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.‘”
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.
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.
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.”
Kim Hesse shares her insights into the comparatively new field of testing ENDS products.
By Timothy S. Donahue
In late October, a health regulatory body in Mexico said its scientists had developed a new methodology to analyze the aerosols in electronic nicotine-delivery systems (ENDS) because “no one else has come up with one.” Cofepris chief Alejandro Svarch said that the final results of a new analysis of ENDS products using the new method will be published in scientific journals in the coming months. Svarch added that the “pioneering methodology” developed in Mexico will be of interest to health authorities in other countries.
The situation is puzzling at best since researchers have had the ability to evaluate aerosols in ENDS products for some time. Additionally, the sale of ENDS products was banned in Mexico in June. This led to many in the vaping industry to wonder how the nation could justify an ENDS ban when it now claims it had no ability to test the safety of the products.
Every country that regulates vaping products requires that the products be tested for various elements, such as harmful and potentially harmful constituents (HPHCs) and heavy metals. According to Kim Hesse, vice president of sales and marketing for McKinney Regulatory Science Advisors, researchers have used aerosol testing methodologies to evaluate air quality, combustible cigarette smoke and inhaled medical product aerosols for many years, and ENDS aerosol testing has existed for nearly 15 years.
“This knowledge was then adapted to the ENDS industry. The earliest known third-party tobacco testing laboratory of ENDS products occurred in 2008 by one of the largest tobacco laboratories. Most other third-party labs began testing no later than 2015,” explained Hesse. “Coresta [Cooperation Centre for Scientific Research Relative to Tobacco, an organization that promotes international cooperation in scientific research relating to tobacco] has been working on validating methods for ENDS products for many years. The organization has validated method[s] for smoke collection and instrumentation while continuing to work on many more method needs for the ENDS category.”
Hesse said that it is important to test ENDS products to ensure the general public is not inhaling unacceptable levels of potentially harmful compounds (e.g., heavy metals or diacetyl). By testing these products, the industry can ensure consistency and provide regulators, such as the U.S. Food and Drug Administration and other government agencies, the data needed to evaluate ENDS products. She sat down with Vapor Voice to answer several questions related to ENDS testing.
Vapor Voice: What type of experience do you have in testing tobacco and ENDS products?
Hesse: We published several scientific articles that demonstrate our knowledge, capabilities and experience testing tobacco and ENDS products. For example, we recently published an article that provides instructions on the importance of conventional toxicological metrics when generating and characterizing ENDS aerosols.
How is testing e-cigarette vapor different from testing combustible cigarettes?
It depends. Testing combustible cigarette smoke, which contains a particle and gas phase, is a bit more challenging than simply testing an ENDS aerosol.
However, when you consider product variability, ENDS products present many challenges that cigarettes don’t. ENDS products come in all different shapes and sizes. Some have round mouthpieces while others have square. This alone poses a challenge in connecting the device to the smoking instruments, whose adaptors are round. Some devices have actuators, all of which are in different locations. Some vaping machines have push actuators that do not work well with the various actuator shapes and locations. Cigarettes, on the other hand, are standard size, and 20 cigarettes can be lit at one time with a standardized lighter that is built into the smoking machine.
Combustible cigarettes are tested to completion, and e-cigs are only tested for a set number of puffs. After the aerosol or smoke collection is accomplished, the remainder of the testing for the various compounds proceeds in essentially the same fashion regardless of whether it is aerosol or smoke. The e-cigs and cigarettes are tested on essentially the same instruments, but the method regimes (number of puffs, interval between puffs and volume) are slightly different.
Are there different standards for testing, and how does a company know which ones to use?
Both combustible cigarettes and ENDS products have a standard Coresta regime for ambient (ISO) testing. The Health Canada (intense) method for e-cigarettes [is] determined by the manufacturer’s scientists and is established based on the limitations of the devices (some devices have puff duration limits).
