Blog - Tobacco Reporter

Failure to Launch

Zimbabwe’s attempt to diversify into cannabis is proving more challenging than some anticipated.

By Daisy Jeremani

Zimbabwe announced its approval for cannabis growing for medicinal and industrial use in April 2018 amid much hope for an immediate economic impact.

Finance Minister Mthuli Ncube projected export revenues of up to usd1.2 billion in the first year of growing, processing and exporting the crop and its products. The forecast is almost at par with what gold, the southern African country’s most lucrative export, brings in—and higher than the amount it generates from tobacco, its current No. 1 agricultural export. Cannabis was, too, touted as a diversification route for tobacco growers amid declining demand for the golden leaf.

However, experts have cautioned that Zimbabwe may not realize the benefits as rapidly as authorities initially projected. Forty-two months since the government issued the first licenses, only 15 out of the 57 companies have started work, hampered by a plethora of challenges. Chief among them: lack of financing and expertise.

Speaking to Tobacco Reporter just after her organization, Zimbabwe Industrial Hemp Trust (ZIHT), hosted a cannabis roundtable under the theme “Unpacking the Challenges and Potential of Cannabis as a Medicine” in Harare, the capital city, on Sept. 7, 2022, Zorodzai Maroveke said a lot of work still needs to be done for the country to realize gains from the crop.

A key proponent of legal cannabis production, Maroveke said most licensees lack guaranteed off-take agreements. An unstable market has not helped matters, she added, as prices have kept fluctuating since Zimbabwe became Africa’s second nation after Lesotho to legalize cannabis for medicinal and industrial use.

“An unstable market has been a major challenge for investors to move forward with this project in Zimbabwe and also the issue of funding. Most banks are not willing to finance cannabis because they still don’t understand it,” said the ZIHT founder and CEO.

Another obstacle for license holders is that they have to import expertise as this is a new frontier for the country. Recruiting the right skills is expensive. The cannabis regulatory framework, which she described as very strict, has also hampered the speed at which the industry is progressing.

Maroveke said the cost implications of growing medicinal cannabis are high, citing the European Union’s good manufacturing practices (GMP), which force producers to set up facilities of a high standard of hygiene and security and hire well-trained personnel.

“You will find that for a very small project, maybe even a hectare project, one would potentially pump out not less than usd1million,” said Maroveke.

So if one is to expand, there is a need for more funding, not considering money that must be paid for the GMP compliance auditors as well as inputs, like seeds, which are not only expensive but are also imported.

Though industrial hemp is generally cheaper to produce than medicinal cannabis, the cost depends on its type, she noted. If it is botanical, which is grain hemp for the CBD flower, one should be prepared to part with at least usd200 for a 5 ha project. The market determines the standards and quality that the farmer has to put in.

“So if you’re going to do hemp for fiber and grain, it’s obviously going to be cheaper; you’re looking at usd3,000–usd4,000 a hectare. But Zimbabwe’s hemp and grain industry hasn’t developed to that extent, so we don’t have many activities in those particular subsectors of industrial hemp,” she said.

The Sept. 8 roundtable was meant to find, bridge and plug the knowledge gap not only among health professionals but also other experts along the value chain. It is against that backdrop that a top Zimbabwean pharmaceutical supplier, New Avakash International, awarded scholarships to 100 health personnel to undergo training to make them more conversant with cannabis.

At the moment, local varieties are at the research stage. Due to the dictates of the market, buyers direct farmers toward the genetics they want, which at this stage are all imported. As a result, roundtable participants called for more investment in research and development and the development of local growing and processing expertise. As the industry tries to find its place, Maroveke said the government should support it through tax breaks and other incentives for cannabis value addition to be accelerated.

She said Zimbabwe will only realize the gains from cannabis once production kicks off and the export markets are stable and guaranteed.

Former Zimbabwe Tobacco Research Board (TRB) CEO Dahlia Garwe noted that the country leapt in headfirst without conducting proper market research.

“We were supposed to look at what kind of varieties we should be growing and where exactly the material will end. We have a lot of cases where people grew cannabis, but they don’t know what to do with it,” she said.

Garwe noted that the costs involved in setting up facilities for the processing of the herb and for a basic setup are as high as usd400,000. For a facility that is compliant with all the necessary health requirements, the costs can be about usd3 million.

With regards to research that is underway, she said experts are looking for locally adapted germplasm, with the TRB going around the country to identify varieties adapted to the local environment. After that, they would breed local varieties and material from elsewhere to come up with varieties that are most suitable for Zimbabwe.

“That is ongoing work. It will obviously take a few years before we get to a point where we say we have locally adapted varieties,” she said.

However, this is not to say varieties developed elsewhere can’t do well in Zimbabwe, “but that’s where the research comes in, where you’re actually evaluating varieties coming from elsewhere and you see whether they actually work or not.”

