks of cigarette smoking, we are still involved in research in respect of traditional tobacco products. Cigarettes are the most common way of consuming tobacco, and while the health risks of using tobacco are well-known, it remains important to apply sound product stewardship principles to ingredients used in cigarettes to make sure they do not add to the inherent risks of smoking. Through our research we aim to increase the scientific understanding of the harm caused by the use of tobacco and nicotine products and seek to apply this knowledge to the development and testing of potentially reduced-risk products.

    Would you please describe the sorts of research that you are carrying out in respect of traditional tobacco products?
    We have several research programs ongoing at our facilities in Southampton and Cambridge in the U.K. We have for many years worked on identifying the toxic constituents of tobacco smoke and understanding how they are formed and whether they can be reduced. We also conduct studies aimed at how people use their products, studies aimed at understanding the development of disease and studies of the tobacco plant itself.

    Smoke chemistry and dosimetry: We have for many years studied the complex chemistry of cigarette smoke. We are now studying how the aerosol properties of tobacco smoke—the size, concentration and chemical composition—impact on how and where smoke is deposited in the lungs and how its component chemicals are then delivered systemically. By understanding what people are exposed to, we can start to better understand the disease process.

    In vitro testing: We are currently investigating a range of specific lab-based disease models relevant to a number of tobacco-related diseases. The aim is to develop physiologically relevant screening tools that will help us to understand and investigate the mechanisms of cigarette smoke toxicity as well as to identify and assess disease-related biomarkers. These tests can be used to determine whether a change in cigarette smoke composition results in a change in the response of one or more of these models. Some of these models could form part of a framework for testing next-generation products.

    Tobacco genomics: Many of the toxicants in cigarette smoke have their origins in the cellular structure of the tobacco plant or might be affected by processes in the plant during growing or curing, for example. Understanding the genes involved may help develop new plants that result in lower toxicants both in the tobacco and in cigarette smoke. We have a very active biotechnology program working on this.

    Is some research having to be directed at addressing issues arising from the introduction of new regulations, such as those to do with restrictions on the use of flavors and additives, or are such issues addressed mainly through leaf tobacco research?
    Some of the research is focused on being responsive to developing regulations. For example, in the EU there are requests from the regulators for more scientific information on certain ingredients added to cigarettes.

    Not long ago, BAT was heavily involved in research aimed at developing traditional tobacco cigarettes that could be shown to be less risky than were mainstream products. Is this work still in progress?
    We developed a number of technologies, which when used in combination were found to significantly reduce the levels of certain smoke toxicants in cigarette smoke. We published the results of clinical studies that showed that there was a corresponding reduction in smokers’ exposure to these toxicants. We were unable to demonstrate that this reduction in exposure had a biologically relevant effect.

    This finding led us to accelerate our work on alternative tobacco and nicotine products such as e-cigarettes. However, we have maintained some effort on new technologies that could help reduce cigarette smoke toxicants.

    Would it be true to say that most of BAT’s product research is now focusing on noncombustible tobacco products and, especially, on nicotine-delivery devices?
    The renaissance in product innovation away from traditional combustible cigarettes has certainly seen a boom in research on next-generation products and the emergence of some very new technology. We are constantly looking at ways of improving our existing products and developing new concepts. We have several products in our pipeline, including medicinal nicotine products, e-cigarettes, tobacco-heating products and hybrid products.

    In addition to developing these new technologies, we also develop methods and tests to help ensure that products based on new technologies are as safe as they can be. Our research led to the development of a scientific framework that can be used to assess the reduced-risk potential of innovative nicotine and tobacco products.

    This framework employs a four-stage process that uses lab-based and clinical tests along with real-world observations of individual and population perception and use. The first step is understanding how consumers use the products and using this information to then understand the products. This is followed by clinical testing to determine that these products produce and deliver fewer toxicants than conventional cigarettes. Then the testing moves into the real-world use to determine what impact, if any, this reduction in toxicants will have on a person’s individual risk and also on the collective risk of the population using the products.

    What are the most exciting areas of research in respect of noncombustible tobacco products and nicotine delivery devices?
    Perhaps the most exciting, and most challenging, is our research into characterizing the potential health risks of the emerging technologies. Here we are investing significantly in the toxicological sciences, and in particular in vitro models of disease.

    What other areas of research is BAT pursuing?
    One thing that we are working particularly hard on is developing scientific approaches to “bridge” from one data set to another. When technologies are evolving so rapidly, it is necessary to find ways in which, for example, the scientific package of data on a generation-two e-cigarette can be applied to a generation-three device without having to repeat all of the key studies.

    Is there a level of frustration among scientists researching in the field of tobacco harm reduction because some are having to repeat badly conducted studies that give a false picture of less risky products?
    I think all researchers have a duty to conduct their research with openness and transparency and that the research should be grounded in a practical application. Unrealistic experimental conditions can produce results that would not be expected under more realistic conditions. But it is also up to the industry to publish widely so that independent scientists can look at all the science generated and make decisions on what is real and what is not.

    Having seen you speak during a transparency debate at the 2016 Global Forum on Nicotine [GFN] in Warsaw, Poland, in June, I am aware that you are somewhat frustrated at various aspects of the publication of scientific papers. This is of particular concern, I suppose, when the science is aimed at reducing the harm caused by tobacco. Do you think you are making progress?
    As I said at the GFN, I believe we need more transparency, not less, in scientific research. Next-generation products like e-cigarettes have the potential to save millions of lives, and this potential must not be lost in a zeal that sees a desire to eliminate tobacco-related disease confused with a desire to eliminate an industry. These products are new and changing rapidly, and regulators and the public alike should have as much information available to them as possible. We need to be able to trust the science. Making the science available for review and critique is essential. Being able to publish that science is the only way to do this. Having said that, there are only a handful of journals with a policy not to process any papers based on research funded by the tobacco industry. But no science should be censored.

  • Next move?

    Next move?

    Your post-deeming strategy starts with a proper understanding of the FDA’s new rules.

    By David Jaroslaw

    On May 5, 2016, the U.S. Food and Drug Administration (FDA) published its long-awaited final rule for deeming other tobacco products to be subject to its authority. While cigarettes and smokeless tobacco have been subject to FDA regulation since the original passage of the Family Smoking Prevention and Tobacco Control Act (TCA) in 2009, the deeming regulations set forth what additional types of tobacco-related products will be regulated by the FDA, and which restrictions will apply to the introduction, sale, marketing and labeling of those products.

    Some had advocated that the FDA apply different rules to different products, based on an assessment of their comparative health risks and usage patterns, particularly the extent to which they were used by youth. However, the FDA has instead opted to “deem”—i.e., to subject to its jurisdiction—all tobacco or tobacco-related products, including e-cigarettes, cigars, pipe tobacco and hookah tobacco, and to apply to all these products a generally uniform set of standards, with the only significant differences being related to product warning labels. The deeming regulations were formally published in the Federal Register on May 10, 2016, and have an effective date of Aug. 8, 2016.

    This article addresses (i) the methods the FDA has established for gaining FDA approval for tobacco products, (ii) the relevant time periods for submissions of applications for such products, (iii) the FDA’s rationale for regulating e-cigarettes and cigars in essentially the same manner as cigarettes, (iv) the relevant restrictions on sale and marketing of such products, and (v) the warning labels that such products must carry.

    1. Introduction of new tobacco products

    Following the passage of the TCA in 2009, the FDA issued regulations regarding the regulatory approval of the sale of cigarettes, the dominant tobacco product in the market. These regulations set forth three “pathways” for approval. These pathways were:

    • Substantial equivalence (SE)
    • Exemption from SE
    • Premarket tobacco product application (PMTA)

    Under the SE pathway, the FDA allowed manufacturers to make comparisons with products already on the market as of Feb. 15, 2007 (the “grandfather” date for product approval). Thus, because cigarettes have been on the market for over a century, manufacturers of cigarettes that were essentially similar to a product already on the market as of the grandfather date (such a pre-2007 product is referred to as a “predicate product”) could apply for FDA approval using the SE pathway. Substantial equivalence was defined as a product not differing from a predicate product in ingredients, mode of heating or health risks. If a cigarette manufacturer could show such substantial equivalence, the product would be eligible for FDA approval. Once a product was approved, minor changes in characteristics, such as the use of previously approved flavorings, would require only an application using the “exemption from SE” pathway. Manufacturers of all other products—i.e., those that had no predicate product or those that differed from existing products in ingredients, mode of use or health risks—would have to submit a detailed application using the PMTA pathway. Under this pathway, a manufacturer would have to submit information regarding product composition and mode of use and, of particular note, scientific data regarding the likely health risks of using the product.

    Under the TCA as originally passed in 2009, the FDA provided cigarette manufacturers with a relatively straightforward approval process, using the SE pathway to address relatively uniform products arguably little different from commonly available predicate products. However, under the new deeming regulations, manufacturers of e-cigarettes and cigars face a more difficult road.

    For e-cigarettes, the problem is the lack of predicate products, without which manufacturers cannot use the SE pathway. E-cigarettes differ fundamentally from combustible tobacco products. They do not burn or even contain tobacco, and thus do not produce tobacco smoke. Rather, e-cigarettes heat and vaporize a nicotine-containing liquid. They were first invented in their current form in the mid-2000s and were not generally commercially available until this decade. Manufacturers and others commenting on the proposed deeming regulations noted that while the grandfather date of Feb. 15, 2007, was uncontroversial for cigarette manufacturers, application of this same date to e-cigarettes would effectively exclude e-cigarette manufacturers from using the SE pathway. Instead, such manufacturers would be required to use the far more burdensome and costly PMTA pathway. Estimates of how much it would cost to complete a PMTA vary, but the deeming regulations note that costs are expected to be more than $800,000 per manufacturer in the first year of compliance. In the final deeming regulations, however, the FDA concludes that it is compelled by the language of the TCA to use the same Feb. 15, 2007, grandfather date for all tobacco-related products. The FDA comments that there may have been products on the market as of that date that could be used as a predicate product (it referred specifically to one unflavored e-cigar as a possibility) but notes that this will require further analysis.

    Additionally, the deeming regulations state that a product that differs from a putative predicate product in any significant way, including differences in flavoring or strength, is in fact a different product, requiring its own PMTA. Indeed, given that the various e-cigarette products differ from each other precisely in flavoring and strength, each product (rather than a brand family) will likely require its own PMTA. Moreover, a significant percentage of the current e-cigarette market consists of small “manufacturers,” such as vape shops, which often create their own custom products. It is unlikely that many such small-scale producers could afford the cost of a PMTA for even a single product, leave aside the cost of an application for each individual blend. Thus, in what is a considerable understatement, the deeming regulations note that the proportion of vape shops that mix their own blends is likely to fall during the initial compliance period.

    For cigar manufacturers, the problem is not the lack of predicate products on which to base an application using the SE pathway—cigars have been on the market even longer than cigarettes. Rather, the difficulty lies in the variations in tobacco blends between types of cigars. While the deeming regulations state that blending changes made solely to address natural variations in tobacco, such as seasonal variation, will likely not prevent a manufacturer from using the SE pathway, changes that affect characteristics such as pH, nicotine levels or flavors (the regulations refer specifically to changes in “smoothness” and “harshness”) will require a manufacturer to use the PMTA pathway for each product variety. An important part of the cigar market is the introduction of new products, particularly in the premium cigar sector. Further, much as is the case with e-cigarettes, many cigar manufacturers, particularly in the premium market, are relatively small-scale operations and might not be able to afford the substantial expense of a PMTA.

    1. Time periods for new product applications

    The deeming regulations provide a “staggered” schedule for the submission of applications seeking FDA approval for newly deemed tobacco products. The period for the simplest application, the “exemption from SE” pathway, is the shortest; the period for the most complex application, the PMTA pathway, is the longest. These time periods are as follows:

    • Exemption from SE: 12 months from the effective date
    • SE: 18 months from the effective date
    • PMTA: 24 months from the effective date

    If an application for a product is not submitted for review within 24 months of the effective date, the product will be subject to enforcement action by the FDA, meaning its removal from the market, along with possible penalties or injunctive action. The deeming regulations state that the FDA expects that it should take 180 days (six months) to complete its review of an application. However, the deeming regulations also state that, regardless of the state of review, enforcement will begin 12 months after the application is submitted.

