Letter to The Times, 14 March 2013 on how misguided excessive regulation threatens one of the most promising technologies for public health – the e-cigarette.
‘Red tape threat’ to e-cigarette market
The e-cigarette is an emerging technology that could radically reduce the death toll from smoking and should be encouraged
Sir, The World Health Organisation states that tobacco could be responsible for one billion deaths in the 21st century. The e-cigarette is an emerging technology that could radically reduce this toll and disrupt the tobacco industry’s entrenched business model.
E-cigarettes deliver nicotine in aerosol form without the hazards that accompany tobacco smoking. Nicotine itself has minimal health impacts, so e-cigarettes can dramatically reduce the harm to smokers who cannot or will not give up their cigarettes.
From trials, testimonials and the rapid growth of the e-cigarette market, we know that e-cigarettes work for smokers, and work in a different way to nicotine patches and gum. We are witnessing a market-based, consumer-led public health revolution, requiring no NHS resources.
However, governments in the UK, Europe and the United States are now gearing up to classify these products as medicines, thus imposing heavy regulatory burdens, costs and restrictions. It would be an appalling paradox if regulators, in the name of safety, ended up smothering the e-cigarette market with red tape, and so tipped the competitive balance back in favour of cigarettes.
Gerry Stimson
Emeritus Professor, ICL LondonKarl Fagerstrom
Emeritus Professor, University of UppsalaDr Delon Human
SwitzerlandClive Bates
Former director, ASH
This has prompted an article in The Times: E-cigarettes ‘save lives’, top public health experts tell Government (£). The full article is available to subscribers to The Times. But I would like to draw out an interesting quote from the Medicines and Healthcare Products Regulatory Authority:
“We are currently working towards making a decision about how to regulate e-cigarettes and we will announce this soon.
“Our view is that products designed to help you beat the addiction to nicotine can fall within the definition of a medicinal product. We would regard any e-cigarette presented as an aid to quitting smoking as being a medicinal product. In the UK, it is illegal to sell e-cigarettes as a ‘quit smoking’ aid unless they are licensed as a medicine by the MHRA.”
I think I might even agree with this formulation. But of course e-cigarettes are not designed to overcome nicotine addiction – they satisfy a nicotine addiction rather than help deal with cravings arising from withdrawal. Nor are they presented as an aid to quitting smoking – the producers do not make claims or seek an ‘indication’ for their products as a ‘quit smoking aid’. The products are simply offered as alternative nicotine delivery system to the crudely-antiquated, disease-inducing tobacco cigarette.
It is easy to read too much into a comment like this, so let’s not get carried away. But maybe it signals a forthcoming outbreak of ‘proportionality’ and appropriate regulation, that might actually be in line with EU law.
To add to the idea that e-cigarettes don’t fit the logic because they aren’t intended as quit aids, including them in a requirement to be classified as drugs would be akin to classifying pens, toothpicks and regular chewing gum as medicines. People quitting smoking use all those things in the process of quitting. Pharma products aren’t the only game in town when it comes to trying to give up smoking.
Eliquids are not medicinal products for some simple and true reasons: They do not cure anything, they do not prevent any health status. They do deliver nicotine so they are not a useful product to help against nicotine addiction. Eliquids and e-cigarettes aim people who are not ill. Smokers are addicted to nicotine but they get nicotine with 4000 other highly toxic chemicals in the tobacco cigarette (after pyrolysis take place).So, it is better to think of e-cigs as an anti-toxic and effective filter for nicotine addicted persons. All the other words about limits are just for people who believe in war-making humanity.
Nicotine patches, nicotine gum, and nicotine inhalers all deliver nicotine and are all considered safe and effective products to help smokers quit. Just sayin’.
Yes – but these have a different purpose – to reduce cravings in someone trying to give up nicotine. E-cigs are an alternative way of smoking, with 99% of the downsides eliminated. They have been totally unimaginative and uninnovative – if that’s what this highly regulated industry can do with all its resources and clout, then I don’t see much of a future.
All the other anti-cigarettes addiction products have not developed such a market and they were not a real threat to this cigarettes manufacturers. As this market is growing unexpectedly huge, they are now trying through their big channels to bring it down. Is going to happen one of this days anyway, as the governments are deeply involved in this.
