Important things to know about battery safety

By Tom Pruen

About Lithium-ion batteries

 The batteries in electronic cigarettes have a chemistry that is known as Lithium-ion (Li-ion). Li-ion batteries offer extremely high energy density (they store a lot of power in a small space), which is why they have been adopted for use in small, power-hungry devices such as mobile phones, laptops and electronic cigarettes. The high energy density enables a small battery to provide a useful amount of power, but if something causes the battery to fail in a way that releases this power quickly, the results can be dramatic, and dangerous. This has been seen in rare cases with pretty much every device that uses a Li-ion battery. Li-ion batteries are most vulnerable to failure during charging, as this is when the energy density is highest, and there is an increased risk of an inappropriate voltage being applied to the battery.


Despite the dramatic nature of the way in which Lithium-ion batteries fail, they are generally very safe. Most of us own a cell phone or laptop, or indeed both, but have never experienced any issues. Similarly, there are literally millions of e-cig batteries in use, and incidents of this nature are few and far between.

 

Why do batteries fail?

The main causes of battery failure (aside from physical damage), are electrical shorts, wrong charging voltage or current, and thermal runaway.

Incorrect charging power is almost always the result of using the wrong charger, or power supply. The USB specification is for maximum current of 500mA, but many power supplies extend this to 1000 or more mA, for devices such as iPads. A variety of chargers and batteries are on the market, with some chargers containing the charge control circuits to control power supply and prevent overcharging, while some have this contained in the battery. Mixing chargers, therefore, runs the risk of omitting the control circuitry completely, resulting in either too high a voltage, or too high a current being supplied to the Li-ion cell. There is also then the potential for overcharging, as continuing to try and fill an already full battery will, not surprisingly, damage it.

Electrical shorts are usually a result of damage to the connector where the atomiser and charger screw in. The positive and negative poles are separated by an insulator, and this can be physically damaged, usually by over-tightening the screw fitting. If the connector is damaged, this effectively attempts to empty all the power of the battery back into the battery, causing thermal runaway.

Thermal runaway in use is usually a result of a manufacturing defect in the battery which causes an internal chemical reaction in the battery, which once started leads to an ongoing reaction which destroys the battery. This is rare, but to avoid this, you should buy batteries from a reputable vendor who has invested in quality control. It is also caused by both electrical shorts and overcharging. Physically heating a battery also significantly increases the risk of failure, and while this may seem unlikely, it’s worth bearing in mind for the summer sun.

 

So how can the risks be minimised?

Always buy batteries from a reputable vendor. We would particularly recommend using ECITA members’ products because this offers the reassurance that all the safety testing and compliance documentation is in place and has been checked.

Never over-tighten either atomiser or charger into the battery. Screw things in until they work, and then stop; never screw in until it is as tight as you can make it.

Always use the charger that matches the battery (don’t mix and match chargers and batteries from different brands or models)

Always use a standard (500mA) USB power supply

Do not leave batteries charging unattended! (It’s always better to be safe than sorry.)

Never leave batteries in your car (especially with good weather being on the way, hopefully)

Keep dry. (Obvious, but important!)

Check that the contacts are free of e-liquid and clean with a cotton bud or tissue if needed (added thanks to the very valid comment from Mike)

As an extra layer of safety, there are products available to place batteries in while charging (usually called Li-po bags). These are intended to contain any failure of the battery while charging, but should not be used as a substitute for all of the advice above!

 

Posted in EU, FDA, MHRA, Safety | 6 Comments

What impact will the TPD have on the market?

By Tom Pruen

Having studied the directive, and assumed (for the time being) a reasonable implementation regime, this is my estimate of what the implications of the TPD are on current products, and why. It also assumes that e-cig hardware will be regulated regardless of the inclusion of nicotine, in large part because this is provided for in the Directive text:

electronic cigarette’ means a product that can be used for consumption of nicotine-containing vapour via a mouth piece, or any component of that product, including a cartridge, a tank and the device without cartridge or tank. Electronic cigarettes can be disposable or refillable by means of a refill container and a tank, or rechargeable with single use cartridges

All currently available refillable products would be banned; they do not “have a mechanism that ensures refilling without leakage”. Yup, everything refillable on the market is banned by the TPD. It’s also worth noting that the responsibility for designing a mechanism for this purpose lies with the European Commission (EC); not exactly the world’s leading e-cig experts.

