Tag: PMTA

  • 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.”

  • 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.

  • Court: Reynolds Likely to Prevail in PMTA Lawsuit

    Court: Reynolds Likely to Prevail in PMTA Lawsuit

    scales of justice
    Credit: Sang Hyun Cho

    When the U.S. Court of Appeals for the 5th Circuit granted a stay to RJ Reynolds Vapor Co. (RJRV) of the U.S. Food and Drug Administration’s denial of its 150,000-page premarket tobacco product application (PMTA) for its menthol Vuse products, the judges indicated that the court believes RJRV is likely to prevail on the merits when the full review is heard. 

    Tobacco harm reduction expert Clive Bates, of Counterfactual, said the substantive decision rests on three main arguments, as outlined by the judges granting the stay. The order states:

    Specifically, RJRV demonstrates that the FDA failed to reasonably consider the company’s legitimate reliance interests concerning the need for longitudinal studies and marketing plans; failed to consider relevant evidence, inter alia, that youthful users do not like menthol-flavored e-cigarettes; and has created a de facto rule banning all non-tobacco-flavored e-cigarettes without following APA notice and comment requirements.

    The three main points argued by the court are outlined below:

    FDA changed the decision-making criteria after the application.

    1. Legitimate reliance interests

    “The FDA did not reasonably consider RJRV’s legitimate reliance interests before changing its position on the types of comparative studies and marketing plans critical to a compliant and complete PMTA.”

    Failure to consider Reynolds’ arguments adequately 

    2. Failure to consider relevant factors

    The FDA did not adequately address RJRV’s evidence that substantial health benefits would accrue to adult and youth cigarette smokers alike who switched to menthol Vuse, while popularity among youth would remain low overall. For example, RJRV’s application contained studies that “switching from smoking to use of menthol Vuse Vibe substantially reduces toxicant exposure in a manner similar to smoking abstinence.” RJRV also submitted evidence of low popularity among youth relative to other flavored ENDS.

    Bates stated that at least one portion part of the court’s argument looks troubling for Brian King, the newly appointed director of FDA’s Center for Tobacco Products (CTP).

    Then in July 2022, a new CTP director appeared on the scene and told OS that “the approach to menthol-flavored ENDS should be the same as for other flavored ENDS, i.e., the products could be found [appropriate for the protection of the public health] only if the evidence showed that the benefits of the menthol-flavored ENDS were greater than tobacco-flavored ENDS, which pose lower risk to youth.” OS then changed its position.

    FDA has been implementing a de facto tobacco product standard (a flavor ban) without using the rule-making process, public comment etc. 

    3. “Tobacco product standard”

    RJRV has adduced evidence that the FDA has effectively banned all non-tobacco-flavored e-cigarettes, pursuant to its new and secret heightened evidentiary standard, without affording affected persons any notice or the opportunity for public comment. There is no dispute that the TCA requires the FDA to abide by notice-and-comment rulemaking procedures before establishing a “tobacco product standard.”8 21 U.S.C. § 387g(c)–(d). Similarly, it is clear that a ban on all but tobacco-flavored e-cigarettes would constitute a “tobacco product standard.” 

    Bates explains that the court justifies its assertion that FDA is imposing a de facto standard with reference to the so-called “fatal flaw memo.” This was an expedited decision-making regime that stipulated that applications for non-tobacco-flavored products must be supported with controlled trials or longitudinal studies showing a quitting or switching advantage over a tobacco flavor. Otherwise, they would be automatically denied. 

    We conclude that the Fatal Flaw memo’s heightened evidentiary standard “bears all the hallmarks” of a substantive rule. City of Arlington, 668 F.3d at 242. First, the memo is binding on its face by mandating that applications contain “the necessary type of studies.” Second, it has been applied in a way that indicates it is binding; indeed, the subsequent, myriad Denial Orders refer to the same deficiencies identified as “fatal” in the memo. Third, it took away the FDA reviewers’ former discretion to consider individual PMTAs solely on their merits and instead requires a cursory, boxchecking review.

    Finally, it affected the rights of literally hundreds of thousands of applicants whose PMTAs were denied. This is not a close call.

    Bates stated that the third point the court makes is potentially “very” serious for the FDA and “not a close call,” as the court suggests. “A tobacco product standard under the TCA s.907 means that the burden is on FDA to show that its de facto standard is appropriate for the protection of public health – e.g. considering the impact of closing down all vape shops, likely impact on adults or youth who smoke, unintended consequences, illicit trade etc,” explains Bates. “It shifts the analysis from the individual applicant (PMTA) to the system-wide impact (Product Standard) – and FDA will find this difficult or impossible to meet, in my view.”

