Smoore International Holdings is the only vaping technology company to make the Forbes 2021 Global 2000 list. The list ranks the world’s largest 2000 public companies. Smoore’s placement on the list confirms the legitimacy of the entire industry as a fast-growing and better alternative to cigarettes, with an expected compound annual growth rate (CAGR) of 28.1% from 2021 to 2028, according to Grandview Research.
Recognition on the list is a reflection of the company’s performance throughout 2020 and growth in market share from 16.5 percent in 2019 to 18.9 percent. The parent company to the Vaporesso brand, Smoore has over 1000 technology patents and more employees in R&D than sales, leading the vaping industry since 2009, according to a press release.
“These cutting-edge innovations are then worked into marketable products by Smoore’s sub-brands including Vaporesso, FEELM Lab and CCELL to be distributed around the world,” the release states. “Also, Smoore is proactively promoting atomization technology to other industries around the world. Vaporesso has been setting new industry standards and further driving innovation in this emerging industry with many more to come.”
Taking a snapshot of the world of business, the Forbes Global 2000 list measures companies using four equally weighted metrics: assets, market value, sales, and profits. Under Smoore, Vaporesso is committed to helping its vast network of international partners abroad and, driven by a strong sense of social responsibility, launched a series of campaigns aimed at helping those most affected, according to the release.
“Under the umbrella of Vaporesso Care, these campaigns helped affected communities in Indonesia where Vaporesso donated over 70 million rupiah and France where Vaporesso worked with local partners to distribute food to needy people over Christmas,” according to the release.
A lawmaker in Israel wants to tax vaping products the same as traditional tobacco cigarettes. Health Minister Nitzan Horowitz is set to propose legislation to combat smoking addiction in Israel, including disposable electronic cigarettes that he says have become popular among Israeli teenagers.
According to the Isreal Hayom, quoting anonymous sources sources states: “There is concern that in the past the decision-making of the political echelon with regards to e-cigarettes was motivated by unprofessional considerations,” the source states. “Horowitz intends to investigate the matter of disposable electronic cigarettes and government policies and restrictions on smoking products … with the consideration of public health alone.”
Credit: Christoph
As part of his initiative, the health minister is looking to raise the tax on vapors to equal regular cigarettes and tobacco; withdraw the special permit that had been granted to newspapers and other written advertising to print cigarette ads; and adopt graphic warnings on cigarette packages – a measure not yet applied in Israel but used in 120 countries worldwide, according to the story.
“The idea to make electronic cigarettes disposable is a sophisticated and dangerous marketing manipulation,” CEO of nonprofit Smoke Free Israel Shira Kislev said. “Because teenagers then think they are not risking getting addicted to cigarettes because their vapor will only last them one time. But the nicotine content makes these e-cigarettes addictive, and in a cruel way, repeated use makes teenagers smoke them more and more.”
A coalition of 23 organizations have written a letter to the U.S. Food and Drug Administration (FDA) to follow the common-sense recommendations of the Small Business Administration (SBA). The SBA had recommended companies seek a court order to allow vaping manufacturers to keep products on the market while their premarket tobacco product application (PMTA) submissions are being reviewed.
Credit: Tanasin
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications— the FDA has stated publicly that it is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market. All products must be removed from market on Sept. 9, 2022 without FDA approval, according to a court order.
The coalition letter, organized by the Americans for Tax Reform (ATR) acknowledged that FDA promised to exercise discretion in enforcement, stating that “this does not provide the degree of certainty necessary for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by FDA. If an extension is not granted, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality.”
The letter also argues that there “millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty.” The coalition states that the only way to avert a disastrous outcome for businesses and consumers is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year.
“The vaping industry, unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market,” the coalition letter states. “Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.”
The full letter and list of signatories can be read here.
The premarket tobacco product application (PMTA) process has been a struggle for vapor industry companies that took on the time, effort and expense to keep their products on the market. During the Tobacco Plus Expo (TPE), Vapor Voice sat down with Blackbriar Regulatory Services (BRS), a firm specializing in helping small-sized to mid-sized companies navigate the regulatory landscape to bring their FDA-regulated product concepts to market, to discuss the lessons it learned while filing 365 PMTAs for its clients. BRS has helped several clients garner acceptance and filing letters from the FDA.
