The UK government officials are warning e-cigarette and vaping retailers after trading officers discover a large number of illegal products. Vaping devices are highly regulated by the government to control the amount of nicotine available and have to be approved by the Medicines and Healthcare Regulatory Agency (MHRA).
“They should contain no more than 2 per cent nicotine or hold more than two mL of liquid, equivalent to 600 puffs or a packet of cigarettes, according to a news report. “However, in a recent test purchasing exercise across the city to check on compliance, officers were able to buy illegal products at 74 retailers – some containing up to 3,500 puffs, almost six times above the legal limit.”
Officials are now offering retailers the opportunity to contact Trading Standards for advice on their products with the proviso that compliance visits will be carried out in the New Year and any illegal products still on sale will be seized. The council have also been receiving a large number of complaints over the sale of these products to children and is asking parents with information and evidence to contact them.
Using medical licensing to get smokers to switch to vaping products is like using a hammer to crack a nut.
By George Gay
On the face of it, the U.K.’s big tobacco/nicotine news story of 2021 was the announcement that e-cigarettes and other inhaled nicotine-containing products could in the future be prescribed through the National Health Service (NHS) in England. Of course, the problem with “could” stories is that they come pre-loaded with “might not” stories. And there is the nagging concern, also, that this story is not quite as new as it seems. But let’s start on a positive note.
An Oct. 29 press note issued by the peculiarly named Department of Health and Social Care and Office for Health Improvement and Disparities said the Medicines and Healthcare products Regulatory Agency (MHRA) had published updated guidance paving the way for medicinally licensed e-cigarettes to be prescribed for tobacco smokers who wished to quit smoking. The health and social care secretary, Sajid Javid, was quoted as saying that opening the door to a [sic] licensed e-cigarette prescribed on the NHS had the potential to tackle the stark disparities in smoking rates across the country, helping people to stop smoking wherever they lived and whatever their background.
“Manufacturers can approach the MHRA to submit their products to go through the same regulatory approvals process as other medicines available on the health service,” the story said. “This could mean England becomes the first country in the world to prescribe e-cigarettes licensed as a medical product. If a product receives MHRA approval, clinicians could then decide on a case-by-case basis whether it would be appropriate to prescribe an e-cigarette to NHS patients to help them quit smoking.”
In fact, this statement was qualified by a background note saying e-cigarettes could be prescribed only after the National Institute for Health and Care Excellence (NICE) had recommended them for use. It did not spell out the circumstances under which NICE might recommend or reject such prescribing, but it is likely that one possible case for rejection would be a poor cost/benefit ratio.
Nevertheless, the announcement was generally well received. Philip Morris International said in a note published on its website that it supported the U.K. government’s plan to simplify the pathway to license electronic cigarettes and other inhaled nicotine-containing products as medicines in England.
At the same time, John Dunne, director-general of the U.K. Vaping Industry Association, said in a press note the government deserved “huge praise for taking this bold decision to look more closely at the use of vaping when it comes to smoking cessation and for taking an evidence-based, science-led approach rather than the nonsensical anti-vaping, anti-harm reduction stance of some countries.”
Meanwhile, Doug Mutter, director of VPZ, which recently launched a vape clinic service across its retail network of 157 U.K. stores, said in a press note that he believed vaping products being prescribed through the NHS in England could provide a huge leap forward in the country’s ambitions to be smoke-free by 2030. “We fully welcome the news that the NHS in England is exploring opportunities to prescribe vaping products to help people quit smoking,” he said. But he added that he believed it was not simply about prescribing a vape product and smokers going away and quitting smoking. “People need education, expert knowledge, support, advice and a personalized service that meets their individual needs,” he said. “Our vape clinic service responds to this demand and is filling a huge void left by [cuts to NHS] stop-smoking services…”
This need for consumer support had echoes in a new nationwide initiative launched at the end of October and aimed at providing guidance to frontline nursing staff at U.K. hospitals. The initiative, which was being rolled out to every NHS trust by the U.K. Vaping Industry Association and the stop-smoking app, Smoke Free, provides access to a range of resources that provide healthcare practitioners with the knowledge needed for them to give sound advice on how to switch from conventional cigarettes to vape products. It follows a decision by the NHS earlier this year to trial the use of vapes in selected hospitals.
