Author: Staff Writer

  • Indian Committee Mulls Foreign Investment

    Indian Committee Mulls Foreign Investment

    Photo: Taco Tuinstra

    A parliamentary panel in India has proposed foreign direct investment (FDI) in tobacco cultivation and cigarette manufacturing for exports

    Tobacco-related FDI is currently restricted in India.

    Headed by V. Vijaysai Reddy, the Upper House’s standing committee on commerce recommended 100 percent FDI in tobacco cultivation on the lines of tea, coffee and rubber with the safeguard that tobacco produced with the help of foreign capital should be marketed at auction.

    In case of cigarette manufacturing, the panel has backed overseas investment on the condition that it takes place only in special economic zones and that the products are sold outside of India.

    Lawmakers are also mulling proposals to set up “export only” tobacco farms to generate revenue.

    I

  • FDA to List PMTA Applicants

    FDA to List PMTA Applicants

    Mitch Zeller

    The U.S. Food and Drug Administration (FDA) plans to publicly list all e-cigarette manufacturers that want permission to sell their products in the U.S., reports Bloomberg, citing a blog post published on Monday by Mitch Zeller, director of the FDA’s Center for Tobacco Products.

    The move could help consumers and retailers spot illegal products.

    Vapor product manufacturers who want to keep their products on the U.S. market will have to file requests for marketing authorization with the FDA by Sept. 9.

    The FDA has received applications for about 2,000 e-cigarettes and other newly regulated tobacco products already. There are more than 400 million eligible items that would need to apply to stay on the market, according to Zeller.

    Products whose applications were filed on time will have a one-year grace period to stay on the market while the FDA reviews them, unless the agency rejects the request. Large manufacturers, retailers who could be liable for selling illegal products and public-health groups had pushed the FDA to make the process more transparent.

    In a letter to the FDA, several retail associations had asked the agency to release a list of manufacturers that have PMTAs on file so retailers can know what electronic nicotine delivery system (ENDS) brands can remain on store shelves.

     

  • Thank You!

    Thank You!

    The 2020 GTNF would have been impossible without the support of these generous sponsors.

    TR Staff Report

    In a crowded field of tobacco and nicotine events, the Global Tobacco & Nicotine Forum (GTNF) stands out. It is one of the few forums that brings together all stakeholders, including regulators and public health advocates, for a respectful dialogue and constructive exchange of ideas. The GTNF would not be possible without the support of our generous sponsors. We are honored to recognize them below.

    Alliance One International is a tobacco leaf supplier that offers customers high-quality leaf they can trust. With more than 145 years of agricultural experience and customers in approximately 90 countries, Alliance One International purchases tobacco from a network of more than 300,000 farmers worldwide to produce products that are sustainable and fully traceable. Visit the company’s website at www.aointl.com.

    Altria Group holds diversified positions across the tobacco, alcohol and cannabis industries. Through its wholly owned subsidiaries and strategic investments in other companies, Altria Group seeks to provide category leading choices to adult consumers while returning maximum value to shareholders through dividends and growth. Altria Group’s tobacco companies include Philip Morris USA, U.S. Smokeless Tobacco Co., John Middleton and Nat Sherman. Altria owns an 80 percent interest in Helix Innovations. Altria holds equity investments in Anheuser-Busch InBev, Juul Labs and Cronos Group. Visit the company’s website at www.altria.com.

    Based in Richmond, Virginia, USA, Avail is a premium retailer that offers a broad array of products online and in its 97 stores across 12 states. The company delivers on the promise of quality and transparency. Information on Avail products is available through its retail stores and on the web at www.availvapor.com.

    BMJ is the world’s No. 1 partner for specialty paper and packaging materials in the cigarette industry. BMJ produces cigarette paper, plugwrap paper, base tipping paper and printed tipping paper with standard weights of 18 grams to 40 grams per square meter. As a printing packaging company, BMJ represents high-quality packaging utilizing both rotogravure and offset. Visit BMJ’s website at www.bmjpaperpack.com.

    Boegli-Gravures designs, develops and manufactures stateof- the-art embossing tools and solutions for an exacting worldwide clientele. The company’s combination of artistic vision and engineering excellence has brought it recognition as a world leader in high-precision embossing and as an original equipment manufacturer supplier. The secret of Boegli-Gravures’ success lies in the company’s vision and passion for innovation. Visit www.boegli.ch for more information.

    British American Tobacco (BAT) is a leading multicategory consumer goods business. Its purpose is to build “a better tomorrow” by reducing the business’ health impact through offering a greater choice of enjoyable and less risky products. BAT’s ambition is to increasingly transition revenues from cigarettes to noncombustible products over time. BAT employs more than 53,000 people, operates in more than 180 countries and has factories in 43 of those countries. The company’s strategic portfolio comprises its global cigarette brands and a growing range of potentially reduced-risk products. These include vapor, tobacco-heating products, modern oral products, including tobacco-free nicotine pouches, as well as traditional oral products such as snus and moist snuff. In 2019, the BAT Group generated revenue of £25.8 billion ($33.86 million) and profit from operations of more than £9 billion. Visit BAT’s website at www.bat.com.

    Broughton Nicotine Services (BNS) is a privately owned global contract research organization (CRO) offering fully integrated end-to-end services to deliver U.S. premarket tobacco product applications, EU medicinal product applications and EU tobacco product directive notifications. Its business culture is to continue to invest in new science and innovations. By partnering with BNS, clients will know they have access to some of the most experienced electronic nicotine-delivery system project managers and scientific professionals in the world combined with regulatory compliant CRO laboratory facilities committed to developing safer nicotine products. Find the company’s website at www.broughton-ns.com.

    CNT is the world’s largest supplier of highly purified tobacco-derived nicotine to the pharmaceutical and e-cigarette industries. In addition to offering pure nicotine and derivatives such as Nicotine Polacrilex, CNT supplies pure synthetic S-Nicotine. The processing is done in Switzerland by CNT’s exclusive contract manufacturer, Siegfried, under pharmaceutical current good manufacturing practices. Complimentary to its nicotine platform, CNT is one of the world’s leading suppliers of sustainably produced tobacco leaf. For more information, visit http://nicotineusp.com.

    Headquartered in Austria, Delfort is a global leader in tailor-made specialty papers. In addition to thin print paper, release base paper, food packaging paper and electrical applications paper, the company manufactures a complete portfolio of top-quality cigarette paper, plugwrap paper, tipping base paper and printed papers. By utilizing pure and certified raw materials with the most advanced equipment, Delfort ensures that its products meet the most stringent quality requirements. For more information, visit www.delfortgroup.com.

    Part of Smoore, Feelm is a high-end atomization technology brand, a world leader in atomization. Focused on cutting-edge atomization technology research, Feelm also specializes in the development and manufacturing of high-quality atomization devices driven by Feelm black ceramic coil with metallic film. As the research engine of the global electronic atomization industry, Feelm delivers premium experience. Ever since the successful development of Feelm black ceramic coil in 2016, Feelm has had a significant impact on the research and manufacturing of closed vapor products, changing the whole competitive landscape. Feelm has won several domestic and international awards, including a Golden Leaf Award in 2018, a China Patent Award and the iF Design Award in 2020. For more information, visit www.feelmtech.com.

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    Imperial Brands is a dynamic global business borne out of a strong tobacco heritage. Its core business is built around a tobacco portfolio that offers a comprehensive range of cigarettes, fine-cut and smokeless tobaccos, papers and cigars. As nicotine consumption trends continue to evolve, Imperial has broadened its portfolio to proactively transition adult smokers to next-generation products, potentially harm-reducing innovations that deliver nicotine without tobacco combustion. Visit www.imperialbrandsplc.com.

