ASH UK E-Cigarette Regulation PDF:

A Catalogue Of Errors



ASH UK has just released a PDF on e-cigarette regulation, on 1st August 2013:



The regulation of e-cigarettes and other nicotine products in the UK - Q&A.

www.ash.org.uk/files/documents/ASH_897.pdf



The ASH document is mainly based on the MHRA's recent e-cigarette regulation requirements outline, discussed lower down the page.

This white paper is notable for its cleverly disguised disinformation and establishment view of regulation, mixed with an occasional dose of reality. This tends to give the impression that it is a reasonable opinion on ecig regulation, when in fact it contains a catalogue of errors and disinformation (or lies, depending on your point of view). Some of the responsibility for these issues falls on the MHRA; but ASH have given the MHRA version their full backing, so must take some of the blame.

The basis of this document is that pharmaceutical licensing of e-cigarettes and/or ancillaries is both a good idea and a foregone conclusion in the UK / EU, and it lays out the ASH view of the resulting impact on e-cigarettes. It takes the provisions of the MHRA document and explains why ASH think the requirements are a good idea. If this really is their honest view, they are so ignorant of every one of the multitude of issues that it would be difficult to find anyone so utterly devoid of the most basic appreciation of the problems. Such ignorance is unlikely, so the document's position is probably based on expediency.

Luckily, medicalisation is unlikely to prevail, due to the universal rejection by courts everywhere of the use of the law for commercial purposes by the pharmaceutical industry. The courts have very clearly demonstrated that e-cigarettes are a consumer product and not a medical product (low alcohol beer, decaff coffee, e-cigarettes, and other consumer Harm Reduction products are clearly not medicines). Therefore most of / all of the material in the ASH PDF may not be applicable, which is fortunate because a significant percentage is pure fantasy, blind ignorance, or cynical lies - depending on how charitable you feel toward ASH.

You will probably be aware by now that anything from the tobacco control industry (of which ASH are full members) contains more lies per square inch than the cigarette industry itself ever managed; this document is a typical example. It could be argued that such documents simply contain honest errors and a poor appreciation of likely outcomes; if so, they are remarkably consistent in that regard.

A less charitable opinion of documents such as this is that they are full of lies, published by liars, for reasons unconnected with public health. If that were to be your opinion then it would be hard to challenge it on a factual basis: it contains a multitude of errors, some of which ASH must be aware of, along with many examples of deliberate misrepresentation of the facts; and if the EU / MHRA policies supported in the ASH document were to be fully implemented it would have a massively detrimental effect on public health. As an example, most of the 1 million plus UK e-cigarette users would probably return to smoking. It is not normally regarded as a good thing for public health when millions of people return to smoking or don't stop smoking; though in ASH's fantasy world, it may be - things are so far from reality here that anything is possible.

Above all, this is a template for how to protect cigarette sales against serious threats (and in the UK, from the only significant threat).



ASH apparently support e-cigarettes but now reveal that they also support extreme regulation; they are either unable to see that one negates the other, and regulation essentially removes e-cigarettes from access by those who need them, or this was the plan all along - appear to support the use of e-cigarettes but then have them removed by regulation. Regulation (depending in its severity) removes e-cigarettes from the consumer market and restricts them to the medical market, which is less than 1% of the size; it also takes them away from the small businesses who developed the market and gives them to the large tobacco and pharmaceutical companies. Its main effect would be to dramatically reduce sales and remove e-cigarettes as a threat to tobacco cigarette sales (ignoring the growth of a significant black market, which is assured).

ASH are working to protect cigarette sales and working against public health by publishing this opinion piece in support of e-cigarette bans (i.e. virtual removal of half of a binary system by medical licensing of the refills[1]) when consumer THR products are now the only realistic way to significantly reduce smoking in the UK, and it is therefore a legitimate question to ask if they are paid to do so by the cigarette trade; or by the pharmaceutical industry who benefit so greatly from the disease resulting from smoking; or if it is simply to protect, promote and prolong smoking for as long as possible in order to protect their own jobs.



The complexity of the situation

The whole situation is now so complex that it is impossible, at this time, to say what will happen: the EU TPD with its complicated current format and its unknown future status; the balance of medical and tobacco classification being attempted by the EU; transposition into UK law; future legal challenges both in Europe and the UK; how much the MHRA will be able to get away with; and so forth. For this reason it would be perfectly acceptable to argue each and every point in ASH's document (and my responses) and say: "But this is unlikely to happen". Because of this it has been necessary to make some assumptions about the future, or one version of it, in order to be able to comment at all. Some of it is bound to be wrong; please see a more detailed explanation in General Notes at the foot of the page.

In detail

Here is a list, in order, of some of the points we take issue with:

"On 12th June 2013 the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that it would regulate e-cigarettes and other nicotine containing products (NCPs) as medicines."

The MHRA announced they would support e-cigarette regulation, in a press release designed to affect the outcome of the EU ENVI committee vote. It did have the desired effect, as ENVI voted to medicalise e-cigarettes. The UK government has previously blocked this action by the MHRA, indicating that it does not agree; the MHRA has been looking for a way to outmanoeuvre government in order to please its funders, the pharmaceutical industry. It held off obtaining a legal ruling since there is a 100% record of pharmaceutical regulation of e-cigarettes being overturned by the courts; the EU's standard pro-industry anti-consumer process has solved the issue for the MHRA since they can now proceed, with a much stronger legal foundation since EU law is superior. It may require the EU regulations to be overturned first, before any UK regulation implemented by the MHRA can be removed.

No one who knows the issues believes that pharmaceutical licensing can successfully remain imposed on any e-cigarette product; but life is certainly about to become more difficult for the UK vaping, ex-smoking community (of several hundred thousand), who will probably experience strong pressure to return to smoking from around 2016, as various regulatory schemes will start to influence the consumer market at that point; some of the regulations may be unjustifiably severe and hard to challenge.

