To e-puff or not to e-puff: that is the question. A new article from the American Association of the Advancement of Science (AAAS) confronts the differences in views on e-cigarette safety between the UK and the U.S.
Public Health England (PHE), a governmental body the equivalent of the U.S. Centers for Disease Control and Prevention (CDC), recently released an evidence review claiming that e-cigarettes are 95 percent less harmful to health than combustible cigarettes. In recommending that smokers who cannot or will not quit cigarettes try e-cigarettes, PHE takes a position on the opposite side of the aisle from the U.S., where many prominent tobacco control advocates, public health officials, and policymakers are critical of e-cigarettes. Viewpoints in the U.S. range most commonly from unequivocally denouncing e-cigarettes and linking them with adverse health risks to a far less frequent willingness to consider these devices to hold promise for moving tobacco smokers to a less harmful product, a belief held by the Truth Initiative (formerly the American Legacy Foundation).
In a new, thought-provoking “Perspective” in the New England Journal of Medicine, the debate continues. Researchers from Columbia University’s Mailman School of Public Health draw on the history of harm reduction in the UK and U.S., comparing the UK’s conclusion in 1926 that drug addiction was an illness that should be treated by physicians with safe drug practices to the very different U.S. stance of refusing drugs to addicts as a treatment practice. Comparisons like these led the researchers to the question: Do electronic cigarettes work against reducing tobacco smoking or offer the possibility of minimizing harm for those who just cannot quit tobacco cigarettes?
Imagine a time and place where the leading cause of cancer death was consumer consumption patterns, and where innovative technology was developed that allowed these consumers to change their behaviors to something greatly less hazardous. This new technology actually gave them something they preferred and that even cost them less than sticking with the old, deadly alternative. Imagine that businesses were allowed to promote and sell the new technology and competition and sensible regulation led to ever-better, more reliable and safer versions of this new technology. Well, stop imagining, because it has already happened, and we are using it every day.
It was refrigeration. As recently as the 1940s, stomach cancer was our largest cause of cancer deaths. But it was already declining steeply, it continued to fall rapidly, and it’s now thankfully rare. With the advent of refrigeration, diets changed. Out went the highly salted, pickled, smoked and easily contaminated foods, and in came more fresh fruits and vegetables. This huge public health breakthrough was led by entrepreneurs and consumers, and it was self-financing. So if you want to celebrate the ability of innovative technology to largely eliminate the leading cause of cancer death, send a fan letter to General Electric and go hug your refrigerator.
But refrigerators aren’t an anomaly in being an entrepreneurial intervention that saved lives. We can think of the Lambeth Waterworks Company, which opted to source water for its customers in London from upstream in the Thames when the competition was sourcing it downstream from the city’s sewer outlets and causing cholera epidemics. Or those who saw a competitive advantage in sanitary food manufacturing, or in science-based pharmaceuticals in place of snake oil, or in installing safety features in their cars. We live in a world made massively less hazardous through the work of visionaries and the workings of markets.
LEARNING LESSONS
Many business and public health breakthroughs look obvious, even inevitable, in retrospect. People deride the Royal Navy for taking decades to act on information showing citrus prevented scurvy, and decry the nearly 200 years from the time mankind knew how to prevent smallpox until the time we eliminated that horrible disease. So, how will history judge what we are doing about cigarette smoking?
Likely not favorably. We have known for decades that people smoke for the nicotine, but what kills them at such a horrendous rate is the inhalation of the smoke. Getting nicotine without the smoke, as we have seen with Swedish snus and medicinal nicotine, can eliminate the vast majority of all the harms. We also know that consumers are spending roughly $800 billion a year buying cigarettes, and being stuck with that product not through choice but because others have chosen to limit their access to viable alternatives. Given the ability, markets could meet consumer demand in a way that facilitates a breakthrough that could leave hundreds of millions of people with hugely improved health and numerous entrepreneurs having done well by doing good. With policies that actually facilitate market transformation rather than hindering it, the move away from lethal cigarettes could rival the pace of change in other areas of technology. We could make smoking history, and innovation could also facilitate those who are wishing to cease using nicotine altogether.
