TobaccoReporter logo

Category: Uncategorized

  • ‘Forgotten’ Smokers

    ‘Forgotten’ Smokers

    Photo: Chris Ferenzi

    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.”

     

  • Joe Murillo

    Joe Murillo

    Photo: Chris Ferenzi Photography

    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.”

  • Announcing the 2022 Golden Leaf Awards

    Announcing the 2022 Golden Leaf Awards

    Photos: Chris Ferenzi Photography

    Tobacco Reporter presents its 2022 Golden Leaf Awards.

    It’s hard to exaggerate the extent of the changes that have taken place in the nicotine business since the Golden Leaf Awards were conceived more than 15 years ago. When the program debuted in 2006, the news headlines in Tobacco Reporter were mostly about consolidation, privatization and litigation—topics associated with a controversial legacy business playing defense in an increasingly hostile environment.

    Fast-forward to 2022 and the landscape has changed completely. Many of our columns are now dedicated to tobacco harm reduction—a goal that has become feasible in the wake of the breathtaking innovations that have occurred in recent years (which are eloquently described in Tobacco Reporter’s April 2022 special innovation issue). The transformation has been so great that a reader from 2006 would likely struggle to recognize many of the devices evaluated in our new products section.

    Environmental, social and governance (ESG) topics also feature prominently in our news coverage today, reflecting a societal shift in attitudes. Corporations are not only more aware of their societal responsibilities but are also prepared to make a difference. The Golden Leaf Award’s exclusive sponsor, BMJ, for example, has developed impressive programs to reduce the amount of water and energy used in its papermaking process, to source its wood pulp sustainably and to meaningfully engage its employees (for more information, visit www.bmjpaperpack.com).

    To better reflect these changing industry dynamics, the Golden Leaf Awards will place greater emphasis on innovation and ESG initiatives going forward. Starting this year, our judges will recognize initiatives designed to deliver a brighter future not only for the manufacturers and consumers directly involved but also for society at large.

    In the 2022 edition of our awards program, we recognize three companies for various types of innovation and one company for its ESG initiatives. The winners accepted their trophies during a ceremony at the Four Seasons Hotel in Georgetown, Washington DC. We hope that you agree with our judges that the awarded products and programs hold significant potential to help deliver what one well-known multinational on the forefront of our industry’s transition describes as “a better tomorrow.”

    ALD Group has earned a Golden Leaf Award for its Green Cig, an eco-friendly disposable vaping solution.

    Driven by regulatory and competitive developments, disposable e-cigarettes have captured significant market share in recent years. In the United States alone, they now account for about a third of the vapor market, according to data from the market research firm IRI. But while disposable products offer convenience, they also raise environmental issues.

    Alert to societal concerns about mounting waste, ALD Group has developed an e-cigarette with components that are easy to detach and recycle.

    By using biodegradable plastic materials, including PLA and PBAT, for the Green Cig shell and eco-friendly paper-plastic materials for its packaging, ALD Group has managed to decrease the carbon footprint of its vaporizer by approximately 36 percent over that of similar products—without compromising on taste and flavor.

    The degradation rate of the bioplastic component reaches up to 80 percent, according to ALD Group, while battery life is prolonged by sophisticated technology that prevents dry burning.

    Recyclable parts of the Green Cig include its battery, pressure sensor, pogo pin and atomizer. To promote pod recycling, ALD Group has partnered with a third party to develop a program aimed at giving discarded pods a second life.

    Pyxus Agriculture Malawi (PAM) has earned a Golden Leaf Award for its efforts to promote responsible fuel production in Malawi.

    Deforestation is a challenge in many tobacco origins. In Malawi, the main contributors are agriculture and fuel production. About 7 percent of Malawi’s wood is used for curing tobacco or as a construction material for barns.

    In recent years, Malawi has been transitioning from wood as a fuel source to charcoal, which is easier to obtain than electricity or gas in the region. Unfortunately, the systems currently used to produce charcoal are unregulated and threaten woodlands.

