Category: This Issue

  • Small Scale, Big Ambition

    Small Scale, Big Ambition

    Zach Gibson Photo Credit: Kaylen Settles
    A small farm in rural South Carolina is producing proprietary hemp that yields high percentages of a proven cancer-fighting cannabinoid.

    By Timothy S. Donahue

    Kura Kuma Farms isn’t a big, fancy hemp-growing operation. Owner Zach Gibson isn’t your typical farmer. He’s a small-scale producer that has the ambition and potential to compete with the major farms in the next few years. His secret is simple. The science behind it is not.

    Genetics within the biometric genome of the cannabis plant can be quite complicated. Certain cannabinoids can be more valuable on the open market. CBG (cannabigerol), for example, can sell for upward of $4,000 per kilo. A lesser known cannabinoid, studies have shown CBG to be effective in killing or slowing bacterial growth.

    It has also been shown to reduce inflammation (particularly in its acidic CBGA form), inhibit cell growth in tumor/cancer cells and promote bone growth. CBG is also said to help regulate mood because of its ability to boost anandamide, often called the “bliss” molecule for the way it boosts positivity in the human body. Gibson explains that CBD tends to be more relaxing while CBG users tend to feel more energetic.

    Most hemp plant strains do not carry very much CBG. To obtain higher yields of CBG, breeders have been experimenting with genetic manipulation and the crossbreeding of hemp plant varieties. “It was the unicorn. We were very fortunate to have come across this genetic material. We took a gamble on some unknown seed stock,” explains Gibson. “We started with hundreds of seeds and narrowed it down to some of the best as far as growth characteristics and health levels.”

    From the final 12 seeds, Gibson said one strain had a very high amount of CBG, nearly 10 times the amount of a typical hemp plant. “Some of them had high THC [the psychoactive component of marijuana] content. Some of them had just a little bit of THC and moderate amounts of CBD but no CBG,” says Gibson. “There was this one plant, though. It had almost 12 percent CBG, which is extremely rare. So, yeah, that ended up being a really big win for our farm. We are very excited.”

    Beyond his current agricultural enterprise, Gibson would like to expand his farm and begin his in-house breeding program. It’s challenging, he explains. “A big part of this is that it’s a new strain, or it’s a new genotype. We are dealing with a specific cannabinoid that has some incredible uses in the market,” says Gibson. “It’s only been the last couple years that growers have started to try to expand these plant profiles (CBG), and it’s typically been 1 percent at the highest. So, anything over 5 percent is huge.”

    To be a successful farmer, Gibson believed that he needed both a variety of products and something unique. He now has both. He didn’t want to be the person selling directly to farms, however, so he needed a partner. While nothing is set in stone, he thinks he is on the right track. “I’m working with a larger company that has a national platform for farmers where, if I’m able to impress them with the genetics that I come up with, they’re willing to bring them onto their catalog and sell them for me,” he says. “I’d rather be more hands-off and just focus on the fun, experimental side of creating new genetics and things like that. And playing in the dirt; I like to play in the dirt.”

    GETTING STARTED

    Gibson honed his skills in

    Photo: Kaylen Settles

    the legal marijuana industry. He learned how to grow hemp from a cannabis farming community in Oregon. “I became friends with some guys that had been longtime medical cannabis growers in the area, and I ended up being taken under the wing of a guy who was a second-generation grower. That led to me working in a couple of cannabis warehouses where I started off doing trimming and other low-level positions,” says Gibson. “I worked my way up to assistant gardener and was helping with the daily chores involved in taking care of the plants. Eventually, I got my license and started my medical farm in 2012.”

    By 2018, Gibson was growing homesick for his home state of South Carolina. His mom had recently passed away, and his sister had just had her first child. “I just wanted to get back closer to family and take steps toward a new direction. I had a great thing going on in Oregon, but I felt like I had hit a ceiling,” says Gibson. “It happened to be perfect timing; it was right when South Carolina was moving into its second year of the [hemp] research program. I applied and was awarded a license to start growing hemp.”

    Gibson received one of only 40 permits issued in South Carolina in 2018 out of an estimated 175 applicants. After the 2018 farm bill passed, legalizing hemp farming, the Palmetto State issued an additional 36 permits. “We started getting the farm ready. There was a lot to do,” explains Gibson. “Last year was our first year growing outdoors on a large scale. We constructed an 80-foot greenhouse, then we did a lot of our own propagation, and that’s really what helped save on our overhead costs.”

    Instead of buying seeds or clones from a major producer, Gibson used plants he had been growing in a smaller indoor operation on the farm. He says it saved him about $30,000 and allowed him to plant nearly three acres. He expects to plant about the same acreage this year. “The industry is flush with biomass right now,” he says. “We need to be doing something specific and in extremely high quality to stand out.” He estimates his 31-acre farm has 5 acres to 6 acres of plottable land for future growth.

    Kura Kuma Farms gets part of its name (Kuma) from a childhood pet of Gibson. Kuroi kuma means “black bear” in Japanese (it sounds the same as Kura Kuma) and Gibson liked the idea of calling his farm something unique for South Carolina. The land has been in his family for more than two generations and has never been an actual farm. The land was used mostly for agrotourism. “My mother and father hosted kids’ birthday parties and would have business meetings and groups of people come out to the farm and just do different sorts of tours,” he says. “We had a bunch of goats and a bunch of different fowl, from peacocks to guineas and chickens, and rabbits. A couple of horses for a while too.”

    The lack of farming on the land means the soil is clean and mostly free of any pesticides or heavy metals. That makes for quality hemp, which acts like a vacuum cleaner and soaks up any impurities in the soil. “Our soil is very clean,” he says. “We have the opportunity and ability to grow some high-grade hemp flower as well as provide quality consumer goods … It’s super exciting.”

    REGULATORY CHALLENGES

    The hemp industry is growing fast. With that growth comes regulation. In late 2019, the U.S. Department of Agriculture (USDA) released its guidelines for hemp farmers. Industrial hemp is defined as Cannabis sativa L. and is required to be below a THC threshold of 0.3 percent, according to the USDA. To produce hemp, farmers must first be licensed under a state or tribal hemp program or through the USDA hemp program.

    According to the Farm Bureau (FB), the 0.3 percent THC rule presents a risk to farmers. Seed varieties grown in two different geographical regions, for example, can express certain traits differently. “The same type of seed grown in two different parts of the country can produce one crop with THC concentrations less than 0.3 percent and another with plants above that THC threshold,” according to the FB.

    This means that farmers have a tough time making sure THC levels are right. The consequences for making the mistake of having “hot” plants too often could mean losing your license, according to Gibson. “The new regulations are [that] anything that tests over 0.5 percent total THC, which is the big controversial definition now, is considered negligence,” explains Gibson. “They’re not going to punish you with a fine or take you to jail; however, that’s going to be pretty stressful for a lot of farmers that are working with new genetics for the first time or are still working with genetics that may not be super stable.” At a minimum, if a farmer negligently “violates a state or tribal plan three times in five years, they will be ineligible to produce hemp for the next five years,” according to the USDA.

    Another concern is testing for THC levels, according to Gibson. Regulations require testing to be completed by a U.S. “Drug Enforcement Administration-registered laboratory using a reliable methodology for testing the THC level,” according to the FB. There are two certified labs in South Carolina. “Guess how many there are in Oregon? One. So, they’re not prevalent,” says Gibson. The USDA has said it is working to address the number of labs available for hemp testing.

    Labs are also not testing in the same ways. Gibson says that a laboratory on the West Coast could have the same samples sent to them as another lab on the East Coast, and they could end up with different results because they have different standards. “So that’s a problem,” he says. The FB acknowledges this is still an issue, stating that “the measurement of uncertainty depends on multiple variables, such as the equipment being used, the methodology of the test, the sample size, the sample quality and other variables, and as such, it will vary with each sample that is tested.” The USDA has stated that it is working on a solution.

    Finally, a growing concern for farmers is the amount of biomass entering the market. Gibson says it is making it very difficult for farmers to earn a decent wage. “There was so much biomass growth in 2019, and it flooded the market, which crushed prices. I saw expos where there was beautiful biomass being offered at an extremely low price,” he says. “People still weren’t touching it just because I think it got to the point where the market, as far as demand, it wasn’t able to keep up with the production it was trying to put out there.”

    Gibson says he is hoping growth in consumer demand and some farmers leaving the industry will help alleviate the excess biomass. “Something has to give. It’s probably the industry’s most immediate concern,” he says. “I believe we will see fewer farmers by 2021. I think a lot of people jumped into it thinking, ‘Oh, this is going to be easy. We’re going to make a million dollars growing hemp.’ Now they have started to understand that it’s not as easy as you might think.”

    DIVERSIFIED OUTLOOK

    To better diversify his business, Gibson has started producing and marketing

    Photo: Kaylen Settles

    his CBD products under the brand name Tenaj (a tribute to his mother, Janet). “The urban dictionary says it also means ‘forbidden love.’ So, that was also topic appropriate given the nature of the plant and its history,” says Gibson. Tenaj can be found in several retail outlets as well as online at www.kurakumafarms.com.

    Moving forward, Gibson hopes he can turn over his CBD brand to a third-party manufacturer and focus strictly on his farm. “I’d like to just be the farmer and have the other companies manufacture my raw product into consumer products for me,” he says. “It’s important, but it’s also not something I want to have to constantly worry about managing when I have the farm to work too.”

    Currently, the Tenaj brand has pre-roll products, tinctures and a topical ointment. Gibson says he would like to expand his product line, but right now, he is just trying to keep overhead “low and tight, especially understanding what state the industry is in right now … there are a lot of CBD products out there and way too much biomass on the market.”

    Gibson says that the hemp industry has a lot of variables. For example, he has been seeing media reports about several large hemp processors going out of business. He says that scares him. He’s building the genetics side of his business, which means Kura Kuma Farms is going to be dependent on other farms succeeding. “A lot of people are kind of holding their cards and being extremely cautious about how they’re moving forward next year,” he says. “The future of the hemp industry is not crystal clear. The money doesn’t actually grow on the trees. There’s a lot more to the industry.”