    Taking everything into account, the court weighs up its decision to grant the stay against four criteria, as Bates outlined: 

    Our judgment is “guided by sound legal principles” that “have been distilled into consideration of four factors: (1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.”

    Bates stated that the first of these four criteria reflects the courts’ view on the merits discussed in the three above-stated substantive arguments. In the fourth: (4) where the public interest lies, the court gives significant weight to the “highest public importance that federal agencies follow the law” and states: 

    In sum, “there is generally no public interest in the perpetuation of unlawful agency action,” Texas v. Biden, 10 F.4th at 560. And there is no evidence that “Congress’s policy choice” included an exemption from mandatory federal administrative procedures.

    No date has been set for the court to complete its full review.

  • U.S. FDA Webinar Outlines Warning Letter Response

    U.S. FDA Webinar Outlines Warning Letter Response

    Credit: Marcus Krauss

    The U.S. Food and Drug Administration has posted a new webinar to help manufacturers and vape shop owners respond to warning letters from the agency’s Center for Tobacco Products (CTP).

    The webinar outlines the appropriate items for a response to a warning letter, which should be received by FDA within 15 business days. The webinar also includes an explanation of proper documentation concerning corrective actions that entities have taken.

    In the webinar, participants will learn about:

    • Preparation for a response to CTP
    • Important items to include in a response
    • Additional compliance resources
  • U.S. FDA Files First Civil Money Penalties for Illicit Sales

    U.S. FDA Files First Civil Money Penalties for Illicit Sales

    Credit: VetKit

    Some manufacturers of e-liquids could soon be paying nearly $20,000 per violation for selling vaping products without approval. Today, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization.

    This marks the first time the regulatory agency has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket tobacco product application (PMTA) process.

    The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s PMTA requirements and that failure to correct these violations could lead to enforcement action, such as a CMP, according to a press release.

    Despite the agency’s warning, the companies continue to make and sell their unauthorized e-liquids to consumers.

    “Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We are prepared to use the full scope of our authorities to enforce the law—especially against those who have continued to violate the law after being warned by the agency.”

    As of Feb. 21, the FDA has filed CMP complaints against the following four manufacturers:

    • BAM Group LLC doing business as VapEscape
    • Great American Vapes LLC doing business as Great American Vapes
    • The Vapor Corner Inc. doing business as Vapor Corner Inc., The Vapor Corner, and Vapor Corner
    • 13 Vapor Co. LLC doing business as 13 Vapor

    Currently, under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA typically seeks the statutory maximum allowed by law and is doing so in these four cases.

    The companies the FDA has filed CMP complaints against can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Companies that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.

    “These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct,” said King. “These actions should be a wakeup call that all tobacco product manufacturers—big or small—are required to obey the law.”    

    Manufacturers that continue to violate the law risk subsequent enforcement, according to the FDA. In addition to CMPs, the agency also has the authority to take other enforcement action, as appropriate, including seizures, injunctions, and criminal prosecutions.

  • Status Report Confirms FDA Time Changes to PMTAs

    Status Report Confirms FDA Time Changes to PMTAs

    Credit: Fizkes

    The U.S. Food and Drug Administration has submitted a new timeline for its expected finish to the review of premarket tobacco product applications (PMTAs) in a court-mandated status report. As previously reported by Vapor Voice, the agency doesn’t expect to complete PMTAs for the most popular vaping products until the end of the year.

    In prior status reports, the FDA indicated that it expected to finalize actions on all covered applications by June 30, 2023. Filed with the Maryland Federal District Court on Jan. 24, 2023, the agency’s fourth report states that it now expects to have taken action on PMTAs as follows:

    • 52 percent of Covered Applications by March 31, 2023
    • 53 percent of Covered Applications by June 30, 2023
    • 55 percent of Covered Applications by Sept. 30, 2023
    • 100 percent of Covered Applications by Dec. 31, 2023

    The FDA is expected to give its next status update to the court on April 24.

    The FDA is under a Maryland Federal District Court order to file regular status reports on the agency’s review of PMTAs. The court case that ended in a court-imposed deadline for the FDA was filed by health groups seeking a timeline for the review of the PMTAs that were filed with the agency by Sept. 9, 2020.

    In the order requiring the FDA to submit status reports, the Maryland court stated that covered applications are limited to applications for products that are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market & Players or Disposable E-Cig Market & Players’ reports.

    The original completion date was Sept. 9, 2021, however, the FDA was unable to meet it due to the extremely large number of PMTAs filed by manufacturers.

    The most recent delay is partially being caused by ongoing litigation and by the agency accepting some amendments to already filed PMTAs that the agency now needs to review, according to the report.

