The Impact of the TPD

As we know, the revised tobacco products directive enters into force this month, and while many held out hope that it would be overturned by the Article 20 Legal Challenge (among other challenges) there has been a distinct lack of impact analysis of the Directive.

Thanks to Lorien Jollye for bringing this to my attention from ASH. The trouble with the ASH analysis is there is so much wrong with it.

From 20 May 2016 e-cigarettes will be available for sale under EU TPD regulation. There are transitional arrangements allowed by the TPD so that in the UK electronic cigarettes or refill containers which are not in compliance with the TPD can be released for sale on the UK market until 20 November 2016. From 20 May 2017 all products sold to consumers must be fully compliant with the TPD.

While it is true that some devices will still be available under the new regulation, they are most likely the later first generation and some second generation devices that many experienced vapers wouldn’t use. The thing here is that it isn’t all about the longer term vaper, new switchers may find these early devices about as useful as a chocolate fireguard.

Fortunately for us in the UK, our legislation is somewhat more lenient in the implementation timescale, though the end result is going to be the same regardless of whether the legislation is implemented on May 20th 2016 or May 20th 2017.

Products which are regulated under the TPD only need to be notified to the appropriate regulatory authority (in the UK this will also be the MHRA). The TPD is intended to introduce harmonised standards across the EU, improve the quality of products and reduce the risk of accidents, particularly in relation to children accidentally drinking liquids or products leaking. To achieve this it includes a number of standards which products must meet.

Product notification is via a single, common portal. How long do you think that this portal will stay on-line come the impending influx of notification requests from 28 Member States?

The thing is, the goal of the TPD is indeed to harmonise and facilitate the smooth operation of the internal market – a laudable goal to be sure, yet it fails dismally with many Member States taking completely different approaches to things like cross-border sale and indeed notification costs (yes Belgium I’m looking at you), which by the way is only for the notification, this doesn’t include any costs associated with providing the toxicology reports (liquid testing) – which, by the way the vaunted EU have yet to determine the testing regimen so no-one knows what to test for (thanks Liam for pointing that out).

We can all agree that product standards are needed, but isn’t that what the BSI publication is all about without all the unnecessary fluff and puff from the Commission. I’m looking at the two devices sitting on my desk, neither of which would meet the standards set out in the Directive. Not even close. So that’s two devices that I’ll not be able to use come May 2017 as I won’t be able to get replacement parts for them. I also won’t be able to get my favourite e-liquid in the bottle size I like. Talk about wasteful.

Checks will be made to ensure the notification is complete and that the information provided demonstrates that the product meets the standards set out in the Tobacco and Related Products Regulations 2016. These include:

These checks include:

  • Child resistant / tamper evident packaging for liquids and devices
  • Device must be protected against breakage, leakage and be capable of being refilled without leakage
  • Devices must deliver a consistent dose of nicotine under normal conditions
  • Tank & cartridge size must be no more than 2ml in volume and nicotine strengths to be no more than 20mg/ml

So the “child resistant / tamper evident packaging” effectively means that 10ml bottles will be placed inside one of those horrible plastic packages that is, frankly utterly pointless. Instead of a bottle that takes a relatively small space, we’ll now how these horrible plastic wrapped products that will create an untold amount of extra manufacturing, packaging and last but not least waste. Where’s the sense in that?

Devices to be unbreakable, leak-proof and leak-free filling? Please. Most tanks I use are made of glass and similar material. Over the course of my “vaping life” I’ve broken two tanks just by knocking them over on my desk. Sure there are new designs that offer a lot more protection to the tank, but in most cases it makes it impossible to see how much liquid I have left in there. Again, utterly pointless.

I really would like to see their definitions of “consistent dose” as the whole idea behind these products is self-titration – we use what we want, when we want it. If that is to be limited to x amount per puff then it is no better than a Nicorette inhalator (which are utterly shocking).

The briefing goes on to address concerns about the TPD with “facts”.

Flavours

The TPD itself does not prohibit the sale of any flavours. Member States retain powers to regulate flavours if they choose and some may do so. The Directive is clear that there is value to allowing flavours: “It could be useful for Member States to consider allowing the placing on the market of flavoured products… Any prohibition of such flavoured products would need to be justified…”. The UK Government has no current plans to go further than the TPD in this matter. As such there will be no blanket ban on flavours in the UK.

