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Could new EU legislation spell the end for vaping?

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Vapers hold their breath as EU finalises onslaught on e-cigarette industry

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Smoking is a vice to which many law students and practitioners, like other individuals, sadly succumb. Whether it be a hurried puff prior to that daunting LPC property exam or first County Court appearance, cigarettes are often a lawyer’s go-to when the pressure’s on; despite numerous studies indicating that the belief nicotine offers a calming effect is little but a myth.

Having been a smoker for some 15 years, at the start of this year I decided that enough was enough. I was fed up with the tight chest and smelly clothes that inevitably came the morning after Friday night drinks and, at friend’s suggestion, I ordered an electronic cigarette (e-cigarette) from a renowned online retailer. It promptly arrived and thus began my journey into the increasingly popular world of “vaping”.

For the uninformed, vaping is the exercise of inhaling and exhaling vapour, produced by an e-cigarette or similar device, to replicate the sensation of smoking a traditional tobacco product.

And vaping has taken off in a big way. A Public Health England report, published last August, estimates that around five percent of the British adult population now use e-cigarettes.

Whilst vapers were previously content to use relatively inconspicuous and low-powered e-cigarettes, the market for vaping products has exploded over recent years. A subculture of sorts now exists, in which more adventurous vapers (commonly bearded Shoreditch types) push for evermore exotic e-liquids (the flavoured nicotine-containing solutions that are inhaled as vapour) and customisable vaping devices that allow for improved taste, increased vapour production, and a “smoother vape”.

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However, as of next month, all this is set to change due to the commencement of the controversial Tobacco and Related Products Regulations 2016, which serve to transpose the EU’s revised Tobacco Products Directive into domestic law.

The directive repeals existing EU legislation and seeks to better harmonise the regulation of tobacco and related products (in particular e-cigarettes) across member states. Many of its provisions relating to traditional tobacco products have received widespread coverage in the national media. For example, the prohibition of packets containing fewer than 20 cigarettes, prohibition of cigarettes with “characterising flavours” (notably this includes menthol cigarettes) and the inclusion more prominent health warnings on tobacco products.

Regulations to be made in respect of e-cigarettes, despite their popularity, have received considerably less coverage outside of the vaping community, yet are likely to have a significant impact on both the industry and individual vapers alike.

Part 6 of the draft regulations transposes article 20 of the directive and it is these provisions that primarily impact on e-cigarettes. Matters covered by the regulations include the following:

Notification scheme

The regulations introduce a requirement by which producers of e-cigarettes and e-liquid refill containers must notify the Department of Health prior to supplying their products to the public. Such notification must be made via a prescribed electronic format, not less than six months prior to commencement of the intended supply.

Following notification, a range of factors will be scrutinised including ingredients, toxicology data, manufacturing processes and components used in respect of products. The notification process will apply to both new and existing products and will also have to be revisited by producers when an e-liquid or e-cigarette has been subject to any “substantial modification” (although this term is not defined in the regulations, which may lead to interpretive ambiguity).

In any event, compliance with the notification scheme is likely to prove difficult to smaller producers commanding limited resources and one struggles to envisage quite how such producers will continue to operate in light of the tightened bureaucracy. Producers of e-liquids, for example, often offer a wide range of flavours, many with only very subtle variants and compiling the necessary data required for each notification is expected to be both a time consuming and expensive task. Such concerns were expressed by producers during the government’s consultation process on the implementation of the directive.

Producers who do survive the regulations are likely to pass the increased costs on to consumers and given that one distinct advantage of e-cigarettes over tobacco products is their lower cost, this poses a concern. If there is no financial incentive for existing smokers to make the jump to e-cigarettes, they may simply opt to continue using tobacco, which is widely regarded as being much more detrimental to health (although, admittedly, debate amongst medical professionals continues in this area).

