Author: Staff Writer

  • Imperial Launches Pulze 2.0 Heated Tobacco Device

    Imperial Launches Pulze 2.0 Heated Tobacco Device

    Image: Imperial Brands

    Imperial Brands has launched the first all-new upgrade of its Pulze heated tobacco device, as it continues to innovate to create more compelling, potentially reduced harm products.

    Pulze 2.0 offers new levels of convenience with a compact all-in-one design and 25 or more sessions from a single charge.

    Paired with Imperial’s iD sticks now available in 10 different flavors, Pulze offers an attractive, potentially less risky alternative to consumers seeking to switch away from combustible cigarettes, according to Imperial.

    “Our consumer-centric approach to innovation is accelerating the pace of development across all categories,” said Andy Dasgupta, Imperial Brands’ chief consumer officer, in a statement. “Pulze 2.0 is another important milestone on Imperial’s journey to build a healthier future and offers consumers alternative ways to enjoy moments of relaxation and pleasure.”

    Heated tobacco devices such as Pulze release nicotine and tobacco aromas without burning and producing smoke. This means that aerosols produced by Pulze contain substantially lower levels of harmful chemicals than those found in cigarette smoke, research shows.

    Pulze 2.0 is being launched initially in four markets—Italy, Poland, the Czech Republic and Greece—and will be rolled out more widely across Imperial’s heated tobacco footprint in Europe during the remainder of 2023.

    Heated tobacco forms part of Imperial’s multi-category approach to building a strong, focused next generation products business. The company has also recently unveiled major product innovations in vape, with the new Blu 2.0 and Blu bar devices, and modern oral with nine new varieties of its fast-growing Zone X brand.

    The launch of Pulze 2.0 comes as Imperial CEO Stefan Bomhard and CFO Lukas Paravicini today present on the progress of the business’ transformation at the Consumer Analyst Group of New York conference in Boca Raton, Florida, USA.

    The presentation by Bomhard and Paravicini starts at 4 pm EST. Participants can register here.

  • Researchers Condemn Medical Body’s Position on E-cigarettes

    Researchers Condemn Medical Body’s Position on E-cigarettes

    Colin Mendelsohn

    Australia’s National Health and Medical Research Council’s (NHMRC) statement on e-cigarettes fails to meet the scientific standard expected of a leading national scientific body, according to 11 addiction scientists, reports Medical Express.

    Published in June 2022, the NHMRC statement aims to provide “public health advice on the safety and impacts of electronic cigarettes (e-cigarettes) based on review of the current evidence.”

    This critique of the NHMRC statement, published in Addiction, argues that the statement inaccurately summarizes the current evidence on e-cigarettes. The authors contend that the NHMRC exaggerates the risks of vaping and fails to compare them with smoking;  incorrectly claims that adolescent vaping causes subsequent smoking; and ignores evidence of the benefits of vaping in helping smokers quit.

    The NHMRC statement also ignores evidence that vaping is likely already having a positive effect on public health and misapplies the precautionary principle, which requires policymakers to compare the risks of introducing a product with the risks of delaying its introduction.

    “Many leading international scientists in the field hold more supportive views than the NHMRC on the potential of e-cigarettes as a strategy to improve public health,” said Colin Mendelsohn, lead author of the Addiction article. “In particular, invoking the precautionary principle to prevent the use of much less harmful smoke-free products is unjustified in the face of the massive public health burden of smoking.”

  • Taxation Situation

    Taxation Situation

    Credit: enterlinedesign

    Excise taxes on vapor and OTPs can present considerable administrative burdens on businesses.

    By Bryan Haynes, Christina Sava and Robert Claiborne

    Excise taxes on vapor products and tobacco products other than cigarettes, also referred to as “other tobacco products” (OTPs), present considerable administrative burdens on businesses dealing in these products. All 50 states impose excise taxes on most traditional OTPs, and have for a long time, but operators in the vapor category have been subject to rapidly shifting regulatory conditions as states update their OTP laws and other laws to account for vapor products.