Speaking while commissioning a usd27 million medicinal cannabis project by Swiss Bioceuticals in May 2022, Zimbabwean President Emmerson Mnangagwa expressed frustration over the slow investment by licensees.

“It is disappointing that since 2018, only 15 out of 57 entities issued with cannabis licenses are operational,” he said. “Such licenses should not be held for speculative purposes, and those not using them risk government invoking the ‘use it or lose it’ principle.”

Former Tobacco Industry and Marketing Board chairperson Monica Chinamasa said farmers are still waiting for the ongoing research on varieties that are suitable for the local climate.

“We are still waiting for the TRB to guide us on this matter,” she said.

The EU requires GMP and good agricultural collection practices certificates to be in place before a cannabis producer can venture into that business. The financial implications for applying for the certification are huge for some Zimbabwean investors, said Munyaradzi Shamhudzarir of Voedsel Cannabis, one of the few Zimbabwe-owned companies to have planted cannabis.

“The process of getting these certifications is also very long—at least three years before you can complete all the audits and get certification,” he said.

October 3, 2022

Transformation and Its Enemies

The twin strategies of migration away from combustible nicotine products and diversification into new businesses underpin the tobacco industry transformation. Why is there so much opposition?

By Clive Bates

How should a rational and dispassionate public health advocate think about tobacco companies? How should tobacco companies think about public health?

The simple and lazy answer is that they are sworn enemies in a permanent and irreconcilable conflict. This idea has now been immortalized as a guiding principle by the World Health Organization. The “scream test” devised by Australian anti-tobacco campaigners was a crude forerunner of the WHO’s principle: “If a new policy gets no reaction from the tobacco industry, it rarely has an impact, but if the industry screams blue murder, the impact will be large.” If the industry hates it, it must be good for public health.

But what if there are policies, practices and messages that are good for the tobacco industry and public health? Or bad for both? One of the accusations frequently thrown at public health advocates who favor tobacco harm reduction is that they are doing the bidding of Big Tobacco. No one likes to be accused of that. But implicit in that accusation is either the assumption that tobacco harm reduction cannot be good for both or worse, that it is more important to hurt the tobacco industry than to serve public health. We see this playing out in the industry’s twin-track efforts to transform by migration and diversification: migration into noncombustible nicotine products and diversification into non-nicotine businesses in which they have natural commercial advantages.

These issues loom large in the transition strategies of tobacco companies, which range across a continuum from “not bothered; we like the business as it is” to “this is the competitive play of the 21st century, and we’re all in.” In my view, the transition strategies of the companies will be highly beneficial for both public health and the companies that successfully transform. Transition involves giant companies moving out of the merchant-of-death business and into something closer to selling mild and popular recreational stimulants. For public health reasons, I would be happy if tobacco companies made handsome profits from a diversified business far less reliant on cigarettes. Yet their efforts to attempt this attract strident opposition at every turn.

Why? I think it is worth unpacking this opposition a little.

First, is the continued sale of cigarettes just too much to bear? How can public health welcome transformation when the companies involved are still hooking kids, selling trillions of cigarettes and killing millions of people? Here, public health advocates must understand the nature of the market and a corporation. Every country has a lawful market for cigarettes. Commercial tobacco sales are permitted, regulated and taxed by governments. There is also a demand for cigarettes, with over a billion smokers consuming over 5 trillion cigarettes annually. This demand will inevitably be matched by supply, and the suppliers are, by definition, the tobacco industry. We should treat this as a given not an act of evil—a fact of life that we may not like that much but that constitutes the reality in which we try to secure public health gains. I am all for putting pressure on the cigarette trade through tobacco control measures, but these are the prerogative of governments. We should expect companies to compete vigorously for market share within the parameters set by policy and law. That should not be a shock; it is what companies do. Public health advocacy should be focused on influencing the regulatory, fiscal and communications environment in which tobacco companies operate and challenging abusive business practices. Other than gratifying righteousness, it serves little purpose to condemn tobacco companies for what they are and must be. What matters is how this can change.

Second, should we only trust the tobacco industry when they pull out of cigarettes? There have been numerous calls for companies to stop selling cigarettes. The problem is that the advocates of this idea believe the companies should just do it unilaterally. Public health colleagues need a better grasp of shareholders and fiduciary duties. The companies cannot simply squeeze or shut down a lucrative earnings flow to their shareholders. The management would be fired, the company taken over or the cigarette assets sold as a going concern with no public health benefit. Ironically, the companies, to varying degrees, do have viable exit strategies for cigarettes—migration of the nicotine business to noncombustibles and diversification to “adjacent” industries such as plant biotechnology and vaccines, inhalation technologies and recreational stimulants. This strategy to exit the cigarette trade meets an essential requirement; if successful, it can work well for shareholders. The irony is that public health campaigners lament the slow progress in phasing out cigarettes. Yet, at the same time, they oppose every element of the only commercially viable strategy to bring it about: migration and diversification.

