Eurocrats are Trying to Kill You

by Adam Auger

Unless you have been sleeping under a rock for the last year you have probably noticed there is a war going on. It is close to home, and involves the people of the European Union (EU) and the Political Institutions who serve them (ostensibly).  This war involves no guns, no bombs, no conscientious objectors; only legislation brought into European law that will effectively kill more people than died in The Black Plague and both World Wars combined.

The Electronic Cigarette (Ecig), in all its various forms, has the ability to literally change the world; it offers smokers the option to move to a safer alternative without the tar and chemical diseases associated with burnt tobacco. It may also have the power to start a revolution if the EU populace are denied it.

The Eurocrats believe that the Ecig should be designated a ‘medicine’, not the smoking alternative it actually is (despite the fact that seven EU Courts have already ruled that this is illegal); that its use should be the same as that of NRT (no doubt with similarly appalling failure rates); that it helps nicotine users ‘quit smoking’ (despite the apparently deliberate confusion with ‘quitting nicotine’). Perversely, it is this belief in the medicalisation of ecigs that would actually wipe out ecigs and result in the aforementioned death toll.

The first question that may pop into your head is: why would they do this? Good question. Some may say that the Eurocrats, in their unfaltering wisdom, believe that they know what’s best for their beloved subjects, and since it appears (on the surface) that they are, in fact, a medicinal item, they believe they should be regulated as such. (It is important to note that a small handful of MEPs, following correspondence directly from their constituents, have fought hard against this, but despite the European Parliament’s very clear vote against medicinal regulation, what we now have is meds regs in all but name.) Others may point out that, since the first draft of the Tobacco Products Directive (TPD) was steered by former Commissioner John Dalli, (the one who was forced to resign from his job as EU Health Commissioner) an avid hater of the ecig technology and generally corrupt politician, we shouldn’t be surprised that the majority of the Eurocrats have followed his lead. Yet more would point out that, as the Corporate Europe Observatory released its somewhat existentialist findings that NONE OF US EXIST (pats self-down, just checking),  it made it easy for the Eurocrats to come to their preconceived conclusions without the bothersome, non-existent ecig users to hassle them anymore.

Looking at some numbers, according to RolandBerger.com, the EU collected 107bn EUR in taxes and VAT from tobacco in 2012. The UK government alone collected £12.1bn in taxes and VAT in 2011-2012. Possibly a fair assumption to suggest, that if people switched from tobacco to ecigs, some Member States may wonder how they will continue to run their economies efficiently. ASH estimates that the NHS spends £2.7bn a year on smoking related diseases, though some studies have placed the amount at almost £5.7bn a year. If the reader decided to be pessimistic and take the larger figure then that still leaves the UK government sitting on a cool £6.4bn a year. Add to that the constant price hikes on tobacco with each budget (it’s ok, the users are addicted) then that number can only rise.

The next question that would undoubtedly follow might well be: are ecig consumers doing anything about this? It would be a fair answer to say that a massive grassroots movement has sprung up, in an effort to fight the powers that wish to end their lives prematurely. No one would argue that starting smoking in the first place was a fatal mistake, but the choice to try and do something about it, when a viable opportunity presents itself, such as vaping for instance? Well that is a grand personal gesture to one’s lungs. To then have that taken away, along with many other such erroneous actions, by a body of people that believe they know what’s best for you… well, it’s enough to grate the nerves.

Many letters have been written to MEPs and MPs, detailing the personal experiences of people that switched to ecigs after years of smoking; people who had become disillusioned with the notion of ever being able to quit such an addictive habit. Twitter and other social websites have been ablaze with vapers and those that support public health, trying to reach out to their aggressors. On the day of the ENVI vote in Brussels, many ecig users from across Europe joined together to peacefully protest outside the European Parliament against a de-facto ban, with the UK’s own contingent, led by a popular VTTV presenter, like Moses leading the Israelites, into the Capital. Sadly, these efforts have been to no avail. The ENVI vote went against the vapers, the European Parliament redeemed itself by voting overwhelmingly against meds regs, but the final agreed text not only bans a majority of the effective products, but also bans VTTV! It is as if the lords and ladies in their ivory towers have been muttering, ‘Qu’ils mangent de la brioche’, to themselves, whilst chuckling at their little jokes.

All is not lost though; the end is not nigh; the zombie apocalypse has not yet begun. The Eurocrats may well be trying to kill you, but they haven’t succeeded yet. The fight for freedom from tobacco continues, firstly in the opportunity for amendments during the second Plenary and finally, if all else fails, if/when a Member State decides to bring in Implementing Legislation and it goes to court.

In the words of a late great leader,

“We shall defend our island, whatever the cost may be, we shall fight on the beaches, we shall fight on the landing grounds, we shall fight in the fields and in the streets, we shall fight in the hills; we shall never surrender.”

Posted in EU, MHRA, WHO | 1 Comment

Have Vapers Lost Their Way?

by Vicky Grant

I have started to ask myself this question more and more recently, and it has given me much cause for concern. I am aware that this blog may be controversial, but please hear me out.

During my first year (almost!) as a vaper, and a member of a much-loved community of very passionate and supportive people, I have joined the ranks and fought alongside this growing group. We all believe in our fight against policy changes that would effectively destroy the freedom of choice we have found, and which has led to several million of us across the EU feeling a darn site better – in health and wealth.

My concern began when I stepped back from the heat of the battle, just for a while, and I started to realise that maybe we were pushing just a little too hard in a manner that could potentially and irretrievably damage our reputations as reasonable people. I KNOW that we are reasonable people and it pains me to see how blinkered we have become about the issues we confront.  I have found some of the many twitter exchanges hard to read; forum posts that seem to do nothing but inflame and hurt people who are trying nothing more than to support our cause, but see it from a different point of view. Every time I see something where someone doesn’t fully understand or doesn’t support us, we turn like a pack of angry dogs looking for a bone to gnaw.

This clearly demonstrates our passion, but at the same time it has become personal and hurtful and damaging to all, both ‘them’ and ‘us’, if you will. We need to find positive means of engagement, not forceful, destructive methods to get people to understand and support vaping. We see vaping as a positive and beneficial thing and we want others to as well, so you may be able to understand why I am not fully supportive of snarky, hurtful comments in response to a tweet, or  when a forum post descends into finger pointing and yet more hurtful and negative comments.

So now that I have made my point, you’re probably all shouting, ‘Well, smarty pants, what would you do? If you think you could do a better job!!’

Firstly, I believe we all need a few days out. Totally and completely. No twitter, no facebook, and no forums…..nothing to do with the vaping battle. It WILL still be here when you return. This is a time of reflection; a time to gather thoughts and ideas; a time to reject knee-jerk, panicked reactions of how to get people to listen. We need to think of ways to engage the media, yes, but MOST importantly we need to engage the general public – who already seem to be in broad support, but we can educate more of them. We need to STOP engaging with the likes of Simon Chapman, Stanton Glantz and public health nutters who are spouting on about totally unfounded dangers, and who have no evidence to support their claims. They do it to inflame us and it works every time! We know what the evidence says; we know that it supports us; and we know they know it, too. We have no need to argue with them; all it does is make us look just as unreasonable as them – and we could be better using our time educating, and engaging in a more positive, balanced outlook on our treasured vaping.

