Tag: science

  • Abboud Shares Insight Into VTA’s Goals for 2023

    Abboud Shares Insight Into VTA’s Goals for 2023

    Credit: f11photo

    The Vapor Technology Association continues its mission to promote sensible regulation.

    By Timothy S. Donahue

    In many countries, such as the U.K., vaping is synonymous with harm reduction. These governments recognize the harm reduction benefits of vaping versus smoking combustible cigarettes. They actively engage their citizens in “swap to stop” efforts backed by sound policy and known science.  

    In the U.S., however, the Food and Drug Administration is actively pursuing policies that protect, if not elevate, combustible tobacco products’ status in the marketplace and limit consumer access to alternatives that are safer than cigarettes, according to Tony Abboud, the executive director of the Vapor Technology Association (VTA). Abboud and the VTA have been instrumental in advocating for rational science-based regulations for vaping products that will enable a diverse and robust industry to thrive in the U.S.

    Vapor Voice sat down with Abboud to discuss the current state of vaping and the future of the VTA. He said that one needs only look at the fact that the FDA is authorizing combustible tobacco products over less harmful vaping products at a rate of 45:1. This is a huge problem for an evolving and innovative industry but with graver public health consequences.

    Vapor Voice: What is the current state of the vaping industry in the U.S. in your opinion?

    Tony Abboud
    Tony Abboud, director of the Vapor Technology Association. To learn more about the Vapor Technology Association

    Abboud: Today, the U.S. industry remains in unnecessary regulatory chaos due to the FDA’s lack of vision in executing its statutory obligations, loss of focus on its harm reduction mission and reactionary decisions made to ameliorate political pressure of special interest groups untethered from science. 

    [The] FDA’s obstinate inability or refusal to speak truthfully about the importance of less harmful nicotine alternatives, such as vaping and modern oral nicotine products, is imperiling its clearly articulated mission to end smoking. Specifically, [the] FDA’s actions to date have only driven up the public’s irrational fear of nicotine vaping, a fear that can only cement consumers’ bond with cigarettes. 

    [The] FDA’s unscientific and dramatic policy shifts (cloaked as case-by-case decision-making) have plunged the agency and the industry into costly and unnecessary litigation that will take years to resolve, and, thus, it will be years before a rational regulated marketplace will exist. The net result is that, rather than creating a clear and achievable pathway for innovative companies to introduce new technologies that are 2 [times] to 3 times more effective at helping people quit smoking than the few products, FDA’s actions will continue to drive a wedge between people who smoke cigarettes that kill and the myriad options that will give them dramatic relief.

    It is essential that companies in the industry galvanize behind thoughtful efforts to reset the narrative, demand accountability and make common sense changes. It is equally essential that [the] FDA resets its narrative, unapologetically follows the science and uses its power not to rob Americans looking for alternatives to cigarettes but empower them with myriad attractive options that will entice them to switch.  

    Now that the Covid shutdown and Zoom calls have ended, what has changed for the VTA?

    Organizationally, one of the biggest impacts of Covid was the recognition that we had to focus our efforts on the biggest challenges that needed to be addressed rather than taking on every fight. That refocusing has enabled us to architect a thoughtful and impactful strategy to engage with policymakers and decision-makers on the issues most critical to our industry and to public health.

    From a practical perspective, the biggest change in the reopening of this country has been the reopening of congressional offices, which only fully occurred this year. That change has made it possible for our team to sit down across the table this year and have meaningful and essential conversations with congressional offices and to bring voices into the fold that have not been heard before. We are on pace this year to far outstrip our prior levels of congressional engagement with a clear and persuasive policy message not only based on science but also supported by leading tobacco control scientists.

    What are the VTA’s goals for 2023?

    There are 34 million Americans who still smoke. Every two years, a million of them will die from smoking-related diseases. This is an unconscionable and ongoing public health crisis. We can save tens of thousands of lives by not hiding the fact that vaping is far less risky than smoking.

    In this year, our priorities are a set of common sense new marketing standards and smart science-based access restrictions for flavored vape products to ensure such flavored products remain available for adult smokers while less accessible to youth. At the same time, we will continue our constructive engagement with [the] FDA to provide insight on the key policy issues and specific regulatory strategies that are necessary to achieve a rationally regulated marketplace.

    What will it take to accomplish these goals?

    Despite the FDA’s parroting of its mantra that it “follows the science,” the examples of where it has failed to do so have become too numerous to ignore. And despite the FDA’s proclaimed concerns about misinformation, the examples of which it has engaged in are simply too extreme to believe that the agency can easily correct the course it has embarked upon to denigrate, dismiss and deny alternative nicotine products. Hence, public pressure, congressional oversight and accountability in the courts all are necessary to ensure that FDA adheres to the science, follows the law and corrects the record.

    In addition, notwithstanding the dramatic decline in youth vaping (now at pre-“epidemic” levels) that has taken place even with the broad availability of flavored products, the industry must continue to demonstrate its commitment to reducing youth access and appeal by supporting long overdue and common sense marketing restrictions that will further reduce underage use. Additionally, just like with 21-plus legislation, for which the industry advocated, new 21-plus policies can further limit youth access to flavored vaping products.

    Given the chaos in the marketplace created by [the] FDA’s past and present actions, and its apparent policy to bar every nontobacco-flavored vape product from the marketplace, congressional action can help calm the chaos by adopting leading tobacco control scientists’ recommendations that flavored vape products be sold in adult-only stores, making them less accessible to youth while preserving the availability of adults. All of our goals and strategies are based on both data and science as we continue to amplify the voice and role of science in the decision-making process.

    Is there any hope for open systems and/or flavors?

    Yes. Facts are stubborn things. There is no scientific or real-world evidence that youth are attracted to or use open systems in any material numbers. At the same time, data from the National Youth Tobacco Survey year after year proves that flavors are now one of the least cited reasons that youth may experiment with vaping.

    And each day, more and more peer-reviewed science is published proving the important role that flavored vaping plays in the decision to switch away from deadly combustible cigarettes, particularly when compared to the FDA’s favorite ineffective solutions. There is also hope in the fact that the industry will continue to innovate.

    There will be new technologies that capture the market in the future, and we should be open to that—and so should [the] FDA. Flavors are proven to be the preference for adults who are looking to quit, and adults are more likely to succeed when flavors are available to them. Consumers’ demand for flavored nicotine products should be no more paternalistically rejected than consumers’ demand for cannabis products. 

    Are nontobacco nicotine products going to gain broad acceptance, especially with regulators?

    Well, that is entirely up to the FDA now that Congress was convinced by certain industry players that nontobacco nicotine was somehow a problem. True, it was a problem, but primarily for certain businesses which were dependent on tobacco-derived nicotine. But the reality is that nontobacco nicotine is the cleanest and purest form of nicotine available on the market, which is perfectly replicable and traceable to the batch level.

    Nontobacco nicotine is precisely the type of innovation in a constantly changing landscape that should be encouraged as the industry advances toward a combustible-free future. Regulators have a huge opportunity to use their authority to regulate nontobacco (synthetic) nicotine products and to encourage their entry into the marketplace. But, given [the] FDA’s current trend toward eliminating virtually all nicotine alternatives from the market, one can only question whether [the] FDA could seize the opportunity to provide consumers access to products that would allow them to break free from the last vestige of tobacco.

    Do you see congressional action as the only cure to the current FDA regulatory process?

    Congressional action can help, but the challenges are significant. There are three ways that Congress can assist. The first is through its oversight committees, which have jurisdiction to question the FDA’s prior actions that have been inconsistent with the law and inconsistent with, according to CTP’s [Center for Tobacco Products] scientists, the science on vaping.

    The second is through its appropriations committees, which must question exactly how FDA is using the hundreds of millions of dollars it receives, why it uses the majority of its resources to remove e-cigarettes from the market while ushering hundreds of new cigarettes to the market and what could possibly justify its request for another $100 million in fees that ultimately will be borne by the vaping consumer (giving them yet another disincentive to switch).

