Blog

Elfbar to Rebrand as EB Design

Photo: Olivier Le Moal

Shenzhen Weiboli Technology Co. plans to relaunch its Elfbar e-cigarettes under the name EB Design in the United States after losing a trademark dispute in court, reports 2Firsts.
On Feb. 23, a federal judge ordered Weiboli to stop marketing its Elfbar e-cigarettes in the U.S., finding that VPR Brands, which makes and sells Elf brand vapes, is likely to succeed on its claims that the Elfbar vapes infringe its trademark.
In an interview with 2Firsts, Elfbar’s North American public relations manager said that while Elfbar would launch its new name in March, the brand would retain its original logo. The letters E and B in “EB Design” are believed to represent the initials of Elfbar.
Elfbar’s American PR manager said the company would continue to focus on the United States. The brand’s U.S. suppliers and distributors market are aware of the name change and prepared for it, he noted.

March 1, 2023
A Future Without Plastics

Photo courtesy of Greenbutts

With its new environmentally friendly technology, Greenbutts wants to tackle the challenge of filter litter.

By Stefanie Rossel

Of the more than 5 trillion cigarettes produced globally each year, the majority ends up in the environment after consumption. Cigarette butts are the most littered plastic item on earth as many smokers don’t consider them to be litter. According to the Truth Initiative, butts have consistently made up 30 percent to 40 percent of all items collected in annual international coastal and urban cleanups since the 1980s.
While most of a cigarette’s components quickly disintegrate when smoked or disposed of, the filter will stick around for some time. Around 98 percent of cigarette filters comprise cellulose acetate (CA), a polymer that is slow to degrade in the environment. It can take up to 14 years for a CA filter to degrade, depending on the conditions of the environment where it has been discarded.
Tadas Lisauskas
“Our estimation is that more than 4 trillion plastic butts are littered every year, and marine life researchers warn that there could be more plastic than fish in the ocean by 2050,” says Tadas Lisauskas, founder and CEO of California-based Greenbutts. “Urgent action is needed.”
A material-science and impact-driven business, Greenbutts has made it its mission to eliminate CA cigarette litter. The company was founded in 2010 by Lisauskas and Xavier Van Osten, who were newcomers to the cigarette filter business at that time but were acutely aware of the need for a green alternative to the plastics-containing filters polluting the environment.
They soon learned that creating a viable substitute was a science in itself. In addition to degrading quickly when discarded in the environment, a biodegradable filter or filter substrate must meet many requirements, such as adequate smoke chemistry and acceptable sensory performance. The filter must also be suitable for processing on high-speed filter assembly equipment and cigarette making machinery.
To help tackle these challenges, Greenbutts hired a former executive of specialty filter manufacturer Filtrona as technical advisor and teamed up with experts from the U.K. Nonwovens Innovation and Research Institute to evaluate fibers with sufficient porosity and thickness.
Greenbutts spent almost a decade designing and developing filters that provide comparable taste and filtration properties as current CA filters but will disperse in water within several minutes with agitation and begin to degrade in compost within several days.
After years of R&D and testing with tobacco companies, the company came up with a patented substrate and filters made of all-natural, food-grade fibers, such as abaca fiber, cotton flock and industrial hemp as well as a starch-based binder, which were introduced to the market in the summer of 2019. The product is sold in bulk or as ready-made rods of filters and filter tips. The blend of materials allows for the same filter manufacturing rates as acetate filters, according to Greenbutts.

Greenbutts’ patented substrate and filters are made with all-natural, food-grade fibers.

Better Alternative

Greenbutts is now ready to take its innovation to the next level. In November, the company introduced Greenbossing, a trademarked process developed with Boegli-Gravures. According to the companies, the innovation will revolutionize Greenbutts’ filter rod manufacturing. “We want to offer to the tobacco industry not just an alternative but the state-of-the-art solution,” explains Lisauskas. “We believe we are creating the next generation of biodegradable filters by introducing our patented Greenbossing technology. Boegli and Greenbutts are actively innovating together and leading a sustainability pathway and building the future today. The Greenbossing technology arrives at the perfect time to accelerate the transitioning from cellulose acetate, which is a single-use plastic (SUP), to Greenbutts’ fully biodegradable and water dispersible substrate. The innovation will enhance the existing filtration capabilities and sensorial experience and much more, setting the Greenbutts substrate far ahead of all competitors and establishing a new ‘gold standard’ for cigarette filters.”
CA filters are still considered the gold standard in cigarette filtration. While it is still early days, Lisauskas believes they may very well lose that position to his Greenbossing products. “The initial analytical lab tests have shown promising results, and we will be able to share them in due time,” he says.