    There is also some hope that South Carolina could legalize medical cannabis in some form in the next few years. Gibson says he believes there is a place for that additional business to become very profitable. “I would grow it all,” he says. “Yeah, and I’ve already talked to some people about being ready for legalization. That would be fantastic news for small-scale farmers. It would help ease the struggle. Farming is in the heart; it’s a lot of hard work and every little bit helps.”

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • First, Do No Harm

    First, Do No Harm

    Doctors often recommend Chantix to their patients who smoke, but the drug has a long history of serious side effects.

    By Maria Verven

    Smokers have always been at a higher risk of heart and lung disease, but the Covid-19 pandemic has made quitting combustible cigarettes even more urgent. Cigarette smoking is a cause for concern because smoking inhibits the body’s ability to heal from infections such as the coronavirus, says Michael Siegel, a Boston University School of Public Health professor with more than 30 years’ experience in tobacco control, including two years at the U.S. Centers for Disease Control and Prevention (CDC) Office on Smoking and Health.

    While the U.S. Food and Drug Administration (FDA), the CDC and the media often denigrate and vilify e-cigarettes, the drug varenicline, sold as Chantix, continues to fly relatively smoothly under the radar screen. When searching Google for e-cigarettes, you’ll get a whopping 386,000 results, including the predictable articles about youth e-cigarette use. In contrast, a search for Chantix nets only about 7,000 results, including a new study (read on to learn more) the authors use to promote its supposed safety and support the FDA decision to remove its black box warning. 

    Search on the CDC site for Chantix and you’ll get only 66 results versus over 2,200 for e-cigarettes; the top results for e-cigarettes mention “pulmonary disease,” “lung injury” and “youth tobacco use” even though e-cigarettes contain no tobacco. In contrast to nearly 3,300 results for the search term e-cigarette, the FDA site also only lists 78 results in a search for Chantix, and the top result is an update on their September 2016 decision to remove the boxed warning based on the conclusion that the “risk of serious side effects on mood, behavior or thinking is lower than previously suspected.”

    Antwon Mcmullen I Dreamstime.com
    BLOCK BOX WARNS OF SUICIDE AND PSYCHIATRIC PROBLEMS

    Approved under the brand name Chantix in 2006 for smoking cessation, the drug varenicline originally carried a label warning consumers of the risk of suicide and other psychiatric problems, including depression and mania, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety and panic as well as suicide and suicidal ideation and attempt.

    By the end of 2007, the Institute for Safe Medicine Practices (ISMP), a nonprofit medication watchdog, reported that Chantix was responsible for more reports of serious drug adverse events than any other drug in the U.S. “Data show that varenicline, ‘Chantix,’ continues to account for more cases of suicidal, self-injurious or homicidal thoughts than any other therapeutic drug from 2007 through 2013 Q3—more than three times as many as the second-ranked drug,” the ISMP reported.

    Four leading nonprofit consumer, research and medical organizations—Consumer Reports, , the National Center for Health Research, the National Physicians Alliance and Public Citizen—joined the ISMP in filing a citizen petition with the FDA, documenting the extensive scientific evidence of Chantix’s substantial risks.

    The FDA finally added its strongest black box warning in July 2009 after receiving 153 reports from doctors who were deeply concerned when their patients suddenly started exhibiting suicidal behavior.

    By the fall of 2013, Chantix was associated with 2,748 adverse events (14.8 percent of all cases), including 293 suicides, 490 attempted suicides and many other cases involving self-injurious behavior or homicidal ideation—more than any other medication sold in the U.S. The ISMP ultimately recommended that “patients and doctors exercise caution in the use of varenicline and consider the use of alternative approaches to smoking cessation.”

    CLASS-ACTION LAWSUIT FLIES UNDER THE RADAR

    Not surprisingly, these adverse events spurred thousands of lawsuits by families of loved ones who suddenly and inexplicably took their lives while on Chantix. In March 2013, Pfizer, the drug’s maker, settled 80 percent of these lawsuits out of court for an estimated $273 million.

    What’s odd is that any reports of adverse events associated with Chantix end then and there. Try searching for how and when the other 20 percent of lawsuits have been resolved or the latest statistics on how many attempted or successful suicides or homicides have taken place over the last six years, and the trail runs cold.

    However, it’s easy to uncover the fact that Chantix has been linked with a host of neurologic or cardiac risks, including blackouts, convulsions and impaired vision. Due to these and other well-known psychological side effects, the Federal Aviation Administration banned pilots and air traffic controllers from using Chantix; the Department of Defense and the Department of Transportation also disallow its use by missile crews, armed military personnel, police, fire and emergency professionals and anyone in a “sensitive” occupation. 

    Yet it recently became even easier to buy Chantix—as of 2019, at least 12 states now enable consumers to purchase the drug without a doctor’s prescription. Between 2013 and 2018, the cash price for Chantix increased by 106 percent. Pfizer reported that U.S. sales were $899 million in 2019, up 7 percent from 2018. But another development may make the drug even more accessible and affordable: Pfizer’s patent protection expires in May 2020, so a generic version could potentially be available as early as this June.

    Not surprisingly, Pfizer is seeking a court order to block copies of its drug until all its patents have expired—including those set to expire in November 2020, November 2022 and February 2023. 

    SUSPICIOUS STUDIES

    Back in September 2016 when the FDA’s advisory committee met to review the black box label on Chantix, the meeting got quite contentious. There appeared to be much disagreement over whether to remove the boxed warning. Indeed, of the 19-member panel, five actually recommended strengthening the label and four recommended a language change.

    But most suspicious was the evidence used to remove the black box warning: The voting members of the panel were presented with an April 2016 clinical trial paid for by Pfizer. Even the FDA noted a number of violations in Pfizer’s clinical trial protocols, including inconsistencies in source data, missing documents and safety assessments, and failure to record adverse events.

    Plus, the personnel who performed the diagnostic interviews and mental health evaluations failed to meet the most basic professional qualifications. In fact, six of the 10 authors worked for either Pfizer or GlaxoSmithKline, maker of Zyban, a brand of antidepressant bupropion that is used as a quit smoking aid, while three, including the lead and second-named authors, were regular consultants paid to promote Chantix. The study was so poorly done that the FDA’s Office of Scientific Investigation determined that “it was neither feasible nor possible to attempt to adjudicate the cases based on the provided information,” concluding that “[Pfizer’s] investigator assessment of relatedness has been altogether disregarded.”

    A more recent study reported in February 2020 in Addiction Magazine sought to assess Chantix’s relative cardiovascular and neuropsychiatric adverse effects in adults with no history of depression. Lo and behold, the retrospective study of over 600,000 adults found there was a 20 percent lower risk of of developing cardiovascular and neuropsychiatric adverse effects using Chantix when compared with the use of  nicotine-replacement therapies (NRTs) such as nicotine patches and gums, and a 35 percent lower one-year risk of neuropsychiatric hospitalization when compared to patients using NRTs.

    Interestingly, NRT was chosen for the comparison group “because it is the oldest, least expensive treatment, often available without prescription,” according to the authors. However, of the quit methods used, 35 percent of the subjects had substituted some regular cigarettes with e-cigarettes, and 24 percent had switched completely to e-cigarettes (a total of 60 percent) while only 25 percent used nicotine patches or gums.

    The most obvious problem with this study is that it excluded anyone with a history of depression. Indeed, even the authors had to include these caveats: “The exclusion of patients with a diagnosis or treatment for depression limits the external validity of our results.”

    “This study does not necessary demonstrate the safety of Chantix among people with baseline depression,” said Siegel. “It is possible that the suicidal ideation that seemed to be precipitated by Chantix in some cases occurs specifically among people with pre-existing depression.”

    And one must question why the authors chose to compare Chantix with less popular quit methods while neglecting to include comparisons with e-cigarettes. “It only compared Chantix with NRT therapies but excluded the millions of people who have switched to e-cigarettes. The comparison would have been enlightening,” Siegel said.

    WHICH METHOD HELPS SMOKERS QUIT?

    Has Chantix been effective in helping people quit smoking? A study reported in the National Institutes of Health, called “Diminishing benefit of smoking cessation medications,” found that only 18.7 percent of people treated with Chantix remained abstinent from smoking after one year.

    Even NRT, notoriously ineffective for long-term smoking cessation, was more effective. “There is no clinical trial directly comparing e-cigarettes with Chantix,” Siegel said. However, he cited a clinical trial published in the New England Journal of Medicine last year that reported a 20 percent quit rate with e-cigarettes—a similar rate to Chantix. “I would say that the best evidence at the current time suggests that e-cigarettes and Chantix are probably comparable in their efficacy in helping people quit smoking,” he said.

    While there are no studies comparing Chantix and e-cigarettes, a study published in February 2019 in the New England Journal of Medicine that was funded by the National Institute for Health Research and Cancer Research U.K. compared e-cigarettes with NRT. Of the 886 participants, 18 percent who used e-cigarettes achieved abstinence from smoking one year later compared with only 9.9 percent in the NRT group.

    Their conclusion? “E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy when both products were accompanied by behavioral support. Switching completely from cigarette smoking to e-cigarette use would be expected to reduce risks to health.”

    Unfortunately, it may take a long time before physicians and the public health community recommend e-cigarettes over Chantix to patients who want to quit smoking. The American Lung Association launched a “Quit, Don’t Switch” campaign earlier this year. Drawing a hard line that ignores the potential harm reduction offered by NRT and e-cigarettes, the site states, “Switching to e-cigarettes does not mean quitting. Quitting means ending your addiction to nicotine.”

    “I don’t think physicians will widely embrace e-cigarettes for smoking cessation until the FDA has officially approved these products and the major anti-smoking groups have also embraced these products,” Siegel said. “Although the FDA will eventually approve some e-cigarettes, I don’t see the major anti-smoking groups embracing e-cigarettes any time soon.”

    “I think Chantix should be recommended by public health officials as a Plan E smoking cessation remedy after cold turkey, e-cigarettes, smokeless tobacco and NRT, since Chantix poses far greater risks than these four other smoking cessation methods,” said Bill Godshall, founder and executive director of Smokefree Pennsylvania.

    “E-cigarettes should be recommended to smokers who are unable or unwilling to quit by themselves or with Chantix or any other method—and that’s the majority of smokers,” said  Konstantinos Farsalinos, a cardiologist, clinical researcher with the Onassis Cardiac Surgery Center in Athens and often-quoted expert on e-cigarettes.

