Tag: research

  • Research Grant to Study Biopesticides for Hemp

    Research Grant to Study Biopesticides for Hemp

    Credit: Mex Chriss

    The economic importance of hemp is increasing globally and in the United States. However, because federal laws restricted hemp growth and research until recently, commercial hemp production lacks best practices for cultivation, including effective and safe pest and disease management.

    The Foundation for Food & Agriculture Research’s (FFAR) Hemp Research Consortium is providing Cornell University with a $210,000 grant to identify biologically derived crop protection products—biopesticides—to control hemp’s major pest and disease threats.

    BioWorks and the University of Kentucky (UK) are participating in the research, and BioWorks is providing matching funds for a total investment of $420,000.

    “Research on hemp production is still in its infancy, and pests and disease can be an overwhelming challenge for many growers,” said Kathy Munkvold, FFAR scientific program director. “This project is providing actionable knowledge that will help the hemp production industry thrive.”

    Companies developing crop protection products currently focus on fruit, vegetable, and commodity crops such as corn and soy, rather than newer crops like hemp. This project seeks to fill that gap through a partnership between academic institutions and industry, according to a press release.

    Researchers at Cornell, BioWorks and UK, led by Christine Smart, director of Cornell AgriTech, are determining the effectiveness of biopesticides against several hemp diseases and investigating the tolerance of hemp crops to these products.

    They are also studying the compatibility of biopesticides with other crop protection products used in hemp production. In addition, the team is examining how long the microbes in bioproducts remain on the plant, which is important for product application timing and post-harvest hemp microbial testing required for some hemp products.

    The research will broaden the understanding of how to effectively manage the pests and diseases that undermine hemp production and inform recommendations for controlling those threats. Ultimately, growers will save money through the proper use of inputs and higher crop yield, and consumers will gain more comprehensive access to safe, high-quality hemp products, according to a press release.

    “Hemp growers are looking for information on pest and disease control, and I am enthusiastic that this project will enable improved management strategies,” said Smart.

    To learn more about this grant, visit the Evaluating Biopesticides for the Treatment of Hemp page on FFAR’s website.

  • BAT Opens Innovation Center for Reduced Risk Products

    BAT Opens Innovation Center for Reduced Risk Products

    BAT has opened a new state-of-the-art Innovation Centre at its global research and development (R&D) headquarters in Southampton. The center will be key in continuing the company’s transformation as it builds “A Better Tomorrow.”

    The £30 million ($38.55 million) facility strengthens and deepens BAT’s R&D capabilities. It provides nine specially designed technical spaces to aid the development of BAT’s portfolio of Reduced Risk Products, according to a press release.

    These spaces are dedicated to researching modern oral nicotine pouches, liquids, and flavors for vapor products, heated tobacco products, and well-being and stimulation beyond nicotine. The investment will also support work on packaging, engineering, innovation development, and system integration.

    “The opening of this new facility marks an important milestone in BAT’s transformation and will play a key role in making a smokeless future a reality. Evidence provided by objective world-class science is essential to facilitate the migration of adult smokers to smokeless products and support public health objectives,” said James Murphy, BAT’s director of Research and Science. “The investment in our Innovation Centre will support the cutting-edge research and product development efforts of our global R&D team for many years to come.”

    The new facilities will bring together cross-functional and key R&D teams – with 400 specialized scientists and engineers drawn from various advanced fields, including biotechnology and clinical trials. Intended to accelerate the development of the next generation of BAT’s New Category products, their work includes developing the robust scientific evidence necessary to encourage adult smokers to switch to less risky alternatives.

    To date, R&D carried out in BAT’s Southampton facilities has produced over 200 peer reviewed studies for smokeless products published in scientific journals and has contributed to BAT’s filing of hundreds of patents a year. BAT is listed as one of the top patent filers in Europe as the company continues to develop smokeless products.

    The new Innovation Centre is the latest example of BAT’s commitment to invest in the highest standards of scientific research and product development to support its ambition to reduce the health impact of its business and deliver “A Better Tomorrow.”

    BAT’s refined strategy has committed the company to “Building a Smokeless World” and becoming a predominately smokeless business, with 50 percent of revenue generated from Non-Combustibles by 2035.