Regulatory Pressure

In recent years, awareness of the cigarette litter problem has increased. Several countries are considering legislation to reduce cigarette butt waste. In July 2021, the European Union enacted its Single-Use Plastics Directive (SUPD). While the SUPD does not oblige tobacco manufacturers to use plastics-free cigarette filters, it requires producers to fund consumer awareness campaigns, extended producer responsibility schemes and tobacco filter collection initiatives from December 2023.
Luis Sanchez
“The question is not if the CA plastic filters will be banned; the question is when they will be banned,” says Luis Sanches, chief strategy officer at Greenbutts. “The CA butts are the No. 1 most littered single-used plastic item in the world, and there is no logical reason to stop them from being banned. Many other SUPs have already been banned, such as plastic straws, cutlery, plastic bags, plastic cups. And the banning of the CA plastic filters is simply a matter of time. The tobacco business is aware of this, and there is clear indication that they are fully committed to drive the change. We at Greenbutts believe that through awareness and education, the industry will eventually drive the change, the regulators will enforce the change, consumers will deliver the change. We at Greenbutts are facilitating this change to occur.”
Despite the significant problem of cigarette litter, CA filters continue to dominate the market. Not only because CA has been a tried-and-tested, cost-effective material but also because there were no external incentives, such as stricter regulations, encouraging a rethink. In the U.S., the expensive regulatory approval process for new products actually presented a barrier to more environmentally friendly filters. In the first years since the launch, Greenbutts therefore marketed its product to hemp cigarette manufacturers and the marijuana industry.

With agitation, Greenbutts’ filter will disperse in water within several minutes. In the environment, it will start degrading into compost within several days.

Into the Future

The Greenbossing technology may help Greenbutts overcome the regulatory hurdle. “The FDA authorization is a lengthy and meticulous process,” says Lisauskas. “It requires a lot of data, patience and solid science. We have already started the process with the collaboration of world-class scientists and our legal team to embark on this challenging journey.”
As rules for environmental protection tighten around the world, cigarette filter manufacturers and other industry players have stepped up their efforts to provide alternatives to CA-based filters. Most of these solutions, however, are made from paper, a substrate that presents challenges. For example, paper behaves differently than cellulose acetate so that it requires adjustments in the design of the filter and cigarette, and it often comes with a characteristic taste and smell.
“The sensory performance, I would say, is the most challenging factor to overcome,” says Lisauskas. “The chemically and physically modified filaments of cellulose acetate associated with the plasticizer, triacetin, make the plastic filter a very well-designed filtration tool for several chemical compounds present in tobacco smoke.”
The Greenbutts filter with the Greenbossing technology, by contrast, utilizes natural fibers, specifically selected for their sensorial neutrality, filtration capability and mechanical strength. This combination minimizes natural variability, enables airflow control and reduces paper filters’ cellulosic sensorial notes, according to Lisauskas.
The company has recently experienced a clear and growing interest from EU-based tobacco companies in its product. “We can attest that other organizations, outside the EU, want to take the lead on the sustainability agenda by giving consumers what they are looking for: authentic products, no plastic, no chemicals, no additives, and all-natural alternatives,” says Lisauskas.
Sanches hopes that because of the further benefits delivered by the Greenbossing process, the tobacco industry will adopt Greenbossing eventually as its new standard for both combustible and heated-tobacco products. “And it will open up further opportunities for other combustible products beyond tobacco,” he says.
The company already has some experience with heated products. In August 2021, Greenbutts entered into an agreement with Poda Lifestyle and Wellness, which uses the biodegradable filters in its Beyond Burn Poda Pods.
Greenbutts is currently evaluating heated-tobacco products, Lisauskas relates. “There is nothing that should impede the successful application to this sector,” he says. “The Greenbossing process should deliver the perfect match.”

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.

March 1, 2023
High-Tech Quitting

Photos: Qnovia

Qnovia wants to increase smoking cessation rates with a disruptive inhaler technology.
By Stefanie Rossel
For smokers eager to quit, there’s a plethora of nicotine-replacement therapy (NRT) products on the market. However, whether they come in the form of lozenges, patches, gums, nasal sprays or prescription inhalers, the effectiveness of these cessation aids is disappointingly low. A study conducted by the Swiss Institute of Social and Preventive Medicine in 2006 found that the chance of a smoker quitting cigarettes long-term with the help of NRTs was a mere 7 percent. There’s no sign that this rate has improved in recent years. The poor performance is due in part to the fact that NRTs fail to provide instant relief of the physical sensations that contribute to cravings.
Qnovia, a Richmond, Virginia, USA-based medical technology and pharmaceutical company established in 2018, has set out to address this shortcoming with a new drug delivery technology. The firm has developed RespiRx, a handheld, pocket-size device capable of producing a medically safe aerosol without heat. The device consists of a vibrating mesh nebulizer, which is a combination of a vibrating piezoelectric actuator and a piece of mesh that diffuses a drop of liquid into a fine mist on contact.
Piezoelectric materials can produce electric energy upon application of mechanical stress. A commonly known piezoelectric is quartz. The technology, which usually involves clunky equipment and requires regular cleaning, has been used for many years for applications unrelated to smoking cessation.
Qnovia has made it more user-friendly, according to Qnovia CEO Brian Quigley, who spent 16 years with Altria Group, including seven as president and chief executive of the company’s smokeless and innovative products/vapor businesses.
“Vibrating mesh nebulization is a proven and safe method for delivering inhaled therapies; however, our proprietary device is designed to be orientation-agnostic and requires no cleaning or maintenance,“ he says. “Not only are there proprietary elements to achieve this, but the entire nebulizing engine is also miniaturized and part of the drug product containing carriage that continuously feeds the drug to the mesh, maintaining a controlled flow rate and thereby delivering a precise dose when activated with the user’s breath.”
The device works with a 12-week step-down dosage regimen consistent with other Qnovia NRTs. Every three seconds of inhalation registers as an individual dose, with a running count displayed on a panel of the battery unit. Working with a general practitioner or tobacco treatment specialist, patients are given a tapering dosage schedule according to their own consumption level. The concentration of pharmaceutical-grade nicotine in the cartridges remains constant over the duration of the program, with the device limiting the dispensation of doses in a single day and adjusting the limit per the regimen.
RespiRx has a higher pharmacokinetic curve than existing NRTs but a lower one than combustible cigarettes so that patients require progressively fewer doses as cravings subside. According to Quigley, one of the largest problems with existing buccal and transdermal solutions is that they don’t deliver the nicotine to the bloodstream quickly enough to alleviate withdrawal symptoms.

