Category: Featured

  • Doctor’s Orders

    Doctor’s Orders

    Photo: Minerva Studio

    Medical licensing of e-cigarettes and nicotine pouches should be an urgent priority.

    By Derek Yach

    The alarm about the risks of products to health is usually first sounded by physicians. That was certainly the case with tobacco and health. The 1962 Royal College of Physicians (RCP) Report on Smoking as well as the 1964 Surgeon General’s (SG) Report on the same topic were led by physicians and drew upon the best epidemiological evidence available. The reports’ statement that “smoking kills” led to rapid changes in physicians’ smoking behavior well before regulators took up the challenge. The world had to wait eight years before the World Health Organization passed its first modest resolution on smoking. Only then did modest public health policies emerge.

    Internationally, the evidence is clear: No country experiences a serious decline in their smoking rates before it declines among physicians. And it takes about a decade before the population benefits start appearing. Globally, smoking rates among men approach 40 percent to 50 percent in countries as diverse as China, Bulgaria, Jordan and Bangladesh—or 50 years behind where the U.K. is today. Smoking rates among the physicians in these countries are about the same. There are few examples of physician-led reports like those of the RCP or SG from middle-income or lower middle-income countries. In such settings, we cannot expect to see substantial progress in ending smoking if we stick with the status quo.

    Physician Leadership Is Crucial for the Introduction of Innovative Interventions

    Innovations in healthcare are usually led by physicians armed with solid epidemiological and clinical data showing the benefits of new interventions for patients and the population. Physician leadership gives credibility to new products. The opposite is also true. Products that are not endorsed or approved by physicians rarely achieve population benefits and may face stiff regulatory approval.

    Sluggish Progress on Improving Cessation Outcomes

    For decades, physicians have followed a “medicalization” path to cessation, so it is not surprising that they have neglected tobacco harm reduction (THR) options. The basic advice given by physicians has changed little. Quit cold turkey, counseling, nicotine-replacement therapies (NRTs) and a few other pharmaceutical and behavioral services remain the mainstay of cessation. None have success rates that exceed 15 percent over the year, and most are associated with repeated relapses. The World Health Organization’s own reports to the World Health Assembly this year pointed to slow progress in addressing cessation. Numerous reports, such as those issued by the Foundation for a Smoke-Free World, have pointed to the failure of the pharmaceutical industry to bring better cessation tools to the market despite advances in behavioral and neuroscience that have led to new therapies for a range of diseases.

    It is long overdue that physicians have access to far more efficacious and effective ways of ending smoking. We now have a full range of feasible options that have been authorized by the U.S. Food and Drug Administration as “appropriate for the protection of public health”: heated-tobacco products, e-cigarettes, snus and most recently nicotine pouches. E-cigarettes and nicotine pouches are well placed to form the basis of a new approach to cessation and harm reduction.

    How Do We Engage Physicians in Scaling up Access to These Lifesaving Products?

    Recent experience shows that physicians have been resistant to these products for several reasons. They fear these are a new tactic by the tobacco industry to keep the next generation addicted. They seek data on long-term benefits. They are bamboozled daily by well-funded nonprofits and WHO messages about the dangers of these products for kids, and the impact of them on cancer or heart disease. The fact that none of this is based on science has not stopped the opposition.

    Could Medically Licensed Products Break Through and Reach Physicians?

    I strongly believe that they could.

    At a recent Keller and Heckman meeting, Ian Fearon, chief scientific officer at McKinney Scientific Advisors, described the “halo” effect of having medically licensed e-cigarettes on the market. To get medically licensed requires proof of quality, safety and efficacy. Once achieved, this could legitimize the category and open the doors to widespread physician acceptance of the products. The same could happen with nicotine pouches.

     This could start to erode distrust of these products by physicians as they use them and advise their patients to use them. The predictable positive outcomes would accelerate adoptions and use.

    Recall that almost 50 percent of male doctors in many low-income and middle-income countries and countries across the Middle East smoke. Helping them to switch first deserves concerted effort. And having a new medically licensed e-cigarette or nicotine pouch could well trigger the desired cascading impacts on their patients and then among the general population.

    The process to obtain a medical license has been well outlined by the FDA’s Center for Drug Evaluation and Research (CDER) and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA). Neil Benowitz et al. (see below) and Fearon have stressed that CDER requirements are particularly onerous. The MHRA process is more “encouraging.” According to them, a major benefit of the MHRA is that studies required can be conducted in any country whereas only U.S. studies are accepted by the CDER.

