Vapor Voice

Category: This Issue

  • The Voice of Reason

    The Voice of Reason

    The UKVIA does a commendable job of promoting sensible vapor regulations. Will health authorities listen?

    By George Gay

    In March, I received a press note entitled, “The U.K. Vaping Industry Association [UKVIA] blasts World Health Organization [WHO] and says it risks becoming an ‘enemy of harm reduction.’”

    The UKVIA cannot be described as a militant organization. It has firm ideas, but it prefers to work quietly and closely with the U.K. government, health authorities and anybody else willing to listen to its tale of running businesses that promote tobacco harm reduction while trying to turn a profit. So, the tone of the heading made me sit up.

    What the UKVIA objected to in the first instance was what it described as “[r]ecent recommendations made by the WHO study group on Tobacco Product Regulations that would prohibit electronic nicotine[-delivery] and nonnicotine-delivery systems where the user can control device features and liquid ingredients.”

    On the face of it, I can certainly understand the UKVIA’s concern. Banning such products would be like banning automobiles with accelerator pedals because they could be used to make a vehicle travel at beyond the speed limit or banning glasses because they could be used to mix mind-altering drugs with lemonade.

    It has been said—rightly in my view—that newspapers are organizations that cannot tell the difference between a bicycle accident and a world war. By the same token, it would seem the WHO has become an organization that cannot tell the difference between a pandemic and everyday life—admittedly, life in all its messiness.

    The UKVIA said the WHO had called also for a ban on vaping systems that have a higher “abuse liability” than conventional cigarettes have; systems that, for example, allow the user to control the emission rate of nicotine. In this case, I’m so underwhelmed by the sound of the problem that I can assume only that I have misunderstood what is being said here. Isn’t it the case that nicotine uptake is controlled by the inhaler at a subconscious level?

    In any case, I cannot see what business this is of the WHO. Does it want to micromanage every aspect of the lives of everybody on the planet? Is it going to start looking into the “abuse liability” of high-performance cars, over-proof alcohol and sickly candy bars? Of course, if it wants to make itself useful and if it is happy working at a national rather than a world level, it could end no amount of inflicted harm by helping to do something about the abuse liability and abuse reality of the many and increasing dictatorial regimes around the world.

    Empowered personal choice

    The director general of the UKVIA, John Dunne, believes the WHO poses a threat to smoking cessation and harm reduction in the U.K. “While the WHO is scheduled to hold a crucial summit on vaping in November 2021, known as COP9 [the Conference of the Parties to the WHO Framework Convention on Tobacco Control (FCTC)], it continues to find itself at odds with health and industry advocates,” he was quoted in the press note as saying.

    “Certain WHO positions are now so out of date, and so thoroughly refuted by the experts, that they may as well be saying the earth is flat. They deviate dramatically from leading experts, including Public Health England (PHE) and Action on Smoking and Health …

    John Dunne

    “Take for example vaping helping people to quit smoking, which the WHO says there is ‘little evidence’ of. As early as 2019, clinical trials were finding vaping to be almost twice as effective as nicotine-replacement therapy …

    “Just this month, … PHE … found in its Vaping Evidence Review 2021 that smoking quit rates involving a vaping product were higher than with any other method in every single English region. For the WHO to hold such contrary views is either bad science or bad faith. Both risk it becoming an enemy of harm reduction.”

    Dunne made the point that vaping’s success as an industry, and its potential for public health improvements, were built on empowering personal choice. “Different systems, styles and flavors give consumers the options they need to leave combustible cigarettes behind,” he said. “I would urge the WHO to engage with vapers, to hear their stories and discover the life-changing decisions they’ve made… Prohibition is simply not the answer.”

    The press note also said that the U.K. was due to send a delegation to the COP9 summit later this year, the first time it would be attending such a summit since leaving the EU, and it was to be hoped that this would provide an opportunity for it to promote harm-reduction. In addition, it said the UKVIA had been among expert guests invited by the All-Party Parliamentary Group for Vaping to advise on the COP9 delegation’s approach.

    “The U.K. has a genuine opportunity to promote harm reduction as a valid, progressive strategy for public health on the world stage,” said Dunne. “We must not allow misinformation to undermine this potential, irrespective of the source.”

    It is indeed to be hoped that the U.K. delegation to COP9 can bring a little reason to the table, assuming it gets to the table. From what we of the outer dark can ascertain, however, the FCTC does not brook dissent and, as part of its strategy to avoid it, tends to block the attendance at meetings of those not of the true faith. It will be interesting to observe what it will make of a delegation that has been in direct or indirect contact with a vaping body, assuming the delegation does not cave in and join the happy-clappies.

    Return to sender

    Meanwhile, the UKVIA has a further problem. In another press note in March, it said it was deeply concerned by news that U.K. businesses were being impacted by the U.S.’ “vape mail” ban, part of a congressional spending bill passed under former President Trump. By April 27 [after this report was written], leading carriers, such as UPS, FedEx, DHL and the U.S. Postal Service, were due to be off-limits for vaping shipments.

    FedEx had cited “cigarettes, cigars, loose tobacco, smokeless tobacco, hookah or shisha, vaporizers (and) e-cigarettes” as “tobacco products,” which would no longer be accepted. The UPS said it would prohibit “any and all noncombustible liquid or gel, regardless of the presence of nicotine, capable of being used with or for the consumption of nicotine” as well as “all related vape devices, products and accessories …”

    Again, we find ourselves in a bizarre world. I take it these bans are somebody’s idea of a health and safety policy, but, with more “premature deaths” worldwide attributed to outdoor pollution than to tobacco consumption, logically, the carriers should ban deliveries of everything—they should remove themselves from the roads, the air and the sea. Or there should at least be an acceptance that both tobacco smoke and vehicle pollution are health hazards and that whereas carriers might be trying to lessen the pollution they create by switching to cleaner vehicles, craft and vessels, the tobacco industry is trying to lessen the amount of tobacco smoke by getting consumers to switch to vaping, a task not made any easier by carrier bans. Of course, there is little the carriers can do to reverse this nonsense, but they could at least have a word with any politician ready to listen.

    “The vaping supply chain is a global one, bringing together resources and expertise from around the world,” said Dunne. “It is bitterly disappointing to see these American restrictions having a negative impact in the U.K., but the nature of the supply chain makes it inevitable. In the EU, too, we are hearing of vaping businesses being turned away from major carriers.

    “The potential impact on public health is grave as so many people are relying on shipped goods as a lifeline during the pandemic. Without proper access to harm reduction products, we know people can revert to smoking cigarettes, today in the U.S. but perhaps tomorrow in the U.K. With businesses already struggling through lockdown, and our health services under great strain, supply chain issues really are the last thing we need.

    “I call on the distribution industry, many of whom have been partners of the vaping industry for many years, to do all they can to support their U.K. customers and to avoid the blanket implementation of U.S. restrictions worldwide.

    “Furthermore, I call on the U.K. government to ensure that carriers in this country are free to continue to deliver vaping products to retailers and direct to consumers and to resist any urge to follow the U.S. down this regressive route.”

    I take it that the “vape mail” ban is largely about keeping vaping products out of the hands of young people. It’s a strange thing that the activities of adults, which have always been restricted by the need to guard against criminal activities, are now increasingly becoming restricted by perceived threats to young people—often inappropriately referred to as “children” when it becomes necessary to ramp up the emotional blackmail.

    Credit: Haiberliu

    Such restrictive measures would be acceptable in my view if they were applied across the board, but they are not. Young people are seen by many people in authority as having to be protected against the minuscule threat posed by vaping products while many youngsters are allowed to go hungry, threatening their development and negatively affecting their whole lives.

    It would seem that young people are granted protections when those protections do not inconvenience the majority of voters. See how far you would get trying to introduce a 20-mph speed limit in cities so as to cut the number of deaths and injuries suffered by young people in collisions with cars.

    The Conservative Party, which has been in government in the U.K. for more than 10 years, has a poor record on child poverty, which has shot up under its governance, and on child hunger, in the face of which it twice provided relief for the neediest children during lockdowns only after being shamed into doing so by a campaigning footballer.

    But, on the other hand, it has had a good record in respect of supporting the tobacco harm reduction potential of vaping, and the UKVIA is hoping the situation in the U.K. can be improved further following the country’s exit from the EU.

    On March 15, the UKVIA launched its Blueprint for Better Regulation in response to the U.K. government’s consultation on the Tobacco and Related Products Regulations (TRPR) (and the Standardized Packaging of Tobacco Products Regulations), in which it was seeking until March 19 feedback on the effectiveness of the legislation in achieving its objectives and any unintended consequences that may have occurred.

    In a foreword to the blueprint, Dunne said the review of the regulations represented a defining moment in the history of the vaping industry, one of the leading market disruptors in the 21st century responsible for a significant decline in smoking across the U.K. It also presented the biggest opportunity yet for the government to create fair and proportionate vaping regulation that supported its 2030 smoke-free target and ensured the sector could make a bigger contribution to the nation’s public health and economy in the future.

    To achieve such a goal, the UKVIA needs the help of the government to counter the misinformation currently providing an increasingly powerful drag on efforts to encourage people to switch from smoking to vaping. It needs the government’s help in mounting promotional campaigns aimed at such switching, and its permission to mount its own agreed consumer communication campaigns, including with those buying online. And it needs the freedom in which its members can develop vaping products capable of competing with conventional cigarettes on a nicotine-satisfaction basis.

    There is, of course, much more in the UKVIA’s blueprint. No such presentation would be complete without a discussion of the important role flavors play in encouraging people to switch. The blueprint looks at packaging and labeling, descriptors and product quality and safety. It supports age restrictions on the purchase of vaping products and the need to work with trading standards officers in ensuring such restrictions are enforced. And it wants the government to act in relation to vaping in public places.

    What are the chances? Well, Dunne appears to be confident, and, as is mentioned above, the government has in the past been supportive of the tobacco harm reduction argument made in respect of vaping; so it could be willing to work with at least some the UKVIA’s ideas, perhaps all of them. But caution must be advised.

    Two skills the U.K. government is known for are its shape-shifting and U-turns. And one concern must be the government’s likely reaction if it found that conversions to vaping picked up so fast that tax revenues from tobacco fell dramatically. It’s addicted to such revenue, especially since the promised Brexit dividend, not even mentioned in March’s budget, seems to have melted away.

  • Great Expectations

    Great Expectations

    Priscilla Agoncillo, president of the Cannabinoid Industry Association, says the CBD market is poised for massive growth.

    The cannabidiol (CBD) market is growing rapidly. The market is also preparing for industry regulations from the U.S. Food and Drug Administration as well as the possibility of changing rules under a new hemp bill winding its way through the U.S. Congress. Speaking during an online forum presented by TMG, a tobacco media group, Priscilla Agoncillo, president of the Cannabinoid Industry Association (CBDIA), outlined the current state of the CBD industry and what manufacturers, retailers and consumers can expect through 2021.

    Estimates by New Frontier Data say the CBD market will increase from $390 million in 2018 to $1.3 billion in 2022. Additional research by BDS Analytics and ArcView Market Research suggests that CBD sales will reach more than $20 billion in 2024. CBD already comes in numerous forms, such as oils, tinctures, capsules, edibles, even topicals and cosmetics. CBD products also are expected to expand into infused beverages, suppositories, sprays, inhalers and a wide variety of hemp smokable products, according to Agoncillo. There will also be a significant increase in cosmetics and supplements that contain CBD as well as more novel drugs introduced as companies expand research and development efforts.

    “In distribution channels, despite strict rules and regulations, the number of dispensaries and authorized retail storefronts that sell cannabis-based products to consumers will be opening due to new regions and states legalizing (marijuana) to meet the demand of consumers,” Agoncillo said. “Additionally, with the increase of product types, more big-box retailers will be stocking more CBD products and fostering relationships with CBD companies in research and development.”

    Agoncillo expects the popularity of CBD products to continue to grow as the scientific evidence of CBD’s benefits comes to light. The research and findings will also boost efforts by companies looking to introduce new products and develop new uses for various types on cannabinoids, which will increase integration with new technology and delivery systems. There are currently an estimated 104 cannabinoids in the cannabis plant.

    Looking at the top CBD trends in 2021, Agoncillo says that niche market efforts will become larger and more formalized as brands continue to seek out less crowded consumer segments. This will further diversify and differentiate each brand and allow for businesses to achieve higher returns on investments (ROIs) on exploratory segmented marketing efforts.