    “In a real-world setting, I think it is important to approach smoking cessation on an individual level beyond the results of any randomized trials. But most doctors discourage e-cigarette use to those who are unable or unwilling to quit with Chantix,” he said. “Even worse, they discourage vapers who have already quit smoking from using e-cigarettes. The end result is that many of them relapse to smoking.”

    Picture of Maria Verven

    Maria Verven

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

  • Sanitary Solution

    Sanitary Solution

    Credit: Feelm

    After a brief shutdown of all operations, vapor hardware manufacturers in China are now operating at more than 80 percent of pre pandemic production.

    By Timothy S. Donahue

    It’s not the same as it was this time last year. However, vapor hardware manufacturers in China that produce products for the world market are back in service after a brief hiatus due to the Covid-19 pandemic. Mostly based in Shenzhen, the e-cigarette capital of the world, companies say that they are working hard at implementing new standards and processes in order to keep employees and customers safe.

    They are also playing catch-up in collecting data for premarket tobacco product authorizations (PMTA) in the U.S. market. “The coronavirus is indeed having an impact on the PMTA process,” says Welford Ou, CEO of Smoktech, a major manufacturer. “For example, the behavioral investigations have been stopped, and it is also taking more time for us to prepare all the products for the PMTA.” As of this writing, PMTA applications are due to the U.S. Food and Drug Administration (FDA) on May 12.

    Smoore Technologies, the parent to Vaporesso and Feelm, says it “took strong and comprehensive measures” in advance of the virus’ outbreak. “We set up disease prevention and control teams in each of our facilities before the Chinese Spring Festival holiday. Dating back to the 20th of January, Feelm teams started to collect information, investigate employees’ conditions, prepare epidemic prevention supplies and disinfect public areas,” said Sofia Luo, marketing director for Feelm. “Before getting back on track, Feelm handed out a Covid-19 prevention and control booklet to each employee, providing scientific support to enhance health security.”

    All Smoore facilities are now back up to at least 85 percent of pre-pandemic production, according to Luo. She says Feelm is already shipping goods to the U.S. and has been since the middle of February. “Smoore and its subsidiaries have enough key materials inventory, and all of our supply chain has recovered and is back in production,” she said. When asked whether there was a supply shortage, Luo replied, “In general, the impact of supply shortage is under control.”

    Smoktech is getting back to its normal operations and more workers are expected to be hired as the virus outbreak is brought under control, according to Ou, who added that the company is awaiting the return of some workers from Wuhan (located in the Hubei province and the epicenter of the pandemic) where the quarantine was officially lifted on April 8.

    “The sales are doing well even with the Spring Festival and a long time staying at home for virus control,” says Ou. “Our challenge is to get more skilled workers in [a] short amount of time to meet the growing demand. My concern for the world market is [that] hopefully they will embrace vaping and see it is better and safer than smoking cigarettes.”

    Smoore took early action in order to prevent a massive global disruption in the vapor and e-cigarette market, according to Luo. She said that the company started to communicate frequently with its clients at the early stages of the pandemic. “We reminded customers to pay great attention to the epidemic. With the development of Covid-19 worldwide, most of our customers have been prepared (in terms of staff safety and inventory),” Luo stated. “The [virus] was a black swan event of great magnitude.” A “black swan” event refers to an unforeseen occurrence that typically has extreme consequences; in contrast, a “gray rhino” event is an obvious yet ignored threat.

    Luo says that, although Covid-19 is spreading all over the world, the demand for e-cigarettes hasn’t changed. “Vapor stores in many countries remain open. And we know some brands are increasing the online sales and e commerce service,” she said. “We forecast [that] the 2020 industry will be the same size or a slight increase compared with 2019. And after PMTA, [the industry] will get a big increase.”

    When it comes to issues like the limitation of freight and whether the virus could be on packaging, Feelm says the information from official sources are that there’s no limitation of freight, and the World Health Organization (WHO) confirms coronaviruses do not survive for extended periods on objects such as letters or packages and that it’s safe for people to receive packages from China.

    Luo says Feelm will continue to stay updated on related information and adds that the company will spare no efforts to guarantee each product is clean and safe in all aspects from purchasing raw materials to exporting goods. Feelm products have been approved by several international quality and safety systems, according to Luo. “As a leading company in the automatization area, Feelm has the strength to embrace health and security first,” she says. “Disease prevention and control is our responsibility. Feelm is well prepared to protect employees’ safety to recover production and to win the battle.”

    At its factories, Smoore and its other entities’ staff are well-equipped with protection products such as masks, gloves and other safety equipment, according to Luo. “Disinfection in public areas is proceeded twice a day. Exclusive dust bins for used face masks are placed throughout the facilities,” explains Luo. “All these measures lay a solid foundation to protect Feelm and all Smoore employees’ safety. This allows for the greatest possibility for full production recovery.”

     

    THE NEW NORMAL

    United we stand, together we win. Since the outbreak of Covid-19 at the end of last year, the Chinese government has implemented a series of powerful measures that have effectively controlled the spread of the virus, according to Sofia Luo, marketing director for Feelm, a major atomizer company based in Shenzhen, China.

    “At present, production recovery has become the top priority. Allied with government regulations and a corporate plan, Feelm employees started to work online at the beginning of February. Now, all facilities serving Feelm clients are getting back on track,” explains Luo. “Thanks to Feelm’s advantages with having a strong supply chain and the ability to deal with emergencies, Covid-19 has had little impact on production. Once getting back to work, the production capacity will recover soon.”

    In order to ensure the prevention of a recurrence of the virus within the company, Feelm has implemented an eight-step policy to enhance protocols and address health and security concerns for its employees. According to Luo, the first step requires all employees to register their current health status and any other conditions they may have.

    “They must also inform us of the dates they are returning/returned to Shenzhen, the people they have met, etc.,” she says. “They must archive related documents setting up an exceptional first line of defense. Step two: any employees returning to Shenzhen from other places must isolate themselves at home for 14 days. They must work from home or online if applicable, according to Luo. Only if without any suspected symptoms like fever and coughing, are they permitted to return to the office. All employees must wear a face mask at [the] factory.”

    Step three is all factories must have epidemic prevention supplies ready, according to Luo. Employees must wear a face mask while going out and have their temperature taken before stepping into the factory. They must also wash their hands after touching anything and always have disinfectants at hand.

    Step four involves having strict Allied Social Sciences Association (ASSA) access control systems in place. Employees must wear identification badges and have their temperature taken twice a day. “Anyone whose body temperature is over 37.3 degrees Celsius should stay at home for medical observation,” says Luo. “Protecting yourself is protecting others.”

    Luo explains that step five is one of the most vital steps. She says the company actively disinfects all public areas in factories twice a day. “Office areas are disinfected once a day after work. Public space and dormitories are also once a day,” she says. “Production area disinfection is arranged by departments.”

    Step six involves maintaining the cleanliness in production workshops. “Enter the air shower room after disinfection, no more than six persons at one time. [The] distance between two workstations should be wider than one meter,” says Luo. “Reduce the number of employees at one production line. Add extra production lines if necessary. Spare no efforts to guarantee production safety.”

    The final two steps are more lifestyle changes, according to Luo. Step seven centers on employees keeping a one-meter distance from each other while dining. “Dining out is temporarily prohibited. Keep [a] one-meter distance while queueing (getting in line) and dining. Wash hands before and after dinners,” Luo explains. “[A] disposable tableware policy has also been adopted. We also disinfect tables and chairs after using three times a day. Eat at ease, work at ease.”

    Step eight asks for Feelm employees to avoid crowds while commuting. “Walk, ride or drive to work. Try to avoid public transport, if possible,” she says. “If you must, avoid touching anything. Clean phones and keys with wet tissue or medical alcohol often.”

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • Spotlight on Nicotine

    Spotlight on Nicotine

    Liliya623 I Dreamstime.com

    The scientific evidence is clear that nicotine itself is not responsible for smoking-related diseases.

    By Ian Jones

    If you are as old as me, and happen to come from the U.K., you may recall Nick O’Teen, one of the central characters in an anti-smoking campaign run by the U.K. Health Education Council (HEC) in the early 1980s. With his cigarette-butt-shaped top hat and bright yellow teeth, O’Teen was the campaign’s arch villain and was regularly apprehended by the campaign’s hero, Superman.

    Now, obviously, Nick O’Teen’s name is a play on the word “nicotine,” so it is reasonable to assume that people who saw the campaign in the 1980s concluded that nicotine in cigarettes is the direct cause of smoking-related illnesses. In fact, according to recent surveys, this is still a commonly held belief, not only in the U.K. but in several other surveyed countries. But, given what we know today, does nicotine deserve this reputation or, as Mitch Zeller, director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products, the agency in the USA responsible for overseeing the implementation of tobacco product regulation, has previously asked, is it time for a “rethink within society on nicotine”?

    Let’s start with the basics: What exactly is nicotine, and what does it do?

    Nicotine is a chemical naturally found in tobacco and other related plants, in the same way that caffeine is naturally found in tea. Why does tobacco produce nicotine? Well, the commonly held belief is that nicotine helps protect the tobacco leaves from being eaten by insects and other predators. It does this in two ways.

    First, nicotine has a bitter taste, so it could make the leaves unpalatable to some potential diners. Second, and of more relevance to its namesake Nick O’Teen, nicotine mimics one of the natural chemicals that cells in the nervous system of animals use to communicate with each other. Thus, eating nicotine-containing leaves could impact the normal working of the nervous system (in fact, this could even be fatal to some insects).

    Auremar | Dreamstime.com

    Now, in you and me, the chemical that nicotine mimics, acetylcholine, is found throughout the nervous system and performs a myriad of functions. In the brain specifically, acetylcholine acts a bit like a volume control dial, turning up or turning down signals between brain cells. Which way the dial is turned depends on the brain region and the state of mind at the time.

    This is why nicotine, by mimicking acetylcholine, is said to not only help with attention (volume up) but also relaxation (volume down). It also explains the addictive property of nicotine. In the part of the brain responsible for identifying enjoyable experiences, nicotine can turn the volume up, making the experience of smoking stronger.

