Tag: United Kingdom

‘Medical Licensing Realistic Only For Tobacco Companies’

Photo: goodmanphoto
The U.K.’s Medicines and Healthcare Products Regulatory Agency’s (MHRA) recent update to its guidelines to make vapor devices available via medical prescriptions may favor the traditional tobacco industry, reports ECigIntelligence, citing experts.
According to Christopher Snowden of the Institute of Economic Affairs, it’s likely that only tobacco companies will succeed in gaining licensing for their products.
Robert West, professor of health psychology and director of tobacco studies at the University College London, stated that he is not confident “any e-cigarette manufacturer independent of the tobacco industry will have the resources to overcome these hurdles.”
“This could very easily lead to a situation where tobacco company e-cigarettes can be prescribed while others cannot,” West said.
“I am worried that the MHRA may have missed an opportunity here and has not made the process simple enough to generate more successful applications,” said Clive Bates, director of The Counterfactual. He expressed concern that the agency has made the licensing process too complicated by asking for information that is “either unnecessary or too difficult to produce cost effectively.”
Another concern is consistent dosing—many feel that in order to remain consistent with dosing, closed systems will be favored over open systems, where consumers can control the strength of nicotine.
“It would be essential for the MHRA to evaluate the device and liquid together. That favors sealed disposable units and pod-based systems,” said Bates.
Once a company submits a marketing authorization application, the standard timeline is 150 days plus any time needed by the company to answer questions that arise, according to the MHRA. The pathway has been available since 2013 but was “expensive and time-consuming.”
November 10, 2021
PMI Applauds Plan to Simplify E-Cig Licensing

Photo: DW labs Incorporated
Philip Morris International announced its support of the U.K. government’s plan to simplify the pathway to license electronic cigarettes and other inhaled nicotine-containing products as medicines in England.
“The U.K. already has one of Europe’s lowest smoking rates, supported by a high rate of smokers who have switched to better alternatives,” the company wrote in a press note. “This proposal makes the U.K. the first country in the world to encourage the medical licensing of e-cigarettes via prescription as a route to further lower smoking rates, particularly among low-income smokers.”
“The U.K. is a global leader in medicine, science and public health,” said PMI’s senior vice president, of external affairs, Gregoire Verdeaux. “Expert scientific reviews in the U.K. and U.S. are clear that smoke-free alternatives—such as e-cigarettes—offer adults who would otherwise continue to smoke cigarettes a better alternative. We welcome the U.K. government’s continued recognition that regulated e-cigarettes and other inhaled nicotine-containing products, while not risk-free, are less harmful than smoking and can significantly benefit public health.”
PMI said regulators can decisively accelerate the decline of smoking through risk-proportionate regulations for all nicotine-containing consumer products. A growing number of countries—including the U.S., New Zealand, Italy, Portugal, Greece and Bulgaria—have recognized this approach and implemented differentiated regulation for noncombustible alternatives, according to the company.
November 3, 2021
Doctors Reluctant to Prescribe E-Cigarettes

Photo: omphoto
Not all doctors and nurses are enthusiastic about England’s intention to let physicians prescribe e-cigarettes to smokers, reports Daily Mail.
A yet-to-be-published study, involving the University of Oxford, which interviewed 11 medical staff, found most struggled to advise long-term use of e-cigarettes because of concerns about unknown long-term effects.
A survey commissioned by Cancer Research UK two years ago indicates that two in five English nurses and doctors would feel uncomfortable recommending e-cigarettes to smokers and one in six would never do so.
General practitioners “find it difficult handing patients something which may cause them harm, even where e-cigarettes are far safer than cigarettes… They struggle to give people devices which may not be entirely safe or may perpetuate addiction to nicotine,” said Paul Aveyard, professor of behavioral medicine at the University of Oxford, who was involved in both pieces of research.
Martin Marshall of the Royal College of general practitioners urged more investment in community smoking cessation centers. “’Vaping should only be seen as a way to give up smoking, with the intention to then give up vaping,” he said.
Simon Capewell, professor of clinical epidemiology at Liverpool University, called the Department of Health plan for prescription e-cigarettes deeply worrying.
“England is out on a dangerous limb,” he said. “Officials here have fallen for the exaggerated claims of the pro-vaping lobby, and are ignoring the health risks. The main claim, that e-cigarettes are a major aid to quitting, is wrong. If that were true, why would the multinational tobacco corporations be pushing vaping so hard?”
November 2, 2021
Flooding the Market

