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  • On the road

    Will Europe lead the vape space?

    By Norm Bour

    As of Aug. 8, 2016, the business of vaping in the United States became even more volatile and unpredictable. The U.S. Food and Drug Administration’s (FDA) deeming regulations mandated that any vapor products not on the market by that date would be required to undergo an expensive premarket tobacco authorization process.

    The cost could be more than $1 million dollars per SKU, which caused a rush to get all “new” products on the market under the wire. And there would be no guarantee of approval.

    Meanwhile, the EU implemented its revised Tobacco Products Directive (TPD2). Compared with the FDA restrictions, the TPD2 requirements are light. This begs the question: Is now the time to enter and expand into the European market? If you are a vapor professional with the potential to work internationally, your time may be at hand.

    I spoke at three VapExpo events in Europe over a two-month period and visited the largest e-liquid manufacturer in Ireland. Sharing a stage in Amsterdam, Prague and Warsaw, Poland, was eye-opening and led me to believe that the European market may be leading the vape space over the next few years.

    Differences and similarities

    The FDA guidelines cover all products manufactured and sold within the United States. That makes it easy to administer, monitor and enforce. In Europe, Asia and the Baltic nations, they have a patchwork of regulations that are generally more lenient than those of the FDA.

    On one hand, the TPD2 restrictions are easier to comply with, but on the flip side, many countries are now restricting online sales. As of this writing, online sales are banned in Portugal, Spain, Belgium, Italy, Austria, Slovenia, Croatia, Hungary, Poland, Romania, Bulgaria, Greece, Lithuania, Latvia, Estonia and Finland. The TPD2 restrictions include reducing mod tank sizes to 2mL and limiting nicotine strength to 20 mg/mL. Maximum bottle sizes for liquids are now 10mL. Most of the requirements are straightforward and not cost-prohibitive.

    Lessons learned

    VapExpo is a Russian-based events promotion company. It is new to the vaping scene but has been aggressively promoting shows in Russia, Ukraine, the Czech Republic, Poland and the Netherlands.

    Several events have been held in England (London and Birmingham), and they garnered massive crowds. Across the channel, France recently hosted two events over a two-week stretch, and Paris is proving to be a major hub. And China? Though their products have a worldwide reach, only choice companies and visitors have attended shows there. These events are immense and tend to showcase the Shenzhen hardware industry.

    Last year there were events in several smaller countries. This year, there will be shows in Latvia and Austria, among other places.

    The VapExpo teams in their targeted cities are learning valuable lessons. In Amsterdam, what was intended to be a major show turned out to be a private symposium with an impressive speaker list and about 50 attendees. Speakers included Ray Story, founder of the Tobacco Vapor Electronic Cigarette Association; Gregory Conley of the American Vaping Association; Ron Tully of Next Generation Labs; and Chris Dodge, secretary and founder of the Global Vaping Association. The attendees were mostly Europeans, along with a few Americans.

    Michael Young, the manager of two Vape Emporium locations in London, described how liquid manufacturing in England had changed since the United Kingdom voted to leave the EU earlier this year. “This turn of events has opened up new opportunities,” he said. “Many companies that were making juice in England may now consider going outside the country so they can still be part of the EU. Our advantages of being under one umbrella with the EU just went away, so now we’d be considered a foreign country for trade purposes.”

    The Amsterdam show had to be modified because the Dutch Ministry of Economic Affairs indicated that the event, as planned, could potentially violate the law. The Dutch tobacco advertising law prohibits events that draw nonprofessionals—i.e., the public. Instead of a vape fest with loud music and big clouds, it became a private, small and professionally run show.

    VapExpo’s Prague gathering attracted a small number of exhibitors and several hundred attendees over two days. It was heavily skewed toward Eastern Europe. The event featured a great selection of speakers, and the information shared was revealing. While vapor products are currently more expensive than tobacco products in Russia and other eastern European markets, they hold considerable potential, given the comparatively large smoking populations in those countries.

    VaporApe e-liquids from Canada had come to Prague to investigate the potential in Europe. As a manufacturer and distributor it had decided that business outside Canada was worth pursuing, but it was fearful of the U.S. market. “We think that Canadian juice will be popular in Europe,” said company founder Richard Ziske. “[European consumers] seem to like everything unique and unusual, so we fit into that.” Ziske believes that European juice differs from U.S. and Canadian products. “Most of their manufacturing quality is good, but their taste is not quite the same,” he said.

    Alexander Zakharov from Vape Russia shared his experience in the Russian market. “Since we are not part of the EU, we hold a unique position,” he said. “We create products that conform to TPD standards, but yet we can sell to non-EU countries and not have our hands tied.”