I know I may be unpopular for saying all of this, but I believe I am strong enough to take the beating, and if we all step back and look at it a little more objectively, am I wrong?

Please vapers, let’s not lose sight of who we are and what we wish to achieve; please don’t let our battle be lost; we need to be positive and kind and helpful.  Is it essentially about regulations or is it about public health? Is it perhaps about giving the opportunity we have had to others who may wish to enjoy it, too?

Posted in EU, MHRA | 2 Comments

For the Record: ECITA’s Position on the TPD Proposals for Electronic Cigarettes

In accordance with our stated position in previous posts, nothing has changed in ECITA’s view concerning the TPD proposals on electronic cigarettes. There may be one or two of our members who might take a slightly different view, but I know with absolute certainty that this post represents the views of the vast majority of our members.

First of all, I really must acknowledge the sterling efforts of a small number of our elected representatives, who have battled long and hard to TRY to make some sense out of this rather senseless regulatory proposal. Martin Callanan, Rebecca Taylor and Chris Davies were the first and most insistent about trying to get it right, and Frédérique Ries has been equally tireless in her efforts to make good policy. It is not their fault that the Commission and Council have messed it up so badly. We hope that at least some of them will want to continue to fight for the right regulation, and not accept that the current iteration is the best we can hope for. It is simply not good enough.

However, since many public officials and bodies like to generically refer to ‘industry’, I wanted to just set out our stall, very clearly, so that you can see where a generic ‘industry’ position is not necessarily in harmony with ECITA’s consistent position, which has never changed, and will not (because it does not need to). (That may well be stubbornness, but I don’t believe it’s arrogance; I just believe in electronic cigarettes, properly and appropriately – and proportionately regulated. If that is not possible in the context of ‘the Art of the Possible’ then the political system is dangerously broken. That may or may not be the case, but this legislative proposal is most certainly broken – beyond repair.)

Since going into the full detail of the ‘final text’ is going to be rather long-winded, I’ll just clarify what we would like to see happen:

In our view, the right thing to do would be to replace Article 18 as currently drafted with a mandate to the Commission to follow all the necessary procedures and come back with a robust new legislative proposal within an appropriate time frame. That might be 3 years; it might be longer; or it may take less time. This would also allow the other measures in the TPD – the ones which actually relate to Tobacco Products – to be adopted in a timely manner.

The time it takes is less important than the robustness of the process. Firstly, they need to consult – properly. They have never done so for NCPs or electronic cigarettes. At no stage of this TPD revision have they ever consulted the public, stakeholders, NGOs, industry, Member States, etc., as to what sort of regulation is needed for electronic cigarettes. During the public consultation process for this revision of the TPD, the only question consulted on relating to electronic cigarettes was whether or not they should be included in the scope of the TPD. That is not a proper consultation, such as they are required to undertake.

As part of a proper consultation process, the Commission should undertake a risk assessment, and an impact assessment. These should involve gathering robust evidence from a wide range of sources, and these should be presented together with the public consultation documents, for scrutiny by stakeholders and other interested parties. They have never done this for NCPs or electronic cigarettes.

Once all this information has been gathered, the Commission, should present the findings of the consultation process and publish the outcome.

Obviously, having not done a consultation on this, they haven’t been able to present the findings or publish the outcome!

At the end of all that process, the Commission would be in a position to formulate a legislative proposal. This should include very clear, evidence-based justifications for the proposal. They have never done this for NCPs or electronic cigarettes. What we have had to endure instead is a series of new legislative proposals, with no evidence-based justifications, in a dog’s breakfast of a process.

The final – and perhaps most vital – stage is for the proposal to be presented to all the Member States for scrutiny. Then, and only then, it would be ready to go through the Parliamentary Committees, to plenary, and trilogue, and onto the books as a new Directive or other Statutory Instrument.

So this is ECITA’s clear message on this issue:

Do the work first, then bring forward a proper legislative proposal, as opposed to what there is now.

Posted in EU, FDA, MHRA, WHO | 2 Comments

A Brief History of ECITA, and its Current Structure

Some of you know us very well; some of you have been friends of ours for years; some of you we’ve only met recently; and some of you don’t know us at all. Since this wonderful community has been growing so fast, there will be many who might find it useful to know a little more about what we do.

Back in February 2010, when the UK MHRA published its Public Consultation MLX364, hard on the heels of some aggressive noises coming from the FDA in 2009, we ‘early adopters’ were horrified to realise that – having switched to vaping in early 2009 or before – there was suddenly the potential for overzealous regulation to wipe out these life-saving devices.

Looking at what was going on in the UK in terms of how the few vendors then operating were behaving, it seemed pretty obvious that the threat of regulation would be pretty difficult to counter if the industry didn’t get its house in order. It is important to stress that there were a handful of companies at that time who were behaving responsibly, but even they were struggling to get to grips with what precisely the law required of them for this totally new industry sector. As for Trading Standards, they didn’t have a clue.

With Simon Christou of Liberro in March 2010, we worked together on a response to MLX364. During our cooperation, we came up with the idea for a Trade Association, with a specific focus on identifying the existing regulations, and helping member companies achieve compliance with those. We would also assist Trading Standards and other government enforcement agencies in understanding the existing regulations (which are complex), so that they could take appropriate action against the burgeoning number of ‘cowboy vendors’ – all with a view to being able to demonstrate that this could be a responsible industry, which could work within the law. Thereby, we hoped – and still hope – to be able to fend off dangerously restrictive and overzealous regulatory interventions.

The existing regulations we identified were codified into our Industry Standard of Excellence (a summary of which we shall be publishing soon), against which we audit our members to help them ensure that they are fully compliant with everything the law requires of them to sell electronic cigarette products. These are not rules that we have ‘made up’; these are laws drawn from around 17 European Directives (as they change over time), as well as other UK- or other MS-specific Regulations.

We have made one or two additions, over and above what the law requires, which are to insist on an age restriction, and to ask our members to include allergy warnings relating to nut extracts in tobacco flavours (since these are often present but would be unexpected by someone anaphylactically allergic). We believed then, as we do now, that this was necessary to build the credibility of this industry.

ECITA Ltd was incorporated in September 2010, with seven founding members, who formed the Board. The Secretary was Simon Christou, and I remained off the Board, since I was more useful as the Industry Consultant at that stage. The founding Board members voted unanimously to invite Mike Ryan of E-lites to take the Chairmanship, and he has remained in position until now. The Board is reviewing that this month, but whatever decision is taken, nothing can detract from the excellent stewardship we have benefited from under Mike’s Chairmanship, with fantastic support from the whole Board and wider membership.

