Less than a month ago, on December 19th 2012 to be exact, the news from the EU of the proposed updates to the “Tobacco Products Directive” hit the Internet (download here) . As a part of these new directives the proposal to regulate eCigarettes is a significant part of it. Reviewing the directive in detail, and thinking about them and how they might ultimately play out I’ve decided that the EU might be on the best possible track. When you consider that European governments love to regulate, well, everything, what they propose is pretty tame. Hell, it’s almost downright conservative.

Before I get into it, here’s a copy of that specific part of the proposed legislation (with UK spelling to boot!).

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3.7. Nicotine containing products (NCP)
NCP fall outside the scope of Directive 2001/37/EC and Member States have so far taken different regulatory approaches to address these products, including regulating them as medicinal products, applying certain provisions that are used for tobacco products or having no specific legislation.
The proposal stipulates that NCP that either have a nicotine level exceeding 2 mg, a nicotine concentration exceeding 4 mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance24. NCP with nicotine levels below this threshold can be sold as consumer products provided they feature an adapted health warning. The nicotine threshold identified in this proposal has been established by considering the nicotine content of medicinal products
(Nicotine Replacement Therapies, NRTs) for smoking cessation which have already received a market authorisation under the medicinal products’ legislation.
The proposal removes current legislative divergence between Member States and the differential treatment between Nicotine Replacement Therapies and Nicotine
Containing Products, increases legal certainty and consolidates the on-going
development in Member States. It also encourages research and innovation in
smoking cessation with the aim of maximising health gains. Given the novelty and rapid increase of the NCP market as well as their addictive and toxic character there is an urgency to act, before more people – unaware of the content and effects of these products – inadvertently develop a nicotine addiction.
The labelling requirement set out in this proposal for NCP containing nicotine below the identified threshold will better inform consumers about the health risks associated with the products.
It might also be worth noting that by the time any of this is formalized and enacted into law the UK may not even be a part of the EU. The UK has been grumbling about some of the crap that the EU has done since its formation back on February 7, 1992 (20 years now!), or proposing to do in the future, that the threat of pulling out of the EU is always in the air.

Okay, now, let’s get on with it.

Above a certain threshold…

The EU Tobacco Directive sees, in my interpretation anyway, eCigarettes as existing in two categories; one is medicinal and one is, for lack of a better word, recreational. This isn’t a bad way to think about eCigarettes if you think about it. Hell, it’s the way I think about them. They are medicinal when someone is kicking the analog habit, and they are recreational when that habit is kicked and vaping turns into a hobby. (Where the fun begins!) However, in order for eCigarettes to even be considered as smoking cessation products the law there would need to be changed for that alone.

ECigarettes that fly under that ‘certain threshold’ the EU proposes basically nothing new. “Go ahead, knock yourself out” is pretty much what they seem to be saying. As for the warnings that would be placed on the products that fly under the 4MG directive, the worse that could be said, “WarningNicotine is addictive. Best you not go there.” Well, one would think anyway…

Anything flying above the threshold will see a more regulation. Let’s take a look at the ‘above the threshold’ proposals first.

4MG nicotine

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If a vendor sells eLiquid, or cartomizers with eLiquid already in them, containing more than 4MG of nicotine the product would be labeled as a ‘medicinal product’. It would have real benefits to the analog user (debatable to some, not to me). We can debate that 4MG threshold, and they we will for the next 3 years, but it’s a start. Anyway, they (the above 4MG eLiquids) would be treated like any other NRT (nicotine replacement therapies) such as nicotine patches, gum, and so on. In other words, any eLiquid vendor can make eLiquid with levels of nicotine that will benefit the nicotine-addicted and sell them pretty much wherever these other products are sold.

As for the restriction of flavors and whether or not any new proposal would require eCig companies to withhold flavoring, as I read the proposal I see nothing concrete that would apply to eCigarettes directly. To me it seems as though the EU commission doesn’t see eCigarettes as “tobacco products“. Any measures to limit flavoring would not apply.

I don’t live in Europe (though I would love to spend the next 4 years there), but I do know that you can buy nicotine patches without a prescription in the UK. That being the case I doubt there is any danger of losing your ability to buy eLiquids with various levels of nicotine (within reason) wherever you are currently buying them. I can’t quite imagine having the local drug store be the only place to purchase them. In addition to spending the next 3 years considering the 4MG level as being the cutoff I’m sure there will be plenty of ‘consideration’ about where you can get eLiquids. The system they have now, with vape shops and the Internet, is working so I don’t see any changes about availability coming down the pike.

Even their “Cross Border” proposal isn’t all that restrictive for a socialist continent:

3.5. Cross-border distance sales of tobacco products
Cross-border distance sales of tobacco products fall outside the scope of Directive 2001/37/EC. The proposal includes a notification obligation for retailers of tobacco products intending to engage in cross-border distance sales. The proposal allows Member States to require the retailer to appoint a natural person, who ensures
ompliance with the Directive of products delivered to customers in Member States concerned. Mandatory age verification mechanism is also foreseen.

