Category: Also in TR

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  • Battery battle

    Battery battle

    Sub-par production materials and user error are the main causes for battery failure.

    By Timothy S. Donahue

    Batteries can be dangerous. Cellphones, laptops, hover boards and drones all had battery issues in the early stages of their development. This is true for the vapor industry, too. Cheaply made products, improper use and misinformation have been the cause of several well-publicized accidents.

    In April, the U.S. Food and Drug Administration (FDA) held a public workshop centered on battery safety concerns in electronic nicotine-delivery systems (ENDS). The event was moderated by Matthew Holman, the director of the FDA’s Office of Science at the Center for Tobacco Products (CTP). He said the FDA has been collecting data and information on explosions, fires and overheating of vapor products for some time.

    “However, additional data and information would significantly help us better understand these products and how to regulate them in order to minimize this acute public health concern,” he said. “That is why we are here today.”

    Holman emphasized that the FDA intends to use the information presented and discussed during the workshop, as well as ongoing research efforts, to help inform future regulatory actions and decisions related to these products. “[The] FDA makes decisions based on science, and we’ll use the best available science to inform regulations,” he said.

    The “outcome” of the conference can probably be best summarized in two statements: Using high-quality batteries is a necessity for safety, and, if used properly, batteries rarely cause harm. Kevin White, an electrochemist with Exponent, an engineering and scientific consulting firm, told attendees that there are about 100 billion lithium-ion (li-ion) batteries in use today, depending on which market analyst you believe. “So there is a lot of money to be made, and a lot of folks are trying to get their hands into the pot,” he said. “Some are making very nice lithium-ion cells, and some are making questionable lithium-ion cells, and that, again, is a problem.”

    Vapor products wouldn’t be possible without li-ion batteries. Neither would laptops, cellphones or many other devices as we know them. “Lithium ion is a game changer; that’s for sure,” said White. “It’s a technology that puts a lot more power into a small space than we’ve ever been able to do before, and it’s one of the things that enables these nicotine delivery devices to work well. But it is not without risks, and it can be a very safe product if those risks are understood and mitigated. And the industry is maturing to the point where that is possible and could be so for this particular application as well.”

    White said li-ion batteries were first commercialized in 1991. “It’s a fledgling industry, but they’ve gained incredible traction because they are so much better at storing energy than most of the … well, all of the other chemistries that are commercially viable,” he said. “Therein lies the problem. You’ve got a whole bunch of energy in a very small space, and if it comes out in an uncontrolled fashion, it can be a devastating consequence.”

    Data default

    Drawing on information from news sources and the limited e-cigarette fire data that the federal government began tracking in 2015, Lawrence McKenna from the U.S. Fire Administration found 195 discrete incidents of explosion or fire involving ENDS devices worldwide from 2009 through 2016. “The vast majority of the incidents … came out of the media,” he said.

    McKenna found no reports of e-cigarette battery-related deaths in the U.S. There was one death reported in the U.K., but that one had less to do with the ENDS device than it did with the medical device that was being used simultaneously. The victim was vaping in an oxygen tent.

    Some 60 incidents occurred while the device was in the user’s pocket, hand or mouth, according to McKenna. Forty-eight incidents happened while the device was being charged. Eighteen incidents were “in storage”—in a purse or on a countertop, for example. The cause of the remaining occurrences was not specified.

    McKenna said there were 38 severe injuries (requiring hospitalization), 80 moderate injuries (treated in an emergency room) and 62 incidents where no injuries were reported. Fifteen incidents resulted in minor injuries.

    Felicia Williams, a burn surgeon affiliated with the University of North Carolina, blamed e-cigarette batteries for an increase in devastating injuries. She showed several pictures of e-cigarette battery burn victims. During a recent American Burn Association conference, she learned that approximately 70 people suffered injuries from vapor products serious enough to warrant surgery, with most of those happening in 2016. “These are patients that required surgery, not the number of patients that have presented to our clinics,” she said. “You’re talking about 100 patients overall that present to the different clinics with minor injuries that don’t require hospital admission.”

    To put the number of injured users into perspective (although that was not Williams’ intent), Williams noted that there are more than 9 million ENDS users in the U.S. She also stated that a recent change in medical codes for injuries has made it difficult to delineate whether somebody had been burned by a flame, a chemical or a vapor product battery.

    Standard issue

    Battery safety concerns are not specific to vaping products, according to Patricia Kovacevic, general counsel and chief compliance officer for Nicopure Labs. She told attendees that the U.S. Consumer Product Safety Commission recently pointed out issues with safety standards for lithium-ion batteries, following a massive recall of Samsung phones.

    “When people say we don’t have battery standards—actually, we do,” she explained emphatically. “They’re not being applied in the U.S., and they’re not mandatory at this time. [The] FDA has authority to issue product standards. The development and use of standards have been integral to the execution of the mission of [the] FDA since its establishment. These are the very words of the FDA on their own website.”

    Several speakers called the battery business for vapor products the Wild West. Eddie Forouzan, an electrochemist with Artin Engineering and Consulting Group, said the typical safety tests for Li-ion batteries are only meant to verify the design. “That’s another critical point that I think we all need to understand,” he said. “It is impossible to manufacture a lithium cell or integrate systems-engineered lithium cells in a product and expect to have a 100 percent safe product with zero failures.”

    Finances factor in production, too. Forouzan said that some companies, in an effort to save money, buy or source lithium cells from no-name brand manufacturers that use stainless-steel razor blades to cut their electrodes. “So fundamentally, we’ve seen a lot of cases that have to do with cheap, cheap, cheap stuff that’s being used—heap components on the electronic circuitry or cheap manufacturers of lithium cells, relatively unknown sources. Again, that’s a key factor,” he says. “When there’s a name brand to protect, at least they try to protect it. Bottom line: Don’t buy junk.”

    Douglas Burton, from Altria Client Services, said that, in the absence of standards in the development of these e-cigarettes, there has been little guidance on what constitutes a safe device. “We need standards,” he said. “If we don’t have them, we can expect to see the same type of reports that we are currently seeing for adverse events. Good manufacturing practices can improve manufacturing quality.”

    The main reason for battery failures, however, is the end user. Forouzan said that, especially with ENDS products, failures are most commonly related directly to the heating coil. “Now, it doesn’t mean that the heating coil is heating the cell for it to fail, but it’s because the heating coils are messed around with by the end user,” he says.

    User error

    Most speakers agreed that proper use is vital to battery safety. Williams claimed that less than 1 percent of ENDS battery injuries occurred while the device was charging. “So they were either in use or in their pockets, and the overwhelming majority of these injuries had been while they’re in a user’s pocket,” she said.

    The environment in a pocket is conducive to explosions, according to White. But contrary to what some might believe, it’s not due to static electricity. “It’s the fact that you have keys and coins and things like that in your pocket,” said White. “I mean, in an 18650 cell, the separation in the top cap between the positive portion of the cell and the negative portion of the cell is very small,” he said. “So if you have something conductive in your pocket and the protective sleeve that’s around the cell is compromised, you can cause a short circuit to occur in your pocket, and you get heating because of that.”

    Spike Babaian, technical analysis director for the New York State Vapor Association, said the majority of the incidents that cause e-cigarette explosions are because people take loose batteries and put them in their pocket with metal keys and change. “This is a huge deal,” she said. “Another mistake that is frequently made is using the wrong charger. People take a battery that is in an e-cigarette, and they go, ‘Well, it fits into this charger, so I’m going to use this charger, even though I bought this charger at a gas station or airport or wherever.’”

    McKenna said many vapor devices come with a USB port for charging and people will plug them into any USB port they can find. “Whether it’s in their automobile or their computer or their laptop computer—and not all USB ports produce the same amount of voltage,” he said. “And we were seeing with some of the lower-end devices overcharging incidents when you plug a device in that’s meant for 3 volt or 1 volt charging and you plug it into a 3 or 5 volt USB port, and you overcharge the device.”

    The speakers agreed that consumer education is vital. John DeLeeuw, SMS (safety management system) manager for American Airlines, used a vape shop he visited as an example of a process for educating ENDS consumers. He said the shop had cards they would distribute when someone bought a battery.

    The cards contained warnings such as “Keep your batteries in approved battery cases when not in use,” and “Don’t keep your batteries in your pocket, purse or other receptacles with loose change or keys.”

    Babaian’s shop provides a free battery case with all loose batteries.

    To some participants the discussion was unnecessary. They felt the FDA shouldn’t be regulating batteries in the first place. Amy McCann, with the Smoke-Free Alternatives Trade Association (SFATA), says her organization opposes battery law proposals if they single out vapor products from other devices, like cellphones and laptop computers, for enforcement.

    “Proper storage, charging and use patterns are important practices for all batteries that consumers should understand,” she said. “SFATA also opposes defining batteries as a tobacco product and regulating them as such simply because they can be used to power a vapor device.”

    Kovacevic said the FDA may be overreaching in its attempts to regulate batteries and maybe that should be left to a different government agency, such as the Consumer Product Safety Commission.

  • Smooth operator

    Smooth operator

    Advances in processes, materials and technologies are reducing requirements for spare parts.

    By George Gay


    Soon, virtual reality glasses may be aiding operators in machine maintenance.