Vibrating mesh nebulization is a proven and safe method for delivering inhaled therapies; however, our proprietary device is designed to be orientation-agnostic and requires no cleaning or maintenance.

Brian Quigley, CEO, Qnovia

Unique Features
While RespiRx, with its high-tech design and elaborate features, may resemble an electronic cigarette, it is in fact a very different product, according to Quigley. “At its core, our device is a medical technology designed to achieve the FDA’s [U.S. Food and Drug Administration] Center for Drug Evaluation and Research’s [CDER] standards for safety,” he says. “So our device has multiple design features that make it wholly different than an e-cigarette. First, we use no heat to create the aerosol, which ensures there is no risk of exposing the user to thermal byproducts or degradants. Second, our drug product is also designed only using excipients that are safe for inhalation in a drug context, and third, the design of the device is meant to achieve CDER safety standards for airpath and safety, which are not requirements achieved by e-cigarettes.”
RespiRx’s technology also differs from Kind Consumer’s Voke, a breath-activated device that worked like an asthma inhaler. The product was designed to deliver rapid nicotine craving relief without heat, combustion or vapor. It looked like a cigarette, and its consumption ritual mimicked smoking.
The U.K. Medicine and Healthcare products Regulatory Agency granted Voke a medical license in 2015, and Public Health England endorsed the product as a safer alternative to smoking. However, after raising £140 million ($171.42 million) and attracting investments from major companies, including BAT, the venture ended in late 2020.
According to Quigley, Voke delivered the user a cold shot of compressed polybutylene—in essence, a pressurized nicotine liquid, which appears to have impacted the user experience.
By contrast, Qnovia’s device delivers a laminar, nonturbulent aerosol. “Not only does our aerosol appear to look vapor-like, but it’s also designed to be inhaled easily under normal inspiratory conditions, unlike the Voke,” says Quigley.
Quigley is confident that RespiRx won’t suffer the same fate as Voke. “Firstly, the RespiRx’s on-device LCD screen prompts and future mobile app connectivity will play important roles in advancing patient adherence and compliance rates,” he says. “These tech-enabled features simply didn’t exist with Voke’s low-tech, data-absent approach. Secondly, from a broader drug-delivery platform perspective, the RespiRx is actually able to deliver complex, pressure-sensitive molecules like biologics. Voke was tied to one indication area, where the underlying technology for broader API adoption would have been a challenge. The RespiRx, on the other hand, is already engaging in activities to expand Qnovia’s active pharmaceutical ingredient portfolio beyond nicotine.”
According to the company, the RespiRx technology could be used to deliver a variety of drugs for various future indications, including asthma, chronic obstructive pulmonary disease or chronic pain.

Into the Clinical Trial Phase
In the NRT category, RespiRx will compete with FDA-approved nicotine inhalers such as Nicorette, which is available without a prescription. Quigley believes RespiRx will prove to be a more effective solution.
“The Nicorette inhaler delivers large droplets containing nicotine into the patient’s mouth,” he says. “This results in buccal absorption, so it’s not an inhaled delivery mechanism despite its name, which limits the ability of the drug to rapidly and effectively alleviate withdrawal symptoms, where our device delivers an aerosol with particle dynamics that deliver the drug to the lung, which will result in more immediate drug delivery and improved ability to alleviate withdrawals. Also, the inhaler has a very harsh and bitter taste, which limits adoption, whereas our formulation does not have these unpleasant effects.”
Making smoking cessation medication—or novel nicotine-delivery products for that matter—permanently acceptable for smokers continues to be a challenge. Quigley says RespiRx’s formulation has no flavor. Since the product’s target audience is looking to ultimately stop consuming tobacco products altogether, they want an experience that is different from that offered by existing alternatives and one that helps them move away from smoking over the 12-week user regimen.
In October 2022, Qnovia raised $17 million to help RespiRx through the FDA’s Investigational New Drug Application process. “Once we submit our IND, we will execute phase I, II and III studies with FDA guidance; however, the study design, powering and endpoints are all already very clearly defined,” says Quigley.
The company plans to submit its final new drug application to the FDA in 2025. Approval is likely to come faster than for new tobacco products going through the FDA’s premarket tobacco product application process. “At the appropriate time, we expect to also request breakthrough and accelerated review status, which are established programs to facilitate the submission, review and final decisions for drugs,” says Quigley. “Largely, I believe CDER does a very good job hitting its timing performance requirements, and the burden of proof we have to demonstrate is clear and well defined. For all these reasons, I believe we have a significant advantage engaging with CDER despite the cost and time we invest in generating strong data for the agency.”
Instead of marketing RespiRx as an over-the-counter product, Qnovia has chosen to pursue prescription-only status. “We believe that it is important to ensure that this therapy is only used as intended, and we want to be sure to not have abuse liability concerns. Given the design of the pharmacokinetic profile and the delivery of nicotine via inhalation, we strongly believe that a prescription path is important to ensure appropriate use under the care of a physician.”

