Wednesday, 3 February 2010

E-cigarettes could be taken off the market this year


The UK's National Institute for Clinical Excellence (NICE) has formally supported a policy of tobacco harm reduction. This has been seen in some quarters as good news for users of e-cigarettes. I'm not so sure. It is possible that e-cigarettes could be approved and regulated, but it is also possible that they might be banned for good. 

A public consultation has been launched which emphasises the dubious findings of the FDA:

We know from work done by the Food and Drug Administration (FDA) in the United States that laboratory analyses of e-cigarette samples were found to contain carcinogens and toxic chemicals, against which general product safety legislation could not protect.

The UK has previously banned snus and Skoal Bandits, despite undeniable evidence that they are far less harmful than smoking and possibly not harmful at all. When NICE talk about tobacco harm reduction, they are really talking about pharmaceutical nicotine products. E-cigarettes have no real support amongst public health professionals and are very unpopular with John Banzhaf and others in the intensive care wing of the anti-smoking lunatic asylum.

Will e-cigarettes go the way of snus? It's too early to say. For now, the government's objective is to get them off the market. The consultation ends in May and NICE favours doing this within 21 days of a decision being made. Once taken off the market it could be years, if ever, before they return. In the meantime it will be back on the cigarettes for Britain's vapers. Some harm reduction strategy that would be.

The consultation reads:

In order to ensure there is no risk to public health from unlicensed products on the market that have not been assessed for safety, quality and efficacy and in the light of the developing extent of their use and familiarity we are consulting to elicit views on whether and how to bring all products containing nicotine into regulation.

Option 1 – Whether products containing nicotine should be considered by the Agency to be medicinal products by function and, if so, whether all unlicensed NCPs should be removed from the market within 21 days. Currently, MHRA operates a strict practice regarding the period of notice operators are allowed to comply with under the Marketing Authorisation Regulations following the classification of a product as medicinal. Given that these Regulations do not make explicit provisions for a staged withdrawal from the market of an unlicensed medicinal product, immediate cessation of the sale or supply is usually required by the Agency, with written confirmation of the same within 21 days.

Option 2 – Whether products containing nicotine should be considered by the Agency to be medicinal products by function and, if so, whether a notice should be issued to manufacturers that all marketing must cease by a certain date e.g. June 2011. After this date enforcement action would be taken against manufacturers not holding an MA for any such product on the market. This would effectively allow manufacturers a year from the end of public consultation to produce relevant evidence to support an application for an MA, submit it to the MHRA for approval and get the newly licensed products on to the market.

Option 3 – Do nothing and allow these unregulated products containing nicotine that have not been assessed for safety, quality and efficacy to remain on the market.

The MHRA’s preferred option is option 1, which is in line with current practice.



18 comments:

Dick Puddlecote said...

Can we take it from their specifying 'unlicensed' that the pharmaceutical industry is moving in on the e-cig market?

Mark Wadsworth said...

They did that specifically to annoy Leg iron :)

subrosa said...

And me Mark. I use one and also I bought one for a Christmas gift for someone like Leg Iron who finds it easier in their day environment.

Let's hope LI has a wee dram before he reads this or else some injury may occur.

Frank Davis said...

Better stock up, I guess, while stocks last. It's pretty obvious where this is going.

And can we contribute to the 'public consultation', or is it just another fake one, like the one on under-counter sales of cigarettes in corner shops - which ignored the views of corner shops?

I suppose that the pharma companies are behind this. E-cigs are competition for their patches. What better way to deal with the competition than to have their product removed from the market for being potentially unsafe, eh?

timbone said...

ha! I wondered why 'they' hadn't got onto it yet, they obviously had but were keeping quiet about it until now.

Oh well, another illicit drug, another black market, and of course the appearance of suspicious ecigs.

Nothing surprises me any more. Do you think all decision makers have been abducted by aliens and given mind altering drugs with a formula which lacks sensible thought and discussion? No? Neither do I, but I could easily believe it.

Anonymous said...

Yes Pharma want that market.
Im sure the bribing has started already.
Corruption springs to mind.
After all now that they ripped of the dumbo department of health the pollies and the most of all the taxpayer with the modified H1N1 virus they released in mexico then sold on the vaccine ,they need to move on to another scam.
Arent they thick ?
Either that or corrupt to the point of evil.
Ill plump for evil.

westcoast2 said...

This was what I mentioned in the 'Moribund government sets meaningless target' comments. All the headline stuff yet a polarization of the market and smokers given 'harm reduction' only if they want to quit was under the radar.

There is a formal consultation by the MHRA and also a comment request by NICE on their 'Citizens Council report: Smoking and Harm Reduction.'

The comment form for NICE asks what you think of the view that the Majority of Council members had that 'Harm reduction as a way to provide a less harmful alternative to smoking while accepting that nicotine addiction continues' is not a valid strategy.