Credit: Coloures Pic
BRS did not exhibit at the TPE. Don Hashagen, VP of business development, and Kristina Rogers, director of marketing and brand management, attended the show to support its partners that were exhibiting. Some of these partners include the Charlie’s Chalk Dust, The Beard and Humble brands. The pair was also testing the waters for how secure other companies felt about their PMTA submissions.
“If they wait until they get a deficiency letter, that’s too late. That’s 90 days,” said Hashagen. “We want to support the industry whether they have worked with us on their PMTA or not. The more people that make it through PMTA, the better it is for everybody in the industry.”
BRS is offering any company that submitted a PMTA a free gap analysis of their submission. Hashagen said that many companies that submitted PMTAs have yet to complete clinical trials, for example, and the FDA has been clear that it’s a requirement for approval. It’s also time-consuming and expensive.
“The other one is perception and behaviors. We’ve got about 45 people that specialize in PMTAs. Now that we’ve seen enough deficiency letters coming through, we have an understanding of how to respond to those letters,” he said. “Our team can read a PMTA and very quickly say, ‘All right, here’s some major issues you’re going to need to attack. Now, you don’t want to wait too long to get started on a deficiency letter. It’s going to take you more than 90 days to remediate.”
Several manufacturers have received filing letters for their PMTA submissions. This is the stage that the FDA will ask a company to respond to questions the FDA has as well as receive deficiency letters. Because the PMTA is a “living process,” BRS can help a company potentially address a known or found deficiency often before a deficiency letter is even issued.
“Submitting your PMTA is really the first step in a very long, lengthy process. You have multiple audits afterwards with people looking into your manufacturing, into registration, into your PMTA, into post-market surveillance … even after you are authorized for marketing authorization,” explains Rogers. “It’s a long year-to-year process. This is just the beginning of something that’s going to last the length of your product lifetime.”
Having an organization like BRS managing a company’s PMTA allows the client to have access to experts that know what’s coming, says Rogers. BRS knows what’s needed to help take a brand and make it successful in the market while complying with regulatory requirements.
“You spend all this money, you get a market authorization, you’re doing well. But four months later, you trip over your own shoelaces because you did something that could hurt your brand from a marketing standpoint … how you positioned it. Maybe your brand is suddenly considered youth-friendly as FDA guidelines change,” said Rogers. “You can be taken off market almost instantly. As this evolves, you want somebody who’s talking to the [FDA] frequently. We’ve built a working relationship with the agency.” Hashagen says the main reason BRS is offering the free gap analysis is because they really want the industry to not just survive but thrive. “We really want to help people,” he said. “This industry is about helping adult smokers quit combustible tobacco for good. That’s really, really important to us.”
The Hemp Industries Association (HIA) announced support for the legal position that Delta-8 THC, along with all other hemp-derived cannabinoids, were federally legalized by the 2018 Farm Bill. The group cites a legal opinion drafted by attorneys Rod Kight and Philip Snow of Kight Law.
Credit: Elsa Olofsson
“It is clear that the 2018 Farm Bill, which removed hemp from the Controlled Substances Registry, directed that hemp be regulated as an agricultural product, and defined hemp to include its cannabinoids and all tetrahydrocannabinols from hemp, is the governing law for the hemp industry,” the HIA states in a release. “History has shown that natural cannabinoid consumption does not present public health and safety risks like those from alcohol and tobacco, but researchers have only begun to explore the full range of potential hemp-extracted compounds and their various properties. What is needed is a regulatory framework for their production that prioritizes consumer safety while being grounded in science.”
The HIA states that prohibition is a failed concept. It only exacerbates the threat to consumers created by unregulated markets, and is antithetical to the spirit of free enterprise. The HIA wants state lawmakers to eschew ineffective bans in favor of partnering with the hemp industry to craft hemp policy that safely opens markets, fosters innovation, spurs investment, and creates valuable jobs.
The HIA calls on industry leaders to build consumer confidence and expand the market for hemp cannabinoids by adopting the highest quality and potency testing standards for Delta-8 THC and similar minor cannabinoids, by marketing those products responsibly through use of transparent and detailed labeling, including potency data and warnings against consumption by minors.
“Businesses, farmers, and consumers all deserve regulations that support the exploration of the hemp plant’s full potential. This isn’t just about one minor cannabinoid —the list is over a hundred already and growing,” said Jody McGinness, HIA’s Executive Director “Fortunately, the industry has all the expertise legislators could need, and those manufacturing leaders and scientists are engaged and ready to help create productive policy solutions.”