    Herein also lies a very important point; the addictive effects of nicotine are usually paired with a particular enjoyable experience. It explains why one of the common tests for tobacco addiction, the Fagerström Test for Nicotine Dependence, was renamed to the Fagerström Test for Cigarette Dependence; addiction to smoking is not solely due to the addictive nature of nicotine alone, but is a result of the interplay between nicotine, acting as volume up, and a series of sensory and other cues (smell, taste, ritual, etc.).

    But hold on a minute; doesn’t nicotine cause cancer and other diseases associated with smoking?

    This is one of the main misunderstandings about nicotine and the answer is simple—no. The scientific evidence is clear that nicotine itself is not responsible for smoking-related diseases. These are caused by other things in smoke, particularly chemicals formed when tobacco is burnt. Remember, tobacco-derived nicotine is an approved medicine and is even available without prescription in many countries.

    This would not be the case if there were serious health risks associated with its use. Furthermore, the use of tobacco products that are not burned during use, such as Scandinavian snus—a tobacco product that is placed under the consumer’s lip—is associated with much lower risks of developing cancer compared to smoking, even though the product also delivers nicotine to the user. The FDA in the U.S. recently acknowledged this by approving modified-risk claims for certain snus products.

    This is not to say, though, that nicotine is risk free. As mentioned above, it is addictive and can reinforce addiction to certain pleasurable behaviors. By mimicking acetylcholine, it can also affect certain biological processes such as the development of new blood vessels. There are also concerns about the potential effects of nicotine exposure in developing brains, an area that certainly deserves more research focus (as well as effective practical measures to prevent minors from accessing nicotine-containing products).

    OK, so the science to date noes not support the notion that nicotine causes cancer, but what about nicotine salts? I hear they are even worse than nicotine.

    I would contend that this is another misunderstanding, this time in part due to a lack of clear explanation by manufacturers as to what nicotine salts are when they first came onto the market. The key point to remember is that nicotine is nicotine, whether in salt form, nonsalt form (“nicotine base”), naturally derived or synthetic. Nicotine salts are simply nicotine attached to something else, in the same way that cooking salt is sodium attached to chloride (i.e. sodium chloride).

    Whether nicotine attaches to something else is simply down to how acidic the environment is. In acidic environments (e.g. an acidic e-liquid), nicotine is in salt form. At the other end of the scale, in alkaline environments, it is in base form (not attached to anything). In the middle (neutral pH), as in our bodies, nicotine is in a mixture of salt and base forms. An interesting aside is that nicotine salts are therefore not a new discovery; historically, e-liquids have been around neutral pH, so they have in fact always contained some nicotine salts.

    In any case, the fact that our bodies like to maintain a “just so” neutral pH means that, from a biological point of view, the form of the nicotine in the liquid does not really matter much as it will conform to a salt/base mix as soon as it comes in contact with the body. What nicotine salts (and acidic e-liquids in general) do is provide a different sensory experience, especially at higher nicotine levels, which some consumers may prefer.

    So, back to Nick O’Teen. Does he deserve his reputation? In my opinion, he was an arch villain of his time. As we’ve gained more understanding over the intervening years about the effects of nicotine in the body, I think we can indeed rethink the role of nicotine in society, just as Mitch Zeller suggests. Nicotine is not risk free and is certainly not something that minors should ever consume given concerns about the impact on the developing brain. 

    Likewise, there are other susceptible groups of people, such as pregnant women, that either should not use nicotine-containing products or, at a minimum, seek medical advice before deciding whether to do so. For most adults, however, nicotine deserves acceptance of its new non-villainous persona as a cause of tobacco-related illness, and to be seen as an adult lifestyle choice, the same as many other adult consumer products.

    Ian Jones

    Ian Jones is the R&D principal scientist for Japan Tobacco International (JTI).

  • Struggling for Survival

    Struggling for Survival

    VPZ storefront
    Photo: VPZ
    The vapor industry is suffering serious hardships due to closures caused by Covid-19.

    By Timothy S. Donahue

    Several countries have considered vape shops essential businesses during the coronavirus pandemic. Countries such as Spain, France and New Zealand have allowed e-cigarette users to continue to have access to nicotine without returning to combustible cigarettes. In many countries such as the U.K. and the U.S., however, vape shops have been forced to close and many business owners say they may never be able to recover.

    In the U.K., VPZ, the country’s largest vapor retailer, vowed to keep its shops open. On March 20, the company urged British leaders to follow the lead of other European countries and allow all 155 VPZ stores across the U.K. to be added to the list of essential businesses. That request was denied. On March 23, VPZ announced it would be closing all its locations. In an email, Doug Mutter, director of compliance and manufacturing for VPZ, said the company was disappointed with the lack of explanation from the government concerning the status of vapor retailers.

    Doug Mutter
    Doug Mutter | Photo: VPZ

    “Other European nations had recognized the work vaping specialists do in reducing the stress on health services and [have] kept the local stores open,” he said. “We had expected this to be the case and had begun investing in new processes in order to manage our business in such an environment. However, without sufficient clarification and in the interest of keeping our staff and customers safe, we have made the decision to close all 155 stores … for the next three weeks.”

    James Jarvis
    James Jarvis

    James Jarvis owns four shops in the U.S. state of Ohio. Jarvis also heads the Ohio Vapor Trade Association (OHVTA), an industry advocacy group. He closed his Vapor Station locations in Clintonville, Columbus, Gahanna and Hilliard on March 23. He said that while the governor of Ohio has shown great empathy to Ohioans regarding the coronavirus, the OHVTA knew it needed to recommend that its members make consumers aware that a stay-at-home order or shutdown would be likely at some point, and all shop owners needed to inform customers.

    “Many of the shops ran specials, extended hours … to make sure if something happened our consumer family would be well stocked up. I talked to members as well as looking at our own numbers, and over the last few weeks [during the increase in virus reporting], sales were definitely on the rise,” Jarvis told Vapor Voice. “The unfortunate day came on March 22 as an order was signed and a deadline for nonessential business [to close] was set for 11:59 p.m. [on] March 23.”

    The total impact on vape shop closures in the U.S. will be hard to calculate, according to Jarvis. He says that if stores are forced to be closed for more than 14 days, many vapor consumers will get frustrated and turn back to cigarettes, which he says is a huge step backward for public health. “The longer we are closed, the more distant we will be to the consumer,” he explains. “This will also have a negative effect on our employees and our businesses as the uncertainty of how bills, rents and other necessities will be handled.”

    Luckily for Ohioans, the state allows for online sales of vapor products. Many states, such as Utah, Massachusetts, Rhode Island and Washington, have banned the online sale of vapor products. Jarvis says that the challenge is that even if a state allows for online sales, only online sales “will have a dramatic effect on conversion rates for smokers.” He says he worries about smokers using whatever products they can find at their local gas station or c-store and not getting the full education on the products they are using.

    “Vape shops take the time to educate on the products, liquid options, safety and advocacy. With that element being gone, there will be too many opportunities that will be missed, and someone could wind up with a device or liquid that may not be the right thing, the right [nicotine] strength or will be operating the device unsafely,” he says. “In many states, the vape shop also educates on advocacy and any state with a ban or tax increases; it will now be harder to communicate those points to them as well. If the vape shops go away, the true heart and soul of the industry goes away and will be handed over to the very company [large tobacco companies] we are trying to destroy.”

    Jarvis says the industry is also readying for premarket tobacco product application (PMTA) submissions due to the U.S. Food and Drug Administration (FDA) on May 12. The FDA submitted a request to postpone the deadline to the Maryland judge who set the deadline, but as of this writing, no decision had been made.

    “I am hopeful that the FDA will do the right thing, but we need to act as if they will not and continue our due diligence to successfully start and complete a PMTA. There is a group on Facebook called ‘PMTA Sharing’ that is an amazing resource for small manufacturers,” says Jarvis. “Char Owen and her husband are really going to great lengths to make starting and completing the necessary paperwork as easy and painless for all small manufacturers in that group. They are sacrificing a lot of their own personal time and finances and sharing with the group.”

    Jarvis suggests that even if the Ohio leadership changes its mind and allows vape shops to open, there will still be additional challenges. For example, the early Chinese New Year and the outbreak of Covid-19 have made finding some hardware products produced in China more difficult. He explains that even though the Chinese factories are operating again, the virus started to spread in the U.S., and changes were made to customs with regard to shipping.

    “We also had many other states issuing orders that had stoppage effects on shipping. There is definitely a strain on the flow of products right now. The one thing we have been seeing, which is amazing, is that stores are sharing products with other stores, [and] distributors are limiting quantities and working overtime, so everyone gets a little,” he says. “This is truly a community that looks out for one another. It’s great feeling like a part of a group of people that are selfless and want to make sure the consumer and our small businesses are protected at the end of the day.”

    On the other side of the U.S., Burbank, California-based online vapor retailer ProVape says the vapor industry is going to continue to feel the impact of the coronavirus outbreak. In Shenzhen, China, the vapor manufacturing capital of the world, businesses have been allowed to resume operation if they have stringent measures to prevent further spread of the devastating virus (see “Sanitary Solution”).

    There is still a massive problem with the timely shipment of supplies, according to Art Harutyunyan, a senior executive of ProVape. Wholesale vapor suppliers must wait for the coronavirus crisis to end before they can get a steady supply of vaporizer products. “We are constantly told that products are on backorder and are encouraged to stock up with vape hardware [coils, vape kits, pod systems, mods, tanks and disposable vape devices] to avoid any issues in coming months,” says Harutyunyan, adding that the coronavirus is creating a global problem in the vapor industry as manufacturers of vapor products will not be able to produce and deliver some products before coils, pods and other vapor hardware dwindle to a frighteningly low number in the U.S. and around the globe.

    Bob, Patsy and Sean Anderson
    Bob, Patsy and Sean Anderson | Photo: Timothy S. Donahue

    Moving farther west, Patricia Anderson, co-owner of Black Lava Vape (BLV) on the big island of Hawaii, says that as of March 22, their three stores were still open for business, but they stopped vaping in the shop and were only allowing three people at a time in the store. They were also offering curbside service and delivery in a limited area.