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.

March 1, 2023
Hong Kong: Record Cigarette Seizures

Photo: Panksvatouny

Hong Kong customs seized 730 million illicit cigarettes in 2022, 76 percent more than in 2021 and the highest annual figure in more than two decades, reports The Standard.
Officers processed 7,148 cases last year, including 3,436 involving cigarette smuggling and 931 involving drug trafficking.
The illicit cigarettes confiscated in 2022 had a market value of HKD2.01 billion ($256.07 million) and a taxable value of around HKD1.4 billion, according to Customs and Excise Commissioner Louise Ho Pui-shan.
Customs officials attributed the spike in illicit cigarettes to the rising tobacco price under inflation.
The increased seizures follow a relaxation of immigration measures in multiple countries after the Covid-19 pandemic, Ho added, noting Customs would recruit 90 inspectors and 170 officers to strengthen the city’s enforcement capability.

March 1, 2023
$Doing the Math$

Doing the Math

Photo: Fran_kie

The numbers presented on illicit trade (and many other topics) should not always be taken at face value.

By George Gay

Shortly before I was asked to write this story on the illegal trade in cigarettes, the U.K.’s prime minister, Rishi Sunak, came up with a plan aimed, I assume, at helping to ameliorate the damage done to the country by his and previous conservative governments since 2010. His idea was that all pupils should be made to study mathematics until the age of 18, an aim that included some obvious pitfalls. For instance, given the plan was put in place, increasing numbers of people would come into contact with imaginary numbers, and even numbers that are difficult to imagine, such as 0.0005, which is about the percentage of the population who voted for Sunak to become prime minister.
Even if, like me, you’re not a mathematician, it’s worth keeping your eye on figures that are presented to you. And in this regard, I was intrigued by a press note announcing the publication of a paper by Researchers at the International Tobacco Control Policy Evaluation Project, the University of Waterloo, Canada, who were said to have “evaluated the impact of federal and provincial menthol cigarette bans in Canada by surveying smokers of menthol and nonmenthol cigarettes before and after Canada’s menthol ban.” The research study was said to have found that “banning menthol cigarettes does not lead more smokers to purchase menthols from illicit sources, contradicting claims made by the tobacco industry that the proposed ban of menthol cigarettes in the U.S. by the Food and Drug Administration will lead to a significant increase in illicit cigarettes.”
However, even a person with a limited understanding of mathematics would have to wonder whether the study’s findings support this statement, even leaving aside the seemingly important issue that Canada isn’t the U.S. It seems to me that it is a bit of a leap to make the above claim when the number of menthol cigarette smokers who took part in the study seems to have been only 138 (the study included, too, 1,098 smokers of nonmenthol cigarettes, who were used, at least in part, as a “control group”).
As I read things,* menthol cigarette smokers were surveyed in 2016, before the nationwide ban** was brought in, and again in 2018, after the ban was introduced. Of the 138 menthol cigarette smokers who were surveyed in 2018, only 36 reported smoking menthol cigarettes after the ban while brand checks indicated that only 17 were actually smoking menthol cigarettes at that time and that the most recent cigarette purchases of only 13 of those 17 had comprised menthol cigarettes. Again, as I read things, only nine of the 17 bought their menthol cigarettes from outlets on First Nations reserves, but, despite these tiny figures, the researchers present their results to the first decimal place and are happy to conclude that “After Canada’s menthol ban, there was no increase in illicit purchasing of menthol or nonmenthol cigarettes from First Nations reserves.”
The press note seems to push that conclusion further. Its heading, “Study refutes industry claims that ban on menthol cigarettes leads to increased use of illegal smokes,” is not confined to First Nations reserves outlets but presumably encompasses the other outlets covered: convenience stores, the internet, supermarkets and bars/pubs.
This is important, I think. You can imagine somebody in the future quoting the report by saying that 51.2 percent of sales of illicit menthol cigarettes in Canada post the menthol cigarette ban were made on First Nation reserves. That sounds impressive, of course, unless you know that the 51.2 percent figure is based on little more than a handful of purchases.

What is the justification for trying to “save” menthol cigarette smokers, but not other smokers, from the consequences of their own actions?