The analytical methods can also vary slightly between combustible cigarettes and vaping products due to the significant reduction of constituents in the e-cigarettes. The calibration curve is usually much lower in e-cigarette analysis. Other variabilities are the angle in which the e-cigarette devices are tested. The testing angle of the device is based on the model (tank, cigalike, etc.).
Are there many challenges in e-cigarette testing, and how can those difficulties be overcome?
You are required to share data with FDA even if the data is not favorable. Several companies simply have their products tested and then send the report to FDA without knowing if the data supports their product as appropriate for the protection of public health.
There is always room for improvement. We find that most labs are always working on method improvement. As mentioned previously, the various sizes and shapes of the ENDS devices pose a challenge. The lack of standardized testing methods for all the HPHCs and lab variability pose opportunities for improvement.
How accurate are the testing methods and the results that the tests provide?
Currently, analytical methods can detect chemicals at extremely low levels. Chemicals are often detected at levels that do not pose a health risk to humans. Some in public health use detected levels of chemicals rather than the more important harmful level of chemicals to create a public panic and thereby negatively impact the goal of harm reduction.
Coresta has a good working group for ENDS testing and analytical methods. We should focus on having more companies and laboratories actively participate in studies aimed at simplifying and reducing variability of existing methods.
One area of a standardization focus should be on the creation of a reference ENDS device that may be used with any remaining e-liquids—similar to the reference cigarette (1R6F), which is used to compare combustible cigarette data generated by different labs.
From your test results, would you say that vaping is less risky than combustible smoking?
This isn’t about me. What I can say is that Brian King, the director of the FDA’s Center for Tobacco Products, said in the media that he understands that e-cigarettes have “markedly less risk” than a combustible cigarette product. He acknowledged the continuum of risk for tobacco products and where e-cigarettes fall on that continuum. During the recent GTNF 2022 I attended, he said that there are certain products that are lower risk than combustible cigarettes, and that is an important component of the dialogue for the FDA. The FDA acknowledging that e-cigarettes are less harmful than combustible cigarettes is significant.
Do you have any recommendations for companies looking to have their products tested?
First, simply sending samples to a lab without understanding the testing requirements or how to interpret the data is a waste of money. Make sure you are working with a credible group of scientists that guide you through the process of generating scientific data.
I suggest the following: Ensure the laboratory you choose is ISO 17025 certified. It is advisable to use a laboratory the FDA is familiar with. This will make the data review process a bit better and will likely not result in denial of data submission due to laboratory insufficiencies. When choosing a lab, make sure they have filed a tobacco product master file (TPMF) with the FDA and that their methods are validated and validation reports are included in their TPMF.
Most adults who both smoke and vape are likely to carry on smoking or continue dual use over the long term, according to new research published in Tobacco Control.
Researchers looked at 545 dual users in waves one through five (2013/2014 to 2018/2019) of the U.S. Population Assessment of Tobacco and Health Study.
Over the six years of data, quitting vaping early but continuing to smoke was the most common pattern for almost half of participants (42 percent). Only 10 percent of participants quit both vaping and smoking early, and 15 percent of dual users continued to use both products.
The frequency of vaping and smoking, nicotine dependence, use of cannabis and other tobacco products at wave one were all influential. Dual users who smoked less frequently at wave one were more likely to quit both products early or to gradually quit smoking.
This is an observational study, and product use was based on self-report and not biochemically verified. No information was available for product use between waves.
“Our findings suggest that smoking reduction could help dual users to quit using both products; additionally, for those smokers unable or unwilling to quit using nicotine, cutting down on smoking could help them switch to exclusive [vape] use,” wrote the authors.
Their results also suggest that “before 2019, [vaping] did not contribute to substantial smoking cessation at the population level.”
“Continued monitoring of trajectories and their predictors is warranted considering the rapid evolution of the [vaping] marketplace,” the authors wrote in a press release.
The quality of evidence available about heated tobacco products (HTPs) is substandard and policymakers should be wary of claims made about their role in harm reduction, say the authors of a new study published in Tobacco Control.