    Japan Tobacco International (JTI) is a leading international tobacco and vapor company with operations in more than 130 countries. It is the global owner of Winston, the world’s No. 2 cigarette brand, and Camel outside the U.S. and has the largest share in sales for both brands. Other global brands include Mevius and LD. JTI is also a major player in the international vapor market with its Logic brand and its tobacco vapor brand Ploom. Headquartered in Geneva, Switzerland, JTI employs more than 44,000 people and was recognized with a Global Top Employer award for the sixth consecutive year. JTI is a member of the Japan Tobacco Group of Companies. For more information, visit www.jti.com.

    Juul Labs was founded with the goal of helping to transition the world’s 1 billion adult smokers away from combustible cigarettes. The company believes that vapor products can offer adult smokers an alternative to combustible cigarettes and, in so doing, reduce the harm associated with tobacco. At the same time, Juul Labs also knows that providing an alternative to adult smokers is at risk if it comes at the expense of underage use. The company is committed to helping adult smokers transition away from combustible cigarettes while combating the serious problem of underage use. Visit the company’s website at www.juullabs.com.

    Philip Morris International (PMI) is leading a transformation to ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company and its shareholders. PMI manufactures cigarettes as well as smoke-free products and associated electronic devices and accessories and other nicotine-containing products in markets outside the United States. In addition, PMI ships a version of its IQOS Platform 1 device and its consumables authorized by the U.S. Food and Drug Administration to Altria Group for sale in the U.S. under license. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI’s smoke-free IQOS product portfolio includes heat-not-burn and nicotine-containing vapor products. As of June 30, 2020, PMI estimates that approximately 11.2 million adult smokers around the world have already stopped smoking and switched to PMI’s heat-not-burn product, available for sale in 57 markets in key cities or nationwide under the IQOS brand. Visit www.pmi.com and www.pmiscience.com for more information.

    Founded in January 2018, Relx is Asia’s leading e-cigarette brand. Relx’s mission is to empower adult smokers through technology, product and science ethically. Relx independently develops its e-cigarette products at its CNASstandard R&D center and continues to make significant investments in R&D, e-liquid testing and new product development to deliver the best possible experience to its adult users. To protect minors from accessing e-cigarette products, Relx developed the guardian program, a companywide initiative that stretches from product development to sales and marketing, leveraging cutting-edge facial recognition technologies, GPS data and cloud technologies. The company has attracted global talent from Uber, Proctor and Gamble, Huawei, Beats and L’Oreal. Visit https://relxnow.com for more information.

    Smoore is a global leader in offering vapor technology solutions, including manufacturing vapor devices and vapor components for heat-not-burn products on an original design manufacturer basis with advanced R&D technology, strong manufacturing capacity, wide-spectrum product portfolio and diverse customer base. According to Frost & Sullivan, Smoore was the world’s largest vapor device manufacturer in terms of revenue, accounting for 16.5 percent of the total market in 2019. For more information, visit www.feelmtech.com.

    Turning Point Brands continues to grow and evolve to meet changing consumer preferences. Along with a tobacco portfolio that features iconic, historic brands such as Zig-Zag and Stoker’s, the company has expanded into the vapor and tobacco alternative segments with innovative brands such as VaporBeast, VaporFi, Vapor Shark, RipTide and Nu-X. A highly effective sales force and distribution network ensure that consumers, retailers, partners and shareholders benefit from these products. Visit www.turningpointbrands.com  for more information.

    For more than 100 years, Universal Corp. has been finding innovative solutions to serve its customers and meet their agriproducts needs. The company built a global presence, solidified long-term relationships with customers and suppliers, adapted to changing agricultural practices, embraced state-of-the-art technology and emerged as the recognized industry leader. The company conducts business in more than 30 countries on five continents and employs more than 20,000 permanent and seasonal workers. Visit the company’s website at www.universalcorp.com.  

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  • Out of the Bag

    Out of the Bag

    Photo: RAI

    Regulators are trying to catch up with the rapid growth of nicotine pouches.

    By Stefanie Rossel

    It’s a niche within a niche, but it’s growing quickly. An analysis published by 360marketupdates values the global market for nicotine pouches at $619.9 million and projects it to reach $12.97 billion by 2026. This translates into a whopping compound annual growth rate of 53.8 percent.

    The novel products have been rapidly adopted throughout Scandinavia and central and eastern Europe, according to Research and Markets. Nicotine pouches are the younger and “cleaner” siblings of Swedish snus, a pasteurized oral tobacco that has been around for some 200 years. Both products are discrete; consumers place them between their upper lip and gum where the nicotine and taste are then released. Snus and nicotine pouches are spit-free. After use, the pouch is disposed of in household trash.

    Unlike snus, however, nicotine pouches don’t contain tobacco; they are white, pre-portioned bags composed of nicotine applied to a carrier material, such as food-grade fillers. They come in a variety of nicotine strengths and flavors, including mint, coffee and fruit. There are even nicotine-free variants. Like snus, nicotine pouches offer considerable potential for tobacco harm reduction because consumption does not involve combustion. 

    With 9 percent of men and 11 percent of women using cigarettes in 2018, Sweden has by far the lowest smoking rate in the European Union (EU). This enviable situation is widely attributed to the popularity of snus in that country. Decades of scientific research have confirmed the product’s efficiency as a smoking-cessation tool. A study published in the Harm Reduction Journal in November 2019 called snus “a compelling harm reduction alternative to cigarettes.” Using snus is estimated to be between 90 percent and 95 percent safer than smoking cigarettes, which puts the product on par with e-cigarettes on the continuum of risk scale.

    Nevertheless, snus sales have been prohibited throughout the EU since 1992. (When Sweden became part of the EU in 1995, it negotiated an exemption from the ban.) Switzerland, a non-EU member, lifted its ban on snus last year. Following two unsuccessful legal challenges, the EU ban was again endorsed by the European Court of Justice in 2018.

    In recent years, international tobacco companies have started including snus in their portfolios either by purchasing existing players or by developing their own products. And then they started developing the nicotine pouch. By now, all leading global tobacco firms are represented in the category, and nicotine pouches have been eating into the share of traditional snus. In the first quarter of 2020, nicotine pouches accounted for 6.7 percent of Sweden’s snus market, up from 3.2 percent in 2019, according to Swedish Match. In Norway, a non-EU member with a snus tradition, pouches today account for 25.8 percent of the snus market, up from 15.3 percent in 2018.

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    All present

    Competition in the pouch segment has heated up significantly, and manufacturers are increasing production capacity for their “modern oral” products.

    It all started with the introduction of Zyn by Swedish Match, the world’s largest producer of snus in Sweden and a significant player in the U.S. market for smokeless products. In the first quarter of 2020, Zyn was sold in 13 countries outside of the U.S. and Scandinavia, including many EU member states, such as Austria, Croatia, Denmark, Germany, the U.K. and the Czech Republic.

    Growth of Zyn has been so strong that Swedish Match CEO Lars Dahlgren spoke of a “transformational year” for the company, saying that the product had been the key driver of the company’s U.S. smoke-free sales in 2019. In the first quarter of 2020, Swedish Match sold almost 70 million cans of Zyn in the U.S., up from roughly 18 million cans in the same period a year earlier. Swedish Match also filed a premarket tobacco product application (PMTA) with the U.S. Food and Drug Administration (FDA).

    Demand for Zyn has been so strong that Swedish Match announced expansions of its U.S. production facility twice in short succession. Scheduled for completion in 2020, the fourth phase of expansion will increase capacity to more than 200 million cans per year.

    Swedish Match’s competitors have not been idle. By acquiring an 80 percent stake in the global business of Burger Soehne, Altria in June 2019 became the owner of the On! nicotine pouch brand. Altria will provide global distribution for On!, which currently is available at retail outlets in the U.S., Canada, Sweden and Japan as well as globally through the company’s online shop. On! comes in seven flavors, including coffee, berry and citrus, and five different nicotine strengths. In May 2020, Altria submitted a PMTA for 35 On! products to the FDA.