Qualified support
A number of health professionals working in tobacco control also welcomed the government announcement, but many qualified their support. Probably, the most common concern was that, because the process of obtaining a medicines license, even if simplified, would still be complex and expensive, only tobacco companies would be able to attempt it.
There were basically two strands to this concern. One was that some healthcare professionals found the involvement of tobacco companies distasteful, tout court, while another was that consumers might be encouraged to try only licensed, tobacco-company products when other, unlicensed but more efficacious products were available.
This second argument is interesting partly because it raises the question of how much importance would consumers attach to a medicines license. After all, few smokers in the U.K. today started their habit at a time when the risks of smoking were unknown, so we can assume they are not severely risk averse.
Given this, I think it would be reasonable to assume that not all of those who tell researchers they are looking to quit smoking want to do so for health reasons. Additionally, the question raised about the importance smokers attach to health concerns is underlined in the U.K. because switching from smoking to vaping stalled some time ago even though Public Health England (an executive agency of the Department of Health and Social Care whose health protection and health improvement responsibilities were split between two other bodies at the start of October 2021) was on record as saying vaping is probably 95 percent less risky than smoking.
And despite PMI’s positive reaction, it cannot be assumed that all tobacco companies would want to go down the medicines license route. I cannot help thinking, for instance, that it would be something of a disadvantage in getting a product tied to a medicines license because, I assume, it would become petrified within an overall market that was dynamic. Unless the process of obtaining and holding a medicines license for vaping products in the U.K. is to be changed substantially, even obtaining permission to change the font size on the packaging would entail an involved process.
At least, this is what I was told while previously writing a few stories on Voke, which was or is a product developed over 12 years by Kind Consumer and licensed by the MHRA as a medicinal product that was a safer alternative to combustible cigarettes. Voke was not a vaping product but an alternative nicotine-delivery system that used pharmaceutical-standard inhaler technology in a device closely resembling a traditional cigarette in both the way it looked and in the way a consumer, in using the device, mimicked most of the rituals of smoking. Voke, which had no batteries and no electronics and therefore generated no heat and no chemical reactions and produced neither smoke nor vapor, just an invisible, cool, odorless aerosol, could be used anywhere. And its environmental credentials were good given that it was a relatively simple device made of metal, card and plastic: materials that can be recycled.
And yet, despite its medicines license and all the other apparent advantages it offered, it didn’t take off. It is worth noting, however, that British American Tobacco, which had cooperated with Kind in developing Voke, pulled out of the arrangement before the product was launched. It is worth noting, too, that Voke was launched as a consumer product in normal retail outlets, not in pharmacies, and not much seemed to be made of its having a medicines license. Finally, its much-delayed launch was not helped by coinciding with the arrival of the coronavirus pandemic.
Beyond the soundbites
I don’t want to be too downbeat, but it has to be said that the e-cigarettes announcement was made by a government better at sound bites than policy. The reference by Javid to tackling “the stark disparities in smoking rates across the country” would have been meant to have fed into government claims to be intent on levelling up the country, a strategy being honored more in the breach than the observance. Whether the policy announcement will survive mixing with the realities of an NHS struggling from the effects of more than 10 years of austerity and those of the Covid-19 pandemic remains to be seen.
In this regard, it was interesting that one healthcare professional who welcomed the announcement as “excellent news” went on to say one of the reasons why one in three U.K. smokers had not tried e-cigarettes was because of the perceived cost barrier. Having approved devices prescribed would therefore help those least able to afford e-cigarettes.
This raises some interesting questions, not least of which is whether the government has thought through the costs involved if e-cigarette prescriptions started to be given out liberally. And even if it has, has it decided whether ex-smokers should be allowed e-cigarettes on prescription for the rest of their lives rather as a diabetic is provided with insulin for life?
If you follow the logic of most thinking on nicotine addiction, you would have to say that cutting off prescriptions for e-cigarettes at some time in the future would lead only to relapse. Another question is whether the government could hold the line if, after prescribing came in, young, nonsmokers started to cut out the middleman and take up vaping in numbers, as seems possible.
The question has to be faced, also, as to whether general practitioners would be happy to prescribe e-cigarettes. The first step in encouraging them to do so would be convincing many of them that nicotine in the doses delivered by e-cigarettes was not harmful. But even so, there is the question of whether in asking them to do so you would be causing them to be conflicted.