How is a strategy not valid? I can't see anywhere in the report where they say it is not a valid strategy (I may have missed it). They do seem to prefer the alternative 'harm reduction as a way to quit smoking and break addiction' which the comment form describes as valid. It is this definition, basically the same as now, that is being pushed.

The aim was Reduced Harm from Smoking tobacco, not harm reduction from Nicotine. Indeed the report stresses that Nicotine is relatively safe.

There seems great confusion that Stopping smoking=stopping nicotine. (except and this is the 'harm reduction' part, if it is Nicotine it must be NRT) Some may prefer Snus (as in Sweden) but apparently it is only reduced harm if the aim is to quit (nicotine) so Snus is out. Is snus less risky? Acording to the NICE citizens report it is. So using Snus would be less harming yet because of the Quit=No Nicotine 'Harm Reduction' Snus is excluded and indeed the EU ban supported.

Some medical professionals have said the e-cigarette is an order of magnitude less harmful than tobacco cigarettes and some people freely choose them. Since they are not NRT they must be put into the medicines category so that they can become NRT if people want to use them, which would then defeat the whole idea of the e-cigarette.

It seems many people want to use alternative nicotine products to tobacco for a vaiety of reasons yet the 'choices' will be Tobacco, NRT or Quit.

It maybe the reasoning (from the MHRA) for including Nicotine products in the medicinal category could also be applied to Caffeine, Chocolate and even Tomatoes?
----

Anonymous said...

If ecigs are approved, the liquid will cost a fortune as drug companies will have a monopoly. Why does gum cost 20 times what it should? But, is a ban practical? People buy snus and even tobacco via ordering online. Ecigs and refills are not bulky. Will a black market in unregulated nicotine liquid emerge? That would be dangerous.

Anonymous said...

National Institute for Clinical Excellence (NICE).

It sounds like some organization out of a James Bond movie circa 1970's, operated by a villain intent on destroying the world and seizing control, for which British pride, sense of fairness and desire for freedom would have required sending in 007 to infiltrate and do away with the leader.

Only somewhere between 1970 and 2007, everything got turned on its head; and nowadays, 007 would be sent in to make sure NICE, CRUK, ASH are all empowered to take over and rule.

Complete turn-around, the foxes in the henhouse and government giving aid to the foxes.

Those high-markup patches, lozenges and gums enrich and help finance pharmaceuticals, and thus the vaccine requirement propaganda - while the people fearing the forced vaccinations refuse to see where the funding of pharmaceuticals (commensurate with the defunding of the sovereign government, which ideally should protect the people, through tobacco tax loss) originate, through this phony war on smokers and the ETS-Fraud.

Therefore the anti-vaccine people had best prepare to roll up their sleeves as their eyes remain closed, unable to see the flip side of the coin, thus doomed in their efforts.

What a monster - NICE indeed.

Leg-iron said...

They did that specifically to annoy Leg iron

It worked. I won't use the patches or the gum. I'll work out a way to extract the nicotine from them instead. It's water soluble so it shouldn't be hard.

Then I can soak some parsley in it, dry it, roll it up and hey presto, pseudofags.

There is always a way.

Blueblackjack said...

The first sentence of this post is extremely misleading, and seems to be based on a misreporting by another source.

"The UK's National Institute for Clinical Excellence (NICE) has formally supported a policy of tobacco harm reduction."

Not really, the NICE 'citizens council' a collection of bods they use for a sounding board to get their 'man in the street opinion' said they were in favour of it. That'll be used to inform a formal NICE decision, it's not an endorsement by NICE in itself.

That's a long way away from NICE as a clinical body endorsing a policy of harm reduction (which would be produced in formal clinical guidance).

The post you link to by Bill Godshall has totally over-extrapolated the report, probably because he's an American and doesn't really understand how NICE operates as a body. Cranking up the hype factor prematurely I'm afraid.

John R said...

Of course, with all the global warming we're going to experience over the next few years you'll be able to grow your own tobacco plants and stick two fingers up to the gummint, Big Pharma, fake charities and anyone else who wants to get in the way.

timbone said...

In 1979 a 'safer cigarette' was stopped from being marketed because it did not fit the ideal of a smokefree world - all the details are in the book 'Velvet Glove Iron Fist'. The ecig is an even safer cigarette, but it still delivers nicotine, not as a therapy like methadone to the heroin user, but as an alternative safer way to enjoy the benefit of nicotine, which, unlike heroin, does not create physical dependancy and damage.