Third, is tobacco harm reduction just the “nicotine maintenance strategy of Big Tobacco”? The concern is that diversification is merely a cunning ruse to escape the inevitable demise of the tobacco industry and the nicotine market. Here, public health advocates need to think more carefully about the product and where it is heading. I believe there is a far more robust long-term market for nicotine than for smoking. That’s because nicotine use is popular among many for its impacts on stress, anxiety, concentration and pleasurable sensations. And nicotine itself is not that harmful. The main reason people have stopped using nicotine over several decades is the health impacts of smoking and the pressures from policies and taxation to address the health impacts of smoking. The early stages of migration to noncombustibles have been welcomed by many as a harm reduction option for smokers. But in the longer term, the noncombustible products represent the basis for a nicotine market that operates within the normal boundaries of acceptable risk. This may open a frightening vista for some in public health. Nicotine products with minimal harm create weird new challenges that we have yet to fully grasp. The deterrence effects from the harms of smoking are lost, the case for taxes and regulation to control use is diminished, the designation of nicotine as an addictive agent no longer applies and the whole purpose of the vast complex of tobacco control interests is lost. There is only a case for tobacco control if there are serious harms. Otherwise, it becomes a moralistic war on drugs enterprise.

Fourth, is diversification just an exercise in reputation laundering? Much tobacco control activism now relies on “denormalizing” the industry and, by inference, whatever the industry touches. Tobacco companies can deploy their human resources, facilities, assets and intellectual property to branch out into new businesses for which they have inbuilt advantages. Shocking venom and energy have gone into attacking companies and their staff for some of their efforts to develop or acquire pharmaceutical businesses, invest in vaccine production, exploit their plant biotechnology expertise, enter new markets for personal well-being recreational drugs or even provide ventilators to struggling hospitals. It is bizarre. What is achieved by preventing companies from moving into new businesses that reduce the dependence on cigarettes? This can only be explained by a fear that the industry will reform itself into a more normal business and that arguments grounded in denormalization will fail. The arguments from tobacco control are peculiarly aesthetic—it just looks wrong for a tobacco company to make drugs to treat chronic obstructive pulmonary disease (COPD) or provide Covid-19 vaccines. But why is this so wrong? What are the ethics of opposing the development and deployment of a vaccine or COPD treatment if these would otherwise be successful in the market?

Finally, will migration and diversification be additional and not replace cigarettes? Maybe Big Tobacco is building even bigger, more voracious businesses? Here, public health advocates need to grasp what shapes a market. Ultimately, that is up to consumers and what they are inclined to buy. But in a market like this, policymakers and communicators have a role. For example, they can make taxation and regulation proportionate to risk. They can communicate candidly about risks. They can have better insights into unintended consequences or test and reject assumptions that fail to hold water in real life. Some companies may grow bigger through migration and diversification or even acquire a larger share of the cigarette business—that is how competition works. What matters for public health is not what individual companies are doing, though it matters greatly to the companies. What counts is the migration of the whole market to reduced-harm products instead of cigarettes, which is strongly affected by public health policies and communications. If the companies also diversify to keep their shareholders engaged and exploit their advantages during a transition, what exactly is wrong with that?

In public health, we need to stop our warrior rhetoric and think harder about the world as it really works and what will change it for the better.

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

October 3, 2022

Poised for Growth

After the win of its merits case against the FDA, Kaival Brands and Bidi Vapor are back on track.

By Stefanie Rossel

The year 2022 has been both challenging and exciting for Kaival Brands Innovations Group. The Melbourne, Florida, USA-based company is the exclusive distributor of products manufactured by Bidi Vapor, which is best known for its Bidi Stick vape pen, a disposable electronic nicotine-delivery system (ENDS).

In September 2021, Bidi Vapor received a marketing denial order (MDO) from the U.S. Food and Drug Administration for its nontobacco-flavored Bidi Sticks. The company had submitted premarket tobacco product applications (PMTAs) for the product’s nine flavor varieties plus a tobacco and a menthol variant.

In response to Bidi Vapor’s petition for review, the FDA stayed the MDO until December 2021, after which the order was again stayed by the 11th Circuit Court of Appeals. On Aug. 23, 2022, Bidi Vapor won its merits case against the FDA. Granting Bidi Vapor’s petition for review, the 11th Circuit ruled that the MDO was “arbitrary and capricious,” primarily because the FDA failed to consider the relevant marketing and sales access restriction plans included in Bidi Vapor’s PMTAs.