The Board members own ECITA by shareholdings, which vary according to their initial funding contributions which allowed us to get ECITA off the ground. No one member owns more than 25% of the shares, and most have only a 4.5% shareholding, which allows them to vote on policy decisions. I was given a 5% shareholding in ECITA to cover the fact that I was unpaid for quite some time, with only minimal expenses being covered by the fees in those early days. We are yet to make any payment of dividends to any shareholder.

ECITA Ltd was closed and reincorporated as ECITA (EU) Ltd in 2011, at which time the Board voted to make me (Katherine/Doodlebug) ECITA’s President and Tom (Crossbow) ECITA’s Chief Scientific Officer.

As we enter into 2014, we have 30 members representing a significant proportion of the UK market, as well as market representation in several other Member States. We continue to do what we have always done: codify the legislation as it changes over time, apply that to our members, and audit them for compliance. Obviously, we have also had to engage in the political campaigning, as people are finally interested in this subject, but our core objectives have not changed since day one.

ECITA’s mission is simply this:

  • To ensure that smokers – now and far into the future, for as long as necessary – have  access to good quality, sufficiently safe electronic cigarette products in as wide a variety as possible, so that they can find the product that will work for them;
  • This includes a red-line-in-the-sand insistence on vapers’ right to have access to strong enough eliquids, in the devices they want to use, providing these are sufficiently safe and legally compliant;
  • To fight for the right of consumer electronic cigarettes to be recognised as being non-medicinal and non-tobacco products unless they either claim to be a medicine or contain tobacco;
  • To ensure that our members operate within the law, and maintain a strong focus on consumer protection;
  • To offer as much assistance as we reasonably can to the wider community, outside our membership, but while recognising the need to prioritise our efforts for our members, since they pay the bills. (To this end, we shall be introducing an Affiliate Membership scheme early this year);
  • To challenge inaccurate or misleading reporting of scientific research wherever it occurs, and to disseminate good quality science, whether or not it supports electronic cigarettes – good, robust science being far more important to us than ‘cherry picking’; and
  • To ensure that sensible, evidence-based policy decisions are made for the regulation of this vital and vibrant sector.

Nothing has changed, and our work goes on.

Happy and long-lived vaping, my friends. I toast you all with my Touchwood mod, sporting a Vivi Nova 2.8ml tank, containing my 2.4% (24mg/ml) menthol eliquid (which I reserve the right to replace with Absinthe or anything else I fancy, at my whim, including higher strengths, just like all of us in the ECITA operations team!), and like so many of you…

they can have our ecigs when they prise them from our cold dead hands!

 

Posted in EU, FDA, MHRA, WHO | Leave a comment

Public Health Wales – a triumph of ideology over evidence

By Tom Pruen

We need a better standard of what is considered to be, and published as, evidence

Public Health Wales have recently released a report which, in their own words, has the following purpose:

“Public Health Wales has reviewed the available evidence to help health professionals and the public be more informed about the products.”

Sadly it appears that what they actually meant was:

“Public Health Wales has cherry picked from the available evidence to mislead health professionals and the public”

In their search for evidence, they have apparently found no mention that:

E-cigs DO NOT deliver tar or carbon monoxide

Toxic chemicals found in cigarette smoke are either entirely absent from vapour, or at massive reduced levels

Vapour does not hang in the air as long as tobacco smoke, so the potential to expose others is massively reduced

While e-cigs are not regulated as medicines (due in large part to the fact that they ARE NOT MEDICINES),  the sale of them is covered by a huge array of existing legislation

The large user base strongly suggests that many people find e-cigs an incredibly useful reduced harm alternative to smoking

Most of the adult users of these products consider flavours to be a vital component that helps them avoid relapse to smoked tobacco

They did find find that:

Flavours MAY appeal to children (Indeed they may. Equally, they may not. It’s hard to think of any real reason why an e-cigarette would appeal to a non-smoker.)

Nicotine delivery varies between different products (This is hardly surprising, given that they are – shock horror – different products.)

E-cigs MAY hamper the ongoing efforts to denormalise smoking and smokers (Of course, it could equally well be argued that the use of a reduced-harm alternative to smoking only emphasises the dangers of smoking, and allows smokers to be renormalised, without renormalising smoking.)

There is little evidence that e-cigs help in quitting (Of course, since e-cigs provide an alternative way for smokers to enjoy nicotine without killing themselves with smoke, it isn’t really a quit method at all.)

“using behavioural support services like Stop Smoking Wales, which uses a range of tested nicotine replacement products, you are four times more likely to quit smoking than by willpower alone” (The failure rate of NRT is around 94%, although the use of support services does, in the short term at least, reduce this. A pitiful success rate like this hardly something to brag about, however.)

They did, however, make one statement in their report (sadly, it didn’t make it into the press release) that public health, most users,  and the industry can agree with – e-cigs should not be available to those under 18.

I would love to know which pieces of purported ‘evidence’ Public Health Wales ‘examined’ to generate their conclusions, as their references are all secondary sources . I’m sure I could supply them with a more comprehensive list.

So to conclude:

This is not an evaluation of the evidence at all, it is merely the ideological position of Public Health Wales, presented as evidence-based fact.

 

 

 

Posted in Uncategorized | 1 Comment

New study confirms no need for heavy-handed regulatory solution because of lack of problem with ecigs

(and interesting lack of funding bias in scientific research…)

By Tom Pruen

A study, recently accepted for publication in the journal Addiction, examined the levels of nicotine in ecig cartridges, and the delivery of nicotine in the vapour from them. It also touched on a recent literature search into the toxicity of nicotine, which is widely quoted as an LD50 of around 60mg, despite several documented cases of survival after ingested doses of up to 1500mg. There is increasing reason to believe that a more reasonable estimate needs to be derived.

The results, while quite possibly surprising to many outside of the e-cig industry, are much what we in ECITA would have predicted. One particular facet of the results came as quite a surprise to the researchers:

“The fact that the variation of nicotine content of the cartridges has little bearing on nicotine in vapour is the most striking finding of this study.”1

That the ability of a given device to deliver nicotine is dependent on its design, as well as the contents of the cartomiser, is not surprising; in fact it would be more surprising if the design did not affect the delivery. It does serve to show how little most of the researchers know about these products. Another example of this can be found in the suggestion that a specific regulation is required for child proof containers when, in fact, this is already explicitly required as part of the chemical labelling directives.

It may well be that they have been misled by the lack of obvious child proofing on disposable and cartomiser products they were examining. However, ECITA members are required to test both disposables and cartomisers for child resistance (by a recognised consumer product safety expert), and if the products themselves are not inherently child resistant, they need to be packaged in child resistant containers. It is not clear if others in the industry follow this example, but as child resistance is an existing legal requirement, we would anticipate this being the case. (The vast majority of modern cartomisers are inherently child-resistant.)

There is a general tendency in the vaping community (and indeed elsewhere) to assume that the source of funding for research predetermines the outcome of the research. While this can be clearly seen in some cases, it is fairly spectacularly refuted in this instance. Since this research was funded by the MHRA, it would be easy to assume that its predetermined outcome would be a recommendation for the MHRA to regulate ecigs as medicines – but this is far from the case.

