EU 8th Ocotober 2013 : EU rejected ecigs as medecine !

[ournature]

the regulation approved today can be downloaded here:
Texts adopted - Tuesday, 8 October 2013 - Contents

i just read it, the paragraph about advertising says:

the limitations on advertising, sponsorship, audiovisual commercial communication and product placement for tobacco products as set out in Directive 2003/33/EC and Directive 2010/13/EC shall apply to nicotine-containing products;

It only applies to nicotine-containing products, that means e-liquid with nicotine and prefilled cartos or disposable products with nicotine juice inside.
It should not apply to hardware or PVs.
Then i assume you can advertise a non-disposable ecigarette or even a disposable if nicotine is not mentioned.

Am i wrong?

 

[BarryNorton]

Yes and so the UK's proposals to treat e-cigs as medicines is torpedoed today!

Please don't spread misinformation. The amended TPD - even if it passes as it currently reads, which is my no means certain - does not prevent the UK from implementing more restrictive legislation.

 

[maclean]

The article in The Guardian which Barry Norton linked to is definitely worth a read.

Menthol cigarettes to be banned by EU | Society | theguardian.com

The tone of MEPs comments towards e-cigs is vastly different to what we've been used to in the past - ie. ignorance and misinformation. Here are a couple of quotes.

While nicotine is the addictive substance that keeps smokers hooked, Cancer Research UK said it is the toxic cocktail of chemicals in tobacco smoke that kills half of all long-term smokers.

The lack of tobacco in e-cigarettes means they are "almost certainly" a much safer way of getting a nicotine hit than smoking cigarettes, it added.

Liberal Democrat MEP Chris Davies said after the vote: "E-cigs can be a game-changer in the fight against smoking. Hundreds of former smokers have written to tell me that they have helped them give up cigarettes when nothing else worked.

"They are successful because they are not medicines but products that smokers enjoy using as an alternative to cigarettes.

"Every year 700,000 people in Europe die of smoking-related disease. We should not do anything that makes e-cigs harder to obtain than tobacco cigarettes."

Conservative MEP Martin Callanan said: "Forcing e-cigs off the shelves would have been totally crazy.

"These are products that have helped countless people stop smoking more harmful cigarettes and yet some MEPs wanted to make them harder to manufacture than ordinary tobacco.

"I have received countless emails and calls from 'vapers' which were individual personal pleas, not a standard letter copied and pasted from an NGO website as we MEPs often see.

Just goes to show that action by individual vapers CAN make a difference.

mac

 

[Anjaffm]

Woohooo! Great find, maclean!
I happily shared it in the German vapers forum.

 

[Anjaffm]

HAHAHAHAHAHAHA

This comment under the Guardian article (page 2) hits the nail right on the head!
(pls delete this posting if it is not permitted to copy comments and paste them here)

toadalone Patrick Barry

08 October 2013 11:13pm


What was the argument for having eCigs a medical product?

Errrrr.... I can't remember!

So much crap has been piled onto the debate since the original proposal for the TPD (Tobacco Products Directive, or, as I now like to call it after reading this thread, Taco Products Directive) amendment that I can't remember what the original rationale was - if there was one. I suspect it went something like this:

1. People are inhaling something in a way that looks like smoking.
2. EEEEK! It must be bad for them.
3. Definitely is - they're inhaling NICOTINE, everyone knows that gives you Cancer(TM) (* NOTE *).
4. What are we going to do about it?
5. Did I mention, they're enjoying it as well?
6. Then we've definitely got to do something. Can't have people enjoying Drugs(TM). What can we do?
7. Er, it's a round hole, we haven't come across one of those before.
8. Well, we've got a square peg (pharmaceutical licensing).
9. But it's a square peg, it won't go in a round hole.
10. Yes it will, we just need to make up some arguments after the fact to ram it in. Round up the usual Tobacco Control suspects, shout "Nicotine! Cancer! Children! Flavours! Gateway Drug!" at them to get them excited, poke them with sticks a little bit, and before you can say "fix-up" we'll have stacks of "academic research" proving that e-cigs give you cancer just if you look at them, corrupt children, deplete the ozone layer, give you acne, and strangle baby wombats when they think no-one's looking. And that medicinal licensing is the only way to stop this.

