New smoking products in the UK

[Oliver]

As the law stands in the UK, no new tobacco products can be introduced into the market. The only products containing nicotine that are allowed are those classed and licensed as medicinal products.

Unfortunately, this leads to the ironic situation where the most dangerous nictotine products available are the least regulated, and the safest ones the most regulated. Medicinal regulation, while essential to protect the public at large, is a hugely time-consuming enterprise; from invention to licensing, a new medical product can take many years in development.

At the moment, the only way e-cigarettes could make it to the UK market for general sale would be via the medical licensing route.
it is highly doubtful they could be sold as a smoking alternative, since this would probably fall outside the remit of a medical device. More likely, it would have to be sold as NRT, in the same way as current NRT products.

At the moment, there are a few UK based e-cigarette sellers, and it remains to be seen whether the authorities decide to prosecute.

If you are interested in these issues, I highly recommend you read the report into tackling nicotine addiction by the tobacco Advisory Group of the Royal College of Physicians (UK): Harm reduction in nicotine addiction - Helping people who can't quit

 

[elixir]

After introducing the electronic cigarette to my web site http://www.elixirshop.com a couple of months ago I have heard nothing but praise from customers telling me how this product has helped them cut down or quit smoking. It warms the heart to think you are selling something that is doing people good.

Then this morning in my mail I receive a letter and a rather large publication from the MHRA (Medicine and Health product Regulatory Agency) stating they had received a complaint (anonymous of course) about the electronic cigarette.

They now require samples, advertising literature and a whole kit caboodle of stuff to consider the case.

In my opinion I am selling no more than an electronic nicotine inhaler, note you can sell nicotine inhaler legally in shops.

Am I the first, could this be the beginning of the end for the electronic cigarette in the UK?

 

[Oliver]

Oh dear,

You are certainly the first I have heard of in the UK, but I've been expecting this for some time.

Unfortunately it is not classed as a nicotine inhaler but as a separate product entirely. This is due to the unique method of delivery - ie, the atomization process.

You see inhalers are legal because they are sold under a medicines license.

Because the product contains nicotine it must be sold under the laws that govern either medicines or tobacco. Unfortunately the e-cig currently is not a medically approved device, and it can't be sold under on a tobacco license because it is a new product, and (EU) tobacco laws prohibit any new products being introduced to the market. Take Swedish Snus as a prime example.

The only hope at the moment is to see what the results of the Auckland trials are and see what the medicines agency makes of them.

Don't hold your breath though, the tobacco and medicines industries are gonna throw plenty of obstacles in the way, I'll bet you the anonymous tip-off was the first move from one of them.

Good luck friend, and let us know what happens next will you?


SJ

 

[LVD]

I have written my MP Paul Burstow a while agoo about E-cigaretttes, and got a reply last month (21th Feb):

"I was very concerned about the point you raised. I have written to Alan Johson, Secretary of State for Health, enclosing a copy of your letter and asking for his immediate attention and comments"

The matter will be under discussion in parliament, to descide the UK view in regard of the European top, in wich E-smoking should be on the agenda. So do not panic yet, they just want to investigate before they descide.

So Elixir, this was NOT a complaint about you at all, but a plea to leave the sale of E-cigarettes free. Please provide them with all the info and samples they ask for. I think the better informed they are, the more chances we have. If you look at the newspaper article about the Belgian ban in the newspapers today, it is clear this ban was introduced by total and complete ignorance of the Belgian autorities of what this product actually is. At least the Secretary of State for Health in the UK knows about the arguments PRO E-smoking, which I compiled from the Dutch forum (many thanks to all my new Dutch E-smoking friends over there). My sincere appologies for the trouble this caused, but I'm fighting for you the reseller as well me the user.

I'm very much under the impression that Paul Burstow MP, valued the pro E-smoking arguments I've given and is on our side, and he's not regarded as a lightweight regarding health issues in the House of Commons. There is still hope, it will be a European descission. Belgium and Austria already made it clear they want to ban it, the Netherlands as well, but the reaction of E-smokers is getting organised, so this still could change, but the big tree in Europe: Germany, France and the UK still have to descide (not to speak of all the rest).

The tobacco industry as well the pharma industry know politicians all over Europe are in the process of decission making; so the storm of negative publicity we have withnessed today in Dutch and Belgian newspapers is not a coincidence. E-smoking is already well spread in Belgium and the Netherlands, so it is expected those countries will take the lead in the European discussion, and the rest of Europe will blindy follow that lead out of total ignorance. That is the reason why I contacted my MP. It is imperative this is put onto the political agenda in the UK (as in every other EU country, but I can't do it all). A PM or Secretary of Health who doesn't even know E-smoking exists, will follow the lead of Belgium (=total ban). We are making progress in informing the decission makers. I see the story of Elixir as positive news.