It still doesn't 'fit'. Smokers essentially are not users of tobacco, they are users of nicotine, and smoking tobacco gives an instant hit - so does the ecig, unlike the pathetic NRT drip feeding. Ex smokers still miss the joys of nicotine, which is why many of them redirect their energies to bully smokers. As for never smokers, they have never experienced nicotine, like never alcohol drinkers, never meat eaters, never curry eaters, and so on.

Nicotine is a dirty word to many people. When I told a non smoker that there was nicotine (niacin) in the Kalms that they take, they were horrified, and threw them away.

Anonymous said...

' that there was nicotine (niacin) in the Kalms that they take, they were horrified, and threw them away.'

that actually makes sense, i've known of people with adhd having to take ritalin to calm thoughts and go to sleep. this idea of course doesn't suit the nanny state, we mustn't actually use anything to deal with the shit we're shovelled day in day out but learn to accept it as the norm, and, to accept that if we don't we are by definition ill, or mal-adjusted or whatever, except, of course if it's something that can be and should be treated with big pharma and the whole medical fraud that goes with it. it's about control of the rats who should think of not much else but to turn the corperate wheel for a bit of cheese now and then without complaint (obviously dying before aged sixty and possibly costing loads in the process isn't good business practise )

Ann W. said...

(Nicotine Replacement Therapy or just another money grab)
http://en.wikipedia.org/wiki/Murray_Jarvik
"Murray Jarvik began research into the absorption of tobacco contents through the skin and its effects on the human body.[2] His initial exploration into this field began by studying farmers and farmhands in the American South who harvest tobacco by hand for a living.[2]

However, Jarvik and his colleague, then UCLA postdoctoral fellow Jed Rose, could not get approval to conduct their research into tobacco absorption through the skin on human subjects.[2] Instead, Jarvik and Rose began testing the effects of absorption of tobacco contents on themselves.[2] The effects of the tobacco was immediately measurable. In an interview with UCLA Magazine, Jarvik remembered, "We put the tobacco on our skin and waited to see what would happen. Our heart rates increased, adrenaline began pumping, all the things that happen to smokers."[2]

Jarvik and Rose's research led to their invention of the nicotine patch in the early 1990s.[2][1] The nicotine patch is a transdermal patch that delivers nicotine directly through the skin and into to the body to alleviate the urge to smoke and, hopefully, ultimately quit smoking.[2] (Rose now serves as the director of the Center for Nicotine and Smoking Cessation Research at Duke University.)[2]
(wait a minute, that is not what smoking feels like, that is what green tobacco sickness feels like)

Green Tobacco Sickness
http://en.wikipedia.org/wiki/Green_Tobacco_Sickness
Green Tobacco Sickness (GTS) is a type of nicotine poisoning caused by the dermal absorption of nicotine from the surface of wet tobacco plants. Tobacco harvesters, whose clothing becomes saturated from tobacco wet with rain or morning dew, are at high risk of developing GTS. Workers can avoid getting this sickness by waiting to harvest until the tobacco leaves are dry, or by wearing a rain suit. Wet clothing that has come in contact with tobacco leaves should be removed immediately and the skin washed with warm soapy water.

Symptoms of GTS include nausea, vomiting, dizziness, and severe weakness. These symptoms may be accompanied by fluctuations in blood pressure or heart rate. Abdominal cramping, headaches, chills, increased sweating, salivation and difficulty breathing are also common. The illness will resolve on its own within one to two days, but symptoms may be so severe as to require emergency medical treatment.

Anonymous said...

I take it this Citizens Council is a new piece in the fake consultation jigsaw: either to be ignored if it doesn't suit, or to be used as back up for ridiculous and stupid policies. And another thing, where are these consultations advertised? I found the ecig one by chance from a commenter on Michael Siegel's bog.

john said...

Its ironic really, they ban this but to you can continue to buy Cigarettes which we all know are great for your health.I suffer from asthma and have done since childhood, i never smoked a lot never but tried everything to stop smoking, then i ehard about the ecig and low and behold bought one and now i dont smoke real ciggies, the benefits for me are brilliant, since I started vaping i have hardly used my inhaler at all where as before i puffed on it at least 8 times a day, i no longer feel out of breathe when i run anywhere, I dont smell like an ashtray, i also take zantac having suffering with an ulcer which is 100% better since i stopped smoking cigarettes. This product is a life saver for me and many like me, if they ban this then i will just purchase from abroad..Goverment studies in New Zealand proved this product is of no real harm to you with thee xception of the nicotine and when put upa gainst real smoking teh choice they say would be to smoke the ecig and work your way down to non nicotine flavoured juice. This govt study is widely available on the Internet so to me its a case of lets get tax in from this product and we can sell the lisence to the big pharmy companys as well double whammy..Like everything here its another scam y HMG, wished they would go govern and create jobs for people not harass people who have concerns for there ehalth..Take action against the heroin addicts and mugger junkies..No that wont happen simply because that costs money.

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