    In publishing a magazine such as Tobacco Reporter, certain subjects are covered regularly—in some cases, on an annual basis; in others, more frequently. But perhaps it will soon be time to pension off one of these regular features, the one we refer to internally as “spares,” by which we refer to tobacco machinery replacement and wear parts.

    Why? Well the people at Aiger tell me that spare parts constitute a “nonsubject” these days. “In the past, there was clearly a spare parts dedicated activity that involved replacing wear-and-tear or standby parts,” said Arek Druzdzel, the company’s business development director. “Today, however, the quality of the parts has improved, thanks to new processes, materials and technologies. Reliability is much higher. Customers are willing to pay a bit more for machines that include advanced-technology, high-end, long-lifetime parts instead of having to manage inventory, machine shutdowns and spare parts replacement. In fact, today it is every supplier’s obligation to deliver products that are engineered in a way that guarantees low maintenance, reduced spare parts consumption and increased reliability.”

    Courtland Macduff, Aiger’s sales director for Asia, used an automobile analogy to drive home this point. “People don’t want to hear about spare parts,” he said. “They want us to engineer a solution so that they don’t have to replace parts as previously—like in the case of cars, where these days they’re serviced after 20,000 km, not after 2,000 km.”

    Interchangeability is one strategy that can be used to good effect in reducing the number of parts and the logistical issues that go hand in hand with them. “These days, machines use programmable drives rather than mechanical gearboxes to synchronize speeds and positions,” said Macduff. “And some special motors are driven by a programmable inverter. Now instead of having one dedicated inverter for each drive, it is possible to have an empty inverter that Aiger can, from a distance, load with a qualification logic that makes it functional for a particular part of the machine identified by the customer. We don’t have to deliver any spare parts; they don’t have to carry one of each.”

    Parts will not disappear entirely, of course. They will be part of service contracts between the machine supplier and the machine user, of which there will be many forms to suit different customer needs. And such contracts and the relationships that they engender between the machinery supplier and machinery user will probably tend to reduce the use of locally made parts. “What I see is that clients don’t want to use local parts with the new-technology machines,” said Macduff. “They want the [original equipment manufacturer] to provide a very special service.”

    Druzdzel acknowledged, however, that local manufacturing of machine parts was still happening and would probably happen in the future. But in the case of advanced-technology machines, this was not the way forward, he said. Aiger had invested in manufacturing parts so that they extended the service life and improved the performance of machines in a way that was beneficial to the customer. “To me, there is no way back from the progress that we have made into higher technologies and quality parts,” he said.

    Teleservice

    One service area Aiger is investigating covers a teleservice for distance diagnostics: troubleshooting by engineers based at Aiger’s plant in Plovdiv, Bulgaria, directly in a customer’s facility located almost anywhere in the world. Such a teleservice can embrace also distance training and maintenance supervision, for example, by webcam.

    “As we use more drives and programmable inverters/PCs, we sell directly through the net upload programs, new-configuration production specifications and dedicated drive function programs,” said Macduff. “Soon, instead of supplying a spare part to our customer, we will sell the key lock to have the part duplicated at the customer’s facility on a 3-D printer.”

    Such a system sounds like it manages to combine the advantages of quality spare parts and local manufacture, where there is no need for shipping and the delays involved in such activities. The question is, how far are we away from this? In theory, we’re there. In practice, there are still some matters to iron out. Firstly, the machine supplier and the machine user must be operating at similar advanced levels of technology.

    Aiger, for its part, is almost there. Well over 90 percent of the parts used in the company’s machines have been fully digitalized, said Druzdzel, which means the company’s systems contain 3-D models of just about all parts. And the process of digitalization is expected to be completed later this year, which means Aiger is on the threshold of being able to apply 3-D printing technology across the board.

    Of course, 3-D printing covers a range of technologies, and some technologies are more applicable to the tobacco machinery industry than are others. For instance, Druzdzel said, Advanced Manufacturing services included 3-D technology that allowed for printing hard, durable mechanical parts. It was at an early stage, but it was coming. And, as Macduff added, the advantages of machinery users not having to carry stocks of spare parts and of there being no handling issues were such that much pressure was likely to be applied to advancing the technology quickly.

    Of course, matters of timing would still arise, and administrative issues, some of them new, would have to be tackled. 3-D printing would not be an almost instantaneous process as it is when printing a document. With today’s technology, printing could take a couple of hours or so, depending on the complexity of the part and the materials used. And once the technology was in place at both the supplier’s and user’s premises, contracts would have to be drawn up to cover issues such as whether single- or multiple-use was covered. In addition, arrangements would have to be in place to pay for tariffs in those countries where import duties applied. Security, it seems, would not be unduly worrisome. Key lock systems come from banking and refer to safe—as safe as anything can be—data-transmission protocols that allow for sending digitized data.

    Developing relationships

    I wondered, however, whether, despite the best intentions of machinery suppliers, tobacco manufacturers wouldn’t have to carry even more parts in the future as their product portfolios expanded to include new-generation products. But Druzdzel said Aiger’s intention was the opposite; it was to reduce its customers’ spare parts stock holding. “Some spares are vital and a customer will carry them anyway, or [they] will have in place a reliable and fast supply, as Aiger offers with its fast-track contract,” he said. “Aiger offers also a spares supply program: a one-year supply program under which spare parts manufactured by Aiger are supplied at pre-defined time slots.”

    It is all about developing a service relationship that suits the customer. Under a fast-track contract, Aiger works very closely with customers’ maintenance teams. In this case, Aiger delivers parts according to an agreed schedule, and the customers’ engineers carry out the maintenance under the supervision of Aiger engineers “accessing” the machine through a webcam. This is said to be a way of ensuring that machines have the least possible downtime. When Aiger supervised a maintenance program by webcam, said Macduff, it guaranteed that on the day the customer stopped his machine, he would have a crate with everything needed to do the maintenance under supervision. This was where service came in and spare parts became integrated into a new area of business.

    Meanwhile, Druzdzel said it was essential for machinery suppliers to become smarter because some customers simply didn’t want to do anything with their machines. And this meant it was necessary to offer a complete contract that delivered machines with long-life parts and included a teleservice for diagnostics, service and stock management. All of this was possible as part of Aiger’s package of services.

    But this is not to say that the days of the peripatetic engineer are over. Druzdzel said that Aiger has a group of technicians who traveled around the world almost constantly. Sometimes visits were connected with normal installation services, sometimes with maintenance services.

    It is necessary to keep in mind, though, that as we head into the future, nothing is really “normal” anymore—nothing is going to stay the same. One of the next steps is probably going to see virtual reality glasses used as an aid in maintaining machinery. “Aiger is not far away from offering that level of service,” said Macduff.

     

  • Riding high

    Riding high

    Aiger Engineering thrives as new products continue to disrupt the traditional tobacco business. 

    By George Gay

    During an interview at the end of July, I asked Arek Druzdzel, Aiger Engineering’s business development director, if the tobacco machinery business had been tough in recent years, what with falling cigarette sales in many Western markets and much consolidation having taken place and still taking place within the tobacco manufacturing sector. His answer was illuminating. Yes, it had been tough, he said, but not for Aiger.

    Aiger had been the fastest-growing tobacco machinery supplier, with an average annual growth of 18 percent during the past three years, he said, and this year it was promising to deliver a sales growth of 20 percent. Aiger would double its size before 2020, he added.

    So, what is driving such growth? Ideas and their progeny: innovation. Indeed, Aiger says it is following a strategy aimed at positioning the company as the most innovative supplier of flexible machinery for the production of cigarette filters and cigarette packing, as well as the development of novel quality-assurance management systems, such as its Matrix Neo.

    But the ideas and innovation don’t stop with traditional tobacco machinery; they stretch out to include heat-not-burn (HNB) requirements and to imagine a future with other next-generation products.

    OK, every company says that it is innovative, but Aiger has some history in this respect. Aiger was formed 23 years ago, and Courtland Macduff, the company’s sales director for Asia, said that for most of its history the company had been working with multinationals on special projects—what he described as complex engineering projects. So there need be little surprise that in 2015 Aiger took home to its base in Plovdiv the award for Bulgaria’s most innovative company.

    Focus on innovation

    Perhaps something dynamic has built up in the air around Plovdiv, which has 8,000 years of history and which, from the end of the 19th century to World War II, was known unofficially as a tobacco city. In 2019 Plovdiv will enjoy being a European Capital of Culture, while today it is Bulgaria’s fastest-growing business, technology and economic center, attracting investment from international businesses and employing more than 100,000 people in the machinery and components sectors.

    Aiger employs about 220 people at its 7,000-square-meter Plovdiv production facility (about another 20 people are employed at the Aiger Group’s Swiss base) that is set on a site of about 18,000 square meters. It has a diversified workforce within which most of its employees are designers and engineers with master’s degrees, but that includes also assembly and installation engineers, as well as fitters because it produces most of its mechanical parts in-house. The company sources its qualified employees mainly from technical high schools and universities in Bulgaria, and, three years ago, it started its own internal education program called “Aiger Professor,” which is based on the German model of hands-on training during the education of young professionals.

    Aiger’s focus on innovation can be inferred from the fact that more than 50 of its employees are engineers working as part of R&D, mechanical, electrical and software teams. And, in turn, this focus on R&D and design reflects Aiger’s business, which is based on building customized, application-based equipment, including the types needed to produce specialty packs and complex cigarette filters.