    A unique authoring partnership between people who usually disagree about the value of THR concluded that the CDER should “reach out to companies that may be interested in developing smoking cessation products” and indicated that that could include medically approved vapes. Authors included Benowitz and Ken Warner, known supporters of THR, and Matt Myers and Joanne Cohen, who until now have opposed THR.

    They commented that “the deadliest form of nicotine delivery has been subject to limited oversight whereas products marketed to help people quit face far more regulatory barriers.” The fact that agreement can be reached on the value of THR in the context of medically licensed products should be taken as a signal to how broader acceptance might happen.

    Mitch Zeller, previous head of the FDA’s Center for Tobacco Products, jumped into this field recently and urged action on medical licensing when he announced that he had joined a company aiming to bring a medically licensable vape to market.

    Why Has Industry Not Led the Way?

    There can be little doubt that the pharmaceutical industry and leaders in the tobacco industry have long had the scientific knowledge and technical capabilities to develop medically licensed equivalents to e-cigarettes and nicotine pouches. So why has there been no progress? Are short-term commercial interests taking precedent over health needs? I suspect this is a major factor delaying progress by large companies. But thankfully, smaller entrepreneurial companies are pursuing medical licenses at considerable cost to them.

    In addition to commercial interests, industry leaders and analysts have mentioned three other issues as hampering to progress:

    1. Concern that the WHO and anti-harm reduction activists would mount campaigns against them.
    2. Tobacco companies fear that a medically licensed product would reach a small part of the market—people with early symptoms of disease or those deeply concerned about their health. That might turn off other smokers seeking to use safer products for recreation and pleasure. They do not want to be stigmatized as being “patients.”
    3. Any innovation or improvement to a medically licensed reduced-risk product needs costly, lengthy and comprehensive re-appraisals by the regulating body with no guarantee of consumer acceptance. For industries specializing in fast-moving consumer goods, this can be a deterrent.

    What Is the Size of the Market?

    Companies need to look at data on the burden of disease and at data they have showing that an extremely high percentage of e-cigarette users switched from combustibles for health reasons. Global burden of disease data shows that 8 million people die annually from tobacco use. That figure hides the fact that hundreds of millions of tobacco users have early symptoms or signs of cancers, heart and lung disease or tuberculosis. It hides the fact that over 50 percent of people with serious mental illness smoke, that about 60 percent to 70 percent of people with early chronic obstructive pulmonary disease, tuberculosis and schizophrenia smoke at the point they are diagnosed. And that figure does not change much during their treatment, suggesting physicians’ failure to help their patients end smoking.

    It is not surprising that a recent Bloomberg analysis suggests that the size of the nicotine-replacement market could reach $100 billion by 2028. That should stimulate companies to invest in medically licensed options that consumers demand and enjoy in unprecedent numbers.

    How Would These Products Be Marketed?

    Marketing strategies would need to distinguish between products that are medically approved versus others. There are many precedents for designing marketing plans to reach two different audiences using the same basic product. The most recent being how Ozempic addresses the needs of people with diabetes while Wegovy (both made by Novo Nordisk) addresses obesity. Two brands, one set of active ingredients. In an analogous way, initially NRTs were prescription-only in most countries but were changed to “over the counter” use to improve access to “essential medicine,” and NRTs are noted as such in the WHO Model List of Essential Medicines.

    I could see this developing a comparable way for e-cigarettes and nicotine pouches.

    Conclusion

    There is a massive untapped need to get more efficacious cessation products on the market. Medically licensed e-cigarettes and nicotine pouches could well be the key to gaining widespread and critically needed physician support for the categories. That could unblock deep opposition to THR as it has happened with so many innovations that benefit health.

    A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.
  • Conference of Mayors Approves Flavor Ban

    Conference of Mayors Approves Flavor Ban

    Image: Tobacco Reporter archive

    At their annual meeting in Columbus, Ohio, the U.S. Conference of Mayors approved a resolution that supports prohibiting all flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars.