    The third is through committees of jurisdiction that can end the absurd discussion of “ban, ban, ban” when it comes to flavors and instead focus on real solutions to real marketing issues of which vaping opponents have complained for years but have never truly sought to address.

    Congressional action is not the only cure because [the] FDA currently has placed its thumb on the scale by creating a standard for companies seeking to comply and secure marketing approval without giving them the knowledge or opportunity to do so. For that reason, [the] FDA appears content with letting the courts sort out the mess that it has created.

    After all, CTP appears to take delight in declaring that every vaping product on the market is “illegal” and “cannot be lawfully marketed” except for the small handful of tobacco-flavored products [the] FDA has authorized. So, while regulators often complain about industry lawyers, it should come as no surprise that the actions of prior agency leadership, which in a very short period of time demanded a complete reversal of CTP’s priorities, plans and policies as they related to flavored vaping products, would lead to legal challenges.

    In the end, any branch of our federal government can have a major impact in fixing the mess created by a disregard for science and the law. The question now is which one(s) will do so.

  • As Smoking Declines, More Adults Switching to Less-Risky Vaping Products

    As Smoking Declines, More Adults Switching to Less-Risky Vaping Products

    U.S. cigarette smoking dropped to another all-time low last year, with 1 in 9 adults saying they were current smokers, according to government survey data released Thursday. Meanwhile, electronic cigarette use rose, to about 1 in 17 adults.

    The preliminary findings from the U.S. Centers for Disease Control and Prevention are based on survey responses from more than 27,000 adults.

    Cigarette smoking is a risk factor for lung cancer, heart disease and stroke, and it’s long been considered the leading cause of preventable death.

    Last year, the percentage of adult smokers dropped to about 11 percent, down from about 12.5 percent in 2020 and 2021. The survey findings sometimes are revised after further analysis, and CDC is expected to release final 2021 data soon.

    E-cigarette use rose to nearly 6 percent last year, from about 4.5 percent the year before, according to survey data.

  • Louisiana Lawmakers Take Flavor Out of Vaping

    Louisiana Lawmakers Take Flavor Out of Vaping

    Baton Rouge, capital of Louisiana (Credit: Fang)

    In the U.S. state of Louisiana, the House Judiciary Committee voted 7-3 Thursday to advance a bill prohibiting flavored nicotine-based e-liquid products.

    House Bill 179, was authored by Rep. William Wheat who is concerned with the rising use of vapor and tobacco products by younger people. He described it as being “in epidemic proportions.” Brian King, the head of the U.S. Food and Drug Administration’s tobacco center, recently said that there is currently no vaping “epidemic.“

    Witnesses testified about the dangers of vaping. One witness was the mother of a Baton Rouge boy who died after using vapor and nicotine products, according to media reports.

    According to Wheat, 52 percent of high school students have tried e-cigarettes — three times as many as in a study done in 2015.

    The most recent data available from the Louisiana Department of Health’s 2019 youth tobacco survey found that 15 percent of middle school students and 32 percent of high school students currently vape. The trend of youth vaping has declined dramatically since 2019. The U.S. Centers for Disease Control and Prevention reports that in 2022 only 14 percent of high schoolers vape nationally, according to the AP.

    Wheat said a bill was passed in a prior session making it illegal for someone under 21 years old to buy tobacco and nicotine products. However, that has not stopped younger people from obtaining them.

    He went on to say he was trying to “make sense of that and get things headed in a different direction.”

    “HB 179 is not a perfect answer,” Wheat said. He added: “But it is our job to make the first step.”

  • More to NJOY

    More to NJOY

    As Altria sheds the burden of Juul, its leaders are hoping investors ‘Njoy’ the company’s new outlook.

    By Timothy S. Donahue

    It would have been hard to imagine less than five years ago. In September of 2018, Juul had a U.S. vapor market share of 72 percent. By mid-March of this year, Juul’s market share had plummeted to 25.6 percent and continues to drop. Meanwhile, R.J. Reynolds Vapor Co.’s Vuse products have grown from single digits to a more than 47 percent market share during the same period.

    Altria, Juul Labs’ largest minority shareholder, had to do something. Juul’s baggage of lawsuits for youth marketing and ongoing battle with the U.S. Food and Drug Administration over marketing denial orders just became too much to bear. After devaluing its $13 billion investment in Juul Labs to less than $250 million earlier this year, Altria stated that it would exchange its entire minority investment in Juul Labs for a nonexclusive global license for some of Juul’s heated-tobacco intellectual property to potentially boost its IQOS heated-tobacco products. It then did something that surprised no one in the industry.

    The next day, Altria Group announced it had entered into an agreement to acquire Njoy Holdings for approximately $2.75 billion in cash. Altria said it had multiple sources of funding for the deal, including cash from a $2.7 billion agreement with Philip Morris International last year for IQOS. In less than a week, Altria went from vaping product purgatory to owning the best vaping product on the market with a U.S. marketing order, the Njoy Ace. In total, Njoy Holdings has received six of the 23 marketing orders granted by the FDA as of this writing for the entire vaping product category, including pods, disposables and open systems.

    The other major factor in purchasing Njoy is the product didn’t come with the stigma tied to youth vaping, according to Altria CEO Billy Gifford. Speaking during an investor call, Gifford said that his company evaluated Njoy’s marketing practices and national survey data regarding underage use of Njoy tobacco products.

    “We believe Njoy has taken a responsible approach to marketing its products. According to the 2022 National Youth Tobacco Survey, Njoy-branded products are not included among the top usual brands among middle school and high school e-cigarette users. Additionally, Njoy is developing access restriction technology for its devices to further address underage use,” explains Gifford. “Our consumer research indicates that once consumers try Njoy Ace, it is a competitive product for both smokers and vapers. After trying the authorized nonmenthol Ace variant, 19 percent of surveyed smokers and 27 percent of surveyed vapers indicated that they would definitely buy the product.

    “The Ace results were on par with the post-trial findings for Vuse Alto nonmenthol and better than those for Juul nonmenthol. We observed similar post-trial results for the Ace menthol variants when compared to Vuse Alto and Juul menthol products. This encouraging research supports our belief that Ace is a compelling proposition.”

    The FDA said that it authorized Njoy’s products because they were found to meet the appropriate for the protection of public health standard as, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.

    Further, data provided by Njoy demonstrated that participants who had used only the authorized Njoy Ace products had lower levels of exposure to HPHCs compared to the dual users of the new products and combusted cigarettes. Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.

    Additionally, the FDA considered the risks and benefits to the population as a whole, including users and nonusers of tobacco products and, importantly, youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing.

    Open access

    Altria has the ability to take Njoy products to the top. Gifford said that a large number of tobacco consumers are not currently aware of nor have access to the Ace vaping system. Njoy’s Ace, the most technologically advanced FDA-authorized vaping product, is currently available only in an estimated 33,000 stores. Altria services more than 200,000 U.S. stores. Njoy’s sales force is fewer than 50 people. Altria has 1,600.  

    “As a result, total U.S. retail share for Ace pods in 2022 was only 3 percent. Yet, we know that Ace has performed better in stores where it’s visibly merchandised and has consistent distribution. In the top 5 chain accounts where Ace competes with Vuse Alto and Juul, the weighted average share for Ace is approximately 11 percent,” Gifford said. “We believe we can responsibly accelerate U.S. smoker and competitive vaper adoption of Ace in ways that Njoy could not as a standalone company.”

    During the session, Bonnie Herzog, managing director with Goldman Sachs, questioned whether Altria would need to reposition the Njoy brand or change its strategy considering the brand’s relatively small share of the market. After all, several devices have done very well in the market and then disappeared or lost their position. Chris Growe, with Stifel Financial Corp., wanted to know what made the Ace device so unique. Could the Ace device develop another level of brand loyalty it had yet to reach? Gifford said Altria has an extensive relationship with retailers that its “sales force has built over decades.” It’s all about consumers having better access.