Rebuildables – banned. The TPD requires that “electronic cigarettes and refill containers are child- and tamper-proof”. Rebuilding the internals of your atomiser is the very epitome of tampering.

Replaceable heads (as found in many clearomisers) – probably banned. The ability to change the head on your atomiser could very well be seen as tampering, and when the possibility of rebuilding the heads exists, well, that’s definitely tampering!

Every tank over 2ml – banned.

Buy your e-liquid in 30ml (or larger) bottles? Tough luck, everything over 10ml is… banned.

Vari-volt and vari-watt products – either totally gone, or reduced to single model. The TPD requires that products to be placed on the market provide (6 months before placing on the market):

information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions”.

This would require that any adjustable mod would have to have a pharmokinetic (PK) study done on all settings. A single PK study costs around £150,000 which would soon add up to making it prohibitively expensive, but that isn’t all:

electronic cigarettes deliver the nicotine doses at consistent levels under normal conditions of use”.

The implication of this is that those PK tests would have to be done multiple times, to ensure that the delivery is consistent.

Testing a single VV/VW mod would run to several million pounds – and the market isn’t really big enough to support that. These kinds of device are effectively banned.

 

E-liquid flavours – Amazingly, not banned! However there are some issues with the required paperwork – part of the requirement for notification (again, 6 months before placing the product on the market) is:

toxicological data regarding the product’s ingredients and emissions, including when heated, referring in particular to their effects on the health of consumers when inhaled and taking into account, inter alia, any addictive effect”.

This is going to need a lot of work. First, you need an analysis of the liquid and the vapour to know all the chemical components. Then, you need to find data on these products when inhaled. If this doesn’t exist (and it may very well not) you need to generate it. This will involve cytotoxicity testing (to see if it is acutely toxic to cells) and genotoxicity testing (to see if it has the potential to be carcinogenic). This has to be done for every single constituent of the liquid and the vapour.

You then also have to measure (somehow) if these make it more addictive. (How you distinguish between addictiveness and preference is anyone’s guess – very few people like a roast chicken vape, but some people love it).

The result of this? Well, if it is massively time consuming and expensive to generate this file for every flavour in your range, it’s a safe bet one of the first things that will happen is that you will make your range smaller. Much smaller.

As if that were not enough, if there is the potential for the flavouring to affect nicotine absorption, you will need PK tests.

So, no ban on flavourings, but expect the range of available flavours to become very, very limited.

 

E-liquid strengths – If you like 24mg, you’re out of luck. Everything over 20mg/ml is banned (unless licensed as a medicine).

Expect to see 18mg as the max strength, as very few people will take the risk of a slight error in nic level making their product illegal. This, of course, means that DIY e-liquid is effectively banned.

 

So what is the result?

Disposable Cigalikes – OK!

Single fill cartomisers? – OK!

18mg/ml and under liquid – OK, but most flavours will be gone.

The bottom line is that, if you sell e-cigs that use single fill cartomisers of less than 20mg, the TPD will be an expensive nuisance, but not much more. (BAT won’t struggle to find the odd couple of million for products such as their Vype, but smaller ecig companies will definitely struggle.)

 

20mg/ml and over liquid? – Gone!

All current tank designs? – Gone!

Rebuildables? – Gone!

VV/VW – Gone!

If you sell e-cigs that are refillable, you won’t have any products to sell, until the EC designs a leak-free mechanism, and the Chinese adopt it into new products.

 

If you sell e-liquids, testing costs will shrink your range to a very small selection; DIY will be no more; and customers who need more than 20mg/ml will stop buying, lost to either the black market or smoking.

 

Customer choice? – Gone!

What is the ultimate outcome of this assault on customer choice? Well, the Chinese manufacturers will still be there, so it will be trivially easy for a black market to spring up, and given the demonstrated demand, it clearly will. This over-regulation of e-cigs will therefore make the products in people’s hands LESS REGULATED THAN THEY ARE NOW. Is the man selling e-cigs from his Transit van in the pub car park going to be testing the quality of his eliquid? Is he going to give a guarantee? Is he going to care about exploding batteries? Is he going to be around to answer any of these questions when something goes wrong, or will he have disappeared in a cloud of black market vapour? A black market = zero traceability and zero accountability.

 

Proportionate?

Sensible?

Protects consumers?