    British American Tobacco (BAT) is represented in the nicotine pouch market through its Lyft brand, which it sells in the U.K., Sweden and Kenya. Going forward, BAT plans to market all its modern oral products under the name Velo—the brand under which BAT subsidiary Reynolds American Inc. (RAI) has been marketing its nicotine pouch product in the U.S. since June 2019.

    To cater to the anticipated increase in demand, BAT in September 2020 built a nicotine pouch factory in Hungary. The investment, estimated at more than HUF7.5 billion ($24.3 million), the investment aims to boost production to more than 1 billion nicotine pouches in 2020, a figure that is expected to triple next year. Initially equipped with one line for the manufacture of nicotine pouches, the factory is supposed to receive a further five production lines by the end of this year. Its output is destined mainly for European markets, including Germany, Austria and the Nordic countries. The Hungarian factory is supposed to become one of BAT’s global hubs for the manufacturing of oral products.

    In June last year, Japan Tobacco International (JTI) entered the race with Nordic Spirit, nicotine pouches that were developed in Sweden and sold in Switzerland and Sweden and online. Upon the launch, the company had said it intends to significantly increase distribution across various trade channels in the near term. Nordic Spirit is currently available in four flavors, including mint and bergamot wild berry.

    Imperial Brands is present in the modern oral nicotine market with Zone X, Killa, BLCK and Pablo, among other products. With a high nicotine content of 50 mg per gram, Pablo is the “strongest” nicotine pouch in the market. Usually, nicotine content in the novel products vary between 2 mg and 24 mg per gram.

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    Product regulation

    In the U.S., tobacco-free nicotine pouches are required to carry the warning “This product contains nicotine. Nicotine is an addictive chemical,” and may be sold only to consumers over 21 years of age. Entry barriers are low compared to those for other tobacco products, but the product is subject to FDA regulation all the same. By contrast, the market for nicotine pouches in the EU currently operates in a regulatory vacuum. Containing no tobacco, the products are not covered by the EU Tobacco Product Directive (TPD2) nor do they belong to any other regulated product category. Unlike tobacco products, they may be advertised on television, radio and billboards throughout the common market.

    Christofer Fjellner, who served as a member of the European Parliament from 2004 to 2019, expects new regulation to be adopted in all important markets in the coming years. In a report published in April 2020, he writes that Sweden and Norway will likely be the first countries to enact regulations for nicotine pouches—a development that could also influence how other European governments will shape legislation. For the time being, Sweden has decided that nicotine pouches are not a food product thereby indirectly approving the product to be placed on the market.

    The country has started defining and categorizing nicotine pouches; its government has tasked a special commissioner with proposing new regulation. Meanwhile, Austria’s chemical authority is referring to the EU’s classification, labeling and packaging regulation, demanding that all nicotine-laced product carry health warning texts and symbols.

    The World Health Organization has yet to take up the topic of nicotine pouches, according to Fjellner. He expects to receive an indication of how the European Commission views nicotine pouches in the implementation report for TPD3, scheduled for May 2021.

    “How the EU chooses to regulate nicotine pouches is influenced by at least three factors,” he says. “Whether EU member states call on the EU to ban nicotine pouches, due to concern about the use of the product in member states—which was the reason for EU ban on snus—whether there are already specific product regulations or national bans in individual member states that new European legislation may be in conflict with, and the number of users of nicotine pouches, and thus a public opinion critical to a new restrictive legislation or ban.”

    The latter, he adds, was one of the reasons e-cigarettes were not banned in the 2014 TPD revision. The way the EU regulated e-cigarettes in 2014, Fjellner says, could be an indicator of how it will likely deal with nicotine pouches, which would indicate a focus on warning texts and the introduction of a maximum nicotine level. For advocates of tobacco harm reduction, such an approach would be preferable over an outright ban.

  • Turning the Tanker

    Turning the Tanker

    Now would be a good time for the World Health Organization to change direction without abdicating from its tobacco responsibility.

    By George Gay

    A few lines from a song by the late Warren Zevon have taken up residence in my head of late: “You can dream the American Dream / But you sleep with the lights on / And wake up with a scream.” Whether or not they buy into the idea of the American Dream, a lot of people around the world, I imagine, are feeling that level of fear because of the Covid-19 pandemic. Take me, for instance: I have been waking with a scream brought on by a recurring dream in which, with the world in the grip of a post-Covid-19 pandemic, I am trying to discover whether the U.K. government has managed finally to get its head and technology around the concept of contact tracing. The answer is no.

    But it’s not all bad news, I’m told. The government is now able to inform me of the whereabouts of every pack of cigarettes in existence, nationally or internationally. There is even some talk about how it might have been able to game Heisenberg’s uncertainty principle since, by using a track-and-trace system developed at the behest of the World Health Organization (WHO) that works in real time, even during deliveries, it is aware of both the position and momentum of each pack. It is at this point that I wake up screaming.

    Why has building a track-and-trace system for cigarette packs apparently been seen as more important and more urgent than developing a globally adaptable, fast-to-implement and efficient contact tracing system for people during times of pandemics? I don’t know, but I can guess at a number of reasons, one of which was playing out across the world as I wrote this piece in June when many of those in authority were demonstrating once again the relative importance they attach to the preservation of people (low) and property (high). 

    In addition, as far as I can see, the cigarette pack track-and-trace system is in place to ensure that those who choose to smoke and thereby risk their health pay the full price for their cigarettes. The “free” market, which the WHO clearly supports, demands that a proper level of profit and tax revenue should be squeezed out of the products that make people sick and that a proper level of profit should be made in treating that sickness.

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    Dismantling the arguments

    But whereas it’s easy to see why some businesses dealing in tobacco and health would appreciate what they would see as the benefits of such a system, I struggle to understand why the WHO would find it advantageous. So let me take a guess about what we might be told if the WHO were, with the help of a nosegay, able to bring itself to answer questions from a representative of the tobacco industry. Firstly, though, it is necessary to understand that the WHO believes that the implementation of its track-and-trace system will reduce—it actually uses the word “eliminate,” but that is the stuff of dreams—the sale of illicit cigarettes and therefore smoking. Given this, I imagine it would say the consumption of tobacco causes the deaths of 8 million people a year whereas Covid-19 has so far (see below) caused the deaths of 430,241, so tobacco is by far the bigger threat.

    There are a number of problems with this argument. The main one as I see things is that whereas tobacco has been around for a long time and therefore has to be subjected to control measures, there is still time to build robust preventative measures to combat the thousands of potential viruses that are lining up to devastate lives and economies around the world. And in the eyes of all but the most virulent free market supporters, prevention must be preferred to control, so a people contact tracing system should be regarded as being way more urgent than a cigarette pack track-and-trace system.

    Another problem with the above argument is that it is based on two figures that are clearly wrong: one being ludicrously rounded, the other being ludicrously precise, even though they are both WHO figures published this year. The 8 million figure was published on May 26 without even the qualification of an “about” while the 430,241 figure was published in respect of the period of the Covid-19 crisis up to June 15.

    Does it matter that these figures are wrong? To my mind, yes. It’s a matter of trust. We seem to have reached a situation whereby any information dumped on the unsuspecting public, no matter how distorted, can be justified on the grounds that it is meant to bring about the most advantageous result, seemingly defined as the result best suited to the ideologies of those putting that information out. And once people and organizations start to believe in this way of carrying on, especially as in the case of the WHO, if they refuse to engage with those of the outer dark, they become reckless. For instance, in recent times, the WHO’s annual tobacco-related deaths figure seems to have been playing 1 million unit leapfrog with its pollution-related deaths figure.

    But it is not only the hyperinflation of these figures that make them look suspect. Given that many people who die of tobacco-related or pollution-related deaths will die from, say, lung disease, how is it possible to accurately ascribe these deaths to their rightful causes? If a smoker living in a flat adjacent to a city’s main diesel bus parking and servicing depot dies, is her death put down to pollution or to smoking? No prizes for correctly guessing the answer.