    We are one vaping world now. What started in the U.S. is now a multibillion-dollar global market and continues to be full of risks. The European market may have more potential and less downside than the U.S. market. Unless the FDA regulations change, it is possible that the vast majority of vapor businesses today will not be able to play in the U.S. There are potential solutions in the form of lawsuits, while H.R. 2058 and the Cole-Bishop amendment may come to the industry’s aid.

    Compared to the new FDA deeming regulations, the TPD seems easier to work with. Who knows how many businesses will be around in the next 12–24 months? Those who survive will do things right, investing money and resources while remaining receptive to new concepts and realities.

     

    Norm Bour is the founder of VapeMentors and creator of the VAPE U online programs. VapeMentors offers services and resources for anyone in the vape space, including vape shops, online stores and e-liquid brands. Bour is also the host of Vape Radio, the world’s largest vapor radio show, with more than 1.3 million downloads. Bour can be reached at norm@vapementors.com.

     

  • GTNF agenda published

    GTNF agenda published

    The Global Tobacco & Nicotine Forum has published the agenda for its upcoming gathering in Brussels.

    Scheduled for Sept. 27-29, the event promises to be the most exciting GTNF yet.

    Click here to view the agenda.

  • Health groups support challenge to deeming rule

    Health groups support challenge to deeming rule

    TechFreedom and the National Center for Public Policy Research have filed an amicus brief in support of Nicopure Labs’ challenge to the U.S. Food and Drug Administration’s (FDA) new regulation of e-cigarettes.

    In May, the FDA finalized its “deeming rule” regulations, which would force e-cigarette manufacturers to undergo an expensive and time-consuming premarket tobacco application process unless their products were on the market—or substantially equivalent to a product on the market—prior to the predicate date of Feb. 15, 2007, long before modern e-cigarettes were introduced.

    The high cost of the application process means most e-cigarette businesses will be forced to shut down, eliminating choices of dramatically safer alternatives to combustible cigarettes, which will leave smokers with fewer options to compete against the most harmful form of nicotine consumption, combustible tobacco.

    The brief concludes:

    The FDA’s Deeming Rule fails to consider the scientific evidence readily available to the agency regarding the safety and the public health benefits of e-cigarettes. The deeming rule is improper under the APA not merely because it fails any manner of scientific analysis, and is therefore arbitrary and capricious, but also because it is in direct conflict with Congress’s intent to prevent smoking and aid cessation through the [Family Smoking Prevention and Tobacco Control] Act.

    “E-cig technology has grown by leaps and bounds since the FDA’s arbitrary predicate date in 2007,” said Evan Swarztrauber, communications director at TechFreedom.

    “Setting a standard using technology from nearly a decade ago is absurd and highly stifling to innovation. The FDA should issue evidence-based regulations that address legitimate safety concerns without hindering products that improve consumer health by providing a less harmful alternative, rather than implementing a ‘Mother, may I innovate?’ approach that’s become all too common among regulatory agencies.”

    “Instead of developing science-based standards which would reduce harm, the FDA directly admitted it didn’t understand or evaluate the potential benefits or harms of e-cigarettes,” said Jeff Stier, senior fellow at the National Center for Public Policy Research. “Without that science, it relied on the ‘precautionary principle’ standard, in direct conflict with the evidence-based standard required by Congress.”

    “Regulations should be promulgated within the constraints of the rule of law, sound policy, and proportionality,” said Daniel Suraci, an attorney working pro bono on behalf of the National Center for Public Policy Research. “The FDA’s heavy-handed approach to e-cigarettes is an affront to smart governance as the regulations are in direct contradiction of the scientific evidence showing the public health benefits of vaping, and push the public back to cancer causing tobacco products.”

  • Mounting evidence

    Mounting evidence

    It’s getting harder to dispute the contribution of vapor products to smoking cessation.

    By Emma Dorey

    Evidence that e-cigarettes greatly benefit public health continues to mount. A raft of recent research findings show that e-cigarettes are effective at helping people quit smoking or reduce consumption—and are mostly used for this purpose—crushing the claims widely peddled by the anti-vaping lobby that e-cigarette use encourages smoking and is just as hazardous.

    In-depth analysis of smoking and e-cigarette use across all 28 EU member states has revealed that e-cigarettes have helped more than 6 million people quit smoking and more than 9 million reduce how much they smoke—the highest rates seen in a population study. Scientists analyzed responses from some 27,460 people aged over 15 years in the Eurobarometer survey, which provided detailed information about patterns of smoking and e-cigarette use, differentiating between experimentation and regular use, current and past use, and nicotine versus non-nicotine. They found that among the 7.5 million current users of e-cigarettes, 35.1 percent have quit smoking while an additional 32.2 percent have reduced smoking consumption (Addiction, June 2016).

