Category: This Issue

  • 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.

  • Fighting for Survival

    Fighting for Survival

    Photo Credit: Peggy und Marco Lachman / Photo Illustration by Mike McDonald

    By Maria Verven

    Char Owen and Amanda Wheeler knew the enormous uphill battle other vape business owners would face when pulling together their premarket tobacco product applications (PMTA) for the U.S. Food and Drug Administration (FDA). After all, the PMTA process—which the FDA has foisted on thousands of small business owners—had been built for billion-dollar tobacco manufacturers. Every flavor in every nicotine level—even the smallest differences—needed its own PMTA, and each PMTA cost hundreds of thousands of dollars.

    Add it all up, and some manufacturers had to submit PMTAs for more than 2,000 products. The costs will be astronomical—estimated in the hundreds of millions. Aside from the costs, there’s another huge hurdle: Very few vape business owners have information technology experts or paid scientists on staff—the kind of expertise necessary to submit the extensive paperwork required by a PMTA.

    And what about the help for small businesses that the FDA promised? It never arrived. So Owen and Wheeler stepped up to help their colleagues. After downloading the complete list of manufacturers from the FDA site, they called each and every one to announce their new group, simply called PMTA Sharing.

    Ultimately, the group grew to 1,700 members, including vape businesses all across the country as well as several suppliers that offered to pitch in to help business owners through the PMTA process. The group’s services are completely free; the only fee members pay is for environmental assessments or cover letters and forms created by industry attorneys.
    Thus far, the PMTA Sharing group has helped more than 200 businesses submit PMTAs for 1.7 million products. But Owen and Wheeler didn’t stop there.

    They’re now starting a new nonprofit trade association called American Vapor Manufacturers (AVM) to help small businesses meet the FDA’s onerous scientific testing requirements (see sidebar).

    Here’s their story.

    Vapor Voice: Tell me more about your vapor businesses. How have your businesses fared over the years?

    Owen: I own two brick-and-mortar vapor shops as well as a very small wholesale line. We started in 2013 as a labor of love dedicated to my father whom I lost from lung cancer in 2001. I’ve since gained more friends in my little town of Seguin, Texas, than I can count. We all have one common goal—keep people away from combustible tobacco.

    We lost some sales due to the EVALI (e-cigarette or vaping product use-associated lung injury) scare, but thankfully most did not return to smoking, and those who did are slowly returning to vaping. Our retail lobby had to close during the shutdowns in Texas, but I fought extremely hard and was able to at least keep curbside service available. So while we lost a bit of sales, we didn’t have to close. We are grateful, as many others were not so lucky.

    Wheeler: I own Jvapes E-liquid, founded in 2011, headquartered in Prescott, Arizona, with stores in Arizona, Colorado and Oklahoma. We also sell online at www.jvapes.com and wholesale at www.wholesalejvapes.com.

    Both my husband and I are former smokers who quit with vaping. At the time, vapor products were not widely available in our local community. We started out with a tiny 400-square-foot store, but the response to vapor products was so positive, our business quickly grew into what it is today.

    With the exception of late 2019 and misinformation surrounding EVALI, our business has fared very well over the years as people have seen for themselves the effectiveness and positive change from vaping. Our target audience are cigarette smokers, age 49 on average, who have not been able to quit by other means. We learned during our PMTA data collection that 83 percent of our customers have quit smoking entirely.

    Have you been involved in vape advocacy?

    Owen: I have been involved with advocacy in Texas for the last three years through SFATA [the Smoke Free Alternatives Trade Association] and have also been involved with federal advocacy. I am a member of SFATA, USVA [U.S. Vaping Association], a monthly supporter of CASAA [Consumer Advocates for Smoke-Free Alternatives Association] and am now the vice president of our new company, AVM.

    Wheeler: I am the president of Rocky Mountain Smoke Free Alliance, our Colorado trade association. I’m also executive director of the Arizona Smoke Free Business Alliance where I’ve worked on everything from vapor taxes to flavor and public vaping bans to licensing. Prior to starting AVM, I was involved in federal advocacy for PMTA reform where we spent over a year lobbying Health and Human Services [HHS] to have small business PMTA applications accepted.

    When and why did you start the PMTA Sharing group?

    Owen: I was in the process of doing my own PMTAs. As a 20-year computer engineer, I had an extensive history in document replication and information technology, so I knew I could create the documents I needed. But I also knew that most small businesses did not have the same ability. Most could not even use Microsoft Excel.

