EU News of a flavored cigerettes ban in the EU, and bad news for ecigs.

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tommy2bad

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Governments weaken EU tobacco curbs to secure agreement | Reuters

The really bad part for us;
As concerns grow over the unregulated use of increasingly popular electronic cigarettes, ministers tightened proposed controls by agreeing that those containing 1 milligram (mg) of nicotine or more would be classified as medicinal products requiring prior EU marketing approval.

That also applied to e-cigarettes containing 2 mg or more per milliliter for those that mix nicotine with water.
Anyone care to explain the water thing? I don't understand what difference water makes?
 

Sophora

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Not sure what is meant there, not even sure if the 2 mg is true or not.

Here is the press release of the meeting of June 21st:
http://www.consilium.europa.eu/uedocs/cms_data/docs/pressdata/en/lsa/137571.pdf

nicotine containing products (such as electronic cigarettes); these products
would be allowed on the market below a certain nicotine threshold provided
they feature health warnings; above this threshold such products would only be
allowed if authorised as medicinal products (e.g. nicotine replacement
therapies);
 

tommy2bad

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So all the bluster from out health minister, who btw chairs this meeting is just that; bluster?
It seems from the press release that they have agreed to impliment whatever is passed under the TPD, well duh!
Color me surprised ! Looks like this isn't going through fast and they need to do something that makes them look like their doing something.
 

gayhalo

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As far as I can see the UK HMRA were meant to ban e cigs this month but if they tried it would have gone to court as they have no mandate or law to make e cigs medicine. Go to the HMRA website and read the about us. It says

But what is, and is not, a medicine?
The law defines a medicine as something used in disease, whether it is used to prevent, treat or diagnose it, in anaesthesia, investigating conditions or interfering with the normal operation of the body. It does not include such things as contact lens fluids, food supplements and cosmetics.

Many factors are considered in deciding whether a product is actually a medicine such as what it contains, what it’s advertised or used for, the way it will be used, any particular targeting of the marketing information and what the promotional literature says.

Claims that a product 'supports' health or a healthy lifestyle is not usually considered as medicinal. Control of medicines starts as soon as they are first discovered and tested in healthy volunteers, all the way through to when a company wants to change the conditions its products are approved for, such as changing the colour of the tablet or what it is used for.

What ever way you read this e cigs are not medicine. I will admit everyone should continue to be careful not to make any health claims or cessation claims as these would open the door to them being medicine.

I think their statement (also on their website) is a copout as they could not go against the EU neither could they go it alone. They are relying on the EU to do it for them. I think we can forget the UK for the time being and concentrate on the EU. I have written to my Euro MPs and have had some positive replies. This post is getting out of hand but let me share one reply with you..

Dear David
Thank you for your recent email concerning possible proposals to introduce MORE EU regulations on tobacco/smoking alternative related products. We would oppose this in the EU Parliament, thus Nikki will be vote against any proposed directive or amendment that would legislate goods such as these sold in the UK .
These proposals if passed would only add to the growing already very BIG list of reasons why we'd be better off out the EU!!
The smoking community needs EU intervention like a fish needs a bicycle – If changes need to be made, those changes should be taken by our democratically elected politicians in Westminster, not by faceless bureaucrats in Brussels.
Yours sincerely,

Office of Nikki Sinclaire MEP - We DEMAND A REFERENDUM MEP for the West Midlands Region
 

gayhalo

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I wrote my last post before I had read the Reuters thing. I have written to all my EU MEPs in the last dive minutes asking ....

Thank you for your reply. I notice today that the EU health ministers were making decisions today on e cigarettes. It looks like anybody in the EU parliament can make decisions on this subject with no democratic representation from the people it affects and no application of the science behind the subject. Do the EU want to kill millions of their subjects, is it that expensive to keep us into old age.

My be a bit over the top but we have to try.
 

rolygate

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As far as I can see the UK HMRA were meant to ban e cigs this month but if they tried it would have gone to court as they have no mandate or law to make e cigs medicine.