* NOTE *: The fact that nicotine causes cancer is an interesting fact. It's what is known as an Untrue Fact. Some people call this kind of fact by other names, such as Bollocks, Total and Utter Bull...., or You're Totally Making This Up Aren't You? Surprisingly, almost half of UK GPs think that it's a True fact, though.

 

[Leio]

Please don't spread misinformation. The amended TPD - even if it passes as it currently reads, which is my no means certain - does not prevent the UK from implementing more restrictive legislation.

Yes and vote must also be confirmed by the European COncil then each country can apply it with more restriction, after that "national "regulations laws" may be attacked at the EUropean Court

Anyway yesterday was a first necesseray step, and obiously a victory for the vapers we are.

http://leiovape.files.wordpress.com/2013/10/evictoire1.gif

 

[Anjaffm]

Yes and vote must also be confirmed by the European COncil then each country can apply it with more restriction, after that "national "regulations laws" may be attacked at the EUropean Court

Yup
And with the National Health Service in Britain shouldering all the cost of health treatment of UK citizens - they may just wake up to the reality of pounds and pence instead of silly ideology

Anyway yesterday was a first necesseray step, and obiously a victory for the vapers we are.

It most certainly was!

 

[yo han]

How long until these new rules will apply?
Time to stock a few liters of 100mg base liquid.

 

[BarryNorton]

3 years. Do. That's already restricted here in the UK.

 

[yo han]

3 years, well that'll give us some time
Not that the 72mg UK restriction is much of a real problem though.
The only downside of these relatively low concentrations is that cost per mg/ml is always higher.
And importing makes it even more expensive since you're paying postage for weight of PG/VG which can be had very cheap locally.

 

[Robino1]

Lets hope that in those three years even more definitive studies come out in our favor and any over regulation will be deemed unnecessary. We've come a long way in just the year I've been vaping.

 

[sebt]

Please don't spread misinformation. The amended TPD - even if it passes as it currently reads, which is my no means certain - does not prevent the UK from implementing more restrictive legislation.

True, and the MHRA hasn't yet said anything about backing down. But I did find this nice nugget in another amendment (165) that passed in the EU debate:

(33) Nicotine-containing products [- including e-cigarettes - inserted by the amendment] are sold on the Union market. However Member States have taken different regulatory approaches to address health and safety concerns associated with these products. There is a need for harmonized rules, therefore all nicotine-containing products should be regulated under this Directive as a related tobacco product. Given the potential of nicotine-containing products to aid smoking cessation, Member States should ensure that they can be made available as widely as tobacco products .

So if the MHRA does persist with the idea of pharmaceutical licensing, this EU amendment might restrict them as to how far they can go. As I read it, the MHRA couldn't do anything that make e-cigs (or other NCPs) less widely available than tobacco products, without falling foul of the TPD. This is just my opinion - if anyone knows more about EU law than I do (which wouldn't be difficult), feel free to correct me. Amendment 170 does specifically say that NCPs should be available "outside pharmacies".

 

[Orb Skewer]

True, and the MHRA hasn't yet said anything about backing down. But I did find this nice nugget in another amendment (165) that passed in the EU debate:

""(33) Nicotine-containing products [- including e-cigarettes - inserted by the amendment] are sold on the Union market. However Member States have taken different regulatory approaches to address health and safety concerns associated with these products. There is a need for harmonized rules, therefore all nicotine-containing products should be regulated under this Directive as a related tobacco product. Given the potential of nicotine-containing products to aid smoking cessation, Member States should ensure that they can be made available as widely as tobacco products .""



So if the MHRA does persist with the idea of pharmaceutical licensing, this EU amendment might restrict them as to how far they can go. As I read it, the MHRA couldn't do anything that make e-cigs (or other NCPs) less widely available than tobacco products, without falling foul of the TPD. This is just my opinion - if anyone knows more about EU law than I do (which wouldn't be difficult), feel free to correct me. Amendment 170 does specifically say that NCPs should be available "outside pharmacies".