At the time of writing, the FDA had yet to announce how it would move forward following the 11th Circuit’s decision. “FDA could seek to appeal the decision by requesting ‘en banc’ review, or a review by the entire 11th Circuit,” explains Eric Mosser, president and chief operating officer of Kaival Brands Innovations Group. “Or they might even try to petition the Supreme Court to review the decision. Regardless, we anticipate being able to continue selling and marketing our flavored products for the duration of any potential appeal, subject to FDA enforcement discretion. It is also possible FDA will simply follow the court’s instructions and review Bidi’s nontobacco PMTAs instead of trying to appeal.”

Flavors, insists Mosser, are a critical matter of public health, and Kaival is adamantly opposed to illegal underage use of tobacco and vape products. “The company has focused on limiting access via contracts with partners prioritizing retailers’ age verification policies, secret shopper audits, repackaging devices to better align with FDA guidance, no use of social media or influencers and no consumer-facing advertising,” he says. “The company even discontinued its online direct sales to consumers—while we had state-of-the-art verification practices, company leaders realized online access was a way that underage youth in general were gaining access to vaping products and decided to eliminate that potential for the Bidi Sticks.”

According to the most recent National Youth Tobacco Survey, Bidi Vapor was not among the top brands that appeal to youth. In 2021, among students who currently used e-cigarettes, Puff Bar was the most commonly reported usual brand (26.8 percent) followed by Vuse (10.5 percent), Smok (8.6 percent), Juul (6.8 percent) and Suorin (2.1 percent).

Victory for Vaping

The 11th Circuit’s decision is a victory not just for Bidi Vapor and Kaival Brands but for the entire vaping and tobacco harm reduction industry, according to Mosser—especially for those companies who have been rigorously following the FDA guidelines in their attempts to obtain market authorization. “We at Kaival Brands have done so on the belief that the FDA will follow the science and allow solid evidence to guide their decisions. If that is the case, then the company is on solid ground, and we are hopeful FDA will ultimately agree that our products, including our nontobacco flavored products, are appropriate for the protection of the public health.”

The PMTA for the company’s tobacco-flavored Classic Bidi Stick is currently undergoing Phase III scientific review. There is no timeline for this process, says Niraj Patel, chief science and regulatory officer for Kaival Brands Innovations Group and president and CEO of Bidi Vapor. The Arctic Bidi Stick, which Bidi Vapor maintains is a menthol product, was characterized as a flavored product by the FDA and subjected to the MDO that was vacated. “Barring an appeal, we anticipate that FDA will soon begin the scientific review of the Arctic Bidi Stick PMTA along with our other nontobacco-flavored products,” says Patel.

Patel founded both companies. With a wholesale distribution network of more than 54,000 stores across the United States, Kaival Brands helped Bidi Sticks, which entered the market prior to 2016 under a different brand name and with limited success, to become the fastest-growing and now No. 1 disposable vape brand in the U.S. market. Despite the MDO, the Bidi Stick is still the bestselling disposable ENDS product based on retail sales for the 52-week period ending on Aug. 27, 2022, Nielsen data shows, according to the companies.

Kaival Brands, which commenced business operations in March 2020, generated a cumulative $100 million in revenues in less than a year. In July 2021, Kaival Brands’ stock began trading on the Nasdaq. In April 2022, the company announced the expansion of additional wholesale and retail accounts, a move expected to increase the reach of Bidi Sticks by about 28,000 stores and to make up for the losses the company experienced in the wake of the MDO.

Difficult Times

In fiscal year 2021, which Patel described as “very challenging,” Kaival Brands reported a net loss of $9 million compared to net income of approximately $3.8 million for fiscal year 2020. In a press release, Patel said the MDO had caused “irreparable harm to both Bidi Vapor and Kaival Brands.”

The greatest revenue loss occurred in the last two quarters of fiscal year 2021, between the lifting of the FDA’s administrative stay and the ordering of the judicial stay, when the company was unable to market its Bidi Sticks. Revenues for fiscal year 2021 were approximately $58.8 million compared to $64.3 million in the prior fiscal year. Kaival Brands’ revenues decreased by approximately $15.7 million in the second quarter of fiscal year 2022 compared to the same period of fiscal year 2021, but revenues rose 11 percent compared with the first quarter of 2022, suggesting further recovery.

The 2021 year also presented challenges to Kaival Brands’ attempted foray into the modern oral nicotine market, a category that is still a niche but that has recently grown dramatically. The global nicotine pouches market size was valued at $1.5 billion in 2021. Grand View Research expects it to increase at a compound annual growth rate (CAGR) of 35.7 percent from 2022 to 2030.

Bidi Vapor had planned to introduce its Bidi Pouch in February 2021, but due to the Covid-19 pandemic, the launch had to be postponed. In September 2021, the company said in a press release that the launch would be further delayed while the company reformulated the product to utilize tobacco-derived nicotine and sought FDA marketing authorization. The company had originally envisioned the pouch to contain synthetic nicotine but pivoted following concerns about the legality of nontobacco-derived nicotine.

