Tobacco control activists have expressed concern about the number of young people smoking e-cigarettes in Thailand, reports The Bangkok Post. While e-cigarettes are illegal in Thailand, they remain readily available across the country.
According to a health survey conducted in 2019 and 2020, 5.3 percent of Thais aged 10 to 19 years have tried vaping and 2.9 percent do so regularly. Around 30 percent of people in this age bracket who smoke e-cigarettes are women, the study showed.
Patcharapan Prajuablap, secretary-general of the Thailand Youth Institute, attributed the popularity of vaping in part to the fact that it is considered safer and more trendy than smoking cigarettes, especially among high school students.
Over the past year, Thai lawmakers have mulled legalizing e-cigarettes to offer smokers a less harmful method of nicotine consumption and to tap a new source of tax revenue.
Alarmed by the underage vaping numbers, Roengrudee Patanavanich, a lecturer at the Faculty of Medicine at Ramathibodi Hospital, urged the government to keep e-cigarettes illegal.
The vaping industry is born of innovation. During GTNF 2022, held in Washington, D.C., Sept. 27–29, nicotine industry stakeholders brought to the forefront the challenges that the electronic nicotine-delivery system (ENDS) market is facing. Many said lives are being lost and the vaping industry is being crippled by regulations that many industry stakeholders say are designed to keep smokers hooked on combustible cigarettes. A well-respected nicotine industry conference, GTNF 2022 highlighted the need to allow nicotine consumers access to less risky delivery systems.
The GTNF is held each year in varying cities around the globe. It consists of representatives and stakeholders in the global nicotine industry. It offers insight to its attendees through expert panels and keynote speakers that provide diverse viewpoints on a variety of aspects concerning the worldwide nicotine industry. The GTNF is also the parent organization for Vapor Voice and its sister publication, Tobacco Reporter.
This year, seminar speakers nearly 300 in-person attendees and 500 online registrants that access to products is being denied mainly by regulations, especially by the U.S. Food and Drug Administration and its Center for Tobacco Products, which is charged with regulating all nonmedical nicotine and tobacco products, including ENDS in that country. In this special section dedicated to GTNF 2022, Vapor Voice shares some of the sessions that helped paint a precise picture of what’s wrong and what could be done to possibly help dispel the current cloud of misinformation that surrounds ENDS products and help adult smokers gain better access to less harmful ways to consume nicotine.
The ENDS industry also won several awards at the GTNF, which hosts the nicotine industry’s Golden Leaf Awards. FEELM, the flagship atomization technology platform belonging to Smoore, the world’s largest vape manufacturer, won “Most Promising Innovation” for its FEELM Max device, and ALD won the “Reducing Environmental Impact Innovation” award for its innovative biodegradable technology design and cutting-edge product concept. Additionally, Innokin won “Best Innovation Breakthrough” for its joint venture with Aquios Labs to develop water-based vaping technology.
Forgotten Smokers
Most smokers belong to vulnerable groups, suffering from issues such as mental illness or unemployment.
By VV staff
Rather than being “forgotten,” as the session’s title suggested, people who smoke are an unexplored, stigmatized and often misunderstood species, according to the participants in a GTNF discussion about consumers. While consumer centricity has become a buzzword in the reduced-risk product industry, companies still have a lot to learn about their target group.
Altria, whose vision is to responsibly lead the transition to a smoke-free future, examined the plight of consumers on their journey to less hazardous products. “We had done a comprehensive research program about the interest in vape products, but what was really missing was to bring the voice of the consumer directly to the organization,” said Brent Taylor, managing director of consumer and marketplace insights at Altria.
Last year, the company initiated “Project 21,” a study of 21 consumers of combustible tobacco who were interested in switching to less harmful nicotine products (see “Listening to Nicotine Users,” Tobacco Reporter, September 2022). Over 21 days, Altria’s researchers catalogued the study participants’ behavior via videos and weekly surveys. The participants were asked to “do their best” but didn’t get any guidance, as Altria wanted to learn how they tackled the challenge on their own. Their progress was checked after three weeks, three months and six months.
After six months, 15 participants were still smoke-free. The people who were most successful were those who really wanted to switch and held themselves accountable. The project also showed that many factors unrelated to the product category, such as a bad day at work, impacted the success of participants in transitioning. Each of the journeys was unique and entailed its own set of complications. For all participants, it was a highly emotional experience, according to Altria.
Kim “Skip” Murray, a person who vapes and a tobacco harm reduction (THR) advocate who until last year ran a vape shop in Minnesota, related experiences from her customers that illustrate how external factors, such as misinformation and economic strain, can impact attempts at switching. One of her customers, a Vietnam veteran with chronic obstructive pulmonary disease, returned to smoking for some months after press reports and health authorities mistakenly attributed the e-cigarette or vaping product use-associated lung injury (EVALI) outbreak to nicotine vapes.
Some clients reverted to more harmful but less expensive cigarettes when their budgets were tight. Discouragingly, the Food and Drug Administration’s marketing denial orders forced products off the market that had helped Murray’s customers quit cigarettes while leaving combustible products widely available. Murray said she was unable to dispel the myths about EVALI and many of the other false narratives about vaping. The number of people who came into her shop wanting to quit dropped substantially, eventually forcing her out of business.
Alex Clark, CEO of the Consumer Advocacy for Smoke-free Alternatives Association, stressed the importance of language in the smoking and health debate. “Smoker,” he said, has become a pejorative term. “We’re now focusing on people who have a history of being underprivileged, undeserved and oppressed—people who we don’t see in offices or at conferences; people who have been pushed to the margin of society.” Having smoked heavily in his youth, Clark recalled being told that his habit was a character flaw. The stigma of having no control over his decisions and essentially being a drug addict, Clark said, stuck with him even after he had switched to vaping.
Most of the 30 million Americans who smoke today belong to vulnerable groups, suffering, for instance, from mental illness or unemployment, according to health behavior consultant Cheryl K. Olson. Among people in custody, the percentage of people who smoke is four times higher across the world. Together with other researchers, Olson explored the potential of vape products for use in a prison environment and found that the acceptance was 95 percent. “For vulnerable groups, harm reduction is a realistic goal if nicotine abstinence is not,” she said. “Our findings about these groups have the potential to rebalance the conversation about appropriateness for the protection of public health.”
Will Godfrey, editor-in-chief of Filter and executive director of the Influence Foundation, bemoaned the lack of synergy between harm reduction for illegal drugs and harm reduction for tobacco.
Many illegal drug users smoke, and it would make sense to apply harm reduction strategies to both habits. In reality, those running drug-related programs are often unwilling to apply harm reduction to tobacco use. Bizarrely, some needle exchange programs for intravenous drug users are accompanied by anti-vaping policies, noted Godfrey.
He blamed the “deep suspicion” of the nicotine industry within the left-wing harm reduction movement as well as the growing influence of Bloomberg Philanthropies, a big funder of anti-smoking programs that is notoriously hostile to vapor products.
Godfrey urged the administrators of drug harm reduction programs to extend the harm reduction principle to smoking. “It is vital that THR, including the industry, builds momentum in this direction,” he said. “The hostility to the industry won’t go away but is surmountable, as the role of pharma in drug harm reduction has shown.”
Reservations Required
Brian King
The FDA’s CTP Director King says the Reagan-Udall review of the agency will be complete by mid-December.
By VV staff
There are plenty of reservations about the way in which the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has handled its responsibilities. During a brief speech at the GTNF 2022, the new director of the CTP, Brian King, did little to quell those concerns. He did, however, acknowledge the continuum of risk. “We do have certain products that are lower risk than combustible cigarettes, and that’s an important component of the dialogue,” said King.
King told attendees that there is an opportunity for the CTP to assess the risk of youth vaping initiation and counterbalance that with the opportunity for adults who use e-cigarettes to quit combustible cigarettes.
“I think that [the] public health standard is pretty critical to the work we do, and it’s definitely a guiding light in terms of my determinations and decision-making,” he said. “Ultimately, it comes down to the science … it’s very critical, to me, to ensure that we use that as our guiding light. And of course, the onus is on the applicants to ensure that they are providing the most robust signs possible to inform decision-making.”
The FDA has long been criticized for its handling of the premarket tobacco product application (PMTA) process and is currently defending multiple lawsuits from vapor companies challenging its marketing denial orders (MDOs), including two from Juul Labs, which recently filed a lawsuit over the regulatory agency’s refusal to disclose documents supporting its MDO.
Juul claims the agency overlooked more than 6,000 pages of the data it submitted on the aerosols that users inhale, according to Joe Murillo, chief regulatory officer at Juul Labs, who also spoke at the conference (see “A Question of Integrity,” page ??).