    I started the PMTA Sharing group on Feb. 17, 2020—a significant date for me because it was my son’s birthday. I lost my son in 2013 just a few weeks before we opened our first brick-and-mortar store. I tried many times to help him quit cigarettes but was never successful.

    So after filing our own PMTAs, we created applications for other businesses to create and file their documents and then held Excel training classes. We even did computer support when their machines were unable run the applications, implemented a Microsoft OneDrive for data collaboration, and created training videos and step-by-step instructions.

    Amanda Wheeler
    Amanda Wheeler

    Wheeler: I began advocating for a streamlined PMTA process for small businesses. I knew that my business as well as my state’s group members and most independent vapor manufacturers would not have the financial resources to complete the full PMTA process. Without significant changes to the process, only large corporations would survive PMTA regulations.

    Does the work keep you up at night?

    Owen: Helping the group submit PMTAs was a monumental undertaking, requiring 14[-hour] to 16-hour workdays most of the time. It has taken a toll on both my physical and mental health.

    We put as much effort as was needed to make sure no one would be left behind. We’ve received tons of feedback [see testimonials] and gratefulness for our group. They now have hope that their small businesses can continue to help people who have quit and those who want to quit smoking.

    It’s an amazing feeling when you’re walking in your town and someone who has smoked for 30-plus years recognizes you and gives you a hug because they can finally live a life away from combustibles. We all feel that same joy with each and every person who puts down cigarettes.

    I remember one lady who called me to thank me, explaining that if it wasn’t for our group, she would have no means to support herself and her two-year-old daughter. Of course that makes me happy, but also very angry that the FDA put her in that situation and treated her as if she was a big tobacco business with all the resources necessary to meet their requirements.

    Char Owen
    Char Owen

    The FDA has publicly acknowledged that the costs associated with the PMTA process may be challenging to small businesses and that many would go out of business. That is not how our government is supposed to operate.

    What else do people in the vapor industry need to know that would help and motivate them?

    Owen: We are optimistic that we will complete this process through sheer determination. While we don’t expect help from the FDA, the HHS has been willing and open to listen to our challenges.

    We hope to move the group through to the testing phase and move the membership to the AVM. We have accomplished the monumental task of completing the first part of the process. It will be difficult, but we will move as many small businesses through the entire process as soon as we possibly can.

    Our colleagues in the vapor industry need to know that we will not stop fighting for them. We understand what they are facing better than anyone. We are them. There is no one better to fight for small manufacturing than small manufacturers. Our hearts are fully invested in this industry.

    Wheeler: I am optimistic. We have a very solid plan and approach, and we have the right scientific, legal and lobbying expertise to get the job done. Many passionate and dedicated individuals are on the AVM board, guiding our organization in the best interests of small businesses.

    We are unified and moving together toward the same goal, and I believe we have a recipe for success.

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

  • Predicting the PMTA

    Predicting the PMTA

    Credit: Andikatalinmueller

    By Mike Huml

    The U.S. Food and Drug Administration’s (FDA) dreaded deadline for its premarket tobacco product application (PMTA) has come and gone after multiple delays. With all that’s happened this year, it may have gone unnoticed for many. Rest assured that the process of submitting a PMTA has been long and tedious for manufacturers and vendors alike, and they have been working hard to ensure that reduced-risk products remain available for as long as possible.

    Many companies have been working tirelessly to submit their applications, but the process is fairly opaque and uncertain. The filing of the PMTA does not ensure FDA acceptance, and each product must be filed separately. Currently, it is largely unknown which specific products have been submitted for FDA approval.

    What is known, however, is which companies intend to submit or have already submitted a PMTA and how far along they are in the process. Keep in mind that being further along in the approval process is not necessarily an indicator of success. No vapor company at the time of this writing has received FDA approval for any product, and the length of time each submission will remain within the approval process is unknown. With so many unknowns, it can be difficult to predict which products will be legal to carry, if any. By looking at which companies are taking part in the PMTA process along with their histories, one can make reasonable assumptions as to which direction the vapor industry will begin to sway.

    First, the bad news. Given that each PMTA is only valid for one “distinct new tobacco product,” and that even the smallest difference in the design of a product could warrant an entirely new SKU, it’s only reasonable to assume that there will be massive consolidation of vapor products. Products that are too similar will need to reconcile, either by being discontinued or redesigned. Even identical products with different colors, flavors, resistances or nicotine strengths could be considered separate SKUs, with each requiring its own PMTA, which has proven to be prohibitively expensive.