Credit: kues1
The obvious answer to this is that healthcare professionals are generally accepting of the concept of harm reduction, but for some I’m sure there would be a difference between giving to heroin addicts clean needles from a medical supplies company and providing smokers with e-cigarettes from a tobacco company. Such conflicts have surely been reflected in the labored approach the U.S. Food and Drug Administration has taken since being saddled with overseeing a harmful product.
A simpler solution
To my way of thinking, one of the best comments on the government announcement came as part of a quote on the Science Media website by Peter Hajek, director of the Tobacco Dependence Research Unit at the Queen Mary University of London, who admitted to being ambivalent about the plan. Hajek welcomed the fact that the initiative provided a positive message that e-cigarettes were much less risky than smoking and helped smokers quit.
“Overall, it would seem easier to just recommend existing products, which are well regulated by consumer protection regulations,” he said. “There is sufficient evidence available now that these products are effective and dramatically reduce the risks of smoking.”
I’m not sure what Hajek meant by “recommend,” but all the government needs to do to promote the shift from smoking to vaping is to allow manufacturers of e-cigarettes complying with consumer protection regulations to state on packaging and advertising agreed wording to the effect outlined by Hajek: “these products are effective and dramatically reduce the risks of smoking.”
It seems to me that, as things stand, using medicines licensing to try to shift smokers from cigarettes to vaping products is like taking a hammer to crack a nut because I’m not convinced the changes made by the MHRA to its guidance for licensing e-cigarettes as medicines would produce the results sought.
I was told the key changes made relate to guidance on the quality standards for dose uniformity, nonclinical toxicological data requirements and the design of the clinical pharmacokinetic studies. The updates were said also to reflect changes to the regulatory environment post-Brexit.
John Britton, emeritus professor of epidemiology at the University of Nottingham, in generally welcoming the government announcement, made the point on Science Media that what was needed urgently was a bespoke regulatory system for all nicotine products that allowed market access and endorsement by health professionals in inverse proportion to those products’ health hazards.
This, to my mind, is correct. The question remains, however, just how bespoke the system needs to be to work. I’m not convinced the changes announced will be enough. In fact, I’m not convinced any bespoke system complying with the necessarily rigorous demands of the MHRA would give rise to a workable system. I hope I’m wrong.
Switzerland’s Federal Council has put forward a plan to tax e-liquids, reports Le News, citing Radio Television Suisse.
The proposal calls for taxing e-liquids at a rate that is 77 percent lower than that levied on combustible cigarettes.
The government wants to discourage young people from taking up vaping without discouraging smokers from transitioning to less unhealthy products.
One idea is to tax the nicotine content in e-cigarette liquids for open systems. This would mean taxes rising with rising nicotine content. For single use e-cigarettes or devices using cartridges, the tax would be levied based on the quantity of liquid contained in them regardless of the nicotine contained in them.
According to the government, such a tax would be easy to put in place and would generate around CHF 15.5 million a year, money which would be used to help fund old age pensions and disability benefits.
The Federal Council’s proposal, which will be discussed until March 31, 2022, responds to a motion approved by the parliament and the Council of States in March 2021.
Today, the U.S. Food and Drug Administration authorized the marketing of 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products (MRTPs). The FDA has not yet granted a MRTP to a vaping product, even though the agency has said e-cigarettes are less harmful than combustible cigarettes. Many experts have said the low-nicotine cigarettes from 22nd Century will actually cause people to smoke more cigarettes.
These are the first combusted cigarettes to be authorized as MRTPs by the agency and the second tobacco products overall to receive “exposure modification” orders, which allows them to be marketed as having a “reduced level of, or presenting a reduced exposure to,” a substance, according to a press release.
“Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”
The exposure modification orders specifically authorize the manufacturer to market “VLN King” and “VLN Menthol King” with certain reduced exposure claims regarding nicotine, including:
“95% less nicotine.” “Helps reduce your nicotine consumption.” “…Greatly reduces your nicotine consumption.”
When using any of the reduced exposure claims in the product label, labeling or advertising, the company must include, “Helps you smoke less.” The FDA also recommends that the labeling and advertising include the statement, “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”
Despite today’s action, these products are not considered safe or “FDA approved.” There are no safe tobacco products, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product, according to a press release. The exposure modification orders do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers. These orders do not allow the company to market these products with therapeutic or cessation claims.
The U.K. Vaping Industry Vaping Industry Association (UKVIA) has labeled an anti-vaping report in TheLancet “incredulous, laughable, untrue and extremely worrying.”
