The number of vapers has increased significantly worldwide, according to the latest research from the Global State of Tobacco Harm Reduction (GSTHR).
A new peer-reviewed paper published this week in Drugs, Habits and Social Policy estimates there are now 82 million vapers worldwide. The GSTHR project, from the U.K. public health agency Knowledge Action Change (KAC), found that the 2021 figure represents a 20 percent on that for 2020.
According to KAC, vaping is a significantly safer alternative to smoking. “Each year, there are 8 million smoking-related deaths worldwide,” the organization wrote in a press note. “The growth in the number of vapers, most of whom will have swapped smoking for vaping, is therefore a hugely positive step in efforts to reduce the harms of combustible cigarettes and hasten the end of smoking.”
The new study comes shortly after the U.K. government announced its Swap to Stop scheme, which aims to give 1 million smokers a free vaping starter kit to help them quit smoking. According to KAC, the U.K.’s permissive vaping laws have helped drive smoking to its lowest level on record.
“The U.K.’s support of vaping for tobacco harm reduction is in sharp contrast to the situation in many countries, however,” KAC wrote. “GSTHR data shows that vapes are banned in 36 countries, and in a further 84 countries there is a regulatory and legislative vacuum. Millions of smokers who want to switch to much safer vaping cannot do so, or may be forced to purchase potentially unsafe products on black or grey markets, due to bans, or poor or non-existent product regulation.”
The GSTHR research shows that despite restrictive regulations or bans in many countries, increasing numbers of people are choosing to switch to safer alternatives to combustible tobacco. “Along with other countries like New Zealand, the U.K. offers strong evidence that positive government messaging about vaping for tobacco harm reduction can hasten reductions in smoking prevalence,” wrote KAC.
“But an international meeting on tobacco control later this year could jeopardize global progress on reducing smoking-related death and disease through tobacco harm reduction,” the public health agency added, referring to the meeting of the parties to the World Health Organization’s Framework Convention on Tobacco Control scheduled for November in Panama City.
The WHO remains opposed to the use of safer nicotine products for smoking cessation, despite supporting harm reduction in other areas of public health such as substance use and HIV/AIDS prevention.
“The updated Global State of Tobacco Harm Reduction estimate suggests that there are now 82 million people worldwide who vape, proving that consumers find these products attractive,” said Gerry Stimson, director of KAC and emeritus professor at Imperial College London. “As evidenced in the U.K., millions are making the switch from smoking. Safer nicotine products give the world’s 1 billion smokers the chance to quit using alternatives that pose significantly fewer risks to their health.”
Up to 1 million smokers will be encouraged to swap their cigarettes for vapes, according to the British government. Pregnant women will be offered financial incentives to switch, reports Reuters.
“Up to two out of three lifelong smokers will die from smoking. Cigarettes are the only product on sale which will kill you if used correctly,” Health Minister Neil O’Brien will say in a speech later on Tuesday, the government said.
“We will offer a million smokers new help to quit. We will be funding a new national ‘swap to stop’ scheme—the first of its kind in the world.”
One million smokers will be given a free vaping starter kit to encourage them to give up tobacco products.
Pregnant women will also be offered up to £400 to stop smoking as part of a package of measures in England unveiled by the government on Tuesday.
A consultation will be launched on compelling cigarette manufacturers to put advice on quitting inside packs.
The UK is set to launch “illicit vapes enforcement squads” as part of a crackdown on the illegal sale of e-cigarettes to youth under the age of 18.
Led by Trading Standards, the squads will work across the country and share knowledge across regional networks and local authorities.
The government says its priority is to prevent people from smoking, and supporting them to quit. It has admitted vaping is a preferable alternative for adults, reports Sky News.
However, it recognizes it has an issue with illegal sales to children and illicit vapes being introduced into the market.
Neil O’Brien, the health minister who will unveil the new plans said the new illicit vapes enforcement squad will work across the country and clamp down on those businesses that sell vapes to children.
“Our call for evidence will also allow us to get a firm understanding of the steps we can take to reduce the number of children accessing and using vapes,” he said.
The disposable vape brand SKE Crystal has been pulled from sale at One Stop and Booker stores in tyhe UK. The products reportedly contain more than the regulatory maximum amount of nicotine e-liquid.
The Grocer reported that multiple independent lab tests had found SKE Crystal devices to contain significantly more than the permitted 2ml of liquid.
Testing commissioned by tobacco company BAT of 15 SKE Crystal Blue Razz Lemonade flavoured devices bought at two One Stop stores in Hereford and Worksop, and a Sainsbury’s store in Leeds, found all contained more than 2ml of liquid.
In one case, a device had a total fill volume of 3.26ml, more than 60 percent over the permitted maximum.
Separate testing supplied by a senior industry source 14 SKE Crystal disposable variants – including Watermelon Strawberry Bubblegum, Fresh Menthol Mojito and Bull Ice – found all contained more than 3ml of nicotine juice.
Lab tests of all SKE Crystal SKUs by Adact Medical, commissioned by vape wholesaler Phoenix 2 Retail and shared with The Grocer, found only one flavour variant – Sour Apple – was found to have a non-compliant tank capacity.
One Stop and Booker – which are both owned by Tesco – have temporarily removed three SKE Crystal variants from sale as a precautionary measure while further tests are carried out by its supplier. The flavours pulled from shelves are: Sour Apple, Pink Lemonade and Bull Ice.
Previously, Elfbar and its subsidiary Lost Mary had its products pulled from UK shelves after testing confirmed that they had more then the maximum allowed for e-liquids.
Another Elfbar brand is being pulled from U.K. store shelves after finding the products surpass the legal limit for e-liquid volumes.