    The massively varied choices that vapers have in products is undoubtedly going to shrink, but by what degree? A mod is considered one SKU, and an atomizer or tank is considered another. If the mod requires separate batteries, those are also considered an SKU, which requires FDA approval. Said batteries require a charger; that’s another SKU. If the mod and the atomizer come as a kit, that would yield yet another SKU. If the atomizer has three coil options of different resistances, that could require three separate PMTA applications. Clearly, this can spiral out of control quickly, so it’s expected that companies will need to streamline their product offerings.

    Two parallel philosophies have been playing out over the past several years. One is to throw everything at the wall and see what sticks. Several companies have been releasing an overwhelming number of products in quick succession to try to get a better feel for what works and what does not. PMTAs are expensive, and many companies have adopted the “measure twice, cut once,” mentality. The past 10 years or so have allowed the industry to innovate, unimpeded by government regulation. This innovation naturally plateaued to a point where vapers have enjoyed a few years of refinement.

    The technology seen today is not much different from the technology introduced three years ago. The difference is that today’s products have gone through a process of refinement due to the growing population of vapers providing feedback with both their voices and their wallets. It’s been a completely free market up until this point, and while manufacturers have been steadily improving their products, now is the time to lock in the best of the best and commit to the long term by submitting PMTA applications.

    The other philosophy is to streamline the product offering, and this can be seen with the popularity of proprietary systems. For example, 510 devices have pretty much stagnated in popularity while pod systems have seen a boom. If a 510 device is compatible with a thousand 510 atomizers, and vice versa, that’s an impossible number of PMTAs, and without an example of a product that has undergone the process, it would be a huge gamble to try to sell the FDA on a device that is compatible with products outside the applicant’s ecosystem.

    The prospect of a device such as a 510-compatible atomizer, which is ripe for facilitating the rise of black market mods, could invalidate the PMTA process on that prospect alone. Not only would the applicant be taking a larger risk by submitting a PMTA for a 510 device, but he would also be complicit in the assumed knowledge that he won’t see a return on that PMTA investment if the end user chooses to go outside said applicant’s ecosystem for complementary products. In short, manufacturer X isn’t going to shell out hundreds of thousands of dollars to submit a PMTA for a 510 mod if vaper Y is just going to turn around and buy an atomizer off the black market.

    The most likely scenario is that each company is going to submit PMTAs for a line of products that keep the customer within their ecosystem. Whether that’s one type of product or several remains to be seen, but it only makes sense for any company to want to see the highest return on investment possible. Additionally, this is only the first round of PMTAs, and no product has made it successfully through the process.

    It’s unlikely that any applicant has already submitted more than a few products for approval. Even with FDA guidance, the industry is figuratively a canary in a coal mine. Until there is a solid example of a product successfully navigating the PMTA process, companies are likely to be conservative in how many products are submitted for approval. Those that do will likely be product types that have proven to be the most profitable and simple.

    Pod systems are the most likely products to have already been submitted, along with e-liquids. They’re the most popular products in today’s market and are the easiest to consolidate. There are many pod systems out there, perhaps too many, but for good reason. They appeal to the widest market and ensure that consumers remain within the ecosystem as they keep coming back for replacement coils and pods.

    Pod systems are also the most resistant pieces of hardware when it comes to a black market, therefore mitigating any risk for a PMTA rejection based on that premise. Many companies have released multiple pod systems over the years and by now have a good idea of which designs are the best. In terms of hardware, expect to see a pod system as the first “FDA-approved” vapor product.

    As for specific companies to keep an eye out for, look at the largest companies. Smok, Innokin, Vaporesso, Juul—these manufacturers have been preparing for the PMTA deadline for years and have already submitted applications. In fact, almost all the big names in the vapor industry have submitted applications, including Uwell, HorizonTech, Sigelei, Suorin and others. Currently no PMTA has been approved, but none have been rejected either. These companies have the most resources, motivation and resolve to see this process through to the end.