    “Brands will move toward proven consumer packaged goods (CPG) models focused on brand family extensions, including the marriage of complementary products and product iterations. Companies will work towards developing diversified portfolios and specific consumer segmentation,” she said.” You will see brands that will follow the Procter & Gamble family of brands business model or create line extensions of existing brands.”

    Priscilla Agoncillo

    Moving forward, Agoncillo says that the success of the CBD market will be predicated on understanding consumer market entry and adoption trends. According to High Yield Insights, CBD gummies are the entry point for most new consumers (at a rate of 60 percent) before trying other types of CBD products. Another growing entry point is CBD-infused beverages. A recent CBD beverage study released by High Yield Insights and Innovate MR revealed just how much legroom there is in the CBD beverage segment, according to Agoncillo. Among 4,200 survey respondents, only 28 percent report finding “a CBD product brand or format that works for them,” according to the research.

    “We project exponential growth in this segment [along with increased] diversity and inclusivity. Asian, Black and Hispanic consumer marketing efforts will support cultural competence, particularly among the nation’s largest brands,” said Agoncillo, citing her organization’s market expectations. “We expect to see more focus on niche marketing as consumer brand loyalty shifts toward the brands that consumers believe, respect and understand. More brands will concentrate on the growth opportunities within the Asian, Black and Hispanic consumer market, which have remained relatively untapped by CBD companies. One of the first signals of brand dominance in this segment market is the introduction of unique campaigns, specifically built to appeal to Black and Hispanic consumers, as well as Spanish-language advertising, packaging and support.”

    Exploding anxiety rates and associated mental health issues, especially surrounding the Covid-19 pandemic, will also provide hemp and CBD brands with new opportunities to promote the efficacy of CBD. Agoncillo says her organization is seeing increased focus on this niche market, which can be tricky to navigate due to advertising restrictions.

    “Brands are finding value in workarounds that allow them to leap over ad restrictions via targeted keyword searches; 25 percent of new market entrants purchased CBD to cope with pandemic-related stress and anxiety,” she said. According to High Yield Insights, more than 83 percent of U.S. employees reported mental health issues during 2021, and over 67 percent of U.S. employers project another mental health crisis within the next two years.

    “We project heightened partnership and growth opportunities in CBD products focused on stress, anxiety and sleep. Staying ahead in CBD as a highly regulated, newly developing industry, it is important that you obtain legal counsel to assist in the understanding of changes in regulations as well as to help you keep up with the constantly changing atmosphere,” explained Agoncillo. “Keep your company in compliance with regulations, always. As many of the regulations have not been finalized to cover the entirety of the CBD industry, it is safer to always err on the side of caution by operating your company according to GMP and other top-tiered standards.”

    New regulations for the CBD industry are also on the horizon. Draft rules from the FDA are currently with the White House’s Office of Management and Budget; however, review of those rules is currently being postponed by the Biden administration. Agoncillo says that no one in the industry knows exactly what those rules entail.

    “It’s very interesting because I remember when that report came out; it was back in October 2020, and the media would contact us and ask for our opinions on what that report was and what the regulations are. The truth is that they didn’t release it to anyone,” she says. “Through the CBDIA, we have a lobbyist in Washington that’s dialed in and has his finger on the pulse of everything that’s happening. And they haven’t shown what those regulations are to anyone. However, we do know that it is suggested that things are moving towards GMP standards. In the U.K., they’ve adopted the novel foods application for their CBD products. They’ve moved full steam ahead there. So there’s a suggestion that it might follow that closely. But obviously, we don’t know until they actually come out. This is why it’s really important to be involved with different industry associations and different organizations because they are going to be the first to get the word of how it’s going to actually roll out.”

    Another legislative change is brewing in the U.S. Congress. On Feb. 4, 2021, Congress introduced another CBD deregulation bill, H.R. 841—the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021. If passed, the bill would legalize the marketing of hemp, CBD or any other ingredient derived from hemp in a dietary supplement, provided the supplement satisfies other applicable requirements. The bill is in committee as of this writing.

    Agoncillo says another important part of the success of a CBD business is participating and supporting the community. She says that owners can help their company succeed by joining and being active in relevant cannabinoid-related industry associations, attending and being present at key conferences and crafting business outreach accordingly. Owners also need to hire the right staff to help them grow.

    “Keep your CBD company ahead by staying on top of the latest medical research and/or participating in the R&D to further advance the science of CBD and the industry as a whole. Hire talent with five-plus years in the cannabis or hemp industry to help navigate through the development of the CBD segment of your business model,” she says. “You will need a seasoned insider that understands the culture and can effectively translate that to your company.”

    Experienced staff can help guide business owners through the smoke and mirrors to avoid pitfalls, harmful partnerships and assist in forming a proper strategy for a business model. Additionally, experienced talent will have key relationships and resources in place to assist in executing business endeavors, according to Agoncillo.

    “We need high-operating brands and companies out there to apply their talents and their products and their technologies into the CBD space. The consumers need it,” she says. “We want it. And there’s no better time to really sink your teeth into this industry. And it’s very exciting because we can form this industry into what we need it to be.”

  • Consumer’s Choice

    Consumer’s Choice

    INNCO works with consumer advocacy groups to promote tobacco harm reduction around the globe.

    By Timothy S. Donahue

    Most of the world’s cigarettes are consumed in low-income to middle-income countries (LMICs). From Armenia to Zambia, these countries can also have high rates of adolescent smoking, particularly among males. Rates in some countries can reach as high as 46 percent, according to the U.S. National Institutes of Health. Research suggests that 80 percent of the world’s combustible cigarette users are in LMICs.

    While numerous studies have shown otherwise, the World Health Organization (WHO) has long insisted that less risky nicotine products, including vapor products and e-cigarettes, are as harmful and dangerous as combustible tobacco products and should be banned or heavily regulated. The International Union Against Tuberculosis and Lung Disease (The Union), a Bloomberg partner for The Initiative to Reduce Tobacco Use, published its fourth position statement on e-cigarettes last year. It called for a blanket ban on all electronic nicotine-delivery systems (ENDS) and heated-tobacco products (HTPs) in all LMICs. These organizations, typically through groups funded by Michael Bloomberg, the billionaire anti-smoking advocate, will often donate millions of dollars to poor or struggling countries if governments agree to ban or heavily restrict access to less risky products.

    As a result of policies based on false information from organizations such as The Union and the WHO, nicotine consumers in LMICs often have no delivery system available other than combustible products. Experts say that the lure of massive amounts of funding is just too great for such countries to resist.

    The International Network of Nicotine Consumer Organisations (INNCO), a global advocate for sensible tobacco harm reduction (THR), states in a recent position paper that bans on ENDS are overly simple solutions that make the problems that come with combustible cigarette use worse. It also states that reduction and substitution are valid goals for smokers in LMICs as replacing combustible tobacco with alternative nicotine products can reduce risk of harm by at least 95 percent.

    “The hundreds of millions of people who smoke in these countries should have the ability to make decisions about safer nicotine products, particularly when their own health is on the line,” said Samrat Chowdhery, president of INNCO’s governing board. “Overly simplistic policy solutions, such as proposed bans on all ENDS and THR products by the Bloomberg Philanthropies-funded The Union, are being offered as a blunt and impractical tool for a situation that requires pragmatism and nuance.”

    The need for INNCO

    INNCO was founded in 2016 to build cooperation between the growing number of global associations that advocate for THR. An organization can join INNCO if they are nonprofit, consumer-controlled and focused on tobacco harm reduction. The organization has 40 members in 35 countries, including the U.S.-based Consumer Advocates for Smoke-free Alternatives Association, a well-established advocacy group that raises awareness and protects the rights of consumers to access reduced harm products. INNCO also has members from Canada, Denmark and Greece to the Philippines, Brazil and Kenya.

    The organization continues to grow. “We are enlisting new members in several countries,” Chowdhery told Vapor Voice after the release of the position paper in March. “We are helping consumers form organizations where there are none. Africa came on board, where we have four, five members from that region this year, and since 80 percent of smokers do live in LMICs, it’s an additional focus that we have developed. It is something that, with this paper, we want to really say, ‘OK. We want to participate in discussions on these issues in LMICs.’”

    Samrat Chowdhery

    When The Union released its position paper calling for outright bans, Chowdhery says the recommendations were discriminatory. It was centered on the idea that if LMICs would not be able to enforce regulations, the only other option was a total ban on reduced-risk products.

    “They were not very mindful of the situation where if you could not regulate, it’s likely that you will also not be able to enforce a ban either. We know this because it’s what has happened in Mexico, Brazil and Thailand, where there have been bans, but products are very easily available,” explains Chowdhery. “If they would have instead implemented some sort of a regulatory control, you could ensure that there are product standards, they’re not sold to minors … but only having them available on the black market, those controls are not there, and you end up increasing the level of population harms to health.”

    Typically, when organizations like the WHO or United Nations develop policy, the organizations involve the industry stakeholders. After all, these are the people and businesses that the policies impact, says Chowdhery. Tobacco is the only industry that consumers and stakeholders do not have a say in policymaking.

    “The media should be taking this up. There is some trickery here,” he says. “The way the debate has been developed and the way Article 5.3 is getting misused all the time—it is a tough fight, but we’re up for it … we have our lives in the balance.” Article 5.3 of the WHO Framework Convention on Tobacco Control (FCTC) states that when setting and implementing their public health policies with respect to tobacco control, “Parties shall act to protect these policies from commercial and other vested interests” of the tobacco industry. Many anti-tobacco organizations have interpreted this as a ban on all interactions with the industry.

    Words of reason

    In the paper, INNCO claims that blanket bans on vaping and HTPs are a detriment to LMICs. The report, “10 Reasons Why Blanket Bans of E-Cigarettes and HTPs in low-[income] and middle-income Countries (LMICs) Are Not Fit for Purpose,” warns policymakers that limiting nicotine consumption options to reduce harm will only increase the number of people smoking combustible tobacco. The paper lists the following reasons:

    • Bans are an overly simplistic solution to a complex issue and will not work.
    • Prioritizing the banning of reduced harm alternatives over cigarettes is illogical.
    • Reduction and substitution are valid goals for smokers in LMICs.
    • People who smoke have the right to choose to reduce their own risk of harm.
    • Reduced harm alternatives can significantly contribute to the aims of global tobacco control.
    • Lack of research in LMICs is not a valid reason to ban reduced harm alternatives.
    • The prohibitionist approach in LMICs is outdated, unrealistic and condescending.
    • Bans will lead to illicit markets with increases in crime and no tax revenue.
    • Banning reduced harm alternatives leads people back to smoking and greater harm.
    • Blanket bans in LMICs are a form of “philanthropic colonialism.”

    INNCO says many LMICs risk an increase in smokers as a result of their policies. Leveraging the paper’s findings, INNCO states that it will work with its global membership to inform policymakers in developing nations to help achieve risk-relative regulations and access to THR products

    “Africa is home to some of the highest-ranked smoker countries on the planet,” said Joseph Magero, chairman of the Campaign for Safer Alternatives, a pan-African nongovernmental member organization dedicated to achieving 100 percent smoke-free environments in Africa. “While improving overall public health has made great strides in these regions, efforts to directly address smoking cessation and harm reduction strategies have lagged due to limited or no access to safer, noncombusti[ble] nicotine products. By denying smokers access to much safer alternatives while leaving cigarettes on the market, policymakers would leave only two options on the table—quit or die.”

    Nancy Loucas of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA), a grassroots alliance of THR advocacy organizations and an INNCO member, said a blanket ban in LMICs is a form of philanthropic colonialism, suggesting that these countries and their citizens cannot be trusted with any level of self-determination. “Inhabitants are treated as second-class citizens, which is offensive,” she said. “There is no benefit in limiting choice of safer nicotine products but only the potential for increasing harm.”

    Samsul Arrifin, president of the Malaysian Organisation of Vape Entities (MOVE) and an INCCO member, concurred with the INNCO assessment, saying that “any move to deprive smokers and consumers of better alternatives to cigarettes, such as vapes, would only contribute [to] the problem that [it] seeks to address.”

    Francisco Ordonez of the Asociacion por la Reduccion de danos del Tabaquismo Iberoamerica, a network of consumer organizations in Latin America and an INNCO member, says that few LMICs have adopted even the most basic prevention measures suggested by the WHO. “Policymakers should embrace harm reduction as a valid goal, particularly in LMICs where access to cessation programs is extremely limited,” said Ordonez. “Replacing combustible tobacco with alternative nicotine products can significantly reduce the risk of harm by at least 95 percent. It works in industrialized nations and can do the same in LMICs.”