Encircled by high taxation,
Advertising blackout,
Smoking cessation (medicalisation-that word again !),


Vapers did not 'win' anything on tuesday the way I see it, there was a large 'lost concession' as regards the 'free availability' to purchase nicotine liquid over 30mg/mil, and up to the present 'legal' limit of 75mg/mil (UK).

If E-cigs are clumped in with other 'tobacco products' then they may incur the astronomical 'sin tax' or other Governmental tax associated with tobacco.

How can a product escape 'medicalisation' because it is below a defined limit, but then that same substance is 'also' a medicine if it goes over that defined limit ?
Does Espresso coffee have the same definition applied ?

Nicotine in solution will have 3 categories then

1: a (recreational) Tobacco product if below 30mg/mil

2: a medicine (available by prescription-after a 'diagnosis') if over 30mg/mil

3: a poison if over 75mg/mil (UK)

 

[BarryNorton]

I did find this nice nugget in another amendment (165) that passed in the EU debate

It's a nice point, but whether you're dealing with the EP or with the IETF/W3C (more my territory) there's a huge difference between SHOULD (not) and MUST (not), sadly.

 

[BarryNorton]

the way I see it, there was a large 'lost concession' as regards the 'free availability' to purchase nicotine liquid over 30mg/mil, and up to the present 'legal' limit of 75mg/mil (UK).

Yes, this is the point I made to my MP and MEPs yesterday in the following letter:

I should first like to express my broad admiration for the decisions taken on electronic cigarettes in yesterday's European Parliament vote on the EU Tobacco Products Directive. Specifically I am relieved about the passing of the amendment that would largely exempt these from wholly inappropriate medical regulation.

In the next stage of the trilogue, during which it is my understanding that national governments are given chance to negotiate on the directive, I strongly urge your party to defend our national industry, there being several profitable UK SMEs involved in the manufacture and sales of these devices and their supplies including nicotine-bearing 'e-liquids' and their ingredient parts.

I should like to bring to your attention to the retail of supplies for 'DIY' e-liquids. By these means many people, including those with a background in scientific research as I have, are enabled to create liquids for personal vapourisation with an absolute surety of their chemical composition. This is an important consideration, given that the single most frequently cited piece of research by the those standing in opposition to electronic cigarettes concerns rogue ingredients in nicotine vapour.

Furthermore I should like to draw your attention to our long-standing national legislation governing nicotine-bearing ingredients. In particular, the Poison Rules 1982 defines the limits for nicotine sales under the Poisons Act 1972:
www.legislation.gov.uk/uksi/1982/218/pdfs/uksi_19820218_en.pdf

There is a discrepancy here with the amended Tobacco Products Directive, which has exempted only up to a 30mg/ml concentration, whereas our national legislation allows for 7.5% by weight, which is more than double this.

It is therefore an argument for inter-state free-trade that we should insist on raising this limit in the Directive in line with our own existing legislation.

Furthermore, at the national level the MHRA had previously announced its intention to class electronic cigarettes as a medical device. In light of the European agreements these plans must now be dropped both as a threat to our own nationally-established industry, but also under respect for the free trade rights of our fellow EU states.

Yours sincerely,

Dr. Barry Norton

 

[drtwain5]

Regrettably, this is a good news, bad (or worse) news outcome. Opposition to ecig is prejudiced, purulent and paternalistic. In short, the EP, under their tobacco products directive, held the view that ecig would be regulated as tobacco products - NOT as medical products - provided no health claims for ecig (i.e., smoking cessation, nicotine replacement therapy) were ever made. The conundrum with this proposition, which won majority, is that regulations on tobacco products (ergo ecig) will be strengthened significantly, perhaps to the point of asphyxiation to manufacturers. Of significant concern and worry is that the European Commission and Council holds the very different view that ecig MUST be under the control of medical product regulations. The EP and EC expect a joint agreement sometime in December, so we are not immune from additional stupidity just yet. Wonder if the Council, in its unfathomable wisdom, will regulate analogs as a medical product, since these are the most efficient pulmonary delivery systems ever designed.