I will recontact my MP referring to the Kiwi study and keep you posted on any progress

 

[elixir]

Thanks for your support.
I’m now pleased to tell you the MHRA have now, after a few modifications, given me the all clear to continue selling electronic cigarettes.
A few days after the MHRA letter arrived trading standards also turned up. Again after some more modification they have given me the ok too.
It seems everybody selling or importing electronic cigarettes in the UK will need to go through this process to sell them legally here.

 

[Oliver]

Fantastic news, Elixir, and I wish you all the best. You've certainly done us e-smokers a big favor getting the e-cig on the first rung of the legal ladder!

Take care,

SJ

 

[bogee]

Does it mean as long as we get permission from MHRA and trading standard service we are ready to sell? does anybody know what does e-cigarette fall into when importing.

 

[bogee]

Does it mean as long as we have permission from MHRA we are ready to sell? Does anybody know which product category e-cigarette falls onto when applying for importing, is it food supplement?

 

[Spider]

Whoooo hoooo! Nice work!

 

[Lady Python]

Phew! After reading that I've just breathed a HUGE sigh of relief.

I should imagine though, that the big pharmas are going to be fuming (pardon the pun) that they've missed out BIG TIME on the e-cigs.

Given that recently there have been several studies done, the results of which are now in the public domain (i.e. media) that nicotine has BENEFICIAL effects, although addictive, the BMA, ASH, CRUK et al cannot use the excuse of Second Hand Smoke or "smoking causes cancer" argument.

However, I have no doubt they will eventually get very stroppy about it and jump on the least little thing to have e-cigs banned so that they can continue to peddle their dubious NRT replacement rubbish. Quite frankly, the big pharmas should be prosecuted for misleading the public, on three counts:

One, their claims that smoking tobacco products is detrimental to health is based on junk science and out and out lies. What came out fairly recently was the late Professor Doll, the scientist/doctor who "discovered" the "link" between tobacco smoking, particularly cigarettes and cancer was in the pockets of the big pharaceuticals and heavy industry at the time, much of the pollution caused by industry was the cause of many cancers but that wouldn't do because industry would have had to pay out too much money to rectify this. He was paid handsomely to "find" cigarette smoking the "cause" of cancer. This is well documented and was released for public view under the 30 year rule. If, as they would have people believe, everyone who smokes will die younger, then as someone writing a comment into one of the papers recently pointed out, there are an awful lot of people in their 80's, 90's and above who are smokers are all about to suddenly pop their clogs!

Two, big pharma want people to buy their overpriced and useless products. I have never bought (nor wanted to) any of their products, but I do know that on every single pack of NRT chewing gum, inhalers, patches etc. the words "Willpower Needed" is printed on every pack.

Three, the big pharmas don't tell you that their products are equally, if not more so, addictive than smoking itself is. One firm I worked for about 3 years ago introduced a smoking ban in our office because out of about 20 staff, one person complained about the smoke in the office. One of my colleagues knew she couldn't get through a 12 hour shift without smoking at her desk (we were allowed smoke breaks) so started using nicotine patches and nicotine chewing gum. Within a couple of months she was completely hooked on both cigarettes and NRT replacement stuff, so big pharmas products, if e-cigs were banned on "health" grounds, would also have to have their products banned too.

I'm sure big pharma will be spitting nails over this, but then again, e-cigs were made in conjunction with the Chinese Health Authority and WHO (as far as I am aware but will stand corrected if I'm wrong on that). It would be very difficult for the medical profession to argue with itself!

As for big pharma, with the article that was front page headlines in yesterday's Daily Express, I'd be very worried about the forthcoming compensation claims regarding cholesterol lowering drugs. Anyone wants the link to that let me know and I'll post it later.

 

[TropicalBob]

This is a forum for e-smoking, so I will resist rebutting an argument that has no place here -- the "merits" of cigarette smoking. There are forums for that on the Web. Find them. Post there about how it's all a conspiracy, etc., to make smoking and cigarettes seem deadly. Just, please, confine your remarks on this forum to e-smoking.

Many here are, admirably, quitting cigarettes. They hardly need "pro smoking" posts.

 

[Lady Python]

Not meant to promote smoking at all TB. Pointing out that big pharma will use any means available to them to ban a product (e-cigs) they might see as losing them £££$$$.