    “Last week [week ending March 21] and over the weekend were probably some of the best days we have had in succession in quite some time. In the vaping world, I would say our products are like toilet paper … people are very afraid that we will run out [of product] sooner or later, or they will close us as a nonessential business, and they will have to go back to cigarettes,” explains Anderson. “To be quite honest, the THC scare [black market THC products causing pulmonary issues] and the always impending ban on flavors was more detrimental to us than the coronavirus [pandemic]. During the THC scare, I had to lay off half of my employees, cut store hours, cut employee hours, and we have been unable to pay ourselves.”

    During the scare, BLV shelves became very hard to stock, and customers even supposed that BLV was closing, says Anderson. The shop went from having more than 10 full-time employees to five, and three are part-time. She says BLV e-juices are all made in the U.S., but their hardware comes from China, and they started seeing availability issues with wholesalers too.

    “We found out [the other day] that two of our wholesalers are not processing any more orders, so that will definitely have an impact on competitive pricing,” Anderson explains. Then the hammer dropped. “Hawaii will be on lockdown starting March 26. I’m guessing we will be closing our doors as I don’t see the state considering us to be an essential business [they are currently allowed to stay open doing curbside service but are not labeled essential]. Our loyal vaping community will disagree, but we knew it was coming; 90 percent of our customers have been laid off [from their jobs].”

    Jarvis says that the industry can’t lose hope. He says the industry needs to continue to stand together and fight for this life-saving industry that has already saved millions of lives from deadly traditional cigarettes. “This industry, as I have said before, is an amazing one to be a part of. We are on the right side of everything,” says Jarvis emphatically. “As long as we continue to work together, look out for each other, stay focused … we can do anything. Together we will be stronger and healthier to be there for the future.”

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • More Pod Than Mod

    More Pod Than Mod

    More Pod Than Mod

    The Grimm Kit by Hellvape appeals to intermediate and advanced vapers looking for alternatives.

    By Mike Huml

    With the recently announced ban of flavors in closed system vapor products, store owners and consumers will both need to adapt. Refillable pods are about to see a jump in popularity given that this will become the most convenient and simple way to vape with flavored e-liquid. As closed system manufacturers adapt, refillable pods for previously closed systems are likely on the way. In the meantime, many refillable pods already exist, and one of the best is the Grimm Kit from Hellvape.

    This refillable pod-AIO hybrid was designed by GrimmGreen and OhmBoyOC and has the potential to not only appeal to a wide market but also fill a need for quality open systems. Everything about the Grimm Kit is simple and effective from its aesthetic to its vape quality. Perhaps most importantly, any flavored e-liquid can be used.

    The Grimm Kit is more akin to a small box mod rather than a large pod system. Not only can the pod be refilled, but the coil can be replaced as well. This makes the “pod” more like a tank that uses a proprietary connection. It’s much like an AIO except that the tank can be removed. It’s an interesting amalgamation of many product types that has the potential to see wide appeal among all types of vapers. It can be used for either restricted lung hits or mouth-to-lung drags. It has a variety of airflow options, and any type of e-liquid is compatible whether it’s VG-heavy, PG-heavy, high strength, low strength, nic-salt or freebase nicotine; it all works flawlessly.

    Two coils are available. The mesh coil has slightly more open airflow, can handle more power and is perfect for restricted lung hits. The wire coil is designed for lower power and has a tighter airflow conducive to mouth-to-lung vaping. Each coil’s airflow can be fine-tuned by adjusting the airflow control ring located on the base of the coil assembly. The mod itself has an old-school OLED screen that displays battery life, coil resistance and a puff counter, and three buttons that allow the user to adjust wattage or voltage.

    The Grimm Kit also looks more like a mod than a pod system. It has a sleek metal and rubberized look that’s much more refined than any traditional pod system. The pod is removed by simply pulling it free from the body, but this is only necessary when installing a coil or replacing the pod. The pod is held in place with clips, which affect how easily the pod can be removed but also hold the pod in place more securely.

    The sense of security and stability is more important here because the pod refills from the top, and the pod will rarely be removed. The fill port is next to the mouthpiece where a latch slides open to reveal the hole. The pod can be filled with up to 3 mL of e-liquid, a substantial improvement compared to the average 1 mL capacity of most other pod systems.

    Luckily, the large capacity is supported by a comparatively large 1200 mAh internal battery. For anyone used to swapping pods and charging batteries multiple times per day, the Grimm Kit will be a massive relief. For light to medium vapers, this means that if the battery is charged overnight and the pod is filled in the morning, realistically the Grimm Kit could last all day or longer. It’s also small enough to be very portable. Although markedly larger than something like the Juul, it will still go anywhere a Juul can. It’s smaller in the frame than a credit card and about 60 percent as wide as a standard deck of playing cards.

    The vape quality provided by the Grimm Kit is superb. The flavor representation and vapor production is on par or better than comparable mod/tank kits and far beyond what many pod systems are capable of. Additionally, liquid strength, airflow and heat can all be adjusted and fine-tuned, offering infinitely more options than a standard pod system with minimal complexity.

    With just a pinch of patience, closed system users could find themselves transported to a whole new world of vaping quality. In short, the Grimm Kit offers far more than enough positive improvements over closed pod systems to justify upgrading, even considering the slight increase to complexity.

    There is the possibility that the Grimm Kit won’t appeal to users of current closed pod systems due to the increased size, button activation and refillable nature. Unfortunately, many people will soon be forced to choose whether they want to continue using closed pod systems and only have access to tobacco and menthol flavors, move to a refillable system or go back to smoking combustible cigarettes. However, there is also the potential for the Grimm Kit to be the perfect transition between pod vaping and mod vaping. While it’s not as simple as a closed system, it’s not difficult to use in the least.

    As with many other pod systems, the Grimm Kit can also serve as a dedicated nic-salt vape for more advanced users craving a variety of different vaping styles or as something more discreet and portable than a multi-battery cloud chucker. There is truly something for everyone with this kit, regardless of past vaping experience. With so many people looking to make changes to their vaping setups due to regulation, carrying a device with such wide appeal would be a wise decision.

    The Grimm Kit is perfectly positioned to be a staple in any shop. It has everything going for it. It’s designed by knowledgeable and well-known personalities from the vaping community. It’s made by a longtime reputable manufacturer—Hellvape. It’s a refillable device in a time when closed systems are under threat, allowing vapers to still choose among a multitude of flavor options. It’s an upgrade from any closed pod system, and many will not just be looking to replace their closed system but to upgrade as well. It offers top-tier build quality, superb performance and stalwart reliability.

    Lastly, it still appeals to intermediate and advanced vapers looking for alternatives to their daily drivers. Perhaps best of all, it’s available right now. Instead of, or in addition to, waiting and hoping that refillable pods become available for products like the Juul, store owners can prepare for the influx of customers looking to find alternatives to their closed pod systems.

    Regulation has always been a dirty word in the vapor industry. While light, sensible regulation has always been supported to ensure safety and quality, overstepping leads to nothing but reduced options for consumers, which in turn can only lead to more people smoking and fewer people vaping. However, every challenge offers an opportunity, and the next several months leading to the dreaded premarket tobacco product application deadline will require vapers and store owners to adapt quickly. There is already a demand for alternatives to closed systems, and the Grimm Kit could serve as the perfect option.

    Picture of Mike Huml

    Mike Huml

    An enthusiast vaper since 2009, Mike Huml is always trying to get his hands on the newest, shiniest mod. Huml has evaluated countless vaping devices over the years, but you’ll usually find him with a mechanical mod and RDA in-hand, surrounded by an aura of fog. His personal motto: “Happiness is a warm coil.”

  • Merchants of Doubt

    Merchants of Doubt

    Credit: Pathdoc

    In the vaping debate, falsehood flies and the truth comes limping after it

    For those of us who support the public health strategy of tobacco harm reduction, it has been a tough few months. Several crises emerged suddenly and the boundaries between them have become blurred: an outbreak of severe lung injuries and deaths, a sharp rise in youth vaping in the United States and the claim that e-liquid flavors are the problem and should be banned.

    The satirist Jonathan Swift summed it up pretty well in 1710:

    “Falsehood flies and truth comes limping after it so that when men come to be undeceived, it is too late; the jest is over, and the tale hath had its effect; like a man, who hath thought of a good repartee when the discourse is changed, or the company parted; or like a physician, who hath found out an infallible medicine, after the patient is dead.”

    What can be done? Falsehood has certainly flown, but could the truth at least break into a jog? Let us examine these crises and try to determine what is true and what is false.

    Vaping causes severe lung injury and death: true or false?

    As of early December, 2,291 vaping-related lung injury hospitalizations and 48 deaths had been recorded in the United States. Many have assumed nicotine e-liquids are implicated. Because the problem emerged in a specific place (the United States) and at a specific time (from July 2019), it was already clear in July 2019 that this was a specific supply chain problem. It had not affected vaping before and had not affected the millions of vapers in the rest of the world. It soon emerged that the cases were dominated by specialized vapes used for cannabis THC oil. The focus should, at that point, have narrowed to the illicit THC vape suppliers with a clear message exonerating commercial nicotine liquids. Instead, major public health agencies became “merchants of doubt,” maintaining that any vapor product was suspect. However, the chance of a parallel problem occurring in the legal and regulated nicotine e-liquid supply chain at the same time, in the same geography and with the identical symptoms is vanishingly small. 

    A minority of the users afflicted had denied or refused to confirm use of THC, so there was some doubt. Of course there was doubt! People do not readily admit to using illicit substances because it can get them into trouble with parents, at school or college, or with their employer. Whenever actual tests were done or when users were pressed harder to tell the truth, THC vaping reliably emerged.

    The mystery doesn’t end there because THC oil itself is not the issue—there are many THC vapes that do not cause this problem. The investigation narrowed further to identify vitamin E acetate as one likely cause. This is used as a thickener to cut expensive THC oil for economic reasons. This is a lipid, a fatty substance that can have exactly the effect on the lungs that has been seen. There is no question of this being added to nicotine liquids. It is not soluble in nicotine liquids and would serve no purpose as there is no reason to thicken nicotine liquids.