The authors of The Lancet article contest the suggestion that e-cigarettes are safer than conventional cigarettes. The U.K. Medicines and Healthcare products Regulatory Agency recently announced plans to allow healthcare providers to prescribe medicinally licensed e-cigarettes for smoking cessation, they write, could prove as harmful as the endorsement of tobacco by physicians between 1920 and 1950.
“We have the greatest respect for the medical profession but for one of its leading journals to carry an article which states that there is no robust evidence to show that vaping has accelerated smoking cessation is quite unbelievable and completely untrue,” said John Dunne, director general of the UKVIA, in a statement.
“Worryingly this isn’t just an article questioning the clinical evidence basis for vaping as a harm reduction tool. Everything about it smacks of anti-vaping propaganda starting with the suggestion that the market is all the making of tobacco companies to line their pockets. This is an insult to all the independent companies across the U.K. and globally who make up the vast majority of the players in the sector and who have not just contributed positively to public health by helping 2.4 million former smokers in the U.K. completely quit their habits but have created huge numbers of jobs at the same time and one of the fastest growing industry’s this century, thereby making a massive contribution to our economy. Our membership is testament to this—out of our nearly 100 members, some 95 percent have no affiliation to tobacco companies.
“Such a highly respected journal as The Lancet should know better when running articles and look at all the evidence that is available and opinions across the healthcare spectrum. Instead, the report which is carried completely ignores research which has clearly shown on more than one occasion vaping to have a hugely positive impact on smoking cessation, and significantly more so than NRTs.
For one of its leading journals to carry an article which states that there is no robust evidence to show that vaping has accelerated smoking cessation is quite unbelievable and completely untrue.
“The article’s assertion that the pro-vaping stance of Public Health England contradicts the rest of the world is nothing short of laughable, choosing to ignore the positions of the likes of Cancer Research UK—which says on its website that there is no good evidence that vaping causes cancer—and the Royal College of Physicians who have both publicly recognized the harm reduction opportunity that vaping offers over smoking. The report also ignores large scale research which backs up the public health potential of e-cigarettes, such as the study produced by the British Heart Foundation and the University of Dundee which suggested that vaping may be less harmful to blood vessels than smoking cigarettes.
“It’s these types of one-sided and misleading articles that leave smokers and vapers confused and questioning the health benefits of vaping versus smoking, leading to them either continuing with or returning to smoking. But, whilst we’re not getting data from hospitals and doctors suggesting that we should be worried about the effects of vaping—and, let’s face it, we would have heard by now given vape products have been available in this country for more than a decade, what is undeniable is that smoking kills—some 78,000 people a year to be exact—and the very death toll that vaping is helping to address. Instead, the report in TheLancet blames the U.K. government for its pro-vaping stance and highlights that they are in danger of presiding over what will be the biggest public health disaster in U.K. history.
“As a responsible industry, we’re more than up for continued independent clinical research into the long term impact of vaping, to prove once and for all that vaping is the biggest public health prize seen this century.”
The French Vaping Association FIVAPE has joined the Independent European Vape Alliance (IEVA). IEVA now brings together eleven national associations from Belgium, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Romania and Spain as well as 13 international corporations in the e-cigarette industry.
“FIVAPE has been at the forefront of responsibility and regulation in the vaping sector, and we believe we can amplify the voice of French vape businesses within IEVA,” said Jean Moiroud, president of FIVAPE, in a statement. “We hope to tackle our industry’s future challenges together.”
“We are delighted that FIVAPE has decided to support the work of IEVA,” said Dustin Dahlmann, president of IEVA. “The French vaping industry is one of the largest and most successful in Europe. We very much look forward to working closely with FIVAPE on ensuring robust yet proportionate regulation for our sector.”
Using e-cigarettes has been linked to DNA damage resembling that of smoking, reported a team of scientists. However, researchers Caitlin Notley and Konstantinos Farsalinos, who were not involved in the study, have recently discussed limitations of the study in an article published in The Conversation.
Credit: Creo2
‘The study recruited a relatively small number of people who were not representative of the population. And it did not consider other lifestyle habits that may affect the measurements, such as alcohol use’, wrote the scientists with a background in public health and addiction research.