    The Bloomberg conundrum

    Much of the ire of the THR community is reserved for Bloomberg Philanthropies (BP). In September 2019, Bloomberg and Matthew Myers, president of the nonprofit Campaign for Tobacco-Free Kids, launched a $160 million three-year campaign to end what they described as an epidemic of e-cigarette use among kids. The campaign is supported by several large nonprofits, like the Truth Initiative, American Cancer Society, American Heart Association and American Lung Association. Together, the organizations are pushing for a national ban on flavored ENDS products in the U.S.

    Chowdhery says that Bloomberg is using philanthropy in an unprecedented manner. “I’ve not seen anyone do this. This is so insidious. You have Bloomberg-funded attack groups,” says Chowdhery. “They were anti-smoking for a long time until these new [reduced-risk] products came on the market. Then they expanded their focus to become anti-nicotine … they are becoming more and more radicalized, proposing more and more extreme ideas as we go along. You have groups that their only stopping-tobacco tactic is just attacking people. That’s their job. That’s all they do.”

    Bloomberg, both as an individual and through his foundation, has committed nearly $1 billion to combating tobacco use worldwide, most of it focused on LMICs, according to BP. “These policies are what we call philanthropic colonialism because they’re just pushing an idea they have, an idea a New York billionaire has, on countries, which may not be suited for this,” explains Chowdhery. “He’s not proposing those policies [total bans] in the U.S.”

    Chowdhery says Bloomberg and his charities spread lies and disinformation without any regard for the negative impact on public health. During an appearance on CBS News, Bloomberg suggested vaping lowers IQ, even though there is no evidence about a relationship between nicotine use and intelligence.

    Chowdhery hopes the INNCO position paper will be read by the policymakers working with Bloomberg. “That was the main objective of the paper: to reach out to policymakers, reach out to media and professionals and let them know … what is being proposed has another side to it,” said Chowdhery. “See, this is a David and Goliath problem. What they have are well-funded organizations to push this narrative. And what they also have is credibility because a lot of this is coming from [well-known nonprofit groups]. Even if they publish a paper with lots of misinformation and have a disclaimer: ‘We received a million dollars from Bloomberg but that did not influence our work.’ That is a big problem.”

    The push forward

    The pandemic hit INNCO hard. Chowdhery, a former journalist, founder of the Council for Harm Reduced Alternatives and the director of the Association of Vapers India, was approached to head INNCO in July 2020. He said the organization had a lot of plans for the year, including regional meetings and setting up networks, projects that required a lot of on-ground activities. Then everything needed to be scaled back. The year 2020 became about recalibrating INNCO’s efforts. “The year was full of uncertainty and adapting and doing things differently. We did a lot of online meetings and a lot of internal objectives online,” said Chowdhery. “We enrolled more members. When we put out a call for a CEO, we got 400 resumes.”

    Chowdhery says that the main goal for INNCO now is to have a say in policymaking and be recognized as a legitimate stakeholder in this tobacco control intervention. It won’t be easy. Already, groups funded by Bloomberg are trying to discredit INNCO. “Our strength is our membership base. They are organizations that might be poor but [are] passionate, and they are volunteering their time and effort[s]. That is the real strength, and we need to leverage that and get everyone on the same platform so that we speak with common messaging,” says Chowdhery. “This is the first year that we actually have a budget to do our work. Unfortunately, we’ve not started because of Covid-19. We’re getting a new CEO, who should be with us soon. Things are looking really good.”

    In a recent essay in the journal Science, “Evidence, Alarm and the Debate Over E-Cigarettes,” five experts in public health state that it is a mistake to restrict access to vaping products while leaving deadly cigarettes on the market. The authors include Cheryl Healton, the former chief executive of the Truth Initiative, who is dean of the New York University school of public health, as well as the deans of the schools of public health at Ohio State and Emory universities. The essay concludes: “Careful analysis of all the data in context indicates that the net benefits of vaped nicotine products outweigh the feared harm to youth.”

    Chowdhery says that 15 years ago, there were no groups championing tobacco consumer rights. It’s now, when safer means of consuming nicotine are available, that consumers want to have access to them. “We consider that a right. This campaign of misinformation and regulatory overreach is a disaster waiting to happen,” says Chowdhery. “People in tobacco control, they’re earning paychecks to develop a policy which they then get passed through Parliament somewhere and they believe their work is done and they go home. The problem is, did legislation stop the use of that product that day? No, it just went underground. It became riskier. Now, it’s costing people their lives.”

  • The Blinc Reflex

    The Blinc Reflex

    Cannabis vaping needed a full-service hardware manufacturer with products designed for CBD and THC oils.

    By Timothy S. Donahue

    When the cannabis industry began to take off in the U.S., vaping became a popular way to consume cannabinoids. However, many of the devices used to vape nicotine products did not work as well with the more viscous cannabinoid oils, especially THC and cannabidiol (CBD). There was a massive need for high quality vaping products that were specific to the fast-growing cannabis industry.

    The Blinc Group started in 2017 to provide industry-specific vaping hardware to cannabis companies in Canada, the U.S. and Europe, according to co-founder and CEO Arnaud Dumas de Rauly. The company offers off-the-shelf products that can be fully customized and creates bespoke products. Dumas de Rauly says Blinc Group isn’t a cannabis company; it’s a technology company that serves the cannabis industry. Blinc Group provides every level of service from product design and customization to compliance testing, manufacturing, shipping and logistics.

    When the legal cannabis industry began to grow and more states legalized marijuana in some form, it wanted to separate itself from the nicotine vaping industry. There was little crossover between products. To Dumas de Rauly, who honed his skills in nicotine vaping hardware, it was baffling that no one was applying the knowledge gained in nicotine vaping to cannabinoids. He says that the cannabis industry today is in the same situation the nicotine vaping industry was in two or three years ago.

    Arnaud Dumas de Rauly
    Arnaud Dumas de Rauly / Credit: The Blinc Group

    “It’s becoming more accepted by regulators, by the general public. However, I can see the cannabis industry making some of the same mistakes that nicotine vaping had made … such as marketing to kids. That is going to bite our industry in the ass over the next couple of years, especially when all of this becomes federally legal,” said Dumas de Rauly. “We’re going to be really frowned upon if we are using cartoons on our packaging, if we don’t use proper standards.”

    In regulatory matters, the cannabis industry was trying to reinvent the wheel. Instead of using manufacturing standards and regulation that had been developed in electronic nicotine-delivery systems (ENDS), the cannabis industry wanted to create its own standards. When the industry started developing its own way of analyzing product emissions, Dumas de Rauly said he had had enough.

    “We already have these standards in nicotine vaping. We can already use that basis and then just add some components we’ll be testing for that are specific to the terpenes that are specific to more viscous extracts, that are specific to cannabinoids. We already have a base,” he explains. “Radioactive components, for example. It’s something that seems logical. It’s in the nicotine vaping standards. We’ve got to make sure that there are no radioactive materials in there. That’s very easy. You just translate over to cannabis. Why the heck won’t we do it? Testing for aldehydes, heavy metals is stuff we’ve already been doing in nicotine vaping for years.”

    Be on the Blinc

    The same couldn’t be said for the hardware. While standards and regulation could be carried over from the nicotine vaping industry, hardware needed to be specific to cannabis. Eric Newman, director of sales for Blinc Group, says the THC industry in the beginning used hardware designed for nicotine but soon shifted to specific cannabis vaping products. Newman said to get the cannabis industry comfortable developing its own hardware was an educational experience.

    Credit: The Blinc Group

    “Different clouds work well with different types of products. Customer experience is something that we take seriously. For us, it was coming from a product perspective and a knowledge and educational perspective as well. We needed to teach the end user that one device or one product is better than the other and why they should use one product over another.”

    Newman says that more companies are moving toward open systems and that is expected to continue moving forward. He said that Blinc Group is dedicated to passing along its knowledge across all stakeholders and getting more people talking about best practices and standard operating procedures [SOPs]. “I think it’s education first then proving that what you’re educating actually works,” says Newman. “Then you open up the network to the masses.”

    A good example of a hardware change to accommodate cannabis products is the move away from poly-type or plastic cartridges, according to Newman. He says Blinc Group now uses strictly glass cartridges.

    “The whole market hasn’t switched to that model, and we’re pushing the market into, from a quality and safety perspective, going to all-glass type cartridges,” he says. “The next step to that process is actually happening already. We’re making full ceramic cartridges, making full glass cartridges. Except for the inner components that still have to have some metal and ceramic cores—but it’s happening in front of us where we’re seeing those type of products. Unfortunately, Blinc Group hasn’t found any that fit our model, but there’s certainly a revolution happening already, and I think Blinc Group’s ahead of the curve on it.”

    Dumas de Rauly attributes much of the Blinc Group’s success to the emphasis it placed on safety and compliance throughout the EVALI crisis of 2019 and the Covid-19 pandemic. Even outside investors are starting to notice. In early January, Blinc Group successfully raised $1.5 million in bridge funding.

    “Our team navigated 2019’s vape crisis helping set standards and advise regulators on testing and compliance, and last year, the company saw our best quarter yet amid the Covid-19 pandemic as the industry learned the benefits of safety and traceability,” said Dumas de Rauly. “We have shown that we are a resilient company that puts consumers first, which has made all the difference.”

    In just over a year, Dumas de Rauly and his two partners managed to turn their company into a business generating approximately $1 million in revenue, adding an additional five team members in the process. By 2019, the company was grossing over $4 million in revenue and had 15 employees. In 2020, Blinc Group more than tripled its orders with more than 330 percent year-over-year growth.

    The technology company seemed to have a knack for expanding in an increasingly difficult regulatory landscape. “I don’t have the exact numbers yet, but I know in terms of sales orders, we hit $14.2 million in 2020,” said Dumas de Rauly. “We have increased our team to 21 members, and we are really excited about our future in this unique and exciting industry.”

    Blinc of an eye

    The Blinc Group specializes in standards and quality. The company was created to help the cannabis industry comply with Canada’s robust regulatory requirements through the highest quality testing and supply chain standards. Canada legalized recreational marijuana in 2017.

    Dumas de Rauly and his two Blinc Group co-founders, Givi Topchishvili and Alexander “Sasha” Aksenov, who also serves as chief innovation officer, had the collective experience needed to change nearly every aspect of how the cannabis industry was operating, from standards and other regulatory needs to lobbying, manufacturing and even sales. Topchishvili is an entrepreneur, investor and author with 30 years of market entry experience in Europe, Asia and the U.S. Aksenov has been in the cannabis vaping industry for more than seven years. He has created several ventures ranging from branding studios, record labels and media management companies to marketing agencies.

    Dumas de Rauly is the scientist. He currently chairs the ISO (International) Standards Committee TC126/SC3 on Vaping Products and the CEN (European) Standards Committee TC437 on Vapor Products. He is also a member of the informal Marijuana Science and Policy Work Group managed by the Colorado Department of Revenue’s Marijuana Enforcement Division and Colorado Department of Public Health and Environment. Dumas de Rauly is also the former president of FIVAPE, the French vaping trade federation, and now serves as the organization’s secretary-general for international relations.

    “As chairman of ISO standards on vaping products, I was getting a lot of friends that were coming up to me and asking me what I thought of their vaping products. And when I looked at them, I quickly saw that the products they were using were not adapted to the format of the [cannabis] extract, which is very, very viscous, oily, in some cases, really like molasses,” explains Dumas de Rauly. “I got concerned about the safety issues, started looking into it and … my partners and I decided to create the Blinc Group to bring the wealth of experience we had in nicotine vaping over to the cannabis industry.”

    What sets Blinc Group apart from other cannabis industry hardware manufacturers is its involvement in every aspect of the process, from design to sales—what Dumas de Rauly calls “enterprise solutions” or consultative sales. The company doesn’t do sales on a traditional transactional basis. Every Blinc team member gets involved. “We can move along the entire vaping value chain. We have done product formulations for clients; we go through automation with filling and capping SOPs all the way down to point of sale and training,” says Dumas de Rauly. “We train our clients’ salespeople on specific hardware. We really insert ourselves throughout the entire value chain of vaping products in cannabis.”

    Eric Newman

    The Blinc Group may be the only cannabis industry vaping hardware manufacturer that controls its entire supply chain. This is important because when a manufacturer orders from a factory in Shenzhen, China, where most vapor hardware is produced, that company has no clue where the raw material is sourced. The factory knows but not the client. Blinc Group sources the raw material suppliers. It then tells the subcontracted factory that those factories need to use the Blinc-sourced suppliers.