    The truth: The lung injuries are a serious problem, but they are nothing at all to do with commercially available nicotine e-liquids. The ultimate problem here is a black market supply chain opportunistically experimenting with novel and untested formulations with no accountability for health consequences. To pretend otherwise is to cause three harms: sending a diluted and contradictory message to THC vapers that may put more lives at direct risk; frightening regular nicotine vapers back to smoking and smokers away from vaping with longer term health consequences; and promoting bad policy responses, like flavor bans, that will tend to increase black market activity and make the problem of adulteration in the supply chain more likely and vaping more risky.

    There is a youth vaping epidemic: true or false?

    The falsehoods here lie in the interpretation of the headline statistics—what you see if you drill down into the data. First, the headlines. In the United States, vaping among high school students rose from 11.7 percent in 2017 up to 20.8 percent in 2018 and on to 27.5 percent in 2019. A dramatic rise by anyone’s standard and undoubtedly a cause for concern.

    But there are three other factors to consider in a drill down. The headline figures refer to any use of an e-cigarette, even a single puff, in the past 30 days, so what is the breakdown between infrequent and frequent use? How many of the frequent vapers also use other tobacco products? For them, vaping may be beneficial. The rise in youth e-cigarette use has been described as an “epidemic of nicotine addiction.” How many show signs of dependence?

    The data to address these questions is only available for 2018, but this breakdown of the headline 20.8 percent vaping figure provides a useful illustration:

    NYTS 2018 dataPercentage of high school students using e-cigarettes Total = 20.8%High school students  No past tobacco use Any past tobacco useFrequent e-cig use: ? 20

    days per month0.6%5.2%Infrequent e-cig use: ? 19

    days per month4.7%10.3%

    First, most adolescent vapers (72 percent) are not frequent users and therefore provide less reason to be concerned. Second, most of the frequent adolescent vapers (90 percent) were already tobacco users. Only 0.6 percent of high school age vapers are both frequent users and have no prior history of tobacco use—and it is also important to recall that smoking is much more harmful than vaping, but in 2018, 13.9 percent had used any combustible product in the past 30 days. Smoking remains the bigger problem.

    Turning to the third question of dependence, the analysis of U.S. youth e-cigarette data by epidemiologists Martin Jarvis and colleagues (Epidemic of youth nicotine addiction? What does the National Youth Tobacco Survey reveal about high school e-cigarette use in the USA?) shows little sign of teenage vaping uptake causing nicotine addiction.

    “Data from the National Youth Tobacco Survey do not support claims of a new epidemic of nicotine addiction stemming from use of e-cigarettes …. Among current e-cigarette users who had never tried tobacco products, responses consistently pointed to minimal dependence.”

    The truth: Many young Americans are trying vaping, but most are not vaping frequently, and it isn’t an especially dangerous youth behavior compared to smoking, using illicit drugs and using alcohol excessively. The frequent or daily vapers are mainly those using other tobacco products. For them, vaping may be a beneficial diversion from smoking. There is reason for concern, but there should not be an overreaction.

    The rise in U.S. youth vaping is driven by flavors: true or false?

    At one level, it is obvious that e-liquid flavors are important—if vendors could only sell unflavored products, there would be few buyers of any age. E-cigarettes are an inherently flavored product in much the same way that pizza would not be pizza without a topping.

    There is much to suggest that flavors form part of the appeal, but they are not the main reason why young people take up vaping. The story is far more complicated: The more credible academic work (e.g., see Nicksic et al. 2019) suggests uptake of vaping is driven by replacing cigarettes and by the “wider social environment.” Flavors are a factor, but they are far from the most important factor. The most recent official analysis of U.S. youth data included reasons for youth vaping uptake (MMWR Table 6). The most important reason given was “I was curious about them,” cited by 56.1 percent of exclusive e-cigarette users. “They are available in flavors, such as mint, candy, fruit or chocolate” came a distant third at 22.3 percent.

    The idea of limiting flavors to just tobacco flavor would be like limiting pizza toppings to allow only a simple Marherita. In both cases, it would kill the category and shut down all the vape shops. The likely response would be an uptick in smoking, a black market in flavored products, home flavor mixing and more international internet trade. No one would gain, and many would lose.

    The high score for curiosity raises an intriguing question. Has the barrage of breathless media coverage, official school-based anti-vaping campaigns, parent mobilization and political outrage actually been a stimulus for youth curiosity about vaping? Is the reaction part of the cause? We can safely assume that no one involved will fund that research.

    The truth: The reasons young people take up vaping are similar to the reasons they take up smoking and can include unpredictable and largely uncontrollable fads and fashions. Vapor products would be nothing without flavors, and banning them would have a range of harmful effects and do little to protect youth from actual harms. If governments want to control flavors, they should focus on flavor descriptors and branded imagery that are aimed at adolescents, not the actual flavors themselves.

    Picture of Clive Bates

    Clive Bates

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).

  • It’s Showtime!

    It’s Showtime!

    IT’S SHOWTIME!

    The Tobacco Plus Expo, the year’s first major industry trade show, sets the scene for the vapor market’s outlook post-May.

    By Timothy S. Donahue

    It keeps getting better. The Tobacco Plus Expo (TPE), the first major industry trade show of the year, continues to grow in both attendance and quality. Since being taken over by the Tobacco Media Group (TMG), which is owned by Kretek International, the TPE has become a show that retailers and manufacturers must seriously consider attending.

    The exhibition brings together players from the vapor, CBD, marijuana, cigar, shisha, snus and other tobacco-related industries. Most importantly, the TPE provides plenty of insight into how the vapor and e-cigarette industry will look for the coming year. If that tradition continues, there is going to be a huge number of disposable flavored vapor bars coming to the market. There are also going to be fewer places for retailers to purchase e-liquids and vapor hardware.

    Since the U.S. Food and Drug Administration (FDA) elected to not include disposable vapor products in its ban of flavored pod systems, several new flavored disposable products have come onto the market. During the TPE, held in Las Vegas in late January, companies offering disposable flavored products nearly outnumbered the amount of e-liquid and hardware manufacturers combined.

    Most of these products are considered new, meaning they were not on the market prior to Aug. 8, 2016, the FDA’s deadline for vapor products to be on the market without a premarket tobacco product application (PMTA) authorization. All vapor products must be removed from the market on May 12, unless they have submitted a PMTA to the FDA.

    Dimitris Agrafiotis, executive director of the Tennessee Smoke Free Association, told attendees during the seminar “Waiting to Exhale—Mastering Today’s Vapor and E-Cigarette Market” that he believes the FDA’s flavor ban only made things more confusing for retailers. Even now, with the ban in effect, most retailers don’t know what products can be sold and what products cannot. “Moreover, … I think the FDA is a little behind on the [actual] issues that are affecting this youth vaping epidemic,” he said. “So, the products that are designed … to be restricted to the youth were probably more popular last year than the products that are popular now for the kids. So again, we’re seeing just this huge delay from [the] FDA to catch up to the issue, the retail perspective.”

    Vaporesso ad

    Agrafiotis was referring to the Puff Bar, which is a brand that has also become synonymous with all disposable pod devices that typically have an average 280 mAh battery with a flavored pod containing from 0 percent to 5 percent nicotine. A representative of the FDA, which had a booth at the show, said he was very surprised by the number of disposable flavored pods being hawked at TPE. Both the FDA’s Center for Tobacco Products Director Mitch Zeller and FDA Commissioner Stephen Hahn have said sales restrictions will target the products most popular with youth and that policy will change accordingly.

    “The good thing about this policy is we have the ability, without jumping through a lot of hoops, to change our enforcement prioritization based on the data we are getting in,” Hahn said when the flavor ban was announced on Jan. 2.

    Beyond the bars, there was a very noticeable decline in the number of e-liquid suppliers at TPE. Since the TPE is the first business-to-business buying show of the year, the significantly lower number of e-liquid and even hardware manufacturers showcasing their products may be a glimpse into how the vapor industry is going to look post-May 12.

    The lower number of e-liquid companies presenting is an unfortunate sign of the times, according to David Rosenthal with Ripe Vapes, which presented at the show. “Companies are so confused about what, if any, chance they have at submitting an acceptable PMTA that they have given up,” he says. “That in conjunction with [what], from what I gather, for most companies was the worst quarter in recent memory (fourth quarter 2019) due to the EVALI scare and the teen use negative press has gutted the resources for most small companies at the worst time. Quite trying times to say the least.”

    Speaking at the same seminar, Chris Howard, vice president, general counsel and chief compliance officer of E-Alternative Solutions, said with a lack of enforcement from the FDA, especially concerning disposable products, banning flavors in closed pod systems has only opened up the door for other companies. “Like we’re seeing now, there’s more of a craze that’s going on to drop the types of products that the consumers wanted … It’s going to [be] a huge disadvantage [for] the independent vape shop,” Howard said. “I think every time you think you can’t be surprised in this industry, there’s another surprise, and the NJoy announcement of them pulling the product that was clearly exempt from the ban left me personally speechless.”

    On Jan. 29, NJoy announced that it would voluntarily halt sales of its fruit-flavored products even though they were exempt from the FDA ban. The company announced that it would stop shipping all products except those formulated to taste like tobacco or menthol when the FDA’s restrictions took effect on Feb. 6. “For NJoy to do this, you never know what’s going on behind the closed doors of a company, so I’m sure they have a lot of motivations for this decision,” explained Howard. “But what I see as an outsider is a company that has always stood for the rights of smokers and that they need an option to quit. And they’ve also said that flavors aren’t the driver of this youth issue. And so, this decision … to voluntarily ban their own flavored disposable products is very much inconsistent with everything they’ve done previously.”

    The massive recent growth of the CBD market was also reflected during the TPE. The mushrooming assortment of products containing CBD is a promising opportunity for vape shop owners looking to supplement the loss of what some show attendees expect to be a more than 50 percent decline in businesses serving the vapor industry. Many vape shop owners find the CBD market challenging because they know very little about the product, according to panelists during an education session called “Brave New World: Making the Jump into CBD.”

    Bethany Gomez, managing director of Brightfield Group, an industry research group, recognized that the CBD category can be overwhelming for retailers who are beginning to turn toward CBD because products run the gamut from pillows and lotions to vape pens and edibles.