For your information a copy of the follow-up letter we have sent The Times in
Dear Sir
The ‘red tape threat’ to e-cigarettes (March 14) is at best curious.
The UK e-cig market is currently worth an estimated £40m and we estimate it’ll grow to £100m in 2014. It’s a rapidly growing industry and a UK success story to be proud of – we alone now employ 130 people across the UK(it was 5 two years ago), we sell our products into over 50 markets across the world and in 2012 our sales replaced the equivalent of over 200 million cigarette sales. The European Union’s proposal, along with governments and regulatory bodies in the UK and elsewhere, for medicinal re-classification would have the effect of removing from the shelves all those products which are popular with consumers. pending medicinal authorisation. We have’nt designed, developed or marketed our products as a medicine. Quite simply, smokers don’t regard smoking as a disease for which they require medicine – rather, it’s a habit for which they might need help to break. Subjecting e-cigs to all the trials, tests and legislation that comes with a medical classification (a lengthy and expensive process commercially viable for only the world’s biggest companies) will merely throw obstacles in the way of people who are seeking an alternative to cigarettes. It would also disregard all that esteemed public health experts, the signatories of yesterday’s letter, are saying about the potential contribution e-cigs can make in reducing the public health harm caused by tobacco.
Why oh why are the European Union and such governments and regulators trying to restrict the availability of e-cigs and make it harder to put them on the market than the harmful products they are designed to replace? We sincerely hope common sense can prevail and that vested interests of others won’t be allowed to shut down a flourishing industry.
Michael Ryan, Chairman E-Lites & Chairman Electronic Cigarette Industry Trade Association
I agree mav. Mixing juice is the low hanging fruit. Get a bit on your fingers and you’ve only got minutes to live. Think of the children. The big problem for the MHRA is the internet. Lots of things are banned, but people have no problem getting hold of them.
Nicotine ejuice is that toxic. The highest concentration you can purchase is 100mg/mL which is 10% solutions. I’ve drop a little on my hands before, I simply wipe it off, and it’s no big deal. All bottles should have child proof caps and labels, but 10% nicotine solutions should be handled and kept away from children like the chemicals under the sink. People dilute their ejuices to concentrations of 10 to 24mg/mL. In the UK, the highest concentration of nicotine you can legally purchase is 72mg/mL (7.2%), and that seems reasonable. To ban e-liquids would seriously cripple the electronic cigarette industry, and send many people back to smoking tobacco.
Pure Nicotine (100%) however should be outright banned. It’s a potential danger to others. The Australian vape forum (aussievapers.com) censors anyone who mentions a vendor (often Chinese) that sells pure nicotine. I think that’s very responsible.
Charles, if they try and regulate ecigs in the UK, your sales won’t suffer too much because uk vapers will be ordering them from overseas. Bit like Golden Virginia tobacco. Thousands of tonnes exported, but I’ve yet to meet a foreigner who smokes it.
Wasn’t it one of your guys advocating a ban on flavoured e-liquid a couple of weeks ago in Brussels? I would say that all e-cigarette sellers should stick together on this, as it looked to me to be a clear attempt to protect your own business at the expense of other vendors.
Might be worth remembering that standing together will be much more successful than trying to harm others for your own greedy gain.
I believe they are only trying to please their Pharmceutical Donators. Even if e-cigs remain as they are in the UK in terms of sales regulations, these future regulations will allow the Pharamceutical companies to have a monopoly over the marketing. Only their products will be allowed to be marketed, for example, on television as quit aids.
This is showing to be true every day. And it is quite depressing to see it fold out right in front of us. It’s very similar to the situation in Australia and New Zealand where nicotine liquids for electronic cigarettes are illegal to be sold (vapers must import), but Pharmeceutical companies are free to sell their Liquid Nicotine Quickmist product.
But the truth is, smoking is not a disease. Therefore, to claim that they help people quit smoking is not a therapetic claim. Pharmeceutical companies have been profiting off the notion that smoking is a disease in and of itself, with NRT products, and they will gain exclusive marketing rights for electronic cigarettes with it also. Nicorette do have an electronic cigarette in their development. People have reported doing survey questionaires for them.
Electronic cigarettes are as much of a medicine for smokers, as is healthy food is for obese people.
@Demoti
Big Pharma & Big Tobacco.. Both of them are very pleased with this regulation!