    PAM is addressing this threat by utilizing existing business structures to produce charcoal responsibly. The company has 15 forest plantations across Malawi that supply firewood to tobacco farmers contracted by its Alliance One Tobacco Malawi subsidiary. After harvesting, there is often wood left that does not meet the criteria for tobacco curing. Now, PAM is using this wood to produce charcoal.

    The company’s existing track-and-trace technology allows the fuel to be traced back to the source with assurance that any lumber used in the manufacturing process will be replenished within the plantation.

    The project not only supports Malawi’s goal to transition from unsustainable wood fuel to sustainable wood fuel but also helps conserve indigenous woodlands. As of November 2021, the initiative was estimated to have saved at least 650 slow-growing indigenous trees. By 2024, PAM aims to be at a level of production that will save more than 12,100 trees per year.

    FEELM has earned a Golden Leaf Award for its FEELM Max, the world’s first ceramic coil disposable pod solution.

    Almost all disposable pods on the market contain traditional cotton coils, which can compromise flavor, generate a burnt taste and produce hazardous substances due to inaccurate temperature control.

    Using FEELM’s updated ceramic coil technology, the FEELM Max offers improved flavor consistency, more puffs and reduced harshness through smaller aerosol particles.

    Most importantly, the FEELM Max offers greater potential for harm reduction. The addition of a platinum group element to the ceramic coil’s metallic heating film improves the anti-corrosion performance and reduces the emission of heavy metals.

    A 24 karat gold coating of conductive components enhances resistance to oxidation while a ceramic substrate resistant to temperatures of over 1,000 degrees Celsius prevents burns and the creation of hazardous substances.

    The introduction of the FEELM Max fits into the company’s mission to enhance the experience for vapers around the world. Founded in 2006, FEELM’s parent company, Smoore, has grown into the world’s leading atomization technology firm, with a 22.8 percent share of the global vaping device market in 2021, according to Frost & Sullivan.

    The company operates 10 research centers, including seven in China and three in the United States, with an additional three under construction.

    Innokin and Aquios Labs have earned a Golden Leaf Award for the Lota Pod, the first and only water-based vaping solution.

    E-juice generally consists of propylene glycol (PG) and vegetable glycerin (VG) along with flavor and nicotine. When heated, PG and VG produce vapor, which allows them to be inhaled. At 189 degrees and 292 degrees Celsius, respectively, the boiling points of PG and VG are relatively high, however.

    Adding water to e-liquid brings down the boiling point and vape temperatures, thus reducing harmful substances in vapor. Water also minimizes dehydration and irritation and helps to deliver nicotine more efficiently while producing a more natural flavor.

    Until now, the low viscosity level of water made it unsuitable for use in vaping devices at any meaningful level. Aquios Labs developed a technology that can support up to 30 percent water vaping but still needed proper hardware to support its new e-liquid.

    Utilizing its extensive experience with vaping hardware, Innokin created new heating, wicking and airflow systems to unleash the potential of water-based e-liquid.

    While the vaping industry has become accustomed to major hardware innovations every 12–18 months, e-liquids have been evolving at a gentler pace. Water-based vaping arguably represents one of the most significant breakthroughs since the introduction of nicotine salts in the vaping industry.

  • Kim Reed

    Kim Reed

    Photo: ITG Brands

    Having joined ITG Brands, the U.S. subsidiary of Imperial Brands, in June 2021 with a background in other consumer goods, Kim Reed related her aims and strategies in her new role. ITG Brands is the third-largest tobacco manufacturer in the U.S. and best known for its Winston, Kool, Salem and Maverick cigarette brands. The company also manufactures mass-market cigars and blu vapor products.

    ITG Brands was formed in June 2015 after Imperial Brands acquired the above-mentioned cigarette brands along with blu Cigs, which Reynolds American Inc. and Lorillard had to divest to satisfy the Federal Trade Commission’s competition requirements. Cigar brands already owned by Imperial included Backwoods, Dutch Masters and Phillies.