    The end result of all this will surely be that no thinking person will trust such figures and, by extension, the individuals and organizations that pump them out with the further consequence that various people will be wringing their hands because the person in the street has become fed up with experts. It is necessary to remember that if you publish dodgy information, as it is passed down the line it will become further distorted until the point where it becomes drivel.

    Take the 430,241 figure. In a story in my newspaper, the writer or editor, presumably concerned that it was not possible to justify such an exact figure, rendered it as “more than 430,000,” which sidesteps one problem but runs into another. What does “more than” mean here: 430,001, 4.3 million, 4.3 billion?

    Meanwhile, a recent note by the British Heart Foundation (BHF), which claimed that “contrary to headlines suggesting that nicotine protects against Covid-19, smokers are more likely [presumably than nonsmokers] to contract the coronavirus.” It makes this claim, even though it quotes a WHO note that says, in part, “There are currently no peer-reviewed studies that have evaluated the risk of SARS-CoV-2 [the virus that causes Covid-19] infection among smokers.”

    But not content with this nonsense, the BHF goes on to say, “Even if smoking did have a small protective effect against Covid-19, this would still be hugely outweighed by the well-known harm that smoking causes.” How can this be justified either at a personal or a smoker-population level, especially when no timeframe is mentioned? To make any such claim, you would firstly have to know what is the level of this so-called “small” protective effect, and this is not known. Then, on an individual level, you would need to know a good deal about the smoker’s personal details, including such things as her age and general state of health. And, as time goes by and we learn more about this novel virus and the disease itself, we would probably need to know more. After all, from my reading of some of the latest findings, the unprecedented damage done to the lungs and other organs while Covid-19 is active in the body far outweighs the damage done by smoking over a similar period.

    The point is, we don’t know enough about Covid-19 to be handing out anything but the most basic advice about such things as hand washing and social distancing. And if we don’t know, we should say we don’t know. We should not be extolling the efficacy, nor the dangers, of nicotine in the fight against the virus unless we are fairly certain that we are right.

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    Wanted: New direction

    And, to give it its due, the WHO took a more balanced view than the BHF in this regard. In fact, despite the above, I’m very much in favor of having a health organization with global reach, but the WHO desperately needs to change the direction set by the previous director general. It has to change its focus from addressing those health issues that individuals can tackle on their own and that are far from existential in nature, such as tobacco and nicotine use, to addressing—and here I mean preventing in preference to controlling—those health issues that the person in the street has no or little control over and that could be existential in nature, such as species-jumping viruses.

    Given the state of unpreparedness that the world found itself in when the Covid-19 virus started crossing borders, it is simply ridiculous that the WHO has held eight international conferences under the auspices of its Framework Convention on Tobacco Control, including more recently its meetings of the Parties to the Protocol to Eliminate Illicit Trade in Tobacco Products. It takes 40 years or so to die from a smoking-related cause—40 years during which the smoker provides an inordinate amount of revenue to the exchequer and, yes, derives pleasure and, perhaps, solace from her habit. It takes three weeks to die of a Covid-19-related disease, and just the threat of the disease causes economic mayhem.

    The good news is that now is an ideal time for the WHO to change direction without abdicating from its tobacco responsibility. Businesses have been and are providing a string of innovative products that can help cigarette smokers switch to these much reduced-risk products, including vapor devices, snus, nicotine pouches and alternative nicotine-delivery devices. The WHO doesn’t have to endorse these products; however, it does need to stop pretending that they are not highly useful products in the fight against smoking—certainly more useful than the sorts of pharmaceutical products that it seems willing to endorse.

    But it’s going to be a hard job turning the WHO tanker around. To coincide with World No Tobacco Day 2020 at the end of May, an international group of independent experts with no conflicting links to the tobacco or vapor industries sharply criticized the WHO for its backward-looking approach to innovation and new technology, such as vapor products. A press note, put out under the Iowa Department of Justice’s Office of the Attorney General, made the point that these experts had become exasperated by the WHO’s dogmatic hostility toward new technology and feared the U.N. health agency would squander the opportunity to avoid millions of premature deaths that will be caused by smoking.

    The attorney general, Thomas J. Miller, the longest-serving state attorney general in U.S. history, who played a leading role in the 1998 Master Settlement Agreement, claimed the WHO had lost its sense of mission and purpose. “It’s as if the WHO has forgotten what it is there to do—to save lives and reduce disease,” he was quoted as saying. “We can do that by helping and encouraging consumers to switch from cigarettes to lower risk products. This means being honest about the much lower risks and by using smarter regulation to make switching more attractive.”

    To my mind, honesty is vital. But it needs to be extended to other institutions—the U.S. Food and Drug Administration and the EU Commission spring to mind—and to governments. It is vital too, to keep in mind that the aim is “to save lives and reduce disease,” though I would like to once again put in a plea here that “reducing disease” should in the first instance focus on prevention and only after failure in that aim to controlling disease. It is necessary to keep banging on about prevention because it is the logic of the free market and of many of the authoritarian and would-be authoritarian regimes around the world that if we had a global health organization that managed through prevention alone to eliminate all diseases in the world, its funding would be cut to zero.

  • Eyes on the Ball

    Eyes on the Ball

    Photo: PMI

    Even as cigarette dollar sales increase during the Covid-19 pandemic, IQOS expansion remains Altria’s primary focus.

    By Timothy S. Donahue

    Covid-19 has slowed the traditional decline of U.S. cigarette sales. With less opportunity to spend on travel and entertainment, consumers have had more money to purchase tobacco products, according to Billy Gifford, CEO of Altria Group. Since the start of pandemic lockdowns in mid-March, traditional cigarette sales have increased over the same period last year, breaking a longstanding trend.

    During Altria’s second-quarter earnings call, Gifford said that the cigarette category has proved resilient during the pandemic. Based on year-to-date industry volume performance, the largest U.S. cigarette manufacturer has adjusted its estimated 2020 volume decline rate to a range of 2 percent to 3.5 percent, down from its previous estimate of 4 percent to 6 percent. The company also increased its annual dividend by 2.4 percent, saying it had more clarity on the pandemic’s effects on consumer demand. It is the company’s 51st consecutive annual dividend increase.

    “Remember, last year, the cigarette category peaked its decline at 6 percent, then it receded to 5.5 percent in the third, and then down to 4.5 percent in the fourth,” Gifford said. “So a little bit tougher comparisons were also included in that forecast. But it’s a fluid environment and it’s something that we’ll continue to monitor.” Altria’s forecast was lower than its prior outlook, which was withdrawn due to the uncertainties around the pandemic’s economic impact.

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    Cigarette sales have seen a series of ebbs and flows through the first half of 2020. When some U.S. state governors began issuing stay-at-home orders in mid-March, combustible cigarette sales volume rose 1.1 percent for the week that ended March 22, according to Nielsen. Those sales were likely generated by consumer stockpiling, according to Gifford. For the four-week period that ended May 16, Nielsen reported only a 0.2 percent decline in sales volume for traditional cigarettes. Comparatively, sales volumes in 2019 fell 8.8 percent over the previous year (2018) in the four weeks to March 23, according to Nielsen data.

    Bonnie Herzog

    Bonnie Herzog, managing director at Goldman Sachs, stated in an email that the cigarette category is now holding steady. All channel cigarette dollar sales growth was up 3.1 percent for the two weeks ending on July 25. “Higher pricing more than offset a deceleration in cigarette volume, which was down 2 percent during the same time,” she said.

    The pandemic is not the only factor driving increases in cigarette sales. Gifford says restrictions on e-cigarette flavors and the Sept. 9 deadline for premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration (FDA) have come together to create a perfect storm that is driving vapers back to combustible cigarettes.