The study did find that there was some variation in both the content and delivery from ecigarettes, but the conclusion they drew from it was:

“The medicinal products accuracy for nebulisers require 9 out

of 10 samples to lie between 75% and 125% of the average value (all must lie between 65% and 135%). The consistency of nicotine content in EC cartridges we tested is not perfect, but it is well within this range and seems overall acceptable”.

Because of the variation in the delivery from different devices, even with similar levels of nicotine in the cartridges, they also concluded:

“Our finding that the nicotine content of eliquid has little if any relationship to nicotine content in vapour (let alone nicotine intake by users) suggests that a pharmaceutical level of accuracy of labelling of the nicotine content in EC cartridges is also unlikely to be informative for the user”

and

“Consumers need to find models that suit their needs”

Despite a maximum variation of 31% within the same product, they concluded:

“Given the large variation in how nicotine is delivered to vapour and how EC are used, the consistency seems adequate.”

I am not entirely convinced of this – I think that the electronic cigarette industry can, and should, do better than this – but I do agree that this doesn’t require additional regulation (and particularly medicinal regulation), but rather reflects a need for vendors to insist on better quality control procedures from their suppliers. The ECITA standard requires a maximum deviation from stated level of 9% of the declared amount, rounded to the nearest 0.1% (i.e. a 2.4% liquid must fall between 2.2 and 2.6%) and we believe this is a level of accuracy that is both desirable and achievable. If one of our member’s products falls outside this margin, we require the product to be either relabelled or removed from sale , and that the member undertake corrective action within their supply chain.

 

The researchers’ conclusions that:

“The consumer protection regulations need to be implemented strictly to ensure that EC are safe, fit for purpose and ‘as described’”

and

“a regulation of EC over and above such consumer protection safeguards seems unnecessary”

are conclusions I can only agree with: what is needed is not a regulatory sledgehammer to solve a non-existent problem and create a perfect product; what is needed is better enforcement of the existing regulations to ensure that products are good enough. In parallel with this there is a real and urgent need for government agencies to stop describing these products as unregulated, and start insisting on the current regulatory regime being firmly enforced.

 

Posted in EU, MHRA, Uncategorized | 1 Comment

Cost of Medicines regulation based on the product ranges of some ECITA members

By Katherine Devlin and Tom Pruen

What does the MHRA proposal mean for real companies?

To us it looks more like “nuke the entire site from orbit, it’s the only way to be sure” than the MHRA’s claimed “light touch” or “right touch” regulation.

 

 

Using the cost data provided by the MHRA, as well information from discussions between the MHRA and ECITA, the cost of applying for medicines authorisation for the product ranges of four companies, demonstrating different business models typical of this industry sector, was calculated.

It is important to note that this excludes a number of areas where detailed cost information is not available:

  • Regulatory consultancy fees
  • Medical device approval costs
  • Cost of upgrading the supply chain
  • Cost of generating toxicological data for the inhalation of flavourings

Each of these would be expected to add costs of a minimum of several thousand pounds, and could potentially (particularly in the case of upgrading the supply chain to comply with the MHRA regulations) run into several million. The companies engaged in the process of gaining an MA have proven reluctant to give any indication of the costs involved in this, beyond the fact that it has proven difficult and expensive. The MHRA also have not provided any data on this.

Also not included are any costs resulting from the MHRA requirement for the nicotine doses to be consistent during the use of the product. This is not part of the design of the products, and achieving this is likely to involve significant redesign. This may be the reason that Mr Mean has been quoted as saying that none of the products currently on the market would meet MHRA standards.

There is also uncertainty as to whether or not different flavours will require a separate MA, as the MHRA has at various times suggested that this may or may not be the case. If flavours do not require an MA, they will still require a dossier and the non-clinical testing to ensure compliance with medical quality and efficacy requirements. (This has been confirmed to ECITA in a meeting with the MHRA). The MHRA have also stated that:

it would be necessary to demonstrate that the liquid is safe and effective in specified electronic cigarettes. Furthermore, such electronic cigarettes would need to be licensed.1

This would require testing each liquid with each atomising device it is intended for use with.

Owing to the huge range in the estimated annual costs for maintaining wholesale and import licences, a median value between the two extremes has been used. This includes educated assumptions of the number of batches produced each year, except where we have specific batch data to work with.

The MHRA has provided cost estimates2 which we have used for the following calculations. In its document Licensing Procedure for Electronic Cigarettes and Other Nicotine Containing Products (NCPs) as Medicines, the MHRA states that: “An electronic cigarette would be expected to be a so-called complex application3, so it is not unreasonable to assume that the costs would be at the upper end of their estimates. The one-off and annual recurring costs for pharmacovigilance have been included as if there would be no difference between a company engaging in pharmacovigilance for a range of three products or for a range of many hundreds, since it is impossible to estimate how these could be applied to different licence holders when some may have a very small range of products, while others would have several hundred.

If the MHRA do not agree with these estimates, we would be fascinated to know what they do estimate for these companies. Our members would be hugely reassured to know that the MHRA’s regulatory proposal would not utterly destroy their businesses, as currently appears to be the case.

For clarity, these are the specific figures used:

 

Marketing Authorisation costs
One-off costs:

£

Preparing dossier

30,000

Pharmaceutical development studies for product quality

50,000

Batch manufacture (pilot scale) and stability studies

50,000

Quality/non-clinical studies (genotoxicity studies of impurities, analysis of vapour constituents, extractables and leachables

90,000

In-vivo pharmacokinetic studies and/or supporting efficacy studies

130,000

MHRA fee for abridged complex application

28,780

One-off cost of applying for a Marketing Authorisation:

378,780

Annual recurring costs:
Annual period fee

452

Annual GSL periodic fee

452

Annual recurring costs for maintaining a MA:

904

 

 

 

Manufacturer/Import Authorisation (MIA) costs
One-off costs:
Costs of preparing application

10,000

MHRA fee

3,027

Establishing testing facilities

10,000

One-off cost of Manufacturer/Import Authorisation

23,027

Recurring costs:
Re-testing products after import (per batch)

2,000

Inspection of manufacturer’s site (adjusted for annual4)

9,250

Inspection of UK site (adjusted for annual)

4,500

Qualified person

80,000

Non salary staff costs

24,000

Annual recurring costs of Manufacturer/Import Authorisation

119,750

Pharmacovigilance (PhV)
One-off costs:
Service provider to establish PhV systems

9,800

One-off costs of pharmacovigilance

9,800

Annual recurring costs:
Annual service provider costs

12,900

Inspection costs (adjusted for annual5)

3,333

Annual recurring costs of pharmacovigilance

16,233

Wholesale dealing
One-off costs:
Application for Wholesale Dealer’s Licence

3,926

Temperature monitoring equipment

3,000

One-off costs of Wholesale dealing

6,926

Annual recurring costs:
Subsequent inspections (adjusted for annual)

607

Compliance with Good Distribution Practice (adjusted for annual)

41,347

Annual recurring costs of Wholesale dealing

41,954

Any attempt to quantify the impact of the proposed regulatory framework on the companies operating within the electronic cigarette industry must acknowledge the diversity and range of the small to medium enterprises (SMEs) which currently make up the vast majority of this sector. Therefore, we have selected four companies to represent some of the different business models, and used the MHRA’s published figures to calculate the potential impact on each different business model.