    E-liquid, however, is a completely different animal. It takes much more to create vapor hardware than it does to create e-liquid, and that means that smaller companies have also been submitting PMTAs for e-liquid. Unfortunately, much more consolidation will likely also be occurring. Remember, if only one flavor is available in four nicotine strengths and three bottle sizes, that’s potentially 12 PMTAs for “one” e-liquid. So even though more e-liquid companies are submitting PMTAs than hardware manufacturers, each e-liquid manufacturer will likely have to consolidate much more than a hardware manufacturer. This is also heavily reliant on how the FDA receives the PMTA. Many e-liquid manufacturers have submitted one PMTA for multiple flavors, but the success of this method remains to be seen, and the FDA’s own language is ambiguous:

    “A manufacturer could submit one premarket application for multiple tobacco products with a single, combined cover letter and table of contents for each product. However, when [the] FDA receives a premarket submission that covers multiple, distinct new tobacco products, we intend to consider information on each product as a separate, individual PMTA …. [The] FDA considers each ENDS product with a differing flavoring variant or nicotine strength to be a different product.

    So will each different nicotine strength of each bottle size require a separate PMTA, or can they be combined? It’s unclear, but some manufacturers such as AMV Holdings are confident that multiple SKUs can be covered by a single PMTA successfully. In a Sept. 9 press release, AMV writes, “AMV has filed an additional 104 PMTA submissions accounting for over 5,000 SKUs.”

    However, even if multiple SKUs can be approved by the FDA under a single PMTA, consolidation will still occur, and only the most popular flavors, strengths and sizes will be submitted, at least initially. Given the popularity of pod systems, many manufacturers will likely submit a PMTA for e-liquids that use nicotine salts for a high concentration of the stimulant. Non-nicotine e-liquid is also likely to be among the first wave of submissions as well as one that is medium-strength. The reason being is that if a vaper prefers a nicotine strength of 3 mg, then unofficially the user can mix a higher strength with the non-nicotine e-liquid to achieve the desired strength.

    Several well-known e-liquid companies have submitted applications, including Humble Juice Co., Suicide Bunny, Charlie’s Chalk Dust and Beard Vape Co. While the more popular flavors may or may not have been submitted, there are several things that can be expected. First, tobacco and menthol flavors will likely be among the first flavors to receive approval, followed by basic fruit flavors.

    Like with nicotine strengths, flavors can be mixed by the end user, and by keeping it simple, mixing becomes much easier. Strawberry mixed with banana is much easier than apple-peach-mango mixed with blueberry mint. Depending on how the FDA treats bottle sizes, those may be consolidated to one size as well. Thirty milliliters is far and away the most popular size bottle for e-liquid, so expect that to become the standard.

    As the top level of the vapor industry consolidates its products, so too must the ground level. Doing so in a similar way to manufacturers is the most pragmatic approach. If and when products begin receiving FDA approval, look for three “levels” of products—beginner, intermediate and advanced—with minimal variation for each.

    At first, all three levels may be pod systems with varying degrees of advanced features, such as variable wattage, temperature control, etc. Beginner devices like disposables and pod systems, such as the Caliburn G from Uwell (see “Building on Success,” page xx), should take priority because even if they are mostly targeted at new and beginning vapers, advanced users can find value in those products as well.

    Intermediate-level products can begin to include features such as variable wattage and a larger battery capacity or e-liquid capacity. These are generally features that are requested by beginners who have had time to use a lower level product and find themselves wanting for more. Perhaps it’s more vapor or just not needing to charge the battery quite as much. Each customer base can vary, but those moving to intermediate devices want “more but better.”

    Advanced products are much the same but with generally higher power capabilities, e-liquid capacities, etc. The advanced user will generally know what they are looking for. In the current state of the industry, advanced devices generally include rebuildable atomizers as well, but these are likely not going to be a priority outside of niche markets. There’s a good chance that the first products brought through the PMTA process will be on the simple side, and rebuildables could require a separate PMTA for each type of wire and wick in order to be usable.

    The mods most commonly used with rebuildables also tend to have removable batteries, of which there are multiple brands that could, again, each require a PMTA submission. There are quite a few “moving parts,” so to speak, when it comes to advanced vapor devices, and until the industry has a more complete knowledge of how to submit a successful PMTA, the more complicated vapor products will likely be left by the wayside.

    The most important thing going forward is to simplify, reduce redundant products and provide a clear advancement pathway for new users. There is massive value in being a one-stop shop for new customers to discover vaping and keep coming back as they progress at their own pace. This may prove much easier throughout the PMTA process as a store owner may very well to be able to pick one manufacturer and stick to it since currently, many products are already similar between companies. Consolidation may also serve to clarify and simplify the development of a product line within a store, making it easier for stores and customers alike.

    The PMTA process is grueling and stressful for the entire industry. Although choices may soon become very limited, rest assured that the most reputable names in the business will continue to make their products available. Consolidation is inevitable, but one way or another the burden of choice is about to become much lighter, for better or for worse.