Congress subsequently changed the definition of a “tobacco product” to include synthetic nicotine products, with the FDA requiring manufacturers of nontobacco nicotine products to submit PMTAs by May 14, 2022. As of July 13, 2022, any new synthetic nicotine product that has not received premarket authorization from the FDA cannot be legally marketed. “We did not launch our nicotine pouch product,” Patel says. “Due to concerns with synthetic nicotine, we decided to focus on tobacco-derived nicotine and will launch in the U.S. only after we obtain FDA PMTA marketing authorization.”

Cooperating with PMI

In June 2022, Patel handed over the management of Kaival Brands to Eric Mosser. The leadership change had always been a part of the plan, according to Mosser. “I was preparing for the leadership role, which was set to occur as soon as plans for international expansion solidified. International distribution came sooner than later once Philip Morris International decided to license technology from Bidi Vapor and now also has distribution rights in certain markets outside the United States.”

Two weeks earlier, Kaival Brands’ newly created wholly owned subsidiary, Kaival Brands International, had entered into a licensing agreement with Philip Morris Products (PMP), a wholly owned affiliate of PMI. The agreement grants to PMP a license of certain intellectual property rights relating to Bidi Vapor’s premium ENDS device, the Bidi Stick, as well as potentially newly developed devices to permit PMP to manufacture, promote, sell and distribute such ENDS devices and newly developed devices in international markets outside of the U.S. Patel called the agreement a major milestone in Kaival Brands’ efforts to expand the global sales and distribution of the Bidi Stick.

Kaival Brands, in turn, announced the launch of Veeba, PMI’s first disposable e-cigarette utilizing Bidi Vapor’s intellectual property, in Canada in late July. PMI’s new product is now the lowest-priced disposable vape on the Canadian market. Mosser says he anticipates revenues through royalties paid by PMP, pursuant to the licensing agreement, in the fourth fiscal quarter. “I see Kaival Brands reclaiming its previous revenue growth trajectory and expanding into additional market segments with new innovative products that we exclusively distribute or own, not only here in the U.S. but also in profitable global markets.”

Disposable e-cigarettes are a growth market. According to report from Future Market Insights, the global disposable e-cigarette market size is expected to be valued at $6.34 billion in 2022. The overall demand for disposable e-cigarettes is projected to grow at a CAGR of 11.2 percent between 2022 and 2032, totaling around $ 18.32 billion by 2032.

Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

October 3, 2022

The PMTA Mystery

How effective must a product be in helping adult smokers quit to overcome the theorized level of harm to youth?

By Neil McKeganey

If there is one thing that you can say about the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process, it is that it is exceedingly data heavy. E-cigarette manufacturers’ submissions under the PMTA process can run to the thousands of pages, reporting the results of research costing millions of dollars. To receive a marketing authorization, e-cigarette manufacturers have to be able to show that their product is “appropriate for the protection of the public health” (APPH).

The APPH standard has become something of a modern-day mantra in the world of tobacco regulation, but what exactly does it mean? While nobody would accuse the FDA of excessive clarity in its communications with industry, this much is clear—in the simplest of terms, manufacturers need to be able to show that their product is helping adult smokers to quit, or at least to substantially reduce their smoking, and that their products are not being used by nonsmokers. This, in a nutshell, is what the FDA means when it talks about the importance of assessing the net public health impact of new tobacco products—the capacity to assess the likely overall impact of a new tobacco product on the nation’s health.

The kind of evidence that manufacturers are required to present under the PMTA process ranges from longitudinal customer studies collecting data from consumers of their products over weeks or months to assess how those products are impacting on the individual’s smoking behavior. Alongside such customer studies are the randomized control trials that monitor changes in smokers’ behavior when they are using the new tobacco product under control conditions. The randomized trials are probably the sort of things most manufacturers have heard of before even if they have not carried them out. These studies are often presented as the gold standard in research evaluating the impact of a new drug. The shortcoming with the control trial design, though, is that it tells you about the impact of your product under controlled conditions; it does not tell you how people will use your product in their real life.

The results of these studies can be presented to the FDA along with studies showing which population groups are currently using the new tobacco product and which ones are likely to start using the new tobacco product if it were approved. This is where the PMTA process starts to get more mysterious. One of the key groups that the FDA wants to know about is young people. With recent studies showing that more than one in 10 young people in the U.S. are using e-cigarettes, the FDA has repeatedly stressed that in deciding whether a manufacturer’s product is going to be judged as APPH, it needs to balance the impact of the product on adult smokers and young people. When the former FDA commissioner stated in 2018 that the “offramp” to adult smoking must not be achieved at the cost of the on-ramp to youth vaping, he was making it clear that the FDA would be prepared to deny approval to a new tobacco product that might be helping adult smokers to quit if at the same time it was being used by youth or likely to be used by youth.