    Many of these laws are framed on traditional distribution models, and businesses’ innovations in routing taxable products to market can raise unique compliance questions. Recent legal changes have also raised new issues over the permissibility of state taxation of products coming in from another state. Where excise taxes are imposed on a product, the sale of such products requires licensure at various points in the supply chain, accurate bookkeeping, regular reporting, and tax remittance practices.

    Typically, distributors and wholesalers of these highly regulated products may be the subject of audits by state revenue departments, and manufacturers and retailers may similarly be subject to audit depending on the auditing state. In our experience, it is a rare audit that does not result in an alleged deficiency. Some deficiency determinations are minor and easily paid while others can add up to hundreds of thousands—and even millions—of dollars due, plus interest and penalties. In such cases, it is imperative to engage the assistance of experienced counsel who can assist you in addressing the assessment.

    A final deficiency determination can be crippling to a business. The audit process itself can be time-consuming and disruptive to normal operations, and any ensuing disputes will be even more so. It’s never a bad time to either establish an audit-readiness plan or clean up existing operating procedures to make sure a future audit and possible dispute go as smoothly as possible. We have drawn on our experience representing clients in such disputes to compile this list of best practices for avoiding or contesting OTP and vapor tax assessments.

    Best Practices for Avoiding a Dispute

    1. Understand your state’s licensure requirements. This tip should go without saying, but it is worth repeating given the rapid evolution of vapor products laws and innovations in businesses’ routing of taxable vapor or OTP products to market. If you do any business in traditional forms of tobacco, and begin selling vapor products, it would be prudent to confirm whether your state requires additional licenses, taxes or reporting for these products.
    2. Know your regulator. For any highly regulated business, it’s important to be familiar with your primary regulatory agency and its agents and maintain a good relationship with them. Any time you are communicating with your regulator is a chance to make a good impression, so remain courteous and professional in your dealings with them, whether via email, by phone or in person. If there are occasions where you disagree with the regulator, you can do so respectfully and without being disagreeable.
    3. Keep and organize accurate books and records. This tip is important for all business owners but especially for businesses that deal in excise-taxed products. Being able to produce accurate documentation of your activities can make all the difference in a dispute as well as prevent disputes. State laws typically establish the minimum record-keeping requirements. A good record-keeping system will include:
    1. copies of invoices and receipts;
    2. copies of bills of lading and other shipping documentation;
    3. copies of all communications with state regulators; and
    4. copies of documentation for any tax payments, tax reports and tax returns.

    Make your records readily accessible as you will be asked to produce them during an audit. You will also want to promptly transmit records to your attorneys if you involve them in any phase of the matter. Verify whether your state requires you to maintain physical copies on-site or whether you can organize your records digitally.

    1. Understand the applicable laws. This one is, again, obvious for all businesses but crucial for those dealing in highly regulated products. Keep track of the tax rate applicable to all of your product classes. If there is a question about whether your products qualify as taxable tobacco or vapor products, you should seek clarification and probably involve your attorney. Some laws, for instance, tax liquid nicotine but not certain other forms of nicotine while other laws tax products, such as vape products, that do not contain nicotine at all. Make sure you are signed up for alerts from your regulatory agency. If you don’t understand a change in law or policy, follow up with the regulator or experienced counsel for clarification. If you are going to seek a formal advisory opinion or even informal guidance from a state department of revenue, you will likely want to involve your attorney to ensure that you inform the department of all material facts and legal grounds that may distinguish your product or activities from coverage under the state’s excise tax laws.
    2. File timely returns. Set up a system for making tax reporting easy and automatic. There are third-party providers that can assist if necessary. Filing thorough, well-prepared returns on time each month generates goodwill and can help prevent audits.
    3. Periodically audit yourself. Set up periodic self-audits to ensure your reporting is accurate. Self-audits can help businesses mitigate issues that, if not discovered sooner, may result in large assessments. If you discover an issue, many state excise tax laws require that returns be corrected proactively. If you discover a major issue, it may be prudent to have a discussion with relevant taxing authorities but involve counsel early if you think you’ve discovered deficiencies. Some states have voluntary disclosure programs that may mitigate potential consequences from noncompliance.
    4. If you are audited, make timely and thorough responses. If you are audited, it is critical to be responsive to auditors’ legitimate requests. Initial interactions with auditors can set the tone for the rest of the audit. Review requests for production thoroughly, note the deadlines and begin working on the responses early. Auditors appreciate well-organized productions, which are easier to provide if they are already organized and you’ve given yourself time to put together a thorough response.