  • Change of the Guard

    Change of the Guard

    What might the new U.S. President’s administration have in store for the vapor industry?

    By Patricia Kovacevic

    At the time of writing, the results of the U.S. elections are still contested by the presidential incumbent, a Republican, via various vote recount requests and litigation; however, it is a virtual certainty that the U.S. will have a new president, representing the Democratic Party, as of Jan. 20, 2021.

    The heads of departments, including the head of the Department of Health and Human Services (HHS), are appointed by the president, subject to confirmation by the Senate, and typically change with the administration. In turn, the Food and Drug Administration (FDA), which is the agency within the HHS with primary jurisdiction over tobacco products (including electronic nicotine-delivery systems, or ENDS) as well as drugs, foods and other products, will be led in the new administration by a new commissioner.

    Given the Covid-19 crisis, the new president will be under immense pressure to appoint a new FDA commissioner immediately. Interestingly and somewhat surprisingly, a former FDA commissioner, David Kessler, was recently named co-chair of the new administration’s Covid-19 task force, although Kessler resigned his commissioner role in November 1996 amid controversy for overbilling his travel expenses during his tenure.

    Also during Kessler’s tenure, the FDA attempted to regulate tobacco products as “delivery devices for the drug nicotine” to bring tobacco products under FDA jurisdiction. Tobacco companies challenged the rules all the way to the Supreme Court and won (FDA v. Brown and Williamson Tobacco Corp.). The Supreme Court ruled that “Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products. Such authority is inconsistent with the intent that Congress has expressed in the FDCA’s [Food, Drug and Cosmetic Act] overall regulatory scheme and in the tobacco-specific legislation that it has enacted subsequent to the FDCA. In light of this clear intent, the FDA’s assertion of jurisdiction is impermissible.”

    Kessler’s wish to see tobacco regulated by the FDA was eventually granted by Congress in June 2009 through the bipartisan passage of the Family Smoking Prevention and Tobacco Control Act. While some speculate that Kessler may be on the short list for HHS commissioner, it is likely that the administration will bring forward new faces. Still, Kessler’s life-long anti-tobacco stance and past working relationship with the current head of the Center for Tobacco Products might give an indication of the increased scrutiny of the tobacco sector in the years to come.

    Patricia Kovacevic
    Patricia Kovacevic

    The ENDS industry status quo, from a legislation point of view, while far from ideal, is by now familiar to the ENDS industry. The recent premarket tobacco product application (PMTA) filing deadline has come and gone, and, as expected, we have not seen a flurry of warning letters post-September 2020 ordering certain vapor manufacturers to stop selling their products because they did not submit a PMTA.

    The FDA is, however, expected to start enforcing this legislation sooner or later. For any dramatic change to occur, the governing legislation, the Food, Drug and Cosmetic Act, would have to be amended, which is not likely to be top of the list for the upcoming Congress given the priorities the new administration announced during the election campaign. Still, the House of Representatives, one of the chambers of the U.S. legislature, remains dominated by the Democrats, the same party whose representatives initiated several tobacco-related bills and called for confrontational hearings on vapor products. The most recent one, in February 2020, was relatively tame compared with the tone of the July 2019 Juul hearing and even with the June 2014 Senate hearing.

    Senate races in Georgia will require runoff elections on Jan. 5, 2021. If Democrats gain both Senate seats in Georgia in January, there would be a 50-50 tie in the Senate, and the vice president would have the tie-breaking vote in case the Senate is deadlocked on a piece of legislation. When the House, Senate and White House are controlled by the same party, the chances of the current administration to pass laws in support of its agenda are greatly increased, though divisions exist within each party, and surprises always happen. Furthermore, 34 out of the 100 Senate seats are up for regular election in two years as well as all 435 House seats; these will be a trying two years for Americans in an economic crisis, and the public sentiment can swing in the other direction. Thus, the new president may have only two years, if even that long, to pass a flurry of laws, and there may be more urgent matters than revisiting the Tobacco Control Act, which, for better or for worse, has worked so far.

    The FDA already has broad powers to expand requirements and restrictions involving ENDS products, including the authority to impose product standards through notice-and-comment rulemaking. Ingredient caps and bans are among the standards the FDA has the authority to promulgate via regulation.