GETTING TO SENSIBLE
To get to such a breakthrough will require some deeper thinking about how best to deal with nicotine, and an abandonment of measures that treat nicotine use as if it were an immoral act rather than an issue of public health and consumer rights. Abstinence-focused campaigns based on imposing an absolutist morality on others intensify the evils they hope to destroy, as the historian Richard Hofstadter pointed out about alcohol prohibition. It has happened with Prohibition, the war on drugs, abstinence-only messages on sexual activity, blame-the-driver approaches to auto safety, and it’s happening now with the war on nicotine. When the stakes are high—and they are exceedingly so, with roughly 1.5 billion people getting their nicotine through inhalation of the products of combustion—pragmatism must win out over dogmatism.
“Getting to sensible” is often a serious public policy challenge, and it’s certainly a difficult task when there are vigorous efforts to create a moral panic about alternatives to cigarettes. Consumers have traditionally lost out in the battles over nicotine because others were able to impose choices on them. Products like medicinal nicotine were so heavily regulated as to not be viable alternatives to cigarettes. Many countries actually banned noncombustible alternatives like snus and moist snuff, thus protecting the much more deadly cigarette business. For decades, consumers desperately looking for safer alternatives were not just denied accurate information on and access to truly less hazardous products; they were also misled into believing that “light” cigarettes were safer.
But innovative technology has a way of disrupting markets, and the rapid transformation of electronics, combined with the role of the Internet for getting information and social media for sharing it, means that vapor products have acted much like Uber. Instead of seeking permission to exist, they simply showed up in the market, and when challenged under what were seen as outdated laws, the entrepreneurs fought back. The end result is that the technology became very widely used before those opposing its existence could stop it. Those who have a vested interest in the status quo must fight not only the innovators but a very broad swath of consumers who prefer the new product. It is hard to ban a product used by millions, just as it is hard to stop a civil rights march if enough people are marching.
The opposition to alternative nicotine products will not die easily. Among other things, major U.S. funding bodies adopted a moral-absolutist goal of a “tobacco-free America” rather than a pragmatic public health one of reducing the burden of disease. Then, in some truly twisted logic, they decided that tobacco-free vapor technology constituted a tobacco product. So we see a near-endless parade of funded studies aimed at furthering a moral panic, reminiscent of what was seen in the war on alcohol and the war on drugs. Studies that often betray rather than honor the goals of science. Studies that will often point to a “potential problem” without either specifying whether there is any actual risk to vapers or comparing any identified risk to that of continued smoking. Studies, in short, that deceive rather than inform.
BETTING ON INNOVATION
So, who is going to win this war on nicotine? Will an abstinence-only approach actually end up protecting the cigarette cartel? Or will a growing band of pragmatic revolutionaries fundamentally change the market and achieve not only a marketplace transformation but a public health breakthrough of historic proportions?
Were one to place a bet, go with the innovators. Matching their creativity, work ethic, personal drive, commitment and consumer support to that of the bureaucrats, moralists and cigarette companies wishing to preserve the status quo is (fortunately) a very uneven fight. We will soon see the market deliver a range of alternative products, some without vapor, some aimed at specific niches of the current cigarette market, some aimed at easing people off nicotine altogether. Many will be hugely better than anything seen to date. Innovation and competition does that. There are millions of lives to be saved and billions of dollars to be made replacing lethal cigarettes. There are simply too many bright people with too great an interest in a better future to believe that innovators will stop innovating and smokers will be denied access to and accurate information about alternatives. Sensible regulators, knowing they can’t defeat innovative technology, will opt to work with it to facilitate the rapid end of the cigarette epidemic.
Lung cancer is now our leading cause of cancer deaths. It dwarfs other types of cancer. Just 80 years ago, before cigarette smoking became the primary vehicle for obtaining nicotine, lung cancer was as rare as stomach cancer is now. Of course, smoking causes a broad array of other cancers and numerous other diseases. It is truly a totally unnecessary modern-day catastrophe, and on many levels—health, economics and consumer rights among them. But modern markets can change quickly, entrepreneurs can see opportunity when it occurs, and consumers with information and options for using it can change the course of history. So go show your refrigerator you are prescient. Tell it that it is about to have company in the annals of historic public health breakthroughs.
