A recent study comparing lung inflammation between smokers and nonsmokers does not prove any causality between the use of e-cigarettes and lung damage, according to researchers from the Center of Excellence for the acceleration of Harm Reduction (CoEHAR) in Catania, Italy.
A recently published study by a team of American researchers compared the scans of the lungs of five electronic cigarette users, five tobacco cigarette smokers and five subjects who never smoked or vaped. Data suggested preliminary evidence that e-cigarette users had greater pulmonary inflammation than cigarette smokers and never smoke/vape controls, implying even a greater damage to health.
In a letter to the editor of The Journal of Nuclear Medicine, the CoEHAR researchers expressed their concern about the study. “The very small sample size and low reproducibility of the tests does not allow us to give a precise and scientific answer on pulmonary inflammation caused by vaping because it does not take into consideration fundamental factors, such as the prior exposure to tobacco smoking,” said CoEHAR founder Riccardo Polosa in a statement.
“The very small sample size and low reproducibility of the tests does not allow us to give a precise and scientific answer on pulmonary inflammation caused by vaping because it does not take into consideration fundamental factors, such as the prior exposure to tobacco smoking.
Because it is impossible to decouple the health impact of e-cigarette aerosol emissions from prior tobacco smoke exposure, only long-term follow-up of exclusive vapers who have never smoked can verify potential harm caused by electronic cigarettes use.
CoEHAR stresses the need to develop and adopt shared scientific research standards and a greater control of publication processes: “We often opposes poor quality designed scientific results that are published in prestigious journals without proper scrutiny: researches that only feed an unfounded anti-vape rhetoric based on preconceptions that try to dissuade smokers from making choices that are less harmful to their health,” said Polosa.
There is a major trust gap in vaping among smokers, with over half now believing they’re just as harmful as cigarettes or more harmful than cigarettes.
The poll of 2,000 smokers revealed a growing distrust in switching to vapes. Nearly 38 percent who lack trust, say it could stop them from attempting to quit their smoking habits through vaping in the future.
The government’s independent Kahn Review said vaping had a central role to play in a smokefree future across the country, with more than 6.5 million people still smoking in the U.K. And evidence last year by the Office for Health Improvement and Disparities (OHID) re-confirmed that vaping was at least 95 percent less harmful than smoking.
But according to the Adult Smokers Trust inVaping study conducted by One Poll and commissioned by SMOORE, pioneers in inhalation technology, 29 percent only trust vaping a little as a method to quit smoking, whilst 13 percent do not trust it at all.
And of those whose trust is diminishing, 35 percent cite the lack of independent long term clinical research showing vaping to be less harmful than smoking. While 31 percent are concerned about the lack of any information available about the harm profile of different vape products. Other factors that had caused a lack of trust included: negative reports and studies that smokers had come across, inconsistency of government attitudes across the world towards vaping, the growing black market for vapes, and the view of the World Health Organization on vaping.
“There’s a major push to get smokers to move to vape products, but as of now, they just do not have all the information they need to make an informed decision to switch,” said Chenxing Pei, a senior aerosol engineer at the Smoore Centre for Analysis, Testing, and Safety Assessment, in a press release publish by the U.K. Vaping Industry Association.
“It’s vital smokers are confident enough to switch, especially since health minister Neil O’Brien said the government must ‘exploit the huge potential of vaping to help adult smokers to quit.’
“But reducing or quitting is incredibly difficult, it’s imperative to give them the belief that what they are attempting isn’t going to be a waste of time.
“And if vaping is to be viewed as a credible way to quit, urgent efforts need to be made to ensure smokers trust these products to have the desired impact.”
The research also revealed how trust among these smokers could be regained, with 30 percent claiming public health campaigns promoting the evidence-based facts could turn the tide. Better education of doctors to give more advice on how vaping can be an effective way to reduce harm caused by smoking, was cited as another key way to build trust.
Meanwhile, 21 percent would welcome advertising regulations for vaping companies to be lifted—as long as they are promoting evidence from credible sources.
But confusion persists among 68 percent of smokers when it comes to understanding which products would be suitable to help quit. And 70 percent now “don’t know who to believe” when it comes to vape products.
Three quarters of smokers want information to be made available on the harm profile of the vape product at the point of purchase. With 87 percent of these saying it is important to know exactly what it is you are inhaling. Many are looking for clarification about the chemical constituents (60 percent), carbon residues (46 percent) and heavy metal content (44 percent) in their vapes.
However, of those who smoke and vape, 74 percent initially started to reduce their reliance on cigarettes, with 58 percent of these claiming they were successful.
The study coincides with Smoore establishing an independent think tank of scientific, smoking cessation and compliance experts from the U.K. and U.S. to lay the foundations for an industry-wide harm reduction rating system that can be communicated to consumers on product packaging or accessed via a QR code.
“The concept of tobacco harm reduction is not widely understood by smokers, and there are widespread misperceptions regarding the relative safety of vaping products compared with cigarette smoking among the general public,” said Ian Fearon, one of the experts on the panel, who has previously worked for Juul Labs and BAT in senior scientific and clinical roles.
“The development of a harm reduction label may help smokers to understand the reduced risk potential of vaping and encourage switching, in addition to reassuring vapers regarding the quality of the products they use and allowing them to differentiate between different products.
“Government statistics last year showed that the proportion of smokers in the U.K. was at its lowest level since records begun, a decline which was attributed largely to the major role played by vapes.
“However, the findings of this study, highlight a significant trust gap amongst adult smokers and it’s crucial for the vaping industry, government, regulators and healthcare professionals to come together to bridge it and support smokers on their quitting journey.
“It’s clear that open and transparent communication is essential in this process and to supporting the government’s ambitions for the country to go smokefree.”