King said that a sizeable portion of youth are still vaping flavored and disposable products. However, he also said that the potential benefits for adult smokers are “mutually exclusive” from youth uptake concerns. “I don’t think that they necessarily have to be separate; they can certainly be explored concurrently,” he said. “But again, we need to ensure that we’re considering the science from both ends when making our decisions.”
King said the agency is “continuing to make progress” on the estimated 1 million PMTAs for nontobacco nicotine products as well. He said over 90 percent of the applications have been completed. “We have 350 acceptances so far, and there’s about 800,000 that have received an RTA [a ‘refuse-to-accept’ letter], and I’m hopeful that within the next few weeks we should be able to get through all 100 percent of those 1 million.”
Being accepted for review is only the first step in the PMTA process. There are six stages, or rounds, to the PMTA process. After acceptance is filing, then a substantive review before an action is taken. King called the first step an important one. “[It’s] an important step, and I’m committed to ensuring that we keep things moving as expeditiously as possible,” King said.
King recently told the AP that he believes “there’s a lot of really important science and innovations” that have occurred in the vaping industry in recent years, adding that the most notable is nicotine salts in e-liquids. “We know that when you smoke a tobacco product, it’s a very efficient way to deliver nicotine across the blood-brain barrier. So it’s been very difficult to rival that efficiency in another product,” said King in the interview. “But in the case of nicotine salts, you have the potential to more efficiently deliver nicotine, which could hold some public health promise in terms of giving smokers enough nicotine that they would transition [off cigarettes] completely.”
King also discussed the FDA’s ability to force companies to comply with its MDOs. So far, very few companies that have been told to remove their products from the market have complied. King said the agency has multiple enforcement options to bring both manufacturers and retailers to heel.
“We have several tools available to us, including advisory actions,” he said. “We also have regulatory enforcement actions, including voluntary recalls as well as various other requested recalls. We can also take administrative action, civil money penalties (in terms of manufacturers, that penalty cannot exceed $15,000 for any single violation or $1 million for any number of violations related to a single action),” explained King. “When it comes to judicial action, we can do seizure, injunction and also criminal prosecution. I will say that when it comes to enforcement and compliance, nothing is off the table.”
King also updated attendees on the FDA’s external review of the CTP’s procedures, which is being conducted by the Reagan-Udall Foundation. Lauren Silvis, a former FDA chief of staff, was named as chair of the panel that has been asked to “evaluate regulatory processes and agency operations related to tobacco to help the center address new challenges as it works to reduce death and disease from tobacco and achieve its public health mission.”
“Within only a few weeks of assuming this role, we were told that there would be an external evaluation,” said King. “I actually wholly welcome it. I think it’s a good opportunity, particularly with new leadership, to identify areas where we’re doing things very well but also identify areas where we can enhance our efficiency and effectiveness. I have had meetings with [Silvis] and her team, and I’m confident that we’re going to get very useful information.
“It’s an ambitious timeline, 60 business days, so it’s going to work out to about 90 days total. It should finish probably by the end of the year, mid-December, and I’m looking forward to the opportunity to hear the recommendations. And I do have a very open mind on this. I’m always for improvement.”
King expects there will also be opportunities for external engagement, including listening sessions. He could not provide specifics during the speech but said he welcomes feedback from others in terms of informing the CTP’s processes.
“It’s not a one-size-fits-all, but I do think that we have some great opportunities here,” he said. “I’m fully committed to listening to the evaluator’s input and ensuring that we use it in a very useful way … then we’ll take it from there … I’m sure many of you have heard publicly, my calendar is rapidly filling up, and we are meeting with many—I know I’ve met with several of you in the room already, and I value those opportunities to meet with folks from across the spectrum, whether it be industry or public health … to hear people’s insights, what your priorities are.
“And those have been very productive and helpful to me. I do listen. I think it’s a very useful opportunity to me in terms of hearing specifically what the recommendations are from industry and what are areas where you feel it would be useful for FDA to engage in to make your life easier in terms of submissions and applications and [what] processes are overly complicated and could be improved,” said King. “I’m fully committed to ensuring that happens.”
A Question of Integrity
Joe Murillo
Juul Labs accuses the FDA of submitting to political pressure when the agency issued Juul an MDO.
By VV staff
Joe Murillo is right. It is hard to believe that the U.S. Food and Drug Administration reviewed Juul’s premarket tobacco product application (PMTA) thoroughly. Murillo, chief regulatory officer for Juul Labs, told attendees of the GTNF 2022 that the regulatory agency wrongly issued Juul a marketing denial order (MDO). That order was later stayed by both a court and the FDA itself.
The FDA says it follows the science; Murillo counters that the entire process is “substantively and procedurally flawed,” adding that the MDO was not based on a fair and complete review of the science in Juul’s PMTAs.
“Our PMTAs included over 125,000 pages of data. They included information and analyses from over 110 scientific studies, and these studies cut across nonclinical, clinical and behavioral research programs,” he said. “We assessed our products relative to combustible cigarettes … and relative to other marketed [electronic nicotine-delivery system] ENDS products. It seems as though, among other things, FDA overlooked at least 6,000 pages of these data.”
Murillo said that the FDA prides itself on having the “highest scientific integrity and public health focus, shielded from political interference.” That statement mirrored what was said by the director of the FDA’s Center for Tobacco Products, Brian King, who spoke at the same conference. “Ultimately, it comes down to the science … it’s very critical, to me, to ensure that we use that as our guiding light,” King said (see “Reservations Required,” page ?).
Despite that stated commitment, the PMTA review process appears to be susceptible to politics, according to Murillo. He noted that the FDA has been under immense pressure to deny Juul Labs’ applications and remove Juul products from the U.S. market. “This political pressure cannot continue,” said Murillo. “FDA cannot allow the hostile conversations around tobacco harm reduction to seep into what should be a science and evidence-based process. The very integrity of the FDA’s review process is now called into question. The FDA must guard against politics and improper attempts to influence their scientific decision-making. We need to find common ground, turn down the temperature of the rhetoric and put people who smoke [combustible cigarettes] at the center.”
Juul Labs is now in a fight for its future. After the e-cigarette maker appealed the MDO in court, the FDA on July 5 stayed its own order. The agency announced that it would review its decision after determining that “There are scientific issues unique to this application that warrant additional review.” Alongside the agency’s internal review, Juul Labs also submitted its own administrative appeal with the FDA.
“In this appeal, we demonstrate how the agency’s denial of our applications was substantively and procedurally flawed,” said Murillo. “We requested, among other relief, that FDA rescind its denial and put our applications back into substantive review. Throughout this process, Juul products will remain on the market, and we are confident we can address any further questions the agency may have. So, we will continue to fight for the millions of adults who use our products. They deserve a complete review of the science and evidence we presented as required by law and without political interference.”
Murillo said that while underage use is a concern, last year’s National Youth Tobacco Survey (NYTS) showed a significant decline in underage use compared with just two years ago, and youth use of cigarettes continues to decline to historic lows. Murillo said the decline in underage years can be attributed to many factors, including raising the minimum purchasing age to 21 and measures to further restrict access and limit appeal.
“But not all trends related to underage use are positive. Many of us are worried about the rise of disposable flavored products among youth,” he said. “In the United States, fly-by-night companies have flooded the market with illegally marketed products. These products flout laws and regulations and present a public health danger.”
According to Murillo, regulators must improve and prioritize enforcement. “True Age, NACS and other stakeholders are firmly committed to reducing and preventing underage access to tobacco products at retail,” he said. “Scientists and public policy experts have put forward thoughtful solutions to preserve the harm reduction opportunity for adults while also protecting youth.”
Meanwhile, regulatory uncertainty has created immense barriers to innovation in reduced-risk products. This uncertainty diminishes confidence in the products themselves and the category, according to Murillo, who said that uncertainty “has a chilling effect” on investment and further innovation.
“To be crystal clear, this uncertainty only prolongs cigarette use,” he said. “Despite challenges for alternatives like ours, with the PMTA process, new combustible cigarettes continue to receive authorization via substantial equivalents and even PMTA and MRTPA [modified-risk tobacco product application] pathways; 13 years after the passage of the Tobacco Control Act, cigarettes remain far and away the most used tobacco product in the United States, making up over 75 percent of the market.
“Less than 3 percent of the total tracked ENDS market is authorized under FDA’s PMTA process … the rest of the market, the vast majority of ENDS products fall into one of three precarious buckets,” explains Murillo. “One, those being sold illegally. This includes companies that have not even submitted to the PMTAs. Two, those awaiting a marketing decision from FDA after years of review; or three, those stuck in a highly opaque administrative process—one that’s subject to a shifting requirement and unpredictable timelines.”