Photo: Lezinav
The U.K. vaping industry sounds the alarm over noncompliant products.
By George Gay
Earlier this year, the U.K. Vaping Industry Association (UKVIA) called for “tough action against resellers of noncompliant disposable vape products,” which were said to be on sale widely across the U.K. and online. Indeed, a UKVIA investigation was said to have found that “illegal and counterfeit products” were “flooding into the market,” posing “a potential health risk to customers.” Inappropriately branded products were being purposely marketed toward children, the release said.
The situation is clearly concerning, but care needs to be taken here because it could be lethally counterproductive if reports about the need to combat the problems caused by the arrival of noncompliant disposable vapes were seized upon and used by those opposed generally to the use of vapor products as harm reduction tools proven to help smokers switch from traditional cigarettes to e-cigarettes. It is important to note that there is nothing inherently wrong with the harm reduction credentials of disposable vape products, given that they are registered with the relevant authorities. In fact, such products can act as a handy entry point for those smokers who have yet to make up their minds about the switch to vaping because disposables do not require a significant capital outlay and they are, relative to traditional cigarettes, inexpensive.
But while this is all well and good when it comes to licit products, things start to fall apart when unregistered products become available, though even here it is not necessarily the case that an illicit product will be more risky or less effective than other products. The problem arises because it is not known under what conditions illicit products have been manufactured and because of the way that such products distort the market. In the eyes of consumers who buy unregistered disposables unwittingly, these products do reputational damage to the legitimate industry and the whole concept of harm reduction if they underperform. And the very existence of unregistered disposables causes reputational damage to the legitimate industry in the eyes of society at large.
Add to this the fact that under-enforcing regulations on a strictly regulated market, as is currently happening, puts the suppliers of licit products at a disadvantage to the suppliers of illicit products in respect of such matters as costs and speed to market. To place a vape product on the U.K.’s market, a company is required to have that product tested by independent, qualified companies in respect of requirements laid down by the Medicines and Healthcare Products Regulatory Agency (MHRA). It has to submit a registration application complete with the results of the required tests to the MHRA, which then has up to six months to approve the application, request more information or reject the application—a service for which it charges a fee. No product may be placed on the market until it has been approved and that approval has appeared on the MHRA’s website.

John Dunne
Facilitating Enforcement
It is hardly surprising then that, while the industry welcomes robust, appropriate regulation, it can lead to frustration when a parallel, nonregulated market opens up and grows, as has happened and is happening in the U.K. While the UKVIA can and does monitor the market and call out where illicit products are on sale, it cannot enforce the regulations. And this is why John Dunne, the UKVIA’s director general, said in the press note that his organization was “calling upon regulators and the online marketplaces to robustly enforce current regulations and do much more in order to ‘clean up’ the disposable vapes market.”
At this point, a question arises, and I asked Dunne during a telephone conversation why the regulations were not being enforced robustly. The reality, he said, was that Trading Standards, which is responsible for ensuring businesses are compliant with regulations governing the sale of vape devices and e-liquids, was under-resourced. This is a common problem in austerity in the U.K. and is unlikely to go away given the current government’s policies, so I asked Dunne whether there were ways in which the UKVIA could help ameliorate the situation. “We are trying to work out some creative ways in which, as an industry, we could help,” he said. The industry was considering the provision of funds for further enforcement if resources comprised the issue. And it had offered to provide training to enforcement officers if product knowledge was the issue.
Dunne added that the UKVIA had recently published a one-page comprehensive guidance on the compliant retailing of disposable vape products in the U.K. And one idea that was in the pipeline was the provision by the UKVIA of one-page documents that include the images and information necessary for Trading Standards officers to easily tell a counterfeit product from a legitimate one, at least in respect of high-profile brands.