    “You’re going to see loyalty in these new spaces that we experience in the tobacco category. When you see the consumer, they’re trying various products. They’re looking for products that satisfy their unmet needs and desires, and once they find a satisfying product, it’s up to us to build a brand around that. I think when you look at Njoy, and I’d reference you back to the consumer research, it was both smokers looking to transition and how they rank the products in the marketplace as well as existing vapers, people that have already converted, and their preference there,” Gifford told the investment advisers.

    “I think you see that we believe this is a strong asset because not only does it bring certainty around the authorization but the consumer is telling us they have preference for this product over some of the other products in the marketplace. That’s the way we think about it and are extremely excited to, again, have that base IP, have a product ready in the marketplace, but then be able to develop on it as we move forward,” Gifford said.

    Gifford told Priya Ohri-Gupta, with Barclays, that prior to closing the deal, Altria would offer none of its services to Njoy but that after closing, Njoy would experience all of the assets Altria has at its disposal. “Our sales force, our regulatory team, our government affairs team, all of that would be available subsequent to close,” said Gifford.

    Gifford said that in the next few years the company expects the FDA will complete marketing determinations on the remaining premarket tobacco product applications, including those filed for synthetic products. He said he also hopes the agency will implement the suggestions from the Reagan-Udall Foundation report.

    Altria expects the vaping market to remain “in flux” until the FDA goes through the enforcement process and removes unauthorized products from the market. Over the next 10 years, U.S. volumes will grow at a single-digit compounded annual growth rate, Gifford predicted.

    After the Njoy acquisition is finalized, Altria will have a compelling portfolio of products and technology across the three largest smoke-free categories, according to Gifford. In the vaping segment, the company will fully own the only FDA-authorized, pod-based product on the market. In oral tobacco, it owns the largest brand, Copenhagen, and holds 100 percent of the global rights to On!, one of the fastest-growing nicotine pouch brands in the U.S. last year.

    “We have differentiated new products in development. And in heated tobacco, we have the majority-owned joint venture with JT Group for the U.S. commercialization of the next-generation Ploom device and Marlboro heated-tobacco sticks,” said Gifford. “We [also] have full ownership of an exciting heated-tobacco capsule technology, which we will discuss further at our Investor Day.”

    Gifford also explained that the Juul IP rights deal is centered on the Ploom device and the capsule technology. He told Herzog that Altria viewed the technology as “very interesting,” and it allows Altria to put it “in the toolkit” of its product developers. That would give Altria the ability to market the new product anywhere around the world. “Our focus, of course, would be the U.S. because that’s the biggest opportunity we see in products,” said Gifford.

    When asked when new heated-tobacco products using the newly acquired IP would make it to the U.S. market, Gifford’s answer became lost in translation. Deciphering the double talk quickly, Herzog ended the conversation by clarifying Gifford’s answer, saying, “OK. So, in a few years. Appreciate it. Thank you.” Gifford did not disagree with Herzog’s assessment.

  • Watchdog Group Says FDA Ignoring Science on Vapor

    Watchdog Group Says FDA Ignoring Science on Vapor

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    The government watchdog group Protect the Public’s Trust filed a complaint with the Department of Health and Human Services over what it says are scientific integrity violations involving the impact of vaping.

    The complaint states the U.S. Food and Drug Administration is promoting public health messages on vaping that appear to be unsupported by its own research and scientific findings, according to Center Square.

    Protect the Public’s Trust stated the FDA was making “scientifically unfounded statements about the vaping industry” contrary to its own research, adding the agency’s own data appeared to contradict the FDA’s public stance on vaping products.

    Protect the Public’s Trust said an FDA report found that “only a subset” of the many harmful compounds found in cigarettes are found in vapes and “at much lower levels” than those in cigarette smoke. That FDA report found that menthol-vapes were helping adult smokers quit cigarettes better than fruit, candy or traditional tobacco flavors.

    In the complaint, Protect the Public’s Trust stated that FDA Commissioner Scott Gottlieb presented vaping as comparable to smoking traditional cigarettes because “several of the dangerous chemicals in tobacco smoke are also present in the aerosol of some [vaping] products.”

    The FDA didn’t respond to an email seeking comment.

    But the FDA declared that “Vaping is not harmless. It carries real health and safety risks, including addiction and other negative health effects.”

    “Many studies suggest e-cigarettes and noncombustible tobacco products may be less harmful than combustible cigarettes. However, there is not yet enough evidence to support claims that e-cigarettes and other ENDS [Electronic Nicotine Delivery System] are effective tools for quitting smoking,” the FDA stated on its website.

    Protect the Public’s Trust stated there has been a pattern of the government not following “the science.” Protect the Public’s Trust also claimed in December 2022 that the Centers for Disease Control and Prevention failed to track side effects of taking the COVID-19 vaccine.

    “Once again, it appears that federal public health leadership has chosen to sacrifice scientific integrity and the public’s rapidly disappearing trust on the altar of political and special interest agendas,” said Michael Chamberlain, director of Protect the Public’s Trust, in an email to The Center Square. “While we were promised that health officials would follow the science, what we have observed instead is a disturbing trend of ignoring or disregarding scientific research and data that don’t fit their particular biases.”

  • Focus on Harm Reduction

    Focus on Harm Reduction

    Experts share their insights relating to tobacco harm reduction during the April 25 In Focus webinar

    In the run-up to the 10th Conference of the Parties to the Framework Convention on Tobacco Control in Panama (COP10) this November, public health professionals, industry representatives and policy experts on April 25 shared their insights into issues relating to tobacco harm reduction (THR) and sustainability as part of the GTNF’s IN FOCUS online series. Following is a summary of the presentations and panel discussions.

    Contributed

    Credit: Red Pixel
    James Murphy

    James Murphy, director of research and science at BAT, opened by saying that tobacco harm reduction is simple in concept: the switching of people who wish to use nicotine from risky forms of combustible tobacco products to lower risk tobacco and nicotine products. He noted that THR was the reason he joined the industry as a scientist almost 20 years ago, and that motivation remains today as the principal driver for coming to work each morning. His focus is making THR the centerpiece for all of BAT’s scientific research efforts.

    Murphy outlined that the challenges to THR are many, but they are outweighed by the opportunities for reducing the health impact of the industry across the globe if stakeholders get it right. He sets out four key topic areas for his remarks: 1) the benefits of THR for reducing the impact of the industry on global public health; 2) the key challenges facing THR; 3) the need for a common view on the race to zero combustion; and 4) the importance of science.

    Murphy stated that adult smokers who wish to continue to use nicotine now have access to a range of reduced-risk products that are better for them and for those around them. In countries that have embraced the concept of THR, including Sweden, the U.K., Japan and the U.S., there have been significant declines in smoking rates as smokers have migrated to noncombustible products, such as heated-tobacco products, vapor products and oral nicotine and tobacco products. Real-world evidence continues to be collected that indicates improvements in quality of life and lower instances of smoking-related morbidity when noncombustible products displace cigarettes.

    Murphy gave an overview of upcoming opportunities for THR to be discussed globally, including the U.K. government’s upcoming publication of a new tobacco control plan, the COP10 meeting in Panama, the recommendations from the Reagan-Udall Foundation’s evaluation of the U.S. Food and Drug Administration’s Center for Tobacco Products, and proposals in 2024 from the EU around the third Tobacco Products Directive (TPD).

    He set out four key challenges on THR: 1) objective science remaining at the core of the debate, with agreed frameworks for all stakeholders on assessing the risk profile of noncombustibles; 2) ensuring each country offers consumer access to regulated noncombustibles; 3) regulations must be enforced to prevent unregulated black market products being sold to consumers; and 4) preventing youth access to nicotine products and balancing the debate with the benefits of adult smokers switching to lower risk products.

    Murphy then turned to the importance of the race to zero combustion, setting out the relative harm reductions (90 percent to 95 percent less) from heated-tobacco, vapor and oral products as compared to combustibles. Consumers using lower risk noncombustible tobacco and nicotine products experience substantially lower levels of toxins, comparable to levels observed in those who quit using tobacco products altogether.

