EU Press release. MHRA proposal

[evan le'garde]

MHRA (Medicines and Healthcare products Regulatory Agency) Proposal announced to make all Electronic Cigarettes subject to medicinal regulation in 2016. After many years of discussions, the MHRA have finally made a statement in the news today that it is their intention that electronic cigarettes should be classified as ‘medical products’.
Many responsible suppliers of electronic cigarettes, and e cigarette e liquid have always insisted on the limitation of sale to adult smokers over the age of 18, and the sale of safe and quality products.
They follow the strict regulatory framework of Trading Standards that is currently in place for consumer products and CHIP packaging regulations, and also voluntarily adhere to ECITA (Electronic Cigarette Industry Trade Association) guidelines.
Whilst the MHRA ‘propose’ medicalization of electronic cigarette products in 2016, the decision now relies on developments within the EU’s tobacco Products Directive. There is every possibility that they will not be classified under medicinal regulations despite the MHRA’s announcement and news that has followed.
Governments in several EU member countries such as Germany, Netherlands and Estonia have already lost court cases to try and classify e cigarettes as ‘medical devices’, and remain as they should – as consumer products.
Clive Bates, a tobacco Control advocate and former Director of Action on Smoking and Health UK (ASH), said: “Medicines regulation should apply to medicines, and electronic cigarettes are not medicines. These products are consumer alternatives to cigarettes – they provide nicotine in a much less harmful way than cigarettes and manufacturers do not make health claims, so why should they face high regulatory burdens?”
So what now? The next stage in the decision has been passed to Brussels, and focus will return again to the Tobacco Products Directive. We hope that a sensible decision will be made in due course, and in the meantime electronic cigarettes and e liquids will continue to be sold as normal in the UK.



Pathetic isn't it !

 

[John Phoenix]

This is the Most important topic hitting the UK right now. This is the equivalent of the FDA in America regulating e-cigs as a medical device, and taxing them heavily. I'm not in the UK but some of us are discussing this on another forum. Here is what an AboveTopSecret.com member " Roguedesiner" has to say on page 2 of the thread.

The dust has settled (slightly) on this now, and it's possible to at least begin to build something of a picture of what's going on. It's not a pretty picture at all; I'm not given to wearing a tinfoil hat and shouting "conspiracy" from my lead lined basement, but everywhere you look it's a tale of deliberate misinformation, bad science and big money lining up against the e-cog industry and the users of its products.

So, first of all if the MHRA gets its own way over the issue of regulation, what does this mean for e-cig manufacturers and users?

Well, it's all in the licensing aspect as far as manufacturers are concerned. Each and every product they sell will have to undergo a licensing process. The cost estimates vary but it's not cheap. Unfortunately I have no solid verifiable information on these costs but it's reckoned to be from £60,000 and upwards just to begin the application process. For each and every product. Immediately, all of the small players, of which there are many, vanish without a trace. Jobs are lost, tax revenues are lost, consumer choice is diminished, but big tobacco and big pharma face fewer of those pesky competitors so that can't be a bad thing can it?

For the consumer this is going to mean a much narrower choice of products. This choice will most likely take the form of a cig-a-like device in maybe two flavours; regular and menthol. The flavours, of course, are themselves under attack from elements within the anti e-cig lobby who want to see all additives removed from them. Flavouring is an additive.

If the MHRA gets its way, the law of unintended consequences is going to come into play. Once regulated, e-digs will become "Licensed Nicotine Containing Products". Who can legally buy these in the UK? Anybody over the age of 12. Wait what? Wasn't one of the issues here to prevent children from using these as a gateway drug? Last time I looked, anybody aged 12 was classed as a child in this country. So… we want to protect children from e-cigs, and the way we're going to do this is by throwing away an industry wide voluntary code of practise whereby sales are strictly refused to anybody under 18. That doesn't make an ounce of sense; unless new legislation is brought in to create two tiers of LNCPs. One tier will, of course, comprise all of the currently available NRTs such as gum, sprays, lozenges and varenicline containing drugs. The other tier will be e-cigs. That's the only way it makes sense, to spend huge amounts of time and money on new legislation. Draw your own conclusions.

Jeremy Mean, the person at the MHRA who has been responsible for guiding this proposal towards regulation, has stated that none of the e-cig products currently available would pass the regulation process. This implies that every currently available product has been tested. Either Mr. Mean is incredibly ignorant with respect to the vast range of products currently available, or he is deliberately misleading people with this statement. Testing has NOT been carried out on every product that is currently available. In any case, how do you test against a regulatory framework that as yet doesn't even exist? Again, nonsense, confusion, obfuscation and deliberate misinformation.

So… what would get through regulation unscathed? Who can afford these licenses for their products? Follow the money. Which companies have very recently jumped onto the e-cig bandwagon?


Altria; the owner of Marlboro cigarettes maker Philip Morris
Reynolds American; the makers of Camel cigarettes
Imperial Tobacco (the same Imperial Tobacco who believed that e-cigs should be immediately regulated and removed from the market within 21 days)
Lorillard; the makers of Newport cigarettes
British American Tobacco



Again, draw your own conclusions. Interestingly this brings up another argument frequently trotted out against e-cigs - they look too much like a real cigarette and encourage smoking of traditional cigarettes. That's actually bad logic but it's a frequently used argument. So surely, these responsible companies won't be making cig-a-likes, will they? Well, actually yes they will be.

http://www.abovetopsecret.com/forum/thread953057/pg1