Altria Group has asked the U.S. Federal Trade Commission to drop its 2020 challenge of the company’s 2018 acquisition of a 35 percent share in Juul Labs, reports Reuters. On March 3, the tobacco giant announced it had exchanged its stake for a license to Juul’s heated tobacco intellectual property rights.
In its legal challenge, the FTC contends that the tobacco giant’s $12.8 billion investment in Juul violates antitrust law because the company acquired the position rather than continuing to compete against Juul in the market for closed-system e-cigarettes.
In February 2022, an administrative law judge dismissed the FTC claims, finding that the evidence failed to sustain the alleged violations.
The next step would have been for the full commission to decide whether to accept that decision and dismiss the FTC case.
“There is nothing left of the transaction to be challenged. Altria and JLI respectfully ask the Commission to dismiss this matter as moot,” Altria Group and Juul Labs wrote in a filing to the FTC.
The Malaysian Society for Harm Reduction (MSHR) has called on the Malaysian government to reassess the generational endgame (GEG) measure regarding vaping, reports the New Straits Times.
Sharifa Ezat Wan Puteh, MSHR chairman, stated that many smokers are using vaping to quit smoking cigarettes and that the GEG could be counterproductive as it positions vaping as equally harmful as smoking.
“While vaping has health risks, we cannot ignore scientific evidence that vaping is at least 95 percent less harmful than smoking,” said Puteh. “Several reputable public health organizations have made that estimate and endorsed by multiple developed countries. In addition, vape is also recognized as an effective tool to reduce smoking hazards and rates.”
The MSHR has suggested that vaping be regulated and training be provided to vendors on proper ways to switch to nicotine-replacement therapies and vapor products. It also suggests forming an independent committee driven by science and evidence to conduct in-depth research on vapor products.
“If we look at the decline in the smoking rates in countries with higher vaping rates, it speeds up as the vaping rate increase[s],” said Puteh.
“Legislative process for the new bill will take a lengthy time,” she said. “In addition, a bill should only be tabled with detailed discussion and studies on the proposed GEG measure that the previous minister proposed.
“Given this, we believe the government should take immediate steps to regulate vape products using existing laws to speed up regulations on the products to protect consumers from prohibited ingredients by introducing standards on the product as well as prohibiting access by minors.”
U.K. Chancellor Jeremy Hunt has rejected calls from health officials to introduce a new levy on single use vapes in the government budget due to be presented on March 15, reports the news outlet I.
The Department of Health and Social Care has been pushing for the new tax to crack down on underage vaping. The proposals are expected to be included in the government’s response to the Khan Review on smoking, but treasury sources told I that the new levy will not be included in the March 15 budget.
“Department of Health officials are keen, but it’s not going to happen,” a source told I.
Anti-smoking activists too have been urging the government to start taxing disposable vapes. “Increasing the tax on single use disposable vapes in the March budget would be easy to do and by making them less affordable could reduce both child vaping and the vast quantities of single use vapes being thrown into landfill,” AHC CEO Deborah Arnott was quoted as saying.
“Adult smokers find vaping useful in helping them quit, and that’s something we support. However, in the light of the recent increase in child vaping, government action is urgently needed to tighten regulation and increase enforcement,” Arnott added.
U.K. ministers are reportedly contemplating a range of measures to discourage underage vaping. Among the plans under consideration are a ban on candy-flavored vaping liquids and a crackdown on colorful marketing that could appeal to youth.
Britain bans sales of vapes to anyone below the age of 18, but national surveys have shown an increasing trend of 11-17 year olds using the devices, with health leaders blaming the rise on the marketing and flavors associated with them.
The U.S. Food and Drug Administration has posted a new webinar to help manufacturers and vape shop owners respond to warning letters from the agency’s Center for Tobacco Products (CTP).
The webinar outlines the appropriate items for a response to a warning letter, which should be received by FDA within 15 business days. The webinar also includes an explanation of proper documentation concerning corrective actions that entities have taken.