    “We have an entire audit trail of every single material that comes into the device. That is one very important [differentiator] and one of our biggest differentiators. It also allows us more resiliency and redundancy within our supply chain because we’re not buying just from one factory,” Dumas de Rauly says. “We have four different manufacturers we work with—or assemblers, as we call them because they don’t really manufacture. They assemble products. And when one of them is not available, we can have the same product manufactured by another one because we own all of that supply chain.”

    Blinc and you’ll miss it

    There is one fundamental reason for controlling the supply chain: safety. Alongside innovation, quality and integrity, Dumas de Rauly says safety is part of Blinc Group’s foundation. It’s the company’s main focus in advocacy as well. For example, recently, the company worked with the U.S. state of Colorado to implement emissions testing in vapor products.

    “[Colorado is] the first state in the U.S. that is requiring emissions testing, but that just goes to show that we’re even willing to put barriers in front of our business to make sure the consumer is safe. We have pioneered the use of medical-grade stainless steel in the products instead of using the regular H59 material to avoid any leaching of lead,” Dumas de Rauly explains. “We push our analysis and the control of the supply chain specifically for these reasons. Another example: In a typical 510-threaded cartridge, you have all of the materials that come into contact with the oil inside. Each one of those materials is sent off from each supplier—and we have four suppliers for each material—to undergo testing in an international lab. And given what we find, we adjust that material to make sure that individually, every single piece one of our cartridges will not leach, for example, heavy metals.”

    Blinc Group has a large presence in Canada specifically because of the company’s compliance and regulatory stance, according to Dumas de Rauly. He expects the U.S. to adopt a similar type of regulatory framework soon. “People have already started understanding the need for regulations since the EVALI vaping crisis,” he said. “I’m very confident that this year, we’re going to be focusing a lot of our attention on the U.S. market and growing our U.S. presence.”

    After Canada legalized recreational marijuana, the country passed the Cannabis Act. It includes some of the most stringent rules for cannabis on compliance and regulation in the world. Batteries, for example, need to be UL 8139 certified. In the U.S., it’s only a recommendation. The certification costs a little more, and the UL process could take anywhere from three-month to six-months, says Dumas de Rauly, but it’s necessary to protect the end user.

    “We were the only ones attacking that market with UL-certified products in terms of batteries. We were the only one attacking that market with FDA, CFR21 or CPG21 certifications for our raw material. That was our edge, and that’s why we made such a big impact in Canada in 2020,” says Dumas de Rauly. “As regulation is becoming a little more stringent in the U.S. and after the EVALI scare, those consumers are starting to understand that they need to be paying attention to what’s in the vaping hardware.”

    Blinc Group virtual meeting

    As EVALI soared in the U.S., many believed the vaping industry was dead and the disposable option was a fad. Dumas de Rauly says that, in reality, cannabis accounts for more than 30 percent of the market in some states. Some states with legal medical marijuana allow only the sale of THC vaporizers. This is because contents and strength can be easily regulated in a vaping product. The same is not true for cannabis flower products. He sees the industry growing even more rapidly in the U.S., especially if marijuana is legalized on a federal level.

    “The road is going to be bumpy. There is going to be more regulation. We are pushing for more regulation because we want to make sure that our business is sustainable over the next five to 10 years,” he says. “We don’t want to see what happened to nicotine vaping happen to cannabis vaping. We’re really pushing for good stewardship for the industry. We are thought leaders in the space, and we want to be at the forefront of education and making sure that consumers get safe products.”

    As the legal cannabis market grows in the U.S., Dumas de Rauly says that the Blinc Group will be growing and continuing to grab more market share as well. He says that the Blinc process is highly developed. It runs like a well-oiled machine. “We have a very strong team,” says Dumas de Rauly. “We have a strong presence. Our processes are well refined. I believe we’re going to be doing very, very good this year.”

  • Field of Dreams

    Field of Dreams

    Credit: Solari Hemp

    Solari Hemp is a Colorado-based fully integrated farm-to-shelf supplier of THC-free CBD products.

    By Timothy S. Donahue

    Cannabidiol (CBD) is one of the fastest-growing industries on the planet. It’s motivated by the ever-growing popularity of the supplements on the global market. However, according to a Consumer Brands Association (CBA) survey, nearly four in 10 Americans incorrectly assume CBD is just another name for marijuana. The survey also found that consumers said that the quality and safety of the product were extremely important when making a CBD purchasing decision.

    Solari Hemp, founded in 2018 in Longmont, Colorado, USA, is a fully integrated farm-to-shelf hemp company with on-premises growing, extracting, shipping and sales/marketing capabilities. The company sells only 100 percent THC-free CBD products. Solari Hemp maintains full control over the production/development process of its products from start to finish, according to Colin Gallagher, co-founder and CEO of Solari Hemp.

    “For us, it’s about being a company that has roots in the C-store industry and understands the needs and complexities of operating with products that are in a regulatory gray area,” he says. “We want our partners to trust the team behind Solari and the people behind it; trust the brand and the quality of the product you’re getting. We test all the way through seed to shelf. We offer transparency in the testing. We are doing things the right way. It’s about being good retail partners. Our success is their success.”

    Colin Gallagher / Credit: Solari Hemp

    Solari means “land exposed to the sun” in Italian. As a child’s name, it can be translated to “beauty greater than the sun.” Gallagher says he and his team wanted to create a packaging design that didn’t have the in-your-face marijuana branding often associated with such products or that could be misconstrued as a pharmaceutical product. The sun became the logo. It even has a little hidden “S” in the middle.

    Gallagher says he was working at Smoker Friendly International, and the CBD market was just starting to grow. The company decided it wanted to start carrying a CBD brand in its stores. Gallagher soon discovered that there was little transparency throughout the CBD supply chain, and many manufacturers could not guarantee consistent quality in their products. No product could meet the quality standards and quantities he needed. Gallagher wanted to do it better. He soon started talking with two industry colleagues and discovered they had similar ideas about what a CBD brand needs to be successful.

    “We decided that we could all work together and create a new company … use our experience, our trust and established relationships within the C-store industry to create a brand and a product that had a full chain of custody from seed to shelf,” he says. “We decided to just get out there and do it ourselves.”

    There is a lot of talent on the Solari team. Myorr Janha, co-founder and chief marketing officer, was previously responsible for global marketing, corporate communications and business development initiatives for Rush Communications and Simmons Design Group. With over 25 years of marketing experience managing a variety of brands spanning diverse sectors in entertainment, lifestyle and philanthropy, Janhaeads Solari’s marketing, advertising and PR strategy.

    Jake Salazar, co-founder and Solari’s chief development officer, is a fifth-generation Colorado native. He was named one of the 100 most influential people in the cannabis industry by High Times magazine in 2018 and 2019 for his accomplishments over the past 12 years in cannabis genetics and the hemp business. Salazar heads genetics R&D and business development for Solari. He also helped craft the original legislation to legalize marijuana in Colorado.

    Gallagher oversees the daily operations of the company. He grew up around consumer product goods and convenience retail operations and previously served as the director of operations and business development for Smoker Friendly.

    Back to the farm

    While many things stand out about Solari, its farming operation is the foundation of the company. In 2017 and 2018, the CBD market was experiencing shortages of wholesale CBD. Gallagher didn’t want to go through the process of creating a product and launching a product only to have a supply shortage and not be able to support sales. That’s when the company started looking for its own farms.

    “We found some farmers who had farmed hemp from early 2014 and then got out of it. They’re traditional, fourth-generation Colorado farmers. We brought them in as equity partners. We really wanted to learn about the product and be leaders in the industry,” explained Gallagher. “There’s still a lot of education that needs to happen in terms of just understanding hemp [compared to marijuana]. We are trying to be a leader in the market and do things the right way, our way, and have full transparency.”

    The Solari team began its first farm on just three acres to test its product. In 2018, Solari farmed 150 acres (about 6,000 plants) and continues to have the ability to expand. Like many hemp farmers, Solari did not farm in 2020 because there was an excess of hemp biomass in the market due to the Covid-19 pandemic. The company needed to step back. It was about survival.

    “The pandemic put a damper on sales. We know a lot of farmers and extractors who went out of business. There are high capital costs in the extraction process, and you have to have high-yielding crops. The higher your CBD potency, the better your yields. It’s all about efficiencies and that effectively impacts your cost of goods sold,” says Gallagher, adding that farming is also expensive. “Farming is challenging. The harvesting technology, drying technology—especially when you have a large crop. You need to get it out of the ground and get it dried and ready for extraction so it doesn’t go bad.”

    Hemp is like a vacuum cleaner, absorbing all that a soil has to offer, both good and bad. Gallagher says that heavy metals and pesticides on the plant or in the soil may be present in the resulting oil after the hemp is refined. The only way to avoid exposure to these contaminants is to know exactly where the hemp is grown. Solari’s seed-to-shelf process ensures its hemp adheres to the company’s high-quality standards. “Our crops are grown on our farms in Colorado without the use of any pesticides and our soil is consistently tested for heavy metals,” says Gallagher. “A reputable brand should always disclose the location [in which] the hemp was grown so a consumer has full disclosure prior to purchasing the product.”

    To isolate the CBD-rich oil from the hemp plant, a multistep extraction process is used to remove fats, lipids, cannabinoids and terpenes. Different extraction methods can provide a variety of advantages; however, testing after extraction for pesticides, heavy metals and residual solvents that can be present during the extraction process is vital. “Extraction is just dialing in the equipment to get the highest yields from the crude. We consistently test all of our final products to ensure there are no harmful chemicals or contaminants present within its extracts before it is sent to a third party to be tested again,” says Gallagher. “We control the entire process. Our retail partners, and consumers too, like having that transparency. It gives us an advantage in the market because it’s a product you can trust and there’s traceability. We do third-party testing to ensure consistency and quality. We also use a CBD isolate that guarantees we have absolutely no THC in our products.”

    Empire of the sun

    Today, the Solari line of products is sold in 2,000 stores to 3,000 stores, including Smoker Friendly, Rutter’s Farms, Town Pump, Food Lion and numerous independent C-stores. The company offers 23 SKUs, including gummies, tinctures, soft gels and topicals (balms, roll-ons and creams).

    Solari
    Credit: Solari Hemp

    Gallagher says that launching a brand at the end of 2019 going into 2020 was greatly impacted by the Covid-19 pandemic. In the C-store channel, it’s about face-to-face meetings, building trust in each other and building trust in the product, according to Gallagher. He says that not being able to fully develop those relationships and not being able to go to trade shows and sample the products was a nightmare.

    “It was a challenge, for sure. But we adapted. For us, it is more about just being able to be fully transparent and able to deliver a high-quality but affordable product. That’s another one of our big things: affordability. In the C-stores, we don’t [expect people] to come in and pay $50, $60 for a tincture,” explains Gallagher. “It’s something that’s kind of a grab-and-go item, so our lowest-priced item is $6.99. Then it’s supporting the brand, supporting the retailer and understanding their business, and working with them to make the product successful. I think this dedication to the retailer separates us from the pack. It’s about those relationships and doing things the right way and not creating more work for our partners.”

    Moving forward, Gallagher says Solari must remain innovative, whether it’s a function of product or delivery. He says the company is currently working on some new products that are expected to come on the market this year. There is so much competition in the CBD industry that Gallagher says you have to think outside the box to survive. He says that CBD beverages, for example, are a fast-growing CBD segment, and that could potentially be part of Solari’s portfolio.

    “We see a huge future for the beverage industry, and that’s on our radar. If you’re going to release a new product, it’s got to be something that grabs people’s attention. I mean, at the end of the day, your product has to work, right?” Gallagher asks. “People have to believe in the product itself and then it needs to be different. If you take something that’s like a pull on the cap of a beverage and you push it down and shake it up, that’s different, right? We are trying to be innovative and thinking about things that aren’t currently on the market.”

    Regulations are also coming soon for the CBD market in the U.S. The FDA has already announced proposals for the industry. Today, most CBD products are manufactured by smaller companies, and, absent consistent regulation, it is up to the individual businesses to invest in the research that protects consumers. Gallagher says he wants to see responsible regulation, and the industry needs to help decide what those regulations may entail.

    “I don’t think it’ll be like the PMTAs [premarket tobacco product applications] the FDA uses with tobacco and vapor. We need input from the industry to get things done the right way. Part of that is keeping the bad actors out,” says Gallagher. “I think this administration will certainly be more friendly to cannabis in general [than it was toward tobacco and e-cigarettes]. I think there will be more regulation on the smokable side, meaning it’s something that you inhale. Anything that is like a tobacco product and used in a similar fashion and is not currently taxed … will be regulated.”