    The U.S., Reed pointed out, is an attractive tobacco market with affordable products, relative marketing freedoms and a transparent, science-based regulatory environment. ITG Brands, she emphasized, is keen to understand its customers. At its size, Reed said, ITG Brands can’t be everything to everyone, but it has a portfolio for all price segments and the advantage of remaining relatively nimble and able to respond quickly to changing consumer demands and preferences.

    ITG Brands has been investing in its Winston and Kool Brands while providing a smoking alternative with its blu e-cigarettes. The company’s sales force has increased to include more than 200 people. While focusing on taste and quality, the company has singled out racing, festivals and music as key touchpoints for communication with adult smokers.

    At the start of her tenure at the helm of ITG Brands, Reed aimed to build a salesforce that best serves their consumers and customers. The salesforce was built to be diverse and dynamic to reflect the diverse consumers the company serves, she said. Reed said she found her experience with other consumer goods companies, such as Pepsi, helpful when she took over at ITG Brands.

    “I try to use lessons learned from consumers to guide not only our business choices but also my personal leadership style,” she explained. “Insights about consumers are critical, and it’s critical to share them with people in our company that work in functions that may be otherwise far removed from daily interaction with consumers.”

    ITG Brands, she concluded, has started a multi-year transformation plan that, based on many initiatives, should strengthen its performance.

  • U.S. Regulation

    U.S. Regulation

    Photo: Chris Ferenzi

    When announcing its comprehensive plan for tobacco and nicotine regulation in 2017, the U.S. Food and Drug Administration stated its ambition to render combustible tobacco products incapable of creating or sustaining addiction, along with its aim to provide adult smokers with a less toxic source of nicotine.

    The agency’s agenda had the potential to transform the nicotine market. In 2019, then-FDA Commissioner Scott Gottlieb emphasized the importance of clarifying “the rules of the road” by explaining to companies what information the FDA needs to review tobacco product applications.

    Five years after the agency’s announcement, however, there are only a handful of authorized cigarette alternatives. To date, only a few tobacco-flavored e-cigarettes have received a green light from the FDA. The single authorized modern-oral product has not been sold in four years.Philip Morris International’s IQOS heat-not-burn product was granted a modified-risk order but is currently unavailable in the U.S. due to a patent dispute.

    The FDA’s comprehensive plan, panelists unanimously agreed, hasn’t worked out. Dave Dobbins, former chief operating officer at The Truth Initiative, an anti-smoking organization, said that in 2017 there was more openness to the FDA’s plan. However, that was stifled by the advent of Juul. Instead of presenting these products as alternatives for adult smokers, he said, Juul Labs marketed them to youth.

    Clive Bates, director of Counterfactual Consulting, described the status quo as a “chaotic rolling fiasco where a credible regulatory regime should be.” Looking back at a regulation impact analysis from 2016, Bates said the FDA had expected to regulate 450 devices and 2,500 e-liquids at an estimated cost of $466,000 per device and $133,000 per liquid.

    Had the FDA known that submissions for more than 6 million products would be made, with the real cost amounting to millions of dollars per application, the agency would have created a more sensible framework, he argued. Being designed to regulate a wide range of nicotine products with a wide range of risks, the current law is unfit for purpose, said Bates. The “appropriate for the protection of public health” concept does not make sense, especially since the respective tests had been so loosely specified that it was open to abuse, he pointed out. “If you can specify very low-nicotine cigarettes as a modified-risk product but deny the order for Juul, this essentially means you can do anything under the umbrella framework,” said Bates. The creation of de facto standards, such as a flavor ban, by using individual assessments rather than going through the rule-making process, was shocking and probably even illegal, Bates explained.