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Unfair Competition
One problem is that such initiatives take time to implement, especially given that Trading Standards offices operate independently in the various counties and countries that make up the U.K., and, in the interim, those interested in scamming the system have a relatively free hand.
Another important question that arises concerns the ways in which products appearing on the market are noncompliant: Why haven’t they been registered with the MHRA? There are two basic answers to this question. One is that while the product in question conforms to U.K. regulations, its supplier has not, for whatever reason, put the product through the registration process or because the process has not been completed and the supplier has jumped the gun.
The other answer as to why a product does not conform with the regulations is obviously more problematic. In some cases, it might be an e-liquid’s nicotine strength that makes its sale on the U.K. market illegal. Dunne said that some of the illicit products that had been identified had nicotine strengths two-and-a-half times the maximum allowed in the U.K. and were clearly marked “For sale in the U.S. only.” In the case of others, it was the tank size that broke U.K. market regulations, something that could be determined from the number of puffs that the device was credited with delivering. Yet other products were noncompliant because of failure to meet packaging requirements, which, as is spelled out in the guidance document issued by the UKVIA, are extensive.
On the positive side, Dunne said that none of the e-liquids in the illicit disposables the UKVIA had tested contained any substances that raised concerns, and while some e-liquids were of a higher strength than was permitted, those strengths were as indicated on the packaging.
Nearly all of the noncompliant products originate in China, but then so do nearly all of the compliant products, a geographical monopoly that has at least one advantage. When factories producing counterfeit products are located in China, the authorities act quickly to close them down. There is, after all, no reason to suffer reputational damage as a harborer of counterfeiters when you can sell the genuine product just as easily.

One of the ways in which consumers can take to protect themselves against illicit products, according to the UKVIA, by consistently buying from a reputable source.
(Photo: VPZ)
Know Your Source
What, for people such as me, is particularly galling about the arrival on the U.K. market by air and by sea of a growing number of illicit vaping products is the fact that this is happening at a time when so many other products are in short supply due, we are told, to Brexit, the Covid-19 pandemic, the Suez snafu and a lack of lorry drivers—when water companies are unable to access all the chemicals they need for treating sewage.
But while illicit disposables arrive with near-impunity, once in the country, it should be another matter. Dunne said it should be possible to identify how counterfeit products were getting through the distribution system because all the manufacturers were supposed to be able to track their products from manufacture through to the consumer. So if they were doing things correctly, it should be possible to take a picture of a pack code and send it to the apparent factory of manufacture for verification or not. That is the theory. In reality, the system is so far not operating fully, so there is room for improvement.
In any case, while the information garnered from such systems can be used to good effect in examining the workings of distribution channels and, in retrospect it has to be said, tighten them up, they do little directly for the consumer. For a consumer to discover, post-purchase, that a product is a fake or not registered merely leaves her in the position of having to decide whether she takes the unknown risk of consuming the product or takes the financial hit of throwing it away. It takes only a few seconds’ thought to realize that this situation is not in the interests of consumers or the industry.
There are, however, some basic precautions that consumers can take to protect themselves. “The advice I always give is that you should buy from a reputable source,” said Dunne. “You buy from your local vape store whose business it is. They know these devices; they know where they come from. And for the most part, they sell only products that are registered correctly or that come from a known supplier.”
Even so, vapers can be misled, especially, for instance, when they buy online. Dunne said he had contacted a number of platforms, including eBay and Amazon, neither of which, to his way of thinking, controlled the vape products displayed on their websites robustly enough. Amazon claimed it didn’t sell any products that contained nicotine, he said, but during the morning of the day I spoke to him, he had quickly identified 10 different high-capacity vape devices on offer on the platform, all of which contained nicotine. Some of them were displayed under a headline that indicated “No nicotine,” yet nicotine strengths could be seen on the pictures of the products. “So,” he said, “my question to Amazon is: How are you policing the products that are being put on your site? Some of these devices are not sold nicotine-free anywhere in the world.”
Finally, picking up on a part of the press note in which it was said that disposables had a major role to play in the vape market, I asked whether it wasn’t the case that they also comprised a potential environmental problem. Dunne readily admitted that this was a concern for the industry. “And that is one of the reasons why the association as well as several manufacturers are looking at how these products can be recycled,” he said. “If we can find recyclers here in the U.K. that can deal with volume, there is an appetite within the industry to set up some sort of pick-up and recycle program.”