    Best Practices for Dealing with a Potential or Actual Dispute

    1. Engage experienced counsel early. Consider contacting counsel the moment a request for records arrives. Counsel does not always have to respond on your behalf, but they can help you evaluate the legitimacy of requests and help you respond. You should contact counsel immediately upon receipt of a deficiency determination.
    2. Be aware of deadlines. This one bears repeating because, in tax matters, missing a deadline can mean you have conceded to the assessment. Review the assessment carefully and note all deadlines. Review statutes, regulations and agency guidance to familiarize yourself with the appeal process, including any additional deadlines that might not have been identified in your notice.
    3. Provide relevant information to your counsel as soon as possible and throughout the dispute. Is the disputed issue one that your business has previously discussed with the tax department? Has the tax department’s position changed at any point? Does the disputed issue concern products that had taxes paid on them in another state? Have there been any changes in the manner in which you conduct your business? What individuals or documents can address the facts in issue? These are just some of the questions your counsel may have, and there will be others depending on the nature of your dispute. It is important to make sure that you fully inform counsel of the relevant facts and documents early on and throughout the matter. 
    4. Keep perspective. Running a business is hard work, and a tax dispute will not make it easier. While you will naturally be eager for the dispute’s resolution, it is important to bear in mind that the dispute process can be lengthy. Most states route tax disputes through a maze of administrative processes before the taxpayer can have its day in court. Either party can have multiple stages for appeal. Also bear in mind that most disputes eventually settle. Keep a cool head, maintain professionalism and know that you’ll eventually be on the other side of this.

    Proactive measures can help you streamline audits and mitigate the risk of tax assessments. If a dispute arises, early engagement with counsel is critical to developing and executing an effective strategy. Troutman Pepper’s tobacco team has substantial experience advising clients in vape and OTP tax matters and, when necessary, assisting them in disputing assessments. In 2022, we assisted clients in successfully disputing more than $45 million in claimed tobacco tax deficiencies.

    When the taxman asserts a deficiency, you don’t have to resign yourself to “be[ing] thankful [he] don’t take it all.”[1]  There is more that you can do before and after that point. Please let us know if we can help.

    Bryan Haynes, Christina Sava and Robert Claiborne are attorneys for the law firm Troutman Pepper Tobacco Practice.

    [1] The Beatles, “Taxman,” on Revolver (1966).

  • House of Cards

    House of Cards

    Credit: Nakul

    If you improve the way that you implement bad policies, you are still left with bad policies.

    By George Gay

    Yet another report has demonstrated that the quest to encourage cigarette smokers to switch to the consumption of less risky tobacco and nicotine products is being subsumed under what now seems to be seen as the loftier aim of counting how many anti-tobacco policies and strategies can dance on the head of a pin. Constantinople is under attack.

    The report, Operational Evaluation of Certain Components of FDA’s Tobacco Program, was drawn up by an Independent Expert Panel convened by the Reagan-Udall Foundation at the request, in July, of U.S. Food and Drug Administration Commissioner Robert Califf.