Have a look at Nicadex:
http://www.medgadget.com/2012/01/nicadex-device-may-become-part-of-formal-smoking-cessation-therapy.html
http://cncbio.com/news/cn-creative-acquired-by-british-american-tobacco/
Funny, isn´t it?
“Why oh why are the European Union and such governments and regulators trying to restrict the availability of e-cigs and make it harder to put them on the market than the harmful products they are designed to replace?”
Most likely, because someone’s encouraging (paying) them to do so.
The major problem with giving Big Pharma or Big Tobacco a monopoly over the electronic cigarette market is that either one of them will seek to overcharge the consumer to protect their other nicotine containing products (i.e NRTs and Tobacco).
If given the chance, Big Tobacco or Big Pharma will try to have eliquid (i.e Loose Juice) eliminated from the market. Under their control of the market, people will only be able to purchase prefilled – non refillable cartridges.
Prices of electronic cigarettes will be far higher than they are today, and there will far less variability and choice which are major attractions to the products. Electronic cigarettes only work because they are customizable – Battery size, battery shape, cartridge/atomizer type, PG/VG ratios, flavours, nicotine levels.
We must do all we can to ensure that both Big Tobacco and Big Pharma do not acquire exclusive rights to the elctronic cigarette market.
I have translated the (in my opinion a very important) letter into German and published the translation in my blog.
I hereby ask for your approval – if this should not be done, I would remove the entry immediately, of course.
Yours faithfully
Rursus
Of course – we’d be delighted!
Here is the translation and my contribution in German:
http://blog.rursus.de/2013/03/top-gesundheitsexperten-sagen-der-regierung-ezigaretten-retten-leben/
I’ ve added a short vita of those who signed the letter.
Thank you, for the approval :)
How is it the MHRA can get away with telling the ecig community what ecigs were designed for? It’s no different to their deciding to regulate coffee after claiming it was designed as a cure for narcolepsy.
Not quite. They would be banishing all those “new” coffein containing drinks and stuff link Cola and Red Bull as coffee cessation aids. Pharmaceutical companies would be delighted.
I have been a smoker for all of forty years,never contemplated giving up,but since buying a tornado tank ,from. Totally wicked I have not had a cigarette for thirty four days.Fantastic!,, please don,t make things difficult and more expensive by bringing out rules and regulations. I really don,t want to start smoking again. Yours sincerely grace ryan
i also smoked for 40 years+, but then tried a ecig also from Totally Wicked, i am pleased to say that i have not had or wanted a a cigarette now for 3 years and 10 days,
but i want to stree that if this stupid ruling comes to pass, then i know i will return to cigarettes, that is after i have used up my stock pile of e-liquid etc, which shopuld last me a good few years yet
i would also like to add, that both my doctor and the whole surgery fully support the use of ecigs after i should them to them, and they have now had several other patients give up smoking by using ecig, for whom patches etc did not work for them
please can someone use put common sense above profits for once
I am thoroughly disappointed in this news and agree with nearly all that has been mentioned here. Disappointed in particular as I have just found these wonderful devices! I don’t see the danger and I am always spilling it on me but never burn off a layer of skin or fall to the ground convulsing and as another suggested, its easily wiped off and children well protected by safety caps. I have no interest in not smoking in one form or another but 100% prefer and want to Vape over smoking all that rubbish that comes with cigarettes. I can smell things again, I am not phlegmed up and chesty, I don’t stink and I’m not endangering my daughter so its a win win situation and I am willing to offer my services to fight any rulings if I am required so please bear that in mind – thanks
Its a common belief in the vaping community that the reason Governments,public health bodies,charities etc oppose e-cigs is for financial reasons usually involving Big pharma. This may well be true in some cases, although impossible to prove without serious investigation. I suggest another reason maybe what I call ‘Paradigm Inertia’, which is when a system of beliefs though valid at a previous time,persist or continue unaltered after new information or methods become available. In this case the beliefs being those associated with tobacco control in general, and the new approach being vaping or Snus, THR in general. The inertia is not just from those actively committed to the earlier approach, but more importantly from the bodies or policy makers that have incorporated it into their policies. It takes a certain amount of time (and effort) to understand a different approach and then revise your policies which in the case of governments,public health bureaucracies etc can be a very long time indeed if at all.
