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.

 

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26 Responses to What impact will the TPD have on the market?

  1. Rhydian Mann says:

    Oh hello costly med regs in disguise!! How did you get passed when e-cigs have been ruled as consumer products and not medical products in courts in EU states.

    For the current device and juice I have, a PK study for 3W to 12W at 0.5W increments is 18 PK studies. Then GC-MS analysis of the juice which I know has 3 different flavourings. Followed by vapour studies (which I am not yet familiar with) and then biochemical studies on effects with cells.

    Thanks a shed load of money just for 1 combination of hardware and e-liquid!!

    It is outrageous!!

  2. emonty says:

    the real impact will be that most vapers will go back to smoking and die from cancer.

    • vapingpoint says:

      Just pointing out that not ALL smokers die from smoking! I know a few in their nineties! One of them tried vaping because she was worried about her smoking. She went back to smoking. It’s a pity guilt has destroyed her pleasure of it.

  3. Tony says:

    When you think about it it is utterly insane how they can get away with doing this.

  4. ClareR says:

    Thanks for the clear summary. I am wondering who in the UK will be responsible for enforcing any rules, a few people have mentioned the MHRA, but as far as I know it will be out of their remit as they only deal with products classified as medicinal. I am thinking (hoping) trading standards, because I think they may kick up a fuss as it would be a massive burden on them.

    • admin says:

      Given the HUGE overlap between the TPD2 requirements and medicines regulations, it is almost certain to be the MHRA, in our opinion.

  5. Steve says:

    I hope ECITA are preparing a legal action.

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  7. There are still some vapers and lots of politicians who prefer to believe the diatribe by those promoting this steam roller as a sensible compromise.
    I can’t.
    There’s too much insidious sledge hammers in there only barely disguised as feathers.
    Even the most positive approach to e-cigs by national law makers can’t prevent those hammers from falling. And I don’t see any positive signals from MHRA’s mean Mr. Mean or our German pharma freaks in control of BfArM etc.. They sure are encouraged by the “recitals” to act as restrictive as possible.

    And to those optimists that say “So what, I’ll just mix my own flavours”:
    How will you get your own liquids into a EU-vaporizer?
    It all depends on what the Commission concocts as “refill mechanism”.
    Remember: Refill bottles have to be tamperproof too!
    So certainly no more: Remove nozzle top, fill with your liquid, afix top again.
    And they’ll certainly need a specific couterpart for the refill concoction. No more simple needle caps.

    Our best hope now is in my opinion EFVI

    If we are forced to resort to legal action, it will be costly and time consuming obstacle course. And until we reach the finish line, all the bans will stay in place.

    I may sound a little pessimistic, but all the daggers in my back from that grootesque EUthanistic gaggle have cut away my optimism.

  8. Fleabag says:

    What makes this all the more ludicrous is that I could walk into any head shop and buy a bong of any size or design.

  9. steffijade says:

    The scale of cynicism and perversion of the true democratic process involved in drafting these amended regulations and then literally forcing them through by means of blackmail are simply staggering when one steps back and examines the ‘big picture’

    We all know that the true intended purpose of them is to try and secure profits for both big pahrama & big tobacco, preserve/secure tax revenue for big government and to perpetuate the existence of big tobacco control, by ignoring the science and desperately trying to scaremonger and tar vaping with the same brush as tobacco.

    It appears that the political process is ultimately too susceptible to corruption and subversion of the facts to be relied upon to provide a scientific, moral and ethical outcome for vapers and the vendors that we rely on.

    It would appear that to get and acceptable outcome, legal proceedings will have to entered into, but as consumers, we are limited in how we can engage in this process. It would seem the ‘fight’ will have to come in the main from bodies such as ECITA.

    This does not mean that vapers are powerless though. The uptake of vaping over the past few years has been boosted significantly by ‘word of mouth’ and personal attestations … smokers are much more likely to be persuaded to try vaping if they know someone who has successfully switched to vaping.

    We can use that same word of mouth to spread knowledge of how the possible benefits to public health through vaping have been damaged by the actions of ‘officials’, who have been misled, been ignorant of the facts or have apparently engaged in corruption in forcing through the TPD.

    We need to let as many people as possible know about this apparent corruption and cause the maximum amount of embarrassment and vilification for those who have guided that apparent corruption (embarrassment and vilification have proven to be effective tools for the anti smoking lobby to use on smokers.. how about giving the antis a taste of their own medicine).

    The more the public know about how the cause of public health has been damaged by these people, the better. At least imho.

    If the public know that ‘they’ can’t be trusted to act the best interests of public health, then ‘their’ opinions will begin to have less impact and validity.

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  12. Sue Wilson says:

    As you say, most existing vapers will resort to the black market, and end up with products that may not be anywhere as safe as UK manufactured/tested liquids/kits. But all existing smokers or vaping novices have little option other than to continue smoking.
    Shame on Pharma/BT for defending cigarettes and useless NRT, but even more shame on the EU and our MEPs for letting the best public health opportunity of the last century be destroyed.

    • Dave says:

      Honest question: how easy do you think it will be to order liquid and vaporisers from outside the EU? I imagine there could possibly be penalties for the buyer – and risks of course – but provided someone (i.e. me) is prepared to risk it, do you think it will be possible?

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  14. AndyK says:

    Only European vapers can sign the petition? That’s sad. Wish I could sign too, I’m from India but I’m a part of the vaping community. Really wish I could sign ..

    • admin says:

      It isn’t actually a petition – it’s a halfhearted attempt at a form of direct representation from the EU itself, so it is only open to EU citizens (who are eligible to vote)

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  19. avaper says:

    I did a search in PubMed and a lot of articles have been already published with a lot of research done on vaping, the most of the chemicals contained in the e-liquids have already gone through tests. Actually what chemicals ? 3 in total. As far as it concerns diluents and flavouring the matter is more complicated but the most are already used elsewhere. The kinetic of vaping has already been studied. So the kinetic of smoking, but they are still after medical devices that are very far away from delivering nicotine like smoking and yet still sold. After 10 years and milions vapers they want to say they do not know any side effects or they want to tell us no side effects recorded? So I am asking myself what is really going on here? Considering that nicotine and some flavours are already a component of the approved inhalers, that beside punishing the smokers with a medical device, have already been proved to have a poor performance, together with gums, patches and all sort of punishments for smokers that do contain nicotine and are sold at the supermarket. So help yourself with the drug. How many plasters are the people sticking on the skin? The more I stick the best they will do to me thinking is well known. On the other hand vaping is nor an inhaler to stop smoking or a tobacco product. So it shouldn’t fall nor into the medical field or into the tobacco. It’s vaping. Beside all this they do consider alchol safe to drink and add aromas like chocolate, mint…safe, and they are not making it fall into the medical or tobacco regulations because it doesn’t produce smoke…well maybe a vin brule is. So free to drink everywhere it’s safe! Of course delivering an e-liquid that has been tested before vaping it it’s not a bad thing, is it? Having containers and devices that are not leaking is fine, the rest is looking a bit too strange. Especially the alcohol regulations.

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