David Sweanor is an adjunct professor with the Faculty of Law at the University of Ottawa. He is also with the Centre for Health Law, Policy & Ethics at the University of Ottawa.
The organizers of the Global Forum on Nicotine (GFN) have announced an outline program for the 2016 conference, which can be viewed here: https://gfn.net.co/programme-2016/program.
The working sessions of the GFN are due to be held in Warsaw, Poland, on June 17-18, under the theme Evidence, Accountability, Transparency.
This year’s event will include a special showing of the landmark documentary, You Are Being Lied To – A Billion Lives, which is due to be screened on June 16, before the conference’s social event.
The documentary will be introduced by Aaron Biebert, the director, who will take part also in a short Q&A session after the screening. All GFN delegates will receive a ticket for the screening and an invitation to the conference social event immediately afterwards. More information is at: https://gfn.net.co.
The US-based Tax Foundation yesterday published a new summary and analysis of vapor product taxes in the US, a subject that it says has received little attention in the past.
‘Many states are grappling with the questions of if and how to tax the new market of vapor products, also known as “e-cigarettes”,’ the foundation said in a news release.
‘Although there is a substantial amount of ongoing research about the health costs of vapor products, there has not been much in the way of guidance on how best to tax them.
‘Currently, only a small handful of states tax the products, but do so in dramatically different ways.’
The study summarizes the basics of what the products are and how they compare to cigarettes in terms of production and health risks, and it provides a detailed overview of enacted and proposed taxes in each state.
The key findings include:
As of January 1, 2016, four states, the District of Columbia, and three local jurisdictions had enacted taxes on vapor products (electronic cigarettes), but their methods and levels of taxation vary dramatically.
In 2015, at least an additional 23 states considered excise taxes on vapor products.
Vapor products are generally found to have a much lower risk profile than traditional incinerated cigarettes.
Public Health England, housed in the British Department of Health, issued findings that vapor products are 95 percent less harmful than are cigarettes and can serve as an effective tobacco-cessation method.
Vapor products are likely have much lower externalities than are traditional cigarettes, and it follows that the excise taxes on the products should be lower or non-existent.
Policymakers should avoid extending punitive tax rates from traditional cigarettes to vapor products because this would limit the consumer’s ability to use vapor products to quit cigarettes, said the foundation’s economist and director of state projects Scott Drenkar.
“Our first reaction should not be to impose cigarette taxes on what is fundamentally a different product.”
The report goes on to discuss why vapor taxes should be based on the volume of nicotine liquid in the product, rather than on the wholesale price, and how pending federal regulation would impact state tax policies.
A significant part of my time goes into attending trade shows all over the world, and each one has something unique to contribute. I view the Tobacco Plus Expo (TPE), which took place Mach 16-18 in Las Vegas, Nevada, USA, as a small microcosm of what’s in store for the industry, as it steadily evolves along with it, and is always one of the first to point to emerging trends. The shift to electronic devices has been steady, as the morphing of products themselves.
Three years ago the show was dominated by cigalikes, open systems such as eGo, and basic liquids. The following year cigalikes where replaced by an avalanche of mods, and premium liquids began to appear. This year was all about premium liquids, which in of itself begs the question—what is a premium liquid these days? When everyone is pandering luxury experience, what makes a brand truly unique?
A major part boils down to branding. The companies are going all out in development of sophisticated packaging and unique brand identification that aims to appeal to various market segments. MYLK is one great example of just that. With its milkshake flavors and clever positioning, Brewell has hit a great niche. The product is all of the latest rave in China even though the Chinese are not major milk consumers nor milkshake aficionados. Cosmic Fog is steadily paving the way with its clear and consistent brand story, and is a great case study of a vape shop-focused company that now made it into a tobacco-centric distribution arena of TPE.
Another important development in the race for a slice of the premium sector is adaptation to simple and crisp flavors. As opposed to offering a 35 options with stereo effects in each liquid, the brands are opting for a flavor lineup that clearly defines their identity, providing a powerful differentiator. From what I see, this is one of the baldest steps towards true premium status, more in line with the accepted lineups of classic high end scotch.