    The Campaign for Tobacco-Free Kids (CTFK) welcomed the move. “We are grateful for the strong leadership provided by the sponsors of this resolution, including Mayors Andy Schor of Lansing, Michigan, Justin Bibb of Cleveland, Ohio, Satya Rhodes-Conway of Madison, Wisconsin, and Alix Desulme of North Miami, Florida,” said John Bowman, the CTFK’s executive vice president for U.S. programs, in a statement.

    According to the CTFK, youth e-cigarette use remains a public health crisis driven by flavored products. In 2022, over 2.5 million U.S. youth were current e-cigarette users, and 85 percent of them reported using flavored products.

    The resolution also supports prohibiting menthol cigarettes.

  • A Ban By Any Other Name

    A Ban By Any Other Name

    Photo: kurgu128

    The FDA’s reluctance to permit flavored e-cigarettes may be hindering adult smokers’ conversions to less harmful products.

    By Neil McKeganey and Andrea Patton

    If there is one phrase that must keep e-cigarette and e-liquid company executives awake at night, it must surely be “flavor ban.” In their public statements, U.S. Food and Drug Administration officials have always denied pursuing a ban on e-liquid flavors, encouraging e-cigarette manufactures instead to “show us the data” where e-cigarette flavors are compared to tobacco flavor in terms of their effectiveness in assisting adult smokers in quitting. 

    The reality of the premarket tobacco application process, however, tells a rather different story. Of the more than 6.7 million applications submitted—over 99 percent of which the FDA has adjudicated upon—not a single flavor other than tobacco has been awarded a marketing authorization. On the basis of those numbers, whether admitted or not, there is an e-cigarette flavor ban in the U.S. in all but name.

    But why have flavors drawn such restrictive regulatory action from the FDA? The answer, of course, lies in youth vaping. So great has been the concern at the increase in youth vaping that politicians, public health officials, the media, parents and others have found themselves asking the questions “why are so many kids vaping, and how can we stop it?” When Scott Gottlieb was the director of the FDA, he offered an answer to that question in railing against “kid-appealing flavors.” In the years following Gottlieb’s tenure, it seems the phrase “kid appealing” has been dropped in reference to characterizing flavors per se as the villain of the piece when it comes to youth vaping.

    But how can we be sure that it is indeed e-liquid flavors that are driving youth vaping? A surprising answer to that question can be found in the latest results from the 2022 National Youth Tobacco Survey. This survey draws upon data from over 28,000 middle school and high school pupils from across the U.S. and is one of the leading influences on government policy when it comes to e-cigarettes.

    When youth who had ever tried an e-cigarette were questioned about the reasons why they first used an e-cigarette, flavors were the ninth most frequently cited reason among middle school pupils and the seventh most frequently cited reason among high school pupils. In explaining their reasons for starting to vape, both middle school and high school pupils much more commonly mentioned curiosity about e-cigarettes, the fact that e-cigarettes were being used by friends or family members, or that they felt anxious, stressed or depressed.

    A very similar picture emerged in relation to the reasons youth participants in the survey offered for why they were currently using e-cigarettes. In this case, flavors were the ninth most frequently cited reason among middle school pupils and seventh among high school pupils. Again, much more influential in explaining their current e-cigarette use were the fact that these devices were seen to be a way of reducing stress, the fact that they were used by friends and the attraction of the nicotine buzz. Flavors may be part of the choices that youth make when they are using an e-cigarettes, but that does not mean that they are the key factor in the reason why youth start vaping or continue vaping.

    On the basis of those results, one would have to say that flavors may well have been miscast as the cause of youth vaping. There is, however, a further problem with restrictive regulatory action targeted on flavors apart from the fact that it may well not be flavors that are driving youth vaping—the fact that flavors might actually be an important part of adult smokers’ journeys away from combustibles. By reducing the range of tobacco flavors adult smokers can use in their e-cigarettes, regulators may be weakening the capacity of these devices to assist adult smokers in quitting. 

    With an e-cigarette flavor ban in all but name being applied in the U.S., it is important that e-cigarette companies, and others, monitor the extent to which the reduced range of available flavors may be resulting in fewer adult smokers using e-cigarettes and fewer smokers managing to quit smoking with these products. It is important to remember that the ratchet of restrictive regulatory prohibition can move both up and down depending upon the evidence. If evidence shows that flavors are not driving youth vaping and that those flavors are helping adult smokers to quit, then a case can be made for allowing flavors to reenter the world of adult vaping. In the meantime, attention needs to be focused on how manufacturers and others can work together to ensure that flavored e-cigarettes, while available for adult use, are inaccessible to youth.