    Such equipment includes also that needed for the manufacture of HNB product components. Already, Aiger supplies a number of pieces of equipment for HNB production lines, such as filter plug platform machines and modular packers. However, it has been involved also in R&D, design and production projects for HNB base filter plugs.

    Overall, Aiger supplies what it describes as a Flex-HNB-making platform—machinery elements into which a specific Flex platform has been integrated. “The benefit of using a proven process enables us to minimize industrial risks but mainly allows our customers to limit their investment risk by providing the possibility of reconfiguring machines to conventional equipment,” said Macduff.

    While it does not provide any equipment for the e-cigarette sector, which, unlike the HNB sector, includes no traditional tobacco industry elements, Druzdzel said that, as an engineering-to-order company, Aiger would look at such developments if there were a partner or customer to work with.

    Cross-fertilization

    Again, Aiger has history here—in this case working outside the field of tobacco—experience that has allowed it to benefit from a cross-fertilization of ideas and that could help it in coming to grips with the challenges of developing machinery to manufacture next-generation products. Although 90 percent of its business involves the tobacco industry, it also builds specialized equipment for clients in the pharmaceutical industry.

    “Currently, we focus on fine dosing small quantities of powder and granulate materials into small vessels and precise, on-line measurement of the dosed masses,” said Druzdzel. “This includes compliance to pharma regulations. Also, based on our experience in the tobacco industry, we build pharma-specific, bespoke inspection systems that allow for online registration of key parameters. Both industries converge as the search for successful new-generation products intensifies on both sides.”

    HNB and other new-generation products certainly constitute one of the areas where Aiger sees its focus on innovation coming to the fore. “Look around,” said Macduff. “Everywhere you see new products that, through the application of new, exciting technologies, have advanced out of sight. There has been a sudden and fast rise of the driverless, electric car, and new tobacco products will move in a similar manner. By 2025, many people will travel in driverless cars, and most big cities will not allow anything but electric vehicles on their streets. Nobody can see into the future of the tobacco industry, but when HNB products are accepted by bodies such as main regulating administrations, international organizations and legislators as being, as claimed, more than 90 percent less risky than are traditional cigarettes, it is likely that soon these products only will be allowed to be [for] sale. It will be like the introduction of seat belts in cars—no ifs and no buts.”

    At that stage, sales of these devices—and therefore sales of the equipment needed to produce them—will take off. And here again, Aiger is prepared—open for future challenges, as Druzdzel puts it. While most of the company’s employees are engineers, the sales team has recently grown to account for 10 percent of the workforce. Aiger has established offices in Brazil, Switzerland and the U.S. It has also recently opened a Moscow office and is in the process of reorganizing its Asia business, something that will involve the opening of another office, probably in Southeast Asia, by the end of this year.

    And with sales agreed, Plovdiv is well-positioned geographically for Aiger to buy in the materials it needs and to send out its machines. The factory is about 3 kilometers from the nearest railway station and 2 kilometers from a major motorway that connects the airport in Sofia, Bulgaria, which is 140 kilometers away, with the Black Sea port of Burgas, which is 250 kilometers away. And there is a good international road network connecting Plovdiv with all neighboring countries and the rest of Europe.

    Fast adapters

    Aiger says its equipment portfolio is focused on two types of flexible and “fast-adapting” machinery: Flex filter makers and EON 300 cigarette packers. It offers a modular “plug and play” machine platform that allows operators to change from simple to complex filters in less than an hour. The Flex modules include those that can insert capsules, flavors and granular materials, and those that can process nonwrapped and paper filters. Each Flex module performs a dedicated function, such as inserting capsules (objects) into the moving tow or rod cavity, while, at the same time, handling the filter plugs and transferring them to an upstream module or to a desired position, defined by a final rod specification.

    In addition, Aiger has developed a twin capsule inserter. The company says that the inserter offers a gentle and cost-effective method of including two different capsules—perhaps capsules of different sizes or containing different flavors—in a single rod, or cigarette.

    Some Flex filter platforms, meanwhile, have been installed for development use in response to customer requests for unique modules to add to their existing complex-filter capabilities. “Moreover, we are introducing our bespoke micro-dosing solution for medical capsule-filling machinery,” said Druzdzel. “This opens a new chapter in the tobacco industry where extreme cleanliness meets extreme, six sigma dosing precision requirements.”

    One of the things that Aiger keeps its eye on is what it terms “legislative drivers,” such as the EU’s revised Tobacco Products Directive (TPD2). The company says that it was the first in the market with a full-size modular packer—the EON 300—that could be converted from conventional to TPD2 compliant packs in two shifts. And down the line, it offers a TPD2-ready compact stamper that can be converted to or from TPD2 format within less than 2 1/2 hours.

    “For packing, we offer a convertible, modular fast-fit system that allows customers to change from simple hinge-lid boxes to complex multichamber boxes—packs that are TPD2 compliant, and ‘Handy Packs’—in under three shifts,” said Druzdzel. “Packs include super-slims, 5-50s, round, square and everything in between.”

    Handy Packs are hinge-lid packs with an inner divider. “We have a TPD2 compliant packer, the Eon 300, that allows inner-divider insertion to create two separate compartments,” said Druzdzel. “This is especially useful for [other tobacco products]. In fact, our most recent innovative machine is the versatile Eon 300 packer for Handy Packs and for MYO applications. This clearly demonstrates the flexibility of our Eon 300 packer, on which we can make a three-cavity box and then feed three different and complex-shaped items into the box.”

    In fact, Aiger has recently sold the Eon 300 for producing limited-edition packs so that the consumer marketing teams of a large manufacturer can test new pack designs in limited production runs.

    As is mentioned above, for quality assurance, Aiger offers its Matrix Neo, which reports via Scada, ERP-SAP or Microsoft Dynamics to ensure constant product quality and data on which management can base corrective actions. It has been installed on filter and cigarette machines to check for dimensions, density, photo recognition, carbon fill, and capsule placement and damage, with explicit management data reporting. Although Aiger no longer offers cigarette makers or rebuilt machinery, it says the Matrix Neo can be retrofitted to any single-rod maker.

    Looking ahead, Aiger is intending to establish a new web shop for its established clients and to prepare for “Industry 4.0”—the fourth industrial revolution. “We have already achieved 90 percent-plus digitalization of all our data and systems,” said Druzdzel. “Aiger has recognized these ongoing processes and the associated business potential, and we have started preparing the company for these new realities.”

    And it is already well-prepared. It has a young workforce, with the average age of its employees being 34—people Macduff describes as brimming with excellent, challenging design ideas and the software skills to implement them.

  • An opportunity for health

    An opportunity for health

    David Sweanor

    David Sweanor shares his thoughts on the taxation of next-generation products

    David T. Sweanor is an adjunct professor in the faculty of law at the University of Ottawa in Canada. As a public health advocate, he has worked at reducing global cigarette smoking since 1983. Tobacco Reporter asked Sweanor for his views on the taxation of next-generation products.

    Tobacco Reporter: The scientific community agrees that the method of nicotine delivery, rather than the nicotine itself, is the culprit with regard to smoking-related diseases, with tobacco combustion carrying the greatest risk. In The New England Journal of Medicine, you argued that taxing products according to their risk level would maximize incentives for tobacco users to switch to less harmful products. Where on the risk continuum do you see taxes on e-cigarettes?

    Sweanor: The goal of public health—not to be confused with those with other agendas claiming to be advocating public health—is the reduction of death, diseases and disability. Where we find risks, we seek to reduce them. Prices impact consumption, and differential prices shape choices. The bigger the price differential, the greater the shift between substitutable goods.

    Anything other than a zero rate of tax on alternatives to cigarettes will result in less incentive to switch, both because of price differentials not being as great and because of the implicit message about the risk differential not being as significant. I would recommend no tax on most noncombustibles and a higher tax on combustibles as the most sensible starting point.

    Some argue that there need to be taxes on noncombustibles to prevent use by nonsmoking youth. But that means accepting a theoretical and preventable long-term health concern taking precedence over the virtual certainty of greater consumption of cigarettes and the resulting diseases in the immediate future. We should prefer alternatives that protect youth without imperiling the lives of their parents.

    What about nicotine-free e-liquids, which are currently also taxed? Does this make sense?

    It doesn’t. It is like identifying someone who gave up excessive drinking for jogging and deciding to tax her running shoes.

    Where on such a differentiated tax scale would tobacco-heating products come in?

    The key thing from a public health perspective is to get people off combustion-based delivery. At this point, discussion about the relative risks of vaping, heat-not-burn, snus, pharmaceutical nicotine, etc., and the potential taxes for each category misses that key point. It is like arguing about whether it is more dangerous to juggle oranges or apples or coconuts when people are currently juggling live hand grenades. The priority needs to be on replacing the truly deadly activity by offering a wide range of low-risk options, and we can discuss the relative merits of those alternatives later.

    While, in the EU states that tax e-cigarettes, a trend is emerging toward taxation on the basis of e-liquid volume, there is no unified policy on taxing e-cigarettes in the U.S. Some states and counties have opted to group e-cigarettes or liquid containing nicotine in the same tax category as “other tobacco products” that only have the wholesale price as a common taxable base. In the case of Pennsylvania, this has led to e-cigarettes being taxed based on the wholesale price, inclusive of the liquid and devices. What should be the taxable basis for e-cigarettes?