    The latest unified agenda of regulatory and deregulatory actions

    As of spring 2020, active regulatory actions include four potential future regulatory actions by the FDA, rolled over from previous agendas, with no clear deadline for publication of a proposed rule:

    Requirements for Tobacco Product Manufacturing Practice (colloquially referred to as “Good Manufacturing Practices”)

    Tobacco Product Standard for Characterizing Flavors in Cigars (follow-up to the 2018 Advance Notice of Proposed Rulemaking); this is unlikely to move into the final rule stage on account of recent courtroom successes by the cigar industry.

    Modified-risk tobacco product applications; this future proposed rule would establish content and format requirements to ensure that modified-risk tobacco product applications contain sufficient information for the FDA to determine whether it should permit the marketing of a modified-risk tobacco product. Additionally, the proposed rule would set forth the basic procedures for modified-risk tobacco product application review and require applicants receiving authorization to market a modified-risk tobacco product to establish and maintain records, conduct post-market surveillance and studies, and submit annual reports to the FDA.

    Premarket tobacco product applications and recordkeeping requirements, a 2019 proposed rule, which would have as a next step at some point in the future, likely in 2020, a final rule.

    Notably, ingredient bans and nicotine caps are not on the regulatory agenda. A first step toward an ingredient ban would likely be an Advance Notice of Proposed Rulemaking (ANPRM), although the FDA can in theory skip this step and move directly to a proposed rule, open a docket for comment, collect comments and consider whether it has sufficient information to finalize the rule. Given the complexity of the issue and the current research focusing on flavor ingredients in ENDS, if the FDA determines that an exploration of a flavor ban is desirable, the FDA will probably go through the ANPRM step.

    One would have to wonder, though, why engage in rulemaking when the FDA already reviews all relevant information about every ENDS product on the U.S. market, present and future, through the PMTA process—thus allowing the agency to make a case-by-case determination—and the FDA will no doubt pay considerable attention to certain flavored products. In the author’s personal opinion, the PMTA process is the FDA’s preferred avenue to make decisions on individual products rather than issuing rules on product categories, which can also be challenged—and the current Supreme Court might entertain challenges to the FDA’s behavior if it came to it down the road.

    Meanwhile, the majority of states by number still lean conservative, which likely means fewer developments in taxation, some scrutiny of ENDS but not necessary priority placed on shrinking the lawful ENDS market as there is no immediately quantifiable health benefit from doing so, and many potential harms. Of note are the California litigation and the potential referendum in California to overturn SB 793 (the flavor ban legislation). By the time this you read this article, we should know whether the bill opponents succeeded at collecting the necessary signatures to place the referendum on the November 2022 California elections ballot and suspend the application of the California flavor ban until then and pending the referendum’s outcome.

    The question we must also ask, given the political, public health and economic crisis context is whether ENDS are a threat to anyone and why any administration would, at this juncture, prioritize overregulating a harm reduction asset over the important, systemic changes Americans expect from the administration and drastically mitigating the Covid impact. The industry is likely to consolidate and survive.

    A global legal and compliance nicotine industry expert, Patricia I. Kovacevic has experience that includes general counsel and chief compliance officer roles at Nicopure Labs as well as leading senior legal and regulatory positions at Philip Morris International and Lorillard. Kovacevic served on the board of directors of the Vapor Technology Association and on the advisory board of the Global Tobacco & Nicotine Forum. She is the founder of RegulationStrategy, a global legal and compliance FDA-regulated industry consultancy.

  • Eyes on the Prize

    Eyes on the Prize

    no smoking
    Credit: Tumisu

    While tobacco harm reduction products have an important role to play, quitting ‘cold turkey’ remains a legitimate strategy in pursuit of better health.

    By George Gay

    According to a joke included at the end of a London Review of Books piece by Jerry Fodor, a keynote speaker opens his remarks at a philosophical conference by saying that, in principle, there are 12 philosophical positions, only to be interrupted by a heckler shouting, “13!” The keynote speaker continues: “As I was saying, there are 12 philosophical positions …” but again the heckler shouts, “13!” The speaker then says that he will describe briefly the 12 philosophical positions. The first, he says, is Naive Realism, according to which things are more or less the way they seem to be. At that point, the heckler shouts, “Oh no, 14!”

    You don’t have to be a philosopher to get the message that there is a danger that complexity can suffocate simplicity and the common-sense benefits that the latter has to offer. This isn’t to say there is no need for complexity—just that there is also a need, at times, for simplicity. As I believe Einstein once put it: Things should be made as simple as possible but no simpler.