Certainly doesn’t look that way to us! In fact, it looks more like it’s designed to protect the existing businesses within the nicotine market and destroy the pesky newcomers, who were on target to cripple the Tobacco Industry within a decade.

 

Posted in EU, MHRA, Uncategorized | 26 Comments

E-cigs need….you!

Or why EFVI is worth supporting

By Tom Pruen

We hear a great deal about (and have had more than a little evidence of) the rather poor way in which the EU represents the wishes of its citizens. There is, however, a means by which the European Commission actively seeks engagement with the ordinary citizens – the European Citizens Initiative (ECI)

On the face of it, this sounds like it would be a fairly easy thing to do, but as explained on the Boiling Frog blog , it is a far from simple process.

Which brings us to the European Free Vaping Initiative (EFVI), for the EFVI are an ECI that is about the availability of e-cigs.

In their own words:

“We, the vapers of Europe and supporters of the subject, demand electronic cigarettes and its related products, regardless of its nicotine content, to be classified as general purpose recreational products through legislation, once and for all, and strictly not as medicinal, tobacco or any other kind of products that would limit or impair the vapers’ access to and use of electronic cigarettes and related products.

The potential outcome of the classification of electronic cigarettes and related products other than general purpose recreational products would effectively lock electronic cigarette related small businesses out of the market by handing the future of vaping into the hands of an industrial group that is not just simply not interested in sustaining the current quality levels and wide range of selection, but it is counter-interested in serving the needs of users of vaping devices.

Vapers made an adult, responsible and private decision when they chose this young but very effective alternative that made possible for them to leave or ease up a deadly habit that claims hundreds of thousands of lives of EU citizens each and every year. The fact that vaping poses no harm to the vicinity of the vaper makes this hobby a private matter of no public interest, therefore any kind of attempt towards the regulation of electronic cigarettes and related products is interpreted as serious offense against our private sphere and personal rights. The matter of electronic cigarettes is intriguing solely for vapers, their close environment, manufacturers and vendors, no other parties should be concerned, in which scope the recent attempts for regulation and the whole overly serious approach towards electronic cigarettes make no sense at all.

The vast majority of vapers keep vaping as a hobby after successfully stopped smoking. We would love to make it very clear: it is not a smoking cessation device, it is a device for recreational purposes that makes it utterly easy to stop smoking and stop seriously harming yourself and your environment while you do it, effectively ending up with a harmless and fun activity.

Anyone who actually knows these devices, their effectiveness and its positive impact on quality of life, vapers have been experiencing for years, cannot find a reason born in good faith that justifies a classification as a medicinal or tobacco product. Especially so since other products with well known and proven harmful effects are kept being freely available to the public.

We do understand however, that in the long run it imposes a serious threat on government treasury incomes and profits of industrial groups intertwined with public health. We understand it and we could not care less. What we care for is our free will, the freedom of choice, and the real protection of the health of ourselves and others in our environment.”

 We think the EFVI is a great idea, and would encourage everyone who agrees with its aims to sign up to it.

ECITA is a trade association, and as such we represent our members, rather than the consumers (although clearly our interests are aligned in most cases, and we certainly have closer ties with the vaping community than other trade associations who claim to represent everybody, despite not even representing a majority of the industry). The EFVI is an opportunity for the ordinary vapers to have a voice that MUST be heard (although there is no guarantee that it will result in any change) and the difficulty in getting an ECI through the process will add significant emphasis to the whole debate.

The online signing process isn’t too complicated, and can be found via the EFVI website: http://www.efvi.eu/ so if vaping matters to you, your family and friends, go and sign up!

Posted in EU, MHRA, Uncategorized | 3 Comments

For the Record: ECITA’s Breakdown of the TPD Proposals on Electronic Cigarettes

Let’s examine this ‘final text’ of the TPD which came out of COREPER on 17th December 2013; what do we have?

Art 18 1

‘Nicotine containing products’ has now been replaced by Electronic Cigarettes, which is an improvement and a problem all at the same time. (There are many conflicts and contradictions in this ‘final text’, so buckle up for the ride….)

OK, so it’s great that Electronic Cigarettes have finally been recognised as the real issue here, but in doing that, hasn’t it now become obvious that a separate regulatory instrument is required? As in, a properly researched legislative proposal to examine what would be the best way to regulate electronic cigarettes specifically? Perhaps a bespoke framework, such as was done with the Cosmetics Directive?