    “These are probably the highest rates of smoking cessation and reduction ever observed in such a large population study,” said Konstantinos Farsalinos, the principal investigator of the study and a researcher at the Onassis Cardiac Surgery Center in Athens, Greece.

    Thought to be one of the most detailed ever used in analyzing e-cigarette use on a population level, the Eurobarometer data also demonstrated that e-cigarette use is largely confined to current and former smokers; although some nonsmokers experiment with e-cigarettes, regular use is rare. “Just 1.3 percent of nonsmokers reported current use of nicotine-containing e-cigarettes and 0.09 percent reported daily use,” said Jacques le Houezec, a neuroscientist at the French National Institute of Health and Medical Research who was also involved in the study. “Practically, there is no current or regular use of nicotine-containing e-cigarettes by nonsmokers, so the concern that electronic cigarettes can be a gateway to smoking is largely rejected by our findings.”

    “Our study shows that e-cigarettes seem to have a beneficial role for the EU population, mainly because of the substantial proportion of smoking cessation and reduction and because of extremely minimal use by never-smokers,” says Farsalinos. “Moreover, there is no initiation with e-cigarettes; thus the gateway to smoking theory cannot be substantiated.”

    These two key findings tally with those from other studies. Researchers at University College London, for example, estimate that the use of e-cigarettes helped 16,000 to 22,000 smokers in England to quit for a year or more (Addiction, March 2016). “E-cigarettes appear to be helping a significant number of smokers to stop who would not have done otherwise—not as many as some e-cigarette enthusiasts claim but a substantial number nonetheless,” said professor Robert West, who led the research team.

    To assess the real-world effectiveness of e-cigarettes when used to aid smoking cessation, West and colleagues conducted a cross-sectional population study using 2014 data from monthly national surveys. Previous research has found that using e-cigarettes increases the chances of quitting success by around 50 percent compared with using no support or one of the traditional nicotine products such as gum or skin patches. This amounts to an additional 16,000–22,000 people stopping who would otherwise have continued smoking, say the researchers.

    Detractors claim that e-cigarettes undermine quitting if smokers use them just to cut down tobacco consumption, and that they act as a gateway into smoking conventional cigarettes, particularly among young people who would otherwise not have tried smoking. “These claims stem from a misunderstanding of what the evidence can tell us at this stage,” said West.

    Indeed, the 2.8 million regular users of e-cigarettes in Britain are almost entirely current and ex-smokers, according to Action on Smoking and Health (ASH), a campaigning public health charity that works to eliminate the harm caused by tobacco. The 47 percent who are ex-smokers are mainly using e-cigarettes to help them quit smoking, while the 51 percent who are current smokers are using e-cigarettes to help them cut down on smoking. Additionally, use among adults and young people who have never smoked is negligible and has not changed since 2012, and there is no evidence in Britain that use of e-cigarettes leads to a takeup of smoking.

    Furthermore, a team with researchers from the U.S., Canada and Australia has shown that, rather than acting as a gateway to smoking, e-cigarettes and other vaping products could actually cut smoking-related deaths in young people by 21 percent.

    The researchers modeled the public-health impact of vapor products in terms of how their availability or absence alters smoking patterns among those who would or would not have otherwise smoked cigarettes. Significantly, the model, which was based on the 1997 birth cohort, focused on young people. It also accounted for possible changes in behavior, such as moving from experimenting to regular use and using both e-cigarettes and tobacco cigarettes. Based on current usage patterns and conservative assumptions, the researchers project a 21 percent reduction in smoking-attributable deaths when vapor products are available, compared to when they are not (Nicotine & Tobacco Research, July 2016).

    “While vaping by youth is a concern, the gateway hypothesis that vapers will become smokers is not as strong a threat as the media has portrayed,” says David Levy, one of the researchers and professor of oncology at Georgetown University.

    This view is consistent with that of the Royal College of Physicians (RCP), which has also concluded that, in the U.K. at least, e-cigarettes are not a gateway to smoking. They are used almost exclusively by smokers who are trying to cut down or quit, and use by nonsmokers is rare. After analyzing the latest available evidence, the RCP concluded that e-cigarette use is likely to lead to attempts to quit smoking that would not otherwise have happened (“Nicotine without smoke: Tobacco harm reduction,” April 2016).