    I should point out, however, that the direction the report took was not due to some gratuitous decision on the part of those serving on the panel but was rather determined by the terms of reference they were given. According to the report, issued in December, the panel members were charged with conducting “an evaluation of the FDA Center for Tobacco Products (CTP) with the aim of addressing immediate issues and providing recommendations to position the center for greater success in the future.”

    But the key to the direction the panel took was provided in the following sentence. “This report focuses on operational issues; it does not address tobacco policy.”

    In other words (my words), the panel members were given the task of addressing the symptoms afflicting the CTP, not the causes of its malaise. Their task resembled that undertaken by engineers charged with halting or slowing the collapse of the Leaning Tower of Pisa. Theirs was not to ask whether the tottering tower was fit for purpose. Theirs was to underpin the edifice.

    Of course, there was a major difference between the engineers working beneath the tower and the academics working to prop up the CTP. The former had the joy of working on a beautiful, if foundationally flawed, Romanesque campanile that each year attracts countless tourists. All panel members had to work on, however, was the CTP edifice, whose superadditions rival those of a Gaudi building while lacking the charm or joie de vivre.

    But I have digressed and, in doing so, skipped over something mentioned above that might have puzzled—even angered—some readers. I can assure you, however, that I detected no implied irony in the statement that the aim of the report should be, in part, to provide “recommendations to position the center for greater success [my emphasis] in the future.”

    Indeed, the report says that, since its creation in 2009, the CTP has accomplished a great deal. “Between 2009 and 2022,” it says, “CTP published 16 proposed rules, 16 final rules, 35 draft guidances and 50 final Level 1 guidances.” And the report continues in that vein, listing such things as the number of applications the CTP has dealt with, the manufacturing and retail inspections it has carried out, the number of warning letters it has sent out and the amount of money it has collected from retailers in civil monetary penalties.

    There are two things that strike me about this. The first is that it seems as though the tasks listed as having been carried out are merely part of the job description and therefore hardly worthy of remark.

    The other point is more important, I think. There was no mention within the paragraph on CTP achievements as to how many smokers the center estimates it has encouraged to quit their habit or how many it has encouraged to move, either partially or wholly, to less risky tobacco and nicotine products.

    Credit: Postmodern Studio

    This is significant because the CTP’s stated mission is to protect people in the U.S. from tobacco-related disease and death, and you’re a million miles from the coalface of such an undertaking if you’re sitting in your office sending out warning letters to retailers. In fact, we seem to be talking mission impossible. “The lack of clarity about CTP’s direction, its priorities and its near-term and longer-term goals and objectives hinders CTP’s ability to effectively carry out its mission,” the report says.

    Indeed, far from mission-judged achievements, the report is clear that things are not going well. “Tobacco is the leading preventable cause of death in the U.S., with cigarette smoking accounting for more than 480,000 deaths annually, according to the Centers for Disease Control and Prevention (CDC),” the report says. “Despite efforts to curb tobacco use, the smoking epidemic continues to contribute to an enormous, avoidable public health catastrophe.”

    And the report then goes on to provide some statistics on smoking and vaping and their outcomes in respect of U.S. adults and young people. With the exception of the references to vaping, that same summation, including the huge death toll, could have been made before the formation of the CTP. It would seem that no progress has been made.

    On the other hand, the report seems very good given the limits of the panel’s mandate, which saw it address four CTP program areas: regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. As far as I am able to judge and given the time restraints involved, the panel members seem to have consulted widely, summed up the situation well and presented a host of necessary recommendations to improve the performance of the CTP.

    I would worry, however, that in trying to implement the recommendations, the CTP would simply take on more work at a time when it is said to be overworked and almost overwhelmed to the point of being regularly reactive rather than proactive. Whereas the recommendations, if implemented, would no doubt be timesaving in the long run, it is difficult to see how the CTP can put those recommendations into place in the short term without additional resources, which we are told are in short supply.