Innovative products that are specifically designed to advance public health have a steep road ahead in the U.S. Murillo said this is alarming. While the technology is available to accelerate the displacement of combustible cigarettes, a slow and uncertain path to the market is a significant obstacle.
“The data suggests that ENDS sales are displacing cigarette sales. So, we can see an emerging path to end the combustible cigarette once and for all. Unfortunately, that path remains blocked by a political and regulatory environment that inhibits meaningful progress … I think most of us in this room appreciate that combustible cigarettes will one day be obsolete,” he said. “Undoubtedly, that is our company’s goal. It’s not a question of whether, but of when … As an industry, we can accelerate this public health goal through product innovation and evidence-based policy development. But the viability of the marketplace is at stake, especially for those companies that don’t sell cigarettes.”
Murillo said an example of innovation in a market that is more accepting of ENDS products as a tool toward harm reduction can be found in the U.K., where Juul Labs launched its Juul 2 product last year. The platform includes cutting-edge technology designed to deliver a more consistent vapor experience with improved nicotine delivery. Its temperature control minimizes the production of toxicants, and the platform can help address underage use through its pod technology.
“We’ve also developed a mobile app that can be used for age verification and locking the device when it’s out of the range of a user’s phone,” said Murillo. “The app has other features that enhance the experience for users as they switch away from cigarettes. We’re confident that Juul 2 delivers a better experience for adult smokers than products currently available, which should result in increased switching from combustible cigarettes.”
In the end, Murillo said he is disappointed with where the ENDS industry is currently, but he has a genuine belief that there is an endgame for combustible tobacco. “Society cannot allow the death and disease associated with smoking to be a part of the incremental progress we’ve made,” he said. “Absent a renewed and fundamental commitment to the very concept of harm reduction, we will lose this opportunity.”
Perceptions of Nicotine
Because of its association with combustible cigarettes as a delivery device, nicotine is surrounded by misconceptions.
By VV staff
Participants in “The Perceptions of Nicotine” panel during the GTNF 2022, began the conversation by drawing comparisons to similar consumer products, most notably caffeine. Nicotine is found in tobacco leaves, but it’s also found, at lower levels, in plants, such as tomatoes, potatoes, eggplants and sweet peppers. However, by far its predominant source is in tobacco leaves.
Caffeine can also be found in multiple food sources, including coffee beans, tea, cocoa beans, Kola nuts and guarana berries. The amount of caffeine in guarana berry seeds is about the same as the amount of nicotine in tobacco leaves, up to about 4 percent, according to a panelist. Unlike caffeine, however, nicotine is tied to tobacco. Nicotine is a public pariah while caffeine is socially acceptable. The panelist agreed that this is due to the differences in how the public has been educated on these products. Medical professionals, for example, get much of their information from medical societies, one panelist noted.
One challenge is that the public and even many medical specialists don’t distinguish between nicotine and smoking. “I think that’s part of the problem,” a speaker said. “How do we untangle that? Nicotine does not produce disease. It’s not carcinogenic. It does increase heart rate and blood pressure. And perhaps there are some positives … it’s a stimulant, it induces pleasure, and it improves concentration, reaction time [and] performance on some tasks, but it can also reduce stress and anxiety.”
For consumers, when asked why they smoke, the most common answer is for enjoyment and pleasure; however, nicotine ranks low on the list of motivations. But when you ask a smoker, “Why do you find smoking difficult to quit?” the answer is “because I’m addicted—addicted to nicotine.” One panelist said when consumers want medical information, more than 70 percent say the first place they go is the internet. The misinformation is rampant, even from seemingly trustworthy sources.
“The first place that they turn for health-related information is the internet. More than 70 percent of people say that’s the first place they go when they’re looking for information … because it’s easy to use, and they find information that way,” a panelist said. “Just doing the quick search yesterday, you put in electronic cigarettes into the Google search engine, and the first thing you see is the Center for Disease Control and Prevention website, which is great; it’s a government resource. The Office on Smoking and Health is the place within the federal government for information on health and smoking.
“But when you click on that link, the first thing you see is information on the EVALI [e-cigarette or vaping product use-associated lung injury] outbreak. The headline is [about an] outbreak of lung injuries from e-cigarettes and vaping products. That’s not the right way to help people understand the comparative risks between cigarettes and electronic cigarettes and nicotine-replacement therapy and other lower risk [nicotine] products.”
Many years ago, smoking and addiction were joined together, and that has now created the assumption in the public that nicotine use equals smoking, which equals addiction. It’s not helping people who smoke understand how they might be able to use the products that are available, including lower risk tobacco and nicotine-containing products as well as nicotine-replacement therapy, to quit smoking. Panelists agreed the misconception was doing more harm than good for public health.
The way vaping and tobacco products are regulated is also partly to blame, according to the panel. Tobacco companies are very limited in the amount of information they can provide on their products. Swedish Match, for example, was the first company to receive an authorization for a modified-risk tobacco product. The U.S. Food and Drug Administration, however, severely restricted the ways in which Swedish Match could communicate the lower risk of its product to consumers.
“We got super excited internally. I mean, here we have a product, it had no carcinogens, no tar, no nitrosamines, significant risk reductions, and when we started looking at how and what we can communicate, it was incredibly limited … as we were going through our process, we had [tried] to figure out how to tell consumers this was different without telling them it was different,” explained a panelist representing Swedish Match. “It was very challenging. We were trying to figure out how to use different colors and different cues. It was a brand-new category, so we’re trying to educate people on a brand-new category with a can, and you didn’t even know what was in it …. It was incredibly difficult to try to do that.”
Swedish Match also gathered customer testimonials, but regulations kept the company from doing anything with them. Another panelist explained that consumers do not separate nicotine from tobacco. Nearly 80 percent of the population agree that those are virtually the same. When asked to compare the risks of products, people list tobacco as the most harmful, followed closely by nicotine and then alcohol.
Caffeine, however, is on the other end of the scale. “Caffeine is on a totally different end of the spectrum. Interestingly, when we think about where the market is moving and things are moving relative to legality, you look at CBD, look at THC, [and caffeine] is more closely associated from a harm perspective to CBD and THC,” a speaker said. “In terms of addictiveness, 96 percent of U.S. consumers would say that nicotine is addictive. Only 76 percent say that caffeine is addictive. But then, you look at harmfulness to health. You can see this wide gap that exists in terms of … the core chemical, 89 percent versus 46 percent in terms of harmfulness to health [nicotine versus caffeine].”
The panelists argued that people who smoke combustible cigarettes are less likely to try less harmful products if they perceive those products to be no different than what they’re currently using in terms of harm. There’s very little motivation for them to try them. There is also very little the industry can do to reverse the misinformation surrounding nicotine.
“The industry’s hands are tied with regard to the voice that the industry can have. But I think the role that the industry can play in it is to continue to develop high-quality, lower risk products that are acceptable alternatives for cigarettes for people who smoked cigarettes, and then get those through the regulatory process,” a panelist said. “It’s up to the FDA to communicate to consumers that there are less risky products to consume nicotine.”
Constitutional Conundrum
Jonathan Adler
Law professor Jonathan Adler says some FDA rules may violate a company’s First Amendment rights.
By VV staff
There are numerous challenges to achieving the goal of tobacco harm reduction. Addressing these challenges might require thinking differently about how to approach the regulatory process and perhaps the extent to which the regulatory process needs to be changed, according to Jonathan Adler, the inaugural Johan Verheij Memorial Professor of Law and the founding director of the Coleman P. Burke Center for Environmental Law at the Case Western Reserve University School of Law, where he teaches courses in environmental, administrative and constitutional law.
Speaking at the GTNF 2022, Adler said that the U.S. Food and Drug Administration’s handling of premarket tobacco product applications (PMTAs) has been arbitrary. It’s been sloppy. It hasn’t followed its own guidances. “It’s pretty clear that the FDA was not prepared for this onslaught of applications, prepared for the volume, prepared for the type of analyses it would have to conduct,” he told attendees. “And [the agency] responded to that with a mixture of cutting corners and adopting shortcuts that would enable it to make decisions, typically negative decisions, so that it could process these applications.”
Companies aren’t happy with how the FDA has handled the PMTA process. Numerous companies have taken the agency to court, with mixed results. There are currently more than 30 court cases surrounding PMTA actions. Adler said that the FDA has responded inconsistently to these lawsuits. After denying Juul’s application, for example, the FDA decided to reconsider and review all the things it was supposed to review before issuing a marketing denial order. The agency took the same type of action with Turning Point Brands.