    BAT’s site in Southampton, the home of its R&D operations since 1956, is one of the largest employers in the region, with over 1,000 current employees drawn predominantly from across the UK, and a local supply chain with over 25 suppliers based within a 30-mile radius.

    The company’s UK operations support 7,100 jobs across the wider economy and contribute over £300 million to the UK’s GDP. The opening of the Innovation Centre exemplifies BAT’s commitment to and ongoing investment in the UK, marking the first stage of an eight-part, multi-phase refurbishment program for BAT’s entire Southampton campus.

    Globally, BAT has over 1,600 R&D specialists spread across the UK, US, Brazil, Indonesia, Malaysia and China. The £30 million investment in the Southampton facility follows the opening of BAT’s Innovation Centres in Trieste (Italy) in 2021 and in Shenzhen (China) in 2022, and an investment of £300 million a year in R&D to develop New Category products and establish substantiation of their reduced risk potential.

  • Study Claims Freebase Nicotine Safer than Salts

    Study Claims Freebase Nicotine Safer than Salts

    A new University of Louisville study shows the nicotine in certain types of electronic cigarettes can increase the risk for an irregular heartbeat, according to a press release.

    Tests in mice showed that nicotine salts used in pod-based e-cigarettes led to heart arrhythmias and could trigger a fight-or-flight response in higher doses.

    “This suggests the nicotine is harmful to the heart and counters popular claims that the nicotine itself is harmless,” Alex Carll, an assistant professor in UofL’s Department of Physiology who led the study, said in a news release Thursday. “Our findings provide new evidence that nicotine type and concentration modify the adverse cardiovascular effects of e-cigarette aerosols, which may have important regulatory implications.”

    Researchers state that regulating nicotine salts could help mitigate the health risks of vaping.

    The research also suggests choosing e-cigarettes with freebase nicotine instead of nicotine salts, or using e-cigarettes with a lower nicotine content could reduce the risk of harm.

  • ECLAT Celebrates THR Study’s 10th Anniversary

    ECLAT Celebrates THR Study’s 10th Anniversary

    Photo: Wlodzimierz

    The Center of Excellence for the acceleration of Harm Reduction (CoEHAR) is celebrating the 10th anniversary of the ECLAT study, which according to the organization marked a significant shift in the science of harm reduction.

    Riccardo Polosa

    The project began in 2011 when a research group led by Riccardo Polosa of the University of Catania in Italy decided to evaluate the use of e-cigarettes on a sample of smokers who wanted to quit.

    After two years of recruitment and follow-ups, the first randomized controlled trial on electronic cigarettes came to light. The ECLAT study provided evidence for the first time that the e-cigarette could help people—even those who had no desire to give up smoking—quit combustible cigarettes.

    The ECLAT study subsequently became a source of inspiration for researchers worldwide. Even then, despite the technical limitations of vaping products at that time, the study showed that at the 52nd week, 8.7 percent of smokers using e-cigarettes quit smoking, while 10.3 percent reduced the consumption of traditional cigarettes by at least 50 percent. Moreover, 73.1 percent of those who had quit did not use the e-cigarette at the end of the study.

    Although these data may appear modest today, the ECLAT study paved the way for a line of research that now engages thousands of researchers worldwide. The most recent Cochrane literature review—which also incorporates the ECLAT study—confirms what was revealed in Catania 10 years ago: e-cigarettes are effective tools in the fight against smoking.

    Reflecting on the ELCAT research, Polosa called for continued innovation and evaluation. “If we want to definitively erase the history of smoking, we must continue with research, encouraging continuous innovation and evaluation studies,” he said in a statement. “Harm reduction can and is already saving millions of lives. The path is the right one and must be followed to the end.‘”

  • Study Finds Young Kiwis Support Generational Ban

    Study Finds Young Kiwis Support Generational Ban

    Image: Nikolay

    Most young New Zealanders support the law to progressively ban smoking, which was recently abandoned, reports RZN, citing the results of an international study.

    The new coalition government plans to repeal changes to the Smokefree Environments and Regulated Products Act that would have barred the sale of cigarettes to anyone born after 2009, among other measures.

    A Canadian-based international study shows 79 percent of New Zealanders aged 16 to 29 favored the ban.