    Surely, the only way out of this vicious circle is to go back to basics and trim the policies to the resources available. This would be no bad thing in any case. The level of complexity of the CTP’s proffered solution to the problem of tobacco consumption is out of all proportion to the problem, or how do we put it now? The “challenge,” or, more recently, the “solution opportunity.” Concentrating on operational aspects means that the CTP, having lost sight of its objectives, is going to redouble its efforts.

    While the panel was robust but diplomatic in its presentation, the report will not have made easy reading for those at the top of the CTP. Reading between the lines, I came away with the impression that the performance of the center has been unnecessarily bureaucratic, confused on the question of the interaction between science and policy, verging on the chaotic and, in large part, ineffective. But, in fairness, I must say that this was broadly my opinion before I read the report, so I cannot claim that my reading was impartial.

    In what I thought was the most important aspect of the report, the panel addressed the tricky issue of science and how it informs the CTP’s work. The report notes that some issues before the CTP were fundamental policy questions that had to be informed by science but were not, themselves, scientific issues. “Rather, they are policy issues with profound societal impacts,” the report said.

    And then it went on to make what is a vital point about an issue that, to my way of thinking, has tripped the CTP up on its mission path. One such question that scientific analysis alone would not resolve, the report said, was how to weigh the public health benefits achieved through smokers using electronic nicotine-delivery systems (ENDS) to completely quit smoking combustible tobacco products against the public health harms that might occur if young people used ENDS and thereby acquired a lifelong addiction to nicotine or proceeded to use combustible tobacco products,

    Again, in fairness, I don’t believe that all the problems that have beset the CTP since it was set up as part of the FDA following the passing in 2009 of the Tobacco Control Act can be laid solely at the door of the center. The decision to hand to the FDA responsibility for the oversight of products whose consumption was known to be risky was fraught, especially given the tendency of politicians to use tobacco as a way of burnishing their often tarnished credentials in the eyes of populations made up overwhelmingly of people who do not use tobacco products. Putting the boot into smokers is generally a vote winner.

    The CTP has been confronted, too, with legal challenges, but here it must be prepared to take a large part of the blame because important aspects of what it has done have been characterized by a lack of consistency. The report is awash with stakeholder comments about a lack of clarity, transparency and communication regarding its priorities and its decision-making processes.

    Application processes were said by stakeholders to be extremely cumbersome and time-consuming, with submission requirements vague, frequently changing and favoring established companies. Application reviews were said to be inefficient and unpredictable, which is unsurprising given that FDA employees described the past several years of application review programs as full of ad hoc troubleshooting and abrupt shifts in direction.

    What will have particularly exercised the minds of most of the readers of this magazine are those sections that deal with tobacco harm reduction issues, though much of what was said will have been widely known. At one point, the report notes that the agency announced its intention to apply a harm reduction strategy designed to move tobacco product consumers down the continuum of risk: switching from using combustible tobacco products to noncombustible products.

    “However, stakeholders observed the agency’s more recent marketing authorization decisions appear to reflect a policy shift—specifically a reluctance to authorize any … ENDS other than those that are tobacco flavored,” the report notes. “If such a policy shift occurred, the agency did not specifically announce it in a regulation or guidance, leaving stakeholders to glean it from documents posted on FDA’s website such as a Technical Project Lead (TPL) review of PMTAs [premarket tobacco product applications], MDOs [marketing denial orders] posted in abbreviated form, or from heavily redacted documents provided in response to Freedom of Information Act (FOIA) requests.”

    There are two main points in the report with which I would take issue. My main gripe concerns the following sentence. “Although CTP has a critical mission to protect the public health from tobacco-related disease and death and is regulating products that have no inherent benefit and huge societal costs, it is a government regulatory program with a duty to run efficiently, fairly and transparently.”

    “No inherent benefit”? Unless I am misunderstanding what is being said here, and I hope that is the case, I have to ask how such a distinguished panel can have arrived at this idea. How can the panel say that a product consumed by, we are told, more than 30 million people in the U.S., often at great financial sacrifice, has no inherent value? Is the panel saying that these people have no agency—are zombie consumers?