    He focused on the need for the industry to codify what is meant by THR: a race to zero combustion, not zero nicotine use, and reducing cigarette prevalence to below 5 percent, the accepted threshold for effectively zero in a country. He highlighted Sweden, which, through the use of snus and oral tobacco products, will achieve its smoking target 16 years ahead of the EU and has the lowest smoking-related disease outcomes anywhere in the EU.

    He then turned to the importance of world-class science in providing a robust evidence base to substantiate the role of reduced-risk products (RRPs) in global THR. Regulators need it to form the basis of regulation; politicians need it so they can cut through the rhetoric; and consumers need it so they can feel confident in switching to lower risk products. He remarked that industry science is necessary as regulators require specific data on the manufactured products, as seen in the U.S. with premarket tobacco product application (PMTA) regulations or in the EU with the TPD.

    Murphy closed by lamenting the polarization of the global debate on THR and the lack of scientific conferences where all stakeholders—industry included—can debate scientific studies and come to common conclusions on THR science to drive progress forward. His final remarks highlighted that the race to zero combustion has only really begun and that common science conclusions must form the basis of what the industry does.

    Riccardo Polosa

    Riccardo Polosa, professor of internal medicine at the University of Catania and founder of the Center of Excellence for the Acceleration of Harm Reduction, began his remarks by stating that there is no doubt that the evidence in favor of e-cigarettes being effective in terms of smoking substitution is quite strong. He highlighted the systematic reviews, randomized control trials and population studies that show evidence that e-cigarettes are important tools in helping smokers quit.

    Turning to heated-tobacco products (HTPs), Polosa explained that it is true that HTPs are similar to e-cigarettes in that they deliver nicotine in an equivalent range and mimic the ritualistic aspects of cigarettes, and both have a potential for smoking substitution. Although there is population evidence to suggest that HTPs are effective in this, to date, there have been no real randomized controlled trials that have proved these assumptions.

    He set out that researchers at the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) had designed and conducted a study to directly compare e-cigarettes with HTPs, involving the first randomized controlled trial of HTPs, in order to compare the effectiveness, tolerability and acceptability of both HTPs and refillable e-cigarettes for the purposes of cigarette substitution. The design of the study was standard: a switching trial, involving the randomization of 220 smokers not intending to quit but interested in trying new technologies and tar-free products. These 220 random subjects were split across two different products: IQOS 2.4 for HTPs and Justfog Q16 for e-cigarettes.

    Polosa highlighted that the results showed clearly that the efficacy in terms of smoking substitution for HTPs is impressive, demonstrating how HTPs can help smokers to quit, with a continuous abstinence rate of 39 percent for HTPs versus 30.8 percent for e-cigarettes. He also showed that the number of dual users reduced over time, with the number of quitters increasing over time, and commented that this is a trajectory not normally seen in conventional smoking cessation trials.

    Looking at risk perception, Polosa stated that there was no difference between the two groups: People using e-cigarettes perceive conventional tobacco as fairly high risk whereas they do not perceive their smoke-free product to be as risky as tobacco or conventional cigarettes. He also highlighted that both groups showed a clear improvement in terms of exercise tolerance over time, with results apparent even in week 4 of the trial, very early after switching.

    He concluded by answering the question of whether HTPs are successful: yes.

    Delon Human

    The next speaker, Delon Human, president of Health Diplomats, started by quoting the definition of Article 1d of the World Health Organization Framework Convention on Tobacco Control (FCTC) and highlighted the phrase “harm reduction strategies” (HRS). He went on to set out that the overall goal of population health is to prevent disease and premature death, but it is important to remember that these are individuals with different needs and lifestyles. It is also important to include health professionals in any discussion on HRS to balance the needs of populations and individual health as well as the rights of individuals to access healthcare and to use nicotine products.

    He stated that he wanted to make three suggestions to accelerate THR.

    The No. 1 issue for Human is engagement. A whole-of-society and whole-of-government approach, involving multi-stakeholder action, is required, and more needs to be done with key stakeholders in the tobacco and nicotine industries, particularly regarding engagement with the WHO and governments. He continued by saying that Article 5.3 of the FCTC does not exclude engagement between industry and government; complex problems can only be solved with multi-stakeholder engagement, and engagement does not mean agreement. This engagement with industry is needed to facilitate the crucial exchange of knowledge and data.

    Turning to his second suggestion, Human made the point about the centrality of science in the debate. The “quit or die” approach is ineffective, irresponsible and disrespectful of patients and consumers. They need to hear the full story and have access to information and products that do not involve combustion, specifically reduced-risk alternatives if they cannot or will not quit.

    He highlighted that this transformation can be accelerated if global public health scientists were to embrace the opportunity to test the benefits of adult smokers switching to reduced-risk products. Human commented that, for too long, the argument has been that there is not enough evidence to validate THR in smoking cessation. HRS have been used successfully with HIV/AIDs, drug control and alcohol consumption, and they should be applied to tobacco control. He raised the speed of Covid vaccine testing, which gave a powerful validation of HRS.

    Human spoke to the opportunity presented by COP10 to prepare the ground for further research in HRS and the new evidence available from countries where governments have allowed properly regulated reduced-risk products. Where THR has been adopted, smoking rates have reduced.

    He gave examples: In Sweden, the smoking rate is the lowest in the EU at 5.6 percent whereas Germany has seen rates increase to up to 36 percent. He lamented that “smoke-free Sweden” should be a case study in successful THR, but little attention has been paid to the public health revolution there. In the U.K., the government’s “swap to stop” scheme has both incentivized and funded adult smokers to switch from combustibles to vaping, and more broadly, the country has seen a 4.3 percent decrease in smoking. In Japan, heat-not-burn (HnB) products launched in 2014 and have led to a significant decline in smoking rates: Between 2016 and 2019, the number of adult smokers fell by 10 percent. In the U.S., nicotine products go through a rigorous and scientific PMTA-testing process, which costs hundreds of millions of dollars to companies, and other countries could benefit from this knowledge to support their adult smokers to quit.

    He closed this section of his remarks by suggesting that each example merits a country case study to consider how each THR approach has reduced incidence of smoking-related diseases and premature deaths, and more engagement among the WHO, governments and the whole of industry would facilitate progress in THR.

    Lastly, Human turned to industry contributions to the debate, highlighting the critical role played by the GTNF in bringing stakeholders together. He highlighted several dimensions that merit industry having a seat at the table: 1) R&D capacity, with companies investing greatly in this, including specific knowledge on consumer behavior; 2) product innovation, with all stakeholders needing to incentivize innovation while ensuring consumer safety and high standards; and 3) responsible marketing practices, with the marketing to children of primary concern.

    In closing, Human stated that there are 100 million consumers worldwide who have switched from combustible cigarettes to noncombustible nicotine alternatives, and now is the time to accelerate, transform and modernize tobacco control by injecting HRS, ensuring that affordable, accessible and acceptable alternatives can make a contribution.

    Following his remarks, Human moderated a panel discussion titled “Using the FCTC to Accelerate Tobacco Harm Reduction” that included the following panelists: Grant Churchill, tutor in medicine at New College Oxford and associate professor in chemical pharmacology at the University of Oxford; Ehsan Latif, senior vice president of grants management and health and science strategy at the Foundation for a Smoke-Free World; Mihaela Raescu, professor in the faculty of dental medicine at Titu Maiorescu University in Bucharest; and Heino Stoever, social scientist and professor of social scientific addiction research at the Frankfurt University of Applied Sciences in Germany.

    Human referenced the positive work done around the work in the harm reduction space, specifically citing Sweden, the U.K. and Japan as world-leading in this field. He spoke of Sweden’s incredibly low smoking rates with only 5.6 percent of the population using combustible tobacco.

    He explained that the success seen in these countries needs to be examined in greater detail to highlight why vapes in the U.K., snus in Sweden and heated tobacco in Japan are increasing in popularity.

    Human then detailed how several of his patients have seen remarkable improvements in their taste, smell and respiration since switching from combustible tobacco to RRPs in only two weeks.