    A similar share supported a reduction in the number of shops which could sell tobacco, while 68 percent wanted manufacturers to have to take nicotine out of cigarettes.

    The International Tobacco Control Policy Evaluation Project investigates attitudes to smoking across several countries. The most recent research was supposed to provide a baseline for New Zealand before the law came into effect.

    “Our overseas colleagues are incredibly disappointed and devastated as we are because the tobacco research world has been really looking to New Zealand,” said co-author Jude Ball from Otago University.

    By contrast, the Coalition of Asia Pacific Harm Reduction Advocates (CAPHRA) expressed its support for the decision to repeal the generational tobacco ban.

    “CAPHRA applauds the government’s decision to prioritize harm reduction strategies,” said the group’s executive coordinator, Nancy Loucas. “We believe that vaping and other harm reduction tools can play a significant role in helping smokers quit, and we are pleased to see the government recognizing this.”

    The organization said it also shares the government’s concerns about the potential for a black market to develop if the sale of tobacco is overly restricted. 

    “A regulated market is always preferable to an unregulated one, where product safety cannot be guaranteed,” Loucas added.

     

  • Study: Adult Vapers Rely on Flavors and Disposables

    Study: Adult Vapers Rely on Flavors and Disposables

    Photo: Atlas

    New industry figures, collected by online vape retailers representing around 43 percent of the U.K. market, have revealed that significant numbers of older adults are users of disposable and flavored vapes, which are the focus of a government consultation to address the issue of youth vaping that will close on Dec. 6.

    The industry warns that any moves to ban single use vapes and flavors, which have been key drivers in the decline of smoking to record low levels in the U.K. over the last two years, will have catastrophic consequences for the nation’s public health and will effectively end any chance of creating a smokefree generation in the near future.

    The data collected from the last quarter sales by four of the country’s leading online retailers, representing nearly a quarter of the U.K. market, revealed that:

    • The most popular flavor category amongst middle-aged adults (35-44 and year olds) was “fruit” flavors, followed “treats and desserts”
    • Highest proportion of tobacco flavor use is in the over-55 age category
    • Menthol flavors and tobacco flavors are significantly less popular amongst middle-aged adults
    • The average age of adult disposable users is 39

    The latest adult vaping statistics follow a survey conducted by One Poll earlier this year, which revealed that 83 percent of vapers said that flavors helped them quit smoking, with one in three saying that a ban on them would lead them back to conventional cigarettes, which would represent around 1.5 million former smokers.

    Why should 4.5 million adults who have spent years trying to kick a habit that kills some 250 people a day, and have managed to do so through vaping, be at risk of having their lifeline taken away?”

    “These statistics show what we in the industry already know—that the very flavors and single use vapes that are now under scrutiny by the government as it looks to tackle youth vaping are a lifeline for former adult smokers,” said Dan Marchant, co-owner of online retailer Vape Club, which contributed to the demographic sales data.

    “The legitimate vaping industry completely recognizes the need to deal with youth vaping but it shouldn’t involve any wholesale bans, as this will affect the adults who depend on them. There is already a ban on vapes for under 18 year olds as it is illegal for retailers to sell devices to minors. That’s why the industry is calling for greater enforcement of the existing law, on-the-spot fines of up to £10,000 ($12,631) per offence and the introduction of a retail licensing scheme to weed out the rogue traders.”

    “Why should 4.5 million adults who have spent years trying to kick a habit that kills some 250 people a day, and have managed to do so through vaping, be at risk of having their lifeline taken away?” asked UKVIA’s Director General John Dunne.

    “If the government goes down the path of banning single use vapes and/or flavors a return to smoking amongst current vapers will be very much on the cards, bringing with it catastrophic consequences for the public health of the nation and wrecking any chances of the government’s smoke free ambition.  The only winners from any potential bans on the vaping industry are the tobacco industry and illicit markets, something that no one in their right mind wants to see.”

     

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

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

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

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

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

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

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

  • Vape Tax Revenues for States a Fraction of Tabacco

    Vape Tax Revenues for States a Fraction of Tabacco

    Credit: Andrii Yalanskyi

    The total tax revenue collected by U.S. states and local governments from the vaping sector remains only a fraction of that extracted from traditional tobacco products, according to a new report published by KBRA.

