Michael Kitt at ecigarettedirect.co.uk has received a letter from a Trading Standards Officer who has (apparently) been told by the Medicines and Healthcare products Regulatory Agency (MHRA) that they will be opting for what they always said was their preferred option and banning all nicotine products. There are are—of course—two major exceptions: the most hazardous nicotine products (smoked tobacco) will continue to be on sale, as will the least effective smoking cessation aids (pharmaceutical nicotine).
From the letter:
I have been in discussions with other Trading Standards authorities and have found out that the consultation is almost complete. The outcome will be that as of a date (yet to be announced) there will be a 21 days period and then these products will be outright banned in the UK, unless the traders apply for certification as a medical device from MHRA. This process could be complicated and costly so it is expected that many traders may cease trading.
What this means for vapers like Leg-Iron is that it's back to the cigarettes. The least harmful nicotine delivery device is to be withdrawn in favour of the most harmful. And in the boardrooms of Pfizer and Philip Morris there was much rejoicing.
How has it comes to this? As I said at the International Harm Reduction Conference back in April, I think it comes down to a combination of fanaticism and pharmaceutical pressure.
Americans for Nonsmokers’ Rights - in a press release titled Electronic Cigarettes are NOT a safe alternative! - criticised the e-cigarette specifically because it mimics the act of smoking and because it contains nicotine.
Only pharmaceutical nicotine products escape criticism, partly because they are marketed as a medicinal cure for a ‘disease’ and partly because they administer nicotine without providing pleasure.
This has led to a somewhat inconsistent view of nicotine, described as being perfectly safe in pharmaceutical products but highly toxic in e-cigarettes, snus and other tobacco products. The EPA describes it as “acutely toxic (Category 1) by all routes of exposure (oral, dermal and inhalation)” while the MHRA says thats “nicotine, while addictive, is actually a very safe drug.”
Five years ago, when I began researching Velvet Glove, Iron Fist, I was wary of making too many claims about the influence of the pharmaceutical lobby. Although Big Pharma (or, more accurately, the pharmaceutical companies who happen to make nicotine products) have funded the anti-smoking movement lavishly over the last twenty years, there were anti-smoking fanatics long before they got involved and, for the most part, the movement's prohibitionist agenda has remained unchanged. While it is important to be aware of the conflicts of interest, especially when nicotine replacement products (NRT) are being touted, people like John Banzhaf and Stanton Glantz were going to be saying the same things with or without Big Pharma's cash.
But I have been saying for some time that the anti-smoking movement's attitude towards the e-cigarette would be the litmus test of pharmaceutical influence. There is no doubt that Big Pharma is seriously worried about the e-cigarette's impact on their sales, as an industry report suggested:
E-Cigarettes Will Revolutionise the Face of Tobacco Smoking and Could Pose a Threat to the Smoking Cessation Market
In February, the Department of Health (of which MHRA is a part) went further than ever before in pushing pharmaceutical nicotine, not just as a smoking cessation aid but as a long-term substitute. Needless to say, this change of emphasis suits the makers of nicotine products just fine.
In the e-cigarette, we have a product that is—at the very least—99% less harmful than cigarettes. In all probability, it is 100% safe (because, as MHRA say, nicotine is "a very safe drug"). Furthermore, there is considerable anecdotal evidence that e-cigarettes are more effective as smoking cessation aids than anything sold by Big Pharma. It is certainly reasonable to say that they require some regulation, if only to prevent contaminated or substandard products going on sale, but to ban them entirely is sheer madness. As Paul Bergen says over at Smokles:
There is good reason for some sort of standards for any widely used product. This is just a very bad way of going about it.
If cigarettes did not exist and e-cigarettes were some unique nicotine delivery device then this approach would not be entirely out of sorts. It would still be unusually demanding in its short time frame for compliance but the worry would center more around commercial concerns than concerns of health.
However we have been repeatedly reminded by national authorities that too many people are dying from smoking, implying that these same authorities think this is not a good thing, and also implying that they would support actions that would bring down those mortality figures.
Quite simply, the ban on e-cigarettes—like the ban on snus—is going to result in more people dying of smoking-related diseases. It is a victory only for those with a bone-headed prohibitionist mindset, it is a victory for the precautionary principle and it is a victory for big business. No organisation that supports the ban can seriously claim to be working in the interests of public health.
If and when this ban is confirmed, will we hear objections from ASH? After all, ASH claims to support harm reduction. There must be some amongst their number who joined the movement because they wanted to help people quit smoking and save lives. Will they speak out or will they keep quiet in deference to the companies who pay for their conferences?
H/T: Kate at Vapersnet.org
13 comments:
They will keep quiet in deference to the companies who pay for their conferences .
Chris
The letter was from a Trading Standards person not the MHRA.
The MHRA have indicated that a decsion will be made in September. This date is not fixed though.
The potential regulations are not specificaly about e-cigs, it is all NCPs (nicotine containing products). Essentially splitting the market between Tobacco and Medicalised nicotine.
As for ASH supporting Harm Reduction, they have said they support this within the context of medicalised nicotine as per the RCP.
westcoast,
Quite right. My mistake. I've amended the post and have quoted from the letter so readers can make their own minds up about the reliability of this source.