    It is a common misconception that nicotine is the cause of death and disease caused by cigarettes; most of the diseases associated with smoking are actually caused by the smoke formed from the combustion of tobacco. Because e-cigarettes are tobacco-free, they deliver nicotine without the toxicants generated by conventional cigarettes—considerably safer for both smokers and bystanders. If smokers switched from conventional cigarettes to e-cigarettes, millions of lives could be saved—a no-brainer in terms of public health.

    Unfortunately, around 8.7 million people in the U.K. alone still smoke tobacco cigarettes. And even though awareness of e-cigarettes is widespread in Britain, only 15 percent of the public accurately believes that e-cigarettes are a lot less harmful than smoking, according to ASH.

    Although the precise long-term health risks associated with e-cigarette use are unknown, Public Health England has concluded that e-cigarettes are around 95 percent less harmful than conventional cigarettes and have the potential to help smokers quit (“E-cigarettes: An evidence update,” August 2015). The RCP has gone further, stating that, despite not being entirely risk-free, the health risks of e-cigarettes are unlikely to exceed 5 percent of those associated with smoked tobacco products and may well be substantially lower.

    “[The RCP] report lays to rest almost all of the concerns over these products and concludes that, with sensible regulation, e-cigarettes have the potential to make a major contribution towards preventing the premature death, disease and social inequalities in health that smoking currently causes in the U.K.,” said John Britton, chair of the RCP’s Tobacco Advisory Group.

    Yet, because nicotine is derived from tobacco, the U.S. Food and Drug Administration has decided to heavily regulate e-cigarettes and other nicotine-containing vaping devices as tobacco products, imposing what many believe to be unjustified and costly demands on producers that are likely to hamper growth of the industry and, with it, efforts to cut smoking-related deaths.

    In the EU, e-cigarettes are regulated under the Tobacco Products Directive, “a strange collection of arbitrary restrictions and expensive but pointless burdens devised in secret by politicians and officials with minimal transparency or accountability,” according to Clive Bates, former director of ASH and a public health commentator who blogs at The Counterfactual. Any e-cigarettes claiming to help with smoking cessation in the U.K. are regulated as medicinal products by the Medicines and Healthcare products Regulatory Agency.

    “We’ve seen a series of studies painting a clear picture of the beneficial impact of vapor products,” says Bates. “Given the RCP’s estimate that e-cigarettes are unlikely to exceed 5 percent of the risk of smoking and are likely to be substantially less than that, we are witnessing the early stages of a major public health success. And it is driven by technology, consumers and innovators—no taxpayers are harmed and no health care resources are consumed.

    “Governments and regulators just need to allow the process to unfold, without smothering the industry with excessive regulation, bans or misclassifying the products as medicines, most of which has the effect of protecting the cigarette trade and encouraging continued smoking.”

    However, there are a huge variety of e-cigarettes, few of which are properly tested. There is no question that, to properly safeguard consumers and reassure those who are concerned about product quality, standards are needed to regulate manufacturing methods, ingredient disclosure and performance.

    According to the RCP’s Morgan Evans, “The RCP would like to see a nicotine regulatory system that applies controls on products in proportion to their potential harm, to promote innovation and diversity, ensure reasonable levels of protection for consumers and, above all, discourage tobacco use.”

  • Sevia USA joins VTA

    Sevia USA joins VTA

    Sevia USA has joined the Vapor Technology Association (VTA), a leading advocate of the vapor industry in the United States. Created in 2016, Sevia USA is committed to assisting advocacy groups fight the unfair regulation of vapor products as tobacco products, ensure the affordability and accessibility of vapor products as a healthier alternative to tobacco and enforce strict industry standards to guarantee consumer safety.

    Sevia USA’s founding members, who are each vapor industry leaders, include Tony Liu, president and founder of Aspire, Danny Zhu, president and founder of Kangertech, James Li, president and founder of Innokin and Henry Chen, president and founder of Smok.

    These owners, along with the other Sevia members and liquid manufacturers, understand how important it is for their products to remain on the market so that smokers have the choices they need to transition to a less harmful alternative.

    “Sevia USA is uniquely aware of what is at stake if the reckless and irresponsible regulations issued by the Food and Drug Administration are left to stand. Like VTA, we believe in a legislative solution that will preserve our industry while establishing strong industry standards to protect consumers, “said Dimitris Agrafiotis, Sevia USA’s executive director. “VTA has the tools necessary to provide effective advocacy for our industry in the United States, and we are excited to support their efforts.”

    “VTA is committed fighting the irresponsible laws and regulations that threaten to endanger public health while changing the conversation around vapor products.” said Tony Abboud, VTA’s National Legislative Director.