Unfortunately, the downside to this recognition is that it leaves a rather dangerous loophole, if we assume that the EU doesn’t recognise its own Directives which already apply to ecigs and nicotine containing products (and every other product which is now or may ever be on the market!): it leaves nicotine containing products which are not ecigs, or medicinal or tobacco products, outside of the regulation. And they do exist.

The upside is that now non-nicotine containing electronic cigarette products would be covered. But covered in what? (Covered in…. Feel free to add your own ideas! ;) )

Art 18 2

Since this Directive conflicts with a lot of “other relevant Union legislation” as well as various international treaty obligations, it is hard to imagine how this made it into the final text.

Of course it does appear – at first blush – to confirm that electronic cigarettes do not have to be reclassified as medicinal products, but since many Member States are in the habit of ‘gold-plating’ EU Directives, and they do have the ability to add extra requirements if they choose to, this is cold comfort. (Fortunately, the Courts have been looking at the real evidence, so no doubt, unwarranted medicalisation of these consumer products will continue to be successfully headed off.)

Art 18 3.JPG

This seems to be some sort of strange hybrid between a Marketing Authorisation for a medicinal product and the notification requirements for tobacco products – plus a bit! Don’t believe me? Check out the detail!

Art 18 4.JPG

Well, (a) above is already largely covered by various existing Directives, but (b) is a step too far. Ingredients? Yes, obviously. That makes sense and is already required, but emissions? These are not tobacco products. We would support emissions testing, but only once enough research has been conducted to be able to form a meaningful standard for such testing. In the absence of a meaningful standard, emissions data is largely irrelevant. There is already sufficient data about the contents of the vapour produced by electronic cigarettes to know that there is a practically negligible risk associated with them. So where is the proportionate justification for demanding such a burdensome, and unclear requirement?

Art 18 5.JPG

(c) sounds like tobacco regulations, but these are not tobacco products.

(d) sounds like medicinal regulations, since it is medicines which have doses, and these are not medicinal products. (How many courts have to rule on this before they will listen?? We are up to 7 rulings now, with the recent one from Hungary. It beggars belief!)

(e) this would be the “refill mechanism” which the Commission hasn’t invented yet. No. Just no.

(f) err… already required by various Directives for compliance with them, and since the “requirements in this article” either don’t apply, are illegal, or are just plain daft, again, no. Just no.

Art 18 6.JPG

Again, this is already enshrined in the legal obligations of manufacturers, together with very clear definitions of who is considered a ‘manufacturer’ (and ‘importer’, ‘distributor’, or any other kind of ‘economic operator’), so it seems a bit pointless to ask for a declaration of what is already a legal obligation under at least 4 other Directives, specifically concerned with product quality and safety. Indeed, a specific Declaration of Conformity is required under the RoHS Directive anyway.

This is yet another indication of the EU Institutions’ total ignorance of the existing regulations – which is all the more shocking, because we have personally introduced them to their own Directives on more than one occasion, to more than one Institution, over several years now!

“Proportionate fees” wouldn’t be a problem, but if only we could have proportionate proposals!

Art 18 8.JPG

Tut tut! Flagrant disregard for international, binding obligations on environmental protection, such as:

“The overarching objective of the Basel Convention is to protect human health and the environment against the adverse effects of hazardous wastes. Its scope of application covers a wide range of wastes defined as “hazardous wastes” based on their origin and/or composition and their characteristics (article 1 and annexes I, III, VIII and IX), as well as two types of wastes defined as “other wastes” (household waste and incinerator ash; article 1 and annex II). The provisions of the Convention center around the following principal aims: (i) the reduction of hazardous waste generation and promotion of environmentally sound management of hazardous wastes, wherever the place of disposal…”

And

“The Bali Declaration on Waste Management for Human Health and Livelihood, adopted by COP 9 in 2008, has affirmed at the political level that waste, if not managed in a safe and environmentally sound manner, may have serious consequences for the environment, human health and sustainable livelihood.”

How can the EU suggest that it would rather see disposable products than the infinitely more environmentally-friendly refillable and rechargeable ones? And obviously, the bigger the tank (or cartridge), the bigger the reduction in waste products. Surely that one is a no-brainer – particularly in the context of the total absence of evidence of harm caused to anyone over the past 8 years by ecig cartridges or tanks.