Product requirements (e-liquid containers)

In addition to the notification scheme itself, the regulations also introduce a number of requirements relating to the notifiable products. It is these requirements that have caused most discontent amongst the vaping community and that are likely to impact upon individual vapers.

E-liquid refill containers will not be permitted to exceed a volume of 10ml. At present, larger receptacles (e.g 30ml or 50ml) are commonplace and consumers will now be unable to benefit from the economies of scale presented through buying in bulk. One may attempt to argue that this issue could simply be overcome through purchasing a vast quantity of 10ml refill containers and that suppliers could offer discounts in this scenario. However, it stands that container manufacturing costs will unavoidably increase and, as touched on earlier, such costs will doubtless be passed on to consumers.

The preamble to the directive suggests that the “10ml requirement” is necessary in order to mitigate the risk of nicotine poisoning, but it is not patently clear how it will assist in this regard. Indeed, over ingestion of nicotine may theoretically be possible not only through the consumption of one large container of e-liquid, but also several smaller containers. The preamble also refers to health risks posed to children, in the event they inadvertently come into possession of e-liquid containers and this is obviously a matter that requires serious consideration. Again, members of the vaping community have been quick to respond, suggesting that the risk to children is sufficiently addressed through the directive’s requirement for child-resistant containers. They also note that other domestic products, such as household bleach, pose a greater risk to children yet are sold in much larger receptacles.

Product requirements (e-cigarette cartridges and tanks)

In addition, the volume of e-cigarette cartridges and tanks (the part in an e-cigarette that holds the e-liquid) will be limited to 2ml. Many e-cigarette tanks currently on the market considerably exceed this capacity, and producers will now have to seriously revise existing designs in order to continue to sell to the UK market. As with the “10ml requirement”, it is difficult to see any justification for imposing a limit on tank/cartridge capacity. All it is likely to lead to is an increase in the frequency vapers are required to refill their e-cigarettes and it will necessitate that they carry refill bottles with them because of the imposition of impractically small tanks.

Curiously, the directive’s efforts to scale down vaping paraphernalia run contrary to its efforts to scale up cigarette packets and one questions quite why there should be disparity in this regard.

Product requirements (potency of e-liquids)

It is also worth noting that e-liquids will be required not to contain nicotine in excess of 20 milligrams per ml. Unlike the above this regulation has not caused much controversy, although initially those transitioning from smoking to vaping often require e-liquids with a higher nicotine content in order to satisfy their cravings.

Information and packaging requirements

E-cigarettes and e-liquids will have to be supplied with a leaflet, setting out detailed information on criteria such as use and storage, possible adverse side effects and toxicity.

Additionally, a list of ingredients (where applicable) will have to be included on packaging, along with a prescribed health warning. Revisions to existing packaging will only serve to add to production costs which, again, will likely be borne by consumers.

Advertising

In respect of product advertising, the requirements of the directive will be transposed not only through the regulations, but also via changes to the Communications Act 2003, Ofcom BCAP Code and Ofcom Broadcasting Code. The government has indicated that in line with the directive, products may no longer be advertised on television, radio; society services (e.g. internet advertising and commercial email) and in printed publications such as newspapers and magazines. Certain product placement and sponsorship activities are also prohibited under the existing draft advertising regulations.

The legislative picture remains somewhat uncertain, but what is obvious is that suppliers will be heavily hit by the stringency of the anticipated advertising provisions.

Other provisions and enforcement

In addition to the above, the regulations also provide for an annual reporting requirement (that broadly requires producers to submit comprehensive sales data), vigilance requirements (requiring producers to collect and report information on unsafe products) and government powers to prohibit the production/supply and require a recall of any products considered to pose a serious risk to human health.

The provisions implemented are not to be taken lightly, with breaches of part 6 of the regulations constituting a criminal offence, punishable by imprisonment of up to two years and/or a fine.

It is quite apparent that the introduction of the regulations is going to considerably stifle the production and supply of e-cigarettes and e-liquids. Many vapers have responded angrily through social media and a government petition was mounted last year, receiving over 18,000 signatures.