"The decision followed a comprehensive consultation with a range of stakeholders,..."

No it didn't. The principal stakeholders in discussions about consumer products are the consumers; unfortunately, the 1 million UK ecig users did not have any realistic input, and therefore the statement that a 'comprehensive consultation' took place, and especially that the major stakeholders had any significant effect on the decision, is simply a lie. However I could be mistaken: the invitation to the UK consumer association to supply input and the high prominence subsequently given to its opinion could have escaped my notice.

To suggest that hundreds of thousands of people who may be forced back to smoking are not stakeholders is the most egregious lie, and this appears to be what ASH is saying.

"...and in-depth analysis of available research and data."

An 'in-depth analysis' would have revealed that there are no concerns for public health, or any credible evidence there might be any concerns. On the other hand, an in-depth analysis of the economic situation reveals that the pharmaceutical industry is under real threat of a $50 billion a year drop in income due to e-cigarettes reducing smoking-related morbidity. Perhaps this may have slightly more weight.

"Following this process the government was led to the conclusion that, to ensure safety and efficacy for consumers, such products should be brought under the same stringent regulatory framework as is applied to medicines."

The UK government has previously blocked e-cigarette medicalisation, on multiple grounds (see the RPC decision, 2010). It therefore appears that the Dept of Pharmaceuticals - I beg your pardon, the Dept of Health - appear to assume they are the government. In fact, according to recent events, Mrs Soubry appears to think she alone is the government. It seems rather propitious for the pharmaceutical industry that they appear to be such very good friends with Mrs 'Government' Soubry.

"This decision is in line with regulation proposed within the European Commission’s draft Tobacco Products Directive,..."

Indeed. In fact it is entirely due to the TPD that the MHRA can take this position, and no other factor at all. A unilateral decision by the MHRA to take this action has already been defeated and would easily be defeated again.

"Why was the decision taken to regulate these products?"

The answer to this is patently obvious: to protect the pharmaceutical industry's vast income from treating sick smokers, by protecting cigarettes from any threat. Why else would the Dept of Pharmaceutical Health act? To suggest otherwise, as ASH appear to be doing, is a lie. That, or Profs. Britton, Phillips, West, Rodu, Siegel, Polosa, Kozlowski, Hajek et al have all got it completely wrong: that their belief that e-cigarettes will save millions of lives (if left alone) is fallacious.

There is a small problem here: do you trust those professors of public health medicine or do you trust ASH? I think this is what is popularly referred to as a 'no-contest'.

Examples

Prof Hajek opposes medicalisation because in his words it will "fossilise" the products and make them impossible to improve. (In practice it might even make them almost as ineffective as current NRTs; licensed e-cigarettes will hardly be as effective as good consumer models.)

Prof Britton's statement that e-cigarettes could save five million lives in the UK just among those alive today is predicated on the assumption that the current consumer product system remains in place; restricting products by removing any effective/attractive refills immediately excludes any application of his thesis. We can certainly expect that medical e-cigarettes will save 5,000 lives, but there is a slight difference between 5,000 and 5 million.

The main pressure to regulate is caused by the negative effect on the volume of cigarette sales and the directly-related profit to the pharmaceutical industry if/when electronic cigarettes gradually take more of the market; if ecigs can somehow be successfully crippled, then cigarette sales are free from threat and pharma can continue to mint money without hindrance. We assume that ASH is working on behalf of pharma, since it seems less likely they are working for the cigarette trade; although since the direct result of their interference is that smoking is protected from its most capable rival, we can legitimately question their motives.

No sane or honest person would act to protect smoking and protect pharmaceutical industry profits by banning / regulating / restricting e-cigarettes when these are the only realistic solution to the smoking mortality and morbidity problem, and when attacking e-cigarettes is therefore a direct attack on public health; therefore it is perfectly acceptable to question ASH's motives. If they are not, in fact, corrupt - then they are stupid beyond belief.

"By making this decision the government proposes to regulate electronic cigarettes and other NCPs as medicinal products - this means ensuring high quality products that are able to support smokers in cutting down and eventually to quit altogether."

Firstly, the government has already decided against regulation of e-cigarettes as a medicinal product. Therefore, the sentence could perhaps more accurately read: "By making this decision, Mrs Soubry proposes to regulate electronic cigarettes and other NCPs as medicinal products..."

Secondly, the problem with this is that e-cigarettes were invented for and are used for the purpose of replacing smoking, for ongoing use. Less than 5% of the e-cigarette community want to quit totally - why would they? People need dietary nicotine supplementation, and like most things it is harmless when not abused. Why pretend otherwise? Smokers who want to quit totally by the use of a medical e-cigarette should be allowed to do so. This has no relevance to the other 95% who intend to use ecigs on an ongoing basis.

'Quality' is an issue the consumer market deals with very efficiently.

"As a means to this end it is important that people have access to NCPs that are of the requisite safety and quality, just like medicines. Unfortunately, many existing products do not meet these standards."

Irrelevant, not to say factually incorrect.

a. You can establish whatever standards you like for medicines. The market determines what consumer products survive or fail - and in an extremely efficient manner, where e-cigarette products are concerned (and it may be unique in this respect). As Prof Hajek has pointed out, there is no danger from nicotine over-consumption with these products; issues with inconsistent nicotine delivery or incorrect labelling are for the consumer market (and this includes consumer product regulation) to resolve - as it does very well.

b. Consumer products such as e-cigarettes (especially in the UK, where they are stringently regulated) are provably thousands of times safer than equivalent pharmaceutical produsts such as Chantix. Thus, medicalisation is a step backward for safety (as any ecig vendor who sold products one-thousandth as dangerous as Chantix would be in jail).