    Gifford told listeners that Marlboro’s second-quarter retail share for the overall cigarette category was 42.8 percent, down six-tenths versus the year-ago period. In April, Altria reported that older smokers who had switched to e-cigarettes were turning back to traditional cigarettes because of negative news coverage and regulatory crackdowns on vaping.

    “As you’ll recall, earlier this year we noted an increase in the number of adult smokers aged 50-plus who moved from the e-vapor category back into cigarettes benefiting volumes from Marlboro and the cigarette category,” he said. “This demographic has a greater tendency to purchase discount brands than younger adult smokers, which increased the discount segment share at the start of the year. We believe the effect of this dynamic will have a lingering impact on Marlboro’s year-over-year retail share comparisons through 2020 … when you think about that, it’s a bit early on to tease out the exact impact from both of those, but that’s something that we’ll continue to monitor as we move forward.”

    Altria’s headquarters in Richmond, Virginia, USA
    Photo: Altria Group

    Looking toward the second half of 2020, Altria has high hopes for its IQOS heat-not-burn device. On July 7, the FDA issued exposure modification orders to IQOS. Gifford said he was pleased with the FDA authorization to market IQOS as a modified-risk tobacco product (MRTP) with a reduced-exposure claim. The FDA’s decision includes the device’s holder and charger as well as Marlboro HeatSticks, Marlboro Smooth Menthol HeatSticks and Marlboro Fresh Menthol HeatSticks.

    IQOS is the first next-generation product to receive an MRTP. In a statement, the agency concluded that the available scientific evidence demonstrates that IQOS is expected to benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.

    According to the FDA website, a reduced-risk claim authorization would generally allow a company to say a product is less harmful than combustible cigarettes. However, according to the FDA, the current reduced-exposure claim authorization allows the manufacturer to only state that IQOS heats rather than burns tobacco and significantly reduces the production of harmful and potentially harmful chemicals. The decision follows a review of the extensive scientific evidence package Philip Morris International (PMI) submitted to the FDA in December 2016 to support its MRTP applications.

    IQOS is produced by PMI and marketed in the U.S. by Philip Morris USA (PM USA), a subsidiary of Altria Group. Gifford said PM USA is making the necessary preparations to communicate the reduced-exposure claim to adult smokers, which includes developing new marketing assets and submitting them to the FDA in advance of being used.

    “We’re looking forward to communicating with adult smokers the additional benefits of switching to IQOS. We’re excited to get back on track with our IQOS rollout and our future expansion plans to accelerate adult smoker conversion,” he said. “As many parts of the country began lifting restrictions in June, PM USA reopened the Atlanta and Richmond IQOS boutiques and just last week launched IQOS in its third lead market by opening a boutique in the SouthPark mall in Charlotte.”

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    Over the next 18 months, PM USA plans to launch IQOS in four new markets with large adult smoker populations and expand the availability of IQOS devices through retail partnerships, explained Gifford. PM USA also plans to expand its HeatStick distribution to the surrounding geographies in all seven IQOS markets. He said the commercialization approach for IQOS is designed to maximize the organic growth potential of the device by focusing first on the densely populated metro areas and then expanding outward as the user base grows.

    “In Charlotte, PM USA launched a more disruptive retail fixture that communicates the benefits of real tobacco, no ash and less odor and expects to begin HeatStick distribution to retail stores in the next few weeks. By the end of August, we expect HeatSticks to be in a total of 700 retail stores across the three lead markets,” he said. “PM USA will continue to leverage its IQOS retail ecosystem, including IQOS mobile, pop-up and kiosk retail formats, which allows for more strategic and agile marketing plans. We’re making several digital enhancements to the IQOS website too.”

    The IQOS website now includes virtual tutorials, and a new expert video chat functionality will be available this fall, according to Gifford. These digital enhancements and “the ability to have devices delivered to smokers in lead markets with the proper age verification” will provide smokers with a variety of options to “learn about and access IQOS,” said Gifford, adding that PM USA expects to use its “first-mover advantage” to expand IQOS responsibly.

    “Our commercialization strategy is based on the learnings from our IQOS lead markets and PMI’s international results paired with our desire to continue avoiding use by unintended audiences. We believe that a sustained focus on the consumer journey from awareness to conversion is the key to achieving our vision,” Gifford said. “Word of mouth among IQOS users and their fellow adult smokers has been a critical factor to the global success of IQOS.”

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  • A Journey, Not a Destination

    A Journey, Not a Destination

    Photo: BNS

    Navigating successful post-market requirements for ENDS products

    By Yvonne Wilding

    This month marks the deadline for submitting premarket tobacco applications to the U.S. Food and Drug Administration (FDA). Many organizations have worked diligently to ensure their submissions are as complete and robust as possible. Their goal is to ensure that they are sufficiently complete to allow acceptance for filing and, following substantive review, that the product may be granted a market order by the FDA, allowing it be sold in the United States. By early September, hundreds of PMTAs for electronic nicotine-delivery systems (ENDS) had been submitted to the FDA, and a number are currently undergoing substantive review.

    However, in this article I will remind applicants that their obligations do not stop at PMTA approval but persist for the entire life cycle of the product in market—and products can be removed from market potentially more easily than they can be brought to it.

    During its PMTA review, the FDA extensively evaluates the provided experimental data to make a risk-benefit assessment of the new product and ascertain its suitability to be designated as “appropriate for the protection of public health” (APPH).

    This includes scrutinization of the quality and compliance aspects of the manufacturing processes and review of extensive research information generated on the specific product to allow the FDA to evaluate any potential public health risks associated with the product. The research aspects are compiled by the applicant into different modules of the eTobacco Technical Dossier and include chemistry and manufacturing, toxicology risk assessment and clinical and human experience evidence.

    There will be a series of investigations in human volunteers to look at the pharmacokinetics (PK) of the product and its delivery of nicotine compared to comparator products. The PK profile of a product has the potential to affect the abuse potential—i.e., how easily someone may become addicted to nicotine. In addition, there will typically be several human behavior studies to check that the users can operate the device safely and effectively and to assess their preference for this product against competing products. Additionally, there is a significant amount of research done in never-smokers to ascertain how likely they are to start smoking with this product. The numbers of volunteers in the studies are often very large and care is taken to look not only at a representative U.S. population from their demographics but also to incorporate a significant number of young adults in order to be able to make extrapolations to a youth (11–18 years of age) population.

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    The research data provided to the FDA also includes extensive data on the performance of the device in laboratory-controlled conditions and its delivery of nicotine in each puff under different device settings and different coil components. Stability of the product on storage and extractables and leachables are measured, and quantitative data on the discharge of harmful and potentially harmful constituents (HPHCs)—a list of 33 chemicals of most toxicological concern detailed in the FDA guidelines) is collected. The toxicology and the chemistry data are linked to consumer behavior information and topography data to indicate how a consumer will use the product, enabling the estimation of the likely exposure to potentially hazardous aerosolized constituents and hereby the risk-benefit of this new product can be ascertained.

    Assessing the actual product though, is only part of the information required. The product must also be assessed for risk-benefit alongside data from existing relevant tobacco-containing products, much of which is obtained from scientific publications. These comparator products would typically be combustible cigarettes or similarly performing ENDS. It would be wrong to assume that ENDS are without risk, but in a PMTA, the risk relative to other comparator products, e.g., combustible cigarettes, is described. Based on this assessment of these actual and relative risk estimates, the FDA will decide on whether the product is APPH. This approval process can be considered the first step of the journey.

    There are several regulatory documents published by the FDA Center for Tobacco Products (CTP). These include Guidance for Industry and Proposed Rule, both of which have sections on post-marketing requirements, although most detail is provided in the Proposed Rule (Federal Register Vol. 84, No. 186, 25 Sep. 2019, Subpart D – Postmarket Requirements section, $1,114.39–$1,114.41).