An Alternative Destination

Having said that, my main gripe with the study was that it was superfluous, and yet the authors called in at least two places for further research into this matter. Why is money spent on such studies when the world is in desperate need of funding for basic science?
I was never sold on the idea that a ban on menthol cigarettes would necessarily and greatly increase the sale of illicit products in the place where the ban was imposed. And I certainly wasn’t sold on the idea that you need to carry out studies to get to the bottom of this question, though I understand that they are needed to keep going the huge economic benefits to be enjoyed by the increasingly large, multi-faceted industry dedicated to making the lives of smokers more miserable.
So the following is my contribution—an open-access, no-cost method of getting to the bottom of the menthol cigarette question. Wait until you are alone, sit down in a not-too-comfortable chair, switch off all electronic distractions, refrain from drinking alcohol and allow yourself the luxury of thinking; and, after a time, it will probably become clear that, assuming those selling menthol cigarettes post a ban will set their prices competitively, three major factors will interact to determine the level of sales of illicit menthol cigarettes in the place where such products are banned. Those are: the appeal of the products in the place where the ban is imposed, the efficiency of the authorities charged with preventing the manufacture and distribution of illicit products in that place and the ease with which the borders of the place can be sealed against the products.
It is not difficult to figure out which countries would find it relatively easy to enforce bans on menthol cigarettes successfully and which would find it more challenging. And, as to the appeal of the products, it only needs to be remembered that the prohibition is not on cigarettes but on menthol. Importantly, the prohibition is not on nicotine, the thing that we are told keeps people coming back for cigarettes, but on a flavor that is preferred by a minority of smokers; so, without moving from my chair, I came to the belief that normally law-abiding, former menthol cigarette smokers were more likely to switch to nonmenthol brands than to go looking for illicit menthol cigarettes. And, in one sense, the research backs this up when it reports that of the 36 people who claimed to be smoking menthol cigarettes after the ban, 19 of them were mistaken. Of course, since the advent of the motor car and the tendency to speed has made most adults fairly flexible when it comes to obeying certain laws, and since it is possible that illicit menthol cigarettes might be offered to them in venues where alcoholic drink is being consumed and, therefore, decision-making flawed, a certain level of illegal trade has to be expected.
But the fear of increasing the illegal trade is probably the least of any number of issues that are raised by bans on menthol cigarettes. One ethical consideration concerns discrimination. What is the justification for discriminating against menthol cigarette smokers? Or, looked at another way, what is the justification for discriminating against the smokers of nonmenthol cigarettes? What is the justification for trying to “save” menthol cigarette smokers, but not other smokers, from the consequences of their own actions?

Rising Poverty

But that’s enough from Canada. Let’s alight briefly in France where, in January, there was a report of a raid on an illicit tobacco factory that resulted in the seizure of more than 100 tons of tobacco-related products said to be worth €17 million ($18.7 million).
Sitting in my chair, I wondered what I was supposed to make of this story. I guess it was meant to come across as a success in which the coordinated powers of national and international law and order foiled the activities of criminals. But I couldn’t help thinking that it described a failure since the main aim of law enforcement should be prevention rather than the clumsier activities associated with detection and prosecution. And there was a rather unpleasant aspect to the story, which described how the French police had arrested nine suspects, “most of them Moldovan nationals.” Unsurprisingly but unfortunately, we shall probably never know what brought these people to feel that their best hope was to live and work in a factory far from their home and constantly with the fear of detection.
Could it be that they were financially impoverished? In a report in The Guardian on Jan. 23, wealth correspondent Rupert Neate quoted Nobel Prize-winning economist Joseph Stiglitz as saying that, in the period defined by the Covid pandemic and its aftermath, many people found life very difficult. And he added that, during the same period, it was shocking how many people and rich corporations made off like bandits. Those bandits, of course, will not be brought to justice.
The question arises as to why it is seen as perfectly legitimate to create within the EU a fertile environment for the illegal trade in cigarettes by applying unfair levels of taxes while mandating that licit cigarettes should be as unpleasant as possible and then spend precious resources on hunting down those who try to get around such obstacles. With the advent of next-generation products (NGPs), the time is overdue for new thinking. Reduce taxes on cigarettes, remove the laws that require licit cigarettes to be unappealing, heavily promote alternative, low-risk tobacco and nicotine products, and the laws of competition will dissolve the problem of the illegal trade in cigarettes.
Of course, NGPs are not immune from being traded illegally, and I was intrigued by a recent press note from the U.K.’s Chartered Trading Standards Institute entitled “Illicit vapes top list of high street threats, say Trading Standards experts.” The note made some good points, but I was pulled up short by one comment. “It’s important we support retailers to ensure that products [vapes] are sold responsibly …. If we don’t, there’s a risk that products could be banned or overregulated, leaving smokers without the option of a product that carries a fraction of the risks of smoking and is an extremely effective aid to quitting.”
At this point, I had to retire to my chair. What was this person saying? That he believes the U.K. government is so muddled in its thinking that it might ban vapes, a product that, in his own words, carries “a fraction of the risks of smoking” and comprises “an extremely effective aid to quitting [smoking],” if those products are sold to children? At the same time, he seemed to be implying that the government would not ban combustible cigarettes, the consumption of which is hugely riskier than is the consumption of vapes, and which are also sold to children.
But perhaps he’s right to be concerned. You have to wonder whether the U.K. government isn’t a little hazy on questions of risk. Last year, while he was chancellor, Sunak was forced to pay a fine for breaking Covid-19 lockdown rules. And he started this year by having to pay a fine for traveling in a vehicle while not wearing a seatbelt.

*Not being a mathematician nor a scientist, I had some difficulty following the figures, in no small part because percentages did not correspond with reported sample sizes, possibly because of the tiny sample sizes involved.

**The report and the press note use, sometimes in the same sentence, both the words “ban” and “bans,” the latter to refer sometimes to provincial bans. I have used only “ban,” reflecting the fact that the menthol cigarette ban now applies nationwide, but I should point out that whereas the provinces introduced menthol cigarette bans between 2015 and 2018, the two surveys took place in 2016 and 2018.