Producers and suppliers have also sought recourse with e-cigarette company, Totally Wicked, challenging the lawfulness of article 20 of the directive at the Court of Justice of the EU in Luxembourg.

The company’s challenge against article 20 is based on four grounds:

1. it imposes a series of obligations which infringe the principle of proportionality, read in conjunction with the principle of legal certainty (i.e the provisions are overly restrictive and imprecisely formulated)

2. it fails to comply with the principle of equality and/or unlawfully distorts competition (by placing e-cigarettes at a competitive disadvantage against tobacco products)

3.
it fails to comply with the principle of subsidiarity (i.e. individual member states could have regulated products themselves, without EU legislation) and

4.
it infringes the rights of electronic cigarette manufacturers or retailers under articles 16 and/or 17 of the EU Charter of Fundamental Rights (which concern the freedom to conduct business and the right to property (including intellectual property) respectively).

Unfortunately, on 23 December 2015, the Advocate General concluded that nothing submitted by Totally Wicked had revealed any factors such as to affect the validity of article 20 and, whilst not binding, her conclusion will clearly influence the court and be of disappointment to producers and suppliers. The court’s decision is expected early next month, prior to the 20 May 2016 directive implementation date.

In the meantime, the vaping community (and please excuse the pun) holds it breath. Although the regulations have not yet been finalised, a curtailment to the industry and products available to vapers now appears very likely. This said, Totally Wicked’s challenge, whilst down, is not yet out and the question as to the appropriateness of tackling e-cigarettes within a directive principally aimed at tobacco based products still remains live for the time being.

John-Mark Tawadrous is a self-employed consultant solicitor.

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27 Comments

Anonymous

Interesting article.

Pantman

Thanks for the detail on this, maybe LC could become a serious journal after all?

I believe that the balance to be struck on the issue of regulating vaping is whether it is better to give smokers more choice in alternative products or to regulate the alternative products (thus probably reducing choice and increasing costs). Personally, as a non-smoker and non-vaper I think it was inevitable that regulation would be introduced in this area, and it is not so onerous so as to completely kill-off the sector.

The alternative, having a more or less completely unregulated market, and/or not having a “single market” across the EU, seem unpalatable to this disinterested bystander.

Anonymous

This will only help the e-cigarette industry in the long run. Having the industry properly regulated will improve safety and increase public confidence. It would certainly be better than the current wild west situation. It will also weaken tobacco lobby arguments about e-cigarettes being untested.

Anonymous

If the reduction to 10ml and 2ml is true (which one has no reason to doubt that is an absolute joke = It will make more people go back to smoking proper cigarettes, mean that more places stink of smoke and more people get sick. The idea of walking around with 3 10ml bottles at any one time ‘just in case’ is a bit silly, not to mention having to re-fil constantly will be a waste of time – and more importantly, what does it achieve? There’s surely no logical argument that this will make people safer or healthier – and it’s things like THIS that really annoy me when it comes to the EU. I’m all for the EU, for harmonization, for safety but ignorant/incompetent legislation not only pisses people off, it’s making the argument to leave EU much easier.

Anonymous

Absolutely. I vape and it has been an amazing way to quit smoking. I’m under no illusions that it’s good for me, but have noticed practically all of the health benefits of quitting and can only conclude that it is the magic bullet we were waiting for.

The reduction in capacity is ludicrous. I plan to buy a large tank before the regulation kicks in. The tiny bottle sizes is absolutely ridiculous too – 30ml is already quite small – less than a week’s worth. 10ml is minuscule. I usually buy my liquid in 100ml bottles online. Fixing smaller bottles is also horrible for the environment as it requires much more packaging.

I’m a strong EU supporter (like practically everyone else in the City), but this is just a horribly thought out piece of legislation. I will be really quite distraught if it passes – it will be a serious barrier to my finally kicking the nicotine what with the increased costs and phenomenal increase in inconvenience.