This I think explains much of the apparently irrational opposition to e-cigs documented on this site and others, without needing to accuse the relevant bodies of corruption or active conspiracies. Great site Clive for exposing the inertia and the resulting madness in action!
I think this paradigm inertia theory is basically right… The big government / tobacco / pharma theories give those industries too much credit for evil intent and ability to execute a successful conspiracy.
With respect,
If an Australian e-cig vendor were to sell their ejuice containing nicotine, they would be fined thousands of dollars. The Australian Law clearly states that nicotine in liquid form is a schedule 7 poison, and therefore not to be sold by anyone, yet Nicorette are marketing their liquid nicotine product outside of pharmacies with person-sized posters. I don’t think it’s a ‘conspiracy theory’ when it’s happening right in front of you.
It’s not a conspiracy theory when a spokesmen for Blu Cig conducts an Ask-Me-Anything on Reddit, and when confronted about selling loose juice and refillable cartomizers, he simply dismisses it as “not part of their business model”.
It’s not a conspiracy theory when a group of ecig companies join together to form an industry association (TVECA) that stands in favor of the FDA regulating ecigs as tobacco products that will force ecig sales offline, and prefilled-non-refillable cartridges to be the only consumer choice.
If it weren’t for consumer advocates such as the folks at CASAA and their supporters, the FDA deeming regulations would have probably been pushed through already, and the only ecigs you would be able to buy are those inferior quality, prefilled, non-refillable, cigarette-lookalike devices that you can only buy retail.
I’ve converted 5 close family and friend smokers now to electronic cigarettes, and every single one of them required a different setup – different battery, different cartridge type (clearo vs carto), different nicotine level, different VG ratio, and different flavour. It took time, sometimes over a month, to sit down with them and find their perfect fit.
It is far more profitable for larger corperations if ‘loose juice’ and refillable cartridges were eliminated from the market. This attempt to keep their profits high will severely restrict consumer choice, and that will cripple the industry, but more to the point, it will not attract smokers.
But this can only happen with the help of legisature whereby they have politicians cut out their competitors by banning certain ecigs types and associated liquids and flavours, or authorities turning a blind eye such as with Nicorette’s Quickmist sales in Australia and NewZealand.
I honestly don’t think these concerns are mere conspiracy theories.
@mav,
That is a very good post and points out the hidden danger of the “cig-a-like” market trying to eliminate the much better forms of e-cigarettes (like the ego-C) because their own products are far inferior, with poor vapor, very poor battery life and very expensive cartridges. A real cash-cow due to the horrendous profit margins on the inferior cartridges compared to juice vendors.
It’s pretty clear what the game is and quite easy to see this is no conspiracy theory.
Very helpful… if they don’t stand together, they’ll hang together.
are you all stupid ? the controlling government is trying yet again to get revenue out of the population , the government like everyone, knows that in 3 years most of the world population will have given up the dreaded tobacco for e-cigs , what will happen to the tax revenue ? they (the government ) will have to crawl back the tax some how . this message was sent by an avid and happy e-cig smoker that used to be on 40 fags a day, 3 months later and i still don’t need a fag .
If anyone wishes to dispute that there is a very real threat to tax income & also to the big tobacco companies then please look at why companies like BAT are buying up small E-cig company ‘innovators’. I had a very interesting conversation with a high up BAT employee who basically said they were running scared & wanted to put real nicotine products (that they own/control) into E-cigs before the synthetic stuff took hold of the market.
Well I don’t discount financial motives, particuarly regarding tobacco tax revenues. I’m addressing the more baffling cases of charities or public health bodies opposing vaping for often very irrational reasons. As a 1 year+ vaper we’re on the same side btw :)
I knew something like this would happen eventually. I too had been smoking since I was 12 years old and I’m now 43 and started vaping 5 months ago and I love it! I cannot stress that more. Everyone I know has said they never ever thought I would give up and thanks to my e-cig I have proved them all wrong. AND have managed to help lots of other friends quit too in the process by recommending the e-cigs. I have no intention of giving up and my aim is to have zero nicotine ones but I shall always use them because I loved smoking despite its obvious health issues. I don’t understand all the government bull but I’m guessing its all about money and stupid red tape. I thought they’d encourage people to find alternatives to tobacco but no. I support & will do all I can to help to keep things exactly as they are. I can feel a letter to my MP coming on!
sarah , the biggest industry in the world is tobacco , lets get the population hooked on nicotine (cheep as chips in 1916 ) then we will raise the price slowly
over the next decade . then we raise the tax revenue .now its nearly £9.00 a packet of 20 and the silly idiots still pay for there smoke he he he , snigger’ snigger’ snigger . all of a sudden ( shock horror ) a product comes on the market that is not taxed ??? what shall we do ? we are losing thousands in tax revenue , ah Mr speaker , we put tax on nicotine . phew old chap well done .