    Having been granted a market order from the FDA, there is an explicit ongoing commitment for each approved SKU to collect and provide information and submit it for regulatory review. Following each review, the FDA will consider whether it is appropriate that the product is maintained in market. Reasons why the FDA may decide to remove a product from market could include any of the following: the product is no longer considered to be APPH; there is inaccurate representation of factual data, the applicant has not set up a system for maintaining records and/or fails to make appropriate records and submit reports.

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    The post-marketing updates required by the FDA can be put into three main categories: changes to manufacturing processes and controls; changes to the health risks associated with the product; and sales, distribution and marketing information.

    Periodic reports need to be submitted to CTP within 60 calendar days of the reporting dates which will be specified in the applicant’s marketing order and must include the following:

    Manufacturing and processes

    • A description of changes to the manufacturing, facilities or controls during the reporting period
    • An explanation of why the changes were made and why these change do not result in the generation of a new tobacco product that is different from the one for which the original order was granted

    Health risks

    • An inventory of ongoing and completed studies by or on behalf of the applicant that have not previously been reported
    • Full reports of information published or known, or which should be reasonably known, to the applicant concerning scientific investigations and literature about the tobacco product that have not been previously reported
    • Significant findings from publications not previously reported
    • A summary and analysis of all serious and unexpected adverse experiences reported to the applicant or that the applicant is aware of
    • A statement of any changes to the overall risk associated with the product and a summary of the health risks, including the nature and frequency of the adverse experience and potential risk factors

    Sales, marketing and distribution

    A summary of sales and distribution of the tobacco product for the reporting period to include:

    • Total U.S. sales and demographic characteristics of purchaser
    • Specimens of labelling and detail of any changes
    • Full-color copies of all advertising material used with dates of dissemination
    • A description of advertising and marketing plans
    • Actions taken to restrict youth access and limit youth exposure to labelling, advertising or promotion
    • Use of social media
    • Use of partners, influencers or bloggers
    • An assessment of the impressions left by advertising and audience demographics

    In addition to the above categories, there is also a requirement to provide any additional information specified or any additional requests under the terms of the marketing order and an overall assessment of how the product continues to be APPH.

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    As well as the requirement for regular submission of post-marketing reports, if there are any serious and unexpected adverse events reported to the applicant, these must be reported to CTP’s Office of Science via the Health and Human Services Safety Reporting Portal within 15 days of the applicant having received the report.

    There are strong concerns among the public, health policy makers and government that the potential health benefits of switching smokers from combustible cigarettes to a less harmful way of accessing nicotine may be dramatically offset by young nonsmokers being attracted to vapor devices and through use of these devices drive an increase in nicotine addiction in youth. Smoking volumes of combustible cigarettes have been falling for many years across the world, which will ultimately lead to significant improvements in health, although the evidence will take several years to become apparent. Understandably, there is much enthusiasm that the scourge of tobacco smoking-related diseases may be, if not eliminated, significantly reduced in future generations.

    It is in the interest of consumers who may wish to move to a safer form of nicotine intake that PMTA applicants are fully compliant with the post-marketing requirements and continue to work with the FDA and lobbyists to contribute to and maintain an appropriate balance of risk reduction and health benefit realization. If these products, stated to be APPH, are no longer available to consumers, then the consumers’ opportunity to potentially improve their long-term health outlook is diminished.

    Many of the larger companies manufacturing ENDS products may have specific regulatory compliance staff and sales and marketing departments that are fully trained, equipped and resourced to deal with the FDA requirements, but for the smaller organizations, without such infrastructure, this resource requirement, skill set, potential complexity and the associated costs, particularly if the organization has a large number of SKUs, can be particularly onerous.

    The cost and resource requirements of maintaining established products in market has been recognized in the pharmaceutical industry for a very long time. As pharma companies typically prefer to invest in novel medicine development or in the enhancement of existing medicines to provide patent life extensions, some older, established products are still very successful and so the maintenance of the post-marketing requirements of these products from a regulatory and pharmacovigilance perspective is often outsourced to specialist contract research organizations (CROs) who collect and report this data on behalf of the pharma companies. These CROs can provide the necessary resources, expertise and experience to make this a cost-effective solution.

    It will be interesting to see how many ENDS products are successful in receiving a positive market order decision from the FDA only to be subsequently removed from the market as they fail to satisfy their post-market approval requirements, causing these products to be potentially as ephemeral as the aerosols they disperse.

     

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  • Damage Done

    Damage Done

    Photo: Stefan Malloch | Dreamstime.com

    Even as last year’s EVALI crisis has abated, the misperceptions it created about vaping persist.

    By Stefanie Rossel

    Roughly a year ago, a mysterious lung illness struck thousands of U.S. vapers. Emergency room visits increased from July 2019 and peaked in September before ebbing off. By Feb. 18, 2020, 68 people had died from complications of the lung disease, which was quickly termed EVALI—“e-cigarette, or vaping, product use associated lung injury.”

    However, EVALI turned out to be a misnomer, and the mystery surrounding vaping illness was quickly resolved—although some experts took longer to recognize the obvious than others. As the Centers for Disease Control (CDC) eventually acknowledged, illegal THC-containing vapor cartridges, also known as carts, were the true cause of the vaping-related illness. They contained a new thickening agent, vitamin E acetate oil, that was used as a diluent for tetrahydrocannabinol (THC), the psychoactive substance in marijuana. By destroying the surfactant, vitamin E acetate oil prevents the lungs from working properly. In addition, when heated, the agent can form a toxin that affects the respiratory tract.

    Tony Abboud

    “It is important to note that vitamin E acetate, a component found in illegal black market THC cartridges, was identified by the CDC as a primary cause of EVALI—and not nicotine vapor, contrary to what was portrayed by the media,” stresses Tony Abboud, executive director of the Vapor Technology Association (VTA). “Industry standard FDA-regulated nicotine-containing vapor products were not involved, much less to blame for cases of lung illnesses in September of 2019.”

    Professor Michael B. Siegel from the Boston University School of Public Health was one of the first to hint at the fact that bootlegged e-liquids containing THC were likely to be the origin of the vaping-related illnesses and deaths. One year after the height of the crisis, he says, EVALI is no longer an issue. “Shortly before we all got distracted by Covid-19, we were already seeing a dramatic decline in EVALI cases. At this point, the outbreak seems to be over. Apparently, the use of vitamin E acetate oil as a thickening agent in THC vape cartridges has been discontinued and by now the remaining carts in the supply chain have been through the life cycle, so the problem is essentially over.”

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    Long-term impact

    But while the illness may have gone away, the impact of the way in which U.S. health authorities handled the crisis lingers on. From September 2019, the two U.S. leading health authorities, the Food and Drug Administration (FDA) and the CDC, issued contradicting advice. The FDA warned against vaping THC purchased from informal sources. The CDC, by contrast, didn’t publicly single out illegal THC liquids as the probable cause of EVALI until November 2019 and continued to caution against vaping all e-cigarettes until January 2020. There has been no official rehabilitation of the legal vapor business, and the sector continues to suffer from an underserved blemish.

    “Unfortunately, and quite sadly, the discovery and confirmation that vitamin E acetate oil thickener was the cause of EVALI has had virtually no impact on the communications that are coming from most state health officials and local health agencies and organizations,” says Siegel. “Very few, if any, state health departments put updates on their websites notifying consumers that the problem was discovered and that THC carts, not e-cigarettes, were found to be the problem. Massachusetts is a great example. The Massachusetts Department of Public Health—to this day—maintains the position that we have no idea what caused the outbreak. It has not corrected its errant and premature conclusion that this was due to e-cigarettes. And it has not issued a clear statement clarifying that the cause was THC vape carts. The majority of the public still believes that e-cigarettes were causing EVALI and have no idea that it was THC vape products.”