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George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.

November 1, 2021
England Paves Way for E-Cig Prescriptions

Photo: goodmanphoto
Doctors in England may soon be prescribing e-cigarettes to help people stop smoking tobacco, according to a news story published by the Department of Health Social Care and the Office for Health Improvement and Disparities. The Medicines and Healthcare products Regulatory Agency (MHRA) is publishing updated guidance that paves the way for medicinally licensed e-cigarette products to be prescribed for smoking cessation.
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.
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. It remains the case that non-smokers and children are strongly advised against using e-cigarettes.

This country continues to be a global leader on healthcare, whether it’s our Covid-19 vaccine rollout saving lives or our innovative public health measures reducing people’s risk of serious illness.
Sajid Javid, Health and Social Care Secretary
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. It remains the case that non-smokers and children are strongly advised against using e-cigarettes.
E-cigarettes contain nicotine and are not risk free, but expert reviews from the U.K. and U.S. have been clear that the regulated e-cigarettes are less harmful than smoking. A medicinally licensed e-cigarette would have to pass even more rigorous safety checks.
Smoking remains the leading preventable cause of premature death and while rates are at record low levels in the U.K., there are still around 6.1 million smokers in England. There are also stark differences in rates across the country, with smoking rates in Blackpool (23.4 percent) and Kingston upon Hull (22.2 percent) poles apart from rates in wealthier areas such as Richmond upon Thames (8 percent).
E-cigarettes were the most popular aid used by smokers trying to quit in England in 2020, according to the Department of Health and Social Care. E-cigarettes have been shown to be highly effective in supporting those trying to quit, with 27.2 percent of smokers using them compared with 18.2 percent using nicotine replacement therapy products such as patches and gum.
Some of the highest success rates of those trying to quit smoking are among people using an e-cigarette to kick their addiction alongside local Stop Smoking services, with up to 68 percent successfully quitting in 2020 -2021.

We fully welcome the news that the NHS in England is exploring opportunities to prescribe vaping products to help people quit smoking.
Doug Mutter, director, VPZ
“This country continues to be a global leader on healthcare, whether it’s our Covid-19 vaccine rollout saving lives or our innovative public health measures reducing people’s risk of serious illness,” said Health and Social Care Secretary Sajid Javid.
“Opening the door to a licensed e-cigarette prescribed on the NHS has the potential to tackle the stark disparities in smoking rates across the country, helping people stop smoking wherever they live and whatever their background.”
Vapor industry representative welcomed the prospect of e-cigarettes on prescription.
“We fully welcome the news that the NHS in England is exploring opportunities to prescribe vaping products to help people quit smoking,” said Doug Mutter, director of VPZ, the U.K.’s largest vaping retailer with 157 stores throughout the country.
“The pandemic has triggered an increase in smoking rates and the public health problem has been compounded by funding cuts for NHS stop smoking services and local support groups.
“However this progressive and innovative approach being considered by the NHS in England has the potential to reverse this damage and bring new momentum to our ambitions of becoming a smoke free nation by 2030.”