    E-cigarettes should not be subjected to excise taxes. Such taxes discourage switching from cigarettes and create compliance issues that disadvantage smaller suppliers, thus harming innovation and protecting the cigarette market. The Pennsylvania tax was a gift to the cigarette trade and would be the equivalent of the state putting a massive tax on clean water when rancid water is readily available and widely used.

    The EU is presently reviewing the rates and structures of excise duty applied to manufactured tobacco and for the first time plans to include vapor products in its tax regime. In the U.S., the hopes of vapers are on the new FDA commissioner, Scott Gottlieb. What’s your advice for them regarding taxation of next-generation tobacco products?

    Put a sign on your wall saying, “It’s the smoke, stupid,” and read it every day. We have an extraordinary opportunity to make one of the greatest-ever breakthroughs in public health by simply giving viable low-risk alternatives to the repeated inhalation of the products of combustion. Keep your eye on the prize. Don’t fail a “vision test.”

    Recent attempts at taxation of vapor products—such as those in California, which no longer differentiates between combustible cigarettes and e-cigarettes—seek to prevent people from switching to e-cigarettes. Obviously, the idea of a risk continuum isn’t plausible to Californian fiscal policymakers, and they are only some among many who think that way. What would be a suitable strategy to convince such fiscal lawmakers of a differential tax strategy?

    Efforts to “prevent switching”—and campaigners for such measures are usually open about that being their goal—are ideologically driven abstinence-only measures. They have been tried on a wide range of issues where there is an absolutist rather than public-health orientation. One need only look at prohibitionist policies on alcoholic beverages, the war on drugs, sex outside of heterosexual marriage, etc., to see the same sort of thinking, the same sorts of harm to health and human rights, and, ultimately, the same abject failure. What is surprising is that ideologues could have pushed through such policies in a place like California despite the presence of very effective advocates there who successfully battled such policies in dealing with AIDS and, lately, drug policies.

    Public Health England was the first health authority to make an official and clear statement about the reduced harm potential of vapor products. How much could more such statements contribute to appropriate legislation and ultimately help answer the question of appropriate taxation of vapor products?

    The U.K. has long been a global leader in pursuing pragmatic strategies to deal with public health issues. Given the history of alcohol, birth control, illicit drugs, workplace safety, etc., it is encouraging but not surprising to see U.K. leadership on nicotine issues. In other jurisdictions, it is often a small group of people with absolutist ideologies who impede progress in reducing risks. As with Wayne Wheeler of the Anti-Saloon League, they are energetic, loud, often very nasty, and wrong.

    Cigarette manufacturers, such as Philip Morris International (PMI), claim they want to design a smoke-free future. What role do tax-based price differentiations play in stimulating the market for reduced-risk products and eventually, perhaps, achieving PMI’s goal?

    Differential pricing is huge, and decisions on taxation shape those differentials. As evolving technology allows the noncombustion products to get ever more acceptable to smokers, price will play a huge role in shaping the market. Tax policy can literally stop a global pandemic of cigarette-caused disease. Finance officials around the world can play a huge role in doing what D.A. Henderson did to smallpox, or Norman Borlaug to reduce famine, and should be no less honored for making it happen.—S.R.

     

  • Outstanding innovations

    Outstanding innovations

    New filter technologies are helping cigarette manufacturers set their products apart.

    By Patrick Meredith

    As with most industries, consumer expectations and industry demands are constantly evolving, leading to new trends and continuous innovation. This is no different in the filters market, with many external factors and different consumer preferences coming into play. As the amount of industry regulation and legislation grows—with increasing restrictions around tobacco content, marketing and packaging, among other things—manufacturers must turn to the filters themselves to differentiate their products and create greater appeal for consumers.

    This has led to numerous exciting innovations, such as different filter diameters, lengths, shapes, flavors and colors. One type of specialist filter that has seen particularly strong growth over the last five years is the capsule filter. Having grown almost exponentially from its first entrance into the market in 2008, the current global capsule market is estimated to be approximately 150 billion sticks per year. Demand for capsule filters has increased significantly as they fulfill changing customer preferences and meet their evolving tastes—capsules provide flexibility, variety and personalization. Capsule filters enable a concept widely known as “mass personalization”; the different filter options allow customers to personalize their experience by choosing which flavors they wish to smoke and when during their consumption they want to release the flavors. In response to this strong customer demand, filter manufacturers around the world have expanded their capsule offerings, providing various new flavors and innovations.

    These innovative capsules can vary in terms of flavors, ranging from the more traditional, such as menthol, to the more exotic, such as rose or green tea. With an audible “pop” when the integrated capsule is crushed, capsule filters enhance the customer experience through the addition of sound as well as taste. At Essentra, a leading global supplier of filters and scientific services, the entry-point capsule filter is the Sensation filter. The Sensation currently comes in a wide range of flavors, including grape, apple, spearmint and osmanthus.

    Leveraging the market’s increasing popularity of products with smaller circumferences, capsule filters are now readily incorporated into slim and super-slim sizes, normally in more premium products. The overall trend toward super-slim products has also been particularly strong in Africa and the Middle East, which saw an increase in sales of almost 12 percent in 2016.

    Capsules can also be incorporated into dual-segment filters to add extra features. For example, capsules can be embedded in dual-segment carbon filters, or they can be included in filters that incorporate a tube segment. By including capsules in these special filters, consumers can enjoy the benefits of both interesting flavors and the more innovative variants. Essentra’s creatively designed Dual Sensation filter provides a number of different combinations for consumers to choose from, including either a capsule segment with a carbon segment or a capsule segment with a visually distinctive filter segment. These combinations present consumers with the choice and ability to personalize their product through several unique taste, smell and visualization options.

    Similarly, dual-segment filters with capsules in both segments mean consumers can enjoy a bespoke experience. A filter with two capsules means consumers only need one filter but can get twice the flavor, on demand—as can be seen with one of Essentra’s most recent proprietary innovations, the TwinSense. Filters with two capsules are seen to be the filter type that offers the customer the most control; consumers can choose not to burst the capsules at all, to burst one for one flavor or to burst both capsules for a combination of the two. An assortment of flavor combinations are available, such as menthol and strawberry or menthol and grape.

    For all variants, to maximize flexibility, the filter tip’s length, circumference and pressure drop can be varied to suit taste and design requirements. As consumers become more discerning, manufacturers must be able to offer flexibility and the ability to create the exact products and services that meet user needs.

    However, with further legislation due to be implemented, there may be limitations within the capsule market. For example, in accordance with the revised EU Tobacco Products Directive (TPD), menthol cigarettes will be banned in the EU by May 2020. Article 7 of the TPD states, “Member states shall prohibit the placing on the market of tobacco products with a characterizing flavor.” In addition, in the U.S., a ban on cigarettes containing certain characterizing flavors (excluding menthol) went into effect, authorized by the Family Smoking Prevention and Tobacco Control Act, as part of a national effort by the U.S. Food and Drug Administration to reduce smoking in America. According to the act, “a cigarette or any of its component parts (including the tobacco, filter or paper) shall not contain, as a constituent or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice … that is a characterizing flavor of the tobacco product or tobacco smoke.”

    Patrick Meredith is innovations director at Essentra.

    Until this legislation is realized, it is therefore still possible to use capsules and capsule filters to differentiate brands. It is also partly why there are now so many variants being introduced into the market. For example, although it’s a slightly different technology, a “water capsule” was recently launched in Japan to show potential different applications and functions that are being investigated. The water capsule itself modifies the taste but in a different way, by cooling rather than imparting a flavor. Water is also known to have some filtration properties if it is present in the appropriate quantities, so there may also be an additional benefit in this regard.

    Therefore, not only do capsules help manufacturers cater to consumer tastes, but they also add value in terms of brand differentiation. As industry regulation and legislation continues to grow with increasing restrictions around tobacco content, marketing and packaging, manufacturers continue to turn to the filters themselves to distinguish their products. Leveraging the capsule in this way creates an opportunity for brands to add value and offer something that their competitors do not. It will be interesting to see how capsules continue to develop and what new innovations are created that can add the same flexibility and personalization that current capsules do but can also comply with any new regulations that come into place.

  • How low can you go?

    How low can you go?

    Scandinavia’s market for combustible tobacco continues to shrink as consumers look for less harmful alternatives.

    By Stefanie Rossel

    Among the Scandinavian countries, Sweden and Norway stand out when it comes to low smoking rates. With only 7 percent of its population using cigarettes, cigars, cigarillos or pipes, Sweden remained best in class in 2016, according to www.statista.com, whereas Norway’s smoking prevalence stood around 12 percent, according to Statistics Norway. With a smoking prevalence of 20 percent, Denmark trails its northern neighbors but is still comfortably below the EU average of 25 percent.

    The record-low figures are attributed to widespread health consciousness and the popularity in Norway and Sweden of snus, a pasteurized oral tobacco that is available as loose leaf and in pouches. In Sweden, snus has been used for 200 years. Throughout the rest of the EU, however, the product is banned. (Norway is outside the EU.)

    Snus is believed to be significantly less harmful than smoking, but that knowledge hasn’t stopped Norway from subjecting the product to strict regulations. When it recently became the fourth European country to introduce standardized packaging for tobacco products, Norway explicitly included snus in the new legislation.