    For Solari, the company remains focused on continuing to being an innovator in the industry, focused on becoming a household name. “We want to be a recognizable label,” says Gallagher. “We want Solari to be the brand that people associate with quality and trust. That’s something that will never change.”

    Credit: Solari
  • An Onerous Burden

    An Onerous Burden

    Many small vapor manufacturers are attempting to overcome the FDA’s rigorous PMTA requirements.

    By Maria Verven

    A process that was built for billion-dollar tobacco manufacturers has posed onerous challenges for small e-liquid manufacturers. With the enormous work of pulling together premarket tobacco product applications (PMTAs) for the U.S. Food and Drug Administration behind them, vapor manufacturers are now gearing up for the formal substantive review phase when the regulatory agency will conduct in-depth evaluations of the applications’ requisite scientific studies.

    Many relied on help from the PMTA Sharing Group on Facebook to meet the challenge of submitting a separate application for every flavor in every nicotine level in every size bottle, sending literally millions of pages to the FDA. In addition, every PMTA had to contain a plethora of research into the product’s relative health risks for current users and nonusers as well as whether marketing the new product would be appropriate for the protection of public health (APPH).

    A full assessment of how users consume their products over time as well as the potential for addictiveness, abuse and misuse was also required. And for those who missed the Sept. 9 deadline and/or failed to meet these requirements? In January 2021, the FDA issued warning letters to 10 e-liquid manufacturers that failed to submit PMTAs by the deadline, advising them that it is now illegal for them to sell their products in the U.S.

    Vapor Voice took on the task of asking several vapor industry experts and business owners for their perspectives on the current situation.

    ​A daunting process

    Lindsey Stroud, policy analyst with the Taxpayers Protection Alliance, a Washington, D.C.-based nonprofit think tank dedicated to educating the public on the government’s effects on the economy, said many of her clients are still in the thick of the testing process.

    Lindsey Stroud
    Lindsey Stroud

    “The process was daunting—among my clients and the folks I assisted, I probably worked on 100,000 to 200,000 individual products. Several of my clients made it past the first step, but there are many more to come,” she said. “AVM (the newly formed American Vapor Manufacturers) is really a genius idea when it comes to these small e-liquid companies. In getting more small businesses involved, the price of testing can slowly come down.

    “In the aftermath of the vaping-related lung illnesses (EVALI) in late 2019, it’s imperative that regulatory agencies know what’s in the products and their effects on the U.S. population. The FDA is bound by law to apply the PMTA equally to all manufacturers, regardless of size. Still, the testing requirements for each and every liquid is unduly burdensome for small e-liquid manufacturers that offer hundreds of flavors, often with many flavor components found in numerous companies’ flavorings.

    “Currently, if a manufacturer sells a strawberry e-liquid in 20 different nicotine strengths and three different bottle sizes, the FDA requires them to test all those products (20 products times three bottle sizes would mean 60 tests for just one flavor), which is inefficient, daunting and expensive. The FDA has shifted and made the PMTA requirements less burdensome; for example, [the] FDA now allows companies to submit a single PMTA instead of individual applications for each of their products

    “Ideally, I would prefer the FDA to allow a flavor manufacturer to have only three tests per flavor—their zero nicotine option, their lowest nicotine option and their highest nicotine option.”

    Phase 3: Substantive review

    The team at North Carolina-based Bantam Vape worked with highly qualified labs to conduct the in-depth, product-specific and non-product-specific testing needed for their PMTAs, according to Bantam Vape spokesperson Anthony Dillon.

    Anthony Dillon

    Offering 21 “uniquely crafted flavors” created by chemists and flavorists in different nicotine levels and sizes, Bantam conducted storage and stability testing, toxicity testing and pharmacokinetic and topography studies as well as submitting an extensive review of available literature on its products. After hearing that the PMTAs for Bantam’s products were initially accepted and filed by the FDA last fall (indicating that the FDA had finished its preliminary review) the Bantam team is now waiting for the formal substantive review phase to commence.

    “We invested significant resources into the foundation of our PMTA submissions, and we continue to invest resources in the PMTA process and post-market surveillance,” Dillon said. “We worked with reputable, like-minded industry players to share key costs to significantly improve efficiencies, which can help us continue selling our high-quality vape at an attractive price point.

    “The PMTA process has certainly impacted the entire e-liquid industry—from manufacturers to retailers to consumers. We believe the PMTA process, though complex and resource-intensive, provides a benchmark for all e-liquid manufacturers, something that the industry, up until now, was lacking. E-liquid companies undergoing the PMTA process must evolve to remain on the market long term. Bantam is, and has always been, committed to developing and manufacturing high-quality, adult-use e-liquid products consistent with FDA guidance and applicable laws. That goal has not changed.

    “With any new process, there are kinks to be ironed out. The PMTA is no different. Wherever possible, we are committed to working with the FDA to streamline and improve the process, and we will also work with our retailers and consumers to help them better understand this complex but necessary process. Currently, our biggest challenges are not due to the regulations but the need for transparency in the process and for enforcement against those that are not in compliance with FDA guidance and applicable laws.

    “The PMTA process provides a benchmark for all e-liquid manufacturers—something that the industry was lacking. We are proud of and confident in the e-liquid products that are going through the PMTA process, and we look forward to Bantam’s products being enjoyed by adult consumers for years to come.”

    Exceptions for artisan cigars

    Established in February 2014, 906 Vapor is located in a small community in Michigan. While at one time, they had about $250,000 in annual revenues, sales plummeted to about $180,000 last year due to a state flavor ban and the EVALI scare. One of 906 Vapor’s first customers, Mark Slis bought the store in October 2015. They currently carry over 100 e-liquid flavors using freebase and salt nicotine, along with kits, tanks and mods, a line of disposables and miscellaneous batteries and accessories.

    Mark Slis 906 Vapor
    Mark Slis

    Since 906 Vapor does not manufacture e-liquids, Slis didn’t have to submit any PMTAs; however, he helped the small Michigan juice manufacturers whose e-liquids he carries submit their PMTAs. Slis lobbied in Michigan, suing the state, health and human services and Governor Whitmer to stop last year’s flavor ban. He also organized a state trade organization and lobbied against flavor bans and other anti-vaping bills in the state’s house and senate, assisting various national organizations in their efforts.

    “The required testing places a massive and completely unnecessary burden on all manufacturers,” Slis said. “The proper regulatory response is to set standards, since all e-liquids utilize the exact same four ingredients with variation only in the specific flavoring(s) used. The ingredients have already been thoroughly studied and tested and found to be safe for human consumption. Only product standards should now be required.

    “Requiring duplicate testing for each of the 419 million flavors registered with the FDA and duplicate testing for each and every nicotine level for the same flavor is a transparent attempt by the FDA to eliminate the electronic cigarette industry—not regulate it. The FDA has already made it abundantly clear where they stand on independent, small vapor manufacturers. They refused to talk to vapor manufacturers and denied them any relief. Yet when artisan cigar manufacturers lobbied the FDA for a realistic approval pathway and assistance, the FDA not only granted them an indefinite exemption from the PMTA; they offered to spend taxpayers’ money to conduct the prohibitively expensive testing on their cigars.

    “In effect, [the FDA] will bend over backward to ensure deadly combustible products remain on the market while regulating smoking cessation out of existence.”

    Concerning job losses

    A member and vice president of the American Vaping Manufacturers (AVM) Association, a member of the Smoke-Free Alternatives Trade Association (SFATA) and the U.S. Vaping Association (USVA), Char Owen owns a small line of wholesale e-liquids called Unchained as well as two brick-and-mortar stores in Texas called Cloud 9 Vapor Shop that opened in December 2013.

    Char Owen
    Char Owen

    “Absolutely no consideration has been given to small business owners except a short PMTA extension during this pandemic,” Owen said, adding that although she contracted Covid-19 in December, she continued to help small businesses while combatting the illness. “There’s no process for notifying the FDA to request an extension when your family has been affected by Covid[-19]. A large company doesn’t need this, but most small companies are one-person shops or only have a few employees.”

    ​With over 800 e-liquid recipes, Owen ended up submitting PMTAs for over 332,000 SKUs to the FDA. As of this writing, all her PMTAs had been received but had not yet been accepted. They held a listening session with the FDA to obtain feedback on a testing protocol that Owen said could significantly cut the cost of testing.

    “The FDA said they will not be creating a simplified pathway for small business,” Owen said. “Testing requirements will put an unnecessary burden on them. These businesses have been selling the same product for many years. I’ve been selling the same product for eight years with zero complaints that our products have caused harm.

    “Using standard testing methods and one of the handfuls of testing labs, the testing requirements would cost me over $9 billion dollars. The market, however, will narrow to only those owned by large tobacco, which sells closed pod systems extremely high in nicotine sold in grocery stores and convenience stores. They are the only ones that can afford the PMTA process.

    “The problem is SKU inflation. In the FDA’s definition, my 800 products equal 332,000 products, or a 41,400 percent inflation of product SKUs. Something as simple as offering a different bottle size—common in our industry—is a major factor in testing costs, even though the original recipe is still the same. In vitro and in vivo studies could be withdrawn since these products have been on the market for almost 10 years. Just the high range of nicotine could be tested, and if those tests are acceptable, then obviously any lower nicotine levels would be acceptable.

    “Vapor shops cater to an over-21 clientele and mainly offer open system e-liquids. They employ a more hands-on approach to helping adults off-ramp from combustibles. We support, educate and help smokers convert to noncombustibles. Because of this support, we see a much higher rate of success than is reported by the FDA, which includes consumers who purchase at convenience stores and big chains. Mainly, we are just trying to help people stay off combustible cigarettes in our local communities.

    “It’s important to realize that this industry was founded by small business. The FDA’s requirements, together with a lack of a streamlined process, could cost over 100,000 people their jobs. We already have a huge job loss in the U.S. It’s the last thing we need.”

    The original “Vaping Vamp,” Maria Verven owns Verve Communications, a P.R. and marketing firm specializing in the vapor industry.

  • Predicting Policy Position

    Predicting Policy Position

    white house
    Credit: Rene Deanda

    Policy experts weigh in on the vaping industry’s future under the Biden administration.

    By Maria Verven

    Within days of assuming office, U.S. President Joe Biden issued executive orders to respond to Covid-19, by far the biggest global health threat in over 100 years. It may be months or even years before anyone knows how the new administration and the U.S. Centers for Disease Control and Prevention (CDC) and its new director, Rochelle Walensky, will respond to another major health threat: the 480,000 annual deaths caused by combustible cigarettes.

    Vapor Voice interviewed vapor industry leaders and legislative experts for their opinions on how the vapor industry might fare under the new administration. The panel includes:

    Mark Anton, executive director, Smoke-Free Alternatives Trade Association (SFATA)

    “Let’s get the junk science funded by big pharma and the tobacco Master Settlement Agreement out of the narrative of harm reduction. The federal government must be guided by the best science to ensure responsible decision-making.”

    Gregory Conley, president, American Vaping Association (AVA)

    “Legal nicotine vaping products are far less hazardous than smoking and serve a vital public health role in helping adult smokers quit.” 

    Michael Siegel, professor, Department of Community Health Sciences, Boston University School of Public Health 

    “Vaping is, for many smokers, a life-saving health decision. It is much safer than smoking and is literally saving the lives of smokers who would likely die if they weren’t able to stop smoking.”

    David T. Sweanor, adjunct professor, advisory board chair, Centre for Health Law, Policy & Ethics, University of Ottawa

    “It’s the smoke, stupid.”

    Vapor Voice: What policy changes might the Biden administration make regarding vaping products?

    Anton: During the Biden administration, SFATA is taking the lead in youth prevention with the creation of the Responsible Industry Network, which we presented to HHS and the FDA. This would allow adults to access flavors while protecting small businesses through the FDA’s PMTA (premarket tobacco product application) process.

    Mark Anton SFATA
    Mark Anton / Credit: SFATA

    Adults need access to products that help them transition away from combustible cigarettes, so unfavorable e-cig policies and flavor bans should not be on their agenda. Vaping is truly a good tool for tobacco harm reduction. The industry is made up of former smokers who strive to develop the best manufacturing practices without the FDA’s help. To protect against youth use, SFATA supports the enforcement of T21 [Tobacco 21], passed by Congress and signed by the president. Covid[-19] policies have prevented true enforcement.

    Finally, the CDC should always give true assessments and release reports to the media and medical and public health journals. Last year, the CDC failed to give a full accounting of EVALI (vaping-related lung illnesses), when they should have made a declarative statement that vaping nicotine e-cigs was not the cause.