A special mention should go out to SQN, which showcased NKTR—a new line of e-juice based on Tobacco-Free Nicotine developed in partnership with the Next Generation Labs. To me it truly set the tone for the next step in luxury liquids in terms of packaging, flavors, and most importantly the science behind the e-juice. This was definitely the product that exceeded expectations on all parameters and should lead the next wave of innovation.
Dmitry Churakov is CEO of Wingle Group, a China-based research and development consulting service geared toward the e-cigarette and adjacent technologies and manufacturing processes. He is also a co-founder of Calumet Advisors, an international strategic consulting company dedicated to the e-cigarette segment.
What the thaw in U.S.-Cuban relations means for the electronic nicotine delivery systems.
By Givi Topchishvili
As U.S. President Barack Obama is making his historic visit to Cuba—the first by sitting American president in almost 90 years—the business community is asking itself what the thawing in relationship means to it. Calumet Advisors recently concluded an assessment of risks and opportunities for the vaping sector in the South American market, with Cuba being a part of the study. While our findings show that the current environment in Cuba is not yet ripe for a serious market entry, we do see a number of opportunities and are happy to share some of these observations.
According to the 2015 revision of the World Population Prospects, the total population of Cuba stands at 11.39 million, and is projected to decrease by 9.2 percent to 10.34 million by 2050. By then Cuba is also projected to become the ninth oldest country in the world, with a median age of 51.9 years.
On the economic front, the Cuban government continues to balance the need for loosening its socialist economic system against a desire for firm political control. As the government has cut state-sector jobs as part of the reform process, it has opened up some retail services to “self-employment,” leading to the rise of so-called “cuentapropistas,” or entrepreneurs. Approximately 476,000 Cuban workers are currently registered as self-employed.
Yet despite the recent reforms, the average Cuban’s standard of living remains at a lower level than before the collapse of the Soviet Union and the resulting downturn of the 1990s, with an average income of just $300 per year. That means very limited buying power for most Cuban consumers, especially for non-essential goods and services.
At the same time, Cuba is home to some of the toughest anti-smoking laws in the region. In 2011 it conducted the Third Survey on Risk Factors of Non-Transmissible Diseases. It polled 9 million people and is recognized as the most important study on the issue to date. The study yielded significant results, such as the fact that 36.4 percent of those interviewed smoked at least once in their lives, and that two out of every 10 women and three out of every 10 men are addicted to cigarettes. As much as 53 percent of all black and mixed-raced people on the island claim to be smokers—a figure of more than double the rate of white Cubans who smoke (24 percent).
At the moment the Cuban authorities are working on new anti-tobacco legislation that would provide the framework for even tougher restrictions on smokers than exist today, and strengthen commercial limitations on tobacco-derived products. In addition to reiterating provisions that forbid smoking in closed spaces and the sale of tobacco products to people under 18, the proposed legislation would include restrictions on the promotion and sponsoring of tobacco products in the country, prohibit their sale at health, educational, and sporting institutions, and the sale of single units or packages with less than 20 cigarettes. It would also raise the prices of tobacco products.
Another important factor to consider is the fact that currently all tobacco products are tightly controlled by Tabacuba, the state tobacco monopoly, which will most likely seek authority over the future sale of e-cigarette and vapor products once the market begins to open up.
Interestingly enough, currently, there are no limitations or restrictions on sale or use of vaping products in Cuba, something that was confirmed by tourists and locals alike. The actual current size of the electronic nicotine delivery systems (ENDS) market there is under $4 million a year, and to date there are no established local retail or online market for vape devices or e-liquid products.
It’s clear that the current economic and political environment in Cuba is not yet welcoming enough to make significant investments in market entry. One possible venue for entry that we identified is an exploration of a joint venture with, or becoming a supplier to Tabacuba. Working with government controlled monopolies comes with a price, but as we have seen in analogous places it carries less risk than attempts to bypass it.