The HIA’s Cannabinoids Council, a newly-formed member body focused on national priorities distinct to the cannabinoids sector of the hemp industry, has identified safe market expansion as a core focus for its early efforts. The stance on Delta-8 THC and other hemp-derived cannabinoids is in line with the HIA’s history of vigorously defending the legality of all hemp products, and supporting the growth of industries utilizing all parts of the hemp plant, according to the release.
The group, a trade association composed primarily of businesses and farms in the hemp industry, is currently engaged in two lawsuits in response to the DEA’s Interim Final Rule on the 2018 Farm Bill that was issued in August of 2020, creating a threat to extractors and manufacturers of hemp cannabinoids. This is the fourth time the association has gone to court to protect hemp since forming in 1994.
New research published today in Internal and Emergency Medicine, provides the first real-world evidence that people switching from cigarettes to exclusive use of glo, BAT’s flagship tobacco heating product (THP), can significantly reduce their exposure to certain toxicants and indicators of potential harm related to several smoking-related diseases compared with continuing to smoke.
The results, recorded at six months of a 12-month study, showed that switching completely to glo resulted in statistically significant changes across a range of “biomarkers of exposure” (BoE), and indicators of potential harm, known as “biomarkers of potential harm” (BoPH), compared with continuing to smoke.
For most biomarkers measured, the reductions seen in people using glo were similar to those in participants who stopped smoking completely.
Based on the toxicants measured, glo users showed a:
Significant reduction in a biomarker for lung cancer risk
Significant reduction in white blood cell count, an inflammatory marker indicative of cardiovascular disease risk (CVD) and other smoking-related diseases
Improvement in HDL cholesterol associated with reduced risk of CVD
Improvements in two key indicators of lung health
Improvement in a key indicator of oxidative stress, a process implicated in several smoking-related diseases, such as CVD and hypertension
“These are exciting results as they allow us to understand the potential for reduction of risk that switching completely to glo can deliver,” said David O’Reilly, director of scientific research at BAT, in a statement. “The study shows that smokers switching to glo can reduce their exposure to certain toxicants, which reduces their risk of developing certain smoking related diseases.
“To have shown a significant reduction in measures of BOPH, some comparable to quitting completely, is very encouraging and provides further scientific substantiation of the harm reduction potential of glo and how it supports our ambition to build A Better Tomorrow by reducing the health impact of our business.”
A new study by Queen Mary University of London, published in Addiction, shows that e-cigarettes are more effective in achieving long-term smoking reduction and cessation than nicotine-replacement therapies (NRT).
The study randomized 135 smokers who had been unable to stop smoking with conventional treatments into two groups—one received an eight-week supply of their choice of NRT and the other received an e-cigarette starter pack with instructions to purchase further e-liquids of their choice of strength and flavor. Products were accompanied by minimal behavioral support.
After six months, 27 percent of those in the e-cigarette group had reduced smoking by at least half compared to 6 percent in the NRT group. Of the participants in the e-cigarette group, 19 percent had stopped smoking altogether versus 3 percent in the NRT group.
“These results have important clinical implications for smokers who have previously been unable to stop smoking using conventional treatments,” said Katie Myers Smith, lead researcher and health psychologist, in Eurasia Review. “E-cigarettes should be recommended to smokers who have previously struggled to quit using other methods, particularly when there is limited behavioral support available.”
“This study shows e-cigarettes can be a very effective tool for people who want to stop smoking, including those who’ve tried to quit before,” said Michelle Mitchell, CEO of Cancer Research U.K., which funded the study. “And research so far shows that vaping is far less harmful than smoking. But e-cigarettes aren’t risk free, and we don’t yet know their long-term effects, so people who have never smoked shouldn’t use them.”
One of the largest vaping retailers in the U.K., VPZ, has announced that it has opened five new stores since the end of lockdown restrictions caused by the Covid-19 pandemic. The new stores are located in Helensburgh, Port Glasgow, Castlemilk, Glenrothes and Farnborough, bringing its total footprint to 159 stores and creating 15 new jobs.
Doug Mutter/Photo: VPZ
Since lockdowns ended in April, the company has seen a 165 percent increase in first-time vapers kit sales. The demand has been driven from smokers having no access to National Health Service (NHS) stop smoking services and vaping retailers being closed due to not being classed as essential during lockdown, according to a press release.