Quality is a consumer market factor influencing success or failure and may be dependant on price. It is not relevant for any purpose other than product success, in an environment where product safety is rigidly controlled such as the UK consumer products market, where, incidentally, products are clearly safer than pharmaceuticals.

"When will this regulation come into effect?"

Well, when it does come into effect it will be overturned by the courts, as they always do - quite rightly. Unless of course the pharmaceutical industry manages to buy the courts this time round. That is always a possibility, of course: it is said that everyone has their price, and the odd €50 million here and there helps a lot; this is just small change for pharma.

If such a judgement does obtain, it will look very strange indeed: all judges in all courts previously have universally decided against imposition of medical licensing on what is obviously a consumer product (all 13 judges were unanimous through every appeal stage, for example, in the USA). It is unclear how the EU, MHRA and pharmaceutical industry intend to prevent the courts overturning their corrupt and harmful regulations, as there is a 100% record of courts doing so.

"Manufacturers therefore have until this date to apply for their products to be licensed. However, the MHRA is currently accepting applications for licences and expects the first licensed NCPs to be on the market within 12 months."

No doubt. By the way, it will have taken around 4 years for an application to succeed, at that point (and about £2 million). The annual license fee of £28,000 is also worth considering (per single product). So, if you apply for a product license in 2016, expect it to be approved around 2020, with costs of around £2 million, and an annual fee of £28,000 (for every product, including every different strength of refill, according to the current MHRA ecig licensing document).

"...only licensed products will be able to be recommended by healthcare professionals as a smoking cessation or harm reduction aid."

Not really relevant to a consumer product chosen as a Harm Reduction substitution product. If patients wish to consult their doctor on how to quit, they can go the Harm Management route if they so wish. (The medical version of harm reduction, with total cessation as the desired endpoint, is called Harm Management; it has no relation to the consumer process called Harm Reduction, which by definition means ongoing consumption by substitution using consumer products, and nothing else).

"The NHS constitution states that patients have a right to drugs and treatments that have been recommended by NICE for use in the NHS. The NICE guidance on tobacco harm reduction recommends the use of licensed NCPs for use in a harm reduction approach to smoking. E-cigarettes, upon gaining a licence, would therefore be prescribable on the NHS to enable smokers to reduce their smoking with a view to quitting."

This is the definition of Harm Management: use of a medical harm reduction product, under supervision by a doctor, to achieve total cessation. It has no relevance to consumer Harm Reduction, which does not encompass cessation (in this instance, of supra-dietary nicotine supplementation by inhalation delivery using a cigarette clone system).

"Concern has been expressed that medicines regulation is excessive, potentially restricting consumer access to products and stifling progression of the NCP market."

And rightly so. Prof Hajek for example states that licensing will fossilise the products and make then unalterable (and possibly as unattractive to consumers as current NRTs). Any licensed product is a 4-year old obsolete old clunker, as a direct result of the protracted licensing process; deliberately unattractive to consumers as an integral part of the process; unchangeable and unmodernisable due to the extensive cost and extended timescale for approval; useless compared to modern products since the products will be obsolete and comparatively poor in effectiveness; unattractive and therefore ineffective since flavours are an integral part of the system and will be prohibited.

Luckily, at present, it appears that the hardware will not need to be licensed, just the refills. Unfortunately all useful and attractive refills will be banned and will not be able to receive a license in any case (as all flavours will be prohibited).

Therefore, concerns about a couple of unattractive unflavoured refills replacing multiple e-liquid base types with thousands of flavours and multiple strength options - in all, many thousands of options - are entirely justified. An extended and expensive process to license a single new tobacco-flavour refill of one single strength, which the MHRA seem reluctant to do in any case, is not good news for the consumer. If ASH are saying that concerns are unjustified, they are clearly lying since the result of removing half of a binary system is obvious.

"In making its decision the MHRA has attempted to balance the interests of consumers while minimising the burden of regulation in such a way that supports and stimulates innovation and competition."

This is an egregious and blatant lie by ASH: the MHRA's agenda has always been and always will be to remove e-cigarettes from the market as far as is possible. This is what their funders demand. How exactly do you think Pfizer feels about it when on Day 1 of the first medically-licensed e-cigarette appearing in the MIMS book every other smoking cessation product is instantly rendered obsolete [4]?

The MHRA would prefer that e-cigarette consumers go away, or preferably die (as this is what their actions will result in). Consumer products and their users are seen as a direct threat by the pharmaceutical industry and their government poodles, and together they try to eliminate them in any way possible; it always was so, is now, and always will be.

The MHRA are not interested in 'balancing' anything - they do what their funders demand (which in the first case is to remove ecigs in any way possible). Unfortunately, in this case their hands are tied and they will eventually have to license an ecig as an NRT.

The idea that the MHRA are interested in 'minimising the burden of regulation' in some way is plainly farcical: they have done everything possible to make licensing as difficult, expensive and protracted as possible - ask Intellicig. Three years (perhaps even four years by the time it eventually happens) and £2 million plus - does this look like some form of 'minimalisation' to you?



And then:

"...in such a way that supports and stimulates innovation and competition."

Please stop these jokes now, it is becoming tedious. It is hard to know how to answer this because there is a point at which something becomes so ridiculous, it simply stops all sane discussion.

This sounds like an advert for the MHRA, phrased in terms of such elegance that a master of propaganda could not aspire to their construction. It is completely opposite to the truth and that's all there is to it. A blatant and outrageous lie. The MHRA fully intends to destroy the existing ecig industry (and replace it with crippled NRT products if forced to do so); that has always been their intention and always will be. Or to be slightly more accurate: it is the intention of their paymasters. Please note that the MHRA does not work for the public or for public health (in this area at any rate): they work for the pharmaceutical industry.