    Churchill tailored his contribution around the misconception of nicotine. He emphasized that tobacco, specifically combustible tobacco, needs to be separated from nicotine. He set out the molecular level of nicotine as a compound and explained that nicotine is not harmful in the concentration it exists within RRPs.

    Churchill outlined that tobacco is made up of 4,000 smaller compounds, many of which are harmful. Nicotine represents only one of those 4,000 compounds and is not nearly as damaging as most of the others found in tobacco. For that reason, the education and rebranding of nicotine is critical in establishing RRPs as safe alternatives to combustible tobacco.

    Latif spoke primarily from the regulatory perspective of the panel and led the conversation about the upcoming COP10 summit hosted in Panama later this year. He expressed his concern over a lack of action and not wanting legislators to make rash decisions. He called for all decisions to be led by facts and science, explaining that no RRP category should ever be prohibited as it will only lead to illicit trade and unregulated, untested products.

    Latif echoed the message from Churchill that combustible tobacco is causing the most harm within the industry and that legislators need to take action to reduce the number of smokers. He emphasized this by saying, “You can’t wait 10 [years] to 15 years and then count the bodies at the end … We need some action now.”

    Raescu explained the oral health benefits of switching from combustible tobacco to RRPs, describing how oral health improves drastically within nine months of making the switch. She mentioned that there is a decrease in bacterial plague concentration and quality, resulting in major oral health improvement.

    Raescu also called for improved education for doctors and other health practitioners regarding nicotine and tobacco. She set out her belief that, currently, a lot of misinformation and misunderstanding results in the wrong advice for patients, having a negative effect on their individual health. Nicotine as a compound must be better understood by medical practitioners in order for it to be correctly conveyed to legislators.

    Stoever started by giving a summary of the focus of his career on harm reduction in Germany. Using his experiences from Covid-19 and other emergencies, Stoever emphasized the importance of education and the lack of this in Germany: 60 percent of Germans think the dangers of vaping equate to those of tobacco. Stoever went on to set out that public health agencies in Germany are not providing adequate information on the benefits of reduced-risk products, and this gap has had to be filled by academics.

    He spoke to the changes observed during the pandemic, where people’s lifestyle patterns changed radically to include working from home: There was an increased observance of people smoking during virtual meetings, which demonstrated the effectiveness of normal structural prevention strategies and social controls on preventing smoking besides behavioral prevention.

    Mary Glindon

    The panel discussion was followed by a keynote presentation by Mary Glindon, Member of Parliament for North Tyneside in the U.K. and vice chair of the All-Party Parliamentary Group (APPG) for Vaping.

    Glindon set out her role at the APPG and the reasons for her interest in the topic of tobacco harm reduction. She spoke about her late husband’s transformation from smoking to vaping—his “pipe”—and the impact more widely that smoking has on her constituents in the northeast of England. Not only does she hear from those who have switched that their health has improved but also their finances, given the lower costs of vaping.

    She spoke of her support for the U.K.’s ambition to be smoke-free by 2030 and the work undertaken by the Office for Health Improvement and Disparities (previously Public Health England) since 2015 to support vaping as a key harm reduction strategy, with it being proven to be at least 95 percent less harmful. Going further, Glindon praised the U.K.’s approach—one that she described as world leading and evidence led—with e-cigarettes at the heart of its strategy. She also highlighted the independent review last year by Javed Khan into “making smoking obsolete,” which included support for vaping as one of his key recommendations.

    However, Glindon then spoke of the concerns Khan had also raised in his report that the U.K. will miss its 2030 target if it does not accelerate the rate of smoking decline by at least 40 percent.

    She gave a series of recommendations on what action the government should take to remedy this while being clear that the preference is that people should neither smoke nor vape, nor should nonsmokers take up vaping. She spoke of tobacco harm reduction through vaping in the U.K. being consumer led but that it had left more than 6 million people who had not yet made the switch. Ensuring access to the right information and tackling misinformation and misperceptions of the relative harms of e-cigarettes versus combustible tobacco is key and must be embedded in all approaches on tobacco harm reduction.

    Glindon also stated the need for effective communication strategies from governments, approved and trusted independent health messaging and the inclusion of the benefits of switching on vape packaging and on cigarette packaging too. She raised the need to ensure that medical professionals at local stop smoking services are sufficiently supported to speak authoritatively on reduced-risk products, with clinicians signposted to the latest clinical guidance and evidence on e-cigarettes.

    Covering the recent announcements by Minister for Public Health Neil O’Brien, Glindon called for the U.K. government to finally release its new tobacco control plan and the new tobacco and related products regulations, both of which are two years overdue. She called for responsible companies like those represented at the GTNF to call out the bad actors who are undermining progress on tobacco harm reduction and for the industry as a whole to prevent youth access, tackle illegal products and promote sustainability.

    Turning to the world stage, Glindon highlighted pressures from outside the U.K., including alternative policy directions from the EU and World Customs Organization on tariffs and taxes. Going further, she spoke to the upcoming COP10 conference in Panama later this year, calling it “the biggest threat to the U.K.’s world-beating harm reduction strategy” with its “singular mission focused on actively encouraging countries to ban vaping as part of its tobacco control approach, purposefully flouting the evidence of vaping’s success.” She called on the U.K. government to show leadership, to send ministers as part of the delegation to COP10 and to “actively take part in leading the conversation instead of only being a passive observer and financial contributor.”

    Glindon then expanded on her concerns around preventing youth access, tackling illegal and noncompliant products and ensuring that the issue of sustainability, particularly with disposable devices, is addressed. She also called for an update on the vaping evidence set out by Public Health England back in 2015, asking how to get to a certainty greater than 95 percent less harmful.

    In her closing remarks, Glindon spoke of the need to expand beyond a focus in the U.K. solely on vaping as a tool for tobacco harm reduction and called for the government to consider HnB and oral nicotine products to help reach the remaining 6.6 million smokers in the U.K. She emphasized the need for more research to be done, independent of commercial interests.

    Finally, Glindon made clear that the industry has to address the key issues it faces—rogue players, youth access and environmental concerns—otherwise it faces being regulated out of existence. Her final words were “Be good: work hard, tackle the problems, seize the future.”

    Derek Yach

    Global health advocate Derek Yach opened by stating how the world’s health is in a much worse state since coming out of the Covid-19 pandemic, particularly regarding noncommunicable diseases (cancers, cardiovascular diseases, diabetes and chronic lung illnesses) as well as mental health.

    He used his own experience in the field of noncommunicable diseases to explain how different approaches must be taken, highlighting his concerns that what worked 20 years ago will no longer work in today’s climate and that modern science and health have to receive political and private sector support.

    He then introduced tobacco harm reduction as a critical category that can help to reduce the growing concerns in this area. Yach spoke to the point that governments around the world are being inactive to, or even dismissive of, the clear and obvious benefits of RRPs. This is risking the health and lives of many of its own citizens.

    Yach gave his own recommendations on how governments should address the 1.1 billion global combustible tobacco smokers still in existence today, referencing the positive work being conducted in the U.K., specifically mentioning the recent review by Javed Khan and the U.K. government’s recently introduced “swap to stop” scheme, which will offer 1 million vape starter kits to current smokers.

    He made a call for the WHO and other governing bodies to appoint a commission that could 1) further develop the science and evidence now available; 2) review the progress of the U.K. and FDA in authorizing this positive change; and 3) take stock of the current situation and set it out in front of COP10 in Panama in November.

    He then outlined the importance of the role of physicians and the need for them to be properly educated to understand the difference between tobacco and nicotine and between cigarettes and e-cigarettes. Without this education, medical professionals are unable to prescribe other, less harmful solutions to their patients.

    Next, Yach spoke of the importance of COP10, urging delegates to showcase positive examples of how RRPs are used around the world to radically reduce the number of combustible tobacco smokers. Sweden, the U.K., South Korea and Japan were all offered as examples of how RRPs have been deployed correctly to help users make the switch away from cigarettes.

