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.
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.