There was a lot of fuss over this but all it turned out to be was a PR from the MHRA, designed to provide support for anti-ecig votes in an EU committee that same week. The MHRA can't ban ('regulate') e-cigarettes as a medicine because it would be overturned in court. They will have to wait until the EU does; and that will also probably be overturned in court, at the ECJ in Strasbourg.

What is likely to happen now is this:

1. The new TPD contains provisions to make (a) some e-cigarette products medically licensed, and (b) some will become tobacco products.

2. It has to go through several more stages in the EU (then in each country) before it becomes law. It is likely to pass all those stages (plenary, council, parliament, notice of adoption by EU). It is then clear to be adopted by each of the 28 countries.

3. Once the new TPD passes and is adopted by the EU, it needs to be reinforced by implementation of the same law in each country before it becomes a legal statute for that country. (This is called the transposition or mirroring procedure.)

4. The trade will challenge any pharmaceutical licensing provisions for ecig products both in individual countries and at the ECJ (European Court of Justice in Strasbourg). They are almost certain to succeed because there is a significant volume of case law in Europe and elsewhere showing that courts do not consider a medical license for consumer products can be supported (and the subtext is that they do not agree that the pharmaceutical industry should be able to use the law to remove commercial rivals). In addition the ecig-related provisions of the TPD will break two principal EU statutes and would be expected to fail at law for those reasons, in addition (the principles of proportionality and free trade between EU states). Indeed the EU's own JURI (law) committee has already stated the ecig provisions in the TPD will fail.

5. The TPD, though, appears to contain tobacco classification provisions that will be much harder to defeat if applied to ecigs. For example, all flavours in tobacco products will be banned (even including menthol) if the TPD passes. The assumption at present is that this is pharma's Plan B for when medical licensing fails (as they are sure to know is likely). No flavours basically means no e-liquid, so you can see what the problem is.

6. This will be stage 1 for pharma's backup plan to remove ecigs in Europe; every couple of years will likely see a new TPD with more 'tobacco product' restrictions that can be applied to ecigs (no web sales, no strength over 12mg, etc).


At any rate this is how I figure it will play out. To suggest that pharma is too stupid to realise that medical licensing will almost certainly fail at law, when they have spent millions of Euros on this TPD process, doesn't make any sense. Therefore they must be banking on the tobacco product restrictions to do the job. As yet no one has contradicted me on this, or explained why this wouldn't work.

So my guess is that ecigs will be shifted over to a tobacco classification when the pharma classification is overturned.

As far as the consumer is concerned, there is a long way to go yet. No need to worry.

As far as the trade is concerned (in the EU), there is a desperate need for all vendors to join some sort of a trade group (or set one up that is cheap to join) in order to work together on this. That applies everywhere of course. Every vendor everywhere should belong to a trade organisation, and if there isn't one appropriate or affordable, they should get together and form another one. Divided we are an easy target. Unless of course the vendor is just in it for a quick buck and doesn't care if the market is shut down in a couple of years.
 
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Barbara21

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<snip>
5. The TPD, though, appears to contain tobacco classification provisions that will be much harder to defeat if applied to ecigs. For example, all flavours in tobacco products will be banned (even including menthol) if the TPD passes. The assumption at present is that this is pharma's Plan B for when medical licensing fails (as they are sure to know is likely). No flavours basically means no e-liquid, so you can see what the problem is.
<snip>

I don't pretend to understand everything you wrote but I have a question regarding the sentence I bolded in the above paragraph. They couldn't ban the sale of flavorings, could they?

On a side note, I've spent a total of three weeks in Berlin this past year. I was sort of surprised that I did not see one vaper anywhere, even though I was constantly walking around and among people.
 

rolygate

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Yes Barbara you are correct, no one could ban flavourings although if they were sold by an ecig company there is always the possibility they will be open to prosecution. Be aware that the MHRA in the UK will use the law to its maximum potential to remove consumer ecig vendors. For example you will see dawn raids with a dozen or more officers, probably with some armed, on the vendor's home property followed by raids on the warehouse, all stock will be confiscated, and the harshest penalties available will be used ('selling dangerous unlicensed drugs' etc). Seen it all before.