The selected business models do not represent the entirety of the existing or possible variations within this sector, but we believe they can provide a useful guide for the purposes of this exercise.

 

Company One

Company one has a very limited product range consisting entirely of products resembling cigarettes. These are sold online as well as through a wide range of retail outlets. The products are available in three flavours, each of one strength, as well as a nicotine free product. Company One sources all its products from China.

Since Company One only has a single atomising device, the costs are relatively small.

 

One-off costs:

£

One-off cost of applying for 3 MAs

1,136,340

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

1,176,093

Annual recurring costs:
Annual recurring cost of maintaining 3 MAs

2,712

Annual recurring cost of maintaining MIA, assuming 3 batches per flavour and strength per year, so 9 batches

18,000

9,250

4,500

80,000

24,000

Sub-total: 135,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

196,649

 

Company Two

Company Two has a small product range, with six flavours in three strengths, six disposable products, and two designs of atomiser. All their liquids are in one excipient base. These are sold online as well as through a variety of retail outlets. Company Two sources all of its products from China.

Since Company 2 has disposable products, and two designs of atomiser, the costs are significantly higher. Company Two has a further twelve nicotine free products that would be unaffected by medicinal regulation.

Case one: flavour, strength and base excipient combinations require a separate MA

 

One-off costs:

£

One-off cost of applying for MAs

15,908,7606

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

15,948,513

Annual recurring costs:
Annual recurring cost of maintaining MAs

37,968

Annual recurring cost of maintaining MIA, assuming 3 batches per flavour and strength per year, so 72 batches

144,000

9,250

4,500

80,000

24,000

Sub-total: 261,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

319,937

 

Case two: only variations in strength and base excipient, but not flavour, require a separate MA. Flavourings would require only the dossier and non-clinical testing

 

One-off costs:

£

One-off cost of applying for MAs

4,545,3607

One-off costs of dossier and non-clinical testing for flavourings (so x6)

720,000

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

5,305,113

Annual recurring costs:
Annual recurring cost of maintaining MAs

10,848

Annual recurring cost of maintaining MIA, assuming 3 batches per flavour and strength per year, so 72 batches

144,000

9,250

4,500

80,000

24,000

Sub-total: 261,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

330,785

 

 

Company Three

Company Three supplies a wide range of liquids in a wide variety of flavours, from a wide range of suppliers, including the UK, US and China. The UK supplier was not counted in the costing, as it assumed that they will bear all the costs themselves, and this will only be reflected in the purchase price for products. Company Three has sixty five types of atomising device. These are sold online and through a number of specialist shops specifically for electronic cigarette products.

Case one: flavours require a separate MA

 

One-off costs:

£

One-off cost of applying for MAs for liquids:
Liquid range one: 37 flavours, 7 strengths, 2 base liquids, so 518 MAs

196,208,040

Liquid range two: 57 flavours, 4 strengths, 2 base liquids, so 456 MAs

172,723,680

Liquid range three: 16 flavours in 3 strengths, 1 base liquid, so 48 MAs

18,181,440

Liquid range four: 4 flavours in 4 strengths, 1 base liquid, so 16 MAs

6,060,480

Liquid range five: 3 flavours in 3 strengths, 1 base liquid, so 9 MAs

3,409,020

Liquid range six: 4 flavours in 4 strengths, 1 base liquid, so 16 MAs

6,060,480

Liquid range seven: 4 flavours in 4 strengths, 1 base liquid, so 16 MAs

6,060,480

Liquid range eight: no flavour, 2 strengths, 2 base liquids, so 4 MAs

1,515,120

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

410,258,493

Assuming that the testing and application for each atomiser design could be combined in the above liquid applications, there would be no additional one-off costs.
If separate testing were required, assuming that each atomiser requires a full MA with one liquid per supplier, and only a dossier and non-clinical testing for other liquids, it would cost:
Liquid range one x 65 atomisers with one liquid formulation

24,620,700

517 liquid formulations requiring dossiers and non-clinical testing

62,040,000

Liquid range two x 65 atomisers with one liquid formulation

24,620,700

455 liquid formulations requiring dossiers and non-clinical testing

54,600,000

 

Liquid range three x 65 atomisers with one liquid formulation

24,620,700

47 liquid formulations requiring dossiers and non-clinical testing

5,640,000

Liquid range four x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range five x 65 atomisers with one liquid formulation

24,620,700

8 liquid formulations requiring dossiers and non-clinical testing

960,000

Liquid range six x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range seven x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range eight x 65 atomisers with one liquid formulation

24,620,700

3 liquid formulations requiring dossiers and non-clinical testing

360,000

Potential additional one-off costs:

325,965,600

Annual recurring costs:
Annual recurring cost of maintaining 1,083 MAs

979,032

Annual recurring cost of maintaining MIA, assuming 3 batches per each of the 8 liquid suppliers, per flavour, per base, per strength, per year, so 3,249 batches

6,498,000

9,250

4,500

80,000

24,000

Sub-total: 6,615,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

7,652,969

Potential additional annual recurring cost (65 atomisers x 8 liquid ranges)

470,080

Potential total annual recurring costs:

8,123,049

 

The cost of testing each atomiser in full with all liquids would run to around £25 billion, and is clearly not worth considering further.

Company Three has an additional 201 non-nicotine products that would be unaffected by medicinal regulations.

 

Case two: only variations in strength and base liquid require a separate MA

 

One-off costs:

£

One-off cost of applying for MAs for liquids:
Liquid range one: 7 strengths, 2 base liquids, so 14 MAs

5,302,920

One-off costs of dossier and non-clinical testing for 37 flavourings

4,440,000

Liquid range two: 4 strengths, 2 base liquids, so 8 MAs

3,030,240

One-off costs of dossier and non-clinical testing for 57 flavourings

6,840,000

Liquid range three: 3 strengths, 1 base liquid, so 3 MAs

1,136,340

One-off costs of dossier and non-clinical testing for 16 flavourings

1,920,000

Liquid range four: 4 strengths, 1 base liquid, so 4 MAs

1,515,120

One-off costs of dossier and non-clinical testing for 4 flavourings

480,000

Liquid range five: 3 strengths, 1 base liquid, so 3 MAs

1,136,340

One-off costs of dossier and non-clinical testing for 3 flavourings

360,000

Liquid range six: 4 strengths, 1 base liquid, so 4 MAs

1,515,120

One-off costs of dossier and non-clinical testing for 4 flavourings

480,000

Liquid range seven: 4 strengths, 1 base liquid, so 4 MAs

1,515,120

One-off costs of dossier and non-clinical testing for 4 flavourings

480,000

Liquid range eight: no flavour, 2 strengths, 2 base liquids, so 4 MAs

1,515,120

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

31,706,073

In the above list, there is a total of 44 MAs for the various liquids. However, this company supplies a total of 65 atomisers. Therefore, at an absolute minimum, another 21 MAs would be required, at a cost of £7,954,380. This presupposes that the remaining atomisers would only be tested with one eliquid.
If separate testing were required, assuming that each atomiser requires a full MA with one liquid per supplier, and only a dossier and non-clinical testing for other liquids, it would cost:
Liquid range one x 65 atomisers with one liquid formulation