    With the exemption of e-cigarettes, chewing tobacco, cigars and pipe tobacco, cigarettes and all other tobacco products are now sold in drab brown-green packaging, bare of manufacturer logos and with brand names in a standardized font. In addition, Norway’s Standardized Packaging of Tobacco Products Law (2017) requires packs to feature large health warnings with text and images showing, for example, diseased lungs.

    Retailers have a transition period of one year to comply with the new legislation, the purpose of which is to prevent children and young people from starting smoking and using snus. Legislatures justified their decision by pointing to the dramatic increase in snus use among young people over the past 10–15 years. During the same period, they claim, many new snus products with appealing packaging designs entered the market. Swedish Match, which leads the snus and moist snuff category in Sweden and Norway, on July 7 filed for a temporary injunction, saying that the measure is disproportionate and inappropriate for the protection of public health.

    In Sweden, the snus news has been more positive. In May 2017, Sweden’s Karolinska Institutet published a study that dismissed the causal relationship between snus and pancreatic cancer. The findings might support the pending legal challenge of the EU snus ban. In July 2016, Swedish Match had brought the challenge to the U.K. High Court; the company was joined by the New Nicotine Alliance, a nongovernmental organization acting as a third party in the public interest. In January 2017, the High Court referred the case, as the litigants had hoped, to the European Court of Justice (ECJ).

    Given the low risk of snus compared to other tobacco products on the market, the plaintiffs argue that the ban is incommensurate and contravenes the EU’s right to a high level of individual and public health protection. While the legal challenge of the EU snus ban follows two earlier, unsuccessful attempts, it’s the first time that infringement of human rights is being brought forward as an argument.

    EU member states and other stakeholders had until July 7 to make a submission to the ECJ commenting on the legal issues. In contrast to earlier occasions when the EU snus ban was challenged, the Swedish government this time chose not to submit an opinion, according to a press release from the New Nicotine Alliance Sweden, which was published in early August. Previously, Sweden’s government had pointed out health risks associated with snus; its opinion was believed to have influenced the ECJ to uphold the ban. The country’s silence may now facilitate a repeal. A ruling by the ECJ is expected in the first half of 2018 at the earliest.

    A legendary love of snus

    In both Norway and Sweden, the snus segment continued to grow in 2016, with pouched snus increasingly outselling traditional loose-leaf products. At the end of last year, portioned snus had a market share of 80 percent throughout Scandinavia, according to Swedish Match.

    In Sweden, the number of snus users surpassed that of cigarette smokers in 2012. Approximately 1 million of the country’s 9.9 million inhabitants now consume the moist snuff. Swedish Match estimated the market comprised about 375 million cans in 2016, up by approximately 4 percent from the previous year. Some 56 percent of the snus market last year was dominated by premium products, but the economy and mid-priced segments continue to grow. Excise tax hikes for the product category stayed moderate; rates were virtually unchanged in January 2016 and saw a less than 1 percent rise in January 2017.

    With a market share of 67.4 percent, Swedish Match dominated the domestic moist snuff market in 2016, followed by Imperial Tobacco Group (ITG), British American Tobacco (BAT) and Japan Tobacco International (JTI). Swedish Match leads the premium-priced snus segment with its General snus brand. The company’s other brands in Sweden include Goteborgs Rapé, Ettan, Grov and Catch.

    Despite its dominance, Swedish Match has been losing market share in the snus category. In the premium category, its share shrank by 1.3 percentage points to 91.8 percent in the first six months of 2017 compared to the first half of 2016. In the economy segment, Swedish Match lost market share to smaller manufacturers. Its share decreased from 38.8 percent in the first half of 2016 to 36.5 percent during the same period this year.

    Shifting categories

    Snus manufacturers have kept busy making their portfolios comply with the requirements of the revised EU Tobacco Products Directive (TPD2). Sweden’s parliament adopted the bill for transposing TPD2 into national law on April 6. In addition to stipulating graphic health warnings for cigarette packs, the law now mandates two health warnings on snus containers and bans the specification of the amounts of tar, nicotine and carbon monoxide on the packaging of tobacco products.

    The value of Sweden’s entire tobacco market shrank from $3.34 billion in 2015 to $3.33 billion in 2016, according to Euromonitor International. The individual product categories experienced significant shifts in 2016. In value terms, cigarettes remained the leading category with sales of $1.94 billion, down from $2.04 billion in 2015. JTI, which is present in Sweden with popular brands such as Blend, Right, Camel and Level, continued to lead the category in 2016 with a market share of 39.6 percent, followed by PMI (31.4 percent) and BAT (26.8 percent).

    Cigars, cigarillos and smoking tobacco decreased to $122.2 million in 2016 ($157.8 million in 2015), whereas the smokeless tobacco category, the majority of which is snus, rose to $1.21 billion in 2016 from $1.14 billion in 2015.

    The Swedish vapor market has recorded solid growth since the product became legal in February 2016, after the country’s Supreme Court rejected pharmaceutical licensing. Its retail value was estimated at $47.7 million in 2016.

    Sales ban on vapor products lifted

    Developments in Norway have mirrored those in Sweden, albeit on a smaller scale. The overall tobacco market retail value shrank from $2.07 billion in 2015 to $2.01 billion last year, according to Euromonitor statistics.

    Increasingly strict regulation and the stigmatization of smokers combined with long-standing health concerns about combustible tobacco contributed to a further decrease in Norwegian cigarette consumption. The cigarette market was valued at $1.03 billion in 2016, down from $1.08 billion one year earlier. The majority of the 2016 market was held by BAT, with a share of 51 percent, followed by PMI (33.6 percent), ITG (11.2 percent), JTI (2 percent) and Scandinavian Tobacco Group (0.5 percent).

    The cigars, cigarillos and smoking tobacco category shrank to $334.9 million in 2016 from $362.8 million in 2015.

    The country’s smokeless tobacco market, by contrast, rose from $595.7 million in 2015 to $629.9 million last year. In 2016, Swedish Match again led the category, with a share of 53.5 percent, followed by ITG and BAT. Just like in its domestic market, Swedish Match has been losing ground in Norway. In the first six months of 2017, the company’s share of the Norwegian market dropped to 51.9 percent, down from 54.1 percent in the same period of 2015.

    For the vapor products category, Euromonitor noted a retail value of $13.4 million in 2016. It will be interesting to see how Norway’s tobacco and vapor markets will develop following the introduction of plain packaging and the legalization of e-cigarettes in December 2016.

    Danes love cloud-chasing

    Although its smoking prevalence is higher than those in other Nordic countries, Denmark’s tobacco trends are similar to those experienced by its neighbors. Due to declining cigarette consumption, anti-smoking campaigns and growing health awareness, the retail value of Denmark’s entire tobacco market contracted to $1.95 billion in 2016 from $2.12 billion in 2015, according to Euromonitor.

    While still representing a majority of the market, the cigarette category declined from $1.78 billion in 2015 to $1.7 billion last year. With a 72.5 percent market share, BAT led the market in 2016, followed by PMI (17.4 percent) and JTI (7.9 percent). ITG and Von Eicken held market shares of 0.2 percent and 0.1 percent, respectively.

    Smokeless tobacco products shrank by $1 million in 2016 from $13.9 million in 2015. The decrease in the segment is due to a new law banning Swedish-style snus from Jan. 1, 2016. Just like Sweden, Denmark had received an exemption when the EU banned snus in 1992 but only for the sale of loose snus, not portioned snus. Following several warnings and, in 2014, a lawsuit by the European Commission, the Danish government prohibited sale of pouched snus. Sales of loose snus are still allowed. The ban effectively wiped out a subcategory that, according to Euromonitor, in 2015 was worth dkk20 million ($3.16 million).

    The only category that bucked the downward trend in the Danish tobacco market was vapor. Its retail value rose to $70.4 million in 2016 from $41.8 million in 2015. The boom was driven by the legalization of nicotine-containing vapor products in June 2016.

    The impressive growth rates in the segment set Denmark apart from its Nordic neighbors. According to Euromonitor, e-cigarettes are emerging as a direct competitor to combustible cigarettes in the small country.

  • Fiscal cacophony

    Fiscal cacophony

    In the absence of a clear category definition, next-generation products are subjected to a bewildering array of tax policies.

    By Stefanie Rossel

    As next-generation tobacco products (NGPs) continue to gain popularity, developing an appropriate taxation policy for novel cigarette alternatives remains a complex issue around the globe. It’s a subject that involves many conflicting interests: Governments are looking for new revenues to make up for “losses” brought about by shrinking cigarette sales. In the absence of long-term studies, policymakers are reluctant to embrace the idea that NGPs might benefit public health and hence need to be promoted by appropriate taxation. Others argue for zero taxation of NGPs to prevent ex-smokers from switching back to combustibles and to encourage current smokers to switch to less unhealthy alternatives.

    Lacking a unified policy on how excise taxes on vapor products should be structured, several member countries of the European Union and an increasing number of states and lower authorities in the U.S. have been going it alone. Recent examples bear witness to the widely varying policy rationales that have developed around the NGP category in the absence of clear definitions. Are vaping devices just as bad—i.e., as hazardous to health—as combustible cigarettes and therefore deserve an equally high punitive tax? Californian voters seem to agree, although scientific evidence suggests that vapor products are a significantly less harmful alternative to tobacco products. In November 2016, voters in the Golden State approved a ballot initiative to increase taxes on cigarettes to $2.87 per pack of 20 and to tax vaping devices at an equivalent rate.