Art 18 39

Obviously, this cannot be an acceptable level, if this is truly about helping smokers make the switch away from tobacco smoking. This is also an egregious and apparently deliberate misinterpretation of the fine work of Drs Farsalinos and Dawkins, and others.

Art 18 40

And in paragraph 4 of Article 6, for tobacco products it says:

Art 18 11.JPGPossibly makes sense for tobacco products, and obviously, we wouldn’t want to see vitamins (or god forbid, Viagra – which doesn’t even vapourise! Doh!) included in eliquid, but since no-one is producing such a product, is this really necessary? As for caffeine, where’s the problem? There are caffeinated eliquids out there, and if people want to vape their caffeine as well as drinking it, then why the hell not? Again, where is the evidence that caffeinated liquids cause health problems? It doesn’t exist.

(c) sounds like a purely tobacco measure, relating to additives for making the smoke look less deadly (perhaps), but certainly doesn’t apply to ecigs. No one is producing eliquid with green vapour. (And yes, that does sound rather appealing, doesn’t it?) Since it’s not smoke, where would the problem be with that? Seriously, though, we would not tolerate such additives under our standard for eliquid manufacturing anyway.

(d) is the anti-menthol cigarettes bit, and is really not appropriate for ecigs, particularly when what is actually needed is improvements in nicotine uptake from ecigs (although we’re not doing too badly for that with the better devices).

(e) Well, everything ecig is “unburnt”, and of course we don’t want to see “additives that are carcinogenic, mutagenic or toxic to reproduction”, but there is plenty of protection against such things in the existing consumer regulations.

This just goes to show why it is daft to try to apply tobacco regulations to non-tobacco products.

OK, so back to Article 18, para 3:

Art 18 12.JPGYes, obviously, and already part of the existing requirements.

Art 18 13.JPGAgain, yes, obviously, and already part of the existing requirements.

Art 18 41

No, because ecigs aren’t medicines. (And yes, I’m as sick of saying it as you are of hearing it!)

Art 18 42

Child-proof already required by CLP, and tamper-evident eliquid bottles is good practice. (‘Tamperproof’ would mean ‘unopenable’, so presumably they mean tamper evident.) However, if tamper evident ‘refill containers’ is to include hardware, such as the tanks on refillables, then this would be hugely problematic, resulting in no rebuildables, no changeable atomising heads, etc.

Art 18 16.JPGShades of Professor Branestawm here. I can’t wait to see what the Commission invents for this. Trouble is, it won’t be an ecig is we know and love them, so no. (Also, as Tom pointed out, since eliquid bottles have to be child-proof, and children aren’t supposed to have these products, children shouldn’t be refilling them, so why would they need “leakage free refilling”? ;) )

Art 18 17.JPGThis is a blend of medicinal, tobacco and consumer regulations. Ends up being a predictable and unnecessary mess. The existing requirements are more than sufficient to protect consumers. (And with a nod to the irony, considering the length of this post, who wants to have to have War and Peace accompanying their ecig?? I mean, there’s quite a bit of information that’s already required under the existing regs. Add this lot and it’ll be a weighty tome!)

Art 18 18.JPGIngredients, nicotine content, and batch number already required. ‘Keep out of reach of children’ has been replaced with ‘Store locked up’ for nicotine products by the CLP Directive, which applies an internationally-binding new system for Globally Harmonized System labelling, which the EU has signed up to. It is interesting to note that ‘keep out of the reach…’ is hazard class 3, whilst ‘store locked up’ is hazard class 4. 4 is more hazardous than 3, so the GHS has strengthened CHIP (which was replaced by CLP under the GHS). No doubt, once the toxicity of nicotine is properly recognised as being far lower than currently assumed, this will change back to hazard class 3, and ‘keep out of the reach of children’ can be properly reintroduced. “Delivery per dose” is a medicinal concept, and doesn’t apply to non-medicinal ecigs.

Art 18 19.JPGArticle 12, paragraph 1(a) is a fairly bizarre proposition, considering it’s in the tobacco products bit:

Art 18 20.JPGTotally and utterly irrelevant to ecigs, which categorically do not promote or encourage smoking – precisely the opposite! And bear in mind that this is increasingly well-supported in the academic literature.