    The other issue has to do with enforcement of the various rules laid down by the CTP, which were seen by some CTP staff and stakeholders as being cumbersome. There seemed to be a suggestion that a task force should be formed of half a dozen or so agencies, including the Bureau of Alcohol, Tobacco, Firearms and Explosives, and the Department of Homeland Security.

    Wouldn’t this be somewhat heavy handed? Whenever such issues arise, surely it is incumbent upon us to take a step back and ask, is enforcement really the problem? Is it time to increase penalties as some apparently suggest, or is it time to say that perhaps the rules are the problem? And, in this case, it seems to me that the rules are the problem, or rather that the problems arise because the rules are changed without warning and are therefore difficult to follow.

    Overall, given such circumstances, I cannot see how this report will help smokers, even indirectly. The problem lies in the CTP’s policies. If you improve the way that you implement bad policies, you are still left with bad policies.

  • Tempe, Arizona Seeks to Implement Vape Shop License

    Tempe, Arizona Seeks to Implement Vape Shop License

    Credit: Bruce

    The city of Tempe, Arizona in the U.S. is considering making retailers buy a license to sell tobacco, including e-cigarettes.

    A proposal from a council committee calls for a citywide registry of businesses that sell tobacco, along with a process to revoke licenses for retailers who repeatedly sell to minors, according to Frontera Desk.

    It also suggests raising the age to buy tobacco products to 21. Federal law already prohibits purchases to anyone under 21, but Arizona does not have a similar state law.

    Tempe will hold two community meetings and an online survey in March before the council takes up the issue in April or May.

  • Sheridan, Wyoming to Consider Criminalizing Youth Vaping

    Sheridan, Wyoming to Consider Criminalizing Youth Vaping

    Credit: Photos 593

    The city council in Sheridan, Wyoming, will meet Tuesday, February 21 for their regularly scheduled business meeting instead of Monday due to the President’s Day holiday. According to Sheridan Media, one of the items the Council will consider is an ordinance pertaining to vaping and tobacco use by minors in the City.

    Under the proposed ordinance, any minor found possessing tobacco or electronic cigarettes (vaping devices) would be subject to a tiered system of fines through Municipal Court.

    There will be a public hearing prior to the Council considering the ordinance on first reading. There will also be a public hearing and subsequent first-reading consideration of an ordinance regarding drug paraphernalia within the City. The City Council will meet Tuesday night at 7 in Council Chambers on the third floor of Sheridan City Hall.

  • Warner: Enough Evidence for Vapes as Cessation Tool

    Warner: Enough Evidence for Vapes as Cessation Tool

    Kenneth Warner (Photo: University of Michigan News)

    There is enough evidence to support using e-cigarettes as a first-line aid for smoking cessation in adults, according to Kenneth Warner, dean emeritus and the Avedis Donabedian Distinguished University Professor Emeritus at the University of Michigan’s School of Public Health.

    “Far too many adults who want to quit smoking are unable to do so,” Warner said in a statement. “E-cigarettes constitute the first new tool to help them in decades. Yet relatively few smokers and indeed health care professionals appreciate their potential value.”

    In a study published in Nature Medicine, Warner and colleagues took a global view of vaping, examining countries that promote vaping as a smoking cessation and countries that don’t. 

    While agencies in the United States and Canada acknowledge the potential benefit of e-cigarette use, they deem the evidence to recommend e-cigarettes for smoking cessation as insufficient, according to the authors.  

    However, in the United Kingdom and New Zealand there is high-level support and promotion of e-cigarettes as a first-line smoking cessation treatment option.

    “We believe that governments, medical professional groups and individual health care professionals in countries such as the U.S., Canada and Australia should give greater consideration to the potential of e-cigarettes for increasing smoking cessation,” Warner said. “E-cigarettes are not the magic bullet that will end the devastation wrought by cigarette smoking, but they can contribute to that lofty public health goal.”