    Credit: JHVEPhoto
  • CTP to Release Reagan-Udall Response in February

    CTP to Release Reagan-Udall Response in February

    The Head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) said in a perspective released today that the Center recently received the findings from the Reagan-Udall Foundation’s independent evaluation of its program and is in the process of closely reviewing the feedback. In February, the Center will provide an update on its planned actions in response to the evaluation.

    When the Reagan-Udall Foundation submitted its recommendations to Robert Califf, commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process.

    CTP Director Brian King also announced the Center has accepted for review more than 8,600 marketing applications for synthetic products. In a recently released perspective, King said the center received more than 1 million premarket tobacco product applications (PMTAs) from 200 companies by May 14, 2022.

    “FDA has also issued refuse-to-accept (RTA) letters for more than 925,000 products in applications submitted by May 14 that do not meet the criteria for acceptance,” King wrote. “The RTA letters state that it is illegal to sell or distribute the product in the U.S. marketplace without a premarket authorization.”

    Brian King / Credit: FDA

    He also stated that in 2022, CTP participated in 52 meetings with stakeholders – averaging one per week – including 25 meetings since King became director. King also stated that starting when the FDA was given the authority by Congress to regulate non-tobacco nicotine products in April 2022, the CTP has issued more than 75 warning letters to manufacturers through Jan. 20, 2023, including manufacturers of brands popular among youth, such as Puff Bar.

    “We have also issued over 585 warning letters to retailers for the sale of non-tobacco nicotine products to underage purchasers as of December 2022. In October 2022, the U.S. Department of Justice (DOJ), on behalf of the FDA,” filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers that failed to submit PMTAs and continued to sell products,” wrote King.

    In a court filing last week, the FDA stated it will take until possibly December 31, 2023, before it completes the PMTA review process for some of the most popular vapes on the market.

    Much like an earlier op-ed this year, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers. 

    King also failed to address the conclusion of a recent investigation conducted by the  U.S. Office of Special Counsel that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.

  • FDA Says PMTA Reviews to Take Until End of Year

    FDA Says PMTA Reviews to Take Until End of Year

    Credit: F Armstrong Photo

    In a court filing this week, the U.S. Food and Drug Administration stated it will take until possibly December 31, 2023, before it completes a premarket tobacco product application (PMTA) review process for some of the most popular vapes on the market.

    Upon being informed of the delay, Senator Dick Durbin of Illinois began demanding the FDA act immediately in removing e-cigarettes and vaping products from store shelves saying the agency has ignored a court order requiring them to take action by September 2021.

    “On Tuesday, in a stunning filing to the federal judge, the Food and Drug Administration disclosed that it will take another six-month delay in fulfilling the public health duty announced by the court years ago. That the Food and Drug Administration will not finish reviewing applications for the most popular e-cigarettes until the end of 2023, is another outrageous delay,” said Durbin. “How can this federal agency knowingly, willingly ignore this court order to protect America’s children?”

    Durbin, who has repeatedly urged FDA to complete the premarket review of e-cigarettes, called on FDA to use its authority to swiftly remove any and all unreviewed vaping products from store shelves for the safety of American consumers.

    “While the FDA has dithered, dallied and delayed, more than one million of America’s kids have started vaping,” Durbin stated this week calling on the agency to obey the court order. “Not next year. Not next month. Immediately. Today,” Durbin stated in a release.

  • Fifth Circuit Grants Triton Rehearing Before Full Court

    Fifth Circuit Grants Triton Rehearing Before Full Court

    Fifth Circuit Court of Appeals

    The U.S. Court of Appeals for the Fifth Circuit granted Wages and White Lion Investments LLC, doing business as Triton Distribution, and Vapetasia LLC’s, request for the full court to re-hear Triton’s appeal of its marketing denial order (MDO), according to a court order handed down today.

    Triton lost before a three-judge panel in July, but attorneys for Triton then filed a petition for a rehearing en banc by the entirety of the Fifth Circuit.

    Most circuit court appeals are decided by a three-judge panel, however, the special circumstances surrounding the U.S. Food and Drug Administration’s denial of Triton’s premarket tobacco product applications (PMTAs) motivated the court to allow a majority of the active judges (an estimated 17 judges) to vote to rehear the case “en banc.”

    The FDA rejected applications to market 55,000 flavored e-cigarettes in August 2021, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval.

    A Fifth Circuit panel in October then agreed with Triton’s claim that the new requirement for long-term studies differed from earlier FDA guidance and called the action a “surprise switcheroo” and the panel allowed Triton to keep selling its e-cigarettes until another panel could hear its appeal.

    The court then denied Triton’s request for review of the agency’s MDOs in a 2-1 decision.

    The Fifth Circuit will hear the en banc argument in Wages and White Lion Investments v. U.S. Food & Drug Administration in May.