Suggest you read my post again to see what I'm driving at

It pays to be wise to the sneaky and underhand ways these people work. As I've said before, I like smoking tobacco and I like e-cigs too. It's bad enough that one is banned. To think that the alternative (and a very good alternative at that) could be banned sometime in the future is unthinkable.

Not so very long ago, people in this country said "They'll never ban smoking" - but they did.

 

[TropicalBob]

We have discussed Big Pharma, Big Tobacco and government's need for tobacco taxes in many past posts. I view them as e-smoking's foes. Formidable foes. E-smoking might well be banned. But what I read into your post was a pro-smoking bias and that's what has no place on a forum where many are trying to quit cigarette smoking.

Our devices must stand on their own when governments finally consider them for regulation. They are not tobacco products. No second-hand smoke arguments will swirl around approval or disapproval of e-devices. So no need to argue those points here. That's what I was objecting to.

Scream at Big Pharma if you want. I'm done it many times on this forum. They fund the anti-tobacco forces! They stand to profit hugely if smokers can't smoke and turn to NRT products. Let's figure a way to help promote approval of e-devices, not fight the rising tide of "no smoking" bans.

 

[Lady Python]

TB. I'm for people being free to make their own choices, not be dictated to by nanny-state governments.

They are not tobacco products

Nicotine is derived from tobacco so that, in a round about way, does make them tobacco products.

There is a rising tide of bans and people have let these bans happen either by swallowing the various scare stories put about by those who profit from it (and not just on the tobacco issue either), but most of all through complacancy, the oh, it will never happen attitude. In this country, it's happened with tobacco (as in other countries too) but now it is spreading to other things. Today, in our papers it would seem the government is now going to clamp down on drinking - after they allowed the pubs to open 24 hours Recently, there was also talk about taxing everyday food like milk, cheese, eggs etc. because of the government and medical profession's latest pet - so-called obesity. People deprived of calcium, especially children can get Rickets. Again, who would profit from this? The big pharmas who would no doubt make a fortune selling calcium and vitamin supplements.

Unless people start fighting back and saying enough is enough - and meaning it, these bans will increase until none of us will have a life worth living.

Oops. Clicked the enter button too soon.

I was going to say, I enjoy my e-cig and hope they are never banned. I also think that eventually e-cigs will take over from tobacco. I think they are the way forward. Evolution if you like.

 

[TropicalBob]

I should have clarified that I was referring to the U.S. when I noted that e-devices are not tobacco products. The cigarette is well defined in U.S. law; it's tobacco in a paper tube. The FDA in this country does NOT (yet) have any jurisdiction over cigarettes. Congress is now trying to give the FDA the authority it lacks.

We have a separate federal agency for alcohol and tobacco regulation. They have already said they are NOT interested in regulating e-cigs, because they don't contain tobacco.

Sadly, the FDA will get interested precisely because this is not a tobacco product but contains the highly addictive drug, nicotine. That makes the e-cig a drug delivery device -- which the FDA has jurisdiction to regulate. The FDA regulates all of Big Pharma's products and has rejected numerous attempts by others to market nicotine in water, candy, lip balm, etc.

The job for e-cig makers like Ruyan (about the only company with enough money to pay for the battles that lie ahead) is to convince the FDA and other agencies that the product does not threaten others, in the way second-hand smoke does, or entice young people to take up an addiction, but does offer health benefits to smokers who cannot or will not stop inhaling tobacco smoke with its multiple carcinogens and mutagens.

The fact that smokers would be healthier using an e-cig will not sway this agency, however. The FDA will contend that there are already numerous, approved, regulated, safe alternatives to inhaling tobacco smoke. Big Pharma has paid millions for clinical studies and tests necessary to bring its products to market. The FDA will not think twice to slap down any alternative product like an e-cig unless studies and tests (like those in New Zealand) have been done and can be entered as evidence.

At a minimum, the FDA will demand extensive regulation, particularly of liquid and cartridge contents, for safety reasons. Can anyone blame them for not trusting liquid of unknown Chinese origin being inhaled by Americans who depend on the FDA for health safety? As in Israel, America's FDA may allow only 0-nicotine stuff to be sold for e-cigs. Or it might follow the Big Pharma limit of 4mg maximum. Kiss higher amounts goodbye; that stuff is poison! Only a tamper-proof Ruyan Vegas-like disposable might be allowed more nicotine.

What must be argued is that this is NOT a cigarette and it does NOT produce smoke. It joins a group of products already legal to sell: Vaporizers. An e-cigarette is simply a handheld vaporizer that has the potential to improve the health of 46 million American cigarette smokers. Herbalists already use vaporizers. Argue the merit of that. And argue that this can deliver healthy substances in the vapor, vitamins even, in addition to nicotine. It can be a heathy practice, unlike deadly cigarette smoking and its societal costs.