    Conley: Sadly, there is no use answering this question as there’s no indication whatsoever that the Biden Administration will make favorable decisions with regard to vaping products. I would be thrilled to be wrong, but after a decade of fantasizing about smart policy and regulations and only getting the opposite, it’s time to stop dreaming and work within the broken system we have.

    Siegel: Introduce legislation to ban the sale of tobacco products, including vaping products, with the exception of stores only open to [consumers] 21-plus that only sell these products. And direct health insurance companies to cover electronic cigarettes just as they cover other forms of nicotine-replacement therapy.

    Encourage physicians to promote vaping for smokers who are unable to quit using other means. And direct the CDC, FDA and other national health agencies to endorse the use of vaping products for smoking cessation, especially when traditional medications do not work. Finally, discontinue the requirement for PMTAs for vaping products and, instead, directly regulate these products by forcing the FDA to promulgate safety regulations.

    Sweanor: Follow the science on relative risk and communicate truthfully with the public. And empower those who use nicotine to have control over their health though ready access to a wide range of low-risk alternatives to cigarettes and risk proportionate regulation of the spectrum of products. Access to alternatives to cigarettes should be no less urgent a public health goal than access to Covid[-19] treatments and vaccines. Government policy should reflect this urgency.

    What were the most egregious policies implemented during the Trump administration? 

    Anton: Clearly, CDC misinformation about EVALI, falsely accusing e-cigarettes and seeking to ban flavors without sufficient scientific evidence is high on the list of misguided policies. And despite all the research to the contrary, they created hysteria by calling e-cigarette use by minors an ‘epidemic’ when it was not. The true epidemic is 480,000 smokers dying every year from smoking combustible cigarettes.

    Conley: [Former]President Trump created a wave of issues when he declared that flavored vaping products should be banned because they were killing people. He was undoubtedly being fed bad information from his advisors, but it was ridiculous coming from the supposed pro-business, anti-regulation POTUS. Even Trump’s biggest fans realized that one of his flaws was his inability to hire competent people who shared his worldview. Putting Alex Azar in as Secretary of Health and Human Services assured there would be no positive movement to reform vaping regulations at any of the agencies HHS oversees.

    conley
    Greg Conley / Credit: AVA

    Siegel: The ban on flavored e-cigarettes in pod systems and the requirement that companies must submit PMTAs to stay on the market both need to be reversed. There does need to be regulation of nicotine strengths, especially for nicotine salts, but getting rid of flavors isn’t going to solve the problem of youth vaping, and it is hurting many adult ex-smokers.

    Sweanor: I think the biggest failure was the failure to remove the mounting barriers confronting less hazardous products such as e-cigarettes. After a steep decline in cigarette sales by substituting safer products, particularly vaping, cigarettes started making a comeback as the CDC and other agencies engaged in a massively misleading campaign against vaping.

    Meanwhile, the FDA put vaping at a marketplace disadvantage compared to cigarettes. Research showed those most at risk were misinformed about the relative risks.

    At the end of Biden’s term, what state do you think the vaping industry will be in?

    Anton: The outlook is not very bright for the small vaping industry based on Biden’s cabinet selections; many have anti-vaping outlooks and ignore the multitude of studies in support of the harm reduction potential of vaping products. The focus has been on youth use even though it’s decreasing at record levels. Much of the vapor industry success or demise will hinge on the Biden administration’s willingness to look honestly at the science. Additionally, Congress has pushed to ban flavors despite the fact that flavors are an important tool for the average smoker to quit smoking.

    Politics have clouded the potential of this industry’s ability to reduce harm in the U.S. regarding smoking combustible cigarettes. If the Biden administration follows this path, we will be worse off. But if they choose science and real life, it will be better. Much hinges on the role the FDA will play in issuing marketing authorizations.

    Conley: Right now, most adult vapers can easily access tens of thousands of different vaping products in every flavor you can think of. While there will always be a gray market and internet sales, the legal market will never be as free as it is today.

    Four years from now, there will still be a legal market for tobacco-derived nicotine vaping products authorized by the FDA. It may not be a great market, but it will exist. Companies with authorized products will do everything in their power to disrupt the gray market such as stand-alone devices, nicotine-free or tobacco-free nicotine e-liquids that many vapers rely on.

    Siegel: It will probably be worse off. If the administration enforces the PMTA rules, many vaping products will be taken off the market. Big tobacco companies and a few large independent companies will dominate the market. The growth of the e-cigarette sector will wane. Many ex-smokers will return to smoking, and e-cigarettes will no longer serve as an off-ramp for as many smokers.

    dr michael siegel
    Dr. Michael Siegel

    Sweanor: Ultimately, disruptive technology, science, rationality and human rights will win, and cigarettes will go the way of previous categories of unreasonably hazardous goods and services. The question of whether that happens within four years depends on the way politics unfolds and the emergence of leaders who see the opportunity and relentlessly pursue it.

    Is limiting the level of nicotine a viable solution for users of conventional tobacco?

    Conley: Bloomberg-funded prohibitionists and legislators who can’t differentiate between classes of vaping products are not going to be swayed by nicotine limits. Their goal is prohibition. When you give in to the prohibitionists, all you’re doing is guaranteeing they’ll be back next year to argue that we need flavor bans because nicotine limits didn’t work.

    Siegel: Yes. Limiting nicotine in e-cigarettes will help reduce youth addiction to these products. There is also evidence that very low nicotine cigarettes can result in much lower levels of addiction in cigarette smokers.

    Sweanor: No. It’s a replication of the disastrous Volstead Act that ushered in Prohibition, which forced beer and wine to have no more than a minimum level of alcohol.

    sweanor-web
    David Sweanor

    The total U.S. nicotine market is over $80 billion, and the cigarette market alone is over $60 billion, with tens of millions of consumers. The products are far more dependence-producing than alcoholic beverages. A prohibitionist policy is very unlikely to garner political acceptance and could rapidly lead to the sort of entrepreneurship and criminality long associated with other abstinence-only campaigns.

    Many who are pushing for such a policy also oppose the wide availability of consumer-acceptable low-risk alternatives to cigarettes, demonstrating that this is a flawed moralistic strategy rather than a pragmatic public health one.

    What chance do any of these proposed changes/solutions have at being implemented?

    Anton: The previous FDA leadership has called the millions of smokers who have transitioned from combustible cigarettes to flavored vapor products ‘anecdotal evidence’ without investing any funds into research. The Biden administration and the new FDA leadership now has the opportunity to affect public health on a massive scale by investigating this hypothesis.

    The U.K.’s National Health policy recommends that smokers who want to quit switch to vaping. They recognize vaping is safer than cigarettes. This is from the country that put warning labels on cigarette packs four years before the U.S. The Responsible Industry Network is a framework that will help prevent youth access, limit marketing to age-restricted stores and develop a pathway to prevent the loss of tens of thousands of small businesses. It brings together all the elements of the Tobacco Control Act (TCA)—protecting youth from smoking and tobacco use while assisting millions of adults who are trying to stop smoking.

    While these are foundational items of the TCA and the FDA, politicians are missing the opportunity to help millions of current smokers because vaping is so politicized and youth use and access to vapor products has been blown out of proportion.

    Siegel: The likelihood [that] these policies will be implemented is very low. I just don’t think the mainstream tobacco control and health organizations support the idea of harm reduction in tobacco control.

    Sweanor: I have little ability to discern the likelihood of rational policies, in part because the current politics around nicotine seem to favor a War on Drugs mentality where the pursuit of total abstinence takes precedence over a public health orientation. Much will depend on Americans who use nicotine, a demographic Biden appears to care very much about.

    The original “Vaping Vamp,” Maria Verven owns Verve Communications, a P.R. and marketing firm specializing in the vapor industry.

  • Thrown Under the Bus

    Thrown Under the Bus

    London double bus
    Credit: Albrecht Fietz

    If society wants a smoke-free world, it cannot allow promising products to die of neglect.

    By George Gay

    Browsing the internet recently, I came across a report claiming that 22 countries with, according to my calculation, a total population of about 2.6 billion, or 34 percent, of the worldwide population, had banned the use of vaping products. I cannot vouch for the accuracy of those figures, but I guess they would be at least as accurate as the widely accepted estimates of worldwide, annual tobacco-related deaths.

    At the same time, many people are living in countries where certain forms of vaping products are banned (Japan, for example, with a population of about 126 million) or where the appeal of vaping products has been deliberately and sometimes severely narrowed by, for instance, restricting flavors (the U.S., 328 million) or limiting nicotine levels (countries of the EU, 448 million post-Brexit).

    Looking at this situation, I couldn’t help wondering whether a person with the foresight 15 years ago to have predicted the arrival on the market of products whose consumption was far less risky than was the consumption of combustible cigarettes and that could substitute for those cigarettes would have foreseen also the wide-ranging and often visceral hostility that has greeted their arrival.

    I can’t help feeling that our seer would have dismissed as ridiculous the idea that these new products, vaping devices as it turned out, would be so badly served by so many governments, companies, organizations and individuals. She would surely have found it incomprehensible that smokers would be let down so badly.

    Why? Well, as is still the case, 15 years ago, the combustible cigarette was the pariah consumer product and, we were told, no amount of effort was being spared in trying to do away with it. It was claimed that this was the only product that killed its consumers when used as it was designed to be used, and this claim was employed to underpin the justification for legislating for the degradation of both the product and its packaging, and the restriction of cigarette sales.

    man holding up hand stop
    Credit: Nadine Shaabana

    And it was not only the product that was seen as unacceptable. Cigarette manufacturers had cynically manipulated their products to make them “more addictive” and thereby keep consumers hooked and the profits rolling in. And consumers were little better. So, in the U.K. at least, they were attacked by officialdom as being smelly and then denormalized to the point where they and their secondhand smoke were cut off from normal society.

    Given this, and given that vaping is recognized by most sensible people to be hugely less risky than is smoking, why is it that vaping has had such a rough ride? There are, of course, any number of reasons based on the vested interests and breath-taking hypocrisy of some individuals, researchers, companies, organizations and governments, for all of whom and which the continued use of tobacco represents a nice little earner.

    But here I would like to speculate about another possible reason. Could the U.K. government at least have decided that the problem of tobacco smoking has been overblown? No, let me put that another way. Could it be that the government has decided that the net problem caused by smoking—that is, the smoking negatives minus the smoking positives—has been overblown, especially when compared with other problems it must confront? For instance, I guess it is becoming just too difficult to ignore the elephant in the morgue: the pollution-related deaths, many of which, I assume, overlap with tobacco-related deaths.

    According to Damian Carrington, environment editor, writing in the Guardian on Jan. 26, a global review in 2019 concluded that air pollution may be damaging every organ in the human body as inhaled particles travel around it and cause inflammation. And it is instructive, I think, that a statement made late last year by the U.N. secretary general, Antonio Guterres, pointing out that air pollution is killing nine million people a year, has, unusually, not been trumped by the World Health Organization coming up with an even higher figure for tobacco-related deaths.

    But I have a more specific reason for believing that the U.K. government might be letting smoking slip down its list of priorities. While it has been progressive in respect of encouraging the use of vaping as a means of getting people to quit smoking, during the Covid-19 pandemic, it has steadfastly refused to allow vape shops to open during lockdowns; that is, it has deemed them not to be essential, whereas a shop selling plugs for the basin in your bathroom apparently is essential. This indicates to me that the government doesn’t put much importance on encouraging people to quit smoking, though that is not to say it isn’t happy to dabble in such an enterprise.

    OK, I hear you ask, could it be that the government does believe that encouraging people to quit smoking is important, but, right now, in the face of a deadly pandemic, such encouragement has had to take a back seat?

    There are a number of reasons why I don’t think this is the case. One is that the government has found the time to deal with all manner of pet issues during the pandemic, such as its undermining of the BBC in an attempt to better control its image. Another was Brexit, which was hugely time-consuming, but its deadline our erstwhile fellow members of the EU had been willing to postpone.

    However, the most telling reason in my view was the government’s announcement at the end of March 2020 that it was to axe Public Health England, an executive agency of the department of health and social care, and transfer some of its responsibilities, but not its smoking prevention and some other obligations, to a new organization, the National Institute for Health Protection.

    Meanwhile, while the government seems to be taking its foot off the quit-smoking pedal, there are some for whom the very existence of the pandemic is seen as underlining the need for the government to encourage the switch from smoking to vaping. The usual suspects have been only too willing to tell smokers, without, I suspect, any solid evidence, that they are at increased risk of suffering severe symptoms if they are infected with Covid-19. And one respected public health professional has argued that the emphasis should be placed on fighting noncommunicable health problems because, in that way, we will all be leaner and fitter to fight the next pandemic. Hmm.