Just now we don't know what will happen. It is likely that the trade will defeat the medicalisation regs at the ECJ in Strasbourg, followed by defeat of the individual country laws that transpose the EU law into national law. However this is not a certainty, just a guess based on past case law. There is always the possibility that pharma can buy a court somehow, in which case the law does not apply ($50m is small change for them).

Another possibility, even if these unjust regulations are overturned, is that there will be a period of time when the law stands and cannot be overturned. For example the FDA continued to block ecig imports even during the course of the legal process that successfully overturned their pharma-backed attempt to ban ecigs in the USA. So it is entirely possible that there will be a year of a total ban on e-liquid (as this is what the regs are attacking) before a medicalisation law can be removed.

If that happens then vendors will need to split their operations somehow: the hardware seems to be unaffected at this point (although we don't really know), so we're looking at a possible ban on refills if the legal process is delayed (or unsuccessful of course). What vendors could do is continue to sell hardware but move their refill supply offshore. As any refill with nicotine will be banned (by the provisions of the medicalisation law), and as any flavour will be banned (by the provisions of the tobacco products law, that as far as we can see will also be applied to ecig products) then it will not be possible to sell any refill with either nicotine or with any flavour. So there seems little point in selling flavourings (as the nic liquid will have to come from outside Europe anyway).

So as far as I can see, at this point (and we have no idea what will happen in any case as it is still all to play for), the only viable option might be to move e-liquid sales outside the EU. And even here there are multiple issues:

- Using a European country not in the EU looks problematic; Norway and Switzerland are probably out due to local law issues there (see the international legal status page on ecigarette-politics.com).

- Using a US operation is expensive for shipping.

- The MHRA are legally able to stop postal supplies of 'unlicensed drugs', which is what they will classify ecig refills as.

- Postal packets from the USA and China will be their #1 priority to stop and open. They have already run a successful pilot project to test their ability to do this.

- The best option for refills will be to smuggle them in as this is the safest route in, literally tons of illegal products are smuggled in all the time (cigarettes, alcohol, drugs).

- A website to sell the refills could be hosted anywhere outside the 28 EU countries, such as Norway, Switzerland or the USA.
 

evan le'garde

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Way i see it is only nicotine can be controlled by the concerned government departments whoever they might be. They can't touch flavourings, base liquids or hardware. So lets look at the market in a whole new way. You should still be able to buy everything else you need to vape from your vendor. Then just pick up some pure nicotine liquid >>> Pure Liquid Nicotine, Pure nicotine.... How many online sites sell that ! So if a vendor has problems with regulations , bans or whatnot then maybe they should be selling all the ingredients, including pure nicotine liquid, seperately or provide a link on their site.

I really don't see how any bans or regulations anywhere in the world could stop people from vaping. Just buy all the ingredients seperately !:)
 
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Cool_Breeze

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...As far as the trade is concerned (in the EU), there is a desperate need for all vendors to join some sort of a trade group (or set one up that is cheap to join) in order to work together on this. That applies everywhere of course. Every vendor everywhere should belong to a trade organisation, and if there isn't one appropriate or affordable, they should get together and form another one. Divided we are an easy target. Unless of course the vendor is just in it for a quick buck and doesn't care if the market is shut down in a couple of years.

I would hope that 'trade groups' wouldn't trade the interests of consumers for their own security.
 

Thin

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Then just pick up some pure nicotine liquid >>> Pure Liquid Nicotine, Pure nicotine.... How many online sites sell that !

I really don't see how any bans or regulations anywhere in the world could stop people from vaping. Just buy all the ingredients seperately !:)

It's already illegal to sell nicotine liquid over 75mg in the UK. It wouldn't be too difficult for them to change that level, or make it illegal altogether, so we'd be left with only the black market for our nicotine. Most law abiding citizens won't do that, and the new "highly regulated" e-cigs that we'll be able to buy from a pharmacy won't have enough nic in them, so the government win again as most vapers return to smoking, thus returning them to huge tobacco revenue.
 
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