In other cases, however, the FDA has been willing to let the courts decide. The challenge in this approach is that the FDA is being strategic about which cases it fights in court and which cases it retreats on. “As someone that follows a lot of administrative litigation, it certainly looks as if FDA is retreating where the cases against its actions are the strongest and allowing cases to proceed where it thinks the challenges are weak,” said Adler. “[This is] either because issues haven’t been raised or because issues haven’t been printed in the strongest way possible or perhaps because the applications were weaker to begin with.
“As these precedents build, it will become easier and easier for FDA to defend against challenges to even the strongest arguments, so this is certainly part of the regulatory challenge …. We know—and this is all information that you’re all aware of—that the majority of people in the United States believe that ENDS [electronic nicotine-delivery systems] are as [dangerous] if not more dangerous than combustible cigarettes.”
There are other challenges too. Adler said the United States also has trust issues on both sides of the aisle. Many of the institutions and authorities that historically have been seen as trustworthy and would provide accurate information aren’t considered to be as reputable anymore.
“And certainly, the experience of Covid and the like has eroded that trust even more,” he said. “We need to think more broadly about how we might overcome this challenge. My own view is that we need to think more about the competitive process and how we discover how to communicate to consumers. And that word ‘discover’ is important. Because it’s not always clear what consumers want, why they want it and how you let them know that what you have might be what they want.”
In the case of nicotine products, due to FDA regulations, companies can’t compete in trying to convince smokers that their product will satisfy the desire for nicotine, or whatever else, in a less risky way. In Section 911 of the Tobacco Control Act, there are strict restrictions on what can be said about modified-risk tobacco products, including factually true statements. Adler said that’s a problem because if companies are able to compete on characteristics like health impact, it affects not only the behavior of those companies, but it also affects consumer understanding.
“This statute has also been interpreted, I would argue quite aggressively, by the FDA. The FDA’s position is that producers of electronic cigarettes can’t quote things that Brian King said here yesterday [the CTP director spoke at the GTNF on Sept. 28]. Can’t quote things the FDA has put in the Federal Register that are indisputably factually true. And if they say things like ‘This might help you quit smoking,’ well, then the FDA’s position is ‘forget [the modified-risk order] …. That makes you a drug device.’ And there’s a whole different approval process you have to go through for that.”
A constitutional law professor, Adler views Section 911 as a potential First Amendment issue. The U.S. Supreme Court, he said, has stated repeatedly that courts should be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. That includes attempts to deprive consumers of accurate information about their chosen product.
“We’re not talking about sensational claims about unproven medications or unproven treatments. We are talking about claims that the FDA itself acknowledges are true. [In a case involving the FDA and a compounding pharmacy that the agency wanted to prevent from advertising,] we rejected the notion that the government has an interest in preventing the dissemination of truthful, commercial information in order to prevent members of the public from making bad decisions with the information.
“And the circuit, in the context of nutritional supplements, has also said that it is clear that when the government chooses a policy of suppression over disclosure, at least where there was no showing that disclosure would not suffice to cure misleadingness, government disregards are far less restrictive means. It violates the relevant standards under the First Amendment.
“The FDA’s position is that no disclaimer, no disclosure can somehow cure the problem of telling people what the FDA itself has said about noncombustible products. It’s not clear to me—I mean that’s not only not rational, [but] it’s not clear to me why that’s constitutional.”
Study Sessions
Showing the FDA that flavors are appropriate for the protection of public health may be a challenge.
By VV staff
Flavors other than tobacco will not be allowed on the U.S. market. In order for that to happen, a manufacturer would need to show the U.S. Food and Drug Administration that flavors other than tobacco are appropriate for the protection of public health (APPH), and that may be more complicated than once thought. This was the opinion of Christopher Russell, director at Russell Burnett Research and Consultancy.
Presenting at the GTNF 2022 in Washington, D.C., Russell described the regulatory rationale and features of several types of research studies that can be conducted to compare the efficacy of flavored electronic nicotine-delivery system (ENDS) products versus tobacco-flavored ENDS products for facilitating switching and reducing cigarette consumption among adult smokers.
For a premarket tobacco product application, the FDA requires a range of valid scientific data and other research information to determine whether permitting the marketing of the new tobacco product qualifies as APPH. However, Russell explains, the Food, Drugs and Cosmetics (FD&C) Act, which guides the FDA’s authority, doesn’t clearly define APPH.
“Instead, to determine whether a new tobacco product meets the APPH standard, Section 910 of the FD&C Act requires FDA to, among other things, weigh the risks and benefits of the new tobacco product to the population as a whole, including users and nonusers of tobacco products, and taking into account both the likelihood that existing tobacco users will stop using such products if the new product is marketed and the likelihood that individuals who do not currently use tobacco products will start to use tobacco products if the new product is marketed,” Russell said.
To consider the marketing of a new tobacco product to be APPH, the FDA states that a PMTA must contain sufficient valid scientific information that demonstrates that the new tobacco product significantly reduces harm or the risk of tobacco-related diseases to individual tobacco users. Additionally, allowing adults access to ENDS and other noncombustible tobacco products cannot come at the expense of addicting a new generation of children and teenagers to nicotine.
“Though the FDA has sought to strike a balance in recent years between reducing youth appeal and access to ENDS on one hand while maintaining opportunities for addicted adult smokers to access ENDS on the other hand, the FDA’s current position expressed most recently in the issuance of marketing denial orders (MDOs) for flavored ENDS products is that the evidence available to FDA is clear in showing that the appeal and the likelihood of use of flavored ENDS by youth harms the public health to a level that is not outweighed by the health benefits of adult smokers switching to ENDS products,” said Russell. “In fact, flavored ENDS do not confer any incremental benefits over and above tobacco-flavored ENDS.”
The FDA has indicated that it may require a randomized controlled trial (RCT) and or a longitudinal cohort study (LCS) that demonstrates the benefit of an applicant’s flavored products help adult smokers more than they entice youth to start vaping. The FDA said it would also consider data that showed the same results through other research routes.
An RCT uses control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments, according to Russell. An LCS is a research study that follows large groups of people over a long time. The groups are alike in many ways but differ by a certain characteristic (for example, vapers who use flavors other than tobacco, those who vape tobacco and those who smoke combustible cigarettes).
“I think FDA is—without being explicit—they are strongly communicating that an RCT or a longitudinal cohort study would provide the strongest evidence of an added benefit of a flavored ENDS product and that any application for a flavored ENDS product that does not contain one of those two studies or both of those studies will leave FDA in a position where they cannot possibly be confident that the potential benefits of the flavored ENDS would outweigh or overcome the risks to youth or would exceed the benefits of a comparable tobacco-flavored product,” said Russell. “I cannot see any circumstance in which flavored ENDS products will receive marketing authorization without having provided FDA with reliable and robust evidence from at least one of these two study designs. RCT is the gold standard in interventional research, and longitudinal cohort studies [are] the gold standard in observational research.”
Innovating for Tomorrow
Innovating should be about improving the vaping industry, not just its next-generation products.
By VV staff
When creating a smoke-free world, innovation must take place not only in terms of products but also in terms of regulation, communication, and sustainability. That was one of the messages of the “Innovating for Tomorrow” panel discussion during the recent GTNF 2022.
Ming Deng, head of Next-Generation Products (NGPs) Industry Study at Yunnan University, spoke about his desire to make NGPs smart and mobile. At present, he said, the electronic functions that differentiate an NGP from a combustible cigarette just serve as a marketing tool. However, the Artificial Intelligence of Things (AIoT)—the combination of artificial intelligence with the Internet of Things—offers considerable opportunity to improve human-machine interactions and enhance data management and analytics, among other benefits. “With AIoT, producers could trace consumers’ needs and innovate products accordingly,” said Deng.
For Meisen Liu, R&D director at Shenzhen Zinwi Bio-Tech, lower temperature atomization is one of the most important objectives in current research as it is safer for human health. A higher atomization temperature causes atomizing agents to decompose into harmful aldehydes whereas atomizing agents with a low boiling point decrease the atomizing temperature and reduce the emission of harmful substances. Liu also described how nicotine salts derived from different acids had different properties regarding sensory stimulation or taste. His company, he said, had created a new type of nicotine salt that allows for enhanced stimulation in markets where the amount of nicotine in e-liquids is restricted.
Kevin Peng, advanced technology scientist at the ALD Group, spoke about technologies to reduce the carbon footprint of vape product manufacturing and consumption. Earlier this year, his company launched a “green cigarette,” a disposable vape product featuring 6 percent lower carbon emissions than combustible cigarettes. The company also developed a super-slim pod for reusable vaping devices made from a material that has only one-third of the carbon emission of ALD’s older materials. This way, he said, his company had achieved a 50 percent emission reduction compared to other pod products.