    There is, however, an important caveat to this schedule: Tucked into a footnote in the deeming regulations is a statement that the delayed enforcement period applies only to products on the market as of the effective date. Any products introduced into the market after Aug. 8, 2016, will be subject to immediate enforcement. Thus, it can be expected that many manufacturers will seek to bring new products to market before this date, in order to take advantage of the 36-month window prior to enforcement.

    All manufacturers will be required to provide a list of “hazardous or potentially hazardous constituents” within 36 months of the effective date, though the FDA has indicated it will provide additional guidance in this regard.

    Restrictions on sales and marketing (see Section IV, below) take effect 90 days from the effective date.

    III. Rationale for deeming

    Much of the text of the deeming regulations consists of a series of comments, essentially FDA summaries of comments submitted by interested parties with regard to its proposed regulations, and responses by the FDA to these comments. Many of these comments and responses address the merits of extending the FDA’s existing regulatory structure for cigarettes to e-cigarettes and cigars. E-cigarettes and cigars (especially the former) are generally considered to have lower health risks than cigarettes. The following provides brief analysis of the FDA’s rationale for its approach.

    1. E-cigarettes

    A broad discussion has occurred in scientific, public health and regulatory circles, in the U.S. and worldwide, with regard to e-cigarettes and the concept of tobacco harm reduction. Tobacco harm reduction proceeds from the principle that there is a continuum of risk among tobacco products, with some products posing a higher health risk to users and others a lower risk. It posits that tobacco users should be encouraged to move from higher-risk products, most commonly referring to combustible cigarettes, to those with lower risk. The working premise is that if cigarette smokers smoke as a way of obtaining nicotine, but die from the smoke itself, then such smokers should be encouraged to find other ways of obtaining nicotine—ones that do not produce tobacco smoke—that they find sufficiently satisfactory to reduce or eliminate their use of cigarettes.

    Two major public health bodies from the United Kingdom, the quasi-public entity Public Health England (PHE) and the Royal College of Physicians (RCP), a body analogous to the American Medical Association, have recently published reports accepting the basic principles of tobacco harm reduction and continuum of risk; these reports take the position that smokers of combustible cigarettes should be actively encouraged to switch to e-cigarettes. The PHE report states that the “current expert estimate” is that the use of e-cigarettes is “around 95 percent safer than smoking” and further notes that there is an “inaccurate perception” that e-cigarette use is “as harmful as cigarettes.” The report also states that there is no evidence that e-cigarette use is “undermining the long-term decline in cigarette smoking,” and that “encouraging smokers who cannot or do not want to stop smoking to switch to [e-cigarettes] could help reduce smoking related disease.” The RCP report similarly states that new products such as e-cigarettes fit into a harm reduction strategy by “providing smokers with the nicotine to which they are addicted without the tobacco smoke that is responsible for almost all of the harm caused by smoking” and adds that these products provide a “viable harm-reduction option.”

    The deeming regulations specifically discuss the concept of continuum of risk, and Mitch Zeller, the director of the FDA’s Center for Tobacco Products, has publicly discussed the opportunity for the FDA to develop “a comprehensive nicotine regulatory policy that is agency-wide and that is keyed to … the continuum of risk.” However, in the deeming regulations, the approach formally adopted by the FDA is very different, choosing to treat all tobacco-related products similarly. This is so despite language in the deeming regulations that suggests a split within the FDA with regard to whether e-cigarettes can serve a positive role in reducing the harm from tobacco use.

    For example, although the deeming regulations contain a subsection titled “Continuum of Risk,” this subsection does not actually provide any data regarding the comparative risk of using the various tobacco-related products covered by the regulations. Rather, it states only that “there is general evidence of harm for all classes of newly deemed products.” The deeming regulations note the assessment by PHE that use of e-cigarettes is likely around 95 percent safer than smoking combustible cigarettes but conclude that there is a “lack of hard evidence” regarding the health risks of e-cigarette use and that, as a result, “the FDA does not find the beliefs … to be sufficiently conclusive on the relative risks of using different tobacco products.” Similarly, the deeming regulations state that while “the effects from nicotine exposure by inhalation are likely not responsible for the high prevalence of tobacco-related death and disease” and that “nicotine has not been shown to cause the chronic disease associated with tobacco use,” there are still “risks associated with nicotine.” With regard to potentially harmful constituents found in at least some samples of e-cigarette vapor, the regulations refer to a Japanese study reporting that e-cigarette vapor contains formaldehyde at one-fiftieth the level found in cigarette smoke, but they once again conclude that there is not adequate long-term data regarding health effects. Finally, in its discussion of usage patterns of e-cigarettes, the FDA states that it must take into account “the increased or decreased likelihood that existing users of tobacco products will stop using such products … and the increased or decreased likelihood that those who do not use tobacco products will start using such products.” The deeming regulations add that while some studies report that usage of e-cigarettes is more common among persons trying to quit smoking combustible cigarettes, “it cannot be determined by the research findings: (1) whether former cigarette smokers who now exclusively use e-cigarettes would not have ceased smoking cigarettes regardless of e-cigarette use; and (2) whether the e-cigarette use preceded quitting or the quitting occurred first and then was followed by later e-cigarette use.”

    1. Cigars

    Cigars have been on the market for centuries, and there is a considerable body of scientific studies regarding the long-term health effects of their use. The major question regarding how the FDA would treat cigars was posed in the proposed regulations and request for comments published by the FDA in April 2014: whether premium cigars (in part defined as those retailing for $10 or more), which have distinct use patterns, would be exempted from the deeming regulations, or at minimum be subject to less onerous regulation. In the deeming regulations, the FDA has opted to treat all cigars similarly. While entities supporting differential regulation of premium cigars noted that users of these products are adults, not youth, and tend to smoke relatively few cigars, typically less than one per day, and that epidemiological data did not support there being an increased risk of mortality among cigar smokers who smoked fewer than two cigars per day, the FDA relies on data reporting that premium cigars are not inherently different in toxicological profile from other cigars, and therefore should be considered to pose the same health risks. The FDA identifies three key reasons for its decision to treat all cigars similarly: that all cigars are similar in composition, from a health risk perspective; that the data provided did not sufficiently establish a difference in usage patterns between cigar types; and that the data regarding youth usage were not sufficient to convince the FDA that this group did not or would not use these products.

    1. Restrictions on sale and marketing

    The deeming regulations extend the restrictions on sales and marketing of tobacco products, which are currently applicable to cigarettes and smokeless tobacco, to all newly deemed products, including e-cigarettes and cigars. The primary restrictions, which take effect 90 days from the effective date, are a prohibition of sale to persons under 18 years of age, with proof of age required for purchase, and a prohibition of sales via vending machines (unless the machines are located in areas where entry by persons under 18 is prohibited).

    1. Warning labels

    The deeming regulations draw one major distinction between e-cigarettes and combustible tobacco products—they will require a different health warning. E-cigarettes will be required to carry a single warning that states: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” Alternatively, the products may replace the first sentence with the following statement: “This product is made from tobacco.”

    Cigars, in contrast, must carry a rotating series of warnings. These warning are:

    • WARNING: This product contains nicotine. Nicotine is an addictive chemical.
    • WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
    • WARNING: Cigar smoking can cause lung cancer and heart disease.
    • WARNING: Cigars are not a safe alternative to cigarettes.
    • WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
    • WARNING: Cigar use while pregnant can harm you and your baby. (Or, as an optional alternative statement: SURGEON GENERAL WARNING: Tobacco use increases the risk of infertility, stillbirth and low birth weight.)

    For cigars sold in boxes, these warnings must cover at least 30 percent of the two main display panels of each box, while for cigars sold individually, they must be displayed on a sign located at the point of sale. For advertisements, the warnings must cover at least 20 percent of each advertisement.

    It remains to be seen how the FDA will implement the deeming regulations in practice. Will a predicate product be found to allow e-cigarettes to use the SE pathway? Will there be some additional leeway granted to small manufacturers (of both e-cigarettes and cigars)? If not, will the group of manufacturers shrink to a small set of large entities with the resources to afford the costs of the PMTA pathway? What sorts of information will the FDA deem suitable for submission in connection with the evaluation of newly deemed products? (The FDA has begun the process of providing draft guidance in this regard, but the path ahead is far from clear.) Given the likely complexity of each new product application, manufacturers of newly deemed products will have to start by navigating with relatively few tools.

     

    David Jaroslaw is a shareholder in Greenspoon Marder’s litigation practice group. He has litigated a broad spectrum of complex civil and criminal matters in both federal and state courts, at the pretrial, trial and appellate levels. Jaroslaw has provided product liability advice and litigated on behalf of manufacturers of products, including tobacco and e-cigarettes, in the United States, Europe and Asia. 

     

  • Destination unknown

    Destination unknown

    Britain’s decision to leave the EU raises serious questions about the country’s future.

    By George Gay

    brexitThis, I’m afraid, is a true story. Longer ago than I care to relate, an acquaintance of mine, in my presence, told a young woman friend that he and his wife were going to Greece for their holiday. The young woman’s response was to ask, in all seriousness, whether Greece was in Spain.

    I couldn’t get that incident out of my mind in the lead-up to the U.K. referendum on whether we should remain within or leave the EU. As a Brit, I hoped desperately that the middle-aged woman, as she would now be, and all the other people like her, were brushing up on the EU ahead of casting their votes.

    I suspect they didn’t. We voted to leave by 52 percent to 48 percent. We had succumbed to the wisdom of Baldrick and decided that the only way to solve the U.K.’s low-ceiling problem was to cut off our own heads. And those who dreamed up the idea of the referendum—surely, it couldn’t have been thought up during waking hours—made it easy for us by setting the bar for this monumental constitutional change at a tad over 50 percent. They might just as well have called in Luke Rhinehart’s Dice Man.

    Some people will take issue with this. A lot of people who voted to remain will have had little idea about the EU either, they will say. This is true, but to vote to remain was to vote for the status quo; it really didn’t require anybody to know very much apart from the fact that they wanted to keep going in the same general direction. But it was surely beholden on anybody who wanted to alter the ship of state’s heading that they were aware of where the new course would take them—and the rest of us.

    A more reasonable complaint might be that I am being elitist, poking fun at somebody just because she couldn’t put Greece on a map. And I accept that it wasn’t altogether her fault. In the U.K., we have had compulsory secondary education for about 100 years and compulsory elementary education for longer than that. However, successive governments have meddled and muddled with the education system and, in doing so, failed the woman mentioned above, countless other people and, ultimately, the state.

    But the problem went deeper than that. Why were the people of the U.K. asked to vote on such a complex issue? Take me for example. I could probably reel off 20 of the 28 nations that come together as the EU, but I would stumble and even struggle with the other eight. I have a rough working knowledge of what goes on within the European Commission, the European Parliament and the Council of the European Union, but I have no in-depth knowledge. And I, along with 99 percent of the population of the U.K., have never read one of the treaties that bind the whole EU edifice together.

    Was I supposed to judge the competing claims of expert economists (in truth, the “leave” campaigners were a little short on such experts); was I supposed to know whether the U.K.’s security was better off with its being a part of the EU? And what of the wider geopolitical situation? How could I be sure that the environmental and animal-welfare concerns I have would be best addressed by being inside or outside the EU? What was I supposed to make of an in/out decision on health, education, collaborative research …? And even if I could make sense of these and the countless other issues that arose in my mind, how could I know what weight to give to each when summing up?

    Or perhaps it was just the economy, stupid—though I would hate to think that the EU project was only about that. Certainly, I based my decision mainly on the words of the poet John Donne: No man is an island, entire of itself; every man is a piece of the continent, a part of the main. If a clod be washed away by the sea, Europe is the less ….

    In fact, I would guess that most people made their decisions on the basis of sound bites, though mostly those issued by living politicians rather than by long-dead poets. And the three sound bites that won out seemed to have been the “leave” camp’s “take back control,” and those that claimed that withdrawal from the EU would allow us to reduce immigration and provide us with an additional £350 million ($458.76 million at press time) a week to spend on the National Health Service. Of course, the facts were that we already had control over nearly all of those issues for which we hadn’t agreed to pool responsibility, that there was very little that could be done to reduce immigration assuming that, post-exit, we wanted to keep within some sort of single European market, and there never was an extra £350 million a week to spend.

