NEWS
The Tobacco Products
Directive and
E-cigarettes – the end
of a golden age?
By Tom Pruen, Chief
Scientific Officer at ECITA
A
s everyone should be aware, the revised Tobacco
Products Directive (TPD) starts taking effect from
May 2016, and all products must be compliant with
it by May 2017.
But what does this actually mean?
The problem is, that we still don’t really know – but what we do
know is mostly bad news.
The TPD requires notification of various things to a government
appointed body, and in the case of the UK, this is the Medicines
& Healthcare products Regulatory Agency (MHRA). Historically,
the e-cigarette industry and MHRA have not enjoyed a good
working relationship, but there are some signs that this may be
changing (this is the only good news in an otherwise gloomy
forecast).
The list of what needs to be notified is, in theory, common
across all of Europe, a ‘Common Notification Format’ (CNF).
Notably, however, while the CNF requires “Name of the emission
produced during the testing of the product” and “Quantity of
emissions produced during the process of using the product
based on the measurement method used,” there is no guidance
on what emissions should be sought.
Modern analytical chemistry is very good at finding even tiny
traces of chemicals in almost any kind of sample, so to keep
costs and time to a reasonable level, it’s useful to know what to
look for.
Without a list of such things (usually referred to as analytes of
interest), the prospect is for identifying everything present in
the emissions, regardless of how low the level, or if there is any
perceived risk. As if that wasn’t bad enough, to give a quantity
of emissions requires additional testing, and these have to
be tailored to the specific chemicals being sought. The more
chemicals to measure quantities of, the more expensive the
testing will be, and the longer it will take.
Since the CNF doesn’t give a list of analytes of interest, it’s quite
likely that each member state will create its own – making the
CNF both uncommon and uncertain. So far, there is also not a
UK list of analytes of interest, so we don’t even know what the
UK position is.
There is worse though – the CNF also requires “Description
of the measurement methods used to assess consistent
dosing and nicotine uptake, including reference to the relevant
approved standard, when available.”
Dose is a very fraught term with respect to electronic cigarettes
– the way the product is used has almost as much bearing on
the nicotine delivery as the actual nicotine content. Worse still,
in the medicinal world, “dosage and uptake” is determined by
Pharmacokinetic (PK) testing.
24 WINTER EDITION VAPOUROUND MAGAZINE
Since this is a test on people, it is expensive, with a cost
upwards of £100,000 per test. Providing this for every single
product would quickly become prohibitively expensive for almost
every company in the market. But an alternative view (and one
that was suggested to the European Commission) is to look at
how much nicotine is delivered to vapour in a single defined puff.
This would cost more like £1,000 per product.
The cost per product notification, therefore, depends on
information that we don’t have, but could vary between a couple
of thousand pounds per product (already too much for some
of the smaller businesses in this market) to quarter of a million
pounds (which is too much for pretty much every business in the
market).
Regardless of what the scale of costs is, there is one clear
outcome of this – the number of products available will fall – and
fall sharply.
But it still gets worse than this – there is a TPD requirement
for the tanks/atomisers to be “leak free”. What this means in
practise isn’t clear, since the TPD gives responsibility to the
European Commission to design a technical specification
for a ‘leak free’ mechanism. The group working on this is not
expected to report back until the 2nd quarter of 2016 – too late
for this design to be incorporated into products prior to the TPD
taking effect. It’s also entirely possible (and in fact likely) that
this mechanism will be incompatible with ALL existing designs,
removing all the currently available products from the market.
The CNF matters here too. Notifications have to take place
6 months before placing products on the market, except for
products already on the market on 20th May 2016, in which case
there is a grace period until 20th November 2016. However,
with the ‘leak-free’ issue, it could well be that there won’t be
any existing designs that are TPD compliant, removing this
exemption.
Everything that isn’t TPD compliant, and notified by 20th
November 2016, has to be taken off the market by May 2017, at
the latest. Will there be time to incorporate the new mechanism
and get it notified by that date? We don’t, and can’t know. We
don’t even know what this mechanism will look like, let alone say
how easy it will be to incorporate it into existing designs.
Since a product has to be notified 6 months in advance of selling
it, at a considerable (but uncertain) cost, we won’t be seeing new
tanks or devices with the frequency we do now.
Exactly what the e-cigarette market will look like after the TPD is
uncertain, but it is implausible to think that it will have the variety
and innovation we see today. The future is uncertain, but it’s
looking very bleak.