When e cigarettes first came onto the market in 2008 we were not allowed to say that they helped you quit smoking. If we did, we would have been shut down. Now, we have Smoking Cessation Services up and down the country plus Public Health England encouraging people to switch from tobacco cigarettes to the electronic ones.
The public health opportunity is in helping smokers to quit, so we may encourage smokers to try vaping but we certainly encourage vapers to stop smoking tobacco completely.
So how did we get here? How did a bunch of disparate ex-smokers change the minds of regulators?
2008/2009 – The Medicines and Healthcare Products Regulatory Agency (MHRA) sent out letters stating that we were not allowed to make any claims that e-cigarettes could help to stop smoking.
2010 – The MHRA return with a very short list of options for regulating the e-cigarette industry.
1) Regulate as medicines and remove from the market within 21 days
2) Regulate as medicines and remove from the market within 1 year
3) Do nothing
A state of panic was felt throughout the industry, thus pinpointing the ‘war on vaping’.
The MHRA held a public consultation on their proposals involving all ‘stakeholders’ and decided that they would do nothing for now, but would undertake more research over the next 18 months.
We thought we had won, but we were naïve in the extreme.
The Last 4 years…
19th December 2012 – The EU is raising its head and in comes the proposal of the European commission.
The European Parliament wanted to regulate e-cigarettes as medicine, which would mean the removal of all devices from the market.
With no support for the vaping industry and the EU commission being backed by the MHRA, the EU anti-tobacco lobby, the pharmaceutical lobby and all the EU governments it seemed like a losing battle.
Although, this was called the Tobacco Products Directive, we came to learn that this was all about regulating e-cigarettes.
Why was the EU rearing its head?
· The paradigm at the time was that if you use something to stop smoking or reduce smoking then it is a defacto medicine.
· The pharmaceutical lobby saw e-cigarettes as a threat to NRT’s. (which would have a fail rate of around 90% after a year)
· The anti-tobacco lobby saw e-cigarettes as another brand of cigarettes because they ‘looked’ a little smoking.
· Many parties stuck rigidly to their opinion that e-cigarettes are a gateway to smoking and aimed at children.
· Pretty much all parties against e-cigarettes depend on people continuing to smoke for their livelihood.
E-cigarettes being regulated as medicine would mean long term clinical trials, costing millions and taking several years. This would not be sustainable for the vaping industry and would pave the way for the pharmaceutical industry to monopolise the market.
The Battle Against TPD
As a nascent industry, we had very little idea of what to do or how to fight the EU, but fight we did. And we fought with our hearts.
An army of vapers rose up in big numbers and some key players included:
· Members of the European Parliament.
· Mark Pawsey MP and Lord Viscount Ridley.
· Vaping advocates that put pen to paper and wrote to the parliament.
· Some well-known scientists supporting the cause.
Then, of course Totally Wicked: We did our very best to inform our customers and indeed everyone we could as to why the TPD was such a bad idea, and we invited both MP’s and MEPs to come and visit TW and see the industry for themselves.
How the battle was fought
· Social media was utilised to spread awareness of the TPD and to reach out to scientists.
Vaper’s had to educate MEP’s and in particular Anna Soubry (secretary of state for Public Health), who thought e-cigarettes had been dropped from TPD.
This proved difficult due to ‘scare stories’ however vapers made progress, helped by the fact that more and more research began to unravel the positive effects of vaping.
It was clear to see that the TPD was to be rushed through to meet the agenda, which did not seem to involve the health of smokers.
Here’s a timeline of how the TPD ran its cause:
Aug/Sep 2013 – MEPs start to lay out their positions. Save E cigs write an open letter to the EU and managed to obtain 3000 signatures. This is then handed over to MEPs in Brussels alongside a press conference and individual visits to MEPs.
October 8th – MEPs say no to medical regulations.
October 2013 – EU Parliament then enters trilogue negotiations regarding the TPD. These are behind ‘closed door talks’ and are deliberately secretive.
November 2013 – we learn that the TPD will not to be debated in the UK parliament.
December 2013 – It is during December that we learn that the article within the TPD referencing e cigarettes (at this stage it was Article 18) is being markedly changed. To quote Clive Bates, “From behind closed doors in Brussels, an utter mess is emerging from the EU on regulation of nicotine containing products such as e cigarettes. Officials who seem to know very little about these products and appear to care even less about the users and the potential, are in a frantic huddle making up new legislation as they go along.”
Eminent Independent European Public Health experts write an open letter in the Times asking the EU not to bring in medical regulations via the back door, referencing the changes made in trilogue.
Jan 2014 – Martin Callan MEP explains the process of the TPD, now trilogue is complete.
Scientists write to the EU, regarding the misrepresentation of the e cigarette science by the EU. “The stakes are high, as smoking kills 700’000 citizens in the EU each year. Several of the recitals and provisions of Article 18 of the Tobacco Products Directive (TPD) which concerns e-cigarettes lack or misrepresent the scientific understanding of the relevant issues. This letter is to help you understand research findings relevant to the current TPD text.”
E cigarette Consumer associations write a joint letter to the EU, “They ask that e-cigarette regulation be based on proper and objective research and not on unproven prejudice.”
Environment, Public Health, and Food Safety (ENVI) committee is called upon by vapers to reject the changes made in trilogue.
The E cigarette Industry unites and write to the EU,” Changes made to Article 18 in trilogue arguably render it a new Directive and we note public health advocates of e-cigarettes and consumer groups are proposing that the European Commission should recommence the process and start a new consultation process on Article 18.”
The UK ban e cigarette sales to under 18’s, (no such provisions for this in the TPD). E-cigarettes are banned from the Commonwealth games.
European Free Vaping Initiative (EFVI) is launched. This is a European Citizens Initiative that needed 1 million signatures to invite the European Commission to make a legislative proposal and to look again at the TPD.
Feb 2014 – statistics show over 40’000 vapers make the switch from smoking to vaping per month. We find that Conference of Presidents decided there would be no split votes allowed on the new amendments from trilogue, so it was all or nothing. This caused some deep unease with many MEPs.
Feb 26th 2014 – TPD voted through.
Since the TPD was voted through, what was Article 18 became Article 20 as the entire TPD was re written and included the changes made in Trilogue.
October 2015 – TW challenged the TPD in the European Courts of Justice, ran a very successful campaign, but unfortunately was not successful.
Since then both Wales and Scotland wanted to ban e cigs in public places, but again the vapers united, fought and educated, and the bans have not occurred.
November 20th 2016 – TRPR rulings come in to force, banning the production and import of e-liquid in bottles with a capacity of over 10ml. These may still be sold until May 2017.
So what now?
We now look ahead to May 2017 when the bulk of TRPR regulations will come in to force. The key new rulings will include:
· Maximum 10ml capacity of e-liquid bottles.
· Maximum e-liquid strength of 20mg/ml. (2.0%)
· A maximum e-cigarette refill capacity of 2ml.
There were, and still are skirmishes and the odd guerrilla tactics coming to light from those that are ideologically opposed to vaping, but hopefully we are now well past e-cigarettes being de-railed due to ideology.
It has been an interesting journey from 2008 to now, not only with the changes in regulations, but the way vaping has brought together entire communities.
We still must remain vigilant, as there are still a few battles to be won, but vaping very much looks like it is here to stay.