In a scenario where youth use of a new tobacco product can become a deal breaker for a company seeking regulatory approval for their new tobacco product, it is clear that the FDA is placing greater weight on youth vaping prevention than on adult smoking cessation. For many people, the greater value placed on youth vaping prevention may seem entirely fair—but the question at the heart of all this is by how much is the FDA valuing youth vaping prevention over adult smoking cessation? The answer to that question, or more accurately, the failure of the FDA to answer that question, is the mystery at the heart of the PMTA process. An e-cigarette manufacturer may be able to present stellar data to the FDA showing the benefit of their product in helping adult smokers to quit and still receive a marketing denial order on the basis that in the view of the FDA, the product poses too great a risk to youth.

In interpreting the results of the empirical studies that manufacturers may have carried out, the FDA is trying to model the likely impact of the product on the total population—adults and youth. Modeling, though, is a mysterious process in which you try to anticipate what you think might happen in the future under various assumed conditions in the present. Some years ago, the National Academies of Science Engineering and Medicine carried out a modeling exercise to try to quantify the impact of e-cigarettes on population health in the U.S. This was a limited exercise carried out under precisely stated assumptions about how effective e-cigarettes might be in helping smokers to quit and how harmful they may be compared to combustible cigarettes. In contrast to such transparency, the FDA has never specified how it is weighing youth harm prevention against adult smoking cessation. As a result, e-cigarette manufacturers will never know how effective their product needs to be in helping adult smokers quit to overcome the theorized level of harm to youth to be judged APPH.

Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

October 3, 2022

‘States Must Use Juul Payouts for Prevention’

Medical groups are urging the U.S. states that recently won a case against Juul Labs to use the money for tobacco prevention and cessation programs, according to Pew. The court case ended in a $438.5 million settlement.

The deal, which resolved an investigation by 33 states into Juul Labs’ marketing practices, requires Juul to pay states over six years to 10 years, prohibits Juul from further marketing to young people, limits where Juul products can be sold and advertised, bans flavors that haven’t been approved by the U.S. Food and Drug Administration and prohibits free samples and brand name merchandise marketing.

Groups, including the Campaign for Tobacco-Free Kids (CTFK), the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Americans for Nonsmokers’ Rights and the Truth Initiative, called on the states involved in the settlement “to both build on the successes of the historic 1998 Master Settlement Agreement with the tobacco industry and avoid some of the mistakes that were made.”

The groups cited a CTFK report showing that of the $27 billion that states collected from tobacco settlements and taxes in fiscal 2022, only 2.7 percent was spent on programs to prevent kids from smoking and help smokers quit.

Several attorneys general have expressed intent to use the Juul settlement money for smoking prevention and cessation programs. The health groups urged the officials to “translate that admirable intention into a firm commitment expressed in the text of the final agreement.”

October 3, 2022

Study: Smoking Costs U.S. Economy Billions

Smoking cost the U.S. economy $891 billion in 2020, almost 10 times the cigarette industry’s revenue of $92 billion, reports Medical Xpress, citing a new American Cancer Society study.

“Economic losses from cigarette smoking far outweigh any economic benefit from the tobacco industry—wages, and salaries of those employed by the industry, tax revenue and industry profit combined,” said Nigar Nargis, senior scientific director of tobacco control research at the cancer society.

“As a society, we can mitigate these economic losses through coordinated and comprehensive evidence-based tobacco control measures, which encourage people to quit smoking and prevent people from starting to smoke in the first place,” Nargis said.

Researchers used economic modeling that measured economic loss from cigarette smoking by state. Kentucky, West Virginia and Arkansas showed the highest losses while Utah, Idaho and Arizona showed the lowest losses.

“The damage this industry causes on individuals’ lives and our nation’s economy is horrifying,” said Lisa Lacasse, president of the American Cancer Society Cancer Action Network.

“It’s particularly alarming, but not surprising, to see some of the states with the highest economic loss have the weakest tobacco control policies in place,” Lacasse said. “We know what works to reduce tobacco use and lessen this burden, and it’s past time we get it done.”

The U.S. Department of Health and Human Services has a goal of reducing smoking to 5 percent of adults by 2030. “The Healthy People 2030 goal provides an important target that will help reduce smoking and correspondingly the negative economic impact of tobacco use,” Nargis said.

October 3, 2022

Prescription Vaping Has Failed: Mendelsohn

Australia’s prescription-only model for nicotine vaping has failed, according to Colin Mendelsohn, founding chairman of the Australian Tobacco Harm Reduction Association. Writing in Filter, he urges the country to adopt a more realistic regulatory model for nicotine products.

In October 2021, the Australian government introduced a policy that requires nicotine vapers get a doctor’s prescription and purchase supplies exclusively from pharmacies or international online vendors.

The regulations were intended to prevent youth vaping and to allow access for adults as a smoking-cessation aid. One year on, the policy has achieved neither of those goals, according to a report prepared by Mendelsohn.

