After the landmark decision from the European Parliament to not regulate e-cigs as medicines, the EU Commission – the arm of the EU responsible for proposing legislation – has pushed ahead and proposed a vastly disproportionate approach to regulating e-cigs. It’s so extreme that it isn’t going too far to suggest that, if enacted, it would constitute a ban of the vast majority of e-cigs on the market. If you’re an EU vaper and you happen to vape delicious flavors, buy anything from other countries, use tanks or refillable cartridges or buy e-liquids of over 20 mg / ml of nicotine, if this goes through, you can kiss your e-cigs goodbye. Needless to say, opposing this proposed legislation is essential for any concerned EU vapers.
ALSO READ: EU Approves Proposed E-Cig Legislation: A Disaster for Public Health
What They're Suggesting
There are a wide range of disturbing suggestions in the EU Commission’s proposed legislation, including:
- A maximum e-liquid nicotine concentration of 20 mg / ml (despite the EU Parliament’s suggested 30 mg / ml limit).
- No refillable cartridges or tanks will be allowed – single-use cartomizers only.
- No more than 10 mg of nicotine in any single cartridge.
- No flavors which aren’t already available in NRT (for example, Nicorette gum is available in a pathetic four flavors), “unless such a flavor is particularly attractive to young people and non-smokers.”
- Demands that e-cigs only “deliver nicotine doses consistently and uniformly.”
- Only high-purity ingredients free from contaminants are to be used in e-liquid manufacture.
- Bans any cross-border sales (so, no buying components from other countries online).
- Bans advertising except in trade publications, or “any form of public or private contribution to any event, activity or individual with the aim or direct or indirect effect of promoting electronic cigarettes” so long as they involve or take place in several member states (or if they have “cross-border effects”).
- Requests that manufacturers and importers collect and provide a wide range of information, including annual sales volumes, information on the preferences of consumer groups such as non-smokers and young people (as well as the “main types of current users”).
- Manufacturers, importers or distributors would have to establish and maintain a system to collect information about all suspected adverse effects.
For Vapers
For vapers, the potential impact of this legislation is immediately obvious. Effectively, this regulation means we’d all be relegated to cig-a-like devices with disposable cartridges at a maximum of 20 mg / ml of nicotine. Since a cartridge contains around 1 ml, this means that a cartridge could only really be filled with 10 mg / ml liquid, but most manufacturers only offer 18 mg / ml, 12 mg / ml and 6 mg / ml strengths. For 18 mg / ml, they could be sold with a maximum of around 0.55 ml per cartridge and for 12 mg / ml there would be a maximum volume of 0.83 ml per cartridge. Since no refillable devices would be allowed, you couldn’t even purchase your own liquid to re-fill a cartridge yourself.
This is absurd for numerous reasons, but the most important is the fact that e-cig users self-titrate (control how much nicotine they consume to create the desired effect on their bodies), as Dr. Konstantinos Farsalinos points out in a blog post shining a light on the discrepancies between the EU Parliament and Commission’s approaches to the issue. In other words, this wouldn’t reduce nicotine consumption or prevent any related health issues (for which there is no evidence in e-cig users); it would just mean that users would require many more cartridges per day for e-cigs to continue to be effective. And this is before we consider the undue waste it would create in comparison to refill cartridges or tanks in combination with e-liquid and the associated increased cost of sticking to cartomizers.
Finally, the proposed restrictions on flavors and online sales can only have one effect: to make life more difficult for vapers and e-cigs a less appealing alternative to smokers unable to quit using traditional methods who want to reduce their harm. The flavors available through NRT are inadequate, which is why you don’t find forums or review sites where NRT users suggest flavors to try to one another but e-cig related ones are widespread. A wide selection of flavors is one of the things which make e-cigs appealing, and internet sales open users up to both a wider range of both products and flavors.