Argue that the public will in no way be inconvenienced by even the close proximity of an e-smoker. Argue that these don't present fire hazards or burn dangers to people or property.

Big Tobacco has a stake here and will counter that its products face exorbitant taxation, so why shouldn't similar taxes be applied to something that looks like a cigarette and is used like one, in place of one.

The government will perk up. Tobacco taxes are essential in the failing American economy. I would guess most countries rely heavily on tobacco taxes. Expect new taxes, particularly on cartridges and liquid, if liquids are allowed at all.

These can be approved, with careful arguments and solid science to back up any health claim, which will be essential to make unless anyone thinks the FDA will embrace a drug delivery device for recreational use!

E-smoking faces a tough challenge in the months to come. It can and should be legal to use these devices if they are properly tested and regulated. Just understand this: The present practice of unknown quality, untested ingredients and blind faith that e-smoking is safer will not get e-smoking approved. And thank Ruyan every night for the testing they're funding in New Zealand. Without that, I believe these e-devices would be banned at the first public hearing.

I could counter these arguments, but it depresses me. I have my e-cig and I really, really want to keep it!

 

[Lady Python]

Thanks for your support.
I’m now pleased to tell you the MHRA have now, after a few modifications, given me the all clear to continue selling electronic cigarettes.
A few days after the MHRA letter arrived trading standards also turned up. Again after some more modification they have given me the ok too.
It seems everybody selling or importing electronic cigarettes in the UK will need to go through this process to sell them legally here.

This is good news for us in the UK. When I read Elixir's first post about this, my heart sank...then I read on and

Yes, e-cigs are largely unknown quantities, but as with all things, you have to weigh up the pros and cons. On the con side, e-cigs are in their early stages of development, the parts differ from one to the next. As you've said, "for not trusting liquid of unknown Chinese origin". Very true. There have already been some scares with Chinese imported stuff used in pet food in America a couple of years back. On the pro side, they're clean, in-so-much that you don't need ashtrays, which even by my 40 years smoking habit I have to admit are nasty, smelly things, you don't need a lighter (unless you do what I did last week and try to light the end of the e-cig - definitely not recommended LOL), they have very few chemicals in them compared to normal cigs and from a purely female point of view, you don't need a handbag (purse I think you call them?) for a special occasion. When I got married, I had a hard job fitting a couple of packs of cigs into my little handbag. E-cig, only need one, spare battery and a couple of cartridges.

From a health point of view, I can't comment personally on that yet - haven't been vaping that long and I've suffered a major setback because I accidentally broke mine. That said, in the first week I saved myself about £30 ($60) by not buying so many packs of cigarettes. Did have a few, but one day I only smoked two. I also noticed more is my son or one of his friends had smoked in the house. Before, I wouldn't have noticed.

To be honest, I can't wait for my replacements to arrive as I'm missing it. I miss the different flavours. Ordinary cigarettes all seem to taste the same. Gone are the days when there was a difference in taste from brand to brand. The only thing that's still pretty much the same is hand-rolling tobacco and I've never been a lover of roll-ups.

TB. Is it just me, or do cigarettes taste different nowadays to what they did in the late 1960's/early 1970's and if so, have you any idea why that is?

Anyway, it's gone 2.30am here and I've got to get up early for work in a few hours. Fingers crossed my new e-cigs will arrive with the morning post

 

[TropicalBob]

Lady Python, I followed a route of "light" cigarettes in America, from Kent to True to USA Gold.

I smoked 30 a day for 50 years. I've been off a bit more than a year now, but have the urge to smoke every morning on awakening and after most dinners. I just say no, then use something else or e-smoke, and the urge quickly passes. But ... the first three months off cigarettes, before I had my e-devices, were very difficult. I was angry most of the time.

I'm not an anti, and despise them. I love the smell of burning tobacco. And I don't appreciate being first forced outside, then to "designated smoking areas" and then off my company's property completely! That was the sequence as tobacco became more demonized.

At work, I sat next to a man who, like me, enjoyed pipes. He would loudly proclaim that there's nothing wrong with tobacco, that all was well until some idiot wrapped the tobacco in paper and convinced people to smoke it that way. Cancer was no big deal for sniffing, chewing or puffing cigars or pipes. Cigarettes, he said, should have been banned long ago. They're the killers. Not tobacco.

I showed him my e-pipe when I first bought it and he was interested. But, he reminded me, there's nothing bad about tobacco until you wrap it in paper and set the paper on fire. He said he'd stick to his pipe. Pipe smokers, after all, live longer than even non-smokers. So I failed to convert him.