The government deserves 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.
John Dunne, director-general, UKVIA
“The government deserves 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,” said John Dunne, Director General of the U.K. Vaping Industry Association.
“This announcement by the Department for Health is just the latest in a long line of breakthroughs for those of us who for years have advocated vaping as the best and most effective method for people looking to quit smoking.”
October 29, 2021
U.K. Lawmakers Want Warnings on Sticks
Photo: vchalup
U.K. lawmakers want to require tobacco manufacturers to print the message “smoking kills” on each individual cigarette, reports The Guardian.
Members of Parliament have submitted an amendment to the health and care bill going through parliament which would allow the health secretary to make such warnings mandatory.
“We know that cigarettes are cancer sticks and kill half the people who use them. So I hope that health warnings on cigarettes would deter people from being tempted to smoke in the first place, especially young people,” said Mary Kelly Foy, the Labour MP behind the move.
Foy’s amendments would also let the health secretary:
Raise the legal age for buying cigarettes from 18 to 21.
Stop e-cigarette makers using tactics that might entice children to try them, such as sweet flavorings and cartoon characters.
Make it illegal to give e-cigarettes away free as sampler products.
Empower the government to impose a new levy on tobacco company profits, with the proceeds being used to fund stop smoking activities.
The plan is backed by Cancer Research UK and the Royal College of Physicians.
These stale and tired ideas have been around for years. The reason they haven’t been adopted in the U.K. is because there is no evidence that they will significantly reduce smoking rates.
Simon Clark, director, Forest
Simon Clark, the director of the pro-smoking group Forest, criticized Foy’s proposal.
“These stale and tired ideas have been around for years,” he said in a statement. “The reason they haven’t been adopted in the UK is because there is no evidence that they will significantly reduce smoking rates or discourage young people from smoking.
“Everyone is aware of the health risks of smoking. There are huge, impossible-to-miss health warnings on every pack of cigarettes including grotesque images of smoking-related diseases.”
He added: “Introducing a levy on tobacco companies would disproportionately hurt less well-off smokers because it will inevitably be passed on to consumers who already pay punitive rates of taxation on tobacco.”
October 21, 2021
British Army to End Smoking by 2022

Photo: niyazz
The British Army will no longer allow smoking from 2022.
British Defense Secretary Ben Wallace has directed the Defense Smoke-Free Working Environment policy to help smokers give up smoking and prevent nonsmokers from taking up the habit. Vaping will still be allowed in designated areas.
The policy will support the British government’s aim to reduce U.K. adult smoking from 15.5 percent to 12 percent.
The policy will prohibit “the use of all tobacco products (including combustible and chewing tobacco products) within the perimeter of a Defense site and/or near to site entrances [with the exception of single living accommodations]. The policy is Whole Force and includes anyone on-site (including contractors, visitors and other non-MOD personnel) all hours and all days.”
October 5, 2021
Juul2 Launched in the United Kingdom

Photo: steheap
Juul Labs has unveiled its Juul2 device in the U.K.
The device features a more consistent vapor experience, a longer battery life and anti-counterfeit technology.
Launching initially on the Juul.co.uk website on Sept. 30, the Juul2 system has been updated from previous versions with new technology and features based on feedback from smokers.
Among other features, the Juul2 features a more consistent vapor experience, a longer battery life and a smart light system communicating e-liquid level and battery life.
The Juul2 also comes with newly designed tobacco and menthol Juul2 pods (18 mg/mL nicotine strength) and technology to prevent unauthorized use. The device will not work when it detects counterfeit pods.
“We are pleased to launch the next-generation Juul2 in the U.K.,” Juul Labs’ EMEA vice president, Dan Thomson, said in a statement. “A key part of our mission is to transition adult smokers away from cigarettes, the leading cause of preventable death in the world, killing some 90,000 Britons annually.
“We believe the best method to switch adult smokers from combustible cigarettes to a potentially less harmful noncombustible alternative is to provide a product that closely resembles the consistency and experience of smoking. With Juul2, we believe we are taking another step in that direction as we aim to transition even more adult smokers.”
A retail rollout is planned for early 2022, and all U.K. retailers stocking Juul products will continue to uphold the company’s Challenge 25 age verification policy, which includes continued mystery shopping audits.
September 30, 2021
Compliance Guidance Issued for Disposables