    This misperception continues to plague the sector today. “The vape market has been under near-constant attack from organizations that fail to recognize the extensive body of science that points to black market THC being the source of the EVALI lung disease,” says Abboud. “Both the FDA and CDC have come to this same conclusion. The damage to the public consciousness that this false narrative perpetuated has caused states to move towards banning some or all nicotine e-cigarettes. Also, some state officials have improperly used the EVALI issue to claim that certain flavored nicotine vapor products should be banned even though there was zero association between flavors and any EVALI case. These actions have had a negative impact on the vapor market and have scared adults back to smoking. Not only does this harm the health and well-being of consumers, but it also has devastating economic impacts.”

    An excuse to crack down

    Michael B. Siegel headshot
    Michael Siegel

    In the wake of the EVALI outbreak, several states and cities have proposed or enacted e-cigarette and flavored e-liquid bans. “Once again, knowledge of the true cause of the EVALI outbreak had no effect in changing public policy,” says Siegel. “All of the states that enacted emergency bans on e-cigarettes or flavored e-cigarettes because they suspected these products were involved continued to implement these bans after it became clear that e-cigarettes played no role. It is as if the science doesn’t matter at all and policymakers simply enact the policies they want regardless of what the science shows or the actual health impact will be.”

    According to Abboud, states continue to create arbitrary and misguided measures to ban flavors for vapor products without addressing marketing issues. “For example, New York left all flavored combustible products on shelves while going after flavored vapor products even though the New York State Department of Health did not find any presence of vitamin E acetate in the nicotine products they tested,” he says. “Opponents of vaping have seized on the EVALI crisis to redouble their efforts to ban flavors despite there being no logical, much less scientific, connection between EVALI and flavors.” Abboud is convinced last summer’s crisis has set off a dangerous chain reaction of policy decisions and regulations that will do more harm than good as they too are focused on the wrong issues.

    Inaccurate or incomplete press reports have contributed considerably to the public’s misperceptions and not just in the U.S., according to an independent analysis of media coverage before, during and after the EVALI outbreak, commissioned by the Foundation for a Smoke-Free World (FSFW).

    The study found that THC vaping and nicotine vaping, which involve different devices, liquids, supply chains and consumers, were consistently confused by the evaluated media, which focused primarily on nicotine vaping and nicotine. Consequently, people who vaped THC during the EVALI outbreak were not alerted to the potentially life-threatening dangers of illicit, tainted versions of these products. What’s more, U.S. adult misunderstanding increased between September 2019 and January 2020. The share of people who believed THC vaping was the cause of EVALI decreased from 34 percent to 28 percent while the share who believed that nicotine vaping was the cause rose from 58 percent to 66 percent. This development, the analysists said, came on top of numerous surveys showing that public misunderstanding of nicotine itself is widespread, potentially discouraging smokers from using nicotine patches, gum and other replacement therapies to quit smoking.

    Similar trends were observed in other countries, none of which experienced EVALI cases. Among other countries, the FSFW study looked at EVALI news coverage in the U.K., where the country’s health agency, Public Health England (PHE), had stated as early as 2015 that vaping nicotine is at least 95 percent safer than smoking combustible cigarettes. Nevertheless, an increasing number of articles sounded alarms about nicotine vaping in the latter half of 2019. Even though U.K. health authorities repeatedly reiterated PHE’s findings, more than a third of smokers in the U.K. believed that e-cigarettes were equally or more harmful than combustible tobacco, according to a March 2020 report in The Independent.

    Return to combustibles

    EVALI had a devastating effect not only on the vapor industry but also on the concept of tobacco harm reduction. “The preliminary analyses I have seen suggest that there were substantial losses in the e-cigarette category and significant gains in the combustible market,” says Siegel. “I have not yet seen a comprehensive analysis but am currently working on conducting such an analysis myself using bar code sales data. My hypothesis is that the combination of the EVALI scare, the flavored e-cigarette bans and Covid-19 led to increases in cigarette consumption with a concomitant decline in e-cigarette use. I should have an answer late this fall. If confirmed, this would represent a tremendous blow to the concept of harm reduction.”

    The fact that the EVALI outbreak remained a U.S. phenomenon has often been put down to the fact that other countries have long introduced strict regulation for vapor products. The European Union, for instance, regulates e-cigarettes through its revised Tobacco Products Directive (TPD2), which came into force in May 2016. Article 20 lays down minimum safety and quality standards for vapor products and refill containers. Among other things, the law restricts the amount of nicotine in e-liquids to 20 milligrams per milliliter. The high nicotine levels in some U.S. products have likely contributed to the rapid spread of youth vaping in the U.S. The EU directive also prohibits the use of ingredients such as taurine, colorings and caffeine in e-liquids. THC liquids, meanwhile, are hard to find in Europe.

    The U.S. too is moving toward a more regulated market. By Sept. 9, all companies that want their novel nicotine products to remain in the market will have to submit a premarket tobacco product application (PMTA) to the FDA. “These applications will give [the] FDA the opportunity to examine all of the science regarding vaping and, most importantly, the science specific to the products for which applications are filed,” says Abboud. “This means [the] FDA will be making its determination on each application of whether the product is ‘appropriate for the protection of public health.’ These determinations will go a long way to finally dispelling the false narrative perpetuated about vaping.”

    For Siegel, the PMTA pathway is no solution, however. “The great irony is that the PMTA approach does nothing to directly address the possibility of another EVALI [crisis] occurring and actually makes it more likely that something similar could recur,” he says. “The major effect of the enforcement of this deadline will be the decimation of the e-cigarette market, with all of the small companies and most vape shops disappearing and the market being shifted largely over to the big companies with a strong retail—convenience store—presence. What this means is there is going to be an expanding market for both DIY [do-it-yourself] and black market products, especially flavored e-liquids. While many suppliers are trustworthy, there are always those who are going to get into the business solely to make money, and those are the ones I worry about. They may take shortcuts. And ironically, this massive black market and DIY market will not be regulated.”

    Science against misperceptions

    Meanwhile, some scientific sources, such as the Harvard Health Blog in April 2020, have used EVALI as a springboard to suggest that there are “other causes for concern” in vapor products, such as humectants, flavoring agents, heating ingredients or the risk of heavy metal inhalation due to repeated use of refillable cartridges.

    “In low-quality products with poor manufacturing standards and poor quality assurance measures, there are causes for concern, including certain flavoring agents, overheating of the e-liquid and potential heavy metal exposure,” Siegel acknowledges. “Sadly, instead of focusing on implementing a set of safety testing and standards that would get these products off the market and ensure the maximal safety of the vaping product supply, the FDA has been wasting its time focusing on getting rid of cherry vapes and soon will be decimating the entire market. I believe that instead of the ridiculous PMTA requirements, the FDA should simply promulgate safety regulations for e-cigarettes and vaping products. They should have done this back in 2011 when the American E-Liquids Manufacturing Standards Association (AEMSA) had actually drafted a set of standards that I thought were a good basis for regulation.”

    Abboud points to a 2018 report by the U.S. National Academies of Science, Engineering and Medicine (NASEM), which concluded that there was “no available evidence whether or not e-cigarettes cause respiratory diseases in humans.”

    “The report even concluded that switching from traditional smoking to vapor products would reduce harmful health effects,” he says. “For those concerned about the short-term implications of vaping, NASEM also concluded that vaping instead of smoking creates improved health benefits for the respiratory and cardiovascular systems. Most importantly, the FDA is currently reviewing PMTA applications which contain all the relevant science related to specific products that will remain on the market. ‘Other causes of concern’ will be sorted out by the FDA’s team of scientists and, as of this date, no one has rationally claimed that vaping is not a safer alternative to smoking cigarettes.”

  • Philter of the Future

    Philter of the Future

    The Philter Labs Phlip
    The Philter Labs Pocket

    Philter Labs has developed portable systems to eliminate secondhand smoke and vapor.