    Other questions relate to whether vaping is a gateway to smoking, especially for young people, and whether nicotine is just as much a cause for smoking-related diseases as are the byproducts of combustion. While both theories have been debunked by now, Finland’s fiscal policymakers, like many of their colleagues in other countries that currently tax vape products, still had them in mind when introducing an excise duty of €0.30 ($0.34) per milliliter of e-liquid on Jan. 1.

    In December 2016, Finland amended its tobacco excise tax act to define e-liquid as a tobacco product. The new tax applies to all e-liquids, even those without nicotine. Sales of nicotine-containing liquids had become legal in the Finnish market only in mid-November 2016. Fittingly, Finland now permits only one flavor for e-liquids: tobacco.

    Proof that vapor product taxes are unlikely to compensate for declining cigarette revenues comes from Pennsylvania. In October 2016, a 40 percent tax hike on the wholesale price of e-cigarettes, including devices and liquids, as well as a tax on retailers’ inventories, came into effect. The vapor tax was projected to bring in $13.3 million in revenues but had a devastating effect—more than 100 vape shops across the state went out of business. By the end of March, with three months left in the 2016–2017 fiscal year, Pennsylvania’s Department of Revenue had collected only $7 million in e-cigarette taxes.

    In the focus of EU tax policy

    Among the EU member states that have taxed NGPs, a clear trend is recognizable: E-cigarettes are taxed based on liquid volume. Excise tax on e-liquid is presently levied in Italy and Portugal (since 2014); Latvia, Romania and Slovenia (since 2016); and Hungary, Greece and Finland (since the beginning of this year). In June, Poland’s health ministry released a proposal to impose a tax on vapor liquids.

    Hungary, Latvia, Portugal, Romania and Slovenia have also introduced excise taxes on tobacco-heating products. While it does not tax e-cigarettes, Slovakia joined these states in May. Acknowledging that tobacco-heating products, despite containing tobacco, do not fit into existing classifications, most of these countries created new tax categories.

    The excise tax is typically based on the weight of the heated tobacco mixture, with rates ranging from €62 per kg in Latvia to €88 per kg in Slovenia. Hungary, by contrast, uses tobacco sticks to calculate the rate.

    Guidance in NGP tax matters may eventually come from Brussels. The European Commission is required to review the rates and structures of excise duties applied to manufactured tobacco every four years and propose changes where necessary. This review is currently underway, and for the first time the inclusion of vapor products is being discussed.

    If e-cigarettes were to be included, the commission would have to set a common excise regime for vapor products across all 28 member states. Vapor trade organizations have already cautioned against imposing additional costs and administrative burdens that would make the end product more expensive and act as a disincentive to switching from smoking to vaping.

    In late 2016 and early 2017, the commission held a public consultation about e-cigarette taxation. Asked whether e-cigarettes and liquids should be subject to an additional tax, 89.88 percent of respondents said no. Many fear that hiking taxes on NGPs will increase cross-border sales and cause some users to return to combustibles. The commission is currently assessing the results of the consultation.

    Significant variations

    In the U.S., there is no federal levy on vapor products. States, counties and cities levy taxes, and the methods and levels vary considerably. Among the jurisdictions that currently tax vapor products, four charge excise based on wholesale price. Minnesota has implemented a tax of 95 percent of the wholesale price on tobacco products, including e-cigarettes. California and the District of Columbia tax vapor products at a rate equal to the tax imposed on cigarette packs; in the case of D.C., this means a 67 percent tax. Kansas, Louisiana, North Carolina and West Virginia tax e-cigarettes based on the volume of consumable liquid solution.

    Several cities tax e-cigarettes even if their state does not. Chicago, for example, levies a tax of $0.80 per unit plus a per milliliter rate of $0.20.

    The implementation of high taxes on NGPs in the U.S. has driven smaller vape shops out of business and encouraged vapers to either shop online or out of state. Kansas recently tried to turn this development around. In July, the state reduced its tax per milliliter of e-liquid from $0.20 to $0.05, bringing it in line with the tax in North Carolina and Louisiana.

    While the tax structure and rates for vapor products in those states have now been harmonized, it will be a while before tax authorities around the globe will be singing from the same sheet.

     

  • A shot in the foot

    A shot in the foot

    Is it contradictory for a university to ban vaping but allow handguns?

    By George Gay

    From July 1, people 21 and older have been allowed to carry concealed handguns at Wichita State University in Kansas, USA, but are banned from smoking or vaping there. I should point out right from the start, however, that despite the temporal juxtaposition of these two policies, smoking and vaping are not regarded as shooting offenses.

    Sorry, that was a cheap shot. But then the apparent absurdity of such policies seems to invite ridicule. And this is unfortunate because such ridicule is somewhat misplaced. To a certain extent, this absurdity is occasioned only by the fact that the two separate policies were introduced on the same day. Set apart, they can each be defended, up to a point, but lump them together and—doh!

    First, it is necessary to realize that the handgun policy is one that the university—and other institutions in Kansas—had little choice but to introduce. According to a story by Dion Lefler for The Wichita Eagle, two years ago Kansas passed a law that opened nearly all public spaces and buildings to the carrying of concealed handguns, and though public universities and community colleges were given a period of grace in which to comply, that period ended on July 1. There was a way to beat this requirement, but this would have involved positioning metal detectors and guards to run them at every entrance to the university, something that, not unreasonably, officials said was impractically expensive on campuses with dozens of buildings and hundreds of entrances.

    You, like me, might not agree with it, but there is logic at work here. That logic says that in a country where it is relatively easy to obtain firearms, unless you can be certain that nobody on the campus is carrying a gun, you must allow everyone to carry one so that they can defend themselves and perhaps others against a person who is carrying a weapon with evil intent.

    Of course, you could argue that it would be better if guns weren’t so easily available, but we are where we are. And anyway, chasing that argument you run up against the Second Amendment. U.S. citizens argue on a regular basis over the Second Amendment and gun control, and, as a Brit, I don’t feel qualified or brave enough to intrude on their dispute. So perhaps I could take the coward’s way out and quote a U.S. citizen, the comedian and commentator Rich Hall, who, in a column in The Guardian in February about President Donald Trump’s declaration that he was banning immigrants from seven countries, seemed to sum up well the logic of the Second Amendment in the 21st century. “It is in times like these,” Hall wrote, “that we Americans need to pull our loved ones close, give them a hug and remind them that—Trump aside—the U.S. is still a place where people of all faiths, colors and personal beliefs are welcome to acquire a handgun and fire willy-nilly at other persons of faith, color and personal belief.”

    Quite. But that is not to say that questions cannot be raised. I mean, why, rather than letting everyone carry a handgun, couldn’t such guns be limited to people trained in handling guns and difficult situations who would be appointed to each section of the university, rather like a fire marshal or a first aider might be appointed to each section of a place of employment? It’s a thought, but perhaps there’s a good reason not to have people trained in the use of guns. Certainly, two years ago, Kansas removed the requirement that anyone who carried a concealed handgun had to obtain a permit, acquired by paying a license fee and completing an eight-hour training course. Was the thinking, I wonder, that if somebody was going to go on a rampage, it was better that they were incompetent when it came to handling guns, or perhaps such a requirement offended against the ethos of the free market?

    In fact, in one way this is definitely not a free-market issue because, whereas people are allowed to carry concealed handguns, that is all they may carry. Under the principles of the free market, I assume, better-off students and lecturers would be able to equip themselves with bigger armaments, with the most well-off walking around—rather gingerly, I would imagine—with rocket launchers pushed down behind the waistband of their pants. But no, this is a level killing field.

    But again, I’m being unfair. It is important to be clear that one of the policies introduced on July 1 is about carrying something, whereas the other is about using two products, or rather not using them. People aren’t being given carte blanche to re-enact in the classroom the gunfight at the O.K. Corral, or, for younger readers, scenes from Reservoir Dogs; they are being allowed, according to the supporters of “concealed carry,” to carry with them the means to defend themselves if they are attacked by somebody with a weapon.

    Let’s leave the smoking gun, however, and turn to the question of smoking tobacco. Again, the ban on tobacco smoking is logical up to a point because, while cigarettes carry warnings about the health risks these products pose, as far as I know, handguns do not carry such warnings. Additionally, as far as I can tell, nearly everybody—with the exceptions at least of the U.S. vice president, Mike Pence, and me—is happy to endorse the much-used phrase “smoking kills.” And while fewer people, I think, are happy to go along with the idea that secondhand smoking kills, there are enough supporters of these two ideas to make those at the university think that smoking should be banned.

    In fact, the temporal juxtaposition of the university’s two policies provides an opportunity to examine the idea of being killed. Imagine being on campus with somebody who is shooting a handgun at you. What do you think are your chances of being killed? Of course, it will depend on a few factors, including the distance between you and the person firing the gun, the competence of the person doing the shooting, the type of gun and the type of ammunition being used, what you are wearing, etc. And, for those who believe in the logic of concealed carry, it will depend on how quickly you can get your weapon out of your purse, the type of gun you have, etc. But let’s say that your chances of being killed would be at least 50 percent.

    Now the scene changes, and the person walking toward you is smoking a cigarette. What are your chances of being killed? I think it would be not much more than zero percent, no matter the distance between you and the smoker, the type of cigarette being smoked, the wind speed and the wind direction, etc.