    Vaping devices have gained popularity in recent years, largely due to health concerns around traditional cigarettes, smoking cessation initiatives and rising youth consumption.

    U.S. product sales for e-cigarettes are estimated at $7.4 billion annually. Capitalizing on this trend, many states and local governments have implemented taxes on these tobacco alternatives. Cigarettes have an estimated market volume of $82.67 billion in 2023, according to Statista.

    Despite high expectations, the total tax revenue from these products remains small relative to tobacco taxes—and even smaller as a percentage of the budget.

    The KBRA report provides an overview of the e-cigarette/vape market, examines different forms of taxation by state, and assesses the limitations of these taxes in bolstering state budgets, as well as the possibility for future federal regulation.

    Key findings of the report include:

    • While the number of states that have implemented e-cigarette and vape device taxes has grown, these tax revenues represent only a small fraction of the traditional cigarette market size. Vaping tax collections still contribute a negligible percentage of current governmental revenues for U.S. states.
    • Taxation methods vary among states and localities due to the uniqueness of vaping and tobacco alternative products.
    • While a vapor excise tax regime could provide additional sources of revenue for states and localities, there are concerns surrounding states relying on these revenues as long-term solutions to close their budget gaps.
    • Increased federal regulations on vapor products, as well as the implementation of a federal excise tax, are probable in the years to come, which could potentially curb usage and associated tax revenue collections at the state level.

    The KBRA report provides an overview of the e-cigarette/vape market, examines different forms of taxation by state, and assesses the limitations of these taxes in bolstering state budgets, as well as the possibility for future federal regulation.

  • Licensed to Thrive

    Licensed to Thrive

    There may soon be a licensed medicinal inhaled nicotine product on the market if Qnovia finds success.

    By Timothy S. Donahue

    The story of the vaping industry tends to be dominated by two countries—the United States and the United Kingdom. In the U.S., the world’s largest vaping market, misinformation and a regulatory roller coaster continue to rattle the business of electronic nicotine-delivery systems (ENDS). Meanwhile, in the U.K., vaping products are being embraced as a harm-reduction tool to end the use of combustible cigarettes.

    Elsewhere, the gamut of vaping regulations ranges from complete bans to minimal rules. There has not been any advocacy group, research project or product development that has been able to bring global regulators under one unified ENDS umbrella.

    Many experts have said over the years that licensing ENDS as medicinal products could lend credibility to vaping products and their tobacco harm reduction potential. Approval from both the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Center for Drug Evaluation and Research (CDER), the drug approval division of the U.S. Food and Drug Administration, could provide consumers with confidence that ENDS have the potential to be an effective nicotine-replacement therapy (NRT) product.

    Although several media outlets reported that Johnson & Johnson’s Nicorette QuickMist is the first medically licensed vaping product, it isn’t a vaping product. It’s a mist sprayed into the mouth and is not inhaled. One product, however, does have the potential to make the dream of a medicinal ENDS product a reality. U.S.-based Qnovia is presently working with both the CDER and the MHRA to bring its RespiRx nicotine-containing cessation device to market.  

    Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, according to Qnovia CEO Brian Quigley. Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG. 

    RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal byproducts.

    RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product. 

    “The nebulizing unit (cartridge) gets replaced by the patient every one to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”

    Mario Danek, Qnovia’s founder and chief technical officer, agrees that eliminating the cleaning requirement was a priority. “The idea was to create a technology that emulates the form factor of a successful high-adoption consumer product but that is imbued with technologies that would pass CDER’s stringent standard for safety—combined with Qnovia’s purposeful design features, it should bring patient adherence and quit rates to new highs, which historically have been found lacking in NRT,” he says. “Additionally, from a drug delivery platform perspective, those CDER-aligned device safety requirements are just as imperative to Qnovia’s API expansion strategy into other indication areas.”

    RespiRx is a “step-down” therapy, like many NRT products. However, instead of buying different pods with varying levels of nicotine, Qnovia’s device has a dosage-monitoring system programmed into the device. Uniquely, the use regimen is determined based on how much a smoker is smoking, says Quigley. For example, a one-pack-a-day smoker would start with 20 doses per day. The two-pack-a-day smoker would start with 40 doses per day. 