The aims of the pharmaceutical industry, by definition, are opposed to public health: the greater the number of sick people, and the more sick they are, the better for pharma. Nowhere do they achieve this aim better than in the area of smoking: all significant threats to cigarette sales are aggressively blocked. Smokers can be sacrificed without penalty. People like ASH do their work for them, willingly; and by doing so, they protect cigarettes sales. You might, after all, say that this is understandable: if there are no cigarettes there is no ASH, so it's not too difficult to find a motive here.

Take a look at the future: in Sweden, male smoking prevalence will be 5% by 2016 due to unhindered access to consumer THR products. Not much use for ASH there.

"The NICE guidance on tobacco harm reduction complements the MHRA decision by recommending that only licensed NCPs be used as a harm reduction tool."

NICE PH45 refers to the use of NRTs. You can bend reality as far as you like, to try and make the Dept of Health look as if they are promoting public health instead of protecting pharma income, but you can't make e-cigarettes into an NRT. They are a consumer product designed for permanent smoking replacement. You can license one as an NRT then tell someone they should quit using it, if that's what you want. It's a free country [2].

"Upon gaining a licence, such medicines, which will include licensed e-cigarettes, can then be recommended for use in one of four harm reduction approaches to smoking: to stop completely; to cut down prior to stopping; to reduce smoking without stopping; or to temporarily abstain from smoking."

None of this has anything whatsoever to do with Tobacco Harm Reduction, which employs consumer products such as e-cigarettes. THR has substitution as its #1 priority, and its aims, though not efficiently defined, might look something like this:

1: Replace cigarettes totally with a consumer product that is significantly less harmful.

2: If you can't (or don't want to) initially replace all smoking, then replace some cigarettes, and gradually increase the quantity of cigarettes replaced if you can, and if you wish to.

3: Quit totally if you want to - but don't worry about it.

The rest of their fantastical rubbish is irrelevant to Harm Reduction, it is Harm Management, and needs to be seen for what it is: yet more pharma promotion. A never-ending, unstoppable, continual promotion of expensive and useless fripperies - for profit, at the cost of millions of lives. Yet more pimping for pharma.

Let's be honest: ASH are surely not funded by anyone interested in public health; protecting cigarette sales and pimping useless snake oil cures is not usually seen as beneficial to public health.

"Manufacturers must pay for their product to be assessed in order to gain a licence. However, the cost of this process is likely to be relatively small due to the fact that there is no need to go through the full medicines licensing process. As the pharmacology of nicotine is already well established, licences can therefore be obtained through a streamlined “abridged” process, which minimises costs."

If this is supposed to refer to the current licensing situation then it is the most outrageous lie by ASH. The MHRA have been saying this as long as I have known them. Ask Intellicig how they feel about the above statement: the licensing process is extraordinarily protracted and extremely expensive.

I was told repeatedly by the MHRA that 'costs could be reduced' and 'licenses could be shared' and 'previous documentation could be used', years ago. It doesn't seem to have filtered through to the person who makes the decisions, though.

If ASH are saying that there is currently a streamlined process for e-cigarette licensing, then they are liars. If they are saying that the MHRA has told them it will be streamlined at a later date: then there is no end to their naivety; thus, they are either fools or liars. The MHRA have said the same for years, and will still be saying the same in a year's time. The licensing procedure is extremely complex, extremely protracted, extremely expensive, and prohibitively expensive annually except for large companies with a significant turnover. It has taken Intellicig, the first applicant, about three years and £2 million so far -and they still don't have an MA. Anyone who says otherwise is a blatant liar or complete fantasist.

I accept, though, that there might be an accelerated route if your name is [insert pharma corp here].

"Will licensing make it harder to buy these products?"

Yes - it will be impossible to buy current refills legally, as the manufacturers will have gone out of business, or the supply will be blocked. There will be two or three options as against the current hundreds of thousands that make the system work (one vendor alone offers 7,000 different refill options when type / strength / flavour are multiplied out; and there are thousands of vendors). Vapers will be forced to buy on the black market or go back to smoking.

The latest MHRA information on licensing e-cigarettes is here:

www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con297583.pdf

It also depends on if only the refills need a license, or all equipment needs a license. If only the refills need licensing (and provided that the EU TPD and the UK equivalent that follows it, transposes it and implements the law in the UK are not immediately or pre-emptively overturned by the courts), then consumer refills will look like this:

All usable refill strengths will be prohibited unless licensed (anything over 4mg, when the lowest strength commonly available is 6mg; strengths range from 6mg to 45mg).

All flavours are prohibited, in any case, by the provisions of the TPD for 'tobacco products' (and will also be rejected for licensed products by the MHRA).

The TPD prohibits all flavours, including menthol - so you can expect only tobacco flavour to be allowed.

It is even possible that tobacco flavour will not be allowed since it will have to be an added flavour - e-liquid base is flavourless, so 'tobacco' will be an added flavour.

A £30m UK market (the e-liquid proportion of the £100m UK market) will be destroyed overnight and/or will go offshore. (Note: the market will be larger by that time, possibly double in size or greater.)

A large black market will take over the supply of effective, efficient, attractive and economic refill products; they won't necessarily be safe, as the extremely tough current regulatory system for UK consumer products (that makes them far safer than pharmaceutical products) will be removed [3].

In terms of the licensed refills, this is what will apply:

The huge range of flavours, an integral part of the ecig system, will likely be prohibited by the MHRA, who have already stated that they consider chocolate flavour to be 'marketed to children'.

Medicines are not supposed to be enjoyable, they are designed to be unlikely to be dependence-forming so that use can be ceased more easily. Thus, flavours are not seen as desirable since they may make the product more attractive and so prolong use. Medicines may be prescribed, and the state pays; the state does not want you using medicines in the long term. Medicines, where possible, are designed to be a short-term solution.

The MHRA are not interested in making the product more attractive and enjoyable to use; quite the reverse.

Each variant of any kind may require a separate license. For example, the MHRA state that a device with a different strength refill will require a separate license - so this appears to say that even different strengths of refill will need a separate license.