    “As our newest partner, Sevia USA truly understands the importance of creating laws and regulations that honor the innovative spirit on which this country thrives by working with our elected officials to come up with solutions that not only keep vapor products on the shelves, but also ensure the safety of consumers. Together we will continue to take that fight to Washington.”

     

  • Alfaliquid launched in the U.S.

    Alfaliquid launched in the U.S.

    Gaïatrend, a leading manufacturer of e-liquids in Europe, is launching its Alfaliquid brand in the U.S.

    Currently commanding more than half of the e-liquid market in France, Alfaliquid’s early success in Europe is attributed by Gaïatrend to the brand’s extensive variety of unique, quality e-liquid flavors and the company’s commitment to health and safety regulations for each stage of production.

    Since 2010, Alfaliquid’s products have been developed by flavor artist Xavier Martzel, the son of Gaïatrend founder Didier Martzel and brother of Olivier Martzel, Gaïatrend’s head of production.

    Expertly trained as a “vapologist” and held to similar standards as top chefs or famous perfumers, Xavier creates elaborate and subtle mixtures that appeal to the most refined taste buds.  And, unlike many e-liquids on the market, Alfaliquid’s products are certified diacetyl, acetyl, propionyl, acetoin, formaldehyde, acetaldehyde, or acrolein-free.  Alfaliquid’s products are developed using certified food grade flavors, while drawing from nature and plants.

    “We are very excited to launch Alfaliquid in the United States,” said Arnaud Dumas de Rauly, president of Gaïatrend USA. “Gaïatrend comes from a culture where vaping is accepted and hasn’t been vilified.

    “Given our French roots, the FDA’s deeming regulations and the war on vaping in general, we found Bastille Day the perfect time to launch.  Our mission is to educate, unify and encourage vapers to be vocal about overzealous regulations while offering a quality product that not only serves as a smarter alternative, but can be enjoyed by adult consumers across the globe.”

  • Karnataka to ban e-cigarettes

    The government of the Indian state of Karnataka, acting on the advice of a ‘high power committee on tobacco control’, is set to ban electronic cigarettes, according to a story in the Times of India.

    The principal secretary for health and familymuO0taqmuKkNDnXZH0QNLZw (1) welfare, Shalini Rajneesh, confirmed recently that the government had issued the necessary notification.

    In India, nicotine is a poisonous substance under section five of the Poisons Act 1919.

    The sale of nicotine, apart from that in tobacco products that are regulated under the Control of Tobacco Products Act (COPTA), is permitted only for tobacco cessation in accordance with the Drugs and Cosmetics Act 1940.

    Electronic cigarettes are not regulated under COPTA.

    The Times quoted Health Minister UT Khader as saying it was “shocking” that even pharmacies sold electronic cigarettes.

    “We must curb this in the interests of public health,” he said.

    Meanwhile, the Bangalore District Chemists and Druggists’ Association president, V Harikrishnan, expressed ignorance in respect of the sale of electronic cigarettes at pharmacies.

    “It’s not a medicine,” he said. “How can it be sold at drug stores? I will look into it.”

    The states of Punjab and Maharashtra, and the union territory of Chandigarh, have already banned the production and sale of these devices.

  • Out With The Old

    Out With The Old

    Experts call for change with obsolete tobacco control efforts.

    By Amber Whaley

    It doesn’t take a scientist to see that the world of “smoking” has changed drastically over the past decade. With the invention and innovation of the electronic cigarette, people have been looking at nicotine in a completely different way. And while e-cigarettes do not contain tobacco, they are considered by many, the U.S. Food and Drug Administration (FDA) included, as a new tobacco product. If that is the case, then we have to admit that since 2007, when the first e-cigarette was introduced, the “tobacco” market has changed.

    A recent paper published in the journal BMC Public Health is exploring this fact and at the same time encouraging the modernization of how we design and implement tobacco control strategies.

    Lynn Kozlowski is a professor of community health and health behavior at the University at Buffalo. He co-authored the paper with David Abrams, a professor of health, behavior and society at Johns Hopkins University. Abrams is also the director of the Schroeder Institute for Tobacco Research and Policy Studies at Truth Initiative in Washington, D.C. The two authors believe that the major issue is the lack of adaptation to the changing tobacco product landscape.

    The researchers analyze the history of tobacco control and how it has changed, or in some cases has not changed, over the course of organized tobacco control. Beginning in 1964 with the surgeon general’s warning on cigarettes and tobacco products, U.S. efforts toward tobacco control have had an inconsistent history. For instance, beginning in 1964 there was a large trend toward the newly introduced “light” cigarette, which was touted by public health officials at the time as having less tar—and therefore providing a lower risk of contracting lung cancer. Time would tell, however, that this was not the case.