Partially correct, there won’t be an outright blanket ban on flavours as such, but the legislation on the composition of e-liquid, coupled with the notification regime will likely see a significant reduction in the number of flavours available. The burden here will be on the vendor to notify the products that “meet the requirements” based on their popularity. Big selling flavours will no doubt stay available, but as previously mentioned taste is subjective and many flavours I like, many others probably don’t and vice versa. The whole point of the wide array of flavours is customisation, or as Lorien succinctly puts it – dissociation.

Device Bans

The TPD does not prohibit any specific type of device. In principle refillable tank models could meet TPD standards.
Concerns have also been raised that variable voltage devices will not meet the standards of the TPD. However, there is nothing in the TPD to prohibit variable voltage devices.

The vast majority of what is currently available does not meet TPD standards. There are new devices coming that are getting close to meeting the standards, but the thing is and it is a point that is completely missed, innovation will suffer under the TPD. For months there have been new tanks and mods made available on a regular basis, under the TPD that innovation will slow to a crawl, not least because of the stringent requirements but also thanks to the burdensome notification regime. True, manufacturers could start looking to innovate with the notification in mind so the pace doesn’t slow too much from the public’s perspective, but why should they?

Current Products Removed

As noted above some products currently on the market will need to change to meet the standards set out in the TPD. But many manufacturers have already demonstrated that they are willing and able to alter products to meet the standards.

Some current vapers may already have noticed their products evolving. For example the TPD requires that tanks be no larger than 2ml in volume and some manufacturers have started to implement this change with many making 2ml tanks available as standard. Products are being redesigned to put in place leak-proof refill mechanisms and ensure products are child resistant.

It is true that many products now available will have to change over the coming year, to meet TPD standards. However, a wide range of products will remain on the market for users to choose from.

As noted above, current products that do not meet the arbitrary standards detailed in the TPD and the Member States interpretations of it, will disappear. It is likely that wise manufacturers already have contingencies in place for this – Aspire already have with the Cleito “fatboy” replacement glass which doesn’t need to be notified. But come May 20th 2017 you will not be able to buy a 5ml SubTank. It is also likely that coils for the SubTank and other tanks of that size and variety will also disappear as they are specifically designed for those tanks.

Product evolution will of course happen, and it has been happening, mostly in response to the impending regulations, but it would have happened anyway, the TPD just forced them to do it. Not necessarily a bad thing, but it really wasn’t necessary for eurocrats to force such an intervention.

Nicotine Strengths

Surprisingly, this is one that they kind of got right. For many, having liquid strengths less than 20mg/ml available won’t make a massive difference. The trouble is, they have completely ignored those who might want to switch and it is these new users that will be the most affected. But rest assured, they have an answer for that too.

If you don’t feel you’re getting enough nicotine you could try using an NRT product, such as gum or patch, in addition to the e-cigarette or consider investing in a newer generation device.

Quelle surprise.

Performance Reduction in Existing Products

Most people who have been vaping for a while will have seen products evolve a great deal over the last few years and there is no indication that the pace of innovation is slowing. Indeed, newer generations of products appear to be more efficient at delivering nicotine. Meeting the new standards is likely to drive further innovation while at the same time ensuring that requirements relating to safety and reliability are met. Naturally users fear that the new standards will reduce the appeal or undermine the effectiveness of their products, but that is unlikely to be the case for most users.

I have two trains of thought on this “fact”. One, the pace of innovation will likely slow down initially as manufacturers navigate the Directive requirements, but it should (in theory) return to a similar level to what we are seeing now. Two, the pace of innovation will slow and remain low as the caveats in the Directive allow for Member States to impose bans and other nonsense under “safety claims” – why would a manufacturer invest time and money into developing an efficient, useful product only to have sale of it banned for seemingly no reason ?

It is true that newer devices are far more effective, studies have demonstrated this and continued to demonstrate it. The users can demonstrate it, yet these are the products most under threat from the Directive. Insanity.

