Thursday, June 13, 2013

MHRA decision on e-cigarettes, CASAA’s take on the implications

No doubt you have already heard about the decision about e-cigarettes by the United Kingdom’s MHRA (for Americans who may not know, it is basically the equivalent of the drug regulation arm of the FDA).  MHRA has declared that by 2016, e-cigarettes, as part of the category “nicotine-containing products,” will be regulated as drugs (or “medicines” as the say in the UK).  This might require every e-cigarette variety to go through a lengthy and expensive applications process in order to stay on the legal market.  

Naturally, this has produced a huge uproar among e-cigarette users, merchants, and advocates.  There are very reasonable fears that the implementation could kill the legal market for e-cigarettes (and create a completely unregulated black market).  There are also protests that this is dishonest and anti-public-health, which are well supported by the MHRA’s own announcement statement.  MHRA recited the usual lies about how medicinal nicotine products (NRTs) are a good substitute for e-cigarettes.  MHRA also claimed there is a dire need for regulation because there is something dangerous and scary about e-cigarettes and further claimed that the free market is not serving consumers well.   

CASAA agrees with the observations that treating e-cigarettes as drugs is grossly inappropriate.  There is no doubt that it will hurt consumers and public health.  Obviously, it is insane to do anything that would make e-cigarettes far more difficult to obtain and less enjoyable than cigarettes, but that is almost certainly what even a reasonably sensible version of a medicines classification will do.  Moreover, while no consumer wants a needlessly toxic or mislabelled product, it should be an individual's prerogative to choose to accept possibly slightly higher risks (from, e.g., higher nicotine strengths or flavorings) in exchange for greater satisfaction.  Government standards are likely to arbitrarily prohibit such reasonable choices.

But exactly what is going to happen is far from certain.  Calling an e-cigarette a drug (or a tobacco product, for that matter) is just legalistic semantics, of little consequence in itself.  As is so often the case, the devil is in the details.  And in this particular case, there seems to have been little attention devoted to just how daunting those details will be.

As with the pending FDA regulation of e-cigarettes, as well as the existing FDA regulation of most tobacco products, this seems to have set the parameters of the decision-making process (or “the fight,” if you prefer) rather than the rules.  It is a very long time in e-cigarette years until 2016.  It is quite possible that the announced plan will not stand, but it is certain that if it does, there will need to be a great deal of work put into the details.  Currently the only application process available for e-cigarettes to be granted medicines status (which has been an option for several years, and there are two applications in process) is expensive and effectively locks in the characteristics of a particular product.  If that is the system still in place in 2016, it will indeed effectively ban all but a few e-cigarettes.  But whether that will be the system or whether more flexibility will be allowed remains to be seen.

In the US, the 2009 federal court ruling on e-cigarettes prevented them from being regulated as drugs unless therapeutic claims were being made in the marketing of the product.  Instead, e-cigarettes are (apparently) on the way to being regulated like other tobacco products, which is to say they will be consumer goods, albeit heavily-regulated consumer goods.  The UK had no such court ruling, and the merchants and advocates there hoped to carve out a regulatory definition of e-cigarettes that was neither medicines nor tobacco.  As the MHRA noted, e-cigarettes are currently regulated as consumer products in the UK, but without the “safe haven” of tobacco regulation, the health regulators remained in a position to assert control, and it was probably too optimistic to expect they would not do so.  They could have proposed a new form of lighter-touch health regulation, but regulators are seldom very good at creating new categories from scratch, even if they want to.  In the US, we already had the new, heavily-regulated consumer goods category of tobacco in place, but in the UK there was no such niche, so they are proposing fitting e-cigarettes -- very awkwardly -- into medicines regulation, a round peg in a square hole.

But one important consideration is that all of the questions about how MHRA will implement this may be moot.  Currently the European Union is considering the scheduled revisions of its Tobacco Products Directive (TPD), and this will probably include regulation of e-cigarettes.  As you probably have heard, the original proposal would require medicines approval for any e-cigarettes with more than 0.4% nicotine solutions (4 mg/ml), which is basically the same as just requiring medicines approval.  But there have also been more than a thousand proposed amendments to the proposed TPD, and so it is not clear what will happen with e-cigarettes.  (Sadly, the hope of using this TPD revision to lift the anti-public-health ban on snus in Europe was clearly a non-starter.)  EU regulations take precedence over almost all regulations by the member states, so MHRA may not need to figure out how to implement its announcement.

The timing of MHRA’s announcement about something planned for 2016 appears to be a bald attempt to influence the EU’s TPD.  MHRA could have easily delayed its announcement of vague far-future plans a few months until after the TPD decision was made.  Indeed, since the TPD could render this plan moot, a delay by MHRA would have made sense -- unless, of course, the goal was to push the EU toward “medicines only” regulation of e-cigarettes.  If the EU takes its regulatory cues from the most extreme of its members, as it often does, MRHA’s announcement could be the push that causes a Europe-wide de facto ban on e-cigarettes.  Moreover, unlike the UK proposal, which would ensure that at least a couple of products were approved to remain on the market before the rule took effect (a terrible substitute for the current market, obviously, but at least not nothing), the EU does not seem to have much compunction about imposing draconian rules rapidly and without any regard for sensible transitions.

With that in mind, it seems like the best vapers (and potential vapers) in the UK can hope for is that MHRA will indeed have to figure out how to implement its announcement.  Unlike the FDA, MHRA has no mechanisms in place for regulating consumer products, but some such mechanism is going to be needed.  A million highly-dedicated vapers, as there will be in the UK as this process unfolds (along with a few million other interested citizens), will make it very difficult for MHRA to shoehorn this regulation into a typical medicines regulation, even if the citizens cannot succeed in reversing the decision.  Though MHRA chose not to propose it from the start, it will probably be forced to create an entirely new regulatory mechanism, similar to the FDA’s ongoing struggle to figure out how to regulate tobacco products.  If the EU does not take the bait and bail them out by preempting their decision making, MHRA will probably regret making this move.

The long lead time also means that MHRA will be hoping that the FDA will rescue them if the TPD does not, giving MHRA a roadmap for building this new area of regulation.  So while this seems to increase the UK’s influence on international e-cigarette policies (because MHRA has made a move), it may actually increase the importance of American e-cigarette policy.  We hope that CASAA’s supporters will keep up their efforts to influence US policy, because everything is still in play.  We should stay calm and carry on with the fight.

1 comment:

Junican said...

A belated comment (been on holiday) - the MHRA has taken down the webpage which outlined its plans.