Photo: steheap
The U.K. Vaping Industry Association (UKVIA) has issued compliance guidance for U.K. retailers who sell disposable vape products. Earlier, the association had called on regulators to crack down on resellers and retailers who were found to be flouting U.K. regulations for such products.
An investigation by the UKVIA has revealed mounting evidence of illicit and inappropriately branded disposable vape products hitting the U.K. market and noncompliant sales of such products, particularly in convenience shops and on major online marketplaces. U.K. regulations mean they should contain no more than 20 mg/mL of nicotine, yet evidence collected by the UKVIA reveals that some listed as this amount contain higher concentrations of nicotine and some products are being openly sold with 50 mg/mL strength. Furthermore, product packaging is not including warnings about the nicotine content, which is a legal requirement.
The association has been in discussions with the Medicines and Healthcare Products Regulatory Agency and Trading Standards to address the problem.
“We are doing all we can as a trade association to ensure the industry’s reputation is not tarnished by a minority of resellers and retailers intent on making a quick buck out of a trending product,” said John Dunne, director general of the UKVIA, in a statement. “Whilst disposables have a major role to play in the vape market, like all products, they need to adhere to the legislation.
“Our guidance is designed to ensure retailers keep on the right side of the law. We’re also working closely and are in discussions with leading disposable vape product manufacturers and the major online marketplaces to ensure they play a key role in taking a hard line against those behind the sale of noncompliant products in the country.”
The free guide, available for download here, which has been produced in conjunction with leading vaping compliance specialists Arcus Compliance, provides information on current U.K. regulations in relation to tank/reservoir capacity of devices, nicotine levels and the elements that must be contained on packaging. It also provides details in respect to registrations with and notifications from the MHRA.
September 10, 2021
Calls for Action Against Noncompliant Products

Photo: auremar
The U.K. Vaping Industry Association (UKVIA) is calling for tough action against resellers of noncompliant disposable vape products.
During an investigation, the trade group found that there are significant numbers of noncompliant products entering the U.K. and being sold in particular by convenience shops and on major online marketplaces.
“We are calling upon regulators and the online marketplaces to robustly enforce current regulations and do much more in order to ‘clean up’ the disposable vapes market,” said John Dunne, director general at the UKVIA, in a statement.
The disposable vape sector has enjoyed a significant revival in recent years, appealing as an entry point for adult smokers looking to quit conventional cigarettes. However, an investigation by the UKVIA has identified that illegal products are re-entering the U.K. market. The problem, according to the group, lies with some distributors who are flouting U.K. regulations and managing to get these products imported into the country and sell them on to traders and retailers as well as a lack of proper scrutiny on major online marketplaces.
Disposable vapes are pre-filled with e-liquids and cost around £6 ($8.27) each. U.K. regulations stipulate that they should contain no more than 20 mg/mL of nicotine, yet evidence collected by the UKVIA reveals that some listed as this amount contain higher concentrations of nicotine, and some products are being openly sold with 50 mg/mL strength. Furthermore, product packaging is often missing warnings about the nicotine content, which is a legal requirement.
The UKVIA has been in discussions with the Medicines & Healthcare Products Regulatory Agency (MHRA), which regulates vape products and trading standards, to address the situation. In a major crackdown on unscrupulous suppliers, the association is providing guidance on official distributors and disposable vape products to its members as well as looking at the idea of licensing vape shops to fund enforcement. It’s also working with manufacturers of disposable vapes to ensure they are doing all that is possible to monitor and audit their distributors.
“Robust enforcement of the current regulations is the only answer, and it’s needed now,” said Dunne. “We can provide support to the regulators and educate the industry on how to distinguish between what’s a compliant product or not, and we are in the process of doing this. However, we are not in a position to come down heavy on those breaking the law; that lies with the regulators.
“The vaping sector’s reputation, [which] the industry has taken years to build up and which has made it one of the most successful business markets in the 21st century to date, is being threatened by a minority intent on making a quick buck out of a popular product, and we will not stand back and just watch it happen. Disposables have a major role to play in the vape market, but like all products, they need to adhere to the legislation.”
September 7, 2021