    Surely, another way for those who believe that smoking kills to deal with the smoking issue would be to go down the route of gun logic—to allow everyone to smoke cigarettes on campus so that if you felt that you were being subjected to a deadly assault by tobacco smoke, you could retaliate in kind.

    Finally, we come to the ban on vaping. No, you shouldn’t laugh, because there is logic at work here, even if it takes logic to its breaking point. If you accept the idea that smoking tobacco kills, and if you accept that the U.S. Food and Drug Administration, which, we are told, bases its decisions on scientific assessments, was right in deeming e-cigarettes to be tobacco products, then you have an argument for banning vaping on campus, even if that argument is tenuous in the extreme given that you don’t “smoke” the “tobacco product” that is in reality an e-cigarette. Remember, to some people, egged on by others who should know better, that vapor cloud is just as dangerous as is tobacco smoke. OK, you can laugh now.

    At this point, let’s look at another scene, and, at the end of it, take a multiple-choice test. It’s after dark, there aren’t too many people about, and you need to get to your next lecture. To do so, you must walk down one of two dimly lit, covered alleyways. Coming toward you down alleyway A is a mean-looking man you don’t know who is vaping for all he’s worth and creating a huge cloud of vapor but who you know is not carrying a concealed handgun. Coming down alleyway B, meanwhile, is a mean-looking man you don’t know who is not vaping but who you know is carrying a concealed handgun. Do you take alleyway A or B? Tricky, eh?

    For the university to ban smoking completely, without leaving any sanctuaries where smokers can indulge their habit, seems unfair given the likely size of the smoking population. And it could be regarded as discriminatory. But to ban vaping goes even further and seems to amount to absurdity. It is absurd because, as far as is known, vaping is about 95 percent less risky than is smoking, a habit that itself takes perhaps 40 years before it causes major health problems, and even then not in all of those who indulge in it. But it is monumentally absurd when you consider that vaping is used by many smokers to quit their habit.

    If the university authorities had banned smoking on campus but allowed vaping, this again would have been unfair, but at least many smokers who might not otherwise have tried vaping would no doubt have been tempted to vape while on campus. And if they had tried vaping and liked it, who knows—they might have switched completely, which would have reduced hugely the health risk they were taking. I think the university authorities missed an opportunity here. They might even have shot themselves in the foot. Sorry, that was a cheap shot.

  • What’s next?

    What’s next?

    An interview with Pamela Gorman, executive director of SFATA

    By Maria Verven

    Pamela Gorman
    Pamela Gorman

    The largest and leading trade association in the vapor industry, SFATA—the Smoke-Free Alternatives Trade Association—represents vapor manufacturers, online retailers, brick-and-mortar vape stores, distributors, importers and wholesalers.

    Appointed head of SFATA last fall, Pamela Gorman is president of US Vapor, a boutique public affairs firm, and was previously head of government relations for NJoy. She also served as an Arizona state legislator from 2005–2010.

    As executive director, Gorman is responsible for all of SFATA’s operations, including communications (internal and external), compliance, vendor management, budgeting, and state and federal government relations.

    She spoke to Tobacco Reporter about the most pressing challenges currently facing the industry.

    Tobacco Reporter: You’ve been head of SFATA since last fall. What have been your key challenges so far? 

    Gorman: The biggest challenge was probably stepping into a role that had been vacant pretty much since the FDA [U.S. Food and Drug Administration] put out their deeming regulations. Basically, I entered into a whirlwind at this point in history for the industry, and so I was trying to correct some deficiencies I saw in our processes while also inspiring our members to help us get the regulations changed. Oh, and I was learning my way around a new company while all of this was happening!

    I’m happy with what I’ve been able to accomplish in a relatively short time, though. SFATA had grown by such leaps and bounds that the infrastructure just couldn’t keep up, and it was beginning to cause added frustration to an already stressed-out membership. So I set about to get processes and tools in place to allow our tiny staff to better accommodate the membership, which grew more than tenfold while the staffing levels had actually been reduced. I also made regular and meaningful communication with the members a core activity. Our members are giving us good feedback on all of our recent improvements, as well as the new communication plan, and it is wonderful to see folks increasingly satisfied with our services.

    Building the new website and formulating an entirely reinvented membership system so they could both roll out simultaneously was a huge undertaking, but I’m proud of the results. The new True Value Memberships program now lets our members select the level of benefits that best suits their needs and choose a membership type accordingly. Members can also now find more of what they are looking for, manage their own membership accounts and keep up with the latest happenings on a website that actually works!

    So, you could basically say that my first several months at SFATA have been about identifying what’s broken, finding a solution that is doable within our financial and staff time constraints, and then carrying out an overhaul of all things SFATA. I’m excited to see how these corrections will make this a better-running trade association going forward.

    With less of our time eaten up by chasing data through an archaic manual system, we are now able to turn our attentions toward developing additional value for members through enhanced programming and a dependable level of communication from SFATA so they know where their dues are going each year.

    What are your key priorities for the rest of 2017?

    Key priorities for the remaining months in 2017 are to get the best possible training information to our members about their options and responsibilities in the new regulatory environment, while also executing on new strategies to get the federal government onto a more reasonable regulatory path for our products.

    What effect are the impending FDA regulations having on your members?

    Our last survey to shop owners demonstrated an effect that is more about the psychology of what is going on than the actual regulatory impact. People are working on their exit strategies in many cases, not their business plans for the future. It is sad to see this happening to good people who were lead innovators before the FDA regulations became a realistic threat to their livelihoods.

    I’ve also seen more and more companies looking to expand to foreign markets, which is probably a good idea if you are able. This will allow these companies to continue to have a revenue stream while we claw back our rights to function as responsible businesses under a federal regulation that actually makes sense.

    Do you think the more regulated environment will affect future SFATA membership?

    I imagine it will. If there are fewer companies overall, because some simply choose not to continue to try to comply, it would follow that there would also be fewer companies involved in a trade association.

    How will the change in membership ranks affect your organization and your ability to be effective?

    Like any company faced with a financial strain and commitment to continuing to deliver the highest-caliber services, I’ve had to find ways to do more with less money and less staff than ever before. We are on good footing with our new technology now, such that I can do more in less time. Beyond that, we have also built partnerships that allow me to stretch our operations budget and offer even more value to our members at all levels.

    Naturally, with [fewer] members paying dues, there will be less revenue coming into the organization if all else stays the same. This would limit our ability to do all that we would like as a trade association, if we don’t make other changes. So, we are working hard to demonstrate value to those member companies who are investing more to keep SFATA’s operational costs covered, while also providing evidence of value to members (and potential members) of all sizes.

    One of the important priorities in reinventing our membership structure was to create a clear return on investment such that those who provide the financial resources needed to sustain the association also have a greater input and engagement in terms of the direction the organization heads in this new reality.

    SFATA has always been a broad organization made up of all sizes of companies but has had a particularly strong presence in the [small-business] and microbusiness segment of the industry. We know our “story” is about American small businesses, and we never forget this is our strength and that it is worth protecting. So we have worked to keep a low-priced “basic” membership in our mix of new offerings for those that just want to continue to have the same sort of membership benefits as always.

    What do you think is the biggest value of being a member of SFATA?

    Honestly, I’ve learned the answer to this is different for each member. I believe our seat at the table representing the broad vapor industry’s interests in important federal discussions is key. To be honest, my history in lawmaking, and then advocating for lawmaking, makes our time at “the table” more meaningful than perhaps many members even realize. But our members come in all sizes and all levels of business acumen. So, for some, the biggest value may have more to do with our trainings and information we share. For others, the networking with other companies to get ideas, leads on new business or even solutions to operational problems is huge.

    SFATA membership is made up of both small-business owners and representatives from Big Tobacco. Is it possible to represent both? What conflicts do you run into? What are some of the ways these different members work together?

    SFATA membership is varied, though Big Tobacco has not joined our organization. But I have an easy fix to any possible “conflicts” that might arise among our members that would work even if Big Tobacco were to become SFATA members someday.

    All of our policy positions are published on our website, and all members are able to see what we are working to accomplish in public policy. In essence, we work on policy positions that keep the market open for competition and that keep these products attractive, accessible and affordable for consumers. These policies are the best for the growth of the marketplace, and those joining SFATA know this is where we are going to come down on policy debates.

    If a company in our midst wants to redirect policy such that it would harm another company, or take a competitive advantage by way of government intrusion, they would need to hire a lobbyist and give it a go on their own. SFATA doesn’t choose winners and losers from among our membership companies.

    We can and have found ways to work in healthy collaboration with representatives from “Big Tobacco” in the past and will continue to do so as long as the synergies are beneficial to SFATA member companies. While those companies have multimillion-dollar advocacy budgets and can provide resources on the ground, we have the real human story in our SFATA small businesses. Our small businesses matter to policymakers, and I’m sure tobacco folks see this value in working alongside us in battles to protect the market. There have been some instances, though, were we simply cannot work together because their policy agenda would not be in line with SFATA’s own. And that is OK. It is actually perfectly normal, as anyone who works in public policy professionally would tell you.

    What do you think the key legislative challenges will be for the rest of 2017 and beyond?