    To help remedy the situation, Bates suggested moving behavioral population studies from premarket assessment to postmarket surveillance. Instead of focusing on individual products, the U.S. should enact a national surveillance system covering the entire market. The barrier to market entry must be dramatically lowered, Bates said, with a focus on individual risk and toxicity. He also called for de facto standards to ease passage through the regulatory process. It would also make sense for the FDA to make some findings of fact to avoid perpetual reinvention of the wheel. “This would lead to a more economically efficient, transparent and predictable process that would help the FDA deal with the backlog and establish an innovation pipeline that doesn’t require a five-year review,” he said. Presently, every applicant must prove the safety case for excipients, nicotine, etc.

    Stacey Ehrlich, partner at Kleinfeld Kaplan and Becker, pointed out that none of the companies had figured in litigation cost when they submitted their premarket tobacco product applications (PMTAs). The FDA’s rejection of all applications for nontobacco-flavored e-cigarettes—condemned by the 11th Circuit Court in August—looks like an attempt to eliminate many applications without having to look at the science, she said. Ehrlich also criticized the agency’s lack of transparency: “Companies that received a marketing denial order still don’t know why their product failed to get a PMTA,” she said.

    While claiming a commitment to science-driven policymaking, the FDA does not play by its own rules, according to Paige Magness, senior vice president of regulatory affairs at Altria. “FDA does have guidance on PMTAs but clearly didn’t follow the science when they applied the Fatal Flaw rule,” she said, referring to a shortcut the regulatory agency used to expedite the processing of applications.

    Ray Niaura, professor of social and behavioral sciences and epidemiology and chair of the Department of Epidemiology at New York University’s School of Global Public Health, urged the FDA to make greater use of modeling and to better explain the rationales for its decisions.

  • Hong Kong May Reverse Vapes Re-Export Ban

    Hong Kong May Reverse Vapes Re-Export Ban

    Photo: Cozyta

    Hong Kong may reverse its ban on the re-export of e-cigarettes and heated-tobacco products, reports the South China Morning Post, citing unnamed sources.

    In April, the city prohibited the sale, manufacture and trade in alternative smoking products.

    Authorities are now reportedly considering amending the law, with an eye on the billions of dollars that trade generates annually.

    Hong Kong is close to Shenzhen, the world’s largest manufacturing hub for vapor devices.

  • Brian King

    Brian King

    Photo: Chris Ferenzi

    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 in Washington, D.C., 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.

    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.”

  • Adam Afriyie

    Adam Afriyie

    Photo: Chris Ferenzi

    Adam Afriyie, Member of Parliament for Windsor and vice chair of the All Parliamentary Group on Vaping, examined the successful U.K. approach to tobacco harm reduction and the lessons it might hold for other countries.

    This was an appropriate time to do so, he insisted, with life returning to a semblance of order following the Covid-19 pandemic and regulators around the world poised to make decisions—“life-and-death decisions”—about alternatives to smoking.

    Despite progress, smoking still kills 75,000 people in England yearly. Britain’s National Health Service spends about £2.5 billion ($2.82 billion) annually treating smoking-related illnesses. Every year, tobacco use results in economic losses of £17 billion through ill health, absence and low productivity.

    Afriyie distinguished four elements in the U.K. approach, which started with Britain setting a target to make smoking obsolete by 2030.

    Second, the government and the health establishment accepted the evidence that vaping and other smoking cessation products, such as patches, pouches and snus, are all part of the legitimate arsenal of weapons against smoking—a conclusion that was reinforced by the Department of Health’s conclusion that vaping is at least 95 percent less risky than smoking. “What matters is the relative harm,” said Afriyie. Rather than relying on conjecture, emotion or the fear of Big Tobacco, the government relied on data, he noted.

    Third, the government regulated vaping as consumer product, setting minimum standards for quality and safety, such as a requirement to sell e-liquids in child-resistant packs. This framework, said Afriyie, allows adults to make informed decisions while protecting children from marketing and harm. All new products must be registered with the Medicines and Healthcare products Regulatory Agency. While vapes are not considered medical products in Britain, this prerequisite installs a discipline among manufacturers to be cognizant of the evidence base behind their offerings, said Afriyie.