In the UK, campaigners say figures in a new report showed inmates are spending more than £7 million ($8.5 million) a year on e-cigarettes.
The amount spent in canteens has risen every year since 2019 after a smoking ban was phased in by the government across closed jails in England and Wales.
In the previous financial year, inmates spent £7,655,766 on vapes and £7,930 on e-cigarettes — a three-year high overall, according to media reports.
Prisoners have already spent £6,730,176 of their own money on vapes alone in the current period up to January.
British American Tobacco (BAT) and Manchester-headquartered Supreme Imports Ltd. were named as suppliers of the products in the data released by the Ministry of Justice (MoJ).
E-cigarette use among teens in Vietnam is rising, reports The Star. In 2022, 3.5 percent of 13 year-olds to 15 year-olds were reported to use e-cigarettes compared to 2.6 percent in 2019.
Vietnam is ranked third among Southeast Asian countries with the highest smoking prevalence, behind Indonesia and the Philippines.
Low cost has been cited as a motivator; Angela Pratt, a World Health Organization representative, said that prices are so low they do not create a barrier for teens starting to smoke. Pratt suggested raising taxes to help curb smoking.
Vietnam’s tobacco tax rate is 35.6 percent of retail price compared to the world average of 56 percent and the WHO’s recommended 70 percent.
The Ministry of Finance is seeking a public consensus to raise the special consumption tax on tobacco, beer, alcohol and sweetened drinks.
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.
Members of the European Parliament (MEPs) are less aware of key issues surrounding new nicotine products than in previous years despite being asked to vote on important new legislation concerning the topic in the coming months, according to a new survey, reports BusinessWire.
The third annual survey, conducted by business intelligence researcher Tamarind Intelligence, publisher of ECigIntelligence and TobaccoIntelligence, shows that the more MEPs know about new nicotine products (e-cigarettes, nicotine pouches and heated tobacco), the more likely they are to consider that these products are less harmful than cigarettes.
The report shows that: MEPs rarely believe that new nicotine products are as harmful as smoking—only 19 percent of responses, the lowest number since the annual survey was launched in 2020—and a majority believe they are less harmful than smoking; MEPs with no knowledge of new nicotine products are becoming far more likely to acknowledge that they don’t know the risks; MEPs with some knowledge of new nicotine products strongly tend to believe (76 percent of responses) that they are less harmful than smoking; and while very few MEPs consider that new nicotine products should be more restricted than traditional tobacco, and a majority believe online sales should be allowed for adults (with age verification), more MEPs are unsure how they should be regulated than in previous years.
“Our third annual MEP survey results are particularly relevant given the recent launch of the European Commission’s public consultation on evaluating the legislative framework for tobacco control at the end of February 2023 and the adoption by the European Parliament of the BECA committee’s recommendations over a year ago,” said Tim Phillips, managing director of Tamarind Intelligence. “As some of the questions in the commission’s consultation are similar to the ones we asked in our MEP survey, it will be fascinating to see if MEPs’ views on the topic of new nicotine products will be in line with responses to the public consultation.”
The survey was carried out online and anonymously, and all data from it remains confidential other than as used in consolidated analysis. The survey was sent to all MEPs (from all member states and political parties), and responses were obtained from 43 MEPs representing 6 percent of the European Parliament.
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.”
One in eight youth aged 14 to 25 in French-speaking Switzerland is a frequent e-cigarette user, reports Le News.
A study by Unisante, which surveyed 1,362 young people, 59 percent said they had consumed e-cigarettes at least once and 12 percent said they used them frequently (more than 10 days over the past month). Of those that responded, 59 percent said they consume the products when out at night while 40 percent said they consume them at home. The survey showed that 63 percent of respondents preferred e-cigarettes because of the flavors while 40 percent cited lack of tobacco smell and 30 percent cited ease of use.
Disposables are the most popular choice for youth, and 49.4 percent of respondents said their parents knew they used the products. Half of respondents said they’d seen advertising for the products, and two-thirds were aware of the health risks and risk of addiction.
In Switzerland, 19 percent of those aged 15 to 24 smoked combustible cigarettes daily in 2017.
The U.K. Vaping Industry Association (UKVIA) has published its 2022 annual report.
Among the highlights of 2022 was the launch of the UKVIA-commissioned Economic Impact Report from the Centre for Economics and Business Research, which—for the first time—detailed the national and regional contribution that the U.K. vape industry made to the economy, according to the UKVIA.
“Our industry is under scrutiny like never before, and we must tackle the big issues, such as underage vaping, the environmental impact of disposable devices and the massive influx of fake and illegal imports,” said John Dunne, director general of the UKVIA. “Any one of these issues has the potential to see regulators clamp down hard on vaping, and the fact that they are all happening at once demonstrates that it is crucial that we get our house in order without delay.”
FDA considered comments received on the draft guidance, issued in July 2020, as the agency worked to finalize the suggested rules. Changes from the draft to the final guidance include clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for investigational new drug (IND) applications in various stages of drug development, and providing guidance on quality considerations for INDs.
The final guidance also:
Lists applicable United States Pharmacopeia chapters on quality testing, including the assessment of leachables from packaging and delivery systems.
Identifies relevant International Council for Harmonisation guidelines, FDA guidances, and considerations for devices used in combination with a drug.
Addresses the calculation of delta-9 THC content, which is relevant to determine control status for cannabis and cannabis-derived compounds.
“It is critical FDA continues to support robust scientific research needed to develop new drugs from cannabis,” the release states. “FDA believes the drug development and approval process represents the best way to ensure that safe, effective, and high-quality new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.”
Earlier this month, The FDA said it is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements.