    While light cigarettes did not prove to be the harm reducers many were hoping for, they should not have erased the idea of harm reducers in general. However, according to the researchers, by the 1980s the popular thought was more aligned to an “all or nothing” approach—smoking was seen as bad and no alternative product should ever be considered acceptable for use.

    Also in the 1980s, broader bans on cigarette advertising were introduced and the overall feel of tobacco control turned. No longer were people trying to make claims about harm reduction with lower-tar cigarettes or alternative smoking methods; smoking was just bad. The failure of the low-tar harm reduction fiasco is that it has affected the feel of tobacco control now, even years later. The authors say it is time for a change. “Tobacco control needs to be guided by a modern understanding of differential risks from different modes of delivery of tobacco/nicotine containing products in the practice of tobacco control, not crude, unjustified claims of product risks based on the fraudulent industry behavior of the light/low tar disaster,” they write.

    Indeed, the authors’ main point rests around the sense that something different needs to be done. No longer should e-cigarettes, snus and other different methods of nicotine delivery be lumped together with other combustible tobacco products. Abrams and Kozlowski propose redefining the ideas that now preside over tobacco control strategies in our country. “A new reframing can align action plans to more powerfully and rapidly achieve population-level benefit and minimize harm to eliminate in our lifetime the use of the most deadly combustible tobacco products and thus prevent the premature deaths of 1 billion people projected to occur worldwide by 2100.”

    In turn, once the framework is changed, policymakers need to take notice. “Regulators and policymakers must keep the big picture in mind when framing key messages to accurately inform consumers.”

    Since the tobacco product landscape has grown and changed so rapidly, it is hard for researchers and policymakers both to stay caught up. E-cigarettes, as well as other noncombustible tobacco alternatives, have quickly become popular among former smokers who are seeking different ways to administer nicotine without the harmful cigarette smoke. Several health organizations, such as the Royal College of Physicians and Public Health England, have backed e-cigarettes as harm reducers, reporting that they are as much as 95 percent less harmful than regular cigarettes. Compared with traditional cigarettes, which kill over 400,000 people a year, e-cigarettes can offer a pathway to nicotine use that excludes the harmful smoke and tar.

    That is why the authors are so reluctant to allow e-cigarettes to continue to be grouped with combustible tobacco products. Kozlowski and Abrams state that e-cigarettes and other alternative nicotine-delivery systems “have substantially lower harms than cigarettes. Going forward, it is important to sharpen themes and key messages of tobacco control, while continuing to emphasize the extreme lethality of the inhaled smoke from cigarettes or from use of any combusting tobacco product.”

    The changing landscape needs to be acknowledged, especially for regulators who are now making drastic decisions based on an antiquated system. Kozlowski believes that regulation needs to be addressed in order to reflect this changing landscape and unique opportunity that e-cigarettes can represent. “Regulation should be used to strike the balance so urgently needed between protecting nonusers, especially youth, while maximizing benefits of newly regulated noncombustible e-cigarette products that have been shown to help current smokers either to switch or, ideally, to quit.”

    The report is an important commentary, coming from American experts just when e-cigarettes are facing so many regulation challenges. The authors bring to light the important first step in the acceptance of vaping, and that is to recognize just how differently we have to view the tobacco product landscape in general. Kozlowski puts it into perspective: “Not since the invention of the cigarette-rolling machine in 1882 has the product landscape changed so dramatically. For the first time in over a century, there are products that could make the defective and deadly cigarette obsolete.”

  • Squonk story

    Squonk story

    The Kanger Dripbox 160

    By Mike Huml

    Right on the heels of Kanger’s original Dripbox kit comes the new Dripbox 160. It’s a 160-watt variable device with a squonk design, previously known as a “bottom feeder” design. The premise here is that instead of an RDA being drip-fed from the top, a bottle housed within the mod is squeezed and liquid flows from the bottom through the hollow positive pin. It’s a historically niche design that Kanger has made available to a larger market. It’s a viable alternative to a significantly more expensive squonk mod, but don’t forget the old saying: “You get what you pay for.”

    Like other Kanger products, Dripbox is the designation referring to the kit as a whole, which comprises the Dripmod 160 and the Subdrip 160 RDA. Aesthetically, these paired together resemble the Wismec Reuleaux, with Kanger obviously trying to play to that market. In place of a third battery, the Dripmod features a 70 mL soft plastic bottle. As a result, the Dripmod will have a similar ergonomic sensation to the Reuleaux, albeit with shorter battery life and a lower maximum power. In addition, those accustomed to the Reuleaux may need to adjust how they hold the Dripbox due to the fact that the 510 connection is on the opposite side of the fire button. It’s a small inconvenience, but the end result is that many users may not find the Dripbox quite as comfortable to hold as the Reuleaux.