However, the real opportunity for development and expansion of ENDS market at the moment is within the smoking-cessation campaign going on in Cuba. Now is the time to influence the public perception and legislative work pointing at Cuban antismoking environment. It is worth considering respective lobbying efforts, especially with the high number of U.S. and European tourists willing to visit Cuba in the future. It is noteworthy that the U.K. has just ruled on licensing BAT e-cigarettes as quit-smoking medicine, which was announced in January 2016. This U.K. ruling may pave the way for other countries to follow this route and should be closely monitored in general and in the context of entering the Cuban market in particular. With a population base of 11 million people and 3 million tourists annually, Cuba could, potentially, become a large player in the Caribbean vape market.
Givi Topchishvili is a co-founder of Calumet Advisors, an international strategic consulting company dedicated to the e-cigarette segment.
Gaïatrend, a leading vapor company in France, is expanding into the United States, where it will be launching its flagship brand, Alfaliquid.Industry veteran and executive Arnaud Dumas de Rauly will lead Gaïatrend USA’s development as president.
Currently commanding more than 50 percent of the e-liquid market in France, Alfaliquid’s early success in Europe can be attributed 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.
Gaïatrend will initially be rolling out 15 flavors in the U.S. market across Alfaliquid’s three e-liquid collections, Heritage, Harvest and Reserve. Understanding the importance of transparency, particularly in an unregulated U.S. industry, Alfaliquid will also work to educate consumers about e-liquids and their ingredients as they have done successfully in France.
De Rauly is the former president of FIVAPE, a European vaping trade association. He currently serves as the organization’s Secretary General for International Relations and is also a board member of the Vapor Technology Association, currently serving as Treasurer.
De Rauly also plays an integral role in the development of industry standards as a founding member of the AFNOR (French Standards Body) technical committee on vaping and vapor products, current member of the CEN (European Standards Body), and current member of the ISO International Standards Organization. He frequently serves as a keynote speaker at international vaping shows across the globe.
“We are thrilled to announce Gaïatrend’s expansion to the U.S.,” says De Rauly. “With the advent of a real vaping culture across the globe, we see tremendous opportunity for Alfaliquid in the U.S. Alfaliquid has set the industry standard in Europe through quality and innovation, and we look forward to introducing our e-liquid products to adult consumers in the states. With our expansion to the U.S., we will also work to educate adult consumers about e-liquids and their ingredients, as well as the importance of health and safety standards.”
Alfaliquid e-liquids are manufactured by Gaïatrend in the French region of Lorraine.
Tony Scanlan has been appointed CEO of Madvapes U.K. to lead the company’s business expansion strategy in the United Kingdom and the Republic of Ireland.
Scanlan is an experienced international manager who has spent his career building businesses in the tobacco, mobile phone and of late the e-cigarette sectors.
Having spent many years at Rothmans International, where he built brands and sales in Europe, the Middle East and Africa, Scanlan looked for business opportunities to suit his talent. He built a business in the emerging mobile phone e-transaction space, which grew to a turnover of €65 million ($71.93 million) within three years and sold to investors within five.
As e-cigarettes started to emerge as a serious option for consumers, he joined a fast-growing manufacturer and led it to become a leading brand in the U.K. market and No. 2 in Ireland.
The U.K. vaping market is growing at a tremendous pace as technology improves and more mainstream consumers are attracted to vaping, according to Madvapes.
The current retail environment is beginning to mature, giving ideal conditions for Madvapes to establish a chain of corporate owned and franchised stores across the country.
“Having owned a retail franchise myself I am fully aware of the success criteria and am confident the U.S. model will fit very well in the U.K. and Ireland,” said Scanlan.
“We welcome Tony to the Madvapes team, we have tremendous confidence in his experience and ability to lead our brand in the U.K. and beyond,” said Mark Kehaya, chairman of Madvapes Holdings.
A series of cell-based tests developed to compare the biological impact of cigarette smoke with e-cigarette vapor revealed no activity in cells exposed to vapor from Vype ePen, a commercially available e-cigarette. In contrast, when the cell culture systems were exposed to cigarette smoke, they exhibited a series of responses including stress responses, DNA damage and cellular transformation, depending on the assay used.
The use of these tests to assess the biological impact of e-cigarettes was reported by scientists from British American Tobacco (BAT) at the annual meeting of the Society of Toxicology in New Orleans, Louisiana, USA, today.
