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.”
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.”
A vaping industry veteran uses some time-tested adages to reflect on his 11 years in the space.
By Chris Howard
In the new year, as I reflect on my past 11 years of experiences in the vapor space, I think it is better late than never to share some thoughts on where we have been and where we should be headed. Because we are never too old to learn, I thought I would strike while the iron is hot (hopefully you can see the theme here).
From 2018 to 2021, the industry suffered incalculable upheaval and uncertainty as we went through a shortened premarket tobacco product application (PMTA) period and a seemingly never-ending series of marketing denial orders (MDOs). While 2022 wasn’t necessarily any better for industry, it sure got a lot worse for the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP).
To recap, we saw multiple challenges to MDOs that shed some inconvenient light on the CTP review processes. We also witnessed significant delays in the CTP’s ability to meet the Maryland Court-imposed deadlines. Congress regularly attacked the CTP (and the greater FDA) for perceived shortcomings. And, finally, we saw the results of the Reagan-Udall Foundation review that, even with the soft touch given to the CTP, did not paint a flattering picture of the workings of our regulator. In all, it was a rough year for a new center director and the staff.
With the above in mind, a few time-tested adages can aptly describe my reflection on the vapor industry—which I offer here for your consideration:
Make a Long Story Short. After nearly seven years since the finalization of the Deeming Rule, the CTP and industry have collectively learned that some of the standards/requirements making up the PMTA process could be streamlined to say the least. By way of example, does the CTP really need for each company to spend thousands of dollars on the same literature review? Are behavioral surveys to show youth aren’t attracted to tobacco-flavored products necessary at this point?
Are there other commonalities across numerous applications that could now be updated or otherwise removed from consideration given consistent findings? As suggested by the Reagan-Udall Foundation, the CTP should consider providing more detailed summaries of applications that have made it through the process—so that industry can place emphasis on areas that the agency deems to be a higher priority and eliminate superfluous activities that ultimately add little value. Doing this and taking steps to simplify the requirements would ultimately enable both the industry and the CTP to employ a more focused approach, resulting in greater efficiency for all involved.
You Get Out What You Put In. Applicants who skimped and filed weak applications without regard to the requirements set forth by the CTP have nearly universally learned a valuable lesson. The PMTA process is expensive, and extremely rigorous science is required to show that your products are appropriate for the protection of public health (APPH). While many sought shortcuts and/or complain that the CTP’s guidance is unclear and/or vague, several companies have demonstrated that vapor products can indeed meet the FDA’s high standards.
Which companies are these? These are the companies who expended significant time and resources to develop robust applications covering each scientific discipline and other requirements set forth in the June 2019 “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, Guidance for Industry” and in the November 2021 Final Rule regarding “Premarket Tobacco Applications and Recordkeeping Requirements.”
Don’t Hold Your Breath. It’s hard to believe it now, but there was a time when both applicants and the CTP shared an optimism that reviews of applications could be accomplished in accordance with the prescribed timeline. This “certainty” provided an objective framework enabling industry to develop various business plans for all deemed products in the pipeline.
Unfortunately, the ultimate glut of applications proved to be an insurmountable burden for the FDA—resulting in nearly all timelines falling by the wayside. For anyone with pending PMTAs and for those manufacturers contemplating filing new PMTAs, don’t expect to obtain results quickly. Hopefully, the CTP will adopt some of the recommendations contained in the Reagan-Udall Foundation report to increase its overall efficiency and enable the industry to plan more effectively.
When Life Gives You Lemons, Make Lemonade. For innovators in the vapor space, initially life was very good. They had a great product that was considered profitable and a key to moving harm reduction forward. Unfortunately, things didn’t go exactly as expected, and life gave everyone in the vapor space lemons—and a huge basket of lemons at that. We had youth vaping; e-cigarette or vaping product use-associated lung injury (EVALI); near constant, questionable scientific studies demonizing electronic nicotine-delivery systems (ENDS); state and federal legislation to tax, limit and ban; a regulatory agency that swept the market nearly clean of flavored products—the list goes on.
It’s quite easy to despair, but now is the time to make lemonade. As an industry, we need to innovate within the narrow confines provided. We need to continue to ensure that the FDA makes its decisions based on science while we develop improved nonflavored options and better marketing schemes to prevent youth exposure. Smokers deserve our efforts to offer satisfying, reduced-harm products—I’m confident this innovative and adaptable industry can do just that.
It’s Not Over Until It’s Over. Over the past 11 years, I have seen so many industry advocates walk away from the vapor category due to a variety of circumstances. Unfortunately, with each powerful voice that leaves, the ultimate goal of ensuring that vapor products are an important part of an FDA-sponsored harm reduction platform becomes even more difficult to reach. In my opinion, the story isn’t over. Several vapor products have received market granted orders, and I expect that we will see more in the near future.