For Manufacturers
For manufacturers, the proposals are equally terrible. Delivering a “consistent and uniform” dose of nicotine is irrelevant if these proposals go through, because all it would mean is that e-cigs would consistently deliver an inadequate dose of nicotine. Regardless of this fact, manufacturers would still be required to ensure their products deliver a consistent dose of nicotine. This is extremely challenging, given that voltage drops as a battery drains and the amount of vaporization (and thereby the amount of nicotine consumed) varies as a result. That’s why the e-cig you’re using now (regardless of what it is) probably wouldn’t be suitable under the proposed legislation.
The proposed requirement for e-liquid to be free from contaminants is one that is not even applied to NRT products, which contain roughly the same amount of contaminants as e-cigs. Big Pharma could continue to deliver the innocuously tiny quantities of carcinogens present in their gums and patches, but e-cig manufacturers would have to ensure that no such contaminants were present. In fact, this means that pharmaceutical grade nicotine wouldn’t be suitable for e-cigs, since the tobacco-specific nitrosamines come from the nicotine extraction process.
On top of this, there are the additional restrictions on advertising. Preventing specific types of business from advertising is obviously an issue if you’re thinking about fair rules for industry. For tobacco cigarettes – undeniable killers – the restrictions may be a little extreme (given that people still smoke in a world without cigarette ads) but are understandable. For e-cigarettes – probable life-savers – similar restrictions have no justification whatsoever. Of course, they repeat the oft-cited load of crap that “[E-cigs] … are increasingly used and marketed to young people and non-smokers.” Since this is in no way true, it would at least be prudent for them to present some form of evidence for this allegation, but they didn’t – presumably because there is no such evidence.
Protecting Public Health?
The core problem with all of these propositions is that e-cigs are dramatically and undeniably safer than smoking. Given the current body of evidence, even calling e-cigs “potentially dangerous” would be a challenge to justify. The sum of evidence thus far provides reason to believe that e-cigs have the potential to save millions of lives, and doing anything to limit their effectiveness could therefore be seen as putting those lives at risk. If these proposals go through, many e-cig users would be driven back to tobacco, or even – as Dr. Farsalinos argues – to the black market.
Public health commentator Clive Bates points out that alongside the deluge of moronic suggestions, the proposal does not follow the rules of good policy making established by the EU themselves. It’s not a revision of the existing content of Article 18, but effectively a new proposal entirely, being around five times longer than the original legislation. There has been no scrutiny from national parliaments, no consultation with researchers or affected parties and no justification provided for their proposed regulations.
What Can You Do?
So, what can you do? In his post on the topic, Clive Bates suggests that if you’re an EU resident you can contact your MP or MEP. If you contact your UK-based MP, “Ask them to (1) contact Jane Ellison MP, Minister for Public Health to put your views across or (2) contact colleagues on the European Scrutiny Committee to demand that this is scrutinised properly.” For MEPs, “Ask them to relay your concerns to those MEPs who are negotiating with the Council. These are:
- Matthias Groote (German S&D includes Labour) in the chair,
- Linda McAvan (British Labour / S&D)
- Karl Heinz Florenz (German EPP – the large centre-right grouping)
- Carl Schlyter (Swedish Green)
- Frédérique Ries (Belgian ALDE – group includes Lib Dems)
- Martin Callanan (ECR includes British Conservatives)
- Martina Anderson (Irish Nationalist)
- Giancarlo Scottà (Italian EFD right winger – his political group in EP includes UKIP)”
This should be done as soon as possible, with a deadline for comment set at as the 3rd of December, according to the ECF.
Conclusion
These proposals are – at best – a ridiculous, unjustified, counterproductive, scientifically-challenged and industry-decimating set of suggestions, and at worst, they could be construed as a cynical attempt to protect Big Tobacco and Big Pharma revenues. As an EU resident, I’m unsure which of these explanations I prefer, because at least if the proposals were cynically driven by backhanded bribes from potentially impacted industries then I wouldn’t have to deal with the notion that the European Commission is this monumentally incompetent.