    It’s the same scenario for many consumers. Jacopo D’Alessandris, president and CEO of E-Alternative Solutions, told Vapor Voice after the session that there’s currently just a lot of confusion overall around CBD. He says that nearly everyone has seemingly heard about CBD, but most people don’t really understand what the product does or the state of the current regulatory environment. For example, the FDA does not allow any CBD brand to make any health claims.

    “Is it for me? Is it not for me? How much should I use? The problem is you cannot really say much [in advertising or on packaging]. You cannot make any health claim,” he explains. “Shoppers don’t have a lot of experience with CBD. They need the right price point. They need to be given a good first impression … also [many] small upstart brands may not take having the necessary ingredients seriously and [may] be competing on price. There are a lot of cowboy [brands] out there, and one day the sheriff will come to town. A lot more oversight is coming.”

    Picture of Timothy Donahue

    Timothy Donahue

    Timothy S. Donahue is the co-founder and managing editor of Vapor Voice.

    Tim spends much of his time on the road, attending conferences and interviewing industry representatives.

    His networking skills, work ethic and quick mind are valuable assets to our diverse audience.

  • Prioritized Enforcement

    Prioritized Enforcement

    PRIORITIZED ENFORCEMENT

    The U.S. government has banned all nontobacco flavors in closed pod systems without a PMTA.

    By Timothy S. Donahue

    The new year had barely begun. On Jan. 2, the U.S. Food and Drug Administration (FDA) finalized its policy for banning flavors in some vapor products. It could have been much worse. The FDA is only currently enforcing the flavor ban in closed pod systems (prefilled tanks with separate batteries), so the industry should still survive. “We have to protect our families,” U.S. President Donald Trump said about the ban. “At the same time, it’s a big industry, [and] we want to protect the industry.”

    The new regulatory guidelines came just weeks after Trump approved raising the federal minimum age for buying and consuming tobacco products from 18 to 21. Trump signed the new tobacco minimum-age language into law Dec. 20 as part of a federal spending bill. The flavored pod ban is a step back from the nearly complete flavored vape ban the Trump administration initially expressed back in September as lung injuries from vaping were on the rise.

    The regulations, which went into effect on Feb. 6, require that companies stop manufacturing or distributing, or selling “any flavored, cartridge-based ENDS [electronic nicotine-delivery system] product (other than a tobacco-[flavored] or menthol-flavored ENDS product)” or face the risk of FDA enforcement actions. The rule does not include open-tank systems or completely self-contained, disposable products. Any product that markets toward “kids” or “youth” is also illegal.

    The FDA defines an e-liquid cartridge as “any small, enclosed unit sealed or unsealed, designed to fit within or operate as part of an electronic nicotine delivery system (ENDS). Ray Keller, CEO of GoodCat Laboratories, a Naples, Florida-based e-liquid manufacturer, says he believes the FDA language was intended to delineate between a mod system and a small stick pod system. “The thought being there that the larger mod systems are too bulky[;] they’ll have to have a bottle [of e-liquid] with them,” explains Keller. “[Youth] can’t hide them as easily. The mod systems make a lot of vapor that you can’t really hide. So, I think that’s what they were trying to get at.”

    Companies should be aware that the flavor ban DOES cover pod systems that are refillable and non-refillable, however, the FDA hasn’t been clear on how it will regulate refillable pods that do not contain e-liquid, according to Agustin Rodriguez, an attorney with Troutman-Sanders, a law firm with 12 offices across the U.S. that specializes in the vapor and tobacco industries. “Because empty refillable pods don’t yet contain a flavor, it is our expectation that [the] FDA will not prioritize refillable pods that contain no liquid unless the particular product or the circumstances of its sale raise another regulatory concern beyond product format,” Rodriguez said.

    Companies should also be aware that flavor-ban guidance does not affect the existing deadline for the filing of premarket tobacco product applications (PMTAs) with the FDA, Rodriguez explains. Manufacturers must submit a PMTA for their e-cigarette and vaping products by May 12. “From that date, every nicotine vapor product for sale on the market (whether an open or closed system and regardless of flavor profile) must be the subject of a PMTA and will be permissible for sale for another period of 12 months so long as [the] FDA takes no negative action with respect to that PMTA,” Rodriguez said. “While the guidance may lead to additional legal actions by [the] industry to attempt to delay the May 2020 implementation date, we are strongly counseling tobacco product manufacturers not to rely solely on a litigation strategy with respect to the question of PMTAs.”

    Keller says that flavored disposable systems aren’t currently being regulated by the FDA, but if the rule is abused (and youth start using flavored disposables), the FDA can change it. “Everybody’s going to try to get by the rules,” he says. “The people selling; the people buying it; they’re all going to try and get around this. And then on May 13th, if there’s no PMTA, it’s not on the market anyway.”

    The PMTA requirement will greatly impact vape shops that produce their own e-liquids in-house. These shops are considered manufacturers and must submit PMTAs in order to continue to sell their products while the FDA reviews their PMTA application, according to the FDA. “A vape shop that is in the business of manufacturing, by mixing nicotine and flavors, has a decision that it has to make about what business it wants to be in going forward,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “If they are involved in the manufacturing process, they are subject to the law.”

    The FDA has stated that it advises retailers and wholesalers to adopt practices to ensure compliance with the prohibition on marketing or selling flavored ENDS products. The agency stated that it recognizes that retailers and wholesalers may need to store unsold products beyond the Feb. 6 deadline until products can be returned to a distributor or manufacturer.

    It’s hard to predict what the vapor market will look like post-May 12, but there is a high risk of significant confusion over what products are lawfully being sold. This is because the FDA does not publish products that are the subject of a PMTA, states Rodriguez. “The opportunity for the industry is to come up with ways to assure the public that the products still for sale are lawfully being made available,” he says. “We are working with our clients on ways to address that opportunity.”

    On May 13, the day after the PMTA deadline, Keller thinks that most companies are going to be out of business. He says there’s also the possibility that there is a mass exodus from the market before the May 12 deadline. He also predicts a rise in the availability of illegal products. “I just don’t see how anybody except the largest players are going to be able to put this [PMTA] together and have it handed over in completion on May 12,” he says. “So, I think a lot of shops are going to close. I think the internet business will pick up. At first, there’s going to be some black market activity. But that’s going to happen any time prohibition gets involved, and no matter what the product, there’s always going to be a little black market activity.”

    The ban was not met with enthusiasm from anti-vaping groups. Gary Reedy, chief executive of the American Cancer Society, called it “a hollowed-out policy that will allow the tobacco industry to continue to attract kids to a lifetime of nicotine addiction.” Matt Myers, president of the Campaign for Tobacco-Free Kids, said that “the evidence indicates that if menthol e-cigarettes are left on the market, kids will shift to them. Decades of experience with menthol cigarettes demonstrate that menthol appeals to kids.”

    Many vaping industry insiders also don’t agree with the FDA’s approach to youth use. They say a flavor ban (other than tobacco-related flavors) simply won’t work and better options are available. Flavors aren’t the issue; it’s the nicotine, according to Keller. He says that youth aren’t using vapor products because they like the strawberry or the watermelon taste; they want the nicotine. “In essence, I think what this is going to do is it’s just going to teach [kids] to like tobacco flavors. Right? It’s an acquired taste,” he explains. “They’re going to get used to it. It’s just like drinking coffee. Remember your first cup of coffee? It wasn’t really that good and now I can’t drink enough black coffee.”

    The amount of nicotine allowed in vapor products is also a potential issue, according to Keller. With some products offering 50 mL of nicotine or more, users get a “buzz” instead of just satisfaction. “You have to take that buzz away. If you have a 50 mL mix, it’s going to spin your head a little bit,” he says. “Take that buzz away and I think you would have a better chance of quitting rather than just putting it down and giving up. But now, they’re going to start using other products and other flavors. Maybe tobacco becomes popular or they switch to disposable devices. There are better options than banning flavors to end the uptick in youth use.”

    Tony Abboud, executive director at the Vapor Technology Association (VTA), a vapor industry advocacy group, explains that his organization doesn’t see flavor bans as the appropriate approach to youth use either. He says the current ban could easily lead to a domino effect that will wipe out the broader industry.

    “It is safe to say that the opponents of public health will not stop until they ban all flavors and we will not rest in our efforts to defend and preserve flavor options for adult smokers that are desperately trying to quit smoking,” Abboud wrote in an email. “We have fought just about every battle and have won many. But, as with all things, we maintain a steely-eyed focus on winning the war and creating the regulatory framework for a well-regulated industry filled with a diverse array of products and flavors to give adult consumers the choices they are demanding and the choices that they need.

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    Sidebar

    Tempered expectations

    It was like a flashback to 1994. In early February, The House Energy and Commerce oversight and investigations subcommittee grilled the CEOs of Juul Labs, Reynolds American (RAI) and NJOY, as well as the presidents of Logic Technology Development and Fontem U.S. It was reminiscent of when, in 1994, the CEOs from seven major tobacco companies testified before Congress about the marketing tactics for tobacco products. The tension in the rooms was also similar.

    Ryan Nivakoff, CEO of NJOY, reminded lawmakers about comments from former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb that support the harm reduction of vapor products. “[Gottlieb] said: ‘If you can fully switch every currently addicted adult smoker who is using combustible tobacco products onto e-cigarettes, you will have a profound impact on public health,’” said Nivakoff. “The National Academies of Sciences, Engineering, and Medicine has said: ‘complete switching from combustible tobacco cigarettes to e-cigarettes would be expected to reduce tobacco-related health risk.’”

    For more than two hours, lawmakers on the House Energy and Commerce Subcommittee on Oversight and Investigations asked questions ranging from marketing strategies to how to curb youth usage of these products. K.C. Crosthwaite, CEO of Juul Labs, expressed his understanding of the serious need for companies to combat the uptick in youth use.

    “I fully recognize that the opportunity for the millions of adult smokers who still use combustible cigarettes to have an alternative is at risk if we don’t address this issue,” K.C. Crosthwaite, Juul’s CEO, said. “We are focused on combating underage access because I know it puts it all at risk if we don’t make progress here.”