    The Subdrip 160 RDA is a fairly standard RDA with one unique feature: The entire deck can be unscrewed and replaced with another pre-made RDA deck. This is a great way to introduce dripping (arguably the most versatile and satisfying way to vape) to the greater market. The option remains to rebuild if so desired, but several different replacement decks are available. While not perfectly built compared to what even an intermediate builder could accomplish, they do the trick and offer an experience far superior to any sub-ohm tank on the market. That aside, the Subdrip 160 RDA has a medium-wide chuff cap that doubles as the airflow control adjustment, which lends itself well to both direct-lung and mouth-to-lung hitting. It’s a surprisingly good RDA with a smaller than usual Velocity-style deck, and while it serves its purpose well, it won’t impress those with an established RDA collection. At its maximum, the airflow is more open than any sub-ohm tank and will provide a satisfying experience for a wide range of vapers.

    The menu and screen are bright and easy to read, but there’s nothing of particular note to write home about. It does its job and is easy to use. The Dripbox as a whole is standard Kanger fare when it comes to build quality—it’s good but not great. The buttons are made of plastic but have a nice click to them when pressed. Compared to the original Dripbox, the Dripbox 160 allows you to adjust your wattage easily with the obligatory plus and minus buttons. That alone should persuade any store owner to immediately replace the older Dripbox with the new iteration. It allows for infinitely more customization options and makes it easier to fine-tune the vape experience. In addition, the Dripmod 160 features temperature control for nickel, titanium, nichrome and stainless steel. Overall, these settings work fine but are not 100 percent accurate. All are capable of resisting burning and dry hits, but the temperature setting needs to be experimented with individually for each wire type. With the intended use being RDAs, temperature control generally isn’t as desirable as it would be with a tank, where wicking properties add another dimension that could contribute to dry hits.

    So where does the Dripbox 160 fall a bit short? The leaking potential. With so much going on here, there are several points of potential failure, not to mention that many of these points can result in leaking into the mod itself. On paper, there’s no reason why the Dripmod shouldn’t work with other RDAs with a squonk pin, like the Velocity V2. In reality, the size of the hole in which the liquid is fed with these other RDAs can make all the difference. The Subdrip 160 seems to have a much wider hole than other RDAs, and therefore it works the best because there is little resistance when the bottle is squeezed. For RDAs with a tighter hole and more resistance, it can be difficult to feed liquid fast enough, if at all. In some cases, the pressure needed to feed the juice can cause leakage into the internals of the Dripmod, which can result in all sorts of chaos. It can cause the device to auto-fire, or not power on at all. It might simply be annoying to mop up juice on a regular basis, or it could cause complete device failure. This is the worst type of problem to have: an inconsistent one. If multiple units of the same device all have the same problem, it’s easy to identify and fix. With so many points of failure and unpredictable results, the Dripbox is a wild card.

    The moral of the story here is that while the Dripmod works fairly well with the included Subdrip 160 RDA, it’s not to be recommended for use with other RDAs. If the user decides to tempt fate, that’s his or her prerogative. For a business owner, it’s an unnecessary risk, and it should be acknowledged that this limits the versatility of the device. There are two possible scenarios that arise when this problem comes to light. First, there is still the option to use a regular RDA and drip from the top. However, there are far better options if a customer isn’t interested in the bottom-feed usability of the Dripmod. There are dual-battery mods that are smaller and more ergonomic, and there’s the Reuleaux, which offers a more comfortable feel and longer battery life for a similar investment. On the other hand, since the use of another squonk-capable RDA is a huge unknown, customers are virtually stuck with this one setup. The Subdrip can be used on another device, but the hollow positive pin means that liquid will constantly leak out of the 510 connection with nowhere for it to go except all over the mod or into the pin, which could cause a short circuit or device failure. All this leads to the fact that the potential buyer must be interested in the Dripbox setup, and that setup only.

    One could do far worse than the Dripbox, but also far better. It’s a familiar tale from Kanger: a great idea in theory but only mediocre in practice. The one standout purpose of the Dripbox is to introduce dripping to those unfamiliar with it in an easy and simple way. Kanger is often forgiven for many missteps in their products, but those missteps can’t always be ignored. A device that could have been extremely versatile with a wide appeal instead falls into the niche market trap. While it may pique the curiosity of many a Kanger aficionado, the potential for a sharp decline in interest is present. With regulation on the horizon, versatility is a stronger selling point than ever, and the Dripbox hamstrings itself by inadvertently limiting its usage possibilities.