    I cannot agree with these people’s reasoning, but I do maintain that this is not the time to let the opportunities offered by new generation products slip through our fingers. And in this regard, I would like to put in a word for Kind Consumer and Voke, whose fortunes I have followed on and off for a number of years. Voke, as I wrote about last year, is a product that was developed by Kind and licensed by the U.K. Medicines and Healthcare products Regulatory Agency as a medicinal product that is a safer alternative to smoking. Voke is not a vaping product but an alternative nicotine-delivery system that uses pharmaceutical-standard inhaler technology in a device that closely resembles a traditional cigarette in both the way it looks and in the way a consumer, in using the device, mimics most of the rituals of smoking.

    Voke, which has no batteries and no electronics and therefore generates no heat and no chemical reactions, produces no smoke nor vapor, just an invisible, odorless aerosol, so it can be used anywhere. And its environmental credentials are good given that it is a relatively simple device made of metal, card and plastic: materials that can be recycled.

    Last year, I wrote that, in theory at least, Voke should be a game-changer and that it would be interesting to follow its fortunes on the market to discover how committed smokers and vapers were to the pursuit of reduced risk.

    I’m now concerned that I may never know. Voke was launched in November 2019 exclusively online, but when I visited the Voke website in January this year, this is what I was told: “Due to Covid-19 and the current financial climate, we are unable to accept any orders.”
    Meanwhile, a Sky news story toward the end of last year said it was understood that Kind, which had raised £140 million from investors since it was set up [in 2006], had, at the beginning of December, called in the administrators and that they had signed off on the sale of Kind’s assets to OBG Consumer Scientific, a subsidiary of Pharmaserve, a privately owned group, for £1.6 million.

    Pharmaserve, which is based in Runcorn, U.K., did not respond to requests for information, so I am unaware of what fate awaits Voke. However, one source told me that Pharmaserve had been part of the Voke supply chain, providing the device’s cannisters, and this aligns with information provided by Kind, which said last year that one of two manufacturing sites it was using was at Runcorn (the other was said to be at Waterford in Ireland). If this is the case, it is quite possible that the product will be relaunched.

    It would certainly be a crime if Voke were allowed to disappear without fully testing whether it can become a game-changer. There is no doubt that, because it delivers a cool aerosol rather than a warm vapor, it presents a challenge to smokers wishing to switch. But, at the same time, its nicotine delivery is efficient enough that it has to deliver only a low dose, 0.45 mg, from which, if the U.S. Food and Drug Administration is correct, it could be inferred that it creates a significantly lower risk of sustaining addiction than do cigarettes or e-cigarettes.

    And Voke seems to have some as-yet untested advantages over cigarettes and electronic cigarettes when it comes to sales channels. While the product had a medicines license that allowed it to be prescribed by a doctor in the U.K., it had also an over-the-counter drug or general sales list label, so it could have been sold anywhere from pharmacies to major retailers, corner shops and garage forecourts. And there was no reason why Voke, under another name and possibly modified, could not be sold in other jurisdictions simply as a consumer product.

    Many societies that claim they want to become smoke-free have thrown obstacle after obstacle into the path of vaping devices. Surely, we are not going to let Voke fail for the want of a little investment. According to the Sky story, Kind had been looking to raise only another £36 million to deliver a revised business plan, so here, perhaps, was an opportunity for a tobacco company—or even the U.K. government.

    man breaking cigarette
    Credit: Martin Budenbender

    Of course, the U.K. government is ideologically opposed to public involvement in the private sphere, but there were some good reasons why it could have justified keeping Kind and Voke going. I don’t know why Kind got to the point where it had to call in the administrators, but certainly, fate had not been kind to it. When, in 2009, Kind set out in earnest on the development of Voke, it immediately found itself in a commercial bind.

    At that time, when vaping devices were still something of a novelty, it was believed that, under the then forthcoming revised EU Tobacco Products Directive, all such products sold in the EU would need to have a medicines license. But such a requirement fell by the wayside; so Voke, a device being developed at great expense within the constraints necessary to make it conform with a medicines license, was destined to compete with devices developed at less expense without such constraints. And to cap it all, Voke was launched just as the world was hit by the start of the coronavirus pandemic.

    If societies believe that tobacco smoking is as harmful as it is generally made out to be, and if they are truly aiming to go smoke-free, they cannot afford to allow the army of naysayers to keep throwing vaping devices under the bus, and they certainly cannot allow a promising product to die of neglect.

  • Industrial Strength

    Industrial Strength

    Canada

    In less than two years, Canada’s Vaping Industry Trade Association has made great strides in saving lives.

    By Timothy S. Donahue

    Like nearly everywhere else in the world, the vaping industry in Canada is under fire. Lawmakers at all levels of government are seeking to or already have raised taxes, criminalized public vaping and banned flavored e-liquids. Moving into 2021, it is expected that the Canadian government will continue to try to ban flavors or possibly make regulations so onerous they kill the industry.

    These kinds of regulatory actions have the potential to push former smokers back to combustible cigarettes, leading to an increase in the number of deaths caused by smoking every year. This is a major concern for trade industry groups like Canada’s Vaping Industry Trade Association (VITA). While relatively new to the game, VITA has quickly grown into one of the largest and most vocal vaping trade associations in Canada.

    Daniel David, a former smoker who used vapor products to quit traditional cigarettes, says that in mid-2019, VITA opened its doors with a goal of keeping Canada’s vaping industry from being regulated into oblivion. David, who opened Canada’s first vape shop in 2010, said VITA was founded after the Canadian government released its rules for electronic nicotine-delivery systems in mid-2018 (Tobacco and Vaping Products Act). He now serves as the advocacy group’s president and CEO.

    Daniel David
    Daniel David – Credit: VITA

    When David began his journey in the vaping industry, there were not any regulations on vaping in Canada. He says the industry just stepped up and figured out regulations themselves. They implemented age restrictions and standards for testing e-liquids. He says he got into advocacy because, as a retailer, when people would come into his shop and discover vaping products, they would often cry and give him a hug. They would tell him that they had resigned themselves to dying from smoking cigarettes. “We got them vaping, and they didn’t want to go back to smoking,” he said. “It’s that kind of experience that makes vapor advocates so passionate because we know what the potential is with this product. The science is there.”

    When he and his team decided to start VITA, David made the decision to dedicate himself to the organization full time. He asked his wife to take over running the business. “I made the decision that this is really important,” he said. “I needed to be able to dedicate my full time and attention to advocacy. I got into it early on because I wanted this industry to become something real, a legitimate industry. And I wanted to make sure that the products that we are selling are as safe and effective as they possibly can be. And when we started this adventure, there was a regulatory gap.”

    When regulations came, they arrived quickly. They were also all over the board. Some provinces were implementing age restrictions (which VITA supports), while others were taking a more hardcore approach and wanted to ban flavors (which VITA does not support). Then a lung disease that many health groups and media outlets blamed on nicotine vaping began to envelop the industry.

    Troubled waters

    VITA got its start during the peak of the e-cigarette or vaping product use-associated lung injury (EVALI) crisis. The term was coined by the U.S. Centers for Disease Control and Prevention (CDC) for a dangerous, newly identified lung disease that was eventually linked to vaping black market marijuana products. However, the CDC had already falsely stated that nicotine vaping may be a contributor, and the global media pounced. By the time the CDC admitted that no nicotine vaping products had been a source of EVALI, the damage had been done. Then came the youth vaping crisis. Then the Covid-19 pandemic. It was the perfect storm for anti-vaping groups to pursue their agenda.

    VITA sign
    Credit: VITA

    “With all of the threats, public perception [for vaping products] took really big hit. EVALI, Covid[-19], youth use … it takes up the media cycle now. So, it’s a challenge in one respect to get mainstream media to say anything that’s factual, that’s relevant about vaping. Mind you, the media wasn’t ever really saying anything too positive about vaping prior,” David explains. “That hasn’t changed. The point is that these threats that we’re facing as an industry moving forward are, by far, the biggest threats that our industry has ever faced. We had multiple provinces that were coming out with new regulatory regimes around vaping, and it was all due to EVALI. A lot of the members in the industry started to see what was happening and it became vitally important that we all work together, or the industry would die.”

    There are six founding members of VITA—Dvine Laboratories, Juul Labs Canada, Valor Distributions, Atelier de Saveurs LaVapeShop, Imperial Tobacco Canada (Vuse) and JTI Canada Tech (Logic). The companies committed to contributing $100,000 each year for three years, which provided a seat on the board for three years. This multi-year financial commitment allows VITA to hire staff and retain legal, government relations and public relations support. The investment also provided capital for programs and initiatives, such Covid-19 protocols and preventing youth access.

    Today, VITA has 44 members and is governed by a 12-member board that represents multiple segments of the vaping industry from small manufacturers, distributors, suppliers and vape shops to the large multi-national tobacco companies that are also moving into the vaping industry. Traditional tobacco companies like Juul Labs and Logic have the same voice on the board as nontobacco affiliated companies such as Dvine Laboratories and LaVapeShop. The six founders also have an (equal) weighted vote share of 40 percent and the six elected (nontobacco affiliated) companies have a weighted vote share of 60 percent.

    “We’ve put ourselves into a position where we have a lot of intelligence; we have a lot of highly experienced professional people that are part of this group. We have resources that we haven’t really had in the past,” said David. “There is still an aspect [of this industry] that people are hesitant about. There’s still a lot of conspiracy theories out there, especially under the view that the tobacco-affiliated [vape] companies just want to see the industry die so they can continue to sell cigarettes. And that’s just not true. We are dedicated to harm reduction. We want to serve as a voice for the entire category, regardless as to the distribution channel.”

    Closer to home

    The Canadian vapor industry is complicated. Restrictions vary across the country. Youth use is a major driver of restrictions in Canada. David says that VITA supports age restrictions, and “minors should not use or have access” to vaping products. “Vaping products are for current adult smokers only, not youth or nonsmokers,” he says emphatically. “Governments should focus on the issues of access, enforcement and education.”

    Restrictions dealing with the Covid-19 pandemic were especially burdensome. In Manitoba, for example, the government established a list of essential businesses and did not include vape shops. The province then forced all nonessential businesses to close. They even went a step further and only deemed certain products as essential. This meant that convenience stores were open as an essential business; however, the stores could only sell essential products, according to David.

    “They have a list of what is essential and what is not. On that list, you have tobacco products are essential, and it specifically states vape products are not. So, the smoking population and vaping population in Manitoba [are] faced with a choice,” explains David. “They can’t get their vape products from vape shops because they’re all closed. If they were to go into a gas station or convenience store, which are open, they are only allowed to buy tobacco cigarettes. The vape products that are two inches below that tobacco cigarette, because it’s nonessential, customers can’t purchase.”

    VITA Covid best practice
    Credit: VITA

    In April 2020, Nova Scotia instituted a 20 mg/mL nicotine cap coupled with a flavor ban. Neilson data showed that cigarette sales increased over 25 percent—a rate four times higher than surrounding provinces, according to David. Moreover, 50 percent of all specialty vape shops immediately closed. Hundreds of Canadians were out of work.
    Then, in July 2020, the Canadian government unveiled new regulations related to the marketing of vaping products. The new rules prohibit the display of any branding in a “place or manner visible to young people and will ensure that vaping devices are not visible at point of sale in places where young people might be present.”

    By December 2020, Nova Scotia’s regulatory framework had creeped its way across the country and into Canada’s House of Parliament. The federal government proposed lowering allowable nicotine levels in regulated vapor products to 20 mg/mL, which David said would minimize their value to adult smokers seeking to transition to less risky products. “Considering the disparity of harm between vaping and smoking, we don’t understand why the federal government would be using Health Canada resources during a global pandemic to explore making it harder for adult smokers to switch to a reduced risk product.”

    Canada continues to pursue several vapor industry regulations. It has already passed multiple measures, including implementing child-resistant container (CRC) usage nationwide. VITA applauded the effort for e-liquid bottles but was concerned about the challenges and timeframe of applying the same standard to tank/pod hardware. However, the VITA team has been actively engaged with international device manufacturers, associated companies and Health Canada regarding the implementation of the new requirements for refillable tanks and pods. In support of compliance efforts, VITA even developed a list of certified products that are currently (or soon to be) available for retailers on the Canadian market.

    “The CRC list has been set up so that it can be updated live, meaning that as new products are certified and released, the list will be updated and automatically distributed to subscribers at the end of the week,” says David. “Stakeholders are encouraged to share this within the industry and to notify VITA staff of any certified device currently not on this list.”