George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.

March 1, 2023
Questioning the Numbers

Image: megaflopp | Adobe Stock

Changes in the U.S. Tobacco Tax and Trade Bureau’s reports have made its data less useful.

By Marissa Dean

Each month, the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) publishes excise tax statistical reports for tobacco products. In November 2022, the TTB announced that it would be changing the way in which it releases and reports this data—changes that significantly affect the quality of the data for its previous users.
The reporting changes are attributed to the decrease in market players; the TTB stated that with so few remaining players, the data, as it had been published, made it easy to identify specific companies and their production and sales levels. This made for an unfair market, with some manufacturers privy to information that may affect product pricing and create unfair marketing practices.
While at face value, the changes may not seem relevant, especially to those not adept at interpreting tax data, they are actually quite substantial. The TTB’s changes have led to shifts in the categories listed (categories now consist of cigarettes and a smaller number of other tobacco products) and the aggregation of tax-exempt data from all product categories; additionally, some months are missing data points. Tobacco products that are greatly affected include large cigars, little cigars, chewing tobacco, pipe tobacco and roll-your-own tobacco. As vapor products are not subject to a federal excise tax, the TTB does not, and did not previously, release any data regarding electronic cigarettes, e-liquid or other novel tobacco products.
The trade association TMA uses the TTB’s tobacco tax data to create reports dissecting the information to discuss the U.S. tobacco product markets and trends. With the TTB’s changes, this information is now less useful than before. Overall, cigarette data hasn’t changed significantly outside of the lack of specific tax-exempt information; however, the other tobacco products are lacking much information that was previously available, making it impossible to get a complete picture of the market.
When the TTB implemented its changes, it implemented them retroactively, meaning all of its previous excise tax statistical reports were removed from its website. The TTB also does not plan on notating which figures have been changed in revised reports to accommodate the new aggregation system, according to a source familiar with the matter.
This poses a problem for TTB data users. Now, there are likely to be more discrepancies in data because one source may be using the “new” data while another may be using the previously published data. There are likely to be more gaps in information as well because many categories are missing information due to the aggregation—data comparisons are more difficult to obtain if missing data points become more common. Sources are less likely to be able to effectively discuss market outlooks and comparisons as well due to the gaps in data and the fact that categories have been combined. At best, they would be estimations and educated guesses based on historical data and trends.
The aggregated information now provided by the TTB is useful in small part to give a snapshot of the market, but with gaps in data and large category aggregation, there is no way to dissect the market and understand possible trends in any comprehensive manner. Unless more players enter the game, it is unlikely that the TTB will revert to the way in which it originally reported the statistical data, creating a roadblock for those trying to discern potential market changes.

Marissa Dean joined Tobacco Reporter in the summer of 2018 as a copy editor. Since that time, she has taken on additional responsibilities, including feature writing. Her skills span the publishing industry from layout and design to copy editing to content creation.

March 1, 2023
Where’s the Parade?

Photo: TRITOOTH

Record-low youth smoking rates get no respect.

By Cheryl K. Olson

Back in 2009, when planning its 10-year public health objectives, the U.S. Department of Health and Human Services (DHHS) set an ambitious goal for reducing youth smoking. At the time, said government data, one in five teens (19.5 percent) had lit up in the past month. The Healthy People 2020 target was 16 percent.
These targets aren’t meant to be slam-dunks. In 2020, a third of the 985 trackable Healthy People objectives were met; the rest improved some, stayed the same or got worse. So what happened with high school smoking?
It plummeted. After passing the goal in 2013 (15.7 percent), teen cigarette use kept on falling. At the ten-year mark, in 2019, it hit 6 percent.
The Healthy People 2030 youth smoking target is 3.4 percent. The newest national figures suggest we’ve already left that number in the dust. The 2022 National Youth Tobacco Survey (NYTS) pegged high school cigarette use at an astonishingly low 2.0 percent. That’s even just a puff in the past 30 days, not daily use.
Dave Dobbins
“We’re crushing it, right? It’s great news,” says Dave Dobbins, former chief operating officer at the Truth Initiative who is now a consultant for Altria. “For many years, I never thought we’d get youth smoking under 5 percent; I thought the job would be done around seven or eight. And we’re beating the heck out of that.”
Did I miss the champagne cork-pop celebration? Why aren’t we talking about this?
There’s a clue in the title of this 2016 DHHS press release: “Cigarette smoking among U.S. high school students at an all-time low, but e-cigarette use a concern.”
In the 2022 NYTS, past-month e-cigarette use was 14.1 percent. The answer may be that we’d have to give e-cigarettes some credit for choking off youth smoking. And we have decidedly mixed feelings about that.