  • U.S. Senator queries FDA’s vapor rules

    He may as well have just asked them what the real reason is for such onerous restrictions. The U.S. Food and Drug Administration (FDA), after all, freely admits it doesn’t have enough “scientific evidence” on e-cigarettes to “fully determine what effects they have on the public health.”

    Sen. Ron Johnson, chairman of the Senate Homeland Security and GovernRon_Johnson,_official_portrait,_112th_Congressmental Affairs Committee, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf raising concerns about the agency’s recent e-cigarette regulation, which could create undue burdens on small businesses and possibly lead to negative unintended health consequences.

    Johnson asked the FDA whether it will revise its rule if scientific findings indicate that e-cigarettes are safer than traditional cigarettes.

    “Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences,” Johnson wrote in the letter.

    “The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking. It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.”

    The letter is below:

    May 17, 2016

    The Honorable Robert M. Califf, MD

    Commissioner

    U.S. Food and Drug Administration

    10903 New Hampshire Avenue

    Silver Spring, MD 20993

    Dear Dr. Califf:

    The Committee on Homeland Security and Governmental Affairs is examining the regulatory burdens that federal agencies place on small businesses. On May 5, 2016, the U.S. Food and Drug Administration (FDA) finalized a new regulation that expanded its authority over electronic cigarettes, commonly known as “e-cigarettes.” I write to request your assistance in understanding the consequences that this new regulation may have on small businesses and the public’s health.

    According to the FDA, the final rule extends “the Agency’s ‘tobacco product’ authorities in the [Federal Food, Drug, and Cosmetic Act],” as amended by the Family Smoking Prevention and Tobacco Control Act, to include other products such as e-cigarettes. The new rule prohibits the sale of e-cigarettes to people under the age of 18.

    The regulations also require e-cigarette manufactures to submit premarket applications to the FDA in order to obtain federal approval for their products. According to recent reports, the new requirements would force e-cigarette companies to complete a burdensome and costly application process. Some manufacturers could spend more than 5,000 hours to complete an application, with a minimum cost of $330,000 per e-cigarette product, according to some estimates. As a result of these expensive and time-consuming applications, many e-cigarette manufacturers—most of which are reportedly small businesses—could close down.

    According to Christian Berkey, the Chief Executive Officer of Johnson Creek Vapor Company located in Hartland, Wisconsin, the FDA e-cigarette regulations would “extinguish a multi-billion dollar industry and put tens of thousands of people out of business.” Mr. Berkey also stated that the new FDA rule would have more than just a burdensome impact on the e-cigarette industry, the effect of the rule would be “catastrophic.” In its regulatory analysis, the FDA itself acknowledged that the cost of the rule “would be high enough to expect additional product exit, consolidation, and reduction in variety compared with the baseline.”

    Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences. The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking. It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.

    In order to assist the Committee in better understanding the FDA’s decision to expand its authority on e-cigarettes, I ask that you please provide the following information and materials:

    1. The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.” Further, the final rule states that “comments were divided on the safety and toxicity of e-liquids, e-cigarettes, and the exhaled aerosol.”

    Will the FDA issue a revised rule if there is sufficient data that finds that e-cigarettes are a safer alternative to traditional cigarettes? Please explain.
    How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health?
    2. Some stakeholders claim that the FDA’s rule on e-cigarettes will stifle innovation and result in the closure of many small businesses that create and sell e-cigarette products.

    Did the FDA determine how many e-cigarette businesses will be affected by the rule? If not, why?
    If so, please provide that data.
    Of the e-cigarette businesses that will be affected by the rule, how many of those businesses does the FDA predict will exit the market as a result of the new requirements?
    3. Has the FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products? Please explain.

    Please provide this material as soon as possible but no later than 5:00 p.m. on May 31, 2016. When delivering production sets, please produce to Majority staff in room 340 of the Dirksen Senate Office Building and to Minority staff in room 613 of the Hart Senate Office Building.

    The Committee on Homeland Security and Governmental Affairs is authorized by Rule XXV of the Standing Rules of the Senate to investigate “the efficiency and economy of operations of all branches of the Government.” Additionally, S. Res. 73 (114th Congress) authorize the Committee to examine “the efficiency and economy of all branches and functions of Government with particular references to the operations and management of Federal regulatory policies and programs.” For purposes of responding to this request, please refer to the definitions and instructions in the enclosure.

    If you have any questions about this request, please contact Scott Wittmann or Josh McLeod of the Committee staff at (202) 224-4751. Thank you for your prompt attention to this matter.

    Sincerely,

    Ron Johnson

    Chairman