Med Regs

I wondered if ASH would talk about this. The thing with medical licensing is the level of bureaucracy involved in getting a device through the scheme. It is time-consuming. It is expensive, and as pointed out only one actual e-cig device has received a license – the e-voke from BAT. That tells you all you need to know about that. If the tobacco industry are the only ones capable (both logistically and financially) of getting a device through medical licensing, what chance do the smaller manufacturers have?

The MHRA has been clear that they will consider licensing any kind of e-cigarette, from any manufacturer, which meets medicinal standards and that they can license devices separately from liquids. There is every reason to believe that a wide range of e-cigarette type products will be able to achieve a licence as medicines, and will do so if there is a market for them.

Hate to burst your bubble there ASH, but it’s unlikely any manufacturer other than a tobacco company will submit a device for medical licensing, no matter how often you suggest it is the “best route”. No one wants a med-e-cig and the e-voke will likely never see the light of day. Give it a rest.

Small Business

The e-cigarette market is a rapidly evolving one. As with many innovative disruptive technologies it started as a market with lots of small companies and a great deal of product innovation.
In recent years the market has begun to consolidate with larger companies buying up smaller operations. Regulation will change the shape of the market, and it is reasonable to say that regulation often benefits larger companies with greater resources. However, it is Government policy to support small businesses, so in developing and implementing the new Regulations it is required to have regard to the specific concerns of this sector.

There is an interesting nugget there – it is reasonable to say that regulation often benefits larger companies with greater resources – as in the tobacco companies. Smaller vendors will get bought up and the tobacco companies will gain a much stronger foothold into an evolving industry. The TPD – caring for the tobacco companies since 2013.

So much wrong with the briefing and very little right. The TPD opens a lot of doors for some very slippery slopes – excise taxation on e-cigarettes (which some EU Member States are already considering), incorporation of e-cigarettes in existing smokefree legislation (looking at you Wales) and disproportionate regulation on advertising and cross-border sales (some Member States can, and will ban cross-border sales despite it not actually being in the Directive).

I’m not averse to sensible, proportionate regulation of e-cigarettes, but that is something the TPD most definitely is not. While the Directive isn’t necessarily treating e-cigarettes as harshly as cigarettes, it isn’t exactly going to be beneficial to them either. If the regulation was based on the continuum of risk, there wouldn’t be any need for the extensive and burdensome Article 20 in its current form, instead we have the most draconian implementation of the precautionary principle with a smattering of “we just don’t like it”.

#Brexit

6 thoughts on “The Impact of the TPD

    • More like an unnecessary and highly damaging ten-car pileup… ;)

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    • Not completely no, it could easily have been much much worse. At least our Government, specifically the MHRA are listening and doing what they can. It’s still a big pile of festering dingo kidneys, but I’ll take what leniency I can.

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  1. Wouldn’t #Brexiting do nothing to change the TPD and it’s implementation though, considering a) it’ll be in place before the vote and 2) it’s likely to be (at the very least) a year before anyone thinks of reviewing the directive? Or have I got it wrong? To be honest, I’m still undecided which way to vote – but I’m erring towards fleeing the sinking ship early before the EU inevitably falls apart in the not too distant future ;)

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    • In the short term, no Brexit won’t make a huge difference. The UK, by and large has been as light touch as the festering pile of dingo kidneys that is the Directive has allowed them to be. True there’s still a lot of things utterly wrong with the implementation, but at least vendors won’t be paying over the odds for notification. I’ll take the small leniencies where I can.

      If we do jump ship, and I sincerely hope that we do, then there’s the 2-5 year actual exit whereupon there’ll be trade negotiations, and all sorts of shenaniganry. Possibly during that time a review of the laws imposed on us by the Commission and some of them will most likely be struck down.

      Longer term for exit, will likely see the implementation of some proper standards via CEN/ISO (which are being worked on and have been since the BSI PAS last year), but the CEN/ISO is still a good 3-4 years away, at least.

      If we don’t exit, which is a major concern for the sanity of those that actually vote that way (imo), then the first review is no later than five years after implementation (which is 2017 for our full implementation). If I recall correctly, there is a clause which allows for an earlier review should there be a significant change in the evidence (which there has been).

      Basically, either way the ref goes we’re kinda stuck with what we have for the immediate future. Unless our Government grows a backbone and says “No, we are not going to implement that festering pile of dingo kidneys” – which is unlikely.

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