Therefore, even if flavours were to be permitted, they would be prohibited by cost: just 20 flavours with the usual 5 strengths, each separate variant requiring a license, would cost £2.8 million annually (100 MA's with an annual fee of £28,000 each). This may not be the eventual full story; but the costs will be prohibitively high except for major corporates - who are not in any case the part of the trade interested in multiple options to suit all customers.

(100 MA's with an annual fee of £28,000 each). This may not be the eventual full story; but the costs will be prohibitively high except for major corporates - who are not in any case the part of the trade interested in multiple options to suit all customers. A licensed refill will be licensed for a specified device. The device to be used with the refill must be specified, in order to get an MA for the refill; it appears impossible to license a refill without an e-cigarette product, and the impression given by the tone of the information in the Licensing Procedure / con297583 document is that they appear unwilling to license refills separately; they want to license a hardware-refill combination.

Inevitably, they will want to remove (or restrict to the point of removal) bottled e-liquid as this is one of the most useful parts of the system.

It may be possible to license a refill by specifying a device it can be used with - although that would almost certainly need a license itself.

So, if the courts do not overturn the MHRA's UK licensing regulations (which would probably require the EU TPD to be overturned first), then in essence e-liquid will be banned but hardware will be untouched.

If eventually all equipment needs to be licensed then the situation would be disastrous; we hope this (a) would not be able to be applied and (b) would in any case be removed by the courts - full licensing will remove 99.999% percent of e-cigarette products from the market, instead of just the 90% or so that e-liquid restrictions will achieve. (Removing half of a binary system is, in effect, a 100% ban or close to it; but we must assume that a black market will emerge to support those e-cigarette users who do not wish to return to smoking - however, not everyone will be able to access the effective current products that will subsequently only be available on the black market.)



The MHRA licensing requirements document

It is worth commenting, first, on the format of this document. In appearance, it is unusual, and seems to be something that the agency are ashamed of and can change at any time without advising anyone and while denying any change. It is anonymous, unheaded, unattributed, undated, unversioned and generally appears designed to be deniable. Such a format in a document that significantly affects how hundreds of thousands of people will live or die seems inexcusable.

The bulk of the information contained in the document referenced just above is substantially the same as it has always been. There are two significant differences: mention of an 'abridged version' and a '100 days' process. Neither of these currently apply to e-cigarettes as no license has been issued yet after three years for an applicant who might be expected to be approved faster than any other (as their refill liquid quality is superior, as they use university-managed facilities, and since one basic ecig is pretty much the same as any other).

What the MHRA say is not relevant when what they do is clearly the opposite. Although they currently say the devices will not need a license (unless supplied with nicotine), this depends on what regulations they implement in the UK following the adoption of the new TPD in Brussels - and a country's regulations can be stricter (but not less strict) than the EU central law. Who knows what they will eventually require, since they are among the least trustworthy people you could conceive of and their agenda is to remove ecigs.

Therefore the answer to the question, "Will licensing make it harder to buy these products?" is inevitably yes, since the refills will be exclusively black market unless you want a licensed unflavoured or tobacco flavour product with two or three options, in comparison with the current range of several hundred thousand e-liquid products. The hardware is essentially unaffected, at this time, but the whole purchase procedure will be affected as retailers will need to split their operations so that the refills are available from elsewhere. It will be quite difficult to buy refills especially as the MHRA will attempt to block postal supplies and they have the legal right to do (as e-liquid will be considered an 'unlicensed medicine') and they are permitted to block entry of such products, and have done so in the past. In October 2012 they trialled a pilot project with the Border Agency in which they blocked all imports by all routes of unlicensed medicines; this may have been a dry run for the procedures to be implemented to block e-cigarette products such as e-liquid from being imported or posted in.

ASH appear to be saying that products will not be harder to obtain, which is clearly a lie since an e-cigarette is a binary system that depends on a delivery device and a refill, and the refills will be banned.

"The market for over the counter medicines is currently worth £2.5 billion every year. There is healthy competition between brands, which stimulates innovation and competition, which ultimately benefits the consumer through improved products and lower prices. There is no reason to believe this would be any different if applied to licensed NCPs, such as electronic cigarettes."

There is every reason to believe things will be substantially different from the current situation. Referring to the refill liquids, which will be banned by the TPD and the UK regulations that MHRA will implement to support the EU law: it is absolutely impossible that replacing thousands of products that have a vast number of options with two or three fossilised products with one or two options, at an elevated price for a basic product, would not make a massive difference.

ASH are cleverly misrepresenting the issue here by avoiding mention of the fact that around 99.999% of e-liquids will be banned, and talking about 'competition' in licensed products, while trying to present the situation as essentially unchanged. The result of any such competition will be all but useless since all flavours will most likely be prohibited, and the flavours are the key to the success of the ecig system. Misrepresentation on this scale is lying, and ASH are liars.

"There is little real world evidence of harm from e-cigarettes to date, especially in comparison to smoking."

Interesting - they didn't lie about this: what's going on? Perhaps if pharma is going to own ecigs, then lies about spurious and putative health issues need to be tempered.

"Current, unlicensed, products on the market vary widely in their levels of quality and effectiveness."

Just like any other consumer product. Who cares?

People can easily find out how a product rates by looking at independent reviews. Did ASH never hear of product reviews? Does ASH know what the internet is? Apparently not. Do we need cave dwellers without any basic appreciation of how a consumer market works or is regulated telling us how to live in the modern world?

"Consequently, the variable quality of these products means there is insufficient evidence to recommend them as an effective means of helping people to cut down and quit smoking."

Quite right too, as regards quitting: I haven't personally met anyone who bought an e-cigarette with the intention of using it to quit smoking, but of course they probably exist. The product is intended to replace smoking - and if it doesn't do its job, you get a better one. How is this different to any other consumer product?