Yep, Fuck You

Fuck you and your support for the EU. It’s people like you that led to this. How are you liking being a vaper now?

Roger Hall

An excellent article, however what many non smokers/vapers fail to understand is that the “regulation” of e-cigarettes whilst seemingly designed to make the product “safer” for consumers misses one important fact. Public Health England have already reported that e-cigs even before regulation are at least 95% less harmful than the product that they compete with – tobacco cigarettes. Without any EU regulation they have already proven to be the reason why fewer adults are now smoking tobacco. Smokers now have an alternative and viable product to smoking tobacco that they can choose to use and have done so in their millions. It’s therefore worrying that insofar as the regulatory hoops that e-cigs will now have to jump over, that the regulatory requirements forced upon them in terms of testing etc are in fact greater than is currently forced upon the tobacco cigarette. So a new consumer product (the e-cig) that is preferable from a harm perspective to the one it seeks to replace (the tobacco cigarette) will be regulated to a greater extent. The objective wasn’t consumer safety, but tobacco protection.

Anonymous

I doubt very much these regulations are more onerous than those placed on tobacco cigarettes.

Anonymous

Trust me, this particular vaper certainly does not fail to understand that the legislation completely misses the point.

Anonymous

E-liquid is commonly sold in the following strengths: 0mg, 3mg, 6mg, 12mg, 18mg, 24mg. Many vapers who are seeking to gradually cut out nicotine find these jumps in strength problematic. As a result, more and more vapers are mixing their own ‘DIY’ e-liquid in order to achieve a very gradual reduction in nicotine levels. An auxiliary benefit is that they know exactly which ingredients have gone into their liquid. Should, as seems reasonably likely, the law take the view that nicotine solution (commonly sold at 50mg and 72mg strengths) is under the scope of these regulations, this possibility will effectively be removed. This would represent a considerable step backwards in the progress of vaping as a smoking cessation tool. Whatever one’s view of what the government is able to do in the face of European legislation, the record of successive governments in failing to support smoking cessation tools like vaping in order to achieve a substantial long-term saving against the cost of treating smoking related diseases. Instead, one is all too often left with the impression that short-termist alarm at the loss of taxation revenue should smoking rates drop smartly drives decision making. The sound management of national debt is sacrificed to the imperatives of political careers, at a substantial cost in health and lives among the citizen body.

Anonymous

It’s not just the EU that creates legislation that you may think not fit for purpose. Why is it that you can only buy paracetamol in packets of 16 on shop shelves (you have to ask for bigger packets, kept behind the counter)?

At the end of the day someone is going to complain about whatever is done.

Anonymous

I love you JMT x

Anonymous

Why in h**l this page was made in the way that it is impossible to read with mobile device?

Anonymous

Excellent article. I wasn’t aware of these regulations and as a relatively new vaper am very concerned by the proposed cut in chamber size which will make vaping so much more difficult. Every addicted smoker knows the panic that results from finding you don’t have your cigarettes/tobacco on you, with cigarettes it is easy to pop to a shop and restock, with vaping it is not so easy. My concern is that the restrictions on chamber and re-fill size will make it far more likely that I will be out without sufficient nicotine which is quite likely to lead to a cigarette purchase. I also can’t see any good reason for the restriction.

Ex Smoker

Methinks maybe EU has an ulterior motive for these rules and regulations. Maybe, just maybe they are being paid by the tobacco industry in an effort to make cigarettes easier to use and therefore recoup some of their losses to vaping.

Anonymous

I doubt these regulations have been influenced by the tobacco industry. Much more likely is that fanatical health activists within the Commission won out over more sensible economically-focused officials. (I say ‘fanatical’ because a reasonable health activist would encourage a switch from smoking.)