Italy is readying to toughen the rules for electronic cigarettes. Vaping products are now not allowed to smoke in public places, and smoking near children and pregnant women will be punished.
Fines will be issued by law enforcement officers and rules also minimize the advertising of electronic cigarettes and remove smoking areas at airports, according to the Blitz.
British Prime Minister Rishi Sunak says he will help combat the illegal migration of vaping products across the English Channel.
Italy’s Minister of Infrastructure and Transport Matteo Salvini was outraged by the new law, saying that it was thanks to electronic cigarettes that he quit smoking.
Another Elfbar brand is being pulled from U.K. store shelves after finding the products surpass the legal limit for e-liquid volumes.
Tests on samples of a Double Apple flavor Lost Mary brand vape found them to have an average of 3.6ml of nicotine liquid.
Sainsbury’s and Asda have now reportedly confirmed that they are banning the product following the findings, according to the U.K. mirror.
It comes just weeks after an investigation discovered the watermelon-flavored Elf Bar 600 product had at least 50 percent over the legal limit for nicotine e-liquid.
According to UK law, the amount of nicotine liquid in a vape is legally limited to 2ml with a maximum nicotine strength of 2 percent.
Elf Bar, which launched in 2021, sells around 2.5 million disposable 600s in the UK every week.
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.”
More than a year after the U.K.’s MHRA updated guidance, there are still no medicinal vapes on the market.
By Pete Lomas
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for licensing electronic nicotine-delivery systems (ENDS) as medicinal products on Oct. 29, 2021. The new guidance marked a shift in approach from the MHRA as it began actively encouraging applications and sought to support companies through the process. Over a year on, however, we have to wonder why the industry doesn’t have any medicinal vapes on the market.
The change in direction by the MHRA was likely spurred by the U.K. government’s desire to meet its “Smoke-Free by 2030”1 target, which stipulates that less than 5 percent of the population should be smokers by the end of the decade. Using ENDS can be a good way to reduce the harmful effects of smoking, and the hope is that this new approach will change the perception of ENDS, bringing them more in line with other nicotine-replacement therapies, including gums, sprays and patches.
Pete Lomas
The pathway via which e-cigarette products can be certified as medicinal products is known as a marketing authorization application (MAA). Since nicotine is not a new chemical entity, the MAA can be abbreviated with respect to safety and efficacy information. Instead, the application will rely primarily on a pharmacokinetic study to compare the new product with an appropriate reference medicinal product. Given the intended route of administration, an already approved inhaled nicotine product such as the Nicorette 15 mg Inhalator has been suggested by the MHRA as a suitable comparator.
As well as conforming to the MAA requirements, any ENDS devices will also need to be proven to be electromechanically safe. In the U.K., this will require it to be U.K. Conformity Assessed marked, following assessment by an authorized approved body.
Encourage licensing
In a bid to elucidate the new application process, the MHRA initially ran a webinar titled “Licensing Electronic Cigarettes as Medicines,” which was retroactively made available on YouTube.2 In short, the MHRA is committed to providing as much assistance as is needed to ensure potential applicants understand the process and feel able to make applications in a timely manner.
But the MHRA has gone beyond simply putting on talks and answering questions—it has also widened the goalposts slightly, making applications more likely to succeed. One way this has been done is by adapting how delivered dose uniformity (DDU) is measured. As a medicinal product, vapes are classified in a similar way to conventional pressurized metered dose inhalers (pMDIs), meaning the criteria that must be met before approval is very similar.
E-cigarettes, however, are a fundamentally different technology to pMDIs. Whereas pMDIs use a pressurized canister calibrated to deliver an exact amount of aerosol per puff, an e-cigarette is traditionally based on coil and wick technology. This difference makes the DDU per-puff of an e-cigarette much less consistent, and that is before considering self-titration (the patient taking larger or smaller puffs based on preference and habit) is even considered.
So, if ENDS are subjected to DDU regulations on a per-puff basis, then most will fall short—what to do then? To address this, the MHRA has instead set DDU requirements that are averaged over 10 puffs, rather than one, thus making it easier for vapes to comply.