The DNA research published in Nature Scientific Reports compared gene expression in white blood cells of vapers to that of smokers and people without a history of either vaping or smoking. The scientists from Keck School of Medicine in Los Angeles, California, found the expression of genes involved in cellular respiration and immunity to be dysregulated in both vapers and smokers. However, the number of affected genes was several times higher in smokers, compared to vapers.
‘Our study, for the first time, investigates the biological effects of vaping in adult e-cigarette users, while simultaneously accounting for their past smoking exposure,’ said study lead Professor Ahmad Besaratinia. ‘Our data indicate that vaping, much like smoking, is associated with dysregulation of mitochondrial genes and disruption of molecular pathways involved in immunity and the inflammatory response, which govern health versus disease state.’
Farsalinos and Notley pointed out that although the reported changes in DNA may represent risk factors for disease, the study did not measure any direct effect of vaping on the prevalence of illnesses. They caution this could be misinterpreted by the press and divert from the benefit of using e-cigarettes as a tool to overcome tobacco addiction. ‘It is irresponsible to report sensationalist headlines to the public based on complex studies that in reality do not show any real-world harm. Particularly compared to the immense harms to health of tobacco smoking.’
On the other hand, there is also evidence to suggest that vaping can be an entry to nicotine consumption, particularly among teenagers, according to Besaratinia. “Given the popularity of e-cigarettes among young never-smokers, our findings will be of importance to the regulatory agencies,” he said. “To protect public health, these agencies are in urgent need of scientific evidence to inform the regulation of the manufacture, distribution, and marketing of e-cigarettes.’
VOOPOO products won five awards including the Best Vape Brand 2021 at the annual Ecigclick Vape Awards. It’s the first time a company has won the Best Vape Brand award for two consecutive years.
The Ecigclick Vape Awards attracted more than 200 mainstream brands competing in various categories, according to press release. More than 100,000 global vapers of mainstream communities from North America, the United Kingdom, and the European Union participated in the email voting. Ecigclick is a vape review site based in the UK.
This year, VOOPOO’s four products (ARGUS, DRAG Nano 2, DRAG 3, TPP-X POD TANK) won the Best Vape Kit For Beginners, the Best POD, the Best MOD, and the Best Sub Ohm Tank respectively. Changes in the market environment and technological innovation have created a more demanding consumer, according to the release.
“Scenario-based, lightweight and diversified products are becoming more and more popular in the market,” the release states. “VOOPOO will continue to develop its product ecosystem, allowing its DRAG, VINCI, ARGUS, and V series to integrate with each other, so that consumers can enjoy a safe, reliable, and diverse product ecosystem that can meet diversified needs.”
Turning Point Brands has received a United States Postal Service (USPS) exemption to ship vapor products to thousands of age-restricted vape shops across the United States through VaporBeast and other websites.
Credit:USPS
“We remain focused on providing a positive experience for our customers,” said Marc Waxman, president of NewGen at Turning Point Brands, in a statement.
“As one of the first to apply for and receive an exemption from the USPS, we are now able to increase the number of shipping options we offer our customers. This will allow for optimized order processing, more accurate tracking data and faster overall shipping times. Our network of delivery choices is expanding every week to cover shipments to more and more businesses and adult consumers.”
In late December, former U.S. President Donald Trump signed into law a $2.3 trillion coronavirus relief and government funding bill that contains a provision banning the USPS from delivering vapor products. The USPS was already prohibited from delivering cigarettes and smokeless tobacco products to consumers under the PACT Act. The law passed in December extends the Act’s original definition of “cigarette” to include electronic nicotine delivery systems.
The USPS ban on mailing vapor products took effect Oct. 20.
The Vuse e-cigarette brand has won the Sustainable Product Award in the 2021 SEAL (Sustainability, Environmental Achievement and Leadership) Business Sustainability Awards. The award recognizes innovative and impactful products that are “purpose-built for a sustainable future.”
The SEAL Awards celebrate leadership through business sustainability and environmental journalism awards.
“We are honored to receive this SEAL Sustainable Product Award for our Vuse vapor brand,” said Kingsley Wheaton, BAT’s chief marketing officer, in statement.
“At BAT, we are creating the brands of the future with sustainability at their core. In 2021, Vuse was certified as the first global carbon neutral vape brand. This is part of Vuse’s broader sustainability program, which aims to eliminate single-use plastics and have all packaging recyclable by 2025.
“We are proud that Vuse has set the sustainability standard within the vaping category.”