    Is there not a danger that in pursuing tobacco harm reduction (THR) we are losing sight of the simple? I know it’s unfashionable to ask, but what is wrong with smokers going cold turkey if they want to quit their habit? There was a time when all smokers who wanted to quit went cold turkey because that was the only route out of tobacco. And millions did it. I was one of them.

    What a lot of readers will be thinking, however, is that there’s nothing stopping smokers from going cold turkey, so what’s the problem? Well it’s not quite true that there’s nothing stopping them doing so. I can think of at least two things that would be holding them back.
    One is the fact that various people and organizations have taken a lot of trouble to convince smokers that quitting cold turkey is incredibly difficult, if not impossible. They have tried and largely succeeded in convincing many smokers that they are victims who cannot control their own destiny. Their ability to make decisions about smoking and health has been taken from them by tobacco manufacturers. This, of course, is nonsense, but it is a useful narrative for some people to spread and, regrettably, for others not to counter.

    The other reason is that smokers are given too little help to quit cold turkey. Why couldn’t a large part of THR comprise tobacco tax-funded public announcements encouraging smokers to quit? Of course, there would be a need firstly to sound a very loud warning bell.
    Such announcements should not descend into the type of propaganda beloved of certain governments and organizations where smokers are depicted as being victims of the tobacco industry, patients of the medical profession and the scourge of society. And such announcements should not feed smokers a bunch of lies and half-truths, try to frighten the pants off them and generally treat them as though they were children without the ability to make rational decisions.

    Better still, smokers should be provided with positive rather than negative information. They should be told how quickly, post-quitting, their risk of contracting certain diseases and conditions falls to that of, or near to that of, nonsmokers. And they should be told how, in quitting smoking, and especially in quitting cold turkey, they will be saving money while making a positive contribution to helping prevent pollution and the further degradation of the environment.

    One of the problems is that THR has become monetized—become part of the destructive system under which the worth of everything is judged by its performance on the “market.” We have been fooled into believing that what matters is that smoking is replaced by something that can be sold, preferably for the same sorts of profits that are currently enjoyed in selling cigarettes. That is, cigarettes have to be replaced by less risky tobacco and nicotine products, including nicotine-replacement therapy products manufactured by the pharmaceutical industry.

    And it is true that there would be something to be said for such a way of looking at smoking cessation if it weren’t for the fact that less-risky products seem to be struggling—entangled in endless debates based on science and pseudo-science, conspiracy theories, political shenanigans and great dollops of bureaucracy.
    These debates are all very interesting and take up hours of conference time, but they remain largely unresolved, like Fodor’s philosophical positions two through 12, and they simply leave smokers up a creek without a paddle. The interests of the smoker seem to have been pushed into the background as the various sides in the THR debate defend their own positions and brief against each other.

    That something is seriously wrong with efforts being made to promote smoking cessation is clear from Burning Issues: Global State of Tobacco Harm Reduction 2020, the second (the first appeared in 2018) such report written by Harry Shapiro and published by Knowledge-Action-Change. This 162-page report makes the point that after more than a decade of product availability, there are only nine users of “safer nicotine products” (SNP—vapor devices and heated-tobacco devices, Swedish style snus and some other safer forms of smokeless tobacco) for every 100 smokers.

    This should sound alarm bells, and it does, but those bells are peeling out the wrong message as far as I can hear. They are calling for more of the same. How does it go? Having lost sight of our objectives, we redoubled our efforts.

    I should add, however, that this is an excellent report with masses of information about where we are with THR and the SNPs that underpin it and how we got here. The way forward is less clear because it is difficult to navigate a path in the face of the guerrilla activities employed by those opposed to the THR approach—activities that have so far proved fatally successful in casting doubts in the minds of smokers and vapers. Nevertheless, the report contains 15 recommendations (as well as 20 conclusions) that map out a route to the future. Though, in the light of the short history of THR, some of those recommendations might better be described as wishful thinking.

    One of the things that becomes clear in the report is how little success had been achieved in pushing the quit-smoking agenda before the incorporation of the sorts of harm reduction principles that had already been well established in respect of other health challenges. And little wonder given that pre-THR, the approach had been to bully smokers into quitting. THR takes an altogether more humane approach, as the report spells out:
    “Harm reduction refers to a range of pragmatic policies, regulations and actions, which either reduce health risks by providing safer forms of products or substances, or encourage less risky behaviors. Harm reduction does not focus primarily on the eradication of products or behaviors.”