    Interestingly, even many of the people who led the “leave” campaigns seemed to have thought little beyond their own sound bites. They seemed to be as surprised/shocked as anybody when they won; so as soon as the result was declared, they went to ground, presumably while they thought things through for the first time. And when they did emerge, they started to row back from their promises. Indeed, on reappearing from his bunker, Boris Johnson, the Conservative member of Parliament, former mayor of London and one of the leaders of the “leave” campaign, seemed to indicate that what the “leave” side wanted was something that sounded very much like membership of the EU.

    Hitting out

    city
    Many U.K. companies believe their prospects have dimmed in the wake of the EU referendum.

    But the “leave” campaign strategy was clearly more effective than was the “remain” camp’s attempt to scare people into voting for continued EU membership. Experts from various international institutions were lined up to explain how the economy would tank should the U.K. leave the EU, and we were threatened with yet another £30 billion—it’s always £30 billion for some reason I cannot explain—in tax rises and austerity cuts. But whereas such threats might have worked with a few leafy-suburb southerners, they were never going to work on people living in the regions already ravaged by Conservative austerity measures—the people existing on the charity of soup kitchens, food banks and skips. The figure of £30 billion would have been meaningless to them. It might just have well have been £3 trillion. You might just as well have threatened that the major banks would relocate to the moon and Iceland would knock England out of the Euro 2016 football competition.

    In fact, the people running the “remain” campaign could have learned a lesson from tobacco. Anti-tobacco campaigners have made huge efforts in trying to scare smokers away from their habit without success simply because they have no idea of who they are dealing with and what their lives are like. They offer people imprisoned within sink estates 10 years of extra life and wonder why the ingrates don’t accept.

    I find it easy to understand why people living lives blighted by incompetent bankers and economists, greedy company directors, and unsympathetic, unhearing politicians took advantage of the referendum simply to hit out. That, in the main, they struck the wrong target couldn’t be helped. Sure, most of what had happened since 2008 was the fault of the U.K. government, but the EU has to take some blame for having failed to protect these people from the worst effects of globalization.

    After the vote, there seemed at least to be some recognition that the EU needed to change, and there were murmurings to that effect. But then the EU has been talking about change for as long as I can remember, and little of substance seems to happen. So as the headless politicians and bureaucrats ran about in the wake of the “leave” vote, the main areas of concern seemed to be getting the exit negotiations underway as quickly as possible and promising tough negotiations, so as to prevent the anti-EU contagion spreading farther and wider. You have to ask yourself what message this sends out. I was reminded of the old joke about the person who went to an elite English public (read “private” if you live outside the U.K.) school that was difficult to get into, and even harder to get out of.

    Reckless gamble

    Whatever. It all ended, not with a bang but a whimper. In what a Guardian newspaper editorial described as a graceful little speech tendering his resignation, the prime minister, David Cameron, apparently said: “I will do everything I can as prime minister to steady the ship over the coming weeks and months, but I do not think it would be right for me to try to be the captain that steers our country to its next destination.”

    Captain Graceful? Cameron had steered the ship of state—by this time viewed as Votey McVolte-face by the rest of the world—toward Continental Europe for a better look, grounded it, and was in the process of slipping into the resignation lifeboat. This was a man who had tried to sort out a long-standing division over the EU within the ruling Conservative party by putting the future of the country at risk, who, being at such a remove from ordinary people, had failed to judge the mood of the nation, and who, unsurprisingly, had failed to convince with his “remain” message.

    The Guardian went on to say that no speech could salvage his standing in the history books. “Mr. Cameron will go down as the man who gambled the country’s future as a way out of a party difficulty,” it said.

    But it was not only the U.K. that Cameron was willing to use in his high-stakes game. In trying to unite the Conservative Party, he had further divided it into the nasty party, which was in charge, and the really nasty party, which is going to take charge. He had divided families, divided regions of England, divided the U.K. and divided Europe. As President of the European Parliament Martin Schulz said, it was difficult to accept that “a whole continent is taken hostage because of an internal fight in the Tory party.”

    And while all this was going on, the opposition Labour Party, which had campaigned tepidly for “remain” and which, in line with honorable political tradition, should have been putting the boot into the injured Conservatives, instead set out on a bloody internal feud as it enacted the anarcho-syndicalist scene from Monty Python and the Holy Grail.

    The whole story was a tragedy played out in the theater of the absurd, but it made for compulsive viewing. The media had a field day, and social media was afire. As somebody said in the movie No Country for Old Men, if this wasn’t a mess it would do until a mess arrived.

    But then again, Michael Gove, the justice secretary, who was another of the lead leavers, was quoted as saying that Cameron had led the country with courage, dignity and grace, and that he deserved to be remembered as a great prime minister. And this being the U.K.—for the time being at least—Cameron will have his time in the sun again, no matter that the U.K. is ripped asunder, the economy is broken, and the poor and powerless enter another round of paying for the follies and catastrophic failures of the rich and powerful. Sometime in the future, Cameron will be ennobled by the establishment, probably for his services to chaos theory—and practice.

     

     

    Tobacco provides safe haven amid Brexit turmoil

     

    Keep calm and buy tobacco
    Keep calm and buy tobacco


    It’s an ill wind that blows nobody any good, and tobacco companies were, when this story was written, providing something of a haven for investors as stock markets weathered the storm whipped up by the U.K.’s decision to leave the EU. A story in the Winston-Salem Journal in late June quoted analysts as saying that dividend-seeking investors were turning to U.S. tobacco companies such as Reynolds American Inc. (RAI) that lacked international exposure, particularly in Europe.

    Dan Caplinger of The Motley Fool reportedly said that the Altria Group and RAI “are as close to Brexit-proof as you’re likely to find in today’s stock market.” However, he warned that the U.K.’s exit from the EU could have a substantial economic impact in the U.S., adding that “anything that hits discretionary income in Americans’ wallets could hurt tobacco companies.”

    But it wasn’t only U.S. companies that benefited. Shares in British American Tobacco were up as investors turned in part to defensive consumer stocks. According to a Reuters story, those stocks’ resilience was underpinned by the combination of dependable profits, dividends and expectations of earnings upgrades for companies that sold to consumers outside Europe.

    And on the basis of a small TR straw poll of tobacco companies and suppliers operating from the U.K. and in other parts of the EU, it would seem that while there was disappointment at the outcome of the referendum, the most common reaction was that, no matter what happened, it was business as usual. In fact, in the short term, some suppliers operating from within the U.K. were feeling the benefits of a weak pound; although, looking farther ahead, such gains are likely to be canceled out by increased import costs and the general political and economic uncertainties.

    Perhaps Barnaby Page, writing the day after the vote for ECigIntelligence, summed things up best when he said that while there was panic in some quarters and rejoicing in others, “the wise if boringly sensible approach is to sit tight, wait and see what happens.” The decision to leave the EU would have little immediate impact on either vapers or the industry.

    “With the timing and shape of the U.K.’s departure from the EU still supremely unclear, and the details of the latter at least unlikely to be known for many months, we believe any firm forecasting of longer-term effects at this stage would be close to meaningless,” he said.

    “The full response of Brussels and Britain’s European neighbors to the Brexit vote is still uncertain, and to further complicate matters, the U.K. will have a new prime minister within about three months, whose approach to the long process of negotiating exit from the EU also remains to be seen.”

    Nevertheless, Page wrote that for the time being—perhaps for two years—within the U.K. there would be little practical change for vapers because the country would not be able to repeal or very substantially alter its legislation based on the Tobacco Products Directive before formally quitting the EU, even if the new government wanted to do so. (Clearly, this is something that would seem to hold in respect of the tobacco industry also.)

    Further, Page said that there were unlikely to be any important new vapor restrictions, simply because the government would have more pressing matters to deal with.

    And looking to the EU, Page made the point that Britain’s moderate voice on e-cigarettes and related policy—along with its influence generally—would rapidly become close to irrelevant, even before the nation actually left the EU.

    “For the industry both in the U.K. and in the rest of Europe, a likely short-term effect is that international companies looking to expand will be less interested in Britain as a base or British firms as acquisition targets, bearing in mind the risk that the EU departure negotiations could end up with British exporters facing European tariffs and other obstacles to trade,” he said.

    “In the longer term, although a plausible outcome could be more liberal e-cigarette regulation for British vapers along with a less favorable international business environment for U.K. e-cig companies, there are so many factors at play—the departure negotiations, British internal politics, and of course larger trends in the e-cigarette market itself—that about the only sure bet is that there will be unanticipated developments.” —G.G.

     

     

  • Focus on the filter

    Focus on the filter

    As restrictions tighten, the filter has become one of the last bastions of product differentiation.

    By Stefanie Rossel

    backgroundIf you happen to live in Germany, you cannot help but notice the massive billboard advertising campaigns that Philip Morris International (PMI) and British American Tobacco (BAT) have been running since last autumn. (Yes, besides Bulgaria, Germany is the only EU country where tobacco billboards are still allowed). The posters feature new variants of the companies’ flagship brands, Marlboro and Lucky Strike, the eye-catching innovations being their filters.

    Initially launched in Malaysia, Marlboro Advance Blue was the first Marlboro cigarette that came with a recessed filter, which is set back a few millimeters from the mouth end. BAT’s new Lucky Strike Flow Filters employ a different technology: Their tube filter is hollow until further down the filter tip.

    Apart from sporting a different look, the two new tobacco products also come with added value for the smoker: They create a smoother taste and shift the staining observed on the cigarette mouth end away from the consumer.

    Marlboro Advance follows in the footsteps of PMI’s Parliament brand, which was launched in 1931 and is distinctive due to its recessed filter. Introduced at a time when cigarettes had no filters, its specially shaped filter was originally part of an advertising campaign. Today the brand holds strong positions in a number of markets, including Japan, South Korea, Turkey, Ukraine, Russia and the United States. PMI uses recessed-filter technology also in its new-generation products. In November 2015, it launched Parliament HeatSticks for its iQOS device in Moscow. In early 2015, it had introduced a new line of L&M cigarettes with recessed filters in Russia.

    BAT, too, has expanded use of its Flow Filter technology, which is now available also on Dunhill, Kent, Pall Mall and Rothmans cigarettes in several countries. Altogether, Flow Filter variants of its products are for sale in 68 markets. According to a recent investor presentation, tube filters have become a vital part of the company’s marketing strategy.

    Both companies report significant volume growth in the category. Their innovations come at a time when increasingly rigid regulations have left cigarette manufacturers with few means to communicate with customers and make their brands stand out from the competition.

    Patrick Meredith
    Patrick Meredith
    Perry Aliotti
    Perry Aliotti

    “As a result of new legislation concerning marketing restrictions and plain packaging, filters are one of the few components left for tobacco companies to utilize to differentiate themselves and communicate to the consumer,” says Patrick Meredith, innovations director at Essentra, a leading specialty filter provider. “Therefore visual differentiations, such as the shape and color of filters, are increasing.”

    “The current market environment is driving cigarette companies to be innovative in product design and taste, more so than [in] novel packaging,” echoes Perry Aliotti, vice president of cellulose derivatives sales at Celanese Corp.

    This aspect is expected to gain in importance especially in the EU, as the restrictions of the revised Tobacco Products Directive (TPD2) kick in. Among other things, TPD2 bans the use of “characterizing” flavors, prohibits mentholated cigarettes from 2020, and specifies in detail the size, shape and appearance of cigarette packs. The directive even leaves room for the introduction of generic cigarette packaging, which had already been announced in France, Ireland and the U.K. when TPD2 took effect on May 20. All these measures further reduce the range of marketing instruments cigarette manufacturers have at their disposal.

    In response to tobacco companies’ desire to make their products stand out, filter and tow suppliers have significantly extended their product portfolios. This increases the flexibility required to support innovative products while maintaining the sensory experience and smoking mechanics—and meeting legislative requirements.

    Essentra, for example, has launched its Icon range, dedicated to “visual differentiation.” The products allow tobacco manufacturers to include, for example, a thick, extruded cellulose acetate thread shaped with intricate designs in the center of their filters to suit individual brand requirements.

    It is still too early to comment on the full impact of TPD2. For starters, cigarette companies have one year to clear existing stock. Nonetheless, Meredith is convinced there will be an impact. “Innovation in filters has and is continuing,” he says. “For example, tube filters have already seen considerable growth in markets and segments where differentiation in filters is beneficial. Likewise capsule filters are increasingly popular as consumer preference for flavor-on-demand product increases.”

