New e-cigarette regulations are set to shake up the industry for good, as this year, for the first time since its beginning the industry will be scrutinised and inspected like it has never been before. The rapid rise of e-cigarettes meant that the government were a little late to the party in creating legislation proportionate to the evidence that exists on them. In their mission to keep up, the powers that be may have over-reacted and over-regulated. So How should e-cigarette companies stay TPD compliant?
Here’s how the new rules will affect you (vapers)
An in-depth analysis of the TPD
So the Tobacco Products Directive is not as scary as it sounds. Like many vapers you may be worried about the fate of the humble e-cigarette. And why wouldn’t you be? The heartless behemoth that is the EU threw down its mighty anvil like a paid judge’s hammer as they delivered their verdict on the future of the e-cigarette industry in early 2014. A little digging reveals that the particulars of that revised TPD (Article 20) was born out of sneaky, last-minute backroom discussions, where a handful of MEPs and commissioners drew up a whole raft of red tape to over-regulate e-cigarettes that was said to be designed on the back of a fag packet.
Fast forward two years and the updated new e-cigarette regulations are imminent, and so far, what has been clear is the lack of clarity surrounding the TPD. The regulations are due to be rolled out fully by May 2016, but exactly how the government will action certain things is still unclear. The Directive was targeted at the tobacco products industry as a whole. So it doesn’t take a genius to realise its flaw as after all e-cigarettes are not a tobacco product. They may have been unfairly included, but regulation of the industry was only a matter of time. So that’s not something we can dispute, as the European Union declared their position on the Directive which was agreed upon by its member states (including France, the UK and Germany) in March 2014.
The next step is how each member state will choose to enforce the new e-cigarette regulations. Totally Wicked, another e-cigarette company based in the UK challenged Article 20 of the Directive in a legal dispute and the Court of Justice of the European Union will determine whether Article 20 is in fact breaking the law with a verdict expected early this year.
Things are not looking good though as the European Court’s Advocate General delivered her findings concerning the Totally Wicked legal challenge over the New Year and they were largely in favour of the European Court, dismissing the e-cigarette company and their noble efforts. The findings are not legally binding, but are a clear indication of how the legal challenge will end. Assuming Article 20 is not overturned, here’s how it will affect you.
The proposed legislation will not mean the end of the e-cigarette industry
There is a looming fear and hype surrounding the introduction of legislation within the complex TPD. And some scaremongers have suggested an end to vaping, but this is just sensationalism. The new regulations are intended to create a safer approach for the industry with clarity and cohesion of product information a priority. Though their intentions may be good, not forgetting how this entire article was conceived, a prominent MEP, Martin Callanan summed up the verdict at the time saying “The majority of the Tobacco Products Directive is on the zealous end of the scale but we could have accepted it. However, what we could not accept is the draconian restrictions on e-cigs that were adopted.”
The new directive could see an end to large capacity tanks, less choice of e-liquid flavours and standardised refilling mechanisms. Doesn’t sound good does it? Furthermore, companies will have to decide how they will move forward. As a result of the TPD there are two avenues of operation an e-cigarette company can pursue in 2016.
Two approaches available to e-cigarette companies
The notification system
The first and most popular option is to conform to the regulations set out in the TPD. This will mean submitting notifications to the MHRA of products that contain or could contain nicotine in the form of e-liquid. The notification costs themselves are low, instead the costs involved with testing e-liquids in order to satisfy the notification system requirements will be expensive, estimated to be roughly £5,000 per product. However, manufacturers will not be required to submit notification for equipment such as mouthpieces or batteries. This is why smaller companies, especially e-liquid producers will struggle to keep up with the notification fees. The costs associated with this system are as follows:
· £220 for the first notification of an e-cigarette product.
· £60 per year for each additional product.
· £110 for modifications to an existing product, although businesses that expect to frequently customise their products can pay a fixed fee to allow several alterations – therefore, it would seem, getting a bulk discount on modification fees.
· £5000 for pre-notification testing of e-liquids per product
Medical licensing
The second and more expensive option is the medical licensing approach which involves getting a device or product approved by the MHRA, the government’s medical licensing arm, as a medicines product. This can cost upwards of £100,000!
British American Tobacco who own several famous cigarette brands such as Benson and Hedges, have been granted the first medicines licence for their Voke ‘nicotine inhaler’. Which isn’t really an e-cigarette as we know it. The licence was granted late last year by the MHRA and largely went under the radar. The decision to grant the licence has been met with a less than savoury reception. Mainly because of historical links between Tory candidates and big tobacco. It stinks. The implications are hard to get your head around. Just think, the same company that sells the cigarettes that will kill you, could be selling the solution to the NHS if they are offered on prescription.
Due to new product requirements outlined in the revised TPD regulations lots of different flavoured e-liquids and equipment has been discounted and are on sale, so you can catch a bargain on tonnes of vaping stuff right now.