Tests on samples of a Double Apple flavor Lost Mary brand vape found them to have an average of 3.6ml of nicotine liquid.
Sainsbury’s and Asda have now reportedly confirmed that they are banning the product following the findings, according to the U.K. mirror.
It comes just weeks after an investigation discovered the watermelon-flavored Elf Bar 600 product had at least 50 percent over the legal limit for nicotine e-liquid.
According to UK law, the amount of nicotine liquid in a vape is legally limited to 2ml with a maximum nicotine strength of 2 percent.
Elf Bar, which launched in 2021, sells around 2.5 million disposable 600s in the UK every week.
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.
Elf Bar vapes are being sold with e-liquid volumes more than 50 percent over the UK’s legal limit, an investigation has found, according to reporting in Metro.
The Chinese vaping giant admitted “inadvertently” breaking the law and ‘wholeheartedly apologized’ following lab tests of its 600 brand of disposable vape pens.
E-cigarettes bought at branches of Sainsbury’s, Tesco and Morrisons contained between 3ml and 3.2ml of e-liquid, when the legal limit is 2ml (the article states the liquids were over nicotine limits, but there is no evidence of that. The UK limits nicotine strength to no more than 20mg/ml).
The brand, which only launched in 2021, sells 2.5 million Elf Bar 600s in the UK every week, accounting for two in three of all disposable vapes. The devices cost £5.99 each.
An Elf Bar spokesperson insisted the “highly regrettable situation” did not affect the safety of its vapes.
Mark Oates, director of the consumer advocacy group We Vape, said, “The Mail’s findings on Elf Bars are deeply worrying, and it is clear there have been failings on multiple levels.
“Not only are the levels of e-liquid too high, but checks to make sure these guidelines are adhered to either haven’t occurred or are insufficient. Anyone supplying vapes in the U.K. market should be following the legislation.
“It is incredibly frustrating when major players in this sector appear to behave in a way that damages the reputation of something as beneficial as vaping, and we expect the matter to be fully investigated by the Medicines and Healthcare products Regulatory Agency (MHRA).”
An MP in the United Kingdom is set to introduce a bill into parliament next week that will aim to prohibit the sale of disposable e-cigarettes and vapes.
Caroline Johnson, MP for the Sleaford and North Hykenham constituency which includes Great Gonerby, Barrowby, Marston and Cranwell, wants to introduce this bill after an NHS survey conducted in 2021 and published last year found that nearly one in five (18 percent) of fifteen-year-olds considered themselves e-cigarette users.
Johnson, an NHS children’s doctor and member of Parliament’s Health and Social Care Select Committee, is due to highlight the positive impact a potential ban on disposable vapes and e-cigarettes would have on the country as part of her 10-Minute Rule Bill on Wednesday, February 8.
“Reusable e-cigarettes and vapes remain an important aid to quitting smoking, but I fear that their colorful, child-friendly flavored, disposable counterparts are luring non-smokers into a life of addiction, which risks creating a new generation of nicotine addicts,” said Johnson.
“I look forward to presenting my bill to parliament soon and to highlighting the effects disposable e-cigarettes and vapes are having on our nation’s health and natural environment.”
The Scottish government has officially commissioned an “urgent review of the environmental impacts and management of single-use vapes.”
The review, which comes in response to emerging concerns around the negative consequences of disposable vaping devices, will inform potential policy responses, which could include a ban of the products.
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.”
The U.K. Vaping Industry Association (UKVIA) is calling upon its members and the wider industry to innovate products that make them easier to recycle for the waste management sector.
The move comes as pressure mounts to ban single-use disposable devices.
On Jan. 3. upmarket supermarket chain Waitrose announced a complete withdrawal from the single use vapes market. “Selling single use vapes is not something we could justify given the impact on both the environment and the health of young people,” said Commercial Director Charlotte Di Cello.
While environmental campaigners applauded the move, vaping advocates said Waitrose could do more to protect both public health and the planet by instead refusing to sell combustible cigarettes, which are the world’s most littered item.
Just five days later, Scottish PhD student Laura Young made national headlines in the U.K. when a video she posted on Twitter of her collecting 55 discarded disposable vapes while out walking her dog went viral.
Young, who goes by the Twitter handle @LessWasteLaura, gained public support when she posted two more follow-up posts and called for single-use vapes to be banned.
Following the publicity surrounding her anti-disposable campaign, the Scottish Government said it was “considering the emerging issues around single-use disposable vapes’ and urged consumers to dispose of them responsibly.”
We are working to find a waste management solution that minimizes the impact of vapes on the environment so they are seen for what they do best—helping adult smokers kick their habits.
According to the UKVIA, as campaigns like this gain traction, it may be only a matter of time before regulators decide to look closer at the disposable sector of the vape market.
UKVIA Director General John Dunne said that while the vaping industry recognizes its responsibilities to the environment, the recycling of vapes requires collaboration between adult vapers, retailers, manufacturers, the regulators and companies in the waste management sector, which are involved in the current producer compliance schemes under the Waste Electrical and Electronic Equipment (WEEE) regulations.
“Up to now there has been genuine confusion amongst the vaping sector about their responsibilities under the WEEE directive,” said Dunne in a statement. “Earlier this year the Institute of Environmental Management and Assessment alluded to uncertainty around whether regulations covered the type of batteries found in vapes and also questioned the recycling infrastructure in place to support the sector to be more sustainable.
“This is why we are working hard as an industry to find a waste management solution that minimizes the impact of vapes on the environment, particularly when it comes to single use disposables, so they are seen for what they do best—helping adult smokers kick their habits and save the lives of millions as well as millions of pounds for the health service.”