    Warner’s previous research has found considerable evidence suggesting e-cigarettes are an effective smoking-cessation tool for adults in the U.S., where hundreds of thousands of people die of smoking-related illness each year. 

    In addition to evaluating differences in regulatory activities across countries, the researchers examined evidence that vaping increases smoking cessation, the health consequences of e-cigarettes and the implications for clinical care. 

    They also cite the Food and Drug Administration’s designating some e-cigarette brands as “appropriate for the protection of the public health”—the standard required to receive approval for marketing. This action, the researchers say, implies indirectly that the FDA believes e-cigarettes can help some individuals quit smoking who would not do so otherwise.

    Warner and colleagues conclude that “acceptance of the promotion of e-cigarettes as a tool for smoking cessation will likely depend on continuing efforts to reduce access to, and use of, the products by young people who have never smoked. The two objectives can and should co-exist.”

    Study co-authors include Neal Benowitz of the Department of Medicine at the University of California, San Francisco; Ann McNeill of the National Addiction Centre, King’s College London, U.K.; and Nancy Rigotti, Department of Medicine, Harvard Medical School. 

  • Olczak Outlines Harm Reduction Vision at Summit

    Olczak Outlines Harm Reduction Vision at Summit

    Jacek Olczak (Photo: PMI)

    In an address at the recent ET Global Business Summit 2023 in New Delhi, Philip Morris International CEO’s, Jacek Olczak, emphasized the need for leveraging science and technology for a better, more sustainable future, according to a PMI press release.

    Conceived in 2015, and now in its seventh edition, the Global Business Summit seeks to provide solutions to macroeconomic challenges by curating government-to-government interactions, business to government meetings, business-to-business engagements and to serve as a conduit for corporates and governments to secure investments in India from domestic and international allies.

    Held on Feb. 17-18, the New Delhi summit was attended by Indian Prime Minister Narendra Modi, along with several CEOs, policymakers and academics.

    Speaking on the theme “Sustainable economy for the greater good,” Olczak stressed how innovation has grown rapidly over the past decades with investments across a wide range of industries, including the energy and automotive sectors.

    “Science and technology integrated with a collaboration between private and public has proven to be key to identify solutions to overcome difficult challenges,” he said.

    Olczak then touched up PMI’s commitment to realizing a smoke-free future. Thanks to advances in science and technology, it is now possible to eliminate combustion and replace it with controlled heating, at much lower temperatures. At these lower temperatures, these products generate significantly lower levels of harmful compounds, according to Olczak, who also spoke about the clinical and non-clinical studies that have been conducted on PMI’s heated tobacco products.

    Drawing parallels with other industries, Olczak spoke about the need to address challenges at their source, while also working to identify safer alternatives. The harm-reduction principles underpinning the moves from wood-fuel stoves to gas-fueled stoves, and from combustion-engine vehicles to less-polluting alternatives, also apply to tobacco, according to Olczak.

    Taking the example of Japan, he noted how the introduction of heated tobacco products in that country has contributed to a decline in cigarette sales at an annual rate of 1.8 percent on average over the past few years.

    With the expanded availability of heated tobacco products, almost 35 percent of cigarettes in Japan have been replaced by heated tobacco products over the past seven years. Recent analysis has also shown a downward trend in hospitalizations for Chronic Obstructive Pulmonary Disease. Additionally, research funded by the country’s Ministry of Health and Welfare shows there is negligible adoption of these products by minors, according to PMI. “Similar dynamics are being observed in several European countries,” said Olczak.

    Olczak also spoke about how the estimated 200 million users of oral tobacco in India could be offered modern, safer oral tobacco products, like the ones available in Scandinavia.