Doug Mutter, director of VPZ said, the company is spearheading the fight against the nation’s No. 1 killer: smoking.
“The Pandemic has triggered an increase in smoking rates and the public health problem has been compounded by funding cuts for NHS stop smoking services and local support groups,” said Mutter. “This latest investment in our offering and expansion of our store footprint underlines our commitment to playing our part in regaining this lost momentum and helping the UK achieve its ambitions to be a tobacco-free nation by 2030.”
Pyxus International announced results for its quarter and fiscal year ended March 31, 2021.
Combined sales and other operating revenues were $1.33 billion, down 12.8 percent from the prior fiscal year. Combined gross profit as a percent of sales was 12.1 percent, which decreased 2.6 percent from the prior fiscal year.
Combined selling, general and administrative expenses were $197.9 million, which decreased $1.1 million or 0.6 percent from the prior fiscal year.
Combined net loss attributable to Pyxus International was $117.7 million, which decreased $147 million, or 55.5 percent, from the prior fiscal year.
Combined adjusted EBITDA was $93.5 million. Total long-term debt was substantially reduced when compared to the prior fiscal year. Year-end uncommitted inventory was the lowest it has been since fiscal 2016.
“In what was an unprecedented and challenging year, our company adapted to constant change as we navigated the Covid-19 pandemic,” said Pieter Sikkel, Pyxus’ president and CEO, in a statement. “During fiscal 2021, we implemented a series of restructurings and process changes that allowed our business to continue to operate through the Covid-19 pandemic while also positioning us for success in fiscal 2022 and beyond. Through these actions, we substantially reduced our debt and costs throughout our supply chain. We also made the strategic decision to exit our cash flow negative Canadian cannabis businesses, which further supports our SG&A cost containment efforts.
Based on expected first quarter results, we are optimistic about fiscal 2022
“Although our production facilities continued to operate through the pandemic, certain facilities experienced lower production levels than planned due to smaller crop sizes in Africa and the implementation of social distancing requirements and safety practices to reduce the spread of Covid-19 and protect our employees. In addition, the Covid-19 pandemic-related shipping delays of leaf tobacco for certain customer orders resulted in a shift of between $170 million and $180 million of expected revenue and $30 million and $34 million of expected EBITDA from fiscal 2021 into fiscal 2022. However, the impact of Covid-19 on our business yielded innovative changes that will enable us to be more flexible in the future and accelerate certain activities in the crop cycle. Covid-19 has also pushed the tobacco industry to continue to look for ways to reduce supply chain complexity in a responsible manner.
“For the full year, we are expecting fiscal 2022 sales to be between $1.65 billion and $1.8 billion, SG&A expense to be between $140 million and $145 million (excluding nonrecurring items and potential changes in foreign currency exchange rates) and adjusted EBITDA to be between $150 million and $170 million. Based on expected first quarter results, we are optimistic about fiscal 2022. Lastly, we are also excited about sharing more information about our enhanced global environmental, social and governance strategy, which supports our ability to deliver on our expected results for fiscal 2022.”
Joel L. Thomas will be retiring from his position as executive vice president and chief financial officer at Pyxus International upon the appointment of his successor. Thereafter, Thomas will continue to serve as a strategic advisor to facilitate the transition of his responsibilities until he retires from that position on or before June 30, 2022. The company has initiated an executive search for Thomas’ successor.
“On behalf of Pyxus and the board of directors, I would like to thank Joel for his dedication and contributions to the company,” said Pieter Sikkel, president and CEO of Pyxus International, in a statement.
“Throughout his time with the company, Joel has provided financial leadership and implemented innovative financing structures to meet our evolving global requirements. His leadership and dedication were critical over the past year as we navigated the impact of the Covid-19 pandemic and implemented significant restructuring efforts that have positioned our business for long-term success. Joel’s passion for the business, our shareholders, our employees and our customers is evident to anyone who interacts with him, and I wish him all the best in the next chapter of his journey.”
Thomas has spent the past 16 years of his career with the Pyxus International, including serving the last seven years as CFO.
“It has been a privilege to work and serve alongside our talented global team,” said Thomas. “I’m proud of the steps we have taken to create a solid foundation for the company that will enable it to achieve long-term success.”