On the other hand if they are implying that ten million people use e-cigarettes for no reason, rather than being very happy with ecigs as a substitute for tobacco cigarettes, then ASH need a reality check. You can't on the one hand say that cigarettes are strongly addictive and then say ten million people are using ecigs because they don't work well; if cigarettes are strongly addictive, then ecigs must work fairly well if they get so many people to cut down or switch away from smoking (and when pharmaceuticals are spectacularly ineffective in achieving this). Make your mind up - you can't have it both ways.

In any case a bold statement such as that 'there is insufficient evidence' is simply a lie, due to the existence of clinical studies that say otherwise, and the fact so many millions of people use them, and the fact that soon 25% of smokers will have switched. In this particular case ASH have lied without any attempt to conceal the fact.

"...electronic cigarettes are designed only to deliver nicotine."

This is simply wrong, on many levels: it shows that whoever wrote this for ASH has no idea of the issues. It would take too long to educate them here, so I'm not going to bother. If they want to research this further, start with a more accurate description of their purpose: "Electronic cigarettes are designed to replace smoking." This should be enough in the way of clues even for the irretrievably dense at ASH.

"Although currently there is a lack of any firm evidence to establish their absolute safety, such products should be considered many times safer than smoking."

True enough; but why beat about the bush: there is no possible way that e-cigarettes can be 'absolutely safe' - nothing is. Even a medical ecig produced by ASH's friends could not be described as 'safe'. However it will be a great deal safer than some of their other products, that's for sure; about ten thousand times safer.

"In addition, by regulating them in the same way as medicines, the MHRA can provide accurate information to healthcare professionals and the public about the quality, effectiveness and any potential health risks of such devices."

Or, they could simply ask the scientists and expert consumer advocates who already have this information - and far more comprehensively than the MHRA will have for at least another 30 years, because we already have eight year's usage data from millions of users (e-cigarettes were introduced to the UK in 2005). Work it out:

8 year's data, with millions of users, with a unique and highly-engaged community, using thousands of products with tens of thousands of variations, reporting every tiniest health issue, amounting in total to a massive volume of data unequalled for any pharmaceutical product less than about a hundred years old; versus:

Limited clinical feedback for about 3 products with one option each, with no real feedback, avoided like the plague by expert users, dropped ASAP by everyone who finds out there is a black market in real products; and amounting to a tiny and extremely limited data resource, as is normal for pharmaceuticals

The MHRA won't know anything about ecigs for decades; in comparison we already have a vast data resource within the community and its medical advisers. Stop lying.

"Most of the health problems that arise as a result of smoking are associated with the tobacco smoke – not the nicotine, which is relatively harmless."

Please stop confusing the issue with random injections of truth.

"Nicotine is an addictive substance ....."

I may be splitting hairs here - but perhaps ASH can point me toward a published clinical trial of nicotine (a trial of pure nicotine administered to, for example, 100 never-smokers). You can't? Oh dear - this tends to reduce the scientific validity of the statement, then. In fact, in scientific terms, it is rubbish.

Of course we all know that cigarettes are addictive and that after smoking, people are also dependent on nicotine. You may want to consider basic science lessons at some stage - it is easy to make pretty much anything addictive by adding a cocktail of 5,300 other ingredients including freebasers and synergens and other addiction-boosters. Science is not ASH's strong point, unfortunately. Or logic. You'd think the fact there isn't a single clinical trial of nicotine in existence might perhaps flag up the tiny possibility there might be a little problem here.

The meaning of ASH's statement that, "Nicotine is an addictive substance" is scientifically (and legally):

"If pure nicotine is administered to an average selection of the population, who have not been previously exposed to supra-dietary amounts of nicotine in any form, then a significant number will become dependent on it."

- ASH UK

As there is no evidence for this statement, either way, then it cannot be made without accusations of lying - because there is no basis for it, and especially since the small amount of anecdotal evidence shows the opposite: nicotine is not, on average, dependence-forming. Neither position has any proper evidence for it.

There aren't any clinical trials of nicotine because pharma funds research, and pharma probably can't rig a trial so successfully that it shows nicotine to be 'addictive'. Even the tobacco control industry have, on their Nicotine page on Wikipedia, the following statement: "Technically, nicotine is not significantly addictive, as nicotine administered alone does not produce significant reinforcing properties." If ASH would like to consult a scientist (as against their usual crystal ball gazer), they could ask what this means. I'll save them the trouble - here is a true statement of the current knowledge of nicotine's potential for dependence, based on the admittedly small amount of anecdotal evidence:

Nicotine is not dependence-forming on average unless/until it is delivered in cigarette smoke. After administration in tobacco smoke, a change in brain chemistry is presumed to take place. Subsequently, addiction to smoking will be observed in many smokers, and dependence on nicotine may have been created.



It may also be possible to create dependence in some individuals by abuse - administration of repeated very large doses - since this is the case for some other normal dietary ingredients. (Nicotine is a normal and natural ingredient in the diet, and all test positive for it.)

In the above statement the term 'addiction' was used for smoking because the modern usage of this term is for dependence on a substance (or activity) that causes harm in some form; 'dependence' was used for nicotine because its modern usage is for something that is essentially harmless (in terms of modern lifestyles), such as coffee or nicotine.

Prof Killeen's opinion could also be referenced:

"Nicotine is not addictive. The cause of addiction is the release of monoamine oxidase inhibitors, or MAOIs, along with nicotine."

Peter Killeen's opinion may or may not be correct, but currently no one can dispute it, since there is no evidence on which to base any argument. Studies of smoking, smokers or ex-smokers are irrelevant.