Moreover, additional studies continue to show the obvious health benefits of vapor products as compared to combustible cigarettes and that they are a valuable tool for adult smokers seeking to quit. Maybe owning a vape store and selling thousands of flavors isn’t on the horizon, but helping smokers seeking alternatives can still be a meaningful priority. I encourage past and current members of the vapor community to revisit their priorities with a new focus on educating the public—even if the journey hasn’t been as fulfilling as you hoped it might be.
Two Wrongs Don’t Make a Right. In case anyone missed it, several young people decided to experiment with vapor products a few years ago. Fortunately, that trend is unquestionably subsiding thanks to the introduction of T21 and the gradual decrease in the “fad” of vaping. It certainly isn’t right to (and no responsible manufacturer should) sell ENDS products to or in a manner attractive to kids. Unfortunately, the handling of the regulation of ENDS and, more particularly, flavored ENDS by both public health commentators and regulators is also wrong.
In 2016–2017, ENDS were the next best thing. They held the promise and potential to restructure the tobacco use market in the United States from combustible cigarette death and disease to an inhalable nicotine product that reduces risk and disease burden. The “second wrong” in response to Juul, EVALI, the abandonment of harm reduction and an avalanche of inaccurate reporting, propaganda and sensationalism resulted in the gutting of the flavored ENDS space (most of which did not have a youth vaping issue) in the form of refuse-to-file letters and MDOs based on a seemingly arbitrary solution.
These two wrongs, when coupled, don’t make a right—what these two wrongs make is a missed public health opportunity. Unlike the United Kingdom, which has embraced ENDS and driven down smoking rates, the U.S. has moved in the opposite direction—vilifying, banning and restricting. In this case, the two wrongs will result in increased smoking and increased disease.
The Perfect is the Enemy of the Good. As the PMTA review picture gains incremental clarity, we often see policy of pursuit of perfection (e.g., ill-defined demands for long-term cessation trials for flavored products). Whether this pursuit is expedient to remove disfavored products or flavors from the market or we are seeing the level of evidence required to gain a market order rise to a standard only found in the drug center is for you to consider.
However, the net effect is an increasingly complex (and expensive) set of criteria to satisfy the APPH standard. The public health standard, however, should not be a pursuit of perfection—it should be a pursuit of decreasing cigarette smoking mortality and morbidity. While there may be risks associated with some of the reduced-harm products, those risks are dramatically fewer than those posed by cigarettes. Accepting reasonable evidence to support reduction of harm to enact lifesaving and life-extending regulatory policy just makes good sense.
Don’t Miss the Forest for the Trees. Throughout the public health community, harm reduction principles are embraced and promoted to reduce the harms related with drugs, sex and other potentially harmful activities. For some reason, though, with rare exception, nicotine and combustible cigarette smokers don’t seem to merit a harm reduction strategy.
In the face of 460,000 smoker deaths each year, prudent regulatory policy would embrace products down the spectrum of risks—not ban them. European regulators have seen the forest—they promote reduced-harm products while discouraging combustible cigarette smoking. In the U.S., unfortunately, we ran into the first sapling off the trail and haven’t really progressed from there.
While the past 11 years have provided many ups and downs in the vapor space (a lot of downs), I’m hopeful that we can turn a corner in 2023 and beyond. In the past, it seemed like it was the vapor industry versus the world. Today, however, it is possible that we are at the dawn of a new era of tobacco regulation.
My hope is that when I look back on the next 11 years, the CTP has learned from the missteps of the past. I hope the center uses the valuable insights it has been provided, like the findings in the Reagan-Udall Foundation report, to reorient the center on not just prohibiting products but rather crafting policy and standards that assist combustible cigarette smokers in moving away from those harmful products. I hope to look back on tobacco control policy that doesn’t just involve saying “no” to every option but rather embraces harm reduction and doesn’t leave smokers behind. Maybe we can have our cake and eat it too.
Peter Zhang and Luna Wang, co-founders of So Soul vaping products
Global vaping manufacturer So Soul launched three new disposable products during the Total Products Expo (TPE) 2023 in Las Vegas, held from February 22 to 24 at the Las Vegas Convention Center.
China-based So Soul debuted its NOLA Bar, Y6000 and SLIMZ disposable vaping products, company founder and CEO Luna Wang told Vapor Voice during the show.
The SLIMZ is billed as “the world’s thinnest 5000-puff pod” and holds 11mL of 5% nicotine salt e-liquid, a mesh coil, and a 550mAh rechargeable battery. The SLIMZ offers 10 flavor profiles.
The new Y6000 is So Soul’s latest 6000-puff vaping device. The Y6000 holds 14mL of 5% nicotine salt e-liquid and a mesh coil that is powered by a 650mAh rechargeable battery. The Y6000 also offers 10 flavor profiles.