See http://news.sky.com/story/1027436/british-american-tobacco-in-e-cigarettes-deal (copied below)
By Mark Kleinman, City Editor
Britain’s biggest tobacco company is poised to swoop on a pioneer of some of the world’s biggest-selling electric cigarette brands, a vital new frontier in an industry buffeted by growing restrictions on its sales and marketing practices.
I have learned that British American Tobacco (BAT) will announce the acquisition of CN Creative, a Manchester-based company which specialises in the development and production of non-combustible cigarettes.
The takeover is believed to be costing BAT tens of millions of pounds, but insiders say the purchase will be of potentially far-reaching strategic importance to the group.
I understand that the deal will involve CN being acquired by BAT rather than Nicoventures, a BAT subsidiary which was set up last year to focus on what it called “the development and commercialisation of innovative regulatory approved nicotine products”.
Talks between BAT and CN Creative are understood to have been taking place for several months.
CN is one of a small number of companies to have benefited from the Government’s £200m Future Technologies Fund, which was set up by the last Labour administration to give British companies a stronger foothold in life sciences.
Among the Manchester-based company’s products is Intellicig, which it claims is the world’s best e-cigarette, selling in 26 countries around the world, including in the UK.
CN Creative also manufactures ECOpure, a nicotine-based product, and is developing a new generation of products under the name Nicadex that the company says “will exist under the medicines regulatory framework as a smoking cessation device/drug”.
CN Creative is chaired by Dale Pfost, a partner at Advent Life Sciences, one of the company’s investors. The company’s founders are likely to make a substantial multimillion pound sum from the takeover by BAT.
The tobacco industry’s biggest players are seeking to develop credible products which provide alternatives to smoking at a time when pressure on major companies is unrelenting.
New European Union proposals to put graphic images warning of the dangers of smoking have faced intense lobbying from the industry but are widely-viewed as inevitable.
BAT is run by Nicandro Durante, an Italian, who replaced long-serving chief executive Paul Adams two years ago.
The company declined to comment on the CN Creative deal.
I have COPD, diagnosed 7 years ago after 40 years of smoking. I have been using e-cigarettes for over 3 years now. Every year I undergo lung function tests to check the progress of my COPD and there has been no deterioration of my condition during this time. The test results have remained static. A recent CAT scan revealed no ‘nasties’ in my lungs. Had I continued to smoke tobacco I doubt the result would be the same.
I have been smoking -2 packs a day- for 33 years. I’ve tried to stop smoking several times, following several methods, without any success.
3 years ago i’ve switched to electronic cigarettes. Since that day i’ve stopped smoking the real thing. Plain simple and -yes- that easy.
Now i can climb stairs without starting to gasp, i have discovered again a Whole world of odors and tastes, and recent lungs’ x-rays show a clear improvement of my health over previous clinical examinations. And, last but not least, my chances of getting lung cancer are decreasing as time goes by.
Why are they trying to make all this more difficult to achieve?
A proverb of my country says:
“A pensar male si fa peccato, ma spesso ci si azzecca”
(those who think evil is sin, but he’s often right)
Dear Mr. Davis
Thank you for your email outlining your concerns with the EU draft Directive on tobacco and smoking. UKIP, being strongly libertarian, agrees with your personal rights to take tobacco and the like for whatever personal pleasure you take from it. We believe that the EU should have no jurisdiction over us either as persons or as the United Kingdom in these matters, and that we are entirely able to take these decisions for ourselves as responsible individuals and as an independent nation. We will certainly oppose this legislation at all levels, from votes in committee, speeches as opportunity arises, meetings with industry lobbyists (BAT are in contact with us), and final votes in the Strasbourg parliament.