    According to Olczak, PMI’s biggest contribution to society lies in addressing cigarette health effects. Throughout the company’s history, it has been a leading player in the cigarette market. Now, the company is intentionally leaving that behind, he said, embarking on a transformation to provide adults who would otherwise continue to smoke.

    “All that’s needed is for today’s innovative, science-based products to be matched by equally innovative policies that encourage people that smoke to switch to less harmful alternatives. This is where India can help drive positive change for the rest of the world. And as chair of the G20, it can be a prime example for emerging economies,” he opined.

    “Innovation in the tobacco industry is finally a reality,” said Olczak. “The question we must ask ourselves is this: How do we ensure that innovations are used in the service of people? In other words, how do we leverage technology, science, and innovation to accelerate public health progress and get millions of Indian smokers away from cigarettes? Given India’s history in leveraging innovative solutions to solve issues of society, I am confident that India will be a global leader in progressive tobacco policies going forward,” he concluded.

  • U.S. House Bill Could Force FDA to Focus on Disposables

    U.S. House Bill Could Force FDA to Focus on Disposables

    Credit: ArieStudio

    A new House bill would require the FDA to update its enforcement guidance to prioritize its enforcement against disposable electronic nicotine delivery system (ENDS) products.

    U.S. Rep. Sheila Cherfilus-McCormick (D-Fla.) introduced the bill that would also close a legal loophole that allows for the sale of flavored e-cigarettes if the delivery device is disposable.

    “Too many of our youth are forming nicotine addictions, increasing their risk of future addiction to other drugs,” Cherfilus-McCormick said in a news release. “I am even more troubled by the fact that Chinese manufacturers and suppliers are flooding the U.S. market with unregulated, harmful substances that are altering our children’s brain development and lives, according to a release.

    The bill, known as HR 901, was referred last week to the House Committee on Energy and Commerce for review and consideration. The bill wouldn’t ban disposable vapes or give the FDA additional authority if passed.

    The bill could find support from some House members and tobacco companies. Last week, R.J. Reynolds filed a formal FDA citizen petition asking the agency to prioritize enforcement against disposable vapes.

  • Medicinal Cannabis Research Act Survives Senate Committee

    Medicinal Cannabis Research Act Survives Senate Committee

    Credit: EKKAPON

    The Senate Committee on Veterans’ Affairs advanced the VA Medicinal Cannabis Research Act on Thursday, marking the first-ever standalone cannabis bill to be passed out of a Senate committee.

    If passed, it would be only the second standalone marijuana legislation to be passed federally.

    The bipartisan bill, which advanced in a markup session that occurred off the floor, would direct the Secretary of Veterans Affairs to conduct both a study and clinical trials on the “effects of cannabis on certain health outcomes of veterans with chronic pain and post-traumatic stress disorder,” as well as for other conditions. 

    The Senate legislation is sponsored by Montana Sen. Jon Tester, also the chair of the committee, and co-sponsored by Alaska Sen. Dan Sullivan; House Reps. Lou Correa and Jack Bergman have introduced the House version, Cannabis Wire reports. 

    “I’m particularly proud we cleared a number of my bills allowing VA to increase the number of providers in rural areas, authorize important VA projects, and conduct research into medicinal cannabis as an alternative treatment to treating the wounds of war,” Tester said in a statement after the advancement of three veterans bills on Thursday.

    The VA has been an ongoing example of where state and federal cannabis laws clash. While medical cannabis is now legal in a majority of states, cannabis remains a Schedule I substance under federal law. VA doctors, beholden to federal law, have been unable to recommend these products to patients. 

     “Medicinal cannabis is already in use by thousands of veterans across the country, but we don’t yet have the data we need to understand the potential benefits and side effects associated with this alternative therapy,” Sullivan said in a statement when introducing the bill.

    Last year, for the first time, a standalone piece of marijuana reform legislation was signed into law by a U.S. president. The “Medical Marijuana and Cannabidiol Research Expansion Act” is just one signature away from historic enactment.