    Finally, the government commissioned an independent review of the progress toward its smoke-free objective. Published in June, the Javid Kahn report concluded that Britain would miss its target if it continued on the current trajectory. To get the project back on track, Kahn suggested that vaping must be front and center of the drive to eradicate smoking. In light of widespread misperceptions about vaping—50 percent of general practitioners are unaware that vaping is less harmful than smoking—the report also recommended opening a conduit for the industry to communicate the benefits of switching from cigarettes to vapes directly to smokers.

    While Afriyie was inspired by the level of technical innovations in nicotine-delivery products, he was less encouraged by the equally important innovation or evolution of regulatory frameworks internationally. For example, while heat-not-burn products have been thriving in Japan, vapes are nearly impossible to access in that country because they are treated as medical products rather than consumer products.

    The World Health Organization, too, should adopt the U.K. approach, according to Afriyie. Unfortunately, the global health body’s direction of travel, he said, appears to be made in “smoke-filled” rooms, lacking transparency. Rather than basing its policies on science, said Afriyie, the WHO’s stance on tobacco harm reduction products appears to be subject to influences that are not directly to do with public health.

    Concluding his presentation, Afriyie addressed each of the stakeholders in the tobacco harm reduction debate. “My message to smokers is please stop. And if you can’t stop, choose a vaping device or a heat-not-burn product—but move on. My message to investors: Britain is open for business.” His comment drew good-natured laughter, but Afriyie was only half joking, reminding his audience that when it comes to smoking cessation products, Britain is a gateway to the world. “The U.K. regulatory imprimatur on your documentation is a sign of quality and an aid to marketing and acceptance around the globe,” he said.

    “My message to industry: Be good. Conduct open, honest research,” said Afriyie. “If the answers aren’t exactly what you want, don’t hide the results. Every bit of extra information and knowledge that we gain through research is useful.” To regulators, Afriyie stressed the importance of following the science. “Follow the U.K.,” he said. “Do not let the perfect be the enemy of the good.”

  • Science, technology and innovation

    Science, technology and innovation

    Photo: Chris Ferenzi

    Continuous innovation is crucial to the tobacco industry’s transformation process. A substantial part of it is driven by freshly recruited talents from fields not linked to the sector in the past, such as consumer electronics. Despite their far-reaching consequences, the massive changes in the tobacco industry over the last decade have gone largely unnoticed on the outside, causing outdated stereotypes to persist and making talent acquisition challenging.

    To be successful, employers must understand what great talents want today, said Steve Marley, founder and CEO of Ashwood International. “They seek inspirational leadership, flexibility and autonomy; there must be a sense of value and purpose in their job, and they want an inclusive workplace. To attract the best, companies need to make a stance—they must embed environmental, social and governance (ESG) goals in their talent acquisition strategy, build a progressive value proposition and broaden their talent reach.” Today, employees are no longer human resources, but stakeholders, Marley added. “The sooner a company realizes that, the more attractive it will be.”

    Carlista Moore Conde, group head of new sciences at BAT, echoed Marley’s points. Coming from a background in consumer goods, she said she joined BAT because she was attracted to its purpose—helping adult smokers quit combustible cigarettes. Her uncle had died in his mid-sixties from a tobacco-related disease. “To manage consumer satisfaction risk, disruptive science and innovation is required,” she said. “In product development, nicotine companies need to ask themselves the same questions as other fast-moving consumer goods companies and can perhaps learn from them—their products do not only have to taste good but need to give emotional and social benefits as well.”