24,620,700

517 liquid formulations requiring dossiers and non-clinical testing

62,040,000

Liquid range two x 65 atomisers with one liquid formulation

24,620,700

455 liquid formulations requiring dossiers and non-clinical testing

54,600,000

Liquid range three x 65 atomisers with one liquid formulation

24,620,700

47 liquid formulations requiring dossiers and non-clinical testing

5,640,000

Liquid range four x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range five x 65 atomisers with one liquid formulation

24,620,700

8 liquid formulations requiring dossiers and non-clinical testing

960,000

Liquid range six x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range seven x 65 atomisers with one liquid formulation

24,620,700

15 liquid formulations requiring dossiers and non-clinical testing

1,800,000

Liquid range eight x 65 atomisers with one liquid formulation

24,620,700

3 liquid formulations requiring dossiers and non-clinical testing

360,000

Potential additional one-off costs:

325,965,600

Annual recurring costs:
Annual recurring cost of maintaining 65 MAs8

58,760

Annual recurring cost of maintaining MIA, assuming 3 batches per each of the 8 liquid suppliers, per flavour, per base, per strength, per year, so 3,249 batches

6,498,000

9,250

4,500

80,000

24,000

Sub-total: 6,615,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

6,732,697

Potential additional annual recurring cost (65 atomisers x 8 liquid ranges)

470,080

Potential total annual recurring costs:

7,202,777

 

 

Company Four

Company Four is a manufacturer of e-liquids within the UK. It supplies its products predominantly through wholesale to other businesses, but also supplies retail direct to consumers. Company Four does not sell any hardware, but has two hundred and thirteen flavours, in fourteen strengths, in twenty variations of base liquid. In the period Aug 2012 to Aug 2013, Company Four produced a total of 21,679 batches.

 

Case one: flavours require a separate MA

 

One-off costs:
One-off costs of applying for MAs for liquids:

£

213 flavours, 14 strengths, 20 base liquid formulations, so 59,640 MAs

22,590,439,200

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

22,590,478,953

Annual recurring costs:
Annual recurring cost of maintaining MAs

53,914,560

Annual recurring cost of maintaining MIA, based on the 21,679 batches produced between August 2012 and August 2013

43,358,000

9,250

4,500

80,000

24,000

Sub-total: 43,475,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

97,448,497

 

This is clearly beyond the realms of plausibility.

 

Case two: only variations in strength and base liquid require a separate MA

 

One-off costs:
One-off costs of applying for MAs for liquids:

£

14 strengths, 20 base liquid formulations, so 280 MAs

106,058,400

One-off costs of dossier and non-clinical testing for 213 flavourings

25,560,000

One-off costs of applying for MIA, PhV and wholesale licence

39,753

Total one-off costs:

131,658,153

 

Annual recurring costs:
Annual recurring cost of maintaining MAs

253,120

Annual recurring cost of maintaining MIA, based on the 21,679 batches produced between August 2012 and August 2013

43,358,000

9,250

4,500

80,000

24,000

Sub-total: 43,475,750

Annual recurring cost of maintaining PhV and wholesale licence

58,187

Total annual recurring costs:

43,787,057

 

Furthermore, this does not address the problem that this excludes the cost of testing the liquids with the atomising devices used by the various companies that Company Four supplies. Since there are in excess of sixty five atomising devices on the market, the costs associated with gaining approval for the liquids for use with all of them is likely to prohibitive, significantly limiting the ability of Company Four to continue its wholesale business.

However, in reality, these costs are unlikely to apply. We would anticipate that Company Four, taking a common sense approach, would produce its two hundred and thirteen flavours in twenty base combinations as zero nicotine products, and licence unflavoured high strength nicotine in two bases on a single atomiser.

This would allow the consumer to produce their own ‘off label’ e-liquid, and the company to almost totally avoid the MHRA regulations.

This significant loophole would also apply to most companies, particularly where the devices and nicotine are supplied separately, since any product that is not supplied with nicotine would be unaffected by the MHRA regulatory proposal. This would place an unfair burden on those companies who only supply pre-filled products.

This would also significantly complicate the enforcement of the regulation of these products by the front line enforcements agents – trading standards officers. Since the MHRA proposal would set a completely different regulatory framework in place purely on the basis of the presence or absence of nicotine, products would need to be tested for the presence or absence of nicotine before the appropriate regulatory framework could be identified.

ECITA has always sought proportionate and robust regulation of electronic cigarettes, and the MHRA proposal seems to impose excessive costs on some businesses, while providing significant loopholes, in part because of the poor ‘fit’ of the products into the medicines regulations – a framework demonstrably designed for an entirely different product sector. The fact that it would make enforcement more difficult and expensive for the on-the-ground regulators also seems counter-productive.

 

2 http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286852.pdf Please note that the Annex containing the pertinent figures is reproduced hereafter.

4 5 days at £2,500 per day = £12,500, plus £6,000 travel/accommodation = £18,500. MHRA assumes two-yearly inspection, so £18,500 divided by 2 for annual recurring cost of £9,250.

5 MHRA fees of £5,000 plus Inspection hosting costs of £5,000. MHRA assumes 3-yearly inspection, so £10,000 divided by 3 for annual recurring cost of £3,333.

6 42 MAs required for 6 flavours x 3 strengths x 2 atomisers, plus 6 disposable products.

7 12 MAs required for 3 strengths x 2 atomisers, plus 6 disposable products.

8 The total number of MAs required for the liquids is 44, but there must be at least 65 in total, because of the number of atomisers.

 

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Analysis of the MHRA guidance: “Licensing Procedure for Electronic Cigarettes and Other Nicotine Containing Products (NCPs) as Medicines”

By Katherine Devlin and Tom Pruen

 

This is appearing rather belatedly, but is our analysis of the guidance provided for those who wish to seek an MA for electronic cigarette products. It was produced on the 1st of August, immediately following the publication of the guidance by the MHRA.

 

Introduction

The MHRA’s guidance1 is aimed at assisting vendors of NCPs in successfully applying for a Marketing Authorisation for their product(s). Assessing the applicability of this advice to NCPs other than electronic cigarettes is outside our remit, and no comment is made on this.

The MHRA begins its guidance by declaring uncertainty as to the final form the EU regulation will take. Since there is still debate at the European level as to whether electronic cigarettes should be reclassified as medicinal products, there is the possibility that the MHRA’s attempt to pre-empt the regulation may yet have an embarrassing lack of support at EU level. Certainly, France has expressed reservations about this course of action, in part because, in France, this would limit the sale of electronic cigarettes to being through pharmacies only. The same is true of 20 of the 28 EU Member States.