A statement that 'nicotine is addictive' has no scientific validity. It is alarmist and unsupportable for several reasons, including that:

There is no evidence that pure nicotine has potential for dependence in never-smokers (it may have; or, it may not have; either way, there first needs to be some sort of evidence before a definitive statement can be made - and there is none)

The very fact that not a single clinical trial of nicotine in humans has been published, despite the extraordinary interest in this area, indicates that the result of such a trial is already known, and does not fit with current ideology or commercial requirements

To reinforce this, the last large-scale clinical trial to test for nicotine in the general population - a trial with 800 people by the CDC in the USA in which every single subject tested positive for nicotine despite the impossibility of many subjects having had any recent contact with smokers - has also been conveniently buried as deeply as possible

Nicotine is a normal dietary ingredient and everyone tests positive for it

Nicotine supplementation is in any case harmless on average

A mild dependence on common materials (such as coffee) is a normal feature of modern urban life and has no clinical significance

By making a definitive statement of a fear-mongering nature without any evidence to support it, and being in a position of trust due to government funding and public belief in their reliability, and having a public voice, ASH are lying. They have repeated alarmist, unsupportable disinformation with no scientific basis, which appears to be the normal state of affairs for their publicity materials. If you came to the conclusion that they are inveterate liars, you would probably not be alone.

"Existing unlicensed products have no minimum age of sale and persons under the age of 18 can purchase them. However, this will change once they become licensed under medicines regulation. Licensed nicotine containing products will have an age limit – likely to be 18 years of age."

Unfortunately, another blatant lie. NRTs are freely distributed to children in the UK without their parent's consent as a normal practice; it's why there have been hospitalisations of children, in one of which the A&E doctor said (to paraphrase): "It's lucky the child was a smoker, with some tolerance to nicotine, otherwise he'd be dead", after an NGO (like ASH) legally distributed nicotine products to schoolchildren.

Once e-cigarettes become licensed they will be distributed free to children in schools and elsewhere, as are current nicotine medical products. Why lie to cover this up? The only way large numbers of children have access to nicotine products is because they are licensed; something the consumer product vendors would prefer to see prohibited. Just another way consumer products are safer than pharmaceutical products.

Or, if ASH are referring to some future paradise, where NRTs including ecigs are prohibited from distribution in schools, then say so: "The MHRA have told us the law will be changed and their nicotine products will no longer be allowed to be freely distributed to children as they are currently".

Licensed nicotine products are given to schoolchildren by NGOs, without knowledge of their parents, quite legally; and it is accepted practice; and it occasionally leads to incidents of hospitalisation; and the same will apply to licensed e-cigarettes (except fortunately they have no potential for overdose, unlike nicotine skin patches). If ASH are saying otherwise then either they are lying or promoting an MHRA promised but as-yet nonexistent version of the future. The tone of ASH's statement makes it appear that e-cigarettes are not allowed to be given to children, but if an e-cigarette gained an MA tomorrow then it could be legally distributed to schoolchildren by NGOs such as ASH, and would be.

Some future arrangement is irrelevant, children are being legally poisoned with NRTs right now, and ASH appear to be trying to disguise that. Perhaps they are complicit in the arrangement, in some way; understandable since it helps boost their friends' profits.

ASH have again misrepresented the situation, and misrepresentation on this scale, and by a public body, is lying. ASH are liars.

"The MHRA has said that flavours such as bubble gum and chocolate would be deemed to be aimed at children."

The EU TPD in its current form bans all flavours in tobacco products (including menthol), and the TPD appears to deem all e-cigarette products, that are not medical products, to be tobacco products. If this situation persists then flavoured e-liquid will be banned by the new TPD when adopted, along with any usable strength of refill. As far as licensed e-liquid products are concerned, it is unlikely that any flavoured refill will get a license.

It's funny how, in my sixties, I am considered a child because I like chocolate and chocolate-flavour ecig refills. It is of course part of the reason I don't smoke any more: chocolate flavour vapour is a lot nicer than bonfire flavour smoke. The pharmaceutical industry are well aware of this and intend to have the flavours removed, as this is a significant part of the attractiveness of the system (to old people like me).

Kids, on the other hand, like to smoke because it's cool to inhale unpleasant toxic gases from a poisonous, nasty bonfire, to prove you are an adult. I don't any longer, which is why I vape.

Pharma needs to kill ecigs any way they can, and this is as good a way as any. My apologies - I said 'pharma' when what I meant was 'MHRA'. Not that it matters, they are of course interchangeable. Actually, it is becoming increasingly apparent that 'pharma', 'MHRA' and 'ASH' are interchangeable.

"What is the scale of tobacco industry involvement in this area?"

Well, all you need to know, for all practical purposes, is that regulating e-cigarettes hands them over to the tobacco industry on a plate. Presumably, that's what ASH wants.

"Electronic cigarette sales are equivalent to only 1% of the total cigarette market. However, with conventional sales in decline in established markets, and e-cigarette sales doubling in value in 2012 and expected to double again in 2013 to $1 billion , the tobacco industry has begun to launch its own products."

[my underlining - CP]

It would help if ASH had the slightest clue what they are talking about. Sales in the USA alone will reach $1bn this year. The global market will be worth double that by the end of the year. When ASH read some info on ECF they need to ask what it means, as they clearly don't know. There are about 4 million vapers in the US , the same in the EU, and slightly less in the ROTW. In the USA, one ecig firm alone (Blucigs) will post a $220m-plus gross for the current year, as they just posted a $112 million figure for the last half-year (and there are more than a thousand ecig firms in the US). Does that help?

ASH doesn't have a clue, and combined with their obvious lies and fantasy, it does not appear they are reliable commentators. (Sorry to understate that a little...)

"Why do people currently use e-cigarettes?"

"In a survey for ASH, smokers and ex-smokers reported using electronic cigarettes for different reasons. The most popular reported use in ex-smokers was to help maintain a quit attempt (48%) while 32% said they used the devices “to help me keep off tobacco”. Smokers on the other hand reported using e-cigarettes to help reduce their use of tobacco (31%) and to help in a quit attempt (30%)."