    The good fight

    David says there is not time to rest. In order to continue to combat the misconceptions surrounding the vapor industry, VITA had to start at the ground level. The organization launched several programs for member retailers. Age verification, recognizing fake IDs, best practices and business law are just some of the programs offered, according to David. VITA also breaks down the regulatory and legislative responsibilities of different industry segments by province because the rules change throughout the country.

    “When the pandemic hit, VITA developed Covid-19 prevention measures, including specific guidance and signage for members. When the industry is facing something like we’re facing now … Covid-19 had a really big impact because we had to make a major switch,” said David. “We also conducted several webinars for Covid[-19], such as financial support programs from the government. We brought somebody in to talk about what was available and then outline how you would apply.”

    VITA also designed and created a series of webinars for e-liquid manufacturers that were considering retooling to produce hand sanitizer. David said that, like many countries, Canada ran out of hand sanitizer early in the Covid-19 response. “We came up with a way to support manufacturers in the vaping industry to retool and get an urgent license to produce it,” he explains. “All the Covid[-19] measures forced us to change focus temporarily, but we never forgot the other challenges our industry was facing.”

    Canada’s two major regulatory challenges are nicotine restrictions and flavor bans. David says that those two elements put together—a tobacco-only flavor ban—it would kill the industry. “It’s pretty well over at that point, at least for 90 percent of the industry,” he says. “That’s one of those kinds of things that required us to adjust what we were working on and our priorities as the situation evolved.”

    vaping e-liquid
    Credit: Vaporesso

    The VITA team believed that fighting the growing number of regulatory challenges was going to require everyone in the industry working together. So, the VITA board and its allies decided to bring together every vape association in Canada in order to share information and coordinate efforts wherever possible. This includes the Canadian Vaping Association (CVA), the only other national vapor trade association in Canada.

    “What we’re doing right now is the biggest kind of success story. Even though we might not agree on a lot of things, we still now have a group that meets regularly where we can share intelligence,” says David. “We coordinate some of our efforts so that we’re not working against each other or going in completely opposite directions. Obviously, everybody has their own organization, and they operate independently, but it helps significantly when we’re all talking together, pushing in the same direction on the common ground issues that we face.”

    The timing is right. The regulatory challenges won’t be slowing down anytime soon. When the Canadian government released its regulations on limiting nicotine, they stated that [the government] would be looking at banning flavors next, said David. “At a federal level, those two measures, if they were to go through as is, it basically ends the vaping industry in Canada as we know it,” he says. “I think maybe a few shops would survive, but any time you take away 85 [percent to] 90 percent of the products that are the highest margin … and you remove the ability to sell the high-nicotine products, which a lot of people rely on, it makes the whole retail model of a vape shop nonviable.”

    It’s a big fight. The VITA response is going to be educational. David said the organization is letting the public know that the government is proposing to make it harder for smokers to switch to a less harmful alternative. David said getting as many people as possible from the industry, including stakeholders and consumers, engaged in this consultation process is vital to the future of vaping.

    “The more people that we can get involved and activated by letting the government know that this is not the right approach, the better our chances are,” says David. “That kind of goes with working together with any associations and trade groups. There are a lot of threats coming up. We can’t waste our time fighting each other.”

  • Exposing Nicotine

    Exposing Nicotine

    Director Aaron Biebert (left) talks with Paul Newhouse, director of the Center for Cognitive Medicine at Vanderbilt University. / Credit: Third Line Films

    In the film “You Don’t Know Nicotine,” director Aaron Biebert sets out to expose the manipulation, confusion and misinformation in the nicotine industry.

    By Timothy S. Donahue

    The nicotine industry is a complicated one. Nicotine may be considered the vilest of industries on Earth. However, the global tobacco market size was estimated at $849.09 billion in 2019 and is expected to reach $878.35 billion in 2020. Around the world, combustible cigarettes are the leading cause of preventable death. Tobacco use causes more than 7 million deaths per year worldwide, according to the U.S. Centers for Disease Control and Prevention (CDC). If the pattern of smoking combustible cigarettes for nicotine doesn’t change, more than 8 million people a year will die from preventable diseases by 2030.

    It doesn’t need to be that way, according to director Aaron Biebert, who is probably best known for his 2016 documentary A Billion Lives. The film earned several awards for its in-depth investigation into the history and corruption in the tobacco industry and how the vapor industry, a safer alternative to combustible cigarettes, was being attacked through a concerted effort of bad science, misinformation and outright lies. Picking up on where his first film left off, Biebert and the team behind Third Line Films’ latest documentary, You Don’t Know Nicotine, answered many questions that the team felt it had originally left untouched.

    Several scientific studies support e-cigarettes as less harmful than cigarettes and a benefit to public health. Biebert, who also narrates both films, said that after finishing A Billion Lives, he began to be haunted by certain questions surrounding the nicotine industry. He had met with thousands of smokers and wanted to better understand why so many people used combustible cigarettes despite decades of anti-smoking shame campaigns.

    “Is it a case of simple addiction? Why does nicotine primarily affect the oppressed or those with brain differences? I started reading more studies about the effects of nicotine outside of cigarettes and found some surprising information,” Biebert explained to Vapor Voice during an exclusive interview in early December. “I gathered the filmmakers I work with, and we began a new journey to know nicotine and share our findings with the world.”

    To get funding for the new mission, Biebert and his wife, Jennifer, and the rest of the Third Line Films team launched a crowdfunding campaign, and 1,112 people pledged $108,598 to support the cause through Kickstarter. Third Line Films covered the equipment, staff and post-production costs. The group did not seek or take funding from any tobacco, pharmaceutical or anti-nicotine organizations. Biebert said that this allowed for the film to follow the science and remain neutral. 

    “We interviewed people on a variety of sides, and I think that really made a difference with the way the general public is responding to the film,” said Biebert. “While our production crew at Third Line Films did not regularly use nicotine, we do have countless friends, family members and neighbors that did. For millions of people who use nicotine around the world, the method by which they choose to use nicotine—largely impacted by their perception of what nicotine is and does to the body—may truly be a matter of life or death. With so much on the line, our society can’t afford any confusion, interference or misinformation when it comes to understanding nicotine.”

    You Don’t Know Nicotine takes a more centralized focus on the overall nicotine industry. The movie takes an inside look at tobacco control/harm reduction advocates on both sides of the safer nicotine ingestion argument as well as the anti-tobacco/anti-vaping groups that have recently become more generalized as anti-nicotine groups.

    Vapor industry experts say vapor products are a safer way for adults to consume nicotine and are an effective tool in helping cigarette smokers quit smoking. However, anti-tobacco activists view vapor products as just another tool for the large tobacco companies to keep people addicted to nicotine or to hook kids on nicotine. Along with the CDC, they also blame last year’s EVALI crisis wrongly on nicotine vapor products (it was THC). Biebert says his research found something even more sinister at play.

    In the film, Biebert talks about how many anti-vaping groups are the same organizations as the anti-smoking groups, such as the American Cancer Society’s Cancer Action Network and the Campaign for Tobacco-Free Kids’ Tobacco Action Fund. These are 501 c4 groups that can take in unlimited funds and are not required to report donors or amounts. These are often referred to as “dark money” organizations. The funding of these groups comes from a mix of tobacco money (from the Master Settlement Agreement) and private funds from large donors, such as Michael Bloomberg. Bloomberg donated over $1 billion to anti-nicotine efforts and funds activities at the World Health Organization (WHO).

    “Bloomberg also funds the CDC Foundation [an independent nonprofit and the sole entity created by the U.S. Congress to mobilize philanthropic and private-sector resources to support the CDC]. When people started getting sick and dying in 2019 [from EVALI], the CDC [placed the blame] on nicotine vapor products instead of identifying illegal [marijuana vapor] products as the real culprit,” says Biebert in the movie. “The mainstream media, which runs Bloomberg-funded ads against nicotine, parroted the CDC’s warning. Elected officials lobbied by Bloomberg-funded organizations used this confusion to push bans on safer nicotine products while leaving cigarettes on the market. People started to smoke cigarettes again.”

    As the film was wrapping up, Biebert’s team discovered a company tied to Michael Bloomberg that had invested in a new nicotine vapor device called Hale. A product of Hava Health, Hale is an electronic nicotine-delivery system (ENDS) product that aims to promote smoking cessation by gradually lowering nicotine levels.

    “As of 2020, they’re working toward [U.S. Food and Drug Administration] FDA approval. It looks like a flash drive, sleek, modern and uses flavors. It contains nicotine. This sounds very familiar. The harsh legislation pushed by the Bloomberg-funded lobbyists and their fear campaigns will put all the small shops out of business that helped more than 50 million people stop smoking worldwide,” said Biebert. “It has created a regulatory environment where only the wealthiest people will be able to play. The wealthy people can own nicotine businesses and fund [501 c4] organizations that change public opinion to match their own world view.”

    David Goerlitz, the actor who portrayed the “Winston Man” for eight years in the 1980s for Winston cigarettes, is used as a source in You Don’t Know Nicotine. He says the anti-tobacco groups didn’t always have bad intentions. Initially, they set out to do good work. “I’m just saying their intentions were good, like mine were, but sometimes greed outweighs fear, so therefore you take shortcuts and you start doing things that you shouldn’t do,” he explains. “And I’m saying that’s what they did. Now we know what we know, and we have the facts. We have the data … we have liars.”

    Vapor Voice took the opportunity to ask Biebert seven questions concerning his thoughts on You Don’t Know Nicotine and what he learned during the making of the film without giving away too many (more) spoilers. Access to the film can be found by visiting KnowNicotine.com.

    Vapor Voice: What are you most proud of, concerning this film?

    Aaron Biebert: I’m most proud of the impact it’s had for those harboring great burdens regarding nicotine. So much shame, fear and even hatred has been reduced by a new understanding of what nicotine is, what it does and why people use it.

    Why is it important for the nicotine industry to be exposed for what goes on with both major tobacco companies and anti-tobacco advocates?

    I wouldn’t say that we put effort into exposing the nicotine industry or anti-tobacco advocates, we simply aimed to expose the truth and established scientific evidence. My passion doesn’t lie in fighting against people but rather for them. Sometimes anti-science groups and leaders are in the way of helping people, but it wasn’t our intention to expose them.

    Do you support vaping and why/why not?

    I believe it is a human right to have the accurate information needed to make personal health decisions about nicotine use as well as access to the safest nicotine-delivery system a person chooses without facing shame, stigma or “sin taxes.” There is a scientific consensus that nicotine vapor products are safer than cigarettes, so I believe they should be available and encouraged. I also believe nicotine-delivery systems will continue to improve, and innovation should be encouraged.

    What has been your biggest “surprise reaction” that you have had from viewers?

    One person who works for more than one anti-nicotine organization wrote a long Twitter thread about her difficult life, why she hated nicotine and how our documentary gave her peace. She then declared that she would resign from her work fighting nicotine use. That was a massive surprise and gave us a lot of hope that thoughtful people everywhere will take a look at the issue and reconsider their positions in light of the scientific information we shared.

    What was the most interesting thing you learned from making the film?

    It was extremely interesting to learn that there are around 13 possible types of nicotine receptor genes, and each of us has a combination of only six or seven. That means that the effects of nicotine vary widely and that one person’s experience with nicotine could be wildly different than their neighbor’s. It’s important that people have the humility to truly understand they don’t know the effect of nicotine for someone else.

    What do you hope this film accomplishes?

    I hope this film opens up a new era of discourse about nicotine, the effects of nicotine, the people who use nicotine and the anti-science efforts against the use of nicotine. I hope policymakers, mental health professionals, public health leaders and others view our film as a discussion starter as they reset their understandings of nicotine. It’s too serious of a topic to be operating under 70-year-old, outdated information.

    What are your thoughts on the media being slow to report positive studies about vaping because of where they get some funding, which someone mentions in the film?

    As a cine-journalist myself, I don’t believe the “media” is slow to report positive studies because of funding conflicts. Rather, it is the nature of media that is the problem. Bad things attract views and clicks. Helpful science is often not sexy enough. Add in 70 years of unscientific reporting on nicotine and you have a general public unwilling to believe what the few excellent journalists do report.

    If anything, a lack of funding is the issue. Most high-quality journalism is dead, and this topic is much too complex for most underpaid journalists to cover. With nonstop, biased anti-nicotine press releases from “credible” organizations coming to the desks of overworked reporters, it makes sense that they would publish the clickbait headlines provided to them.

    It will take a massive effort to fix this systemic problem.