The EU does have form for double-dealing over tobacco though. For many years when Euro anti-smoking measures were being introduced (in themselves a very good thing) the EU was at the same time paying massive subsidies to southern European tobacco growers to keep the industry from collapsing. So lots of over-production, and billions of Euro ciggies went off to Africa and elsewhere. How very principled.

Well informed vaper

Being uniformed is why you doubt. Actually, the main lobbying for this regulation (in its current form) was from Tobacco and Pharma companies. It very much started out with health professionals, and that’s why the Commission was all set on regulating these devices as medicinal products. However, this changed once the aforementioned industries (with vested interests) got involved.

I don’t understand the feeling the vaping sector was a wild west, unregulated market. It was always covered by (more sensible) consumer regulations, and obviously nicotine is a controlled substance. Responsible manufacturers already part of trade associations, have implemented and keep good practices where necessary (childproofing, warning labels, age-proofing). ECITA already demands that it’s members limit diketones to 0.1%, although I would personally like to see labelled ingredients. But for the most important protections, we didn’t need this regulation at all, especially the guff that is scientifically unsound, which is irrevocable through democratic processes.

I challenge anyone to scientifically justify 10ml bottles and 2ml tanks, from any angle.

daz

ridiculous ideas from the eu,there heads have gone over in the usa there looking at getting them banned altogether!
well i for one wont be buying a 2ml tank,ill stick to my bigger ones thank you,
and if they think they will be fleecing me for more money they can think again,i always paid at least half the uk price for my tobacco when i used to smoke via people who bought it from belgium,ill be doing the same with e liquids if this rubbish comes in they will drive vapers undergound..vaping has got me off of over 20 years of smoking

RichB

as ive always said, the economy can not survive without smokers taxes. The tobacco companies are seriously worried about loss of profits from Vaping.
To keep both the tobacco companies happy and state taxes rolling in, the EU has actively killed the vaping market so people return to smoking instead of vaping.
No government has ever wanted smokers to stop, they simply cant afford them too (honestly presented statistics (as opposed to manipulated ones government use) show the income from smoking far outweighs any cost to the NHS in this country.)

The greedy leaders were worried, the tobacco giants were worried, so they’ve removed the problem.
The only people that will be able to navigate the new complex certification system (financially too) will be the big business tobacco companies.. hence why they started buying up the inferior side of the vape market some time ago (the ineffective budget line you see in supermarkets and local newsagents).
Having bought up companies, surprise, surprise, the new legislation effectively wipes out any device OTHER than the type now owned by the tobacco company… spooky that.

On a side note im still trying to find an official stance regarding the DIY market? Since the VG, PG nor concentrates contain nicotine they are not covered by this new absurd directive. Only the nicotine will fall under it (which can be ordered from non-EU countries anyway), or can be vaped without it for many vapers.

Anyone have any definitive news regarding nicotine free vaping?? without nicotine this corrupt directive doesn’t even apply!

RichB

DO NOT “contain nicotine” I mean.

Evilpixie

Being a cynical sort I agree with all RICH B has said. However, the issue is more complex.

The physical addiction to nicotine and the mental addiction to tobacco are two separate things which just happen to be rolled up (excuse the pun) into one cigarette.

Vaping a nicotine laden juice has enabled me to separate out those two add addictions. Sure it is a substitute, but a much cleaner one. Within 2 years I am seeing all the benefits of someone who has given up smoking, and I am beginning to crave cigarettes less and less. If I choose to do so, I now have an easy way to gradually reduce my nicotine content, although a nicotine addiction itself whilst relatively mentally unhealthy is unlikely to do me much physical harm.

However, the thought occurs, bearing in mind that there is very little research on the actual vapour phase of e-liquid consumption, that one day, myself and all my ex-smoker friends may suddenly find ourselves diagnosed with an incurable lung disease caused by unnecessary diacetyl which has been added to the juice. Undoubtedly there are some wonderful clean juices out there, normally containing much fewer ingredients. Likewise, there must be some completely toxic sweepings from the shop floor, and I for one would like to know the difference so I can direct my purchases accordingly.