    Innovation is key

    Essentra, no. 2As disposable incomes increase, consumers become more interested in specialty products. “For example, Indonesia has a strong preference for kretek cigarettes, and in the Japanese, Korean and Russian markets consumers enjoy carbon filters for sensory reasons,” says Meredith. “As Japan is generally a very innovative market, we often see new products—such as capsule filters—launched and embraced earlier in this market. Additionally the U.S. has a very prominent market for mentholated cigarettes.”

    Like all industry suppliers, filter and tow manufacturers are keenly aware of the declines in global cigarette sales. “Recently, the world demand for cigarette tow peaked and is now declining slightly,” says Aliotti. “Unless there are significant shifts in filter length, in filtered cigarette use in India, or in accelerated growth in developing markets, that trend is likely to continue long-term at a very slow rate. Tow suppliers have rationalized some capacity, but additional moves are expected at high-cost facilities. Celanese has a well-positioned global tow and flake footprint to meet future demands.”

    Novel products, such as e-cigarettes and heated-tobacco devices, have yet to materially impact overall demand for filter tow—but that could change in the future. For the time being, suppliers of filters and tow continue to present new solutions that reduce toxicants in combustible cigarettes and provide a smoother taste. Celanese, for example, recently introduced a technology called CelFX. “This filter offers super-high levels of carbon in a rigid block form while retaining full tar delivery, a low draw resistance and minimal carbon taste,” explains Aliotti (also see “Active innovation,” Tobacco Reporter, March 2016.)

    “Filter tow innovation remains a major factor in all regions of the world since the filter is the first thing a smoker sees when a pack is opened,” he adds. “Hollow filters, super- and micro-slim filters, and capsule filters all require highly specialized tow items.”

    Flavor on demand

    celanese 2Flavor capsule technology has been one of tobacco’s most recent success stories. While EU sales of traditional mentholated cigarettes have declined in recent years, overall menthol market volumes have increased due to the performance of crush-ball products, in which a small capsule in or near the filter can be crushed to release additional menthol or other flavoring solutions. According to Euromonitor International data, sales of cigarettes with flavor capsules in Poland and Finland increased to 2.9 and 4.5 percent from 2.2 and 2.6 percent, respectively, between 2012 and 2014. (Poland and Finland were the leading traditional menthol cigarettes markets in Europe in 2014, with market shares of 19.5 and 19.1 percent, respectively.)

    The first cigarette with a filter containing a menthol capsule was introduced in Japan in 2007. Today, a large variety of brands with capsules is available in many markets. Apart from traditional menthol, they come in different flavors and have been incorporated into diverse cigarette sizes, such as super-slims. The latest product launches even contain two differently flavored capsules.

    “As with many other markets at the moment, consumers are demanding the ability to customize their own products,” says Meredith. “The tobacco industry is no different, producing customizable products primarily through flavor capsules and flavored filters.” For capsule filters, Aliotti adds, the basic material is decisive, too, since they require efficiency tow items to allow full airflow.

    In addition to flavor capsules and tube filters, there are future opportunities within filters with smaller circumferences, Meredith says. “In fact, in recent years, super-slim filters—with circumferences under 15 mm—have shown strong growth in African and the Middle Eastern markets. Slimmer filters also provide advantages from a manufacturer’s point of view: Fewer materials result in cost-efficiencies, more sustainable products, and can help manufacturers to meet new tar and nicotine legislations.”

    To produce super-slim and micro-slim filters, Aliotti explains, tow items are driven to ever-larger fibers and lower total denier levels.

    Going green

    celanese 1Meanwhile, Meredith has also observed a growing interest in sustainability among smokers. “Consumers are becoming increasingly conscious of their environmental responsibility, so it is only natural that we’ve seen a rise in interest in more environmentally friendly products,” he says. “We have seen a growing demand for more biodegradable plugwrap and paper filters, both of which reduce the time taken for cigarettes to break down after being discarded. Paper filters have a somewhat harsher taste, so there is an increasing interest in our Infused paper filters—offering consumers the higher tar retention and faster degradability speed associated with paper filters without compromising on taste.”

    To meet these requirements, Essentra has developed the Ochre filter, which it says degrades three times faster than industry-standard cellulose acetate filters and uses no chemical adhesives to bond the fibers. Its distinctive natural end appearance creates branding opportunity while it retains higher levels of tar and nicotine compared to the standard mono-acetate filter and provides a similar taste to standard cellulose acetate filters, according to the company.

    “We see the challenge [of degradability] more as a litter issue,” reflects Aliotti. “Celanese has a long history of research into filter degradation and technologies to speed the material breakdown, but nothing can make the filter disappear instantly when improperly disposed.  As of today, none of the industry-developed innovations have been commercialized.”

  • After the party

    After the party

    How the Conference of Parties has affected the tobacco industry—and what to expect going forward.

    By Jeannie Cameron

    jeannie cameron
    Jeannie Cameron is managing director of JCIC International

    COP stands for Conference of the Parties. In the tobacco context it is a meeting of the parties to the Framework Convention on Tobacco Control (FCTC) treaty of 2005. There are also COPs associated with the Framework Convention on Climate Change and its Protocols. The parties are representatives of the governments that have given consent to be bound to the provisions of the treaty through an act of ratification or accession. At the time of writing there were 180 parties to the FCTC.

    At each COP, members discuss elements of FCTC implementation, including checking off national actions, hearing the feedback of intersessional working groups and deciding future plans. COP decisions are made by consensus—an absence of a formal objection. So while technically the COP can vote, it is not the norm.

    It therefore has a major role in strategic planning and oversight: to promote and facilitate the exchange of information, as well as to promote and guide the development of research and collection of data. One of its most significant roles is to act as a coordinator and repository for the collection of national reports of FCTC implementation; reports that must be submitted at regular intervals as an FCTC legal obligation.

    The COP can adopt protocols, or sub-treaties, as it has done with the Illicit Trade Protocol, and make amendments to the FCTC. It also has the power to establish the criteria for the participation of observers at its proceedings—it can decide, for example, whether to open or close the viewing gallery to the public, including the tobacco industry. The COP has its own permanent secretariat to provide for functioning and to manage its budget.

    Governments are allowed to put anyone they choose on a COP delegation. Nongovernment participants are known generally as advisors. COP observers are accredited from either from a state that has signed but not ratified the treaty, such as the United States, or from a state that has neither signed nor acceded to the FCTC, despite having taken part in the negotiations, such as Cuba.

    COP observers also include accredited NGOs and most intergovernmental organizations. Nonaccredited NGOs, the tobacco industry and all other members of the public are only permitted to watch proceedings from a public gallery—a right related to proper international governance, which has been eroded in recent COPs.

    A team of advisors, known as “the Bureau” heads the COP Secretariat, and it includes one advisor from each of the WHO regions. The Bureau’s president, five vice presidents and six regional coordinators are elected at the conclusion of each COP and finish their term at the conclusion of the next.

    At COP, all the excitement takes place in Committee A, the body that discusses and adopts the FCTC guidelines. In terms of impact on the tobacco industry, Committee A is the one to watch.

    While it is true that the guidelines are not legally binding—a point that tobacco industry legal departments have always been keen to point out—the FCTC is a political beast and governments will interpret as they wish or are encouraged to do so, as we have seen with plain packaging. Plain packaging does not feature in the legally binding FCTC treaty because in 2000–2003 the majority of the 193 government FCTC negotiators did not want it. Indeed, even graphic health warnings were excluded; the treaty included only pictorial health warnings as something to be considered if it were thought appropriate to do so. This shows clearly how the politics of a COP, the elaboration of guidelines and the subsequent political pressure, brought about policy outcomes the tobacco industry, in its determination to believe only in a legal interpretation, did not expect.

    COP 1 – Geneva 2006

    The six WHO regions take turns to host the COP. The first COP took place in Geneva, Feb. 6–17, 2006, shortly after the FCTC entered into force. At that point there were 113 COP members. During the meeting participants agreed upon financial and procedural rules (which were amended at COP6 in 2014). These rules would ultimately impact the industry because they gave the organization the power to close its public gallery, excluding the public and the tobacco industry from observing the debates in July 2009.

    COP1 got the ball rolling with guidelines for FCTC implementation, and it agreed to initiate the elaboration of guidelines on the substantive issues of Articles 8 (protection from exposure to tobacco smoke) and Article 9 (regulation of the contents of tobacco products). It established working groups to discuss these issues and report back to COP2.

    COP1 also established the reporting system and discussed the possibility of future FCTC protocols on cross-border advertising, promotion and sponsorship and on illicit trade in tobacco products.

    COP2 – Bangkok 2007

    COP2 took place in Bangkok, Thailand, June 30–July 6, 2007. At this time, there were 146 parties. From a personal perspective, this meeting is my favorite meeting to date. I think it was the logistical challenge of getting to the conference center through Bangkok’s notorious rush hour traffic that brought about the idea of traveling over the water instead.

    Each morning we would rent a suitable long boat on the banks of the Chao Praya River. The risk takers among us tobacco-industry representatives would pile in, negotiate the waves and river traffic, and continue the journey to the conference center in tuk-tuks at the other end.

    COP2 went on to adopt guidelines on Article 8 (the protection from exposure to tobacco smoke) and initiated work on further areas: Article 5.3 (tobacco industry participation); Article 11 (packaging and labeling) and Article 13 (advertising and sponsorship). It also began the process for recommendations for Articles 17 and 18 (economically sustainable alternatives to tobacco growing). In addition, COP2 agreed to establish an Intergovernmental Negotiating Body (INB) on a Protocol on Illicit Trade in Tobacco Products.

    I distinctly recall Ian Walton George of the European Anti-Fraud Office (OLAF) arguing that Article 5.3 would not be relevant to the issue of illicit trade as it was not technically a health policy. He also said that, on such an important issue, it was imperative to consult with the tobacco industry.

    I also recall it being the first COP where anti-smoking activists chased us around with cameras, attempting to snap anyone from the industry talking to a government delegate. Alas, that did not happen, and so pictures emerged in the NGO daily news bulletins with captions that stretched the imagination. One appeared showing a picture of me sitting taking notes in the public gallery with the caption that I was looking for marketing opportunities to undermine the discussions on product regulation.

    The public smoking guidelines adopted at COP2 contributed to the stigmatization of smoking and its prohibition in many indoor and even outdoor public places. It also resulted in a significant stiffening of penalties for lighting up in smoke-free areas. These same policies are now impacting e-cigarette users, as well—even though vapor is not the same as tobacco smoke.

    Despite COP2’s clear signals, including references to plain packaging, the tobacco industry at the time underestimated the risk.

    COP 3 – Durban 2008

    COP3 was held in Durban, South Africa, Nov. 17–22, 2008. With more than 600 delegates, it remains one of the largest COPs to date. It was also the first COP where access to the public gallery began to be restricted, with the WHO issuing only 30 passes per day, ostensibly for security reasons.

    We had to get up earlier every day to get a pass, and we had to line up in an underground car park. Not many would believe that we did that—but we did so, quietly and orderly. One potential public applicant fell to his knees in desperation when advised he was number 31. The next day, he was there before 6 a.m. to ensure he’d be among the first 30 when passes were issued at 10 a.m.

    As expected, the intersessional working groups on Article 5.3 (industry participation), Article 11 (packaging and labeling) Article 13 (advertising and sponsorship) delivered their guideline recommendations and the COP unanimously adopted each.

    Even though some countries raised concerns, the guidelines on plain packaging were adopted by consensus. For example, my COP3 notebook reminds me that China asked the COP to delete 50 percent of the Article 11 guidelines. It also asked how plain packaging could be a recommendation of best practice when no country in the world had yet done it?

    The Chair stated that the aim of the guidelines is not to enlarge or extend obligations—it was only to assist in implementation—and then after a few voices of support for no change to the draft, that was it; the guidelines were adopted. The same was true of the Article 13 guidelines regarding domestic enforcement of complete advertising ban, apart from where constitutional issues were found, and that was that—adopted. The working group on 5.3 guidelines, regarding participation of the tobacco industry, presented the draft and some objections began to be raised by the COP. According to my notebook, China argued that anyone interested should be entitled to raise anything. Once again the Chair intervened. “China is right,” he said, “however, we have a timing issue.”

    The COP process is completely different to an INB process in so far as following due process is concerned. At an INB, any government representative taking the floor to speak on behalf of the government must have full powers to do so from either the head of state or the minister for foreign affairs, because in that capacity a representative has the power to legally bind a state to what is being negotiated.