HTPs have gained popularity in recent years, with proponents insisting they are less harmful to health than conventional cigarettes. However, researchers at the University of Bath argue that the evidence underpinning these claims is largely unrepresentative of real-world use and at high-risk of bias.
In their analyses of 40 publicly available clinical trials for HTPs—29 of which were tobacco industry affiliated or funded—the researchers judged most of the available clinical trials “at high risk of bias” given their methodology and choice of study design.
The most common reason for studies being at high risk of bias was performance bias, whereby the interventions allocated were known to participants and those conducting tests. There was also failure to report all results data for all trial measurements, a shortcoming known as selective reporting bias.
The authors argue that presence of these biases compromises the validity of trials and can lead to overestimation of the effects of HTPs. They also identified further limitations within trials, including short durations, restrictive conditions unreflective of real-world circumstances, and a lack of relevant comparators, like e-cigarettes.
Bath’s Tobacco Control Research Group says much more detailed, independent research is needed to assess the short- and long-term health effects of HTPs.
In the meantime, they argue that consumers should be wary of harm reduction claims and that policymakers and regulators should carefully consider the usefulness of these trials when making decisions surrounding HTPs.
“Over recent years we have seen great expansion in the heated tobacco market in the U.K. and around the world. This growth has been predicated on a marketing claim that these products are better for health, in comparison with traditional cigarettes,” said lead researcher Sophie Braznell from Bath’s Department for Health.
“Our analysis suggests that the picture is far less clear-cut. The clinical trials available, which are used by the tobacco industry to substantiate these claims, were often substandard in terms of how studies were conducted and reported, and most were industry-affiliated in some way.
“As more consumers move away from cigarettes towards these new generation products, we need much better evidence to assess their health impacts now and into the future. In the meantime, the jury is very much still out on their benefits.”
“These findings in relation to clinical trials for heated tobacco products are significant and we need to be wary of health claims made,” added study co-author Gemma Taylor from the Addiction & Mental Health Group and Deparmtent of Psychology at the University of Bath.
“At the same time though, it is important to note the clear distinction between ‘heated tobacco products’ and ‘e-cigarettes.’ Consumers and health policymakers must not equate the potential benefits of e-cigarettes in helping people to quit smoking with heated tobacco products.”
A health regulatory body for Mexico’s government says its scientists have developed a new methodology to analyze the aerosols in electronic nicotine-delivery systems (ENDS) because “no one else has come up with one.” The sale of ENDS products was banned in Mexico in June.
Final results of a new analysis of ENDS products using the new method will be published in scientific journals in the coming months, according to Cofepris chief Alejandro Svarch, who added that the “pioneering methodology” developed in Mexico will be of interest to health authorities in other countries.
Aerosol testing has been performed on vaping products since at least 2014 in other countries, such as the U.S. and the UK. Svarch offered no explanation on how Mexico’s new testing method is performed or why it is effective or why other methods were not effective, only that a testing method “did not exist.” There was no mention of what products were tested or at what temperatures.
He said an analysis using the exclusive method by health regulator Cofepris detected “30 undisclosed substances in aerosols inhaled” via ENDS products.
Linalool, which can be used as an insecticide, was one of the substances detected, Svarch said during Mexican President López Obrador’s press conference last week.
“This in itself is an enormous deception of consumers, who trust that the product is less harmful than a conventional cigarette, because it [supposedly] only has flavorings and nicotine, when in fact, it has other kinds of substances or ingredients that are highly dangerous for humans,” Svarch said.
Among the “hidden” ingredients that “producers of vaping devices don’t want us to know about,” he said, are dimethyl ether, benzyl alcohol, ethyl propionate, isoamyl acetate, butyl acetate and methyl cinnamate.
Svarch also presented a song commissioned by Cofepris (song starts at 1:40) that warns of the risks of vaping and advises ENDS users to “give up now.”