In a more rear-guard manner, it may also be possible for UKIP to put down amendments to the legislation to water it down in progress, or loosen the limits for such things as milligrams allowed for OTC sales. Unfortunately, our chances of success in these votes and amendments are small as the three old parties all vote against us and in line with the EU band-wagon. The EU is entirely against personal liberty and freedom, and certainly wishes you to be forced to be healthy in the way it decides for you, which is for your own good, in their view. Of course, eventually the EU will see fit to ban all tobacco, let alone other nicotine products, so then only the black market will exist, much as things went in the USSR and Red China.
As a further fall-back position it may be useful to prepare yourself for the worst with research into non-EU controlled sources of nicotine fluid and the like which may spring up in a free market response to the EU Big Brother-Big Nanny State approach to these things, or even be available now. The UK alone does an excellent job of regulating such things, and the EU intrusion is as unnecessary as it is unwelcome.
Please support UKIP by voting thoughtfully in all available situations, we are the only party fighting the EU on these and all other aspects of being ruled by unelected bureaucrats in Brussels. As you did not elect them you cannot vote them out, withdrawal is the only way.
Yours sincerely
Jamie Illingworth
Office of Nigel Farage, Brussels
im gona vote ukip, god bless nigel farage the savior of our rite to smoke e-cigs. god save the queen .
As a realist, I always knew that smoking tobacco was bad for my health, but I also accepted that I didn’t really want to give it up. Even if I had decided to give up, nicotine patches, gums and sprays were never going to be the answer. So e-cigs have proved to be the perfect solution: I get the nicotine delivered in a form I enjoy using, and as a DIY user, it has become something of a hobby. To my mind regulation should only involve ensuring quality of products, especially the liquids, and the usual consumer protections.
I would also add that this is a growth industry with some retail shops opening up, at a time when the UK and Europe need growth more urgently than at any time in recent history.
f europe mate ,vote ukip and get the 3 major party’s out god save our queen .
This whole thing is about money period. The FDA recieves quite a bit of their funding budget from the big pharmaceutical companies that is a fact. Conflict of interest big time. They are constantly being pushed to approve drugs before they should which results in them being recalled and taken off the market years later after finding out they were killing maiming harming more then they helped. It’s sad that we’ve come to this a place where our governments tells what we can and cannot consume? They have no right to parent us! The world’s in real trouble due their stupidity and greed. We must stand together and fight this anyway we can. This is for everything not just e cigarettes I really hate that term it is in no way a cigarette! I’m stocking up and researching how to extract nicotine from tobacco they will not win! I also try and educate as many as I can. A huge thank you to folks out there fighting for us on this.
It ís difficult to find well-informed people about this subject, but you sound like you know what youíre talking about! Thanks
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As a chronic former smoker all I can say is that vaping has changed my life. My cough has gone as has my sleep apnea. I feel great. If it cost the same to vape as smoke I would choose to vape! I would welcome government intervention to make sure that the products I buy actually contain the level of nicotine they advertise and that the batteries are safe and I would happily pay a tax that covered the cost of ensuring this. It would be a small price to pay if it meant I could buy the products as easily as I can the deadly alternative. While I am of the opinion ( after extensive research ) that nicotine is no more harmful in sensible doses than caffeine it is horribly addictive and has no real upside.The last thing I would like to see is my daughter become a nicotine addict via vaping because it is an appetite suppressant therefore I would welcome any legislation that banned the sale of any product sold for the specific purpose of delivering nicotine to anybody born after 1996 ( ie 17 at time of writing). It is blatant hypocrisy to ban a product, for existing users, that cannot POSSIBLY be anymore harmful than its heavily taxed, antisocial and smelly alternative!!
giving up smoking cost the governments money , they loss the tax revenue, and also have to pay out more for the people living longer, it all down to money. i gave up smoking on 15th of july,, i started vaping on the 16th of july in the first week of vapping i wen back to the stop smoking class i blew into the smoking tester they have and blew a non smoking result into it , unlike a week earlier when i blew 24 on the machine, since i stopped smoking and vaping instead i can breath better. that is all i want from it i do not need no government to tell me which is best for me i have worked it out for myself
Nice ideas . I learned a lot from the information , Does anyone know if I could possibly obtain a blank a form document to complete ?