    This is how the FCTC and the protocol were negotiated. At COP, by contrast, anyone can speak for anyone, and this was witnessed often. On one occasion I saw a New Zealand NGO speaking for Saudi Arabia before taking another seat to speak for another country.

    COP3 has had a most significant impact on the tobacco industry—one that has not yet fully played out as governments, fueled by political pressure, continue to implement the FCTC.

    In the typical pattern, in the final hour of the COP, more guidelines were brought on for elaboration. My COP3 notebook reminds me that at the end of COP3, the Philippines raised that the WHO should seek expert advice to elaborate Article 6 (price and tax). One by one the WHO regions supported the Philippines and eventually the European region, represented by France, took the floor, proposing that the EU would draft the resolution on behalf of the COP. Those present could see that France was motivated by the need to reign back in what was fast becoming a rather concerning proposal on tax, and therein the EU became part of the consensus.

    COP3 was also where the notorious “Merchants of Death” poster was circulated. Headed “Beware the Merchants of Death,” the poster carried a picture of me and three colleagues. It was funny on one level, and some delegates even asked for it to be autographed, but it was scary on another level, as the photo of me had been taken during winter and it being summer in the southern hemisphere meant the photo had been in someone’s file.

    COP 4 – Punte del Este 2010

    After COP3, COPs were to take place every two years rather than yearly and so COP4 was held Nov. 15-20, 2010, in Punta del Este, Uruguay. With 137 parties participating, COP4 adopted new implementation guidelines for Article 12 (education, communication, training and public awareness) and Article 14 (demand reduction measures concerning tobacco dependence and cessation) and partial guidelines for Article 9 (regulation of the contents of tobacco products) and Article 10 (regulation of tobacco product disclosures).

    COP4 established a working group to elaborate guidelines on Article 6 (price and tax policies) and to continue the work on economically sustainable alternatives to tobacco growing, as well as to continue negotiations on a protocol to combat illicit trade in tobacco products. COP4 set up an expert group on Article 13 (cross-border advertising, promotion and sponsorship) to keep the COP up to date and to monitor progress in this area of work. At this COP, tobacco growers conducted various lively demonstrations not seen for some while. The growers were intent on making sure the COP understood their specific issues and that their livelihoods were at stake.

    Parties adopted the Punta del Este Declaration aimed at strengthening the implementation and protection of public health policies in relation to tobacco control. They also adopted decisions to engage more actively with international organizations and bodies in promoting treaty implementation. Special focus was placed on the integration of implementation of the WHO FCTC with the existing mechanisms for development cooperation and the “One UN” framework.

    COP 5 – Seoul 2012

    COP5 took place in Seoul, Republic of Korea, Nov. 12–17, 2012, and included 140 parties. “Gangnam Style,” the Korean top of the pops, was order of the day and consequently there were often impromptu performances around the conference center to entertain delegates—or at least those of us who had been voted out of the room when the public gallery closed. As was the case at COP3, we had to get there ever earlier to secure a pass—at least until the lockout occurred. On one occasion that meant arriving at the conference in the dark at 4 a.m. and using a phone torch (flashlight) to navigate to where the queue would begin.

    COP5 adopted a set of guiding principles and recommendations to support the implementation of Article 6 on price and tax measures to reduce the demand for tobacco, and established a working group to finalize the full guidelines. COP5 amended the partial guidelines on Articles 9 and 10 relating to ingredients and product characteristics, and requested this working group to continue its product related work.

    COP5 also began to consider areas of harm reduction by opening up discussion of work in relation to smokeless tobacco and electronic nicotine-delivery systems. It also established an expert group on Article 19 (Liability). This working group is expected to report at COP7, scheduled for later this year in Delhi, India.

    COP5 established a process for further developing policy options and recommendations on economically sustainable alternatives to tobacco growing. Most significantly, it adopted the FCTC’s first Protocol: the Protocol to Eliminate Illicit Trade in Tobacco Products. The COP5 parties also made a collective commitment in the Seoul Declaration, to accelerate implementation of the FCTC and to protect it from interference by the tobacco industry—a growing theme.

    COP 6 – Moscow 2014

    COP6 took place in Moscow, Russia, Oct 13–18, 2014, and was attended only by 135 parties despite there being nearly 170 parties at that point. COP6 finally adopted guidelines on price and tax and issued guidance on smokeless tobacco products, electronic nicotine-delivery systems, electronic nonnicotine-delivery systems, as well as water-pipe tobacco products. COP6 was also where trade and investment issues began to emerge in a significant way, fueled presumably by the various tobacco industry litigation cases taking place around the globe. There was a feeling at the end of COP6 that things had more or less been done, and the momentum of earlier COPs had dissipated. This feeling was fairly widespread and there many that expect therefore, COP7 to be bring about a renaissance.

    COP 7 – New Delhi 2016

    COP 7 will take place in New Delhi India Nov. 7–12, 2016. The first Meeting of the Parties (MOP) for the FCTC protocol is scheduled for Nov. 14–16. The MOP cannot take place until 40 FCTC parties have ratified the protocol, and at time of writing there are only 16 parties to the protocol. There are 54 signatories to date, so a rather large pool for political pressure to be placed upon. There may well be a flurry of ratifications by early August—the time by which a party must submit consent to be bound by the protocol in order for the MOP to take place as scheduled.

    COP7 is expected to focus further on product characteristics, liability, sustainable development, trade and the areas of harm reduction, e-cigarettes, smokeless tobacco products and other nicotine-delivery systems.

    It will be significant for the COP to determine whether it will be able to put public health ahead of politics and accept that tobacco may not harmful in all its forms—and that harm reduction is a policy that can apply to tobacco as well as other areas of public health. The FCTC already requires national tobacco control policy to include harm reduction strategies, and the COP has the capacity to embrace this concept, but it remains to be seen what will emerge. It will require a pragmatic approach.

    U.S. government FCTC delegate Greg Jacob wrote in the Chicago Journal of International Law (2004) that the WHO FCTC process made him feel as though he had stepped into the Geneva edition of the Twilight Zone. He makes the point—one that has not changed—that rather than negotiating with foreign states, governments are negotiating with foreign health ministries that are not necessarily pursuing policies favored by their home governments. “Delegates saw the FCTC as an opportunity to do an end-run around their governments by inserting strong anti-tobacco measures into the convention and then relying on international political pressure to force their governments to join it. Some of the delegates openly admitted their ulterior agendas, making plaintive appeals from the floor to force the hand of their government back home.”

     

     

  • On demand

    On demand

    Smart supply chain solutions facilitate the procurement and storage of spare parts.

    By Stefanie Rossel

    In a previous report on tobacco equipment consumables (see “The real stuff,” October 2014), Tobacco Reporter found that parts are as important to cigarette machinery as capsules are to modern coffee makers. High-quality, properly fitting parts ensure smooth operation and consistent product quality for tobacco producers and coffee connoisseurs alike. Low-quality, improperly fitting parts, by contrast, are likely to create problems. Any savings on the initial purchase price are likely to be wiped out by reduced efficiency, compromised product quality and shortened machinery lifespans.

    As the tobacco industry navigates fundamental market changes, perhaps it’s appropriate to develop this analogy a little further: Imagine that, in addition to offering a vast array of flavors, your favorite coffee vendor would also know when your ristretto is running low. Instead of requiring you to order and stock large volumes, your suppliers would automatically send to you the next batch of coffee—exactly the desired amount and just in time. And this, more or less, is how the supply of spare and wear parts, in its most advanced form, works nowadays.

    While optimizing efficiency has always been a main objective in cigarette production, the speed of such efforts has accelerated in recent years, after leading tobacco manufacturers, in light of falling cigarette sales, began closing factories and centralizing production.

    As a consequence, a lot of relatively new machinery has become available, stifling demand for new equipment. Spare and wear parts have been “set free” as well. For the manufacturers of such consumables, however, the cigarette companies’ moves have turned out to be less negative than might have been expected.

    “The movement of production undoubtedly has an effect on suppliers, as the transition periods can be lengthy and factories seek to run stocks down before relocating,” says Paul Farrell, spares manager at Molins Tobacco Machinery. “We have found that as machinery has ‘cascaded’ it is an opportunity for Molins, as older machinery is brought out of storage and requires spares and overhaul projects. The market is still very nervous about committing to new equipment, however; this has worked in favor of our spares business in the short term.”

    “There is a short impact due to the consolidation of spare parts from other factories,” says Russell Greenwood, spares operations manager at Garbuio Dickinson, which specializes in primary department (PMD) equipment and was acquired by Hauni Maschinenbau in 2014. “This impact is small on PMD equipment, as the level of spares held in stock is minimal.”

    Farrell goes on to explain that, with the tobacco business depressed, his company had lowered its outlook for the spare parts business correspondingly. “However, we have found that for spare parts and additional equipment the market has been very positive,” he says. “Customers who were previously running down inventories now have requirements, and machinery that would previously have been put into storage is still running.”

    Henk Meijer
    Henk Meijer

    Like Garbuio Dickinson, ITM has experienced stable regular spare parts sales. “At ITM Poland we have even seen a boost in the start-up and consumable spares due to the sales of recently launched equipment,” says Henk Meijer, manager of services at ITM.

    The better-than-expected sales are not due to good fortune alone; they are also a result of hard work. “We have worked hard with our customer base to keep the appropriate level of consumable parts in stock constantly and have excellent freight links globally,” says Farrell.

    Meijer points out that all multinational cigarette manufacturers have introduced cost-reduction schemes. “This is also affecting the spare parts business,” he says. “The targets set for spares prices are putting pressure on the margins, and we nowadays have to go through various rounds of negotiations before new spares contracts can be signed.”

    In order to remain competitive, spare parts suppliers must take fresh approaches, says Heiko Geissler, head of service operations at Hauni. With worldwide cigarette production stagnating, he believes the demand for spare parts will stay the same. “Growth can only be generated through new products or added value in the after-sales service,” says Geissler. As an example, he points to the integration of the Decoufle spare parts business into Hauni’s Hamburg operations. “Through this, our customers get some added value as far as performance is concerned,” says Geissler. “In addition, purchasing processes have been facilitated.”

    Growing complexity

    Heiko Geissler - Head of Service Operations, Hauni
    Heiko Geissler

    Supplying spare and wear parts to the tobacco industry has become an increasingly complex business, holding ever-new challenges for suppliers. Geissler says Hauni has used the past 18 months to develop, among other things, a technology that automatically creates certificates of origins for its spares. “This tool will accelerate customs procedures by up to four days,” he says. In addition to having a good understanding of the world’s increasingly complex customs regulations, today’s spare and wear parts suppliers must be aware of the interaction between many independent products and comprehend the interlaced, intelligent supply chain, according to Geissler.

    Meijer observes that, in addition to seeking state-of-the-art parts at the best possible price, clients now also demand obsolescence management. They emphasize issues such as sustainability, recycling and power consumption, which places new demands on equipment manufacturers. “This will have its impact in the long term,” he says.

    After a round of spare part redistribution to accommodate reduced manufacturing footprints, Meijer expects tobacco companies to introduce “meaner and leaner” procurement procedures. “This requires a new approach in the way client and supplier are managing the spare parts supply lines,” he says.

    To comply with cigarette manufacturers’ mentioned requirements, as well as demand for shorter lead times, longer-lasting parts and reduced stocks, additional efforts are required from parts suppliers, according to Meijer.

    “This often means tailor-made solutions that can only be achieved in partnership with the client; therefore we have to move away from the traditional client-customer relationship,” he says. “In order to come to sensible and sound solutions, all aspects of the aftersales business should be taken into account.”

    VMI rising

    Supply chain optimization—particularly inventory management—has increasingly become the focus of suppliers’ efforts. The companies interviewed for this article provide various digital solutions that allow their customers to check availability of spares, obtain online quotations and place orders. All of them have implemented vendor-managed inventory (VMI) systems.

    Garbuio Dickinson uses a customer-relationship management (CRM) tool to help predict demand based on a combination of history, machinery in operation and machinery likely to continue to be in operation.

    “Customers are rightfully seeking to push back inventory holding onto suppliers and request ever-decreasing lead times,” says Farrell of Molins. “We did a large-scale exercise scrutinizing our supply chain, determining what inventory needs to be held in stock, pushing inventory vertically down the supply chain and providing more supply options,” he says. “This has led to Molins being able to reduce the lead times for proprietary parts by an average of 42 percent. We are also happy to work with customers’ needs and hold stock of key items for call-off orders.”