    Finally, Yach held a mirror to the tobacco industry, commenting that it, too, was in need of further analysis of its own practices. He explained that in many low-income and middle-income nations, RRPs are legally available; however, the industry has not launched or given easy access to the range of harm reduction products available.

    To this point, the major focus on RRPs has been in high-income countries, and there needs to be an acceleration of getting these products to all countries around the world.

    Yach concluded his remarks by reflecting on his opening comments: Tobacco harm reduction is about stopping the growing trend of noncommunicable diseases and saving lives.

    Yach then went on to lead a discussion panel titled “Drawing on Behavioral and Consumer Insights to Encourage Harm Reduction,” which included the following panelists: Jessica Zdinak, social and behavioral scientist and owner at Applied Research and Analysis Consulting; Mohamadi Sarkar, scientific strategy and analysis and regulatory affairs at Altria Client Services; and Cother Hajat, public health physician and epidemiologist at Independent Respondent.

    Yach identified several smokers across the world attempting to quit smoking and asked panelists to consider what approaches should be adopted to help them do so. In many of the deprived communities of the world, Yach mentioned that availability of tobacco harm reduction products is an issue in order to get people to quit and tasked the panel to come up with solutions to remedy that.

    Yach lamented the disinformation surrounding the e-cigarette or vaping product use-associated lung injury crisis that appeared in many academic research papers, which can still be found on the internet despite retractions being made by a research journal. He suggested that inspiration could be found from Twitter to ensure that such articles can be traced in order to issue a warning and correction relating to the disinformation.

    Sarkar focused on the personal dimension that needs to be adopted by each of the 1 billion smokers around the world who need to stop smoking and shared his memories of treating smokers with diseases, such as myocardial infarction, when he was a clinician, but who ultimately did not quit.

    Sarkar’s main concern is that disinformation has become a significant barrier to smokers quitting, with 80 percent of Americans in 2021 believing, wrongly, that e-cigarettes are as harmful as, if not more harmful than, combustible cigarettes. He also lamented that 80 percent of doctors surveyed believed that nicotine causes cancer.

    Zdinak criticized the public health profession generally for omitting the basics of psychology and physiology in their appraisal of harm reduction efforts. She asserted that smokers’ basic needs must be met to successfully get consumers to switch to alternative products that are less harmful.

    She went on to say that health communication messages should capture what people are thinking and feeling. In doing so, Zdinak referred to Maslow’s hierarchy of needs and where smoking cessation sits within smokers’ priorities and said that community groups may be necessary to create a higher order for them to consider quitting.

    Hajat stated that the voices of smokers are often missing from research reports and reinforced the need to change that. She praised the U.K. Department of Health for embracing tobacco harm reduction products as vital weapons in its arsenal to improve the health of the nation and welcomed recent proposals to use pack inserts in combustible cigarettes.

    She also welcomed the incentives for pregnant women, who make up 10 percent of the smoking population, and for people on low incomes to receive starter kits to accelerate smoking cessation and meet the government’s 2030 target to become smoke-free.

    Jeremy Lim

    The panel discussion was followed by a keynote presentation from Jeremy Lim, CEO and co-founder of AMiLi. Lim opened by reflecting on the themes developed throughout today’s conference. He started by reaffirming the words of Yach, echoing his sentiment about the polarization of tobacco control and a lack of understanding of the differences between combustible tobacco and other nicotine products. He made clear that this is essential for countries in the developing world, which are chronically short of doctors, making misinformation even more problematic.

    He supported the concept of introducing a WHO commission that specifically analyzes the positive progress made in countries like Sweden, the U.K. and Japan, which could result in a homogenized view of tobacco harm reduction, eradicating the misunderstanding about tobacco and reduced-risk products.

    Lim then reemphasized what Sarkar had set out, explaining that much of the focus and attention is around theoretical concerns, such as youth access and environmental impact, but not enough spotlight is given to the individual smokers themselves who suffer the greatest impact from their addiction. He spoke of a systemic bias against smokers, citing the perception that smoking is a self-inflicted issue where subtle blame is given to the individuals who smoke. Smoking is not seen as a mental health or social health issue—it is seen as a choice.

    Offering his own thoughts on the role society plays in helping or hindering the progress of tobacco harm reduction, Lim used the analogy of a person pushing a large cylinder up a steep hill. The gradient of that hill is determined by society—the more society hampers harm reduction, the harder it will be for people to quit; vice versa, the more society embraces the concept, the more support each smoker is given to quit.

    Lim outlined his concern over the rising cases of youth access to vaping products, calling for a joint effort from everyone involved in the industry to remove these “bad players.”

    He concluded his remarks by urging the industry to put its ideological and political preferences aside and to focus on science and on individual smokers instead.

  • Mixed Messages

    Mixed Messages

    Credit: Onticello

    The head of the FDA’s Center for Tobacco Products sent mixed messages during a recent public event.

    By VV staff

    When the American Vapor Manufacturers (AVM) Association announced it had secured a Q&A session with the Brian King, the industry was taken by surprise. It was the first time King, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), would speak with vaping industry advocates publicly and answer questions from the audience. Surprisingly, King was quite candid. He did shy away from certain questions, however, and some of his responses were questionable.

    Brian King

    Youth e-cigarette use was first declared a national epidemic in December 2018 by then U.S. Surgeon General Jerome Adams. King said the “FDA has not used that terminology” (epidemic) in its “most recent estimates” of youth use. However, during a hearing of the House Oversight Subcommittee on Economic and Consumer Policy in 2021, then acting FDA Commissioner Janet Woodcock was asked if Juul Labs was “the e-cigarette company most responsible for creating this epidemic.”

    She answered that it does “appear” to be the case. The title of the FDA’s own press release was “An Epidemic Continues: Youth Vaping in America.” A 2018 FDA focus group study conducted by the agency reported that “‘epidemic’ ads [had a] perceived effectiveness score of 4.17 out 5.0.” King defended the agency’s youth-oriented anti-vaping ads, which he said were “rigorously evaluated” before and after they aired and were effective at reaching teenagers. King ignored that the ads continue to use the FDA’s approved youth vaping “epidemic” terminology.

    “So, I believe you’re thinking about the CDC [U.S. Centers for Disease Control and Prevention]. And FDA has not used that terminology to view the most recent estimates of youth use. I will say that I’m an epidemiologist by training, so I’m fully cognizant of the definition of an epidemic, which is unprecedented increases over what you’d expect at baseline,” said King. “That said, I think, no, that science has shown a decline in the number of youth users. And that’s a good thing. Over the past couple of years, we have seen [a] decline since the peak in 2019. It’s still too high.

    “Since I’ve started, I have not [used the term]. I’m not aware of any of my staff. But as far as I’m aware, we have not used the term. It’s ultimately up to respected individuals. There’s certainly disagreements among epidemiologists. Like there is in any discipline, you’re going to find people disagree.”

    It should be noted that King’s disdain for vaping is well-documented. King is credited with creating the term “e-cigarette or vaping product use-associated lung injury,” or EVALI. The term was used by the CDC for the lung injuries caused by the 2019 spread of illicit THC cartridges tainted with vitamin E acetate during King’s tenure at the CDC. The name suggested that nicotine vaping products (e-cigarettes) were responsible for at least 70 deaths attributed to black market THC products. No nicotine vaping device has ever been associated with an EVALI death or any death; however, King and the CDC have never tried to correct the misinformation.

    The event was moderated by AVM Vice President Allison Boughner and its director of legislative and external affairs, Gregory Conley. When the moderators asked King if the FDA had ever identified a single nicotine vaping product, not an illicit THC cartridge (referencing EVALI deaths), that could be more hazardous than combustible smoking, King dodged the question.

    “I would say that at present, we evaluate the merits of evidence that has been submitted to this agency. In terms of applications and science on their products, at present, we have authorized 23 e-cigarette products or devices that we have found and that benefits outweigh the risks,” he explained. “And we’ll continue to do that. The onus is on the applicants to submit that information. And we’re fully open to evaluating that information and then making an informed scientific decision.”