    Legislators also wanted to understand the possible health effects vapor products pose to consumers and the role each company sees itself playing in the ongoing effort to curb the nation’s uptick of youth use. Antoine Blonde, president of Fontem, said the company had a detailed youth access prevention program and maintained efforts to safeguard its products from youth.

    “Fontem uses industry-standard online age-gating and age-verification mechanisms to prevent youth access to its products online,” Blonde said. “For example, for all purchases through our website, Fontem relies on industry-standard age-verification technology that compares a potential purchaser’s information against records of trusted data sources to verify the age of the purchaser.”

    Blonde said Fontem recognizes that there “may be” bad actors in the marketplace who attempt to purchase bulk quantities of its products through e-commerce websites in order to resell them (a practice often called “strawman sales”). “Fontem has always had policies in place to monitor for strawman sales and further is implementing a strict 4-stage standard to monitor site access for any potential strawman purchases on its online platform,” Blonde explained. “This standard will track registered adult consumers’ monthly order frequency of pods from its online platform and will flag potential strawman sales.”

    The companies are said to represent nearly 97 percent of the $19.3 billion U.S. e-cigarette market, according to Rep. Diana DeGette, chairwoman of the subcommittee. That data only includes convenience store sales, and many industry insiders say the figure is grossly inaccurate. Vape shop sales are not included in the Nielsen data DeGette is citing.

    “While consumers remain in the dark of the possible health consequences, these companies are making billions of dollars as they lure a new generation of young people into a lifetime of nicotine addiction,” DeGette, the chair of the oversight panel conducting the hearing, wrote in a press release.

    Ricardo Oberlander, president and CEO of RAI, said the increase in youth vaping over the past two years, and serious health issues from illicit products, are now at the heart of a national discussion. “These issues are being discussed within families, by educators, and in state and local governments. They are being discussed in law enforcement communities, the White House, and here today, in the United States Congress,” he said, adding his company had submitted products for the PMTA. “Looking forward, [the] FDA’s premarket tobacco application process provides a pathway for vapor products aligned with public health priorities. We believe vapor products can be manufactured and marketed responsibly within this framework.”

    Instead of imposing new requirements, such as “one size fits all” flavor bans that unfairly penalize responsible companies and limit consumer choice, Jerry Loftin, president of Logic, said that his company believes that regulators must strengthen the enforcement of existing requirements. “The [FDA] should immediately enforce premarket authorization requirements for all ENDS [electronic nicotine-delivery system] products currently on the market and take action against companies that make unauthorized modified risk or smoking cessation claims or who market their products in ways that are uniquely appealing to minors,” he said. “Failure to do so disadvantages companies that are acting responsibly and distorts the ENDS marketplace to the public detriment.”

    In other congressional news, a bill was introduced in the U.S. Senate in late January that would charge e-cigarette manufacturers higher user fees, which fund many of the FDA’s regulatory activities. Six senators, led by Democrat Jeanne Shaheen, introduced the legislation. A corresponding bill led by Rep. Cheri Bustos has also been introduced in the House.

    The Senate bill would raise the tobacco industry’s fees from $712 million to $812 million—the same increase as the Trump administration’s 2020 proposed budget. Vapor industry manufactures would be expected to pay fees based on their market share or risk fines and possibly even have products removed from the market. – VV staff

    Picture of Timothy Donahue

    Timothy Donahue

    Timothy S. Donahue is the co-founder and managing editor of Vapor Voice.

    Tim spends much of his time on the road, attending conferences and interviewing industry representatives.

    His networking skills, work ethic and quick mind are valuable assets to our diverse audience.

  • Weathering the Storm

    Weathering the Storm

    Many small vapor businesses have not been able to recover from the EVALI panic caused by the U.S. CDC.

    By John Castle

    Any small business is liable to face obstacles, including financial, logistical and bureaucratic issues. A small business in an industry centered on disruptive technology also faces not only those obstacles but outright hostility from their well-entrenched and well-funded legacy industry competitors. Add on various levels of government dependent on the revenue generated by those legacy competitors and going into business can, in a sense, mean going to war.

    By now, we all know what happened in the late summer of 2019. To give the following its proper context, however, perhaps a very brief recap is in order. Beginning in July and progressing into August, adolescents began arriving at local hospitals with symptoms similar to those of acute lipoid pneumonia. Each patient said they had been vaping (either THC, nicotine or both).

    On Aug. 23, the first reported death related to this phenomenon emerged from Illinois health officials. It would not be until December 2019 that the U.S. Centers for Disease Control and Prevention (CDC) would conclusively state that the culprit behind the illnesses and deaths was not nicotine vaping but the use of black market THC products adulterated with vitamin E acetate. By then, the damage caused by their ambiguous reporting and the ensuing media firestorm was unrepairable.

    Many small businesses faced devastation and even closure as a result of lost sales that were driven both by consumer fears and regulatory overreaction. States like Massachusetts and New York enacted bans, amplifying a trend that had previously been seen only at the municipal and county levels in states such as California. The panic caused by what the CDC has labeled e-cigarette or vaping-associated lung injury (EVALI) was so powerful that it reached the United Kingdom.

    Andy Brown, an employee at a vape shop in Mildenhall, England, for the past three years, came into the business prior to the establishment of the European Tobacco Products Directive (TPD). With a small-town shop surrounded by three American military bases, most of Brown’s customers were American service members.

    Brown explained that shortly after the crisis began in the U.S., British wholesalers and others in the trade stated that average sales were down 30 percent to 50 percent across the country. “The subsequent news articles around the world have since undone so much hard work in harm reduction. People that had switched from smoking to vaping were returning to cigarettes believing that it was the safer option,” Brown said. “This has been an issue worldwide, and despite the truth eventually coming out about the real cause of the illnesses and in the U.K. Public Health England and the Royal College of Physicians standing by their well-researched claims that vaping remains at least 95 percent safer than using combustible tobacco, the media had already done so much damage.”

    Back in the U.S., Jennifer Madsen of Dripped Out Vapers in Palm Bay, Florida, said she saw her business sales decimated, and the effects have been far-reaching. While noting that she can only speak directly about her business, she added that she knows the entire state’s vapor industry felt the impact. “I think that people not involved in vaping don’t understand the community. Vape shops aren’t just retail shops that supply a product,” Madsen said. “For a lot of people, we become a club, a place to make friends, to vent about your job and family, to be heard and to be accepted. I’ve had customers come to me and ask if they can meet a blind date at my shop (we have beer and wine) because they feel safe there. I’ve had customers bring their new boyfriends/girlfriends to meet me because we’ve become a family; we’ve become part of each other’s lives.”

    For many like Lisa Talarico of Exotic Vapors in Buffalo, New York, and Elizabeth Robinson Pharis of Underground Vapor Lounge in Rusk, Texas, financially crippled businesses have already meant lost employees and lost jobs that may or may not return. “I own a vape shop in New York [and] my sales are down over 50 percent [with] some days even as high as 80 percent,” said Talarico. “I am working seven days a week now because I had to lay my employee off.”

    Pharis said she understands the issues Talarico has been facing. She explains that her business saw a significant drop in sales too. “We are the only vape shop in town; we still weren’t safe from the hype. Business dropped 70 percent and we’re still not beginning to recover. We let go of all of our employees, and my daughter had to drop out of college; we just couldn’t afford it,” she said. “I still wake up every morning waiting for the bomb to go off and hear an announcement that flavors are now gone. I just wish there was a definitive answer.”

    The effects of the CDC’s and the media’s reporting weren’t confined to vape shops. Even comparatively large businesses such as manufacturers and distributors were crippled. Chris Weidlich, a former employee of Purebacco USA, said the ban cost him his livelihood. “I have been an employee with Purebacco USA where we manufactured for Akston Hughes, FlavorZ and Namberjuice e-liquid brands,” he said. “A Michigan flavor ban enacted by the governor set in motion a series of events that have led to the permanent closing of a legacy manufacturing company and the unemployment of many employees, including my own imminent loss of employment at the end of [2019].”

    Some businesses have begun to see some recovery. However, the uncertainty of the industry still haunts them. Andrew Simpson with Tri Guys Vapor in Salem, Missouri, said the EVALI panic hit his business with full force. “A month after the ‘outbreak’ started, I had to take my employees down to part time. We survived like that for a while. Then Trump announced that he was going to ban flavors. The next day, I wrote my employees a month’s wage check each and told them that they deserve to have a chance to find a job because I [knew] I wouldn’t be able to afford to pay them the next month due to sales continuing to drop,” explained Simpson. “For the first time in my life, and before my child was born, I was petrified that I couldn’t give my family the life that I promised my wife when I married her. I was scared we weren’t going to have a home for my child. I was scared he wasn’t going to have clothes. I was scared he would go hungry. I was just plain scared.”

    Simpson said he quit his job as an emergency medical technician so he could give his undivided attention to his vape shop. “I cut all of my costs down to nothing. I hunkered down and budgeted and prepared the shop to be able to stay open for four months without making a dime (I’m thankful it never had to come to that),” he said. “But we had to radically change our lives to prepare for the worst. We looked at options and were prepared to go completely bankrupt. But I wasn’t ready to give up on my business and customers. We were already in debt … and were looking at bankruptcy anyway; what does it matter if we’re completely broke when we closed.”

    While Tri Guys has recovered to a level Simpson describes as “only down about 20 percent from our average before all the propaganda happened,” he says the fear and sense of betrayal remain. “It really showed me how corrupt and broken our system is. This known and proven life-saving technology is going to be ripped off the market because of money,” he said. “They genuinely don’t care about the American people. They don’t care that 440,000 people die so they can get a paycheck. They don’t care about me or my family like I thought they did growing up. I’ve never felt so betrayed.”

    The vapor industry doesn’t seem optimistic about vaping’s prospects in 2020 either. However, there are a lot of fighters still not ready to call it quits. Many of the owners who are still in the fight say that a fight is exactly what this is. Brown could only offer a call to action. “The truth needs to be shared far and wide. Be under no illusion that if nothing is happening in your country that affects vaping [then] nothing will. Don’t be the, ‘I’m all right, Jack’ person,” Brown said. “Share your experiences with people, tell the truth about life-saving vapor products and harm reduction, and advocate until you are blue in the face. If we don’t fight to keep our vapor products, we will lose them.”

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