    Contrast this with the methods employed before THR and that are still pushed by many governments, organizations and individuals—methods that are based on discouragement or punishment. Such methods include the degradation of the products that smokers enjoy through pointless controls on nicotine levels, the banning of harmless flavors and the despoiling of packaging. They include the inexcusable use of smoker “denormalization” or officially sanctioned discrimination. And they include the imposition of grossly unfair levels of taxation.

    guy vaping
    Credit : Omni Matryx

    Meanwhile, there are issues brought up in the report that I believe could usefully be subjected to further analysis in any forthcoming edition of Burning Issues. The report mentions that the World Health Organization (WHO) has “not revised downwards its estimate that one billion lives could be lost to smoking-related disease by the end of the century.”

    Despite the fact that many of us are highly critical of the WHO’s attempts at encouraging smoking cessation, we tend to accept its figures unquestioningly. But whereas, for instance, a figure of one billion is convenient to throw about, when you think about it, it is ludicrously rounded. And given that this is a worldwide figure, you have to ask yourself how the data are gathered in many countries, especially in those where, perhaps because of wars, there are no fully functioning administrations.

    And it would be good to see some of the methodologies used in compiling such figures. Since, I guess, some people die of “tobacco-related diseases” that might also be seen as “pollution-related diseases,” how are these deaths divided up? I suspect that the default setting is to put such deaths into the tobacco-related deaths column, in which case the WHO’s tobacco-related deaths figures are likely to be inflated.

    This is not an attempt to get tobacco partly off the hook but to make sure that we are taking action where action is required and not just where some people would like to see it applied. There is no point in developing vapor devices if the disease problem is down to the pollution caused by air travel, etc.

    But what I would like to see, especially, is detailed information on how “tobacco-related” diseases and deaths have fallen with the reduction in smoking in those countries where such smoking reductions have occurred. In countries such as the U.K., smoking has been falling long enough for the related diseases to be also showing declines, and there should be a recognizable correspondence between the two.

    lady vaping
    Credit: Kjerstin Michaela Haraldsen

    The problem with accepting blind what the WHO has to say is that one can end up being mesmerized by huge figures and drawing some questionable conclusions. The report states, for instance, that the one billion tobacco-related deaths “[are] equivalent to the combined populations of Indonesia, Brazil, Nigeria, Bangladesh and the Philippines dying from Covid-19.” I know that it is considered rather trite to say so, but shit happens, people die, and it is necessary to keep a sense of proportion.

    If you look at a long enough time frame, you could probably say that the equivalent of the population of Belgium will die from having pieces of toffee stuck in their windpipes. And I think the reference to Covid-19 doesn’t stack up.

    There is a world of difference between smoking and Covid-19. A lot of people won’t agree with me here, but people have a choice about whether or not they smoke. But the ordinary person in the street has next to no control over the rise and spread of viruses. That is why, to my way of thinking, viruses are a valid area of interest for the WHO whereas smoking is not.
    I’m not saying that we should row back from THR products, but, at the same time as we are improving these products and making them available, we should be putting our foot down harder on the cold turkey pedal just in case those opposed to THR win the day. It’s not just me being pessimistic. This is from the report.

    As the environment for THR has grown ever more toxic since our last report, we have turned our attention this time to the mechanisms of the well-orchestrated and well-funded global campaigning driving an increasingly prohibitionist response to SNP.
    Despite the above, it is claimed in the report that SNPs have been “disruptive” and that they have provided one of the most startling public health success stories of modern times, claims that, given the slow conversion rate from smoking to using SNPs, seem not to be supported by the evidence. Or perhaps I’m looking at things from the wrong direction. This, too, is from the report:

    “Globally, the value of the vaping market has continued to grow since our 2018 report and is projected to grow further. The chart from Statista43 shows the value of the e-cigarette market at around $19 billion and its steady projected growth from 2012 through to 2023.”
    I see. So it is about monetization, is it? OK, we have to be practical. We have to allow companies to make money, but there’s clearly a problem here. Declines in smoking predated the arrival of SNPs in many of the countries where these sorts of products are affordable, basically the West, but smoking is still on the increase in many low-income and middle-income countries where they are less affordable. If we are not careful, THR will become a system that helps to underpin health inequalities. If you’re rich, you can afford the products to keep you healthy; if you are not … well, too bad.

    By all means, let’s redouble our efforts, but let’s make sure we’re still focused on the goal of encouraging people to stop smoking. We might need to look for new ways of doing this or even old ways, such as cold turkey.