    By Marissa Dean

    For years, public health officials have warned that secondhand smoke is just as dangerous as smoking, if not more so, and more recently, elusive “thirdhand” smoke—the residual nicotine and other chemicals left on indoor surfaces by tobacco smoke—has been a topic of concern. And with the creation of vapes came the controversy of how harmful exhaled vapor may be, especially with the current pandemic at hand.  

    With all that in mind, Philter Labs, a technology company in San Diego, California, USA, created two products—one that eliminates secondhand smoke from cigarettes and secondhand vapor from vaporizers and another that removes secondhand vapor from pen and stick vapor products.

    Philter Labs was co-founded in 2014 by Christos Nicolaidis, a veteran entrepreneur and CEO of Philter Labs, and John Grimm and Yuval Shenkel, product engineers with decades of experience designing innovative medical components for Fortune 500 companies. After seeing how vaporizers were changing the way people consumed nicotine, they wanted to find a way to get rid not only of traditional secondhand smoke but also of secondhand vapor.

    The company’s goal, according to its website, is to allow “adult vapers and nonvapers to socially coexist … while eliminating secondhand smoke and protecting their personal right to vape or smoke.” A bonus comes in the form of environmentally friendly clean air, void of the pollutants that are found in secondhand smoke and vapor.

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    As people have become more health-conscious, concern about secondhand smoke and vapor has increased accordingly. “Our surveys have found that 67 percent of people who smoke and vape are concerned with secondhand smoke [and vapor] and how it affects the environment around them,” writes Nicolaidis. This shift toward more responsible vaping and smoking has led to a higher demand for Philter’s environmentally conscious filter technology, leading to a sales increase for the company and a more than 20 percent customer return rate. Naturally, the Covid-19 outbreak has affected this as well—many users are looking for ways to continue to vape without putting those around them at risk. It’s still unclear exactly how vaping and smoking aid in the spread of the virus, but it has been suggested that vapor and smoke clouds can suspend the virus in the air and spread it to others. Using Philter devices would help prevent this.

    When asked in an email exchange how Philter’s technology works, Nicolaidis said, “It’s important to first point out that our products are designed to preserve users’ normal smoking or vaping experience, so we never interfere with the inhale. But upon exhale, the user has the option to blow their smoke back into our Philter instead of the air. Inside the Philter, a proprietary combination of filtration mediums and airflow algorithms work together to capture 97 percent of airborne particulates, pollutants and VOCs [volatile organic compounds] down to a particulate size about 30 times smaller than the width of a human hair.” The products do not capture the smoke emitted by the lit ends of combustibles, however.

    “Our Philter is the first in the nanofiltration space for vaping that has been validated as EN 1822 HEPA compliant by a globally recognized independent particulate testing laboratory,” Nicolaidis added.

    Philter products, made for use with tobacco, cannabis and CBD, differ from existing solutions in three ways, according to Nicolaidis. The first notable difference is that Philter products do not simply mask secondhand smoke and vapor—they capture it and eliminate the harmful elements. Philter’s science-based filtration processes have been granted three utility patents with several others pending.

    The second difference is in size. Nicolaidis describes Philter products as “small, discrete and sophisticated” while stating that most other products are “oversized and impractical to carry.” The two products promoted on the company’s website—which are available for purchase online, on Amazon or at a variety of brick-and-mortar stores throughout North America—the Pocket and the Phlip, offer users options for carrying their products; the Phlip works in coordination with pen and stick vapor products, allowing users to carry one product. The vapor product inserts into the allotted space on the filter, and users inhale from the vape then flip the device around to exhale into the filter. The Pocket, on the other hand, requires users to carry two devices, but it can be used with combustibles as well as vapor products. Instead of inserting the device or combustible into the Pocket, users exhale into the Pocket after inhaling from their vape or combustible as normal. The Pocket captures the secondhand smoke or vapor rather than it being released into the air. Each filter is good for 150 exhales. While both products require you to carry an additional piece, neither is much bigger than the products they are used in conjunction with.

    The third difference focuses on brand marketing. “Our brand messaging is positive and inspirational,” Nicolaidis writes. “Philter use provides an opportunity for people who vape and people who don’t to safely share the same space without the fear or stigma of secondhand smoke. It’s truly a win-win for everyone involved.”

    The goal of keeping the products small and efficient created a few hurdles in development; it took more than four years and 20 prototypes before Philter Labs created a version that was ready for commercialization. The chief technology officer used his experience working on cardiac and spine-related medical devices to help create a miniature microfiltration system “roughly the size of a tube of lipstick.” Engineers also had to consider airflow and exhale to make them feel as natural as possible, realizing each user’s physiology and exhale capacity is different. 

    The company is also working on new technology: “The ‘Moonshot’ for our industry would be a device that captures and eliminates all smoke [including that emitted by the lit end] from a traditional cigarette. While we can’t divulge any details at this time, I can say that Philter’s brilliant minds are hard at work on a Moonshot product, and we expect liftoff in late 2021.” On top of that, Nicolaidis notes that the company is “about to announce a new cutting-edge product that will allow for widespread adoption of [Philter’s] patented filtration technology. It’s a product that’s been in the works for several years and will bring accessibility, ease of use and a high-quality experience to consumers. This is not only a game-changer with respect to the future of vaping and the opportunity to finally begin normalizing vape use in public settings but will also have a positive impact with regard to public policy and how political leaders can offer a solution that protects individuals’ rights while preserving the freedom of people who do not vape or smoke in virtually ‘any’ setting.” Helping to move these projects forward is a recent $1 million funding investment to support corporate growth, which includes new product launches and research and development. In 2018 and 2019, the company also received $2 million in seed financing from Bravos Capital, Explorer Equity and a global Private Equity Fund.  

    The future of filters is changing, and Philter Labs seems to be at the forefront of innovation. Time will tell how its technology will change the vapor industry and the public health landscape—one day soon those clouds of cigarette smoke and vapor may be problems of the past.

    Beyond technology

    Philter Labs’ work doesn’t stop with its nanofiltration technology. The company recently launched an advocacy division, the Philter Project, to help improve communities throughout the U.S. and abroad. Funds have gone toward planting trees in the Amazon through the One Tree Planted initiative, providing veterans suffering from PTSD with Philter Phlips and supporting cannabis-related criminal justice reforms through the Last Prisoner Project.

  • Swisher International Becomes Swisher

    Swisher International Becomes Swisher

    Photo: Swisher

    Swisher International will change its corporate identity to Swisher, signifying the expansion of Swisher’s vision, offerings and focus on adult consumer lifestyle.

    “While Swisher has always been anchored around its loyal adult consumers, partners and employees, the company is working to build a bold future centered on creativity and innovation,” the company wrote in a press note.

    John Miller

    “We have truly seen an evolution in the tastes of adult consumers, including the preference for lifestyle products within the tobacco category and beyond,” said John Miller, president of Swisher. “We are poised to explore and innovate in new categories while also preserving the legacies and strengths of our existing product portfolios.”

    Best known for its Swisher Sweets cigars and classic tobacco brands such as Optimo, Goodies, King Edward and Mail Pouch, Swisher has in recent years expanded its offerings with Drew Estate’s premium cigars, Hempire hemp rolling papers and Rogue’s portfolio of nicotine-on-demand products.

    This strategic approach expands Swisher’s capability to address shifting adult consumer preferences while continuing to focus on success in its core businesses, according to the company.

    “Swisher’s five strategic businesses—Swisher Sweets Cigar Company (Large & Little/Filtered Cigars); Fat Lip Brands (Smokeless); Drew Estate (Premium Cigars); Hempire (Hemp Products); and Rogue Holdings (Modern Oral Nicotine)—provide category expertise, product knowledge and a focused approach under a renewed purpose for the company,” the company stated.