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UK’s MHRA to regulate electronic cigarettes as medicines

In April of 2010, I attended a meeting with the MHRA at their London headquarters by the River Thames. The meeting was convened by the regulators to discuss Nicotine Containing Products (NCPs) with stakeholders. I smuggled my way in, despite not really being a stakeholder in the sense that they meant.

It turned out to be quite a significant day. The vendors who attended the meeting went on to form ECITA, the UK's e-cigarette trade body, in a pub at the back MHRA towers. But the event itself was pretty bizarre. In 2010 you could still meet people who had never heard of electronic cigarettes - in fact, most people had never heard of electronic cigarettes. The MHRA had heard of them, but they'd also heard of nicotine water and nicotine lollypops, and they didn't really know which of these products was most significant. It came as some surprise to them that every one of the 20+ vendors in attendance was an e-cigarette supplier.

We sat through a presentation by Jeremy Mean, a very likeable man, who explained that the MHRA had a legislative duty to regulate these products since "they had an appreciable effect on human metabolism", and that they were accordingly mandated to look at how they should be regulated. We were then told that there were 3 options available to them (do nothing, regulate as medicines, regulate under another system) and then we had a Q&A. It didn't really feel like much was achieved that day, and the next we heard from the MHRA on the issue was today, 3 years later.

Meanwhile in Europe, The  new Tobacco Products Directive (TPD) has been, slowly, making its way through the judicial process of the European Parliament. In the first draft, the section on electronic cigarettes proposed to ban any e-cig containing more than a trivial amount of nicotine, save for ones which received medicinal regulation. More recent drafts (amendment 1250) have proposed to allow them on the market, but to remove flavorings and to establish regulatory burdens (authorisations) that will cause many suppliers to cease trading.

The MHRA's announcement today (June 12th) makes it clear that they view medicinal regulation as necessary. However, they are waiting for the TPD to formalize the regulatory framework, a process that, according to ASH UK (pdf), will be complete next year. In other words, the MHRA aren't actually going to do the regulation, but are going to implement the most severe interpretation of the EU regulatory structure once it's passed into law. However, if they are wavering on whether or not to regulate as medicines, why are the MHRA annoucing this now?

It looks to me like the MHRA's announcement is an attempt to force the EU's hand, while not actually doing anything themselves. Additionally, by making the announcement now, when the ban comes up in 3 year's time, the MHRA cannot be accused of not giving suppliers enough time to comply.

In the end, though, if medicines regulation is the way that this goes, who stands to win? What is the bottom line for consumers and the industry?

Currently, the only company that is actively pursuing medicines regulation is CN Creative (Intellicig), which was bought by British American Tobacco last year. So, assuming that they are the only ones to have completed the licensing procedure by the time this regulation goes 'live', we'll be in the amazing position that the MHRA's decision has directly handed this entire industry to Big Tobacco!

From the consumer's point of view, this regulation will do 2 things. Firstly, it will increase prices - all this licensing has to be paid for, and fewer competitors in the market means higher prices. Secondly, and this is far more important, almost all of the products that vapers want and need will no longer be available. Flavored liquid? Gone. APVs and associated consumables? Gone. All that will be left are a few devices, completely uncustomizable, and useless for the majority of vapers.

So, is this all going to happen? Are we really living in a golden age of vaping, never to be repeated? It's not finished yet, and the fight is still on. But the omen's are not good, and today is a bad day for European vapers. But what will the effect be elsewhere? Thankfully, in the US, the supreme court has already declared that e-cigs cannot be regulated as medicines, but that's not to say that the FDA won't use the EU situation to tightly restrict sales. The next few weeks are going to be even tenser as we await the FDA's ruling.

In the meantime, here are two excellent blog posts which outline exactly why medicines regulation is completely wrong for e-cigarettes: Clive Bates' (former director of ASH UK) on "10 reasons not to regulate e-cigarettes as medicines", and Dr. Farsalinos on "MHRA has decided to ban e-cigarettes"

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