Presumably to avoid this, the MHRA is suggesting that applicants should apply for Marketing Authorisations (MAs) on the basis of presentation (i.e. should make a medicinal claim which will require testing for efficacy). This evades the current debate in Europe, as well as the questionable legality of determining electronic cigarettes as medicines by function. Regulation as a medicine by presentation is universally accepted as a legally viable option; it is the regulation of the products in the absence of medical claims that is legally questionable (according to the Opinion of Sir Francis Jacobs QC2).

The potential future importance of the difference between classification as a medicine by function, or by presentation, is not mentioned in MHRA’s guidance. This is likely to mislead applicants who may not understand that they would be effectively ‘trapped’ by having made medicinal claims for otherwise non-medicinal products.

The vast majority of the advice consists of links to existing documents on the method of applying for an MA, and does not discuss how these relate to electronic cigarettes (or indeed other NCPs). The Q&A section does, however, attempt to clarify the position as regards electronic cigarettes.

Key points

 

  • Emissions testing would require that nicotine liquids are only sold for use on specific devices – this is not the way the market currently operates;
  • Flavours without available literature on inhalation would be impossible to license, even if there is also no evidence of harm;
  • The cost of a single SME electronic cigarette company applying for MAs for its products (£315m, minimum) exceeds the total value of over-the-counter NRT market (£100m);
  • Ability of users to combine different products (an important aspect of the current market) is extremely problematic within the medicines framework in many areas
  • This user combination of products will make pharmacovigilance effectively impossible;
  • Medicines regulation completely ignores electronic cigarettes that do not contain nicotine – even where the devices are the same;
  • The creation of two completely different regulatory frameworks will increase the cost and difficulty of regulation;
  • There is an absence of evidence that such expensive and complicated regulation is actually required.

Detailed analysis

The first question is “What is involved in the marketing authorisation application – what do I need to submit?

This provides guidance on literature searches and pharmacokinetic studies that would be expected. However, it also states:

 “The safety of the product can be supported by literature only, assuming that the vapour produced by the device does not contain any components that may raise concerns and that the literature data supports the safety of all components of the formulation via the inhaled route.”

 This is directly contradicted by comments made in a face to face meeting between ECITA and the MHRA on the same day that the guidance was published. Amongst the MHRA representatives at this meeting was Dr Ryan Tomlinson, Unit Manager of the Product Lifecycle Assessment Team, who, we were told, would be assessing any applications from electronic cigarette companies. Dr Tomlinson said that not only does the MHRA have concerns about the potential for acrolein and formaldehyde in the vapour due to publications in the literature, but it has not had any data submitted to it on this point; in his words: “we don’t know” if the products of vapourisation are acceptably safe. (We would suggest the published literature, particularly a recent meta-study perform by Dr Igor Burstyn3 indicate that there is good evidence to suggest that the products of vapourisation are acceptably safe). When ECITA pointed out that the emissions from an electronic cigarette would depend on both the liquid used and the device used to vapourise it, Dr Tomlinson suggested that data would have to be generated for each liquid and every device it was intended for use in. Given that there are upwards of 20 atomising device designs currently in widespread use, this would require either that the applicant conduct 20 sets of testing for each nicotine solution that they placed on the market, or that the applicant restrict such liquids only for use in a single specified device. This is not the way the market currently functions, and would not fit with the expectations, needs, or use-patterns of consumers.

There is also very limited information in the literature about the safety profile of inhaled flavourings, making such a search much more problematic than the MHRA implies.

Since food flavourings (in order to be considered safe for use in food at the levels found) must have a plausible method of metabolism or excretion in order to be safe in food, there is limited prospect of them being dangerous if inhaled. It is also important to note that the quantities of flavoured nicotine solution consumed in a day are quite small, with almost every user consuming between 2 and 5 millilitres per day (approximately 2 to 5 grams) of ‘eliquid’, containing at most 20% flavourings. This would result in users consuming no more than 0.4 to 1 millilitre (approximately 0.4 to 1 gram) of the flavourings over the course of 24 hours. (The amount of flavouring added is usually closer to 10%, so this represents the most extreme example.) The MHRA position, therefore, is a prohibition on flavours that cannot be proven to be safe based on existing data, rather than a more sensible prohibition on flavours that have been proven dangerous, or those that are proven so in the future.

 

This point is also addressed in questions 3 and 12 “What do I need for the non-clinical (safety) part of the marketing authorisation application?” which also discusses the potential problem of leaching from the atomising device into the liquid/vapour, and “Do I need a marketing authorisation if my product is an e-liquid or nicotine liquid only?

 

The MHRA guidance states:

 “A comprehensive evaluation of the potential extractables and leachables originating from all components of the electronic cigarette should also be provided, with associated toxicological review.”

 and

 “It would thus be possible to apply for a MA for the nicotine liquid only. However, it would be necessary to demonstrate that the liquid is safe and effective in specified electronic cigarettes. Furthermore, such electronic cigarettes would need to be licensed.”

 How this might be achieved, when – in the current market – a large proportion of users buy the liquid and hardware separately (and not infrequently from different vendors), is not addressed. We can only assume that this would again require the liquid to be sold for use only in one or more specified licensed devices. As Dr Tomlinson said during the meeting between MHRA and ECITA, “It would become very complicated.”

 

Question 4 addresses efficacy: “What do I need for the clinical (efficacy and safety) part of the marketing authorisation application?Oddly, this does not appear to make any reference back to the claim made when presenting the product (while the MHRA is taking voluntary applications on the basis of presentation), but assumes that nicotine delivery is the key measure, which is to treat the product as a medicine by function. The guidance does, however, then state that the product must “demonstrate safe and efficacious levels of nicotine for each claimed indication”, which seems to contradict this. Furthermore, it does not provide any useful information on the MHRA’s stated intent to regulate the products by function (i.e with no claims made). The bulk of the evidence required for this, according to the guidance, is comparison of bioequivalence of the product with an existing medicinal NRT product, in a small scale clinical trial. The form of these trials was discussed at the meeting between MHRA and ECITA, specifically concerning the effect this might have on the pace of innovation within the market, particularly with regard to the introduction of new electronic cigarettes. During this discussion, Dr Tomlinson informed us that these studies (as well as lab testing) would need to be done to determine if a design change to a product would make it sufficiently different to ‘trigger’ a new Marketing Authorisation. This would have to be done prior to placing a new product on the market, and the clinical trial alone, according to the MHRA estimates, would cost between 50 and 100 thousand pounds.

This would clearly have a negative effect on innovation within the market.

 

Question 5 addresses the regulation of the electronic cigarette hardware as medical devices:

 “The MHRA considers the part of the electronic cigarette containing the battery together with any associated charging accessories to be a Class IIa medical device as an active therapeutic medical device.”

 However, a significant proportion of electronic cigarette products are sold with nicotine supplied separately from hardware (i.e. the liquid is sold separately from the hardware it is to be used with). Where this is the case, the MHRA has stated (in question 10 of their guidance) that if an electronic cigarette contains no nicotine, and makes no medical claims, then they do not intend to regulate it.