Achieving DDU
Despite the leeway given by the MHRA, delivering dose uniformity is still very important. For products to reach medicinal standards, they must be designed to be as consistent, puff to puff, as possible. In that respect, any applicant seeking approval will need to focus on three key points: consistent power, consistent delivery of liquid and consistent airflow—achieve all three and a device stands a good chance of complying with the new guidance.
Modern developments in vape technology will help address the issue of DDU further. Non-heated vaping technologies based on ultrasonics, piezo-ceramic mesh and micro-nozzles are now being used to develop these products and offer greater inhalation consistency. Piezo-ceramic technology, in particular, is well suited for medicinal products as it offers the ability to fine-tune the mesh, vibration frequency or other parameters within the device, depending on the liquid formulation.
Another key difference between ENDS and their inhaler cousins is that the performance of electronic products tends to vary at the beginning and end of the product’s lifecycle. That means priming and end-of-life doses may not deliver the same uniformity as is expected for the bulk of the product’s use. Within the new guidance, applicants will now be able to define these different doses and exclude them from the uniformity criteria, so long as appropriate justification is provided and information on these differences is communicated to the end users.
Achieving MAA licensing
To date, only one e-cigarette product has successfully passed through the MAA process, around a decade ago. However, smokers did not find the product sufficiently satisfying to make a permanent switch. It was withdrawn from the market only a couple of years after launch due to low smoker compliance. Technology has evolved much since then, resulting in products that are much more satisfying for smokers, allowing them to transition away from combustible cigarettes altogether.
Typically, performing the necessary studies and data gathering for the application would be expected to take 12 months to 18 months. Once collected, the MHRA offers a 150-day accelerated assessment for “high-quality” MAAs, with an intervening “clock-off period” where further clarification and information can be provided, as required. The clock-off period should last no longer than 60 days.
For applicants with products undergoing a U.S. FDA premarket tobacco product application (PMTA) process, or for the 23 ENDS that have already been approved3 via this route, there is opportunity to reduce the number of new studies that are required for an MAA. The MHRA has said it is happy to discuss what data may be relevant for a U.K. MAA, therefore reducing the need for additional studies in some cases.
Even if the majority of the data from a PMTA cannot be used directly as part of the MAA, data generated for the PMTA can be used to help strengthen the Pharmaceutical Development section within Module 3 of the application. In addition, a successful product on the U.S. market will provide confidence to regulators of consumer acceptance, which can be an important consideration.
All told, any applicant beginning data collection for an MAA should anticipate the entire process, from product finalization to market approval, taking in the region of two years. This explains why we are yet to see a product reach approval since the guidance was only updated in October 2021. As we approach the two-year mark at the back end of 2023, it seems plausible that the first medicinally licensed ENDS could come on sale in the U.K.
Credit: Minerva Studio
Where to find medicinal vapes
If the license granted permits the product to be sold and supplied as a General Sales List (GSL) medicine, then the retailer does not need to be a pharmacy. Examples of common GSL medicines include ibuprofen and paracetamol, which can be purchased from retail outlets such as convenience stores and supermarkets, where they are available for self-selection, albeit with appropriate sale restrictions on purchaser age and quantity of the product.
Most existing nicotine-replacement therapies—products like patches, gum and sprays—are listed as GSL items, and so the assumption is that ENDS would be made available in the same way. That said, approval onto the GSL doesn’t automatically exclude a product from being prescribed to patients by a healthcare professional. Applicants may still wish to secure contracts with healthcare providers to distribute their product through alternative channels, which can include being exclusively sold as a prescription treatment.
Making a difference
It is fair to say that the perception of vaping, both in the eyes of the public and healthcare professionals, has declined in recent years. A 2021 survey by Action on Smoking and Health4 (ASH), for example, found that nearly a third (32 percent) of smokers incorrectly believe that vaping is more or equally as harmful as smoking. Whatever the reasons are behind this—I suspect there are several—it needs to change if we are to reach the smoke-free target by 2030.