    While we have the current FDA deeming regulations in place, with the looming deadlines for the probably impossible PMTA [premarket tobacco product application], this is the “biggie” for now. If we change this, we will still have the ongoing multiple challenges at the state level. I expect those will continue to be taxation, raising the age of purchase, licensing, indoor vaping bans, etc. We must stay vigilant on protecting our marketplace at the state level so there is something left when we overcome the nationwide trouble with the current federal regulations.

    There are lots of “what if” scenarios, but the biggest one is: What if the Cole-Bishop bill doesn’t proceed or pass? What next?

    If the Cole-Bishop bill [H.R. 1136] doesn’t proceed or pass—incidentally, this is the most likely outcome—we will still have put dozens of lawmakers on the record in support of saving this industry. That is helpful for everything else we are working on at the federal level, which is why we continue to encourage our members to keep in regular contact to educate their own congressmen.

    But, without the predicate date change that is the basis of the Cole-Bishop bill, the regulations will have to be changed in order to allow for innovation. Without going too deeply into my nerdy policy wonk explanation, here is why: There are no predicate products now, with the old predicate date cutoff, on which to make improvements and submit them for a “substantially equivalent” approval. Even if a company should manage to get a few SKUs through the onerous PMTA process, those products do not become predicate products that can then be further innovated easily.

    So, regardless of what happens—or doesn’t happen—with the Cole-Bishop bill, SFATA is working hard to convince our federal government that the FDA rules are in need of change. There is a ton that can be done by the agencies without Congress taking a single vote. We work on those things alongside the efforts to change the predicate date because all of these things must work together for a sustainable industry marketplace to exist in a year.

    There will soon likely be an appeal filed in the R2B/Nicopure case against the FDA [also see xx], and we are hopeful this—or one of the other lawsuits—will move the needle to give us the reprieve we need to continue to confidently plan our business futures.

    It is important to remember that government affairs is a “long game” and [to] not lose faith or stop working on a change because you don’t get it the first time—or the 10th time—you try. That is how this system works in America—not even close to perfect, but I believe the best in the world by far.

  • Canaries in the coal mine

    The largest e-liquid companies have the most to lose. They’re also the first to enter the minefield of impending FDA regulations.

    By Maria Verven

    Looking down the road at the rigorous requirements handed down by the U.S. Food and Drug Administration (FDA), vapor businesses are gearing up for a rough ride.

    There’s little doubt that the FDA will be regulating the e-cigarette industry in some way, shape or form. What is in doubt is whether pro-vaping legislation will mitigate some of the more rigorous requirements in the FDA’s 2016 regulations that are slated to go into full effect in August 2018.

    Many are hedging their bets, praying that the Cole-Bishop amendment (H.R. 1136)—if included in the fiscal 2018 federal budget—or the Duncan Hunter bill (H.R. 2194) will challenge the FDA’s draconian regulations and the predicate date. If successful, products on the market after that date could be “grandfathered,” removing the onerous requirement that vapor businesses submit a premarket tobacco product application (PMTA) for every product introduced after Feb. 15, 2007.

    Gregory Conley, president of the American Vaping Association (AVA), says the glass looks more half full than half empty. “The most important priority is modernizing the 2007 predicate date via a policy rider in an appropriations bill. There’s also hope that an alternative regulatory framework could be developed by Congress.”

    By the FDA’s own estimates, building and submitting a PMTA will take an average of 1,713 hours to compile and could cost several million dollars per product. Only products that go through this process will be allowed to remain on the market.

    Tobacco Reporter spoke with representatives of two companies about their attitudes and levels of preparedness with the FDA: Schell Hammel, president and owner of The Vapor Bar, Forbidden Premium E-Liquids and Forever E-Liquids, and Allen Querido, CEO of Ruthless E-Juice.

    Allen Querido

    What is your strategy for complying with the FDA regulations? Have you been in contact with the agency?

    Hammel: We have met with the FDA. We try to be ahead of the curve and work with a legal team and staff of toxicologists, physicians and scientists on every step in our e-liquid purity and testing. However, based on the current regulations, there’s no way we would be able to put through a PMTA on our products.

    Querido: The FDA first contacted us, and we’ve had informal discussions with them. Our PMTA strategy will address everything from our SOPs to our manufacturing facilities/certifications, toxicology reports and clinical trials. In addition to bolstering our quality-assurance measures and good manufacturing practices, we built an ISO 7 state-of-the-art clean room. We are preparing our pre-PMTA package based on the current FDA guidelines and will be ready for our formal meeting with them.

    How does the proposed Cole-Bishop bill affect your strategy and/or timeline? Are you actively advocating for reasonable regulation?

    Hammel: If the predicate date or the FDA’s regulations aren’t changed, we will all fail, unless you have very deep pockets. However, I am more optimistic than I have ever been about the potential success of one of our legal or legislative strategies. It is vitally important for other business owners and consumers to reach out to their representatives and ask them to support the Cole-Bishop amendment and the Hunter bill.

    Since the beginning, The Vapor Bar has been part of the Right to be Smoke-Free Coalition, a nonprofit, industry-led trade association of e-vapor businesses dedicated to advocating for reasonable and responsible laws and regulations. I have served on the national and state boards of SFATA [the Smoke-Free Alternatives Trade Association] and am currently director of state chapter relations for SFATA, as well as the chairperson of AEMSA’s (American E-Liquid Manufacturing Standards Association) legislative committee.

    Querido: Our goal is to provide the best and safest products for our clientele. We are continuously improving our facilities, and our operating procedures and guidelines either match or exceed pharmacopeia standards as well as the FDA’s requirements.

    How many different flavors and different levels of nicotine do you currently offer? How many do you plan to submit a PMTA for?

    Hammel: The Vapor Bar submitted well over 2,000 SKUs to the FDA, including 146 flavors in three or four nicotine levels. Our most popular flavors are Shaded, a smooth tobacco; Hell Frozen Over, a cinnamon-mint combination; and Hummingbird, a watermelon combination.

    To prepare for a PMTA, we would have to invest over a million dollars in just one flavor. Smart business sense prevents me from doing that. In the event we would have the money to put one through the process, it is a huge gamble. The FDA already said they don’t have to answer; if they don’t, we would have to pull the product from the market. Based on my research and data, they have not been timely in approving new tobacco products. So, it’s not a gamble I’m willing to make on my business or my family’s future.

    Querido:  We’ve already registered thousands of SKUs with the long-term goal of completing the PMTA process for most, if not all of them. However, the guidelines and proposed regulations are still in flux. Only time will tell what the final guidelines will look like and how the FDA will respond to our PMTA strategy, as well as those proposed by the other industry leaders.

    What steps have you taken so far in preparation for submitting PMTAs?

    Hammel: The Vapor Bar has already changed its labels to comply with the new FDA regulations. We also registered with the FDA and established a testing structure to comply with the regulations. We believe testing is inevitable and will have no problems complying with reasonable testing and regulations.

    Querido: We’ve been preparing for years, as we sensed a change in the environment and foresaw the need to build a strong infrastructure that can handle anything. In addition to hiring experts who have worked with the FDA, we’ve also built relationships with other industry leaders in various fields. We’ve built an expert, forward-thinking team and are confident of our course of action.

    Shell Hammel

    Do you believe your company will be a “survivor” if the FDA regulations remain unchanged?

    Hammel: There’s no way we could survive the FDA regulations in their current form. We would have to restructure our company completely, and I am uncertain what that would look like at this point.

    Querido: Benjamin Franklin said, “By failing to prepare, you are preparing to fail.” This has been our mantra with everything from hiring to choosing vendors and building our facilities. We’ve analyzed, built and adapted our infrastructure over a long period and are confident we will pass and/or exceed the FDA’s standards.

    Unfortunately, lack of time and potentially exorbitant costs could cause other companies to fail. Already, many companies of varying sizes are simply liquidating and making what they can in the next year and a half or so.

    Do you think the FDA will be able to enforce its regulations?

    Hammel: It is uncertain if or how the FDA will effectively enforce regulations. I anticipate they will enforce it in ways that will fall under the radar, aside from engaging small government agencies. I assume that wholesale nicotine would be harder to obtain, and online sales could become illegal. There are many ways they can enforce the regulations without walking into a shop, which will make it very difficult to continue to operate.

    A black market is a sure bet because anyone can obtain all the ingredients they need to make e-liquids.

    Querido: Staffing [at the FDA] is another unknown, but we want to ensure that we’re prepared regardless. At the end of the day, we’ll be offering a better, safer and arguably healthier product than those who choose to take shortcuts.

    We’re fully aware that some will try to operate under the FDA’s radar and attempt to start a black market, but we’re confident that the FDA will enforce its regulations as it does with other industries. After all, any fines it imposes will generate revenue.

    Please describe your long-term vision for your company as it relates to the regulatory environment and the competitive landscape. 

    Hammel: Our company vision is ever changing, as I imagine it is with many. Competitively, The Vapor Bar has always focused on helping smokers and educating our customers on quality, safety and legislative advancements. We maintained that focus throughout; that will be our constant until something changes, either legally or legislatively.

    Querido: We foresee continuing to be an industry leader and one of the few companies that is left standing. In our quest to give our clients the best and safest products, we will continue to improve upon the solid infrastructure that we’ve built.

     

    The original “Vaping Vamp,” Maria Verven is a 35-year PR veteran and owner of Verve Communications, a marketing firm focused on the vapor industry.