    Being more direct, moderators asked King if vaping products are far less hazardous than smoking cigarettes and if that is something consumers should know. “I would agree with the statement that if an adult smoker were to transition completely from a cigarette to an e-cigarette, that would be a benefit to their health, yes,” King responded. Moderators then questioned whether it was ethical to mislead the public, letting people believe that vaping isn’t safer than smoking cigarettes.

    “Although we know that in general, e-cigarettes have lower risks than a conventional cigarette, there’s a broad class, and there’s a lot of different factors that can influence the extent of risk. And so it’s not just a simple statement that every single e-cigarette is going to be lower risk,” King said. “There are different factors that we have to consider, particularly when it comes to risks to vulnerable populations like kids.”

    Fighting misinformation

    Credit: Vadim Pastuh

    King acknowledged that vaping has been effective at helping smokers quit smoking. He added that the FDA and CTP don’t want people using combustible cigarettes. Combustible products introduce 7,000 chemicals and 70 carcinogens into users. However, the misinformation surrounding vaping products is massive. King acknowledged that he is “fully cognizant” of the misperceptions.

    “I am wholly open to enhanced efforts by the Center for Tobacco Products to message not only on the continuum of risk but also misperceptions related to nicotine,” he said. “But again, the devil is going to be in the details there in terms of making sure that we have scientifically defensible messages and that we’re delivering it to the target population, which is adult smokers, and not inadvertently delivering it to the unintended populations where there’s consequences, including youth.”

    The FDA’s fight against misinformation is confusing at best. For the last several years, former CTP Director Mitch Zeller and several CTP employees have repeatedly stated in public that correcting misperceptions surrounding vaping and nicotine are part of the CTP’s agenda. King seemed to imply that little had been done so far in accomplishing that goal. He said that little had been done, and that was due to competing priorities at the CTP.

    “When you have a finite number of resources and people, you have to prioritize what you do to have the greatest impact. And so, I will say that for my part, coming into this position, there’s four key tenants that I am adhering to, and that’s strong science, stakeholder relations, communications and health equity,” King said. “And so, obviously, the stakeholder relations and communications are pivotal to this. In terms of my prioritization, I think it’s important that we engage with people, hear them out, but also use science to inform our communication strategies moving forward. It’s not that we haven’t done this work before but it’s just where prioritization is moving forward. And I can tell you that we’re working on it.”

    Concerning misperceptions and the FDA’s message in the public arena, moderators questioned King on the FDA’s advertising. FDA ads have portrayed vapers as being possessed by demons or shapeshifting metal dragons, and vaping will cause huge parasites to crawl through your skin. None of these things have ever been reported as being true. King said that the agency does a “rigorous evaluation” both before and after the implementation of any of its campaigns, and all of the FDA’s youth-centric campaigns have very targeted strategies to reach that target population.

    “We cognitively test them and do science in the beginning, and then we evaluate them on the back end. And that science has shown demonstrably that there is a beneficial impact. That said, I think that we’ve got opportunity for better public engagement on our campaigns,” he said, which didn’t really provide a clear answer to the question. “That is a critical component of our work. We don’t function in silos, and we want the opportunity to engage, but we’ve got to give people that opportunity. And if they’ve got data, if they’ve got evidence to demonstrate that a certain message or a certain target audience is going to be problematic in terms of the campaign, we welcome it.”

    Illicitly speaking

    confusedBans on consumer goods haven’t worked well historically. Prohibition of alcohol and marijuana led to massive black markets for those products. U.S. states that have enacted tobacco flavor bans, such as Massachusetts, have seen a huge increase in black markets. King said this depends on how an illicit source is defined. He added that any vaping or other tobacco product on the market that does not have FDA authorization is considered illegal, and anyone selling those products is operating in the black market.

    “In terms of our enforcement and compliance strategy, we’re committed to taking action to address those that are violating it. And that can take a broad spectrum of action, whether it’ll be warning letters all the way up to civil money penalties as well as injunctions,” he said. “But we have an obligation to enforce the law. And that’s what we will do. That is what Congress has told us to do. And so we’re committed to continuing to do that. But in addition, we’re also working to make sure we get efficiencies and ramp up our efforts around reviewing applications.”

    When questioned whether he had concerns about the black market continuing to grow, King said the CTP is committed to continuing to review premarket tobacco product applications as quickly as possible to guarantee a clear pathway to a marketing order. He’s also equally committed to making sure that the regulatory agency enforces the law. He says he’s committed to continue to implement the law.

    “This is what Congress has told us to do. We have specific authorities that we are responsible for, and in my job as the director [of the CTP], I have to make sure that we exercise those authorities, and toward that end, I don’t think we’re perfect,” said King. “I think we’ve got opportunity for improvement. I think that there’s always [an] opportunity for improvement. We acknowledge that. I think we can do some things better, and from our part, I’m happy to continue to move us into the next chapter of the center to make sure that we’re engaging people in a meaningful way.”

    On the enforcement front, King was asked why only small businesses bore the brunt of FDA action. King said that the CTP does not have a policy against small business and that its enforcement compliance actions have been taken against small and large businesses. However, one participant explained, many small businesses don’t have the finances to hire lawyers to petition the courts to fight the FDA. They also question whether the FDA would ever approve open-system products, which are mostly sold by independent vape shops.

    “We’re committed to enforcing the law. I will say that some of the recent actions in terms of the civil money penalties and also the injunctions were a result of companies that did not obey the law after repeated warnings. And there are many small businesses that are obeying the law and have submitted their applications and have gone through the process,” said King. And so it’s certainly possible. I will say that for our part, we’re committed to continuing to explore opportunities where we can better provide information to applicants to make sure that the process is as flexible and straightforward as possible.”

    A bad taste

    During the open question session, one participant questioned whether the FDA would ever approve a flavor other than tobacco. The business owner wanted to know if the FDA intended to have an outright ban on flavored products or any open system with potential for flavored e-juice options. King said the CTP does not have an outright ban on flavored products, but the onus is on the applicants to submit the evidence to demonstrate that the benefits among adult smokers outweigh the risks to youth.

    “So, there is no de facto policy within this center that would prevent the authorization of a flavored e-cigarette. But I will say that with continued high rates of youth use, the onus is high to make sure … to demonstrate that benefit to adult smokers,” King said. “But it’s not impossible. We’ve seen the authorization of several products already, all tobacco flavored, but we are certainly open to applications on flavored products.

    “And if the science demonstrated that there was a net benefit compared to the risk, we would authorize it. And so that’s my take-home here [that] there’s no blanket policy against flavored, but we’ve got to follow the science, and at present, we have not got sufficiently strong evidence that demonstrates that the flavors are needed for the adult smoker to quit.”

    King was also asked about memos submitted to the U.S. Court of Appeals for the 3rd Circuit but an attorney for Logic Technology showed that King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists. King said that that was an “erroneous description” of what occurred. It was not an overrule.

    “In this case, there was [an] initial assessment of that science, and then there was further scientific discussion. And I am a scientist by training. I have been for many, many years. And we sat down and discussed the merits of the available science that was presented,” explained King. “And after the discussion of that science and those merits, the determination was made that the applicant did not meet the standard.”

    A recent report published in the journal Addiction examined e-cigarette use in England among young adults between 2007 and 2018. That study concluded that 18-year-olds to 24-year-olds who use e-cigarettes did not use vaping as a gateway to smoke combustible cigarettes. King was asked about the study and whether he believed a “gateway effect” existed despite evidence that one did not. King responded that there’s still a strong body of evidence that suggests that the gateway does exist, but it’s dependent on a variety of different factors.

    “[It’s] certainly not conclusive evidence, but there’s moderate evidence to demonstrate that [a gateway exists]. But you also have to look at the net impact of the science. And so I’ve said publicly many times that you do have some gateway effects. We’ve seen that through the past study and others, but that doesn’t mean that every single kid who’s using an e-cigarette is going to go on to smoke,” King explained. “There’s a variety of factors that impact that. So I caution folks against definitive statements like that, that every person is going to transition who uses the product. It’s certainly happening. But when you look at the net effect, we’ve definitely seen a decline in overall e-cigarette use.”