The proposal facilitates legal activity without removing any sales channels, while allowing consumers legitimate access to tobacco products not available on their domestic market. It reinforces the effect on the internal market by preventing
purchasing of products not complying with the provisions of the Directive, including health warnings in the right language and ingredients regulation. It also aims at addressing underage purchasing. An unintended side-effect is that the proposal will reduce the availability of cheaper products not respecting national price policies.

There are a few other positives that can come out of being labeled “medicinal products” as well. Higher quality eLiquids for one, accurate nicotine levels for another. Most importantly it might make getting into the business of selling eLiquids a little harder, and I certainly wouldn’t mind it if the eLiquid vendor I bought from had to be inspected or maintain a license to sell the product. I have no doubts about the companies I buy from because I vet them pretty well now. If the EU proposals come to pass ‘as is’ the governments there will also vet them.

About the only thing negative about these proposed regulations is the cost to the consumer. Surely, any regulation is going to drive costs up and those costs will be passed on to the customer. As long as the costs remain substantially lower than analogs I can live with it. Well, I think so anyway, it really depends on how badly our economy is managed moving forward in the second-term of Obama-nomics.

Like I said, the truth is that electronic cigarettes are medicinal at first, why try and hide that? Afterwards, when the hobby part of vaping begins, it’s not medicinal. Again, why hide it?

Under 4MG

From what I understand, if eLiquids are produced with under 4MG of nicotine they would pretty much be considered recreational. I take that to mean that the EU has accepted the fact that eCigarettes are basically harmless. That is a major victory for Vapers. I want the FDA to think the same way.

New Vapers come from the land-of-analogs and are in need of higher nicotine eLiquids. As these previous smokers adopt the eCigarette into their lifestyle they get healthier and the only thing they are left with is the nicotine addiction, which is also basically harmless, or at least no more harmful than a cup of coffee. But, as Vapers move from novice to veteran many of them begin to move down the nicotine path, going from 24mg to 18mg, then 12mg, and even down to 6mg or lower.

Sure some people want to stay at the higher levels, and they can, but lowering the nicotine levels in your eLiquids allows you buy less expensive eLiquids because those regulated under the ‘medicinal’ label are surely to be more expensive. Remember, 4MG of nicotine and under isn’t regulated as medicinal so the cost passed to the consumer will (hopefully) be less. That’s an incentive to lower your nicotine levels right there, but not to stop vaping.

3-Year Consultation

None of these proposals are law right now. There is time to negotiate a better directive and I’m sure that as more science lends credence to the safety of vaping a more lenient deal can be worked out.

For the next three years the EU will explore the implications of these proposals, as they should. They could change their minds and go in either direction. If, during the 3 years, it is revealed that eCigarettes are more dangerous than believed the proposals could change. How is that a bad thing? If eCigarettes can cause cancer I want to know. If the 3 years of consultations reveal that eCigarettes are even more harmless than we believe now, at higher nicotine levels the proposals might also be less intrusive. Perhaps the medicinal level will be raised to something like 12MG.  I know, I know, wishful thinking.

In any case, I think it was a wise move to take 3 years to think about it, investigate it, and to come to a fully formed decision. In the meantime “go about your business and vape as you usually do” is the attitude I’m hearing from the EU Directive. Sounds a little like freedom from where I’m sitting.

What Vapers Know

We all know that vaping is a thousand times safer than smoking. Hell, not only is it as safe as anything else, it is the only viable (read: successful) alternative to smoking cigarettes. We’ve all seen the data on nicotine patches, gum, and all the other products out there. None of them work. No current NRT works any better than placebos.  The electronic cigarette, on the other hand, does work.

 Opinion-EU-Feature

No one in their right mind thinks smoking cigarettes is not dangerous. This has been drilled into us since the 60’s and has firmly taken root. Still, 20% of Americans still smoke. Give them a real alternative, a great tasting; easy-to-use electronic cigarette and they will leave tobacco cigarettes behind in droves. You and I have seen it happen over and over. It worked with us, it worked with our vaping friends. There is no getting away from the success rate of the electronic cigarette.

In conclusion…

I could be wrong, but I see the EU’s proposal as probably the best government intrusion anyone could expect. There is nothing better than self-regulation but in this current age of nanny-to-grave mommy states where millions of people gladly turn over their personal freedoms in exchange for a free cell phone and a welfare check, minimal regulation like the EU proposals are better than I think will happen here when the FDA finally makes it move. I still believe that will not happen in 2013, but it will happen. I’m convinced of that now. Probably some time after the government runs out of new regulations. At the rate they are posting new regulations to the government websites (4200 and counting) that could be sooner than I thought.

For those of us in the United States I fear that in our current culture of “socialism is awesome payback for all those nasty rich people that I’m completely jealous of” we can expect our fearless leader and his minions to regulate the shit out of eCigarettes and everything else they can get their corrupt little hands on (Boy am I a negative-nancy when it comes to our government or what?). So, those of you in Europe and the UK, thank your lucky stars that the EU proposal as it pertains to the regulation of ecigarettes is pretty damned mature and sensible, from a government standpoint anyway. You could here, don’t forget that.

John Manzione

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