Instead, the rules have created a thriving illicit market for unregulated vaping products that do not comply with Australian standards. Meanwhile, vaping by adolescents has reportedly increased in Australia. With no age controls in an unregulated market, vaping products are easily accessible by teens from stores and through social media.

Nicotine liquid should be an adult consumer product, sold from licensed retail outlets such as vape shops, convenience stores, tobacconists and general stores as it is in other countries.

Colin Mendelsohn, founding chairman of the Australian Tobacco Harm Reduction Association

While the prescription model has made it harder for adults legally access nicotine vapes, combustible cigarettes remain widely available.

According to two recent surveys, between 88 to 97 percent of vapers do not have a prescription and only 2 percent of purchases are made from a pharmacy. Exposed to frequent negative messaging by Australia’s medicines regulator, the Therapeutic Goods Administration, general practitioners have been reluctant to prescribe nicotine.

The only way forward, according to Mendelsohn, is to replace the prescription-only model with a legal and regulated retail market. “Nicotine liquid should be an adult consumer product, sold from licensed retail outlets such as vape shops, convenience stores, tobacconists and general stores as it is in other countries,” he writes. “There should be strict age verification and penalties up to loss of license for underage sales.”

October 3, 2022

Report: Vaping Less Harmful Than Smoking

Using vaping products rather than cigarettes leads to a substantial reduction in exposure to toxicants that promote cancer, lung disease and cardiovascular disease, according to new research from the Institute of Psychiatry, Psychology and Neuroscience at King’s College London.

Commissioned by the Department of Health and Social Care’s Office for Health Improvement and Disparities, the independent report represents the most comprehensive review of the risks of vaping to date. It found that, while vaping is not risk free—particularly for people who have never smoked—it poses a small fraction of the health risks of smoking in the short to medium term.

The report reviewed many aspects of vaping, including who is vaping and what products, the effects on health (both absolute and compared with smoking) and public perceptions of harm. The authors examined studies of biomarkers of exposure (measures of potentially harmful substance levels in the body) as well as biomarkers of potential harm (measures of biological changes in the body) due to vaping or smoking.

The strongest evidence came from biomarkers of exposure. An exploration of the available studies found that levels of tobacco specific nitrosamines, volatile organic compounds and other toxicants implicated in the main diseases caused by smoking were found at significantly lower levels in vapers. Among vapers, overall levels of nicotine were lower or similar to smokers.

When comparing biomarkers between people who vape and people who don’t smoke or vape, they were often similar, but in some cases there was higher exposure when vaping. The investigators therefore concluded that whilst less harmful than smoking, vaping is likely to sustain some risks particularly for people who have never smoked.

While the investigators are clear on the benefits of vaping vs smoking, they found that public perceptions are lagging behind. In 2021, only 34 percent of adults who smoked accurately perceived that vaping was less harmful than smoking, while only 11 percent of adult smokers knew that nicotine wasn’t the primary cause of the health risks connected to smoking tobacco.

Vaping has gained popularity among British adults. According to the latest data from the Action on Smoking and Health (ASH) Smokefree GB Adult survey, current vaping prevalence is 8.3 percent in 2022, compared with 7.1 percent in 2021 and 6.3 percent in 2020.

Vaping has also increased among young people. Data from the ASH Smokefree GB Youth survey of 11-to 18-year-olds in England show that current vaping prevalence (including occasional and regular) is 8.6 percent in 2022, compared with 4.0 percent in 2021 and 4.8 percent in 2020. Use of disposable vaping products has increased substantially over the last year. Vaping among young people who have never smoked remains very low at 1.7 percent.

“This important study is the latest in a series which carefully pulls together the science on vaping to help reduce the damage from smoking,” said Jeanelle DeGruchy, deputy chief medical officer for England, in a King’s College press note.

“Vaping is substantially less harmful than smoking so the message is clear, if the choice is between smoking and vaping, choose vaping. If the choice is between vaping and fresh air, choose fresh air.”

October 2, 2022

Transformation Index Finds ‘Differentiated’ THR Progress

The world’s 15 largest tobacco companies have made limited progress since 2020 to reduce the harm of their products, with high-risk combustible products still accounting for around 95 percent of retail sales volume, according to the second edition of the Tobacco Transformation Index, an initiative of the Foundation for a Smoke-Free World.

The Index was created to accelerate the reduction of harm caused by tobacco use by ranking the world’s 15 largest tobacco companies on their relative progress or the lack thereof. The first Index was published in 2020.

Presented during the recent GTNF 2022 conference in Washington DC, The 2022 Index evaluates tobacco companies’ behavior across six categories and 35 underlying indicators that cover measures indicative of harm reduction, from product sales to capital allocation and marketing policies.

Swedish Match ranked first in the 2022 Index, with Philip Morris International, Altria and British American Tobacco in second, third and fourth places, respectively; Djarum of Indonesia ranked last.