    “Then the device will, over the 12 weeks, gradually reduce the available number of doses to that patient. It is a much more manageable step-down over the 12 weeks, unlike currently available cessation methods. And the device itself will prevent the patient from using more than they’re supposed to use,” says Quigley. “Patients would also have the on-device LCD screen interface to help them understand how to use their doses. That, too, is another benefit of our product versus the existing smoking cessation therapies.” 

    Brian Quigley

    Every smoker smokes differently. One smoker may have their first cigarette after their morning coffee. Another may have to light up the moment they wake up. Quigley says that Qnovia patients can use their daily doses to replace each occasion where they’re used to having their combustible cigarette. They have hand-to-mouth action. They get reinforcements to those behavioral cues that smokers have become accustomed to. 

    “With a piece of gum or a patch, if you have a patch on and you’re having your cup of coffee and you’re fighting through your cravings, it just doesn’t work. I think there’s a lot of benefits to this type of therapy to really help the patient replace their occasion when they need to smoke and then stick with that 12-week step-down program,” says Quigley.

    Choosing sides

    In the U.K., Quigley says the process to become a medicine is less challenging than in the U.S. “Whereas in the U.S., we have to go through a pretty rigorous process and really our competition is once that patient decides they want to try to quit smoking [and] we’re competing against the existing NRTs, which every smoker has tried. Consumers know that none of them are as effective as an inhalable product,” he says.

    If RespiRx decided to be a tobacco product instead of medicine in the U.S., the device may have already been on the market. The FDA’s premarket tobacco product application process is less stringent than the CDER approval process. However, drugs gain approval all the time, while the FDA has approved only 23 vaping products for market, and most of those are technologically obsolete. An NRT comes with less baggage than a tobacco product, and as far as the FDA’s Center for Tobacco Products (CTP) is concerned, vaping products are tobacco products.

    “I think the unfortunate reality facing reduced-risk products is that FDA on the CTP side—they’re in a very tough spot. The industry is kind of stuck in the middle where, yes, the FDA needs to review these applications and approve reduced-risk products, but over the long term, I think FDA will ultimately continue to constrain that industry,” says Quigley. “Ultimately, I think the long-range path of CTP will be to continue to tighten regulations on all tobacco products. That would be a very challenging environment. That space presents a lot of risk.”

    While a much longer and more expensive process, Quigley says the CDER standard is straightforward. It’s about safety and efficacy. It’s a balance between scientific risk and regulatory risk. When the CDER asks a question, it usually requires a study to answer. Studies can be very expensive. “I think that another potential challenge will be that we’ll generate data, and we expect the FDA will be very conservative,” he says. “They could ask us questions that require us to generate additional data that we didn’t think we had to generate. But our view is that we’re going to do this right. If they need data, we’re going to generate it for them. The biggest risk is really the time and money to get through the approval process … but I do believe that we are taking a proactive scientific approach.”

    For Qnovia, the premise that the CDER must be more directly involved with a company working on a new drug than the CTP needs to be when working with the e-cigarette industry was important. Quigley says that he also believes that having less harmful vaping products on the market available to consumers is important in the fight to end combustible tobacco use. He says having e-cigarettes available to former or current smokers who want to continue to have nicotine be part of their life is important. But for Qnovia, its client base is those smokers who are saying they want to end their addiction to nicotine.

    “CDER, for example, has timelines it must adhere to. When we give CDER information, they stick to these timelines. I think it’s a more responsive center than CTP needs to be with e-cigarette manufacturers,” explains Quigley, adding that the company likes the engagement opportunity with the CDER to advance a potential breakthrough therapy for smoking cessation. “The conversation we have with FDA on helping to provide more effective cessation tools is very different than a conversation a tobacco company would have. I do think that we have the opportunity to be viewed as an ally with FDA in their fight against smoking. We’re trying to help solve a problem that is important.”

    Mario Danek

    One of the main issues that the FDA has with vaping products is heat. E-liquid is heated, and that heating process has the potential to create harmful and potentially harmful constituents in the vapor. Quigley says that this is why he doesn’t ever see a vaping product with an atomizer that heats the liquid to vaporize being approved as an NRT product. While e-cigarettes are surely less harmful than combustible cigarettes, there are still potential constituents in the e-liquid aerosol, and the CDER would have a problem approving a vaping product with the potential to have those constituents.