In the Rearview Mirror

The article in the New York Times Magazine was provocatively titled “If It’s Good for Philip Morris, Can It Also Be Good for Public Health?” It included an interview with Matthew L. Myers, president of the Campaign for Tobacco-Free Kids.
“The challenge to me is not to eliminate smoking but the death and disease from smoking,” Myers said in 2006. “That should be the end goal. If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee! I have to believe that if the marketplace incentives were such that over time someone could devise a product that would give the same satisfaction as tobacco but didn’t kill them, people would flock to it.”
In that first decade of our century, the future of youth smoking looked gloomy. This 2010 DHHS press release title summed up the mood: “Little Progress Being Made in Reducing Smoking Among High School Students.” It noted that cigarettes’ rate of decline had slowed.
Kathleen Sebelius, then secretary of health and human services, wrote an introduction to the 2012 Surgeon General’s report Preventing Tobacco Use Among Youth and Young Adults. “Despite the well-known health risks, youth and adult smoking rates that had been dropping for many years have stalled,” she stated.
Michael Pesko
The surprise decline in teen smoking that followed isn’t fully explained by tobacco control policies or changing demographics, experts say. Michael Pesko, an associate professor of economics at Georgia State University, has published over 20 papers on e-cigarette policies and their effects.
“Something unexpected clearly happened between 2012 through 2019 that caused this exceeding of the smoking reduction goal by 400 percent,” he says.
“Tobacco 21 happened, and research suggests this had an impact in the later part of the decade. But the other big thing that happened was wider availability of e-cigarettes.”

The Pivot to E-Cigarettes

Rather than celebrating minuscule smoking rates, anti-tobacco organizations pivoted to e-cigarettes and nicotine addiction. Consider a recent Campaign for Tobacco-Free Kids press release on the 2022 Monitoring the Future survey findings. In his statement, Myers relegated smoking’s decline—“a remarkable public health success story that will save lives for generations to come”—to the third paragraph. He led with youth e-cigarette use and a call for the Food and Drug Administration to eliminate “the flavored products driving this youth addiction crisis.”
The Healthy People website today describes tobacco use in teens as “getting worse.” Reducing past-month tobacco use is a 2030 target. The new focus is on “cigarettes, e-cigarettes, cigars, smokeless tobacco, hookah, pipe tobacco and/or bidis.”
“I understand the reasoning of people who are skeptical of reduced-risk products,” says Dobbins. “There’s a fear that people who otherwise would not have used nicotine will use them and then be more likely to transition to cigarettes if they continue to exist in the market.”
“However, this has yet to be reflected in population data,” he continues. “Instead, the data suggest a transition to less harmful products. I think we have done a better job at educating people of all ages about the dangers of smoking than I gave credit.”

Is Vaping Displacing Smoking?

Pesko and colleagues have been analyzing the natural experiments created by variations in state policies regarding sales of e-cigarettes. He points out the remarkable consistency across a large body of research, none of it industry funded. In short, when governments regulate e-cigarettes—including taxes, minimum legal sales ages and advertising restrictions—it reduces e-cigarette sales to and use by both youth and adults.
“And it also increases combustible cigarette use, again across all populations,” Pesko says.
“The laws operate as intended in terms of reducing e-cigarette use but with the large unintended effect of increasing combustible use.”
Vaping appears to be displacing smoking. Set aside the moral panic over vaping and legitimate fears of this new unknown; what’s left looks like a public health success story.
“That’s what I believe is happening: a remarkable public health achievement,” says Pesko. He applauds advocates for passing Tobacco 21 but says nicotine companies also deserve credit. “Sometimes there is overlap between profit incentive and public health. The adoption of e-cigarettes may have been one of those things.”

Nicotine Gut Check

How should we feel about nicotine once it’s separated from combustible cigarettes? If, as Myers speculated about in 2006, we have appealing but addictive products with health risks similar to coffee … is that OK? This is a massive cultural adjustment that may take years to process.
Social scientists Kirsten Bell and Helen Keane described our confused emotions in an article critiquing the gateway theory. “The nicotine in NRT [nicotine-replacement therapy] products is ‘good’ because it weans smokers off the ‘bad’ nicotine in cigarettes and ideally nicotine itself,” they wrote. “The nicotine in e-cigarettes is ‘bad’ because it facilitates addiction to nicotine, which, in turn, drives the user to seek it in ‘harder’ or more dangerous forms.”
“My belief is that there will be an ongoing persistent demand for nicotine,” says Dobbins. “And if I’m right, it’s important that that demand be met with products that don’t subject the user to disease and death.”
Another new objective for Healthy People 2030 is “Eliminate cigarette smoking initiation in adolescents and youth adults.” In 2018, four percent of youth aged 12 to 25 first picked up a cigarette. The 2030 target: zero percent. Does this trajectory suggest that zero youth use of nicotine should be the next goal?
Pesko is not a fan of that approach. He uses the analogy of the Environmental Protection Agency’s regulation of water. They generally don’t use a zero standard for even nasty things like lead.
“It’s so expensive to go from that trace level to zero, and the benefit is so small,” he notes. “It’s a reasonable goal to try to get use very low and with as safe a nicotine product as possible. But to go to zero nicotine use by kids, I can’t imagine the types of aggressive regulation and extra policing we’d need to do that. And even then, we wouldn’t achieve the goal, as we’ve seen with the war on drugs.”