    In the end, King said that the one thing people should realize is that he’s the type of person who speaks plainly and honestly. He doesn’t have the stereotypical characteristics of a civil servant. “If there’s anything that folks know about me, it’s I aim to be the most nonbureaucratic bureaucrat that you’ve ever met, and that involves just straight-shooting. And so, if we can do better, I want to know about it, and we can definitely enhance the communication on that front,” explains King. “So, I would say more to come, but the science is going to drive it. And we’re at the initial stages in informing what effective messages are most critical to reach the target audience without unintended consequences.”

  • Insurance Agent Sued for ‘Quietly’ Excluding Batteries

    Insurance Agent Sued for ‘Quietly’ Excluding Batteries

    A federal lawsuit has been filed by four companies that sell vaping devices against Kinsale Insurance Co., claiming the insurer dropped coverage for batteries but failed to fully inform the policyholders before denying a claim.

    If the case goes to trial and appeal, it could potentially help clarify insurers’ and insureds’ responsibilities when policy wording is changed or exclusions are added.

    “Defendant owed a fiduciary duty to plaintiffs based on trust and good faith that required defendant to act in the best interest of plaintiffs, its customers,” reads the lawsuit complaint, filed last week in U.S. District Court in Nashville. “It is reasonable for the insured to assume the policies provided the requested coverage.”

    Kinsale Insurance, based in Richmond, Virginia, offers casualty and specialty casualty insurance for cannabis, transportation and other industries. It has not yet filed an answer to the complaint, according to the Insurance Journal.

    Industry experts, however, said that the practice of changing coverage without fully notifying customers is not uncommon, and is rarely challenged. And Tennessee law may be less than crystal-clear on how far an insurer must go in notifying policyholders of changes and how specific notifications should be.

    Battery fires from nicotine and cannabis vape devices are relatively uncommon but have become a worldwide concern for consumers, fire departments and insurers. In October 2022, Michael and Elisha Schmidt suffered a fire, reportedly from a vape pen battery, and sued the four vape companies over the damage.

    The companies, Isabella Industries, Maelynn Industries, Sancia Industries and Illumivaption Inc., all had umbrella and general liability policies with Kinsale for seven years. But when the vape sellers renewed their policies in October 2022, Kinsale excluded batteries and battery-fire claims from the policies, while raising premiums, the suit claims.

    “Defendant led plaintiffs to believe that the batteries were covered after the renewal,” the complaint reads. “Defendant did not inform plaintiffs that it had removed batteries from the coverage and did not ask Plaintiffs prior to doing so.”

    The plaintiffs also argue that the policy wording was ambiguous and illusory, and thus, unenforceable under Tennessee law. The companies had always paid their premiums on time and had been loyal customers to Kinsale, they noted.

    When the Schmidts filed their lawsuit, the vape companies filed claims with Kinsale. But the insurer denied the claims, arguing that the policies did not cover batteries. Kinsale would not provide a legal defense for the insureds.

    The vape sellers argue that Kinsale’s refusal amounted to bad faith and unfair trade practices, and has cost the companies damages and attorney fees. They are asking for compensatory damages, punitive damages, legal fees and a declaration that the insurer must provide coverage and a defense.

  • Malaysia Removes Nicotine E-Liquids From Poisons List

    Malaysia Removes Nicotine E-Liquids From Poisons List

    Credit: Gerey

    Malaysia’s government has removed e-liquid containing nicotine used in e-cigarettes and other vaping products from the country’s Poisons List of controlled substances. The move enables taxation on e-liquids.

    Media reports claim the removal effectively legalizes e-cigarettes with nicotine without any regulations in place, as the current Control of Tobacco Products Regulations 2004 under the Food Act 1983 only cover conventional cigarettes and other tobacco products.

    The Control of Tobacco Product and Smoking Bill 2022 – which seeks to regulate both tobacco and vape products, besides a ban on these products for anyone born from 2007 – has yet to be tabled in the current 15th Parliament, reports Code Blue.

    Health Minister Zaliha Mustafa gazetted an order Friday to exempt nicotine “preparation of a kind used for smoking through electronic cigarette and electric vaporizing device, in the form of liquid or gel” from the Poisons List under the Poisons Act 1952 – overriding the Poisons Board that unanimously rejected the proposal last Wednesday.

    The Excise Duties (Amendment) Order 2023 – which subjects e-liquid or gel containing nicotine to excise duty of 40 sen ($0.004) per milliliter – gazetted by Finance Minister Anwar Ibrahim, who is also the prime minister, was dated last March 29, the same day as the Poisons Board meeting.

    The tax on e-liquids with nicotine went into effect on April 1.

    CodeBlue reported that the Poisons Board, an independent body formed under the Poisons Act, wholly objected to the government’s proposal to exclude nicotine-containing e-liquid from the Poisons List on the basis that the harm of allowing e-cigarettes to be sold to anyone, including children, outweighed the benefit of tax revenue from such products containing nicotine, a highly addictive substance.

  • House Oversight Committee to Probe CTP Failures

    House Oversight Committee to Probe CTP Failures

    The U.S. House Oversight and Accountability Committee announced its intent to investigate the practices of the Food and Drug Administration’s Center for Tobacco Products (CTP).

    Chairman James Comer is conducting the probe of the FDA’s regulation of tobacco and nicotine products through the CTP, stating that the center has failed to effectively define and administer its tobacco and nicotine regulatory programs.

    The failure has resulted in industry uncertainty and unsafe products reaching the marketplace, according to a committee press release. In a letter to FDA Commissioner Robert Califf, Comer is requesting documents, communications, and a staff-level briefing related to the CTP’s activities to ensure it is performing its regulatory function as intended.

    “The Committee on Oversight and Accountability is conducting oversight of the Food and Drug Administration’s (FDA) regulation of tobacco and nicotine products through its Center for Tobacco Products (CTP). A recent evaluation of CTP by the Reagan-Udall Foundation (RUF) found that CTP has not clearly set out the most basic elements of its tobacco and nicotine regulatory programs. This has resulted in confusion, inefficiency, litigation and suspicions of political interference. CTP has fostered uncertainty in the marketplace and has allowed unsafe and unregulated products to proliferate. Therefore, we seek documents and information regarding CTP’s activities to enable transparency and to ensure the CTP is performing required functions,” wrote Comer.

    An evaluation of the CTP by the Reagan-Udall Foundation stated that the CTP is unable to perform its basic functions and ensure that Americans have access to products that have the potential to lower the rate of smoking-related disease and death. Amidst unclear policies, stakeholders have even reported having to guess what the CTP’s regulations might be. Congressional oversight is needed to bring transparency to the CTP’s lack of clear policies that have resulted in market uncertainty, unregulated products and enforcement failures, according to the press release.

    “We have deep concerns that CTP’s decisions have been influenced by political concerns rather than scientific evidence,” wrote Comer. “Comments from FDA staff to RUF, which are no longer available on its website, reflect such concerns. For example, one commenter said, ‘[i]n cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.’ Another stated, ‘scientific disagreement is frowned upon, if not entirely suppressed,’ while a third said leadership was ‘… unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.’ FDA must clearly identify and publicize what scientific criteria are necessary for a product, to include [electronic nicotine-delivery system (ENDS) products] and smokeless products, to be authorized through the PMTA pathway and—where appropriate—the subsequent [modified-risk tobacco product applications (MRTPs)] pathway.”

    Comer specifically asked the FDA to provide: FDA staff comments to the Reagan-Udall evaluation; all communications with the White House and Department of Health and Human Services (HHS) regarding tobacco or nicotine policy; documents and communications between the FDA and the Centers for Disease Control and Prevention (CDC) regarding CTP policies; documents and communications between the FDA and “public health advocacy groups” regarding CTP policies; all documents that describe the specific analytic process the FDA uses to apply the “appropriate for the protection of public health” standard; and all documents and communications related to the FDA’s enforcement efforts to remove illegally marketed tobacco or nicotine products from retail locations.