    According to Farrell, spares demand levels vary rapidly and Molins’ systems are constantly monitoring and adjusting stock levels to ensure the perfect balance, maintaining the highest percentage of in-stock availability. “Our machinery design team always considers the reduction of parts count and use of common parts for various machine groups, which in turn reduces our and our customers’ stock level requirements,” he says.

    Molins experience with VMI has been positive. “We frequently receive requests from customers to provide recommended essential spares lists for their machinery; we then provide the customer with an update on what we recommend they purchase now and in the future,” says Farrell. “This has to be a two-way process to work, as our estimations on consumption come from the customer providing us with production information; however, this helps to foster trust and understanding within our relationships.”

    One of the challenges in implementing such an advanced management tool, notes Meijer, is that its success depends largely on the sophistication of clients’ IT systems and customers’ ability to predict their parts requirements. VMI has been an option in recent ITM projects, and the company can offer it as part of a service package. “Such a package is part of an agreed after-sales service contract with a mutually agreed scope and fee,” says Meijer.

    The latest generation of tobacco machinery features smart sensors to accurately predict when parts must be replaced, according to Geissler. “Combined with the remote service Hauni offers, technicians at our site in Hamburg-Bergedorf can directly access the machine, make recommendations and intervene if necessary,” he says. “Supported by our intelligent-supply concepts, the required spare part can be sent out immediately.”

    He adds that, in addition to Hauni’s web shop and electronic data-interchange (EDI) system, VMI has established itself as an independent e-commerce service. “Our VMI services continue to be in high demand,” says Geissler. “We now have connected around 50 customers with this tool. While clients were skeptical in the beginning, they are now increasingly willing to shift responsibility for their materials supply to the supplier. This readiness is the basis for talks about further developments because an active management of customers’ inventories leaves ample scope with many chances for the client. The integration of Decoufle’s spare parts provides us with the potential to expand our VMI offer for existing and new customers.”

    Carefree sourcing

    “Challenges to deliver a high-quality product with ever-decreasing resources relies on reliable and effective operations not only from individual assets but [also from] all the processes that make up a manufacturing unit,” says Alex Cormack, operations director at Gemba Solutions, a U.K.-based IT solutions provider specializing, among other things, in overall equipment effectiveness. Many manufacturers now run a mixture of OEM and older equipment—a situation that, according to Cormack, can affect reliability and failure rates, impacting the manufacturer’s return on investment.

    To optimize performance even in a mixed-equipment scenario, ITM uses Gemba Solutions’ production-efficiency software and services. Taking a holistic view, ITM is able to monitor not just its own equipment but any machine or process in the production process. This ability enables the company to pinpoint failures in real time and manage capacity improvement activity while maintaining output levels from older equipment.

    “Excellent support and spares strategies can reduce the impact of older equipment failure, though the frequency and modes may become more difficult to manage when assets age beyond their predicted reliable years,” says Meijer. “This old equipment may not employ the latest condition-based monitoring systems. The introduction of modern manufacturing techniques is increasingly becoming a must-have culture within the cigarette industry. The basis of Lean, Agile and Six Sigma methods are all reliant on the ease of collection and analysis of good data; the ITM Gemba system and support helps drive these seamlessly.”

    Hauni also offers a comprehensive spare parts supply chain-management solution. The company provides spare parts from more than 1,100 suppliers. Its system offers customers more than 400,000 items 24/7, 365 days a year.

    Claus Peters
    Claus Peters

    Based on forecasting methods, Hauni can take over its customers’ spare parts planning. The company independently defines the optimal inventory level of each spare that needs to be in stock at the customer’s site. “To achieve this, we file each spare part in different clusters, based on its history of consumption,” explains Claus Peters, group manager of services at Hauni. “Dependent on this, we determine the desired scope of supply together with our customer in an initial provisioning study. We then agree [on] a service level. The service level is aligned to the availability of the agreed range of spare parts. In combination with the spares permanently available ex-Hauni and the articles stored at the customer’s site, it stands at 99.5 percent.”

    As soon as the initial provisioning study has been finalized, the scope of supply is being mapped onto Hauni’s forecast and planning tools. The company then takes on the materials planning of the agreed array of spare parts. The cluster assignment of the individual parts with regard to ongoing consumption is checked regularly and adapted if necessary. “The customer profits in many ways from this solution,” says Peters. “By means of tailor-made logistics concepts it significantly improves the availability of materials and ad hoc supply; through optimized stock levels it enhances capital lockup. In addition, it considerably reduces the complexity of customers’ procure processes and brings about operational relief, thus creating more room for clients to focus on their core business.”

     

     

     

     

     

     

  • A remarkable journey

    Tanzania’s transformation into a prominent leaf tobacco supplier has been a process rather than an event—and it continues today.

    By Taco Tuinstra

    truck
    The road to Morogoro in 1997.

    When Tobacco Reporter first traveled to Tanzania in 1997, the road from Dar es Salaam, the country’s administrative capital, to Morogoro, its tobacco capital, was in poor shape, with potholes deep enough to wreck even the toughest suspension.

    Few drivers adjusted their speeds to road conditions, however. We witnessed multiple fresh accidents during the 200 km (124 miles) journey; not the occasional fender-bender like you might expect in Europe or the United States, but major incidents, with full-sized freight trucks lying upside down, their cargos scattered over the road. And that was before it started raining.

    As thunder clouds gathered, entrepreneurial villagers gathered alongside the road, ready to offer their services to stranded motorists. For a small stipend, they would help push stalled cars or, if that failed, carry the hapless passengers to higher, drier ground. Fortunately, our rugged Toyota Land Cruiser—the tobacco industry’s vehicle of choice in many remote sourcing areas—never required such assistance, but it still took the better part of the day to reach our destination.

    By comparison, today’s travelers have it easy. The road has been paved and, presumably, equipped with better drainage, although you must still be alert for unexpected moves by fellow motorists—the drivers of Tanzania’s long-haul buses have a reputation for particularly reckless behavior. If you can get up early enough to avoid Dar es Salaam’s notorious rush hour, however, you should be able to make it to Morogoro in less than three hours.

    The road to Morogoro in 2015. Note the bags of charcoal offered for sale on the roadside. While charcoal production is believed to account for the lion's share of deforestation in Tanzania, critics are eager to point fingers at tobacco farmers, who use wood for curing.
    The road to Morogoro in 2015. Note the bags of charcoal offered for sale on the roadside. While charcoal production is believed to account for the lion’s share of deforestation in Tanzania, critics blame tobacco farmers, who use wood for curing.

    Transformation

    For a tobacco man, it’s a journey well worth making because Tanzania’s industry has changed beyond recognition. At the turn of the century, the country produced less than 20 million kg of flue-cured Virginia (FCV) tobacco. In 2010–2011, Tanzanian farmers harvested a record 122.9 million kg. The 2010–2011 season was exceptional for several reasons, but the trend has been irrefutably upward, with this year’s crop expected to be 90 million to 100 million kg.

    Quality has improved, too. “I remember Tanzania tobacco being mostly filler leaf,” says Alex Tait, leaf and sales director at Alliance One Tobacco Tanzania (AOI), who previously worked in Zimbabwe. “Now Tanzania produces the full range, from filler to semi-flavor/flavor styles,” he marvels.

    “In the 1990s, ‘Tanzania’ was a two-color crop,” echoes Rob Glenn, general manager of JTI Leaf Service (JTILS), which started operations in Tanzania only recently. “Today, the country produces a good quality, with the ripe, semi-flavor styles that are liked by blue-chip customers.”

    Importantly, Tanzanian tobacco today is striving hard to meet requirements in terms of regulatory compliance.

    Needless to say, the changes did not happen overnight. As stakeholders repeatedly pointed out during Tobacco Reporter’s visit, the transformation of Tanzania’s tobacco industry has been a process rather than an event. It has been the result of a concerted effort by all stakeholders to improve the reputation of Tanzanian leaf, which plays a key role in the country’s economy.

    Tobacco is the No. 1 foreign exchange earner among all of Tanzania’s traditional cash crops, raking in more than $100 million per year. In addition, it is a leading source of employment. There are nearly 100,000 tobacco farmers in Tanzania, according to the Tanzania Tobacco Board (TTB). Add to that farm laborers, factory workers and people working in support industries—plus all of their dependents—and you get an idea of the industry’s significance.

    The golden leaf arrived in Tanzania from Malawi in the 1930s. Cultivation started in the south of the country but gradually spread to other regions. Over time, Tabora evolved into the biggest production center; today, the region accounts for 60 percent of Tanzania’s production. Some 95 percent of Tanzanian leaf is FCV. The country still grows dark fired varieties in Songea, but volumes have dwindled rapidly as the global market for that style continues to decline.

    But while tobacco production spread to multiple regions, leaf processing concentrated in Morogoro, an area oddly ill-suited for tobacco cultivation due to its climate (too hot) and elevation (too low). Part of that was due to logistics: The vast majority of Tanzanian leaf is exported, and all roads from the growing areas to the port pass through Morogoro. The other reason was Morogoro’s relatively high level of development. “You need ample supplies of water and electricity to run a tobacco processing plant,” says David Crowhurst, factory director at Tanzania Tobacco Processors Limited (TTPL), the Tanzanian processing subsidiary company of Universal Leaf Tobacco Co. (ULT) Both are more readily and reliably available in Morogoro than they are in Tabora and other growing areas.

    Tobacco research centers such as Torita and Urambo have played a significant role in the development of Tanzanian leaf.
    Tobacco research centers such as Torita and Urambo have played a significant role in the development of Tanzanian leaf.

    The separation of growing and processing is also an attribute of the current legal framework; it’s against the law to export green tobacco. Unlike other cash crops in Tanzania, tobacco promotes local agro-processing, creating additional employment.

    This situation has helped spread the wealth generated by tobacco, but it also left the tobacco industry with a massive area of operations. Whereas the vast majority of Zimbabwean tobacco is grown in a comparatively small area around Harare, Tanzanian tobacco is scattered far and wide. The leaf-growing area in Tanzania is the size of Germany, according to Glenn—but without a German-style Autobahn network. Tabora and Morogoro are almost 700 km apart, and though this road, too, has improved, some stretches apparently still resemble the Dar es Salaam-Morogoro “highway” of the 1990s.

    Along the more desolate parts of this route, security is an issue. Rather than driving directly from Morogoro to Tabora, Tobacco Reporter was advised to fly from Dar es Salaam to Mwanza, on the southern shores of Lake Victoria, and continue to Tabora by road from there. This would significantly lessen the risk of highway banditry. Tobacco truckers don’t have the luxury of taking such a detour, of course, but apparently the danger to them is lower because the robbers are more interested in cash and electronic gadgets than they are in unprocessed tobacco leaf—even if the leaf passing through their territories is of a higher quality than ever.

    The tobacco produced today more closely matches what merchants want to buy
    The tobacco produced today more closely matches what merchants want to buy

    Reform

    Asked about the Tanzanian tobacco industry’s remarkable growth, stakeholders cite three factors: economic liberalization, effective extension services and the eagerness of Tanzania’s farmers to learn. The decline of Zimbabwean tobacco production after 2000, as a result of political instability in that country, provided an opportunity for Tanzania as well.

    After independence in the early 1960s, Tanzania initially pursued a form of socialism, collectivizing farms and nationalizing industries. The TTB’s predecessor, the Tanzania Tobacco Processing and Marketing Board (TTPMB), supplied tobacco farmers with inputs such as seeds, fertilizers and crop-protection agents. After the crop had been grown, the TTPMB would deduct the cost of its inputs from the tobacco price. What remained was income for the farmer. As it name implied, the TTPMB was also responsible for processing and marketing the crop. The board operated a tobacco processing factory in Morogoro.

    The system did not work well, however. Because of extensive bureaucracy and a lack of funds at the TTPMB, farmers often received their inputs too late or not at all. There were als

    Urambo Seed Farm manager Michael Mshaga inspects a batch of tobacco.
    Urambo Seed Farm manager Michael Mshaga inspects a batch of tobacco.

    o difficulties with payments.

    Things changed in the 1990s, after the Soviet bloc collapsed and many former command economies started embracing free-market policies. “Government has no business doing business,” President Benjamin William Mkapa famously declared after his election in 1995. The state got out of the tobacco trade, reforming its tobacco board and selling its processing factory (ULT won the bid; AOI later built its own factory). The newly created TTB would focus on regulation, administering one of the world’s most intricate tobacco-marketing systems.