This would create a situation where the same hardware would be on the market, but regulated in completely different ways, solely on the basis of the inclusion of nicotine. This places a disproportionate burden on those companies who supply prefilled products, and since in most cases the same hardware would be available with much lighter regulatory costs, prevent such companies remaining competitive.

This combination of heavy-handed and expensive regulation, while simultaneously allowing the current state of regulation to continue will also increase the problems of enforcement, since in order to determine how a product should be regulated, it will first require a determination as to whether or not it contains nicotine. This will make the role of the enforcement agents (Trading Standards Officers) much harder, and increase the costs of enforcement, since samples will have to be analysed for the presence of nicotine prior to even being sure which regulatory framework applies.

Question 6 addresses the costs of an MA, with a link to the MHRA table of periodic fees. This however provides rather less information than the costs estimated in the MHRA’s “Impact assessment to support the UK’s position in EU negotiations on the regulation of Nicotine Containing Products, which are currently being considered along with changes to the Tobacco Products Directive4, which estimates the combined cost of an MA application at between £215,000 and £350,000 per application. Since the MHRA states that “An electronic cigarette would be expected to be a so-called complex application”, it is not unreasonable to assume that the costs would be at the upper end of this estimate.

This led to a situation where an ECITA member company contacted the MHRA directly, and was told that they would require 900 MAs to cover their product range. Based on the MHRA cost estimates, this would cost £315,000,000 purely for MAs. This does not include the associated costs of GMP compliance, nor importing, wholesale, or pharmacovigilance fees, which would also add significant costs. It also takes no account of future costs, such as R&D into new products, which would also require significant expenditure.

This is the cost for a mid-sized company with a turnover of around £5 million. Clearly, it is not possible for this type of company – which is very typical of the SMEs which make up the electronic cigarette industry – to invest such an excessive amount of money.

In its document “Proportionate regulation5 the MHRA states that the value of the over-the-counter market in licensed NRT products is £100 million – less than the cost of a single electronic cigarette company applying for MAs for its product range, and with no guarantee that it will receive them.

It is also not clear why electronic cigarette companies should engage in pharmacovigilance for their products, when tobacco cigarettes – the most direct competition as a nicotine delivery method – do not, despite the very clearly demonstrated harms caused by smoking. It is also not clear how the MHRA intends to apply pharmacovigilance in an industry where a consumer can buy the three components of an electronic cigarette (battery, atomiser and nicotine solution) from three completely unrelated suppliers (except that, as noted, the current market would be destroyed by the MHRA’s regulatory proposal). It is difficult to reconcile this with the MHRA statement that “The cost of regulation need not affect price or competition…”.

This is precisely why the vast majority in the industry, and also the consumers of these products, view medicines regulation of these products as a de facto ban.

This does not appear to be proportionate regulation by any measure, particularly since the MHRA has not made a compelling argument that electronic cigarettes need to be shoe-horned into medicines regulation – despite the demonstrable lack of ‘fit’. The fact that the electronic cigarette industry covers such a vast range of products, supplied with and without nicotine, makes it particularly inappropriate to apply the medicinal regulatory framework, since this would leave all non-nicotine containing electronic cigarettes under an entirely different regulatory regime. If the MHRA considers the current regulations so unfit for purpose as to require the sledgehammer of medical regulations, why are they so willing to leave products on the market under the current regulatory framework?

Perhaps this is because, despite the concern they express over the current regulations, they have stated in their published documents:

 

However, as yet there is an absence of scientific evidence that shows long term harm to health is occurring in reality because of product safety6

While contaminants in ENDS have been identified, and the long term health effects of inhaling ENDS vapour are unknown, so far there is an absence of evidence that shows that these problems create significant harm to health.7

Safety concerns have been reported. Given the extent of use, however, and despite the lack of a formal reporting mechanism (such as the yellow card scheme), these do not of themselves suggest a major public health concern.8

Given the low toxicity of nicotine at the doses observed and the fact that long before any dangerous levels of nicotine concentration could be reached, an over-enthusiastic user would be warned by nausea, there is little concern that e-cigarettes can harm their users by delivering toxic nicotine levels.9

 

 

 

 

 

 

 

 

5 http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con286850.pdf (Note also, on this document, that ‘Light Touch Regulation’ has been recast as ‘Right Touch Regulation’.)

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The Daily Fail strikes again

By Tom Pruen

The Daily Mail has a considerable history of reporting on e-cigs that is not so much poor as pathetic (for the past history of the Mail’s ineptitude on this subject, Try our blog here, and here, and Clive Bates complaint to the Press Complaints Commission (PCC) here, which was resolved in his favour).

It seems that the Mail are not only so lacking in journalists that can do research that they are happy to publish other peoples press releases as verbatim truth, but also that these journalists feel the need to add in their own interpretation of the press release. Sadly, it is immediately evident that these reporters lack the basic knowledge which would make these interpretations anything other than scaremongering nonsense.

The Mail’s headline is “E-cigarettes are as harmful as cigarettes and could cause cancer, claims study”. Unfortunately, however, this is not what the study claims, nor is it what they found. Of the varied models and brands that were studied, some had levels of a single potential carcinogen that rivalled those in traditional tobacco cigarettes. They did not find many of the thousands of other carcinogens in tobacco smoke. It is therefore incorrect to claim the E-cigarettes are as harmful as tobacco ones, based on the evidence in this study. It does not take an expert in toxicology or risk assessment to discern this; it is well within the grasp of any educated individual.

It is true to say that e-cigs do appear to have some slight risk associated with them, something which we would agree with. The study also calls for further research, which we would also agree with, since if the risks can be reduced even further, it can only be a good thing. There is nothing in this study to suggest that our long held position is incorrect, however. E-cigs offer massively reduced harm compared with tobacco cigarettes, and offer a huge potential for smokers to be able to choose, for themselves, a safer alternative.

Given that this headline is similar to the last one, “E-cigarette ‘can cause more harm than smoking’, experts say” and the evidence to support it is just as lacking now as it was then, we expect the verdict of the PCC to be very similar. What this means that in contrast to the big headlines the Mail are currently misleading people with, in a couple of months, they will publish a small paragraph (probably virtually identical to this one) retracting it. But by then, of course, the damage is already done, and people will have been dissuaded from switching to e-cigs, or even worse scared into swapping back from e-cigarettes to the deadly tobacco ones.

This is journalism that is shoddy to the point of potentially causing actual harm to consumers.

So there we have it, the Daily Fail – where having a scary headline about electronic cigarettes is more important than anything resembling the truth – seem to be a clear example of why there must be controls on a free press.

We can only hope the PCC insists on a more robust retraction this time.

*Update*

The Mail have since modified the news story to make it a little more accurate, but it still does a very poor job of providing accurate information.

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The full text of Sir Francis Jacobs QC’s Opinion on the legality of medicines regulation of electronic cigarettes in the revisions to the TPD (and elsewhere)

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