Among the cautionary tales offered via the song’s lyrics are the cases of a woman who lost three teeth due to vaping and a handsome man who became known as “burnt face” because his “beloved vape” exploded while he was using it, according to media reports.
A groundbreaking new clinical trial taking place at Georgetown University that is studying the use of nicotine to treat memory loss.
Georgetown University’s Clinical Trials Manager, Angelica Forero, said the study is personal for her. “I think it’s wonderful,” said Forero. “In my family, I have my grandmother who has been diagnosed with Alzheimer’s.”
Her grandmother’s struggle with Alzheimer’s Disease is inspiring her to find a cure. It’s called the “(MIND) study.”
“Don’t be afraid, nicotine has been around for a very long time. Nicotine is not bad, what is bad is the tar and chemicals used in cigarettes. Nicotine does not cause cancer or heart disease or respiratory illnesses,” Forero told abcNews7.
Forero maintains nicotine has been used for more than 30 years for conditions like Parkinson’s, depression, mental illness and now memory loss.
“So, we know that nicotine stimulates areas of the brain associated with memory and attention,” said Forero, adding thar they need more participants from minority communities.
“Hispanic and Black communities are disproportionately affected by Alzheimer’s Disease and memory impairment, higher than white adults. You make a difference. Whether you are Hispanic or Latino or Black or white, you make a difference in participating in clinical trials. The more people that we get, the better because we learn more about it and we just hope that it will become an approved treatment for mild memory loss just as a way to prevent Alzheimer’s Disease,” said Forero.
The MIND study is a guided trial, not something individuals should try in any form on their own. Click here to learn more.
There is no cost to take part in the MIND study, and Georgetown University will cover transportation costs for you to come to the 12 visits that are required. It’s a two-year commitment for participants in the trial.
Qnovia has raised $17 million to continue development of its RespiRx nicotine replacement product, reports Richmond Business Sense.
RespiRx is a portable, hand-held nebulizer, a powered medical device that delivers medicine as an inhaled mist and is similar to an inhaler. The device is designed to deliver a nicotine hit more quickly than existing therapies, thus enabling users to better manage withdrawals and, therefore, increase the likelihood of smoking cessation.
Qnovia was founded in 2018 in Los Angeles by Mario Danek as Respira Technologies and rebranded in September. In May, the company appointed former Altria executive Brian Quigley as CEO and Danek as chief technology officer.
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.
Qnovia will use the newly raised funds to develop a proof of concept for RespiRx as a nicotine replacement therapy product and move it through an FDA approval process before the anticipated start of human clinical trials in 2023.
The product is expected to hit the market as a prescription treatment. Qnovia is also interested in exploring how RespiRx can be used for asthma, pain management, vaccines and other uses.
A new study carried out by the Center of Excellence for the Acceleration of Harm Reduction in Sicily confirms that vaping presents a lower risk to heart health than does smoking.
The researchers replicated a 2017 BAT study, which demonstrated that the endothelial cell migration inhibition caused by cigarette smoke is not caused by e-cigarette aerosol exposure. (The endothelium is a membrane lining the heart and blood vessels).
Using the Vype ePen3 and the heated-tobacco products Glo Pro and IQOS 3 Duo, the Replica study corroborated the findings of the BAT study.
Riccardo Polosa
“The interesting fact is that switching to combustion-free products reduces vascular damages and prevents the possibility of the onset of smoking-related diseases, such as arteriosclerosis and hypertension,” said Massimo Caruso, an author of the study. “Once again, our research has challenged the notion that e-cigarettes or heated tobacco cause similar damage to that of combustible cigarettes.”
The study is part of the Replica Project, whose mission is to replicate studies conducted by tobacco companies—whose research is routinely dismissed as conflicted—in order to independently assess their scientific validity.
“By replicating the findings generated by tobacco industry studies on e-cigarettes and heated tobacco products, we are proving that these results are robust and trustworthy,” CoEHAR founder Riccardo Polosa told Filter.