Only ASH could produce market research that shows 141% of smokers use e-cigarettes.

In any case ASH's surveys use the wrong questions to get correct answers on these topics (perhaps deliberately). The MHRA have already been exposed for lying in market research in order to accomplish this: the famous 2010 focus groups that involved lying to the participants in order to get the 'right' answers.

Why not ask the simplest and most obvious question possible? So let's play: in a hypothetical market research project, we asked 10,000 smokers:

"Would you like to keep smoking if you could reduce the risk by 99.9% and keep smoking with hardly any chance of harm and if it also only cost 25% as much?"

Well I'll be blowed - 99% answered YES YES PLEASE YES. That could just be why ecigs are so popular. I'm simply guessing here.

"With this regulation, will people be allowed to smoke electronic cigarettes in enclosed public places, such as on public transport or in bars?"

This could prove extremely difficult as many e-cigarette users no longer carry a lighter. I have never seen anyone smoke a Nicotrol nicotine inhaler or an asthma inhaler or an ecig; it sounds dangerous, though, and I cannot advise it. No doubt this sort of conduct is popular in prisons, but, luckily, it seems rare in the general population. My personal advice would always be: don't set fire to a nebuliser, it is not designed for it.

"As “electronic cigarettes” do not create smoke....."

That's right. However, ASH seem to have a rather tenuous grasp of this point. Inhalation of nebulised water-based vapour from a device generally of metallic construction containing a battery is, by definition, not smoking (on several counts); and perhaps, with luck, ASH will perceive this quite important fact at some later stage.

Conclusion

An interesting melange of blatant lies, pure ignorance, and the occasional inescapable fact all thrown in and mixed up together, along with a dash of innocent naivety. Attractive for its authoritative tone and hopeful expectation, we can't be sure who this farrago of factless supposition and disinformation is supposed to be aimed at, though politicians would be a good guess.

This sort of unmitigated rubbish is a public health disaster, presumably designed to placate pharmaceutical industry funders and crackpot ideologist colleagues. In a perfect world, people like ASH would eventually be sued for the widescale preventable death their materials might cause - if anyone were stupid enough to believe any of it.

It is also a demonstration of how thoroughly corrupted our public health system is; we might as well rename it the Rothmans-Pfizer Department of Health Revenues, since that is what it appears to be now.



We must heartily congratulate ASH on their sterling work to protect cigarette sales.





General notes

There are many factors affecting the future legal / regulatory situation - no one knows how the UK / EU electronic cigarette regulation scenario will work out. The MHRA do not know, ASH does not know, lawyers don't know, and neither does anyone else. The EU TPD is now immensely complex, with multiple addenda and edits (there were more than 1,200 proposed amendments before the ENVI committee vote); its current situation is not clear; no one knows if it will pass the next three stages it must go through before official adoption; it is understood that the MHRA will need to have a UK law passed before the EU regulation is lawful here (this is the 'transposition' or 'mirroring' process) - but no one knows if that will pass, in any case; it is not clear, if it passes, if the TPD must first be overturned at the ECJ before the UK law can be challenged here; no one can give an accurate opinion on the tobacco product provisions of the TPD and if/how they will be applied to e-cigarettes (which is a crucial issue since it looks as if the EU have ecigs covered two ways, by medical regs and by tobacco regs); no one is prepared to state definitively if the TPD's tobacco regulations cover e-cigarettes or not; and so on.

Therefore, the MHRA's documentation, the ASH position paper, my commentary, and any/all other narratives are strictly guesswork. In the responses above, I have had to assume several things in order to be able to get anywhere:

- That the TPD passes the final EU Parliamentary vote in the form we are vaguely familiar with currently, and is officially adopted in 2015 or 2016;

- That the MHRA manage to have a UK law passed that transposes and adopts the EU TPD as law here, by 2016;

- That there will be a period in which the new laws are operational and before the trade can arrange a challenge (a similar thing happened in the US with the FDA - there was an extended period in which it was not possible to enforce an injunction on them to cease and desist);

- That the TPD contains provisions which will act as a fallback should medicalisation ultimately fail: a classification of all e-cigarette products as a tobacco product;

- That such a tobacco product classification will enable a ban on flavours to be enforced;

...and so on. The above is one possible scenario out of many. Any, all, or none of the above may come to pass - we just don't know.





Notes

This page was edited and updated on Monday, 5th August 2013.

It has not been updated subsequently to reflect recent regulatory proposals or any other event - it is an accurate picture of the situation in August 2013.



[1] An e-cigarette is a binary system: a device that depends on two parts, the hardware (the delivery device) and the refill (the product delivered). Without both it is useless. The hardware when used with a non-functional refill is the same as a good refill in a non-functional device: all but useless. The EU, followed by the UK's MHRA, intend to ban (license) the refills.

[2] If only that were true; welcome to the new commercial gulag of UK 2013. Just pay your taxes, buy only the approved products, lie down, shut up, and die.

[3] It is inconceivable that any consumer product could remain on the market that had even one-thousandth of the risk of varenicline: the directors of the company concerned would be in jail and the company would have gone bust. Some pharmaceuticals are proven to be tens of thousands of times more dangerous than e-cigarettes.

[4] In the UK there is a monthly edition of all common pharmaceuticals in the form of a small, convenient and easily-referenced book, called the MIMS book. It looks a lot like the Screwfix catalogue booklet, without the pictures.

Almost all nurses use it in preference to the BNF, as it is so quick and easy to use; this is relevant because senior nurses handle most of the smoking cessation business in surgeries and clinics. It is not necessary for the practitioner to be in front of a computer screen, connected to the network, and logged in with the practice's account; and in addition, as everyone will be aware, it is far easier to find a solution if you are not sure what you are looking for in the first place when searching a book rather than a web or computer resource.



created 2013-08-03

last update 2013-08-05