I do think cigarettes have changed, as you suggest, but can't say how the content has been manipulated to make that happen. I do know I used to defend Big Tobacco. Once the lies began to become public, I no longer felt any fondness for them. They knew. And they hid the harmful truths about their products! How many died because of their actions? Now, they tell us to stop smoking. Isn't that special? Why are they now telling us the opposite of what they begged us to do a few years ago? Lawsuits. They got burned for billions of dollars in wrongful deaths of smokers and now they want to walk into some future courtroom and say, "We told them to quit, your honor. We told them our product would kill them if they kept using it, but they just kept on giving us their money. What's a businessman to do?"

So I've lost respect for them. To hell with them. They deserve the decline they're in. And I'll no longer give them my money. Hey, they told me to quit! They were right for once. Now, leave my e-cigs alone.

 

[Lady Python]

Morning Bob (at least it's morning over here). I've overslept this morning but hey! It was worth it. Both my new e-cigs arrived a few minutes ago

You're right about the tobacco companies though. While many in the UK have been fighting against the smoking ban, the silence from the tobacco companies has been deafening That has been commented on more than once by the pro-choice organisation I belong to.

Anyway, got to dash. Horrendously late for work now8-o

 

[TropicalBob]

Here in the States, I don't expect Big Tobacco to do anything other than oppose e-smoking. Cigarette sales have been in decline here for years. Big Tobacco sells tobacco, not electronic whiz-bang gizmos from China. Don't expect support for those.

Big Tobacco notes well that only "smokeless tobacco" is showing an increase in profit and use. Even young people are taking up that practice. That's why we have new American snus products coming to market and new agreements with Swedish snus makers for branded product. Snus uses tobacco. There's money there for Big Tobacco. E-liquid can get nicotine from any plant with it. Tobacco isn't essential.

Like Big Pharma, Big Tobacco will work behind the scenes to prevent a future of e-smoking. Both will use "citizen groups" to forward or promote special interests.

Maybe the pendulum in England should swing backward. Your country was foremost in the use of nasal snuff. Your Parliamentarians sniffed it from sleeves during speeches. Your elite loved it. You moved on to cigars and pipes, and made the Dunhill line one of the world's finest. Then came tobacco in a paper wrapper that is a killer in everyone's book. Bad move. Now we all need to backtrack, or make an end run to the future.

If e-smoking is allowed, I'm convinced that it is the next evolutionary step in nicotine delivery -- and that's why we smoke. From chew to snuff to pipes to cigars to cigarettes, and, now the e-cigarette.

If it's not approved, the tumble backwards must go all the way to nasal snuff. Without e-smoking, all public smoking of tobacco is likely a dead issue.

 

[Lady Python]

Then came tobacco in a paper wrapper that is a killer in everyone's book

What utter and complete rubbish. Not a killer in everyone's book. The only ones who keep banging on about that are the big pharmas and people they have successfully brainwashed into hating smokers and smoking and by ensuring smokers are persecuted because they are making billions out of the biggest scam of all time - SHS aka Second Hand Smoke.

You tell me why studies that have been done with an opposite result to the studies backed by big pharma are hushed up? What is big pharma and the health fascists afraid of? That they might be shown up for the lying con-merchants that they are?

As for the tobacco companies, seems to me you have an outright hatred of them. Why is this TB? Is it because they've been very quiet on the tobacco issue? Frankly, who can blame them. A couple of lawsuits, of course, in America where else, where the compensation culture rules supreme, where they had to pay out X amount in compensation made them very afraid. Exactly what the antis (who by their own admission have lied - the real reason they want bans to continue is nothing to do with your health or mine - but everything to do that they don't like the smell of tobacco smoke and don't like the THOUGHT of people smoking).

One person in the UK about 5 or 6 years ago, tried to copy the American precedent of suing one of the tobacco companies, citing cigarette smoking as the cause of her husband's death. Her reason being that her late husband hadn't been told of the (so-called) dangers of smoking. The judge in that case had the commonsense and good judgement to throw the case out of court because no-one forced her husband to start smoking. Like all of us who smoke, he chose to start smoking himself.

Day by day the anti-smoking movement is being discredited - even by the medical profession themselves. Day by day they show themselves up for what they are - lying, interfering busybodies and jobsworths.

Perhaps before you go spouting off about what happens in my country, about smoking in general, whether it is tobacco or e-cigs, you would be wise to take a broader, more balanced view because right now, you come across as being an anti-smoker, and indeed even anti e-cig

I have never seen anyone write in such a negative fashion about something that is new and could become very popular.