Also, in Article 12, paragraph 1(c), it reads:

Capture 1Capture 2

So, in direct contravention to the regulations surrounding Misleading Marketing and product descriptions, we would no longer be allowed to describe the flavour of the products! Ridiculous!

Article 18 goes on:

Art 18 21.JPGIt’s bad enough that we can’t tell the full truth about the products now, but the notion of putting these misleading warnings on ecigs is anathema. Talk about contrary to the “high level of public health” obligation!

Art 18 22.JPGAnd paragraph 2 of Article 11 (for tobacco products) refers to Article 8(4):

Art 18 23.JPGwhich sets out the requirements for those distinctive tobacco warnings:

Art 18 24.JPGSurely, it would be dangerously misleading for consumers to see tobacco-style health warnings on a safer, non-tobacco product??? What can the EU be thinking?

And back we go to Article 18, paragraph 5 (they do like to send you all over the document, don’t they?):

Art 18 25.JPGOh dear, oh dear. So that’s no VTTV, no RY4 Radio, no forums which allow vendors to post (so that includes all of them) – but fortunately, this is a totally illegal infringement of Treaty obligations under the TFEU (amongst other reasons), so cannot survive to the end game.

Art 18 26.JPGNo.

Art 18 27.JPGSo no multi-state Vapemeets then. Like that could be stopped! They’re deluded if they think this can work!

Art 18 28.JPGFortunately, the ASA is working on sensible, sector-specific guidance, so this should be easy enough to overcome.

Art 18 29.JPGAnd yup, you guessed it: Article 16 describes the ban on cross-border sales of tobacco products. They can just about get away with this contravention of the Treaty obligations, because of the WHO FCTC, but that’s for tobacco products, not ecigs. Not a chance!

Art 18 30.JPGCan you think of a single other consumer product for which manufacturers are expected to undertake such a burdensome procedure, in addition to the legal compliance they already have to achieve? No, neither can I.

Art 18 31.JPGThat’ll be like watching paint dry then, but fair enough. No doubt no news will go on being good news in that respect.

Art 18 32.JPG… as they are obliged to do, yes.

Art 18 33.JPG

“Adverse effects” is a medicinal concept. Consumer products are either ‘safe under reasonably foreseeable conditions of use’, or they are not, and if they are not, they are graded by how dangerous they are. This is a good system. It works. There’s even a well-coordinated EU-wide system for reporting dangerous consumer products: RAPEX.

So let’s just put this hysterical fear of possible (and as yet, undocumented) “risk to health and safety” in context, shall we? For the whole of 2013, there were 6 RAPEX alerts recorded under the search term “electronic cigarette”, and 1 further one recorded under the search term “e-cigarette”, all of which were either for non-compliance with the Low Voltage Directive, or non-compliance with CHIP/CLP for labelling. (In other words, if those vendors had been compliant with the existing regulations, there wouldn’t have been a problem.)

By contrast, for the whole of 2013, there were 482 RAPEX alerts recorded under the search term “toy”, of which 457 were “serious” (the same level as for all 7 of the RAPEX alerts for electronic cigarette products recorded for that year).

Art 18 34.JPGThey do seem to want to watch a lot of paint drying, don’t they? And since almost all the currently available products would no longer be available under this proposal, what can they learn?Art 18 35.JPGOK, this one actually sounds scarier than it is, to a certain extent, because they DO have to have “reasonable grounds for concern”, and the “competent authority” may take “appropriate measures”… which is kind of what happens with RAPEX already.

They seem to be increasingly desperate for some evidence of harm, don’t they? We just need to make sure we don’t give it to them.

Art 18 36.JPGAgain, “justified grounds” and their action has to be “justified and proportionate”.

I realise it’s cold comfort, when this TPD revision was supposed to be “justified and proportionate”, but demonstrably isn’t. Nevertheless, it ain’t over til the fat lady sings… and I ain’t singin’ yet! ;)

Art 18 37.JPGROFL. Would be amazing if it became factual, wouldn’t it?

Art 18 38.JPGWho knew that the future ecig innovations would be coming from… the Commission? I really can’t wait to see it.

Phew! Long, isn’t it? Twice as long as the original proposal… and a bit late in the day – within this Directive at least – to be introducing completely new ideas, still with no proper consultation, impact or risk assessment, scrutiny, justification or due process.

It’s shameful.

Posted in EU, MHRA, WHO | 2 Comments

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