“The results of these tests show that toxicity and biological activity is unaffected by the vapor from the e-cigarette tested, Vype ePen,’ said Kevin McAdam, head of next-generation product (NGP) research at BAT. “These tests are part of a suite of tests being developed to test novel tobacco and nicotine products and could be used to help develop standards for these products in the future,” he said.
E-cigarette vapor can contain nicotine, humectants, flavorings and thermal degradation products, so it is important to understand the potential impact on biological systems.
A number of tests were used to compare the biological impact of cigarette smoke and e-cigarette vapor: cell stress tests, looking at the production of intracellular antioxidants, free radicals and inflammatory markers; assessment of DNA damage, which can set the scene for cancer; and a transformation assay, which measures the transformation or conversion of normal cells into a cancerous cell phenotype.
Cells respond to stress in a number of ways. They can produce compounds that protect the cellular structures or they can recruit compounds from the immune system to help protect the cell or commit suicide.
By measuring the levels of the various compounds produced and the level of cell apoptosis/death, it is possible to determine the levels of cellular stress.
The cell culture systems tested conventional 3R4F reference cigarette and Vype ePen, a commercially available e-cigarette. When cells were exposed to the cigarette smoke, all cell stress responses were activated. These same cell stress responses were not activated on exposure to e-cigarette vapor.
Cellular DNA can become damaged by exposure to toxicants, especially when stressed. DNA double-strand breaks (DSB) in which both strands of the double helix are broken, is the most serious type of DNA damage. This is a possible precursor to cancer and potentially lethal to the cell. The cell attempts to repair the DNA damage by modifying the histone or protein around which the DNA is wrapped. The changes observed in this histone can be used as an indicator of the level of DSB.
When this test was used to compare the impact of conventional 3R4F reference cigarette and Vype ePen on DSBs, the results showed that cigarette smoke induced significant DNA damage in human lung cells. This was dose dependent, that is, the higher the dose, the more DNA damage was induced. E-cigarette vapor produced no affect, even when the dose used was 15 times higher than the equivalent smoke exposure.
Damaged cells often go on to become cancerous. The cells are transformed from normal cells to abnormal cells that clump together and grow uncontrollably, eventually becoming tumor-like. This process can be mimicked in the lab by using cells that are already damaged and testing the tumor-promoting activities of different compounds.
In this case, the cell culture system was used to test the ability of conventional 3R4F reference cigarette and Vype ePen to promote tumor formation in a specialized cell type called Bhas 42.
After exposure to reference cigarettes, the layers of cells were seen to become transformed, clumping together to create colonies, suggesting that the smoke is a tumor promoter. By contrast, the e-cigarette produced no activity.
In each test, the e-cigarette produced the same results as an untreated control – there was no activity.
Many in the public health community believe that e-cigarettes are substantially reduced risk compared to cigarettes. Public Health England, an executive body of the UK Department of Health, recently published a report saying that e-cigarettes are 95% safer than cigarettes. But there are still no internationally agreed testing protocols to establish this.
Innokin and Nerudia have established a strategic partnership to ensure that some of the world’s most popular vaporizers achieve compliance with the new EU Tobacco Products Directive.
Nerudia will begin work immediately on preparing a TPD notification for the Innokin Endura T18, which is a simple, high-performance device. The two companies will continue to update the market on the progress of this notification so as to ensure wholesalers and distributors can buy the product with confidence.
Nerudia will also audit Innokin’s manufacturing facilities and help the manufacturer ensure that its production meets the directive’s stringent requirements. It will also monitor Innokin’s compliance with the body of European law that already applies to vaping products.
“We are delighted to be working in partnership with Innokin, who have made some fantastic devices that have helped to shape the vaping industry as we know it,” says David Lawson, Nerudia chief regulatory officer.
“Nerudia looks forward to helping Innokin grow by making sure that they continue to lead the field when TPD comes into force”.
“When we chose our TPD Compliance partner Nerudia really stood out,” says James Li, general manager of Innokin. “They offer a service that is more robust than any other we have seen in the market, and we are confident that they will lead us to a successful future in this newly regulated market.”
from the American Association of the Advancement of Science (AAAS) confronts the differences in views on e-cigarette safety between the UK and the U.S.