So Soul’s NOLA Bar is a 10,000-puff disposable device that offers 5% nicotine salt in 10 flavor profiles. The NOLA Bar holds 22mL of e-liquid with a 650mAh rechargeable battery.
In mid-2021, Luna Wang joined forces with another experienced vapor industry entrepreneur, Peter Zhang. Both also had previous experience working with Fortune 500 companies. Together, they started the So Soul brand in Shenzhen, China, the global capital of e-cigarette manufacturing, said Wang.
So Soul began because its creators believed something was missing in the market. Aside from a device’s appearance, aroma and flavor were two areas that Wang and Zhang felt were lacking in the Chinese vaping industry. The company founded its own research and development laboratory, staffed by the world’s top experts in the field, to develop products that could meet Wang’s high standards.
The company devotes 60 percent of its profits to R&D in an effort to always be improving. It wants its products to stand out for their “combination of style, substance and soul,” explains Wang. “We are dedicated to providing our customers with products that are not only stylish and cutting-edge but also made with the highest quality ingredients and backed by extensive research and development.”
Vaporesso, one of the largest open-system vaping hardware manufacturers in the world, launched its new 80W Pod Mod, the Luxe XR Max during this year’s Total Product Expo (TPE) 2023 in Las Vegas, held from February 22 to 24 at the Las Vegas Convention Center.
The China-based subsidiary of Smoore International, the largest vaping company in the world, said that the XR Max is the latest member of Luxe X family and is fully compatible with other LUXE X products.
The Luxe products combine the core features SSS leak-resistant technology, and COREX, an innovative heating and flavor-boosting technique developed by Vaporesso, and is powered by the company’s signature Axon Chip,
The Luxe XR MAX offers an easier-than-ever user interface to help vapers get the best possible performance out of their vaping devices. The chip also equips Vaporesso’s products with a smart use mode.
As part of the new design, the Luxe XR MAX adopts the classic clear, futuristic shape of the Luxe X series, and offers users a heightened vaping. Its SSS leak-resistant design, coupled with the brand’s COREX heating technology effectively increases the flavor and the lifespan of GTX coil.
The new model also has a longer battery life, making it an ideal fit for direct-to-lung (DTL) users, according to Vaporesso.
Some manufacturers of e-liquids could soon be paying nearly $20,000 per violation for selling vaping products without approval. Today, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization.
This marks the first time the regulatory agency has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket tobacco product application (PMTA) process.
The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s PMTA requirements and that failure to correct these violations could lead to enforcement action, such as a CMP, according to a press release.
Despite the agency’s warning, the companies continue to make and sell their unauthorized e-liquids to consumers.
“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We are prepared to use the full scope of our authorities to enforce the law—especially against those who have continued to violate the law after being warned by the agency.”
As of Feb. 21, the FDA has filed CMP complaints against the following four manufacturers:
BAM Group LLC doing business as VapEscape
Great American Vapes LLC doing business as Great American Vapes
The Vapor Corner Inc. doing business as Vapor Corner Inc., The Vapor Corner, and Vapor Corner
13 Vapor Co. LLC doing business as 13 Vapor
Currently, under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA typically seeks the statutory maximum allowed by law and is doing so in these four cases.
The companies the FDA has filed CMP complaints against can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Companies that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
“These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct,” said King. “These actions should be a wakeup call that all tobacco product manufacturers—big or small—are required to obey the law.”
Manufacturers that continue to violate the law risk subsequent enforcement, according to the FDA. In addition to CMPs, the agency also has the authority to take other enforcement action, as appropriate, including seizures, injunctions, and criminal prosecutions.
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.”
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.
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.
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.
The new director of the U.S. Food and Drug Administration’s tobacco science division is Matthew Farrelly, former chief scientist and director of the Center for Health Analytics, Media, and Policy for RTI International.
In an announcement, The FDA’s Center of Tobacco Products (CTP) stated that Farrelly’s extensive work in the field of tobacco and nicotine science for more than 25 years, and being recognized internationally as an expert with proven leadership and organizational management skills will help him succeed as the director of the CTP’s Office of Science.
“He has led or been involved with numerous scientific endeavors related to tobacco control policies and regulatory approaches, including those related to graphic health warning labels, excise taxes, smoke-free policies, quitlines, state tobacco control programs, retail advertising, and flavored tobacco products,” the release states. “He has also extensively researched the influence of mass reach health campaigns, including FDA’s The Real Cost.”
Farrelly also has authored or co-authored over 120 articles in peer-reviewed scientific literature, which have been cited over 10,000 times. He earned his Ph.D. in Economics from the University of Maryland at College Park.
Farrelly will replace Matt Holman, who left the position last year to Philip Morris International. Holman was hired in 2017 and took over for David Ashley.