    Qnovia is preparing to submit its investigational new drug application to the FDA. It also expects to begin human clinical trials this year, according to Quigley. Ultimately, Qnovia’s goal is to have its new drug application, its final drug application, submitted to the FDA in 2025.

    “The IND, basically, is where we give them all of our safety data, all of our drug manufacturing and device characterization data. And after that application is submitted, once the FDA gives us the approval, then we can begin human clinicals,” says Quigley. “And we have a phase one, phase two and phase three human clinical plan that we will have to execute.”

    A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, clinical research, FDA review and FDA postmarket safety monitoring. Importantly, a major difference between the CTP and the CDER pathways to market is that drug applicants have safety standards that e-cigarette manufacturers don’t have. For example, for RespiRx, the container that holds the nicotine needs to be sterilized. It needs to be filled aseptically in an ISO 5 cleanroom environment. The vaping industry would only require an ISO 6-certified lab.

    “I think another element is our airpath safety. It’s something that FDA really cares about on the drug side. When the patient is actually inhaling on the device, not only the aerosol but even the breath path, where they’re drawing air from, has to be totally sealed off and isolated from electronics and other materials,” says Quigley “That’s not the case with standard e-cigarettes. Everything, the breath-activation function and all the electronics have to be sealed off entirely from the drug-containing reservoir and the patient’s airpath. These are more stringent safety requirements that have forced us to do extra work from a design perspective and a safety perspective.”

    Forward thinking

    Qnovia was founded in 2018 in Los Angeles by Danek as Respira Technologies. Danek invented the underlying technology. He rebranded the company as Qnovia last year. The company also moved to Richmond, Virginia, in part because that state offers a more business-friendly environment, according to Quigley, whose tobacco career included a six-year stint as CEO of Altria’s U.S. Smokeless Tobacco Co. subsidiary.

    In addition, many of the partners the company works with are on the East Coast. Qnovia contracts with a Boston manufacturer to make its device and a firm in Pennsylvania to create the medicine administered through the device.

    One controversial aspect of e-cigarettes is unlikely to be a problem for Qnovia: The role RespiRx is to play in a medical context offers an opportunity to make use of flavors. Quigley says flavors could potentially help a smoker make the transition from combustibles and stick through the therapy and ultimately quit.

    “I think that the lens is those flavors; it just becomes a safety question. Which is, you just have to make sure that whatever flavors you wanted to include, you’re actually generating the safety data to support new questions of safety by including those flavors. You have to check the safety box,” says Quigley. “E-cigarettes or e-vapor products are a different experience than what our smoker is used to, and flavors play or can play an important role in helping smokers switch to that reduced-risk platform.

    “There’s also a lot of data that show that flavors are an important part of helping smokers move to reduced-risk products. But now the industry has been put in a very tight, constricting box. Over time, hopefully, that will kind of correct itself, but it’s going to have to happen with data. I think that the industry understands that—regulators and public health officials look at flavors as a youth appeal issue.”

    The industry now must figure out how to ensure that it’s not creating a youth appeal issue but still creating a product that is going to be appealing to a smoker trying to switch to reduced-risk products, according to Quigley. “I think it’s going to be a long, slow road, but vapor products will continue to be a part of the reduced-risk product landscape in the U.S., but I think it’s going to be challenging,” he says.

    RespiRx is expected to hit the market as a prescription-only treatment. Qnovia is also interested in exploring how the technology can be used for asthma, pain management, vaccines and other applications. As far as using synthetic nicotine, Quigley says it is not out of the question but says he is concerned that currently, the FDA doesn’t know enough about synthetic nicotine to be able to approve a synthetic product.

    “We’re using pharma-grade nicotine. It is tobacco derived. I think with synthetic nicotine, the FDA may have lots of questions whereas they have a deep body of evidence and understanding of tobacco-derived nicotine,” says Quigley. “However, if there was data to show that synthetic nicotine is safer because it in no way can have any kind of nitrosamines, for example, it’s something we could consider in the future with strong safety data.”

  • 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.