More Productive Policies

Given limited resources, where might policymakers and regulators most productively put their attention to reduce tobacco product risks to youth?
First, if we accept that the demand for nicotine exists, steer it toward reduced harm. “In terms of policy, having lower regulation of e-cigarettes than cigarettes makes a lot of sense,” says Pesko. “We want to incentivize people to use safer products. We should be taxing proportional to risk.”
He would also like to see lower regulatory hurdles for products like e-cigarettes and nicotine pouches and incorporation of studies like his into appropriate for the protection of public health calculations: “Natural experiments are a strong, consistent body of evidence that could be used to approve more PMTA [premarket tobacco product application] applications. I’d like the FDA to use this body of work more.”
Another suggestion is to turn up the heat on those nicotine companies known to sell to youth. Journalists have reported on the FDA failing to police vape products with candy flavors and toy-like packaging. Reynolds American even submitted a citizen petition a to the FDA requesting ramped-up enforcement of disposable e-cigarettes like Puff Bar and Elf Bar.
Dobbins understands the discomfort of many anti-tobacco advocates with this evolution in thinking.
“The reduced-harm products option allows companies that make money off selling cigarettes to continue doing business, albeit with much less harmful products,” he says. “But I think the most likely alternative of restrictive policies will be a move to a gray market that won’t be accountable to regulatory systems or the law, the way large companies must operate in the present.”
Recalling industry chiefs’ past staunch denials of tobacco harms, Dobbins adds, “We must acknowledge that we are nearly 30 years from 1994.”

Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.

March 1, 2023
Altria in Talks to Buy Njoy

Image: Tobacco Reporter archive

Altria Group is in advanced talks to buy e-cigarette startup Njoy Holdings for at least $2.75 billion, the Wall Street Journal reported, citing people familiar with the matter, according to Reuters.
The Njoy deal could be announced as soon as this week, though the talks could still fall through, according to the report.
The proposed deal includes an additional $500 million earnout if regulatory milestones are met.
The potential deal follows Altria’s decision last year to be released from its noncompete deal with Juul Labs almost four years after buying a 35 percent stake in the company. Altria was planning to divest its stake in Juul. As of Dec. 31, Altria valued the stake at $250 million.
It was reported in July that Njoy had hired bankers for a possible sale of the company. The privately held firm is likely to be valued at up to $5 billion.
Njoy has a roughly 2 percent of the U.S. vape market by volume, according to Jefferies, Juul, by contrast, accounts for around a quarter of American vapor product sales.
Unlike Juul, however, Njoy is one of the few vape brands that have permission from the U.S. Food and Drug Administration to continue to sell its products. Juul is waiting to hear whether the FDA will allow its e-cigarettes to remain on the market.
In June 2022, the agency ordered Juul to remove its products from the market after finding that premarket tobacco product application failed to prove they would “appropriate for the protection of public health.
The FDA agreed to take another look at Juul’s application after the company appealed the marketing denial order in court. The company can continue selling its products at least until the agency makes a final decision.
Altria is keen to supplement its income from combustible products with earnings from smoking alternatives, such as e-cigarettes.
Its cigarette sales volumes fell 9.5 percent last year as high gasoline prices and general inflation pinched smokers’ disposable income.

February 28, 2023
Top Court Declines to Hear Flavor Ban Appeal

Image: Tobacco Reporter archive

The U.S. Supreme Court on Feb. 27 declined to hear an appeal by three Reynolds American Inc. subsidiaries seeking to overturn the county of Los Angeles ban on flavored tobacco products, reports Law360.
R.J. Reynolds Vapor Co., American Snuff Co. and Santa Fe Natural Tobacco Co. had petitioned the high court in October to take another look at the case after the full 9th Circuit upheld a lower court’s dismissal of the suit.
The RAI companies said the 9th Circuit had twice before erred in allowing sales bans at the state and local level that were preempted by federal law.
While the federal Tobacco Control Act grants state and local municipalities broad authority to regulate the sale of tobacco products, it does not allow them to completely prohibit the sale of those products for failing to meet state or local tobacco product standards, the companies argued.
In dismissing their initial suit, District Judge Dale S. Fischer in 2021 found that the ban doesn’t regulate tobacco product standards. The judge said the ordinance is protected by the federal law’s preservation clause, which allows states and localities to prohibit the sale of tobacco products even if those bans are stricter than federal law.
The companies appealed, calling the ban unconstitutional and saying state and local governments can’t bar the sale of tobacco products because they disagree with federal tobacco standards.
L.A. County countered that the ban doesn’t pose an obstacle to federal policy since the FDA announced it intends to ban menthol cigarettes and all flavored cigars.

February 28, 2023
Youth Protection Guidelines Updated

The U.K. Vaping Industry Association has updated its guide to retailers on preventing underage sales.
UKVIA Director General John Dunne said tackling the sale of vaping products to minors was “one of the most fundamental challenges facing the industry.”
The UKVIA is making its “Preventing Underage Sales Guide” freely available via its website.
The 20-page guide has been developed in partnership with the association’s Primary Authority Partners, Buckinghamshire and Surrey and Trading Standards.
Dunne said: “The entire UKVIA membership is united behind the message that we must do all in our power to stop underage sales.
“This is one battle that we simply have to win, but we need the support of government, regulators and enforcement authorities in order to do so.
“Our underage sales guide will give retailers all the information they need so that they don’t inadvertently sell to someone under 18.
“Policymakers, politicians and consumers must have confidence that the vaping industry is a responsible sector, and this will be undermined if businesses do not implement and uphold robust age verification processes.
“The guide gives clear advice on how to implement a ‘Challenge 25’ policy and why it is important that anyone who appears to be younger than 25 should be asked to provide ID.”

February 28, 2023