     

    Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.
    Andrea Patton, is a behavioral epidemiologist and head of prevalence research within the Centre for Substance Use Research, Glasgow, U.K. Patton has over 15 years of experience working in public health for academia, regulatory bodies and industry leaders in Europe and the United States.
  • Labour: Generational Ban Upon Election

    Labour: Generational Ban Upon Election

    The U.K. will embrace a New Zealand-style generational tobacco ban if the Labour Party wins the next elections, reports the Daily Mail, citing a BBC interview with Shadow Secretary of State for Health and Social Care Wes Streeting.

    In 2008, New Zealand passed legislation banning the sale of cigarettes to anyone born after 2008. The Act also slashed the number of outlets able to sell cigarettes and cut nicotine in cigarettes to nonaddictive levels.

    Interviewed by BBC Radio 4, Streeting said he was keen to adopt a plan that would be workable if Labour won the next election. 

    “The question for me on the New Zealand-style smoking ban isn’t whether it’s desirable because I think in policy terms, and in terms of public opinion, interestingly, I think there is an appetite and a policy driver there to do it,” he said.

    Ministers have previously set an objective for England to be smoke-free by 2030. An independent review by Javed Khan, ordered by former Health Secretary Sajid Javid, was published in August and recommended a series of actions to help eradicate smoking in England.

    Khan warned that, without further action, England will miss the 2030 target by at least seven years, and the poorest areas in society will not meet it until 2044.

    Smoking rates in the U.K. have fallen from about half of the population in the 1970s to around just 15 percent now.

  • Vaping Industry Unimpressed by CTP ‘Reset’

    Vaping Industry Unimpressed by CTP ‘Reset’

    Photo: aleksandar kamasi

    Vaping industry representatives are unimpressed by the U.S. Food and Drug Administration’s plan, announced Feb. 24, to address the shortcomings in the operations of its Center for Tobacco Products (CTP) identified by independent evaluators working through the Reagan-Udall Foundation.

    “While the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product,” Tony Abboud of the Vapor Technology Association told AP News.

    The CTP has come under fire from various sides, with health advocates urging the agency to more aggressively police regular cigarettes and flavored e-cigarettes, and tobacco companies complaining that the FDA is unwilling to approve new products, including e-cigarettes, which might help adults quit smoking.

    To address such criticisms, FDA Commissioner Robert Califf in July 2022 ordered an independent investigation into the CTP’s operations.

    On Dec. 19, 2022, the Reagan-Udall panel issued a blistering report. Evaluators described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.

    In response, the FDA pledged a reset to the agency’s tobacco program. The CTP director promised to develop a five-year plan by the end of 2023 outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.

    Nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product.

    Tony Abboud, executive director, Vapor Technology Association

    Vaping industry representatives expressed disappointment with the FDA announcement, which they said would continue to result in denials for most vaping products.

    “After the scorching findings from the Reagan-Udall report, the FDA should be issuing a mea culpa to the American public for the calamity created by the agency’s insistence on crushing the nicotine vaping market,” the American Vapor Manufacturers Association wrote in a statement.

    “But instead of taking responsibility, the agency is proposing yet more task forces, more bureaucrats and even a so-called ‘five-year plan,’ which is government shorthand for punt, retreat, and see you later. It’s not good enough, not by a long shot, and the millions of Americans relying on vaping products to stay off cigarettes have once again been bast to the wind by the FDA’s chronic negligence and indifference.”

    Americans for Tax Reform described the CTP’s response as “inadequate,” saying it fails to address the critical issues highlighted by the Reagan-Udall Foundation. “Since [CTP] Director King and FDA are clearly unwilling to step in and fix the problems plaguing the Center for Tobacco Products, this falls upon Congress, and specifically the new Republican House Majority, to use oversight powers to reestablish trust in FDA and improve public health,” the group wrote in a statement.

  • Vaping Industry Unimpressed by CTP ‘Reset’

    Vaping Industry Unimpressed by CTP ‘Reset’

    Photo: aleksandar kamasi

    Vaping industry representatives are unimpressed by the U.S. Food and Drug Administration’s plan, announced Feb. 24, to address the shortcomings in the operations of its Center for Tobacco Products (CTP) identified by independent evaluators working through the Reagan-Udall Foundation.