ALD also conducted an emission assessment for its organization and products. “ESG [environmental, social and governance] is a much more difficult thing than we thought,” Peng stated. “We found that most suppliers are not very responsive in terms of such requirements.” He called for a unified industry ESG standard for suppliers, which would make it easier to reduce emissions.
To help accelerate its transformation, BAT established Btomorrow Ventures two-and-a-half years ago. Lisa Smith, the subsidiary’s managing director, related how Btomorrow had set up a number of innovative ecosystems. “It’s a highly competitive market,” she said. “It’s difficult to find the best innovators out there.” Her company’s role is to be the “handshake” to the outside world to show that BAT is an appropriate partner for innovators. Among the many tasks in BAT’s transformation are to quickly promote the ESG agenda and move beyond nicotine. In order to achieve the latter, she said, the company had to build science and credibility.
ICCPP, a provider of solutions for e-cigarettes and heated-tobacco products, believes that the key to innovation in vaporization might be the ceramic coil. The company, which focuses on research and manufacture of electronic atomizing technologies and is the parent company of the Voopoo vaping brand, introduced the world’s first nano-microcrystalline ceramic core in 2021. According to William Yu, vice president of global ODM business at ICCPP, the core is based on environmentally friendly mineral materials that result in an increased nicotine delivery and stable flavors. In combination with a powder-free technology and a porous structure, the core enables a significant increase in atomization, according to Yu. The company also develops environmentally friendly products, such as a disposable cigarette made from special recyclable paper.
Continuing to innovate is essential as the industry is at a crossroads, said George Cassels-Smith, CEO of Tobacco Technology Inc. (TTI). After the Food and Drug Administration, through its onerous market authorization processes, had “frozen” the U.S. market for next-generation products, TTI opened a new manufacturing site in Italy, which according to Cassels-Smith is more open to innovation. “It’s vital to involve science, which is one of the pillars of what is a quick-moving new technology,” he said. “It needs expertise to focus on this direction because, ultimately, we must find superior products to combustible cigarettes.”
The SKYX Group is taking a three-pronged approach to electronic nicotine-delivery systems.
By Maria Verven
The global crisis of 8 million tobacco-related deaths every year and 1 billion projected deaths this century may be prevented by electronic nicotine-delivery systems, improved pharmaceutical nicotine-replacement therapies and tobacco-free nicotine, among other science-based innovations.
Kylie Halperin is CEO and co-founder of SKYX Group, a two-year-old company based in New York City that’s working at the intersection of all three concepts. SKYX Group is a consumer hardware and biotechnology company that’s designing and manufacturing inhalable devices.
The company currently makes consumer devices for the U.S. and European markets and has submitted premarket tobacco product applications (PMTAs) with the U.S. Food and Drug Administration. The company’s R&D portfolio includes devices serving both the pharmaceutical and biotech industries for the inhalation of various active ingredients.
Halperin co-founded SKYX Group after spending over a decade with leading advertising and marketing firms representing Fortune 500 consumer product companies such as PepsiCo, Dell Revlon and Colgate. In her role with SKYX Group, Halperin is helping create the company’s strategic vision and portfolio positioning and taking a lead role in managing wholesale relationships with major retailers.
She spoke with Vapor Voice about what SKYX Group is doing to create the next generation of inhalable drug-delivery systems.
Vapor Voice: What compelled you to co-found SKYX Group?
Halperin: For me, the story is personal. My father had Parkinson’s disease, and in 2019, it became too hard for him to take his pills. I wished we had access to simple aerosolization devices so he could take his medications.
Other members in my family have been lifelong smokers. My brother smoked a pack a day for over 20 years and couldn’t kick the habit despite trying every alternative: gums, patches, lozenges, different pod systems, pouches—you name it. If our product could help just one person transition from combustible cigarettes, I would consider it a success story.
I co-founded SKYX Group with Martin Steinbauer, a Harvard graduate in applied mathematics and former investment analyst at BlackRock in New York. He handles our engineering and tech-focused initiatives in medical inhalable devices and aerosolization technology. An entrepreneur, investor and inventor, Steinbauer co-founded the tobacco-free nicotine vaporizer company SMOOD, which has grown into a global vaping business built on advanced chemistry, patent-protected hardware and sustainability.
Thanks to our tobacco-flavored SMOOD, my brother has been cigarette-free for over two years. So, there’s a much better chance he can stick around for his children for a long, long time.
What are the key differentiators in your product, and what factors do you think will contribute to SKYX’s success?
There are several consumer-facing subsidiaries in the U.S. and European markets for different market segments. So, it was important that our synthetic nicotine vaporizer—SMOOD—was both affordable and approachable. Our target audience is consumers who are former cigarette smokers with an average age of 39 years.
SMOODoffers a cleaner, smoother nicotine experience without tobacco. A consumer vaporizer company built with advanced technology and sustainability programs, SMOOD was developed by MIT and Harvard medical engineers. We are excited about transforming the vaping sector by focusing on quality control, safety and reliability. SMOOD satisfies consumer preferences in nicotine delivery, vapor intensity and aroma.
The SMOOD nicotine line was built after studying existing products and devices in both the consumer and medical inhaler markets. We examined consumer packaged goods in the cosmetics and coffee markets as well as aerosol-delivery devices in the medical industry. As a consumer product, we designed it to offer a sensation and taste to what consumers are familiar with in their daily smoking rituals.
We also wanted it to be affordable and competitively priced with a pack of cigarettes: one pack of SMOOD is $8.99; two packs are $16.99. One SMOOD (40 mg/2 mL) provides roughly the same amount of nicotine as two packs of cigarettes.
In our mission to provide reduced-risk products to combustible cigarette smokers, we were an early adopter of synthetic nicotine for its purity and absence of minor tobacco alkaloids. Tobacco manufacturing contributes 84 million metric tons of CO2 emissions each year. Since it’s made in the lab and manufactured according to pharmaceutical standards, synthetic nicotine eliminates the vast majority of those emissions.
Last but not least, we created SMOOD to be sustainable and environmentally conscious; the vast majority (94 percent) of SMOOD devices can be upcycled. We used a cradle-to-grave approach, designing the product with its end of life in mind and offering a simple collection and true reuse of electronic waste.
Although it’s disposable, which we know has environmental concerns (see “What a Waste,” Vapor Voice Issue 4, 2022), we found a way to upcycle the device plastics into building materials and upcycle the battery components into new batteries. This is very important to us as we roll out a recycling structure in the greater U.S.
Kylie Halperin & Martin Steinbauer
What are your primary markets, and how will the company distribute and market its products?
While there are synergies between the pharmaceutical and consumer markets for drug delivery systems, consumers will choose a product on its own merits in the retail market. That’s why we are focused on safety, familiarity, affordability and sustainability.
We work with full-service distribution partners in the U.S. and Europe that service single to multi-store retail channels, such as convenience stores and gas stations.
We want to work with retail partners who want to learn more and work with us to place recycling boxes for us to collect. Plus, we want to expand this important call to action to other industry players to work together to proactively combat this issue and build a responsible and sustainable future.
What’s on the horizon for SKYX?
We are excited about protecting public health through quality engineering and smart devices.
On the growth side of the consumer business, we’re growing our distribution footprint in the U.S. and Europe. Thanks to the great feedback we’ve received from consumers and retail partners, we are developing other new and innovative products that offer an effective and viable alternative to combustible cigarettes.
On the R&D side, we’re spending a lot of time on the pharmaceutical side of aerosolization technology—e.g., how existing medications that are inhaled can be better administered through a more suitable delivery system. What would it take to make medications that are taken orally currently a great candidate for inhalation?
On the consumer side, our goal is for SMOOD vaporizers to be approved by the MHRA [Medicines and Healthcare products Regulatory Agency] and ultimately prescribed by British physicians for smoking cessation.
We have submitted our PMTA along with excellent HPHC (harmful and potentially harmful constituents) data to the FDA. SMOOD has garnered intellectual property such as patents on hardware, chemical formulations, age/user verification, IoT [Internet of Things]-enabled devices, supply chain optimization and recycling.
Our team members all have diverse skill sets, and we are dedicated to making a public health impact. But our work has just begun.
In addition to providing an alternative to combustion cigarettes, we’re excited to use similar technologies to create the next generation of inhalable drug-delivery systems for optimized medication delivery.
‘Bear bites man’ is a news story, of course, but ‘man bites bear’ is sure to make page one.
By George Gay
Look out! There’s a brown, big bear in that tree!
No, don’t concern yourself, there’s no bear; I was just making a point. No English speaker would utter that warning. What they would say is: Look out! There’s a big, brown bear in that tree!