The problem is the MHRA haven’t got the money for the necessary science behind what makes a good and bad juice or what makes a good and bad device. So they do what they always do, and let the big companies fight it out, controversially allowing big Tobacco and Pharma to gain the advantage, along with only the wealthiest or more forward thinking of the independent sector. Many good clean products and innovative companies will go by the wayside in this corporate fiscal filtering process. Furthermore, the existing TPD regulations in many ways (labelling, advertising, tank size, bottle size) actively work against the consumer trying to give up smoking… If you are personally annoyed about tank size, imagine what it’s like for someone blind to have to fill a 2ml tank, or someone with crippling arthritis.

However, there is undoubtedly a requirement for regulation within the vaping industry, and looking on the bright side, exiting the EU will allow us to challenge the more ill-fitting aspects of the TPD regulations, and hopefully convert them into a more directly relevant British standard, doing away with the restrictions on advertising, bottle and tank size in the process. The immediate problem is that we don’t leave the EU for two years, and even then these things have a habit of dragging. The TPD will be enforced as of November 20th, which inevitably threatens all businesses unable to afford the expensive laboratory testing. Once we fully know the implications of vaping, the small independent sector will be able to produce e-liquids that are likely to be compliant and will definitely be entirely traceable.

Those producing clean juice will be cherished by the large distributors who will have the money to pay for the necessary emissions testing and various compliance requirements. Eventually normal order will be restored, and the consumer will benefit. Those Flavour Houses refusing to release their ingredients lists (either for reasons of secrecy or even more worrying, because they don’t know) will find themselves unable to find buyers for their products. Meanwhile transparent flavour houses and mixologists who openly release their recipes will flourish, which can only be a good thing. The question remains, how will the smaller independents manage immediately after the November deadline, and how will this affect the consumer in terms of both price and range of choice? The answer can only be negative in the short term.

I am both relieved that the industry is being regulated, and yet alarmed at the way it is happening, which DOES leave the whole process open to exploitation from Big Tobacco and Pharma.

Incidentally zero nicotine IS subject to regulations in Scotland, and quite right too really. Any issues with nicotine should remain a separate subject. With or without nicotine we need to find out the implications of vaping on the health of the vaper, and sooner rather than later.

Fairqueen

ECigs have now been banned in open air fair grounds.
Why is something that has not been proven to be harmful being banned?
I make my own juice with ingredients you use to make food and no Nicotine. I have been off cigarettes and nicotine now for over a mouth thanks in part to E-cigs.
The laws are out of control and ridiculous. Come on over regulating people get a grip. It’s only steam. You get more of that when you cook vegtables on the stove. If you have a breathing treatment it is in liquid form and you breath it in. The person in the room with you is in no danger of getting your meds.
We could us a little less regulation.

also anon

Banned by fair ground operators, or by legislation?

If the former, a business which finds that certain behaviour is annoying other customers they are wholly within their rights to ban it . Nobody cares about people vaping discreetly outdoors (or even indoors) but there’s always that one idiot producing dense plumes of vapour which one can taste several meters away. Is it a health risk? Unlikely, but it is damn annoying and very passive aggressive.

If the latter, citation please.

Vaping

This is a great blog for Electronic Cigarettes and a good explanation about E-cigs which is distinct from smoking,
very nice Information about vape….Thanks for sharing such as informative post

Anonymous

(((Big tobacco)))

Anonymous

looks to me like its geared towards pharma/ nicotine replacement cos that tooled up to produce those little disposable cartomisers and then lost out due to consumers realising just how rubbish they were. the power of lobbing hu?

Yep, Fuck You

Fuck ’em. This is why we left. DIY and vape on and pray for Article 50 to happen very soon.
Let them drown in their steadily worsening economy. 1 by 1 more will leave. Then you will see the back of these old fart grey German and Belgian dictators.

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