    “While the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product,” Tony Abboud of the Vapor Technology Association told AP News.

    The CTP has come under fire from various sides, with health advocates urging the agency to more aggressively police regular cigarettes and flavored e-cigarettes, and tobacco companies complaining that the FDA is unwilling to approve new products, including e-cigarettes, which might help adults quit smoking.

    To address such criticisms, FDA Commissioner Robert Califf in July 2022 ordered an independent investigation into the CTP’s operations.

    On Dec. 19, 2022, the Reagan-Udall panel issued a blistering report. Evaluators described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.

    In response, the FDA pledged a reset to the agency’s tobacco program. The CTP director promised to develop a five-year plan by the end of 2023 outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.

    Nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product.

    Tony Abboud, executive director, Vapor Technology Association

    Vaping industry representatives expressed disappointment with the FDA announcement, which they said would continue to result in denials for most vaping products.

    “After the scorching findings from the Reagan-Udall report, the FDA should be issuing a mea culpa to the American public for the calamity created by the agency’s insistence on crushing the nicotine vaping market,” the American Vapor Manufacturers Association wrote in a statement.

    “But instead of taking responsibility, the agency is proposing yet more task forces, more bureaucrats and even a so-called ‘five-year plan,’ which is government shorthand for punt, retreat, and see you later. It’s not good enough, not by a long shot, and the millions of Americans relying on vaping products to stay off cigarettes have once again been bast to the wind by the FDA’s chronic negligence and indifference.”

    Americans for Tax Reform described the CTP’s response as “inadequate,” saying it fails to address the critical issues highlighted by the Reagan-Udall Foundation. “Since [CTP] Director King and FDA are clearly unwilling to step in and fix the problems plaguing the Center for Tobacco Products, this falls upon Congress, and specifically the new Republican House Majority, to use oversight powers to reestablish trust in FDA and improve public health,” the group wrote in a statement.

    While welcoming the CTP’s new commitment to transparency, the Premium Cigar Association (PCA) expressed concern that the CTP continues to view industry engagement as an afterthought rather than a means to better understand how its approach can be better designed in the developmental phase of regulations, guidance or strategic planning.

    The PCA also questioned the CTP’s desire to increase its workforce and raise more funds through user fees. “Until the systemic failures are addressed, growing an agency that already spans over 1100 employees will only complicate and compound its problems,” the PCA wrote in a statement. “Rather, CTP should embrace Congressional oversight, as does every other Federal Agency, to ensure that its ongoing efforts remain in-line with its statutory mission and public demands.

  • Vaping Industry Unimpressed by CTP ‘Reset’

    Vaping Industry Unimpressed by CTP ‘Reset’

    Photo: aleksandar kamasi

    Vaping industry representatives are unimpressed by the U.S. Food and Drug Administration’s plan, announced Feb. 24, to address the shortcomings in the operations of its Center for Tobacco Products (CTP) identified by independent evaluators working through the Reagan-Udall Foundation.

    “While the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product,” Tony Abboud of the Vapor Technology Association told AP News.

    The CTP has come under fire from various sides, with health advocates urging the agency to more aggressively police regular cigarettes and flavored e-cigarettes, and tobacco companies complaining that the FDA is unwilling to approve new products, including e-cigarettes, which might help adults quit smoking.

    To address such criticisms, FDA Commissioner Robert Califf in July 2022 ordered an independent investigation into the CTP’s operations.

    On Dec. 19, 2022, the Reagan-Udall panel issued a blistering report. Evaluators described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.

    In response, the FDA pledged a reset to the agency’s tobacco program. The CTP director promised to develop a five-year plan by the end of 2023 outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.

    Nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product.

    Tony Abboud, executive director, Vapor Technology Association

    Vaping industry representatives expressed disappointment with the FDA announcement, which they said would continue to result in denials for most vaping products.

    “After the scorching findings from the Reagan-Udall report, the FDA should be issuing a mea culpa to the American public for the calamity created by the agency’s insistence on crushing the nicotine vaping market,” the American Vapor Manufacturers Association wrote in a statement.

    “But instead of taking responsibility, the agency is proposing yet more task forces, more bureaucrats and even a so-called ‘five-year plan,’ which is government shorthand for punt, retreat, and see you later. It’s not good enough, not by a long shot, and the millions of Americans relying on vaping products to stay off cigarettes have once again been bast to the wind by the FDA’s chronic negligence and indifference.”