If you string adjectives together in English, they follow a certain order in which, for instance, size—big—comes before color—brown—and, for that matter, age—old—comes before shape—fat—and both age and shape come between size and color. I don’t know what the order is off the top of my head, so I had to look it up to describe the examples above, but I, like others, use the correct order instinctively almost all the time.
The question is, does the order really matter? Well, from a practical point of view, perhaps.
After all, you wouldn’t want Joe, the person being warned, to get into a semantic argument about whether it was right to say the bear was brown and big or big and brown because, in the meantime, the bear might have come down from the tree and the arguments would turn to whether the animal in question could be described as an angry, big, brown bear, a big, angry brown bear or any of the other adjectival combinations available—and, finally, whether it was creating a big, bloody mess of Joe, or a bloody big mess.
On the other hand, languages evolve, and if it weren’t the case that the human race was going to be wiped out within the next 100 years by the effects of environmental breakdown, it’s not hard to imagine that, many years into the future, the creature in the tree might have become known by English speakers as a brown, big bear or, in a really progressive society, referred to according to a description chosen by bears or their democratically elected representatives.
Already, there is a tendency to flexibility—I would say laxity—over word order, especially when it comes to story headings. Take this one from insidesource.com: “Public health’s misinformation against vaping is eroding its credibility.”
The way that I read this heading is by assuming that “its” refers to vaping because “its” is closer to vaping than it is to the other referential candidate, “public health,” so that what I assume is being said is that the credibility of vaping—as a means of quitting smoking—is being undermined by the misinformation put out under the name of public health.
Credit: Desdemona72
There is truth in this because such misinformation does get through to some smokers. But, when you read the story, it turns out that what is being said is that public health is undermining its own credibility by putting out misinformation about vaping.
Again, the question arises as to whether this confusion matters. I would say yes because I, and perhaps others, would be likely to skip over a story that was about vaping being undermined by public health misinformation because that happens all the time.
I would be much more likely, however, to read a story about the credibility of public health being undermined because such stories are rarer. “Bear bites man” is a story, of course, but “man bites bear” makes page one.
Finally, the point is that the heading could be fixed easily as “Public Health’s credibility eroded by its issuing misinformation on vaping.”
Credibility aside, I shouldn’t think that public health would have been overjoyed to see the following headline from eatthis.com: “Vaping versus smoking marijuana: Which is better for your body?” I cannot help thinking that public health would have found this heading unnecessarily provocative.
Given that both activities carry a level of risk, the question that public health would probably have preferred is “Vaping versus smoking marijuana: Which is worse for your body?” And this is not withstanding that these activities are seen by many people as having some positive outcomes.
This is an interesting heading, however. When I first read it, I thought the physical effects of vaping nicotine were being compared with those of smoking marijuana. It took me a while to work out that it was vaping marijuana and smoking marijuana that were being faced off.
My initial interpretation of the heading might have been perverse, but I think what was written could have been made clearer as “Which is better for your body, vaping marijuana or smoking it?”
While I usually ignore stories whose headings pose questions because I feel that I am going to be asked to do the story’s heavy lifting, this particular heading is intriguing. In fact, I would have read the whole story had I been a little cleverer and been able to activate the link from the synopsis that I saw.
One thing that intrigues me is why the headline writer didn’t pose the more general question: “Vaping versus smoking marijuana: Which is better for you?” And why, if she felt she wanted to be more specific, did she go for the body? Why not the mind? “Which is better for your mind?”
Credit: andriano_cz
Perhaps some would even have preferred the focus to have been on the soul. I don’t think there is a clue in the “eat this” name because in both cases we’re talking about inhalation. I guess I’ll never know.
The next heading I would like to look at is from thedrum.com and is perfectly clear as I read it: “Chinese vaping brand accused of flouting advertising rules designed to protect children.” It is clear, but it is misleading in an important way. Compare this heading: “Cudgel accused of breaking man’s skull in vicious daytime attack.”
Most people would laugh at such a heading, saying that you cannot accuse a cudgel of doing anything; the accusation must be aimed at the person wielding the cudgel. But by the same token, those people would probably not think twice about an accusation being leveled at a vaping brand, an equally ridiculous idea in my view. In fact, it is possibly more ridiculous.
It is conceivable that a cudgel could be made to stand in the dock and eventually be sent to prison as nonhuman animals have been in the past. But a brand does not have a bodily form.
The question is, as always, does any of this matter? I would say yes. Leveling the accusation at the brand lets off the hook those who allegedly caused the rules to be flouted.
What is likely to happen if the allegations are substantiated is that the company that owns the brand name will be fined, a fine that will possibly be recouped through increasing the price customers pay for the product. The person or people who allegedly caused the laws to be flouted will be unaffected and therefore free to repeat the offense either at the same company or at a new one.
I have written previously about the dangers of anthropomorphism, which crops up in such phrases as “vaping brand accused” and, of course, “the market panicked.” But having said that, I have to admit that it is almost impossible to avoid such anthropomorphism at times as observant readers and pedants will have noticed from a couple of stories above where “public health” is said to be up to all sorts of things that, in fact, only people working in public health can do.
The problem is that trying to insert phrases such as “people working in public health” every time becomes clumsy and, frankly, unnecessary. And, of course, there are instances where this sort of thing simply doesn’t matter. I recently saw an advertisement for “meditation for businesses.” But beware when it is said that a business was found to have been involved in money laundering.
Perhaps one problem with headings is that they are thrown together at the last moment and can thus carelessly undermine what might be an article that is worth reading. I noticed this heading in thejournal.ie: “Opinion: E-cigarettes are not part of the solution to a tobacco-free Ireland.”
This seems blindingly obvious to me. The solution to a tobacco-free Ireland must surely be the introduction of tobacco in the same way that the solution to an alcohol-free Ireland would be the introduction of alcohol.
The problem here, I think, is the word “solution,” which has been allowed to slosh about all over the place in recent years, and here is clearly adrift. I guess the heading should have read something like: “Opinion: E-cigarettes will not help solve Ireland’s tobacco smoking problem.”
I must admit that, initially, I was drawn to the following heading on nst.com.my because GEG are my initials: “Two million will die if GEG bill not passed.” Nevertheless, what I really like about this heading is that, without even knowing what GEG stands for, you know that the heading is correct, and, what’s more, you know even that its negation is correct.
So, the headline writer could have written: “Two million will die if GEG bill passed.” This is because people have finite lives. The 2 million people in question will die. That’s a certainty. What I suppose the headline writer must be getting at is that 2 million people will die prematurely if the bill is not passed. But, to my way of thinking, “dying prematurely” is one of those odd concepts that seems nevertheless to be universally accepted. Surely, it’s just a case of when your number’s up, it’s up.
If you quit smoking and, on your first smoke-free day, you don’t stop at the tobacconist, you might get hit and killed by a driver jumping the lights at the intersection, something you would have avoided by stopping at the store. But, to my mind, you wouldn’t have died prematurely even then.
In any case, from the synopsis of the story, it seems as though the emphasis wasn’t on “saving lives;” it was about saving money. Tax revenues from sales of cigarettes weren’t covering the costs of treating smoking-related diseases. A cynical person might be forgiven for reaching the conclusion that the smokers were seen not to be dying “prematurely enough.”
Credit: Alswart
And you can look at this another way. By giving up smoking and living a little longer, those 2 million people will have a greater negative impact on the environment than if they had died earlier and therefore might be responsible for the earlier deaths of others. Life and death are not simple matters.
Now, I would like to draw attention to a heading at colinmendelsohn.com.au: “New Campaign Outlines the Real Truth About Vaping.”
Colin Mendelsohn is one of those brave souls who has for a long time been trying to inject some rational thinking into the debate in Australia about the use of vaping as a means of helping smokers quit their habit—a debate that has been seriously marred by misinformation. I mean, look at the heading. What does it say about us when Mendelsohn feels it necessary to include the word “real” before the word “truth”?
OK, this heading from The Herald is way beyond the usual range of stories for a vape-focused magazine, but I just cannot resist it: “Zimbabwe: Tobacco farmers earn $7 million in three days.” At one and the same time, this heading, reporting on April 5 on the first three days of leaf tobacco sales for the 2021–2022 season, is true but manages to grossly understate the work of tobacco growers and imply, incorrectly, that these growers were enjoying some sort of bonanza.
The first thing to note is that these growers are not people playing the financial markets; they don’t earn that sort of money in three days. The second thing to note is that, in fact, they worked a lot longer than three days just to earn a modest amount of money. And I mean modest.