ASH's support for harm reduction goes beyond medicalised nicotine, at least in theory. As far as I know, their position is still that snus should be legalised. This, admittedly, is not a part of their agenda that they publicise much anymore, probably for the reasons given in this post.
Chris
The pharma companies' strategy is clearly:
1. Push for e-cigarette bans, unless expensive medical safety trials are undertaken;
2. Once existing e-cigarette companies are pushed out, either license those companies' patents or develop their own e-cigarettes and use their expertise, money and influence in running such trials to have the products approved as cessation devices;
3. Use the success of their e-cigarette smoking cessation devices to call for an outright ban on all tobacco products.
It might take them 10 years to achieve the goal, but they will then control the field. And all the way along the path, the anti-smokers and medical associations will tow the line, because they were long ago bought and paid for by the pharma conglomerates.
Anon 2.12. I would say that is their strategy. If a ban on tobacco was completely successful, the markey for patches, gum, inhalators, etc would become negligible. They provide no enjoyment. The drug companies will therefore be relying on a huge tobacco black market - like cannabis, but on a much larger scale. People smoking at home then buying drug company products to get them through the day. The drug companies need smokers.
I have some simple questions. Why are nicotine inhalators claimed to be safe whereas ecigs are claimed to possibly be dangerous? Is the nicotine in drug company products somehow "artificial" and therefore purer than the nicotine used in Ecigs, which (I'm assuming) is derived from the tobacco plant? If it is purer, why don't the ecig companies sell it in their refill bottles?
What a brass-necked scam. I am incensed that the scandal of the Big Pharma goes unpublicised and unreported in the national media. Not even Private Eye seems to care and yet it is a true scandal.
Nicotine is nicotine and the easiest way to get it is from tobacco. There is no artificial version because there's no need. It's not that hard to extract it, it dissolves in water.
Nicotine inhalators are called 'safe' because they are sold by the pharmers. Electrofags are called 'dangerous' because the pharmers don't profit from them. Otherwise, they do the same thing, apart from one looking like smoking and the other looking like sucking a dummy.
Nicotine is not dangerous at cigarette levels, nor at Electrofag levels. Never was. You'd have to drink the concentrated stuff to do any real harm. It's about as toxic as caffeine.
Oh, and I'm not a committed vaper. I use roughly half tobacco, half Electrofag (more tobacco in summer, more Electrofag in winter because there's no shelter at work).
Having been involved in the initial "survey" on this matter, it seems that there are two "forces" at work here - and one bloody big "hole" in the discussions.
The first "force" is the fact that most of the nicotine cartridges are manufactured in China - which has very little in the way of control over what actually goes into these refills and the conditions under which they are manufactured. This, to me, is a legitimate worry - as these are designed to be ingested and control over their quality is sensible - this is how the whole "review" started.
The second "force" is, naturally, Big Pharma - as they are not making money out of this free enterprise product. A product that not only competes with the shit they produce, but is cheaper and better. It is this force that seems to be driving any decisions when it comes to making them a medical item. (So far as safety trials are concerned, there was a peer reviewed study in New Zealand in 2006 which proved, beyond doubt that these products were completely safe - this study seems to have been ignored totally - one wonders why).
The "Bloody Big Hole" in the discussions is that you basic "E-Fag" is merely a delivery system and, without the refill stuck on the end is no more harmful than a torch. It is a battery, with a heater attached - with a hole to let oxygen in (to allow the vapour to form). Banning E-Fags, no matter how much they look like the real thing, is impossible.
Quality control of the refills is another matter entirely. There was discussion of them bringing these under the same kind of controls as any other drug (and nicotine is a drug) - to ensure that "Vapers" can be assured that they are not inhaling anything that could harm them. Knowing and having dealt with companies in China, it is altogether possible that, if they ran out of the correct ingredient, they would substitute it with something that "looks the same" - but may be dangerous.
Quite how this will "pan out" I don't know but, from what I can see, we are not looking at the "banning" of E-Fags - but could be looking at a greater degree of quality control on the refills.
It may well be that traders in these items can carry on selling the basic E-Fags (but not the refills - unless they attain the relevant licence to sell them).
I realise that there will be some costs involved in getting such a licence but, once attained, if one buys refills at 100,000 at a time, they cost around US$0.09 each - and retail at anything up to £0.75 - you work out the maths as to where a £350 licence comes into that sort of turnover.
So far as the E-Fags themselves are concerned - as I said, without the refills, they will NOT come under any such regulation.
Thanks NKB and LI. Anon 18.28.
I realise that there will be some costs involved in getting such a licence but, once attained, if one buys refills at 100,000 at a time, they cost around US$0.09 each - and retail at anything up to £0.75 - you work out the maths as to where a £350 licence comes into that sort of turnover.
It may be worth checking the 'some costs' as estimates I have seen are around £30,000 - £50,000 just for starters. This could well be outside most of one/two person businesses that have sprung up.
In addiition an MA would require clinical trials. Adding to cost and taking time to complete.
While agreeing quality is a legitimate concern, MA licensing goes well beyond general product quality control which can be met without the need to medicalise nicotine.
It is worth reading the MHRA web site to find out what is required.
Great story, its definately an issue the industry will be facing on a larger scale and across the world as the industry grows.
The more honest and open discussion the better.
Jason Healy
President
blu cigs
I would like to exchange links with your site velvetgloveironfist.blogspot.com
Is this possible?
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