The hope is that by licensing ENDS as medicinal products, it will provide credibility that these products are not just safe but have genuine harm reduction potential. MHRA approval will provide customers with confidence that they are making a healthy choice when switching from smoking to vaping.
A barrier to the success of this reclassification of vapes as medicinal products may be smokers’ perceptions of themselves. Many don’t want to be seen as “patients” per se, and so they might resist being bundled into such a group. Medicines, however, are as much about the prevention of disease as for its treatment, and given that these products will hopefully be available as GSL medicines, resistance to their purchase should be minimal. Most people don’t feel like a “patient” when purchasing ibuprofen after all.
The impacts of the change in guidance will only become apparent once we start seeing products approved via this route. For now, there are still over 6 million people5 in the U.K. who smoke cigarettes; e-cigarettes, which have been through the rigorous medicinal licensing process, could be a safe, effective and trusted part of the solution moving forward.
Altria Group has entered into an agreement to acquire NJOY Holdings for approximately $2.75 billion in cash. The transaction terms include an additional $500 million in cash payments that are contingent upon regulatory outcomes with respect to certain NJOY products.
“We believe we can responsibly accelerate U.S. adult smoker and competitive adult vaper adoption of NJOY Ace in ways that NJOY could not as a standalone company,” said Altria CEO Billy Gifford in a statement. “We believe the strengths of our commercial resources can benefit adult tobacco consumers and expand competition. We are also excited to welcome NJOY’s talented employees to Altria at closing.”
“As a result of this transaction, Altria’s enhanced smoke-free portfolio will include full global ownership of products and technologies across the three largest smoke-free categories and a joint venture with JT Group for the U.S. commercialization of heated tobacco stick products.”
“We are excited to add NJOY’s e-vapor intellectual property as a new platform that we believe we can build on to help more adult smokers transition to smoke-free alternatives,” said Olivier Houpert, Altria’s new chief innovation and product officer.
Altria will hold a conference call at 9 a.m. Eastern Time on March 6, 2023. Access to the live webcast is available at. A replay of the webcast and a transcript will be available on the same website following the event.
In 2022, the U.S. vapor category comprised nearly 14 million U.S. adult tobacco consumers, including 9.5 million exclusive adult vapers, according to Altria. The segment generated approximately $7 billion in U.S. retail sales and represented approximately 15 percent of total estimated equivalized U.S. tobacco volumes and more than 50 percent of total estimated equivalized smoke-free tobacco volumes.
To date, the U.S. Food and Drug Administration has approved the marketing of 23 vapor products and devices. In 2022, NJOY received marketing granted orders for the NJOY Ace device, along with several tobacco-flavored pods. The regulatory agency is still reviewing NJOY’s premarket tobacco product applications for several NJOY menthol-flavored e-vapor products.
Altria said it had multiple sources of funding for the deal, including cash from a $2.7 billion agreement with Philip Morris International last year for the IQOS Tobacco Heating System.
The NJOY deal follows an announcement by Altria that it would exchange its entire minority investment in embattled Juul Labs for a nonexclusive global license for certain of Juul’s heated tobacco intellectual property.
Nebraska lawmakers have proposed Legislative Bill 584 would impose an excise tax of 5 cents per milliliter of consumable vaping material, though the senator said she is working on an amendment that would make the tax a percentage of the sales price, perhaps 20 percent.
State Sen. Jana Hughes of Seward, who called it “hooey” that vaping was safer than smoking cigarettes, despite several scientific studies stating otherwise, proposed the bill in to protect children from the dangers of vaping.
Nebraska is one of 20 states that do not, as of Jan. 1, impose an excise tax on vaping products, according to the Urban Institute, according to Nebraska Public Radio.
Hughes said all other products containing nicotine must pay an excise tax. Nebraska, for instance, imposes a 64-cent per pack excise tax on cigarettes.
Earlier this year, Nebraska lawmakers proposed a law that would limit localities in how they regulate electronic smoking devices.