The key takeaways from the 2022 Index findings are as follows:

Only Swedish Match sells a greater volume of reduced-risk products (RRPs) than substantially more harmful combustibles, due in most part to the popularity of its snus in Sweden and non-tobacco nicotine pouches in the U.S. A key feature underpinning the Index is its adoption of the Relative Risk Assessment, based on a systematic review of scientific studies of the health risks associated with 15 nicotine products.
Four Index companies directed the majority of capital and R&D investments toward RRPs. In addition, five Index companies, including three state-owned entities, made incremental investments or early indications of movement toward future production of RRPs during the review period.
However, tobacco companies are also failing to invest in harm reduction in low- and middle-income countries, with the vast majority of sales for their RRPs concentrated in markets with the highest disposable income. One obstacle is that several countries ban RRPs.

Transformation of the tobacco industry toward harm reduction remains inconsistent and in its early stages.

David Janazzo, FSFW

“Transformation of the tobacco industry toward harm reduction remains inconsistent and in its early stages,” said David Janazzo, Index program officer and interim co-president, executive vice president of operations and finance, and chief financial officer at the Foundation for a Smoke-Free World, in a statement.

“That said, the 2022 Index demonstrates that differentiation is forming across the largest tobacco companies, related to measures of commitment, performance and transparency. While some companies are making progress, others regressed. On the whole, they are all failing to deliver outcomes toward a world in which combustible, other forms of toxic tobacco, and smoking related death and disease are eliminated, in order to accomplish the Foundation’s mission of ending smoking in a generation.

“Based on the current trajectory of smoking rates, it is estimated that by the end of the current century up to 1 billion people will die of smoking. The majority of those will live in developing countries, which is why transformation of the tobacco industry is both essential and urgent.

“It is my hope that industry leaders will take heed of the findings in the 2022 Index to push forward and intensify efforts to strengthen harm reduction strategies and tactics.”

The 2022 Index is a reminder of how far tobacco companies have to go. The differing and at times hostile regulatory standards around the world have made implementation of harm reduction more challenging, but many opportunities are not yet fully maximized.

Erik Bloomquist, chair of the Index Technical Committee

“Institutional investors such as banks and pension funds are increasingly looking at harm and harm reduction. The Index is an important tool for those investors to constructively engage and encourage change in the market,” said Erik Bloomquist, chair of the Index Technical Committee.

“The 2022 Index is a reminder of how far tobacco companies have to go. The differing and at times hostile regulatory standards around the world have made implementation of harm reduction more challenging, but many opportunities are not yet fully maximized.”

The 2022 Tobacco Transformation Index can be accessed at www.tobaccotransformationindex.org

October 2, 2022

EU Menthol Ban Helped Smokers Quit: Study

The 2020 European ban on menthol cigarettes made it more likely that menthol smokers would quit smoking, according to a new study published in Tobacco Control.

“This Dutch study is our second major national study to provide evidence of the powerful impact of banning menthol cigarettes on quitting, which supports proposed menthol bans in the U.S. and other countries,” said Geoffrey T. Fong, professor of psychology and public health sciences at Waterloo, and the principal investigator of the ITC Project in a statement.

Previous Canadian research also found a positive public health impact of banning menthol cigarettes.

In the most recent study, the research team surveyed a national sample of adult smokers of menthol and non-menthol cigarettes in the Netherlands before and after the EU menthol ban. Of the menthol smokers surveyed before and after the ban, 26.1 percent had quit smoking. This quit rate was higher than the control group of non-menthol smokers, of whom only 14.1 percent had quit.

In fact, the increased quit rate of 12 percent of menthol smokers after the European ban is greater than the increased quit rate of 7.3 percent found in an ITC study of the menthol ban that was in effect across Canada in 2018.

The World Health Organization’s Framework Convention on Tobacco Control calls upon countries to prohibit or restrict menthol and other additives that make smoking easier.

To date, 35 countries have banned menthol cigarettes. On April 28, 2022, the U.S. Food and Drug Administration announced a proposed rule to ban menthol in cigarettes and cigars. An ITC study published that day on the impact of the Canadian ban projected that a ban on menthol cigarettes in the U.S. would lead more than 1.3 million smokers to quit.

The Dutch study also found that one-third of menthol smokers reported continuing to smoke menthol cigarettes even after the ban. The tobacco industry markets a wide range of accessories to enable people to add menthol flavoring to tobacco products themselves.

“These tobacco industry actions undermine the effectiveness of the menthol ban,” said Marc Willemsen, co-author of the Dutch study and professor in tobacco control research at Maastricht University and scientific director of tobacco control at the Trimbos Institute. “By tightening the regulations to include these menthol add-ons, the impact of the menthol ban on quitting could be even greater.”

October 2, 2022