    Americans for Tax Reform described the CTP’s response as “inadequate,” saying it fails to address the critical issues highlighted by the Reagan-Udall Foundation. “Since [CTP] Director King and FDA are clearly unwilling to step in and fix the problems plaguing the Center for Tobacco Products, this falls upon Congress, and specifically the new Republican House Majority, to use oversight powers to reestablish trust in FDA and improve public health,” the group wrote in a statement.

    While welcoming the CTP’s new commitment to transparency, the Premium Cigar Association (PCA) expressed concern that the CTP continues to view industry engagement as an afterthought rather than a means to better understand how its approach can be better designed in the developmental phase of regulations, guidance or strategic planning.

    The PCA also questioned the CTP’s desire to increase its workforce and raise more funds through user fees. “Until the systemic failures are addressed, growing an agency that already spans over 1100 employees will only complicate and compound its problems,” the PCA wrote in a statement. “Rather, CTP should embrace Congressional oversight, as does every other Federal Agency, to ensure that its ongoing efforts remain in-line with its statutory mission and public demands.

  • Texas Court to Hear Exploding Battery Case

    Texas Court to Hear Exploding Battery Case

    Photo: unlimit3d

    The Supreme Court of Texas has agreed to hear a lawsuit by a vaper burnt by an exploding battery to determine if Texas courts have jurisdiction over LG Chem America, a subsidiary of South Korea-based LG Chem, which made the battery, reports Law360.

    In 2016, Texas resident Tommy Morgan bought an 18650 lithium-ion battery manufactured by LG Chem. He claims it unexpectedly exploded and caught on fire, leading to him suffering permanent and severe injuries, according to his lawsuit filed in 2019 in Brazoria County District Court.

    The companies are facing other lawsuits by Texas residents with similar claims concerning batteries exploding. But intermediate appeals courts have come to different conclusions on whether LG Chem has enough contacts in the state to face claims.

    LG Chem America and LG Chem have argued that Texas courts lack jurisdiction because the companies don’t sell individual batteries in Texas nor directly to Texas customers. LG has consistently stated in litigation throughout the country that this battery was never intended to be used in e-cigarettes or vaping devices.

    Morgan told the Texas high court that the company deliberately shipped its products to Texas customers who were later injured, therefore Texas courts have jurisdiction.

  • CTP Outlines Responses to Reagan-Udall Report

    CTP Outlines Responses to Reagan-Udall Report

    Photo: Tada Images

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) on Feb. 24 outlined the steps it plans to take in response to an external evaluation of its operations conducted by evaluators working through the Reagan-Udall Foundation.

    The expert panel issued its final report on Dec. 19, 2022, and included 15 recommendations across a number of areas.

    To address concerns raised in the report about transparency, the CTP said it would appoint internal transparency liaisons within each CTP Office, who will be responsible for objectively identifying areas for transparency enhancement. The center will also create a new webpage to feature its responses to citizen petitions and will resume posting scientific policy memos and reviewer guides “when appropriate.”

    To enhance efficiency of its premarket tobacco product application review process, the CTP said it has started developing a more efficient framework for high-quality reviews. The center said it aims to better communicate on scientific issues and practices; hire additional staff and increase internal communication to improve scientific engagement and deliberation. Among other activities, the CTP said it will resume posting of scientific policy memos and reviewer guides, along with communication through public events, such as workshops and listening sessions.

    The CTP also expressed its intention to hold more frequent meeting of the Tobacco Products Scientific Advisory Committee to obtain input on scientific issues.

    To improve its operations in the areas of regulations and guidance, the CTP said it will create a new policy unit within the Office of the Center Director that would be responsible for providing overall policy coordination across the CTP.

    The FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products.

    Robert Califf, Commissioner, FDA

    Recognizing opportunities to enhance its compliance and enforcement work, the CTP said it will convene a summit related to enforcement with senior officials from the Department of Health and Human Services, the FDA, and the Department of Justice (DOJ). The CTP will consider whether statutory changes are needed to assist the center in enforcing the law. It will also explore approaches to achieve compliance outside of judicial enforcement actions through DOJ.