    In recruiting, innovation in the tobacco industry has made a huge difference, said Philip Evans, senior advisor at the Boston Consulting Group (BCG). BCG has investigated the issues of trust and reputation that continue to haunt the tobacco sector. “The trustworthiness of a company goes up and down with the industry,” explained Evans. “Trust is slow to build and quick to destroy. For companies, it is important to carry a sense of purpose at every opportunity. The issue of trustworthiness in different countries is co-related and needs to be worked at.”

    Deepak Mishra, president of the Americas region at Philip Morris International, emphasized the shift toward consumer centricity in R&D, which didn’t exist in the industry 10 or 15 years ago. “We need to understand the needs of consumers. Creating a matching portfolio that gets adult smokers to switch to less hazardous products is critical.” He named misinformation, a hindrance through flawed science, as continuous external impediment. “It is getting better every year, but education of the consumer remains important,” he said.

    As important issues for the future, panelists singled out partnering across the industry and a clear model of innovation. Players seeking to merely follow the leading companies in their process of transformation should recognize that no company can ride on the tails of another company—every player is responsible for its own transformation.

  • Brad Rodu

    Brad Rodu

    Photo: Chris Ferenzi

    Brad Rodu, a U.S.-based professor working at the University of Louisville Department of Medicine’s James Graham Brown Cancer Center, delivered a short, sharp shock to attendees at the recent GTNF.

    His presentation was short, under 10 minutes in length, and therefore, by necessity, sharply focused on what was a shocking message, though one that, in different forms, GTNF participants have become all too used to hearing.

    “The mission of a tobacco-free society drives the tobacco control industry, and it is driving bad tobacco science, which is not being addressed either pre-publication by peer reviewers, or post-publication, in any systematic way,” Rodu said at the end of his presentation. “And these … studies, if they are left alone, if they’re not challenged, they are going to deter smokers from switching [from combustible cigarettes to less risky tobacco and nicotine products]. We’ve already seen that, and we’ve had presentations about that. And I believe they will support harsh and unfair regulation.”

    That needs some context, which Rodu provided at the start of his presentation when he told his audience that the U.S. federal government’s mission, the focus of its tobacco program, was aimed at creating a tobacco-free society. Under this program, hundreds of millions of dollars were being transferred from the Food and Drug Administration to the National Institutes of Health, and from there to universities around the U.S. for funding research on tobacco products.

    The issue here is not that this research is being carried out but the way in which it is being carried out. Rodu said that a lot of the research was beset with problems, and he put up a slide showing a list of studies that he and his team had looked at critically and had commented on formally: reviews that could be found on the websites of the journals that had published the original research or on the websites of other journals. The list of studies was formidable, so he mentioned just a few. His team had looked, for instance, at the finding that the U.S.’ smoking population had been “softening” and that harm reduction was therefore unnecessary, a finding—a suggestion—that would have left many in the audience agape. They had looked, too, at the finding that vaping by teenagers was causing them to smoke, that tobacco product use of any sort was increasing mortality, that vaping by teenagers was related to Covid and that vaping by adults was causing heart attacks …. The last-mentioned finding Rodu described as the most famous one because his team had had that paper retracted.

    Rodu then highlighted recent studies that basically claimed to have found that vaping is associated with myocardial infarctions or heart attacks, chronic obstructive pulmonary disease, asthma, emphysema, other pulmonary disorders, strokes and other medical conditions. In reporting these diseases, the researchers had claimed to have statistically accounted for smoking. But Rodu said these claims were completely unreliable, and he described why.

    Rodu and his team found that none of the studies had information about the ages when participants had started smoking, started vaping or when they were first diagnosed with these diseases. When Rodu’s team analyzed the FDA Population Assessment of Tobacco and Health data, which contained this information, they found that all but a tiny percentage of diseases were diagnosed after participants started smoking but before they started vaping. And the small number of people who were diagnosed with diseases about the time they started vaping had all been smokers, making it highly unlikely that those diseases had been caused by vaping.

    Rodu said the bottom line was that studies that did not take into account the ages of people when they started to vape and smoke, and when these vapers and smokers became ill, were unreliable.