    The Tanzanian leaf tobacco industry is dominated by small-scale farmers, with an average plot size of 0.7 hectares. To increase their leverage at the negotiating table, growers organize themselves in “primary societies,” which in turn belong to corporate unions. There are 148 primary societies and seven corporate unions in Tanzania. The buyers include ULT’s local trading subsidiary—Tanzania Leaf Tobacco Co. (TLTC)—AOI, Premium Active Tanzania and JTILS. China’s state tobacco monopoly, too, has recently shown an interest in Tanzanian leaf, but experts caution against inflated expectations, as Chinese buyers tend to be selective.

    Growers and buyers come together in the Tanzania Tobacco Council (TTC), pursuant to Tanzania’s tobacco laws and regulations, to confirm minimum prices per grade and debate industry issues. Agreements are reached by consensus and the TTB serves as an umpire. Prior to the season, the TTB and other stakeholders jointly analyze and determine the cost of production, recommend an appropriate margin and then confirm a minimum price per grade for TTB publication. This way, the farmer will know the minimum he or she will receive for a given quality of tobacco before the season has even started. Because classification is all-important, the system includes elaborate checks and balances, as well as arbitration procedures in case of disagreement.

    Stakeholders say they spend lots of time in meetings, talking “endlessly” to reach consensus, but overall, they appear happy with the setup, which provides a government-mandated, transparent and effective framework. “The key is acceptance,” says Glenn. “Here is a process that everybody understands. It is time-consuming but it works.”

    Extension

    Taking advantage of economic liberalization, the tobacco industry set out to improve agronomic practices. Initially, the tobacco buyers provided their respective contracted growers with finance, inputs and agronomic advice, but like the TTPMB before them, they found it tough going. There were problems with side-marketing (when a farmer contracts with one company but sells to another) and loan recovery. The quality left much to be desired, too. “There was a disconnect between what we wanted to buy and what was produced,” says Richard Sinamtwa, group corporate affairs director at TLTC.

    In 1999, TLTC and AOI’s predecessor companies, with the blessing of the government, created a structure to help address some of these issues—the Association of Tanzania Tobacco Traders (ATTT). The ATTT provides extension services and logistical support to some 53,000 farmers, allowing the tobacco merchants to focus on their core business of buying, processing and exporting tobaccos.

    While TLTC and AOI are currently its only shareholders, others are welcome to join, and the association’s services are available to all players. (Farmers, through their unions, have also been invited to apply for membership.) “We are a neutral middleman; competitive issues stay off our radar,” stresses Alex Gagiano, general manager of the ATTT, which takes great care to protect each client’s confidential and proprietary information. “We are here purely to help train farmers.” JTILS is a client while Premium, which sources most of its tobaccos in Mbeya in the south of the country, has opted to stick with its own crop-development program.

    Virtually everybody interviewed agreed that the ATTT has been a major driver behind tobacco’s transformation in Tanzania. “ATTT should get lots of credit,” says Bruce Coleman, agronomy projects, STP, SRTP and GAP manager at TLTC. With a staff of 1,000, including 600 field technicians, the organization covers an area of 300,000 square kilometers.

    Traditionally, the ATTT’s training sessions have focused on good agricultural practices, advising farmers on the correct dosages of fertilizer and proper topping heights, for example. In recent years, however, the emphasis has shifted toward sustainability and compliance. “Today, I spend 75 percent of my time on sustainability issues,” says Gagiano. “Only 25 percent is dedicated to traditional crop and administrative duties.”

    AOI's Alex Tait and Hamis Liana in front of a map of Tanzania. The country's tobacco-growing area is said to be the size of Germany.
    AOI’s Alex Tait and Hamis Liana. The country’s tobacco-growing area is said to be the size of Germany.

    The sustainability file includes forestry, agricultural labor practices, water and soil management, with forestry and agricultural labor practices demanding the greatest amount of attention. “Trees are now as important a crop as tobacco,” says Gagiano. Tanzania’s tobacco farmers use wood for curing, and the tobacco industry has been blamed for deforestation. Even though studies suggest the lion’s share of forest loss in Tanzania is due to charcoal production for domestic applications, industry representatives agree that the industry must do its bit to address the problem.

    The tobacco industry provides farmers with tree seedlings and encourages the regeneration of natural forests, but changing habits can be a challenge. Many farmers don’t see the problem; they think there are plenty of trees. But others are starting to appreciate the issue. “Growers realize they now have to walk further to get their fire wood,” says Gagiano. Under the motto “No trees, no tobacco,” buyers have made tree planting, as well as the adherence to good agricultural practices, a condition of every tobacco contract. “The goal is for farmers to be self-sufficient in curing wood by 2020,” says Gagiano. The focus is also on curing methods, promoting the most efficient barn technology to limit wood use.

    The tobacco processing factories, too, are doing their share to decrease their environmental footprint. TTPL, for example, is in the process of installing a biomass boiler, which is expected to reduce carbon emissions by 90 percent. The boiler will run on waste generated by a nearby teak timber plantation.

    The other big compliance issue is combatting child labor. The industry in Tanzania goes to great lengths to ensure that farmers adopt good agricultural labor practices and send their children to school. If a farmer is caught with underage workers in his field, he can lose his growing contract.

    Much revolves around education, according to Coleman. One aspect of compliance, for example, is ensuring farm laborers receive at least the minimum wage. But if farmers don’t know there is such a law, they can hardly be expected to adhere to it. Despite the challenges, Gagiano says considerable progress has been made, and many growers are already in full compliance, which is a remarkable achievement considering the ATTT’s vast territory and large number of clients. “When talking about sustainability, you will not find a single NGO with such extensive coverage in Tanzania,” he says.

    The Tanzanian tobacco industry’s efforts to produce a high-quality, sustainable crop have also benefited from the work of two tobacco research institutions—the Tobacco Research Institute of Tanzania (Torita) in Tabora, and TLTC’s Urambo Research and Seed Farm. Torita was established in 2000 to partner with stakeholders and promote good agricultural practices in tobacco production, curing, primary processing and environmental conservation.

    Among other contributions, the institute, in collaboration with the Tanzania Official Seed Certification Institute, has released and registered new, higher-yielding tobacco seed varieties and facilitated the evaluation of suckercide. Torita is also exploring ways to make curing barns more efficient because, as Torita director Jacob Lisuma points out, “A good crop is worthless without proper curing facilities.” Torita research has also shown that, contrary to what critics suggest, tobacco remains the most profitable cash crop for Tanzanian farmers. In 2012, the institute helped disprove suggestions that tobacco growing was negatively affecting honey production in Tabora. As it turned out, the rumor had been started by Kenyan honey traders looking for a deal.

    The Urambo Research and Seed Farm performs similar work as well as other research and development activities, focusing on labor cost, sustainability and fuel efficiency, among other issues. According to Urambo manager Michael Mshaga, inefficient, wooden curing barns dominated the landscape in the 1990s. Today, 98 percent of them are made of brick. “Now we are taking efficiency to the next level by improving the heat channels,” he says. In developing technologies, Urambo strives for solutions appropriate for local conditions. “We can’t simply take a hyper-efficient U.S. barn and install it in Tanzania,” he says.

    alex
    Alex Gagiano, general manager of ATTT, which has been a driving force behind Tanzania’s transformation as a tobacco supplier.

    Moving forward

    Despite the considerable progress made in the Tanzanian leaf tobacco industry, many challenges remain. While the rampant side-selling and problems with debt recovery of the 1990s have been tamed, these issues have not disappeared. Corruption remains a problem at certain levels of government, and there are concerns about corruption and a lack of proper governance in some of the unions and primary societies.

    Cheddy Mhiwa, agronomist at the Western Tobacco Growers Cooperative Union, says his organization is working with all stakeholders to combat the problem, training leaders and developing strategies. In this context, many players have been encouraged by the recent passage of a law banning politicians from assuming management positions in unions and primary societies.

    Overall, however, Tanzania seems to be on the right track. According to Coleman, yields have almost doubled since the 1990s. “Last year, we saw yields of just under 1,500 kg per hectare—of course, that is still only half of what the Brazilians are getting, but in this climate and environment, it’s quite good. It shows that the extension is working,” he says.

    Tobacco buyers who haven’t been to Tanzania in a while may want to consider adding the country back into their travel schedule, and not just because of its vastly improved leaf.

    Tanzania is home to more than 120 tribes and divided almost equally between Christians and Muslims, yet they all manage to rub along peacefully. Nowhere does the country’s diversity become more apparent than on its cheerfully chaotic roads. Tanzanian drivers like to decorate their vehicles with images of their heroes. Returning from Morogoro to Dar es Salaam, we encountered not only the country’s independence leader, Julius Nyerere, but also U.S. President Barack Obama, rap artist Jay Z, Colonel Moammar Gadhafi and Jesus Christ. Muslim drivers, banned by their faith from depicting their prophet, had embellished their vehicles with brightly colored Quranic verses.

    Yet despite the variety in worldviews on display, there were no signs of antagonism, reflecting Tanzania’s cohesion as a nation-state. Rather than quarreling over ideologies, drivers focused on protecting their precious share of asphalt, so as to hasten their journey home. The preoccupation with such everyday concerns bodes well for the tobacco industry because it suggests that Tanzania offers not only a good crop but also a stable business environment—something that is not necessarily a given in other African sourcing areas.

  • A winning approach

    A winning approach

    Jason Rock image and biography

    Jason Rock is the chief technology officer and co-founder of GlobalSubmit.

     

    Rock has been integral in the FDA’s efforts to harmonize regulatory submission standards for the tobacco industry, as he was when the FDA first implemented similar standards for life sciences.

     

    He served as the project lead for the first-ever MRTP application accepted for review by the CTP and the first-ever approved PMTA.

     

    During the April 9–10, 2015, Tobacco Products Scientific Advisory Committee (TPSAC) meeting to discuss MRTP applications submitted by Swedish Match, Rock was the only non-FDA, non-tobacco industry participant to address the audience.

     

    Best practices for filing FDA tobacco product applications

    By Jason Rock

    The final deeming regulation extending the U.S. Food and Drug Administration’s (FDA) authority to additional products has, to put it mildly, captured the attention of the entire tobacco industry. A predicate—or “grandfather”—date of Feb. 15, 2007, will force the majority, if not all, of e-cigarette or electronic nicotine-delivery system manufacturers into the premarket tobacco product application (PMTA) pathway—the costliest and most complex avenue from a regulatory standpoint.

    In this article, I’ll give you an idea of what to expect when filing a large application to the FDA and provide general guidelines for formulating a successful approach.

    Similarities between pharma and tobacco

    A few years ago, I read an account from a major tobacco company executive predicting that tobacco companies would one day be regarded in the same vein as pharmaceuticals. The comparison is especially apt when considering the size and content of applications. Typically, a large New Drug Application (NDA) submitted to the FDA contains 20–25 studies and ranges anywhere from 100,000–300,000 pages. There are always exceptions, and I’ve seen applications with as few as five studies while others have broken the 100-study barrier.

    In all likelihood, PMTAs are comparable in scope, if not equivalent, to these large marketing applications. Modified-risk tobacco products (MRTPs) are much larger, as they require the submission of case report forms. Swedish Match, the first company to receive marketing authorization from the FDA under the PMTA pathway, submitted a 130,000-page MRTP application for eight products.

    Timing and project management

    If you’re committed to the PMTA pathway, the date marked on your calendar is Aug. 8, 2018. A missed filing deadline could trigger FDA enforcement action for your products currently on the market. Work on large pharmaceutical applications typically precedes the filing date by at least 12 months. It’s not unusual for applicants to begin work 18–24 months prior to the filing deadline set for an NDA.

    A winning timing strategy for PMTAs is to start early and set an internal submission target for six months prior to the statutory deadline (Feb. 8, 2018). The natural instinct is to start the submission process once your summary documents are in progress. Don’t wait! Start early to lower your risk. Any studies already completed should be published as soon as possible, whereas other parts of the application can be completed on a rolling basis. Plan for late document delivery and work ahead. We believe it’s better to have 20 percent of the documents 100 percent complete versus 100 percent of the documents 20 percent complete.

    In terms of project management, you’ll want to appoint an internal resource to manage the document production process or find an expert with experience. A custom tracking tool is the most plausible solution for tracking the delivery date and submission readiness for each document.