    The CTP said it plans to create a comprehensive webpage for all enforcement activities for products that are illegally marketed without FDA authorization; routinely reach out to industry stakeholders to keep them apprised of new enforcement priorities and updates; and enhance the FDA’s tobacco product marketing order webpage. Planning has already begun for development of a searchable public database of all tobacco products that have an FDA marketing order, according to the center.

    To improve engagement on its public education campaigns, the CTP said it will develop, publish and promote resources that describe the mechanisms it currently uses to solicit and consider public input on its campaigns. It will also explore new ways for soliciting and considering public input on its campaign program.

    Consistent with the Reagan-Udall report recommendation, the CTP is also engaging with relevant entities within FDA, the Department of Health and Human Services, and the Office of Personnel Management to identify solutions to facilitate more timely and efficient hiring of professionals that match CTP’s needs.

    To achieve its goals, the CPT stressed the importance of having appropriate resources, which it suggested could be raised through additional user fees for regulated products, including e-cigarettes. “Since the agency’s fiscal year 2020 budget request, the FDA has advocated for the authority to collect user fees from e-cigarette companies, which currently do not pay user fees despite the enormous workload to review and make decisions regarding these products,” said FDA Commissioner Robert Califf in a statement.

    A detailed description of the CTP’s plan for addressing the Reagan-Udall recommendations is available at the center’s new website.

  • In Memoriam: Kay O’Neill

    In Memoriam: Kay O’Neill

    Kay O’Neill

    Tobacco Reporter (Vapor Voice‘s sister publication) will be celebrating its 150th anniversary next year, and, understandably, no one today was present for its beginning. However, for Tobacco Reporter’s “modern era”—that is, when its headquarters moved to Raleigh, North Carolina, USA, in 1982—the magazine has been fortunate to enjoy an extraordinarily consistent existence in terms of its personnel. In fact, though many people have contributed over the years, we can easily point to a small handful who have been fundamental and foundational to the evolution of what Tobacco Reporter has today become. Our Mount Rushmore, if you will.

    One of those people, without question, was Evelyn O’Neill. She was better known to the industry, her colleagues and friends simply as Kay. Kay joined Tobacco Reporter in 1991 and served numerous roles for the magazine and its family-like parent companies. On Jan. 17, 2023, after battling illness for far too long, Kay passed away surrounded by her loving family.

    In her professional life, Kay did everything you can imagine on the sales side, developing relationships and fostering partnerships around the globe. She eventually earned the title of associate publisher, but to those who worked with her, her most important role was always being the “sales coordinator.” To translate that term, Kay was the buffer between the editors and designers back at the office who cared way too much about when the magazine was scheduled to go to the printer and the salespeople out on the road who were unfamiliar with the concept of deadlines. Kay handled each side with a magical blend of charm, humor and force as only she could, kept the peace and helped everything move forward with the big picture in mind.

    As her former colleagues shared stories, it became apparent that Kay was the true definition of dichotomy. On one hand, she was a Carolina girl—that is to say, she came off as small-town country with the beautiful Southern twang in her voice—but she was as sharp and worldly as they came. She was equally comfortable networking with industry executives at five-course dinners as she was sharing a plate of Carolina barbecue with tobacco farmers at local extension meetings.

    She wasn’t shy about mincing words and wouldn’t hesitate to kick you in the butt when needed but would protect you like a mother lion in her next breath. Each September, she would travel to one of the world’s great cities as part of the Global Tobacco and Nicotine Forum, staying in lush accommodations, then just a few weeks later, she would be in a giant tent standing over a space heater trying to stay warm as she worked a booth at the fairgrounds for the North Carolina Farm Show. Each of those moments was pure Kay. She was a professional, and she was a friend.

    Those who knew her will not only miss her generous personality and infectious laughter but also her ability to disarm the moment and bring perspective. While Kay appreciated the value of hard work, she never lost sight of what truly matters: health, friends and family.

    Kay is survived by her husband, Don Michael “Mike” O’Neill; her daughter and son-in-law, Laura and Erin Douna; her son and daughter-in-law, Ryan and Meghan O’Neill; her stepson and daughter-in-law, Don Michael and Marie O’Neill; her brother and sister-in-law, David and Regina Peebles; and her grandchildren, Abigail, Finley, Webb, Aubrey, Regan and Michael Wayne—along with a group of grateful friends from more than three decades at Tobacco Reporter.