Tobacco growers work long days, mostly out in the open, during a long, worry-filled season that can be upset by a whole range of often uncontrollable factors, including plant diseases, unhelpful weather and unscrupulous middle operators. And what do they get at the end of it?
Well, according to The Star newspaper, reporting more or less at the end of the sales season, growers received an average of about $3.05 per kilogram for their tobacco, a figure that was up 9.3 percent on the $2.79 per kilogram they received the previous season.
This sounds like a good payday, except that the $3.05 per kilogram of this year was up only 3.7 percent on what they earned in 1996—$2.94 per kilogram. You’re reading that correctly, 1996—more than a quarter of a century ago. The 2022 average price was actually lower than it was in 2008, 2012, 2013 and 2014.
The spoils of Juul Labs’ settlement over its marketing practices is not divided equally among the suing states.
VV staff report
On Sept. 6, e-cigarette maker Juul Labs agreed to pay $438.5 million to 33 U.S. states and Puerto Rico in a settlement following a two-year investigation into the company’s marketing and sales practices. On Sept. 23, at least one state had opted out of the settlement, and other states are considering the same action.
The Maine Attorney General’s Office said the state would be backing out of its $11 million agreement with the e-cigarette manufacturer after objecting to certain conditions from the company. As part of the agreement, Juul wanted states to waive the rights of school districts to pursue their own lawsuits. Maine wasn’t willing to agree to that.
“We are disappointed in the outcome of these negotiations, but ultimately, we were unwilling to waive the rights of other entities who are also trying to hold Juul accountable for its deception,” Attorney General Aaron Frey said in a statement to The Maine Monitor.
For the remaining states, the multimillion-dollar settlement will be paid out over a period of six years to 10 years. Both the financial and injunctive terms exceed any prior agreement Juul Labs has reached with states to date.
“We recently submitted an administrative appeal, based on science and evidence, to [the U.S. Food and Drug Administration], demonstrating that its marketing denial order (MDO) of our products was substantively and procedurally flawed and should be rescinded,” Juul Labs wrote in a statement. “We believe that once the FDA does a complete review of all of the science and evidence presented, as required by law and without political interference, we should receive marketing authorization. As we go through the FDA’s administrative appeals process, we continue to offer our products to adult smokers throughout the U.S.”
The multistate investigation found that Juul became the U.S. e-cigarette market’s leader by “willfully engaging in an advertising campaign that appealed to youth, even though its e-cigarettes are both illegal for youngsters to purchase and are unhealthy for youth to use, according to Connecticut Attorney General William Tong. The investigation found that Juul relentlessly marketed to underage users with launch parties, advertisements using young and trendy-looking models, social media posts and free samples.
According to the investigation report, Juul’s misguided marketing began in 2015 and 2016 when the company bought ad space on websites targeted at youth, like nick.com, nickjr.com, cartoonnetwork.com and others. “It marketed a technology-focused, sleek design that could be easily concealed and sold its product in flavors known to be attractive to underage users,” New Hampshire Attorney General John Formella said in a press release. “Juul also manipulated the chemical composition of its product to make the vapor less harsh on the throats of the young and inexperienced users. To preserve its young customer base, Juul relied on age verification techniques that it knew were ineffective.”
Credit: Standap
The investigation further found that Juul’s original packaging was misleading in that it did not clearly disclose that it contained nicotine and implied that it contained a lower concentration of nicotine than it did. Consumers were also misled to believe that consuming one Juul pod was the equivalent of smoking one pack of combustible cigarettes. The company also misrepresented that its product was a smoking cessation device without FDA approval to make such claims.
“This settlement with 34 [now 33] states and territories is a significant part of our ongoing commitment to resolve issues from the past,” Juul Labs said. “The terms of the agreement are aligned with our current business practices, which we started to implement after our company-wide reset in the fall of 2019.” Altria invested $12.8 billion for a 35 percent stake in Juul in late 2018 and began guiding the company’s new direction in 2019.
The plaintiff states will not be splitting the settlement equally. Connecticut will receive a minimum of $16.2 million through the settlement, for example, while Texas will receive $42.8 million. Oregon will receive at least $18.8 million. Tong stated that the settlement total amounts to about 25 percent of Juul’s U.S. sales of $1.9 billion last year. He stated it was an “agreement in principle,” meaning the states will be finalizing the settlement documents over the next several weeks, so the dollar amounts may not be exact. While not expressly stated, it is believed the amount of Juul products sold in a state determined the settlement amounts.
The money will go to programs, across the states and territory, that aim to reduce tobacco use, especially among young people. The amounts paid begin to increase the longer the company takes to make the payments.
The remainder of the funds after the investigative leaders’ cuts is estimated to be distributed as follows:
Juul previously settled lawsuits in Arizona, Louisiana, North Carolina and Washington. Many states, including Hawaii, also have claims against Altria Group (the parent company of Philip Morris USA and Juul’s largest shareholder) that are not affected by the settlement and remain active. Additionally, the company faces lawsuits filed by New York and California that are still pending, and an estimated 3,600 lawsuits by individuals, school districts and local governments have been consolidated in an action that is still wending its way through a California court.
In addition to the financial terms, the settlement also forces Juul Labs to comply with a series of strict injunctive terms severely limiting the company’s marketing and sales practices. Most of the limits imposed by settlement won’t immediately affect Juul, which halted use of parties, giveaways and other promotions after coming under scrutiny several years ago. The company currently makes up about one-third of the U.S. retail vaping market, down from 75 percent several years ago. As part of the settlement, the embattled manufacturer has agreed to refrain from:
Youth marketing
Funding education programs
Depicting persons under age 35 in any marketing
Use of cartoons
Paid product placement
Sale of brand-name merchandise
Sale of flavors not approved by the FDA
Allowing access to websites without age verification on the landing page
Representations about nicotine not approved by the FDA
Misleading representations about nicotine content
Sponsorships/naming rights
Advertising in outlets unless 85 percent of the audience is adult
Advertising on billboards
Advertising on public transportation
Advertising on social media (other than testimonials by individuals over the age of 35, with no health claims)
Use of paid influencers
Direct-to-consumer ads unless age verified
Free samples
The agreement also includes sales and distribution restrictions, including where the product may be displayed/accessed in stores, online sales limits, retail sales limits, age verification on all sales and a retail compliance check protocol. Juul came under its most intense scrutiny earlier this summer when the U.S. Food and Drug Administration attempted to ban all Juul e-cigarettes from the market. A federal appeals court blocked the government’s ban, and then the FDA placed Juul’s MDO under administrative review.
In late September, the vapor manufacturer filed a lawsuit against the FDA over the agency’s refusal to disclose documents supporting its MDO. In a complaint filed with a federal court in Washington, D.C., Juul Labs accused the FDA of invoking the “widely abused” deliberative process privilege to improperly withhold scientific materials that are “central” to understanding the basis for the June 23 issuance of the MDO, according to Reuters.
The company claims that the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims that Juul e-cigarettes help smokers quit combustible cigarettes and whether the agency’s reasoning was scientifically sound. “The public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinized decisions in recent years,” Juul Labs stated.
An FDA spokeswoman declined to comment, saying the agency does not discuss pending litigation.
In an expected move, Logic Technology Development obtained a court order from the U.S. Circuit Court of Appeals for the Third Circuit that temporarily stays the U.S. Food and Drug Administration’s marketing denial order (MDO).
The temporary stay issued by the circuit court means that both the Logic Pro Menthol e-Liquid package and the Logic Power Menthol e-Liquid package products can be sold by retailers and wholesalers in the United States while the stay is in place.
The Third Circuit will now consider a further motion from Logic regarding the MDO that the company has seven days to file, according to media reports.
“The foregoing motion for a partial administrative stay is GRANTED as follows. The FDA’s marketing-denial order is TEMPORARILY STAYED as to the Logic Pro Menthol e-Liquid Package and the Logic Power Menthol e-Liquid Package products. Within seven days of this order, the petitioner must file its motion for a stay pending the petition,” the order states. “The FDA’s response must be filed within ten days thereafter.
“The panel considering the stay motion may decide it without waiting for a reply […] so any reply must be filed as quickly as possible (and no later than three days after the response).”
The temporary administrative stay will remain in effect until a panel of the court decides on Logic’s new stay motion. If no timely stay motion is filed, the clerk is authorized and directed to vacate the temporary administrative stay.
Numerous comments from purported staffers of the U.S. Food and Drug Administration for the Reagan Udall assessment of the performance of the FDA’s Center for Tobacco Products (CTP) claim the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research.
One comment stated that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs.
“Scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods (e.g., lack of assignments, projects, and other opportunities that are needed for career development/promotion),” the comment states. “In some divisions (e.g., Division of Nonclinical Science [DNCS]), leadership pushes a ‘gotta get em’ mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”
In July, the FDA commissioned an independent review of the regulatory agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews. FDA Commissioner Robert Califf chose the non-profit Reagan-Udall Foundation, a non-governmental research group created by Congress to support the FDA’s work.
The comments are anonymous and open to the public. Many of the comments paint a picture of an agency that is inept and making decisions persuaded by political agendas and not based on the science surrounding next generation nicotine products. One reported FDA staffer claimed that there’s a toxic culture permeating the OS that begins with the FDA’s leadership teams.
“The so-called leaders do not solicit feedbacks from the actual reviewers, instead, listening to few of the loudest ducks, who are not the experts in any of the specific disciplines,” the commenter wrote. “Favoritism/nepotisms, unconscious bias, racism/sexism, permeating the whole office/Division, the minority and women consistently being ignored for their suggestions/feedbacks, although they are the ones who did most amount of work.”
Another comment claims that arbitrary and politically driven timelines set externally (by a judge for example) are driving reviews as opposed to allowing for a thorough scientific review. “When errors are found the CTP reviewers are blamed when in fact the lack of adequate time to complete the reviews are at fault. Staff are burned out and constantly told to do more in less time and blamed for not meeting insane deadlines,” the comment states. “In cases where reviews are finished and scientific decisions are made they are also overruled by political agendas and pushed to change decisions.”
Another comment states that the Tobacco Control Act (TCA) favors combustible tobacco products by allowing new combustible products to take easier pathways to market, such as being considered pre-existing tobacco products or through the standard equivalency (SE) pathway.
“CTP has explicitly stated that the science supports the notion of a continuum of risk, i.e. that combustible products are the deadliest and noncombustible products appear to be nominally safer. Nevertheless, CTP has elected to conduct a product by product premarket review of new tobacco products,” the comment states. “So any innovative product, such as an e-cigarette, would most likely have to undergo a more robust and burdensome pathway to market, e.g. PMTA.”
It not all doom and gloom, however, as some claim that agency staffers are just overworked. One commenter stated that CTP is constantly working under impossible deadlines with long review queues that none of the other centers overseen by the FDA are required to endure.
“The volume of applications it sees and products it regulates are astronomical in comparison, but we are not being given any protection, support, or leeway to handle this burden,” the comment states. “Instead, it seems as if CTP and OS are blamed for having large queues or not making deadlines, without anyone taking a look to see just how much work is being done to ensure that things are done as soon as humanly possible. Treating this Center as the rest of the Centers in terms of queues and timelines is unhelpful and encourages burnout.”
Another commenter wrote that the FDA doesn’t have the ability to give all PMTAs a “fair and equal” review, a claim that has been denied by the agency in court cases surrounding its issuing of marketing denial orders. “There are so many layers to make sure the science makes sense, its being communicated in a way that makes sense. But it doesn’t have the people or breathing room to apply that system to every single application equally,” the comment states. “We are definitely all being overworked and stretched too thin with unreasonable deadlines, lack of protection from those outside of CTP, and a staffing shortage.”
The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) for several menthol-flavored vaping products marketed by Logic Technology Development. The products include the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. It’s the first time the FDA has issued MDOs for menthol products after receiving a scientific review.
The move seems inline with the regulatory agency’s goal to ban menthol flavors from tobacco products. The FDA also isn’t expected to approve any flavored vaping product other than tobacco. In June, the National Institutes of Health and the FDA gave the University of Louisville a $3.6 million grant to study the effects of flavorings like mango and bubblegum used in vaping products. The study is still being conducted.
“Ensuring new tobacco products undergo premarket evaluation is a critical part of the FDA’s work to reduce tobacco-related disease and death,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP), in a release. “We remain committed to evaluating new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, told Vapor Voice the latest move by the FDA to ban menthol vaping flavors is reminiscent of the agency’s “fatal flaw” review of PMTAs that resulted in millions of denials. The term “fatal flaw” was used by the FDA for PMTA submissions that didn’t have specific studies. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process.
“The dysfunction at the FDA knows no bounds. For the last year-plus, the FDA has sat back deferred decision making on menthol vaping products,” Conley said. “Lest anyone believe that FDA was hard at work coming up with ways to achieve balance, today they revealed that their big plan for menthol vaping products is to follow the exact same ‘fatal flaw’ review process that has led to dozens of lawsuits being filed against the agency.”
The agency stated that after reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications “lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health (APPH), the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.”
The FDA stated that the evidence provided within Logic’s denied PMTAs did not demonstrate that menthol-flavored e-cigarettes are more effective in promoting “complete switching or significant cigarette use reduction” relative to tobacco-flavored e-cigarettes.
The announcement is concerning, especially since CTP is undergoing an external review in which many industry stakeholders have called for a comprehensive plan for PMTA reviews, according to Tony Abboud, executive director of the Vapor Technology Association. He says that the FDA’s action raises at least four major concerns.
“First, the announced rationale makes no mention of the net public health benefit prong, begging the question of whether FDA addressed that required element of the APPH test? Second, how is the public health benefitted by FDA’s approval of 123 new menthol cigarette/cigar products, given its inability to authorize a single less-harmful menthol vaping product?” Abboud asks. “Third, how can the Agency continue to rely on general (i.e., non-Logic specific) menthol youth data to impose a heightened Logic-specific cessation standard, especially given the dramatically reduced [National Youth Tobacco Survey] NYTS youth use rates and no apparent tie to Logic products?
“Fourth, is the Agency undermining its proposed menthol cigarette rule, given that FDA’s science shows that half of the predicted quitters under the proposed standard must switch to menthol vapes, none of which have been authorized?”
Logic must now decide if it will resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. However, the FDA states that for non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, “existing evidence demonstrates a known and substantial risk” with regard to youth appeal, uptake and use.
“The FDA conducts a rigorous, scientific review of submitted premarket tobacco product applications, evaluating the data for each product to determine if it meets the public health standard,” said King. “In this case, the applicant did not provide sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks to youth.”
A recently accepted manuscript of an article set for publication in Nicotine & Tobacco Researchfound that flavored vaping and other tobacco sales restrictions in California did not affect youth e-cigarette use.
The MDO letter that Logic received today is not limited to the two products named above, according to the agency. In general, the FDA publicly names only products that the applicant is marketing to avoid potential disclosure of confidential commercial information.
Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action. These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In March, the FDA authorized several tobacco-flavored e-cigarette products from the company under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.
In addition to ensuring that Logic complies with this order, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the “statutorily required premarket authorization” are marketed unlawfully and their distribution or sale is subject to enforcement action.
Recently, the U.S. Department of Justice filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. The cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
Retailers should contact Logic with any questions about products in their inventory.
Chinese and U.S. scientist have identified a bacteria in the human stomach that can degrade nicotine, reports the Xinhua News Agency, citing a new study published in Nature.
A colony of gut bacteria was found to have reduced intestinal nicotine concentrations in nicotine-exposed mice.
Nicotine is known to activate an intestinal molecule called AMPKα. These molecules contribute to the progression of non-alcoholic fatty liver disease (NAFLD), according to the study.
The authors suggest that Bacteroides xylanisolvens can help reduce smoking-exacerbated NAFLD progression.
The study involved researchers from Peking University, Zhejiang University, Fudan University, the First Affiliated Hospital of Wenzhou Medical University and the U.S. National Institutes of Health.
Smoore presented its Feelm Max disposable technology solution at the Indonesia Electronic Atomization Exhibition (IECIE2022), which took place at the Jakarta International Convention and Exhibition Center.
Speaking at the exhibition, Smoore Vice President Clayton Shen highlighted the importance of technological innovation in driving progress in the vaping industry.
Feelm Max features a ceramic coil technology that offers more puffs and consistent flavor, according to a company press release. It is currently sold in more than 10 countries, including the United States and the United Kingdom. Other features include a semi-translucence mouthpiece and to environmentally friendly packaging.
During his presentation of the Feelm Max, Clayton Shen explained that the closed system is the fastest growing category in the new tobacco market and will claim a significant market share in the long run.
According to Smoore, ceramic coils solve longstanding challenges such as liquid leakage and burnt taste, Ceramic coils, said Shen, are used by leading vapor product manufacturers, such as Reynolds Vapor Co., RELX and NJOY.
One of the most influential exhibition platforms for companies operating in the vaping sector, the IECIE covered an area of over 12,000 square meters in Jakarta, with over 100 exhibitors and more than 10,000 visitors.
In recent years, Southeast Asia has become a new industry hub by virtue of its population base and market development potential. Euromonitor expects the Southeast Asian vaping grow by 29 percent in 2023.