    You’ll want to schedule a pre-submission meeting with the FDA to review your strategy. The probability of project success goes up if you can achieve agency buy-in up front.

    Submission publishing standards

    In preparing electronic applications for drug products, pharmaceutical companies have to adhere to internationally harmonized standards for documents and folder structures or face technical rejection. These standards have been in place for over a decade. And while regulatory requirements around PDF versions, bookmarks and hyperlinks, fonts, and headings and hierarchy might sound unduly burdensome, the formatting standards are integral to streamlined document review and timely approval.

    Without the luxury of documented standards as are in place for pharmaceutical companies, tobacco applicants should strive to meet as many existing standards as possible. The men and women who will ultimately review your tobacco applications are descendants of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. The reviewers are familiar with pharmaceutical standards and prefer tobacco submissions to resemble what they are used to receiving.

    Your strategy should center on setting up a pre-submission meeting with the FDA Center for Tobacco Products  and proposing use of existing standards such as CDISC (Clinical Data Interchange Standards Consortium ) or CDISC-like datasets for clinical and nonclinical study data, International Conference on Harmonization E3 guidelines for clinical study reports, pre-eCTD PDF publishing specifications, and best practices for laboratory testing and manufacturing.

    Cost

    How much does it cost to prepare a PMTA?

    The answer depends on who you ask. In the final deeming regulation, the FDA estimated an effort of more than 1,700 hours to prepare a PMTA, which adds up to roughly $1 million per product. Independent tobacco industry figures project a high-end cost of up to $10 million per PMTA, if not higher.

    Submission publishing, project management and quality review of documents fit into the administrative portion of the estimate. As is true in the pharmaceutical industry, these activities are the least expensive part of a very expensive process. Standard rates for submission publishing and related activities are set per page. For a quick ballpark estimation, you can use a $5 per page rate inclusive of publishing, management and other tasks.

    Learn from experience

    Prior to the successful MRTP and PMTA submission filed by Swedish Match, a number of applicants were rejected by the FDA for failure to adhere to the aforementioned standards and failure to adequately articulate a submission strategy.

    In the early preparatory stages of its filing, Swedish Match was challenged about the mechanics of filing an MRTP application. In the end, three key discoveries emerged: (1) the true scope of the project, (2) the FDA’s expectations for document formatting and (3) the role of correspondence with the FDA CTP during the project.

    Successfully filing a PMTA requires drawing on the considerable experience of the pharmaceutical industry, starting the process early and securing the proper expert resources, adhering to existing and agreed upon standards, and following the lead of others who have achieved the desired outcomes.

     

     

     

     

     

     

     

     

  • Beware the nanny state

    Beware the nanny state

    Plain-packaging laws infantilize adult consumers.

    Christopher Snowdon image

    Christopher Snowdon is the head of lifestyle economics at the Institute of Economic Affairs in the U.K.

    He is the author of The Art of Suppression, The Spirit Level Delusion and Velvet Glove, Iron Fist.

    His work focuses on pleasure, prohibition and dodgy statistics.

     

    By Christopher Snowdon

    Canada is the most recent country to make plain packaging of cigarettes compulsory in a bid to cut the rate of smoking, following Australia and the United Kingdom’s lead as governments around the world introduce or consider similar legislation. All this despite the fact that there is no hard evidence to suggest that the introduction of plain packaging had any impact on tobacco consumption and smoking trends in Australia, where the law was introduced in 2012. The potential implications for packaging and branding are huge, extending far beyond the tobacco sector, threatening government interference in many aspects of the average person’s daily life.

    In 2016 Britain was ranked as the third-worst country in the European Union on the Nanny State Index, a list put together by the U.K. Institute for Economic Affairs (IEA). According to the IEA, a nanny state is characterized by “the excessive interest and influence of the government on the lives and choices of its citizens.” The introduction of plain packaging in Britain broadens this excessive influence even further, infantilizing consumers by stripping them of their freedom to make their own decisions in accordance with their own judgment. Informed adults are able to make educated decisions about cigarettes and other products regardless of packaging because they live in a country where there is freedom of information, and they should be trusted to do so.

    The U.K. and Australian governments have effectively decided that the use of trademarks, branding and logos can be forbidden on the premise that it will discourage children from buying adult products. For the food and alcohol industries, this is an alarming concept; if one industry is deprived of its intellectual property then all those who own trademarks should worry. How long before the public health bodies call for plain packaging on fast food, pizza, breakfast cereal, alcohol, sugary drinks and other consumer goods? In Britain and Australia, some have already begun to do so.

    Plain-packaging laws are based on the unproven belief that cigarette packaging encourages nonsmokers to start buying tobacco. They require the removal of trademarks, logos and colors, with the brand name being replaced by a uniform, standard font.

    Trademarks exist because they are important for both consumers and businesses; crucially, they inform people of the quality, reliability and consistency of a product. For businesses, plain-packaging regulations compromise the intellectual property of their brands, which may have taken decades to develop. This is a potent infringement, as ultimately companies are stripped of the associations with their brand.

    What is being dangerously ignored is the potential outcome of plain packaging implementation and the legal precedent set by it. These laws could boost organized crime, hamper investment, affect jobs and damage small businesses—and Australia bears witness to it all.

    Regardless of the measures, nanny state regulations are generally ineffective. The claims that plain packaging facilitates lower rates of tobacco consumption are not supported by empirical evidence, and studies such as the 2016 Nanny State Index show that countries that have imposed rigorous regulations on alcohol and tobacco do not have lower rates of consumption.

    Plain-packaging laws are a prime example of paternalistic governments becoming involved in the private lives of their citizens. In contrast with nations that advocate free choice and respect the decision-making power of adults, plain-packaging regulations have infantilized British citizens, suggesting that without governmental interference British adults are unable to make responsible decisions. The free market is founded on property rights, including intellectual property rights, and it is deeply concerning to see governments sweep them away so lightly. Where this trend will go should be the most serious question.

     

     

     

     

  • Staying sharp

    Staying sharp

    Even as the current tough market favors its business model, Spikker Specials continues to reinvent itself.

    By Taco Tuinstra

    Hans Spikker (third from right) inspects a part, while Hans Schijfs looks on from the other side of the work bench. Spikker Specials takes great pride in the durability of its products.
    Hans Spikker (third from right) inspects a part, while Hans Schijfs looks on from the other side of the work bench.
    Spikker Specials takes great pride in the durability of its products.

    For the tobacco machinery business, the golden days are over. Whereas the sky used to be the limit in terms of production speeds, technical options and other mechanical wizardry, the ghost of austerity now haunts cigarette manufacturers’ procurement departments. Smoking restrictions, rising taxation and growing health awareness have dented cigarette sales. As a result, tobacco companies are postponing investments and consolidating production. Machinery suppliers have felt the chill, with many reporting a downturn in business.

    It’s an ill wind that blows no one any good, however, and some specialist suppliers have fared remarkably well in the economic downturn. Spikker Specials is one such company. Based in Zevenaar, Netherlands, its business—supplying premium machinery parts—seems to have been almost custom-designed for the current environment, in which tobacco companies try to make existing equipment last as long as possible.

    “Today’s emphasis is on efficiency, maintenance and cost,” says Hans Schijfs, sales manager at Spikker Specials. “Those have been our strengths all along.”

    Spikker Specials was founded in 1962, when Gerhard Spikker started making tools and machine parts in a backyard shed. Gerhard Spikker was interested in wear-and-tear-related problems, particularly those of cigarette making and packing machinery. Realizing that the same parts consistently wore down and caused machines to malfunction, he started looking for ways to improve those parts.

    The products he developed earned Spikker Specials an unmatched reputation for quality within the tobacco industry. The company’s offerings are manufactured to such high standards that they outlast OEM varieties by a considerable margin. According to Spikker Specials, the lifespan of its parts is up to five times longer than that of ordinary spare parts, while the price is competitive to achieve a cost reduction for the users.

    Part of the secret lies in the raw materials: Spikker Specials uses carbide, ceramic, powder metallurgical steel and even diamond—materials that are harder and more wear-resistant than ordinary steel grades. The other half of the secret is know-how. Over the years, Spikker Specials’ engineers have developed an unrivaled knowledge of materials, manufacturing processes and the application of parts on machines.

    Hans Spikker, who started helping out in his father’s factory at age 12, took over the business in 1986. Today, the company employs 75 people and sells wear-and-tear parts to tobacco companies worldwide. In the beginning, Spikker Specials supplied primarily local, independent factories; today its customer base includes the leading multinationals.

    Well-prepared

    But while the gods of commerce have smiled on Spikker Specials, it would be a mistake to conclude that the company has been able to sit back as business flowed to Zevenaar. To be sure, the playing field has tilted in Spikker Specials’ favor, but if the company had not done its homework it would not have been in a position to take advantage the way it did. “When the market shifted, we were ready,” says Hans Spikker.

    To adapt to the new market conditions, Spikker Specials had to evolve from an industry supplier into a full-fledged business partner. “It’s no longer sufficient to sell a part,” says Schijfs. “You have to deliver customized solutions and understand your customer’s approach.” For example, as opportunities to promote tobacco products dwindle, cigarette manufacturers are looking for new ways to make their products stand out on the store shelf. As a result, the variety of pack designs has proliferated, while the frequency of redesigns has accelerated. So in addition to individual parts, Spikker Specials now offers format- and size-change kits. The company’s porftolio has expanded to include complete assemblies, along with overhaul and customized offerings. These are available not only for the latest generation of machinery, but also for older equipment for which other suppliers have stopped offering parts and service.

    Intimate knowledge of customers’ equipment allows the company to supply customized solutions quickly. “We say to the client, ‘Just tell us what machine you are using and we’ll supply the appropriate assembly,’” says Schijfs. Speed is of the essence, he insists. Fast deliveries allow customers to reduce their inventories, which in turn lowers cost.

    The company has kept up with evolving information technology, as well. “The new generation of tobacco industry employees is accustomed to working with screens,” says Schijfs. “We must cater to them.” Among other investments, Spikker Specials has updated its electronic data-interchange system so that it can “talk” with customers’ business-management software. “You should make it easy for clients to deal with you,” says Schijfs. “In the wake of corporate restructuring, many tobacco companies no longer have the staff to deal with complexity.”

    Preventive maintenance features prominently in the era of austerity. Spikker Specials now offers a service where it reviews the client’s production line and makes proposals for optimization. “A customer may have 10 machines bought over a period of 15 years,” says Schijfs. “Even if the machines are supplied by the same manufacturer, each of them will be slightly different due to evolving technology. By standardizing the parts, we can not only reduce the inventory required but also facilitate maintenance—and thus save the customer money.”

    While much has changed over the decades, some aspects of the tobacco business remain reassuringly familiar. Despite the advent of modern communication tools, personal relationships are as important now as they were 50 years ago. Spikker and Schijfs fondly remember the days when they were still spreading the word about Spikker Specials, lugging suitcases with samples, polishing parts in their hotel rooms and visiting clients in the world’s remotest outposts.

    Today, Spikker Specials is a household name in the tobacco industry, but the company’s representatives continue to travel the world in order to maintain customer relationships. It’s more than a feel-good exercise: “If clients don’t see you for two years, you will experience a drop in orders,” says Schijfs.

    The other constant in tobacco is the importance of sticking to commitments. “You must deliver what you promise,” says Schijfs. This is the case even if doing so creates considerable stress, as happened last year when Spikker Specials accepted a project for which it still had to do some development. “If you say yes, you take on a huge responsibility because the customer will plan his operations based on your promise,” says Spikker. The successful completion of the 2015 project boosted customer confidence and Spikker Specials’ reputation, but Spikker prefers not to think about the alternative: “They would have shot us!” he says.

    Despite the tobacco industry’s difficult predicament, Spikker sees plenty of opportunity for his company over the next decade. “After that, it’s difficult to predict,” he says. To diversify its business, Spikker Specials has begun investigating additional sectors that might benefit from its products and services. Perhaps surprisingly, that is proving to be more challenging than anticipated. Production speeds in the tobacco industry are famously high, resulting in lots of equipment wear and tear. Other industries, such as food packaging, manufacture at slower speeds, which means parts last longer.

    Spikker and Schijfs are confident that they will eventually identify an industry with demands similar to those of the tobacco business. Until that time, they must console themselves with the strange satisfaction that comes from having products that are almost “too good” for other sectors.