EU Up to date EU legal situation

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Cayetano

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Ostinato

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It's banned. Troops of tax, customs and pharma officers visit shops and take nic liquids.
The situation is bad. They say it is a pharma product and needs to be tested and licenced as a pharma product.
There's a new law suggestion that says selling and keeping nic liquids is a crime that can result in imprisonment of 1 to 5 years.
Hungarian shops are moving abroad.
 

Vocalek

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It's banned. Troops of tax, customs and pharma officers visit shops and take nic liquids.
The situation is bad. They say it is a pharma product and needs to be tested and licenced as a pharma product.
There's a new law suggestion that says selling and keeping nic liquids is a crime that can result in imprisonment of 1 to 5 years.
Hungarian shops are moving abroad.

I'm beginning to understand why my grandparents left Hungary. It seems the leadership there is so stupid (or cruel?) that it prefers to keep people inhaling smoke instead of switching to a product that no research to date has found to be harmful. Of course that was 103 years ago....

The good news is that it is legal in Italy.
 

tommy2bad

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either have a nicotine level exceeding 2mg, a nicotine concentration exceeding 4mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 mg per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance.

Ahem, at a plasma concentration of 4 mg...wouldn't you be dead! Effective yes, safe no.
So many things wrong in that quote, either it got mangled in translation or its a load of tripe that means whatever they want it to mean.

Given the novelty and rapid increase of the NCP market as well as their addictive and toxic character there is an urgency to act, before more people—unaware of the content and effects of these products—inadvertently develop a nicotine addiction.
You have to laugh, I think someone misses the point completely.
 
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rolygate

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.....either have a nicotine level exceeding 2mg, a nicotine concentration exceeding 4mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 mg per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance.

Ahem, at a plasma concentration of 4 mg...wouldn't you be dead! Effective yes, safe no.
So many things wrong in that quote, either it got mangled in translation or its a load of tripe that means whatever they want it to mean.

Yes, you are correct in that there are logic errors in that quote as well as an obvious commercial motive (remove the pharmaceutical industry's rivals).

The first two values quoted are mutually exclusive. However they may have been written this way deliberately in order to confuse legislators into thinking the requirements are logical / reasonable / roughly equivalent. They are nothing of the sort since a total content 'level' of 2mg cannot possibly equal a 'concentration' of 4mg/ml. The two values are miles apart. A total content of 2mg (per package), as this seems to be stating firstly, is equal to a tiny amount (almost unmeasurable) per ml if supplied in a bottle. It might line up if the package is a 1ml carto.

A peak plasma concentration of 4ng/ml (nanogrammes) is a normal state, although extremely low and just above the background noise. As you say, the value they state - 4mg - is presumably a typo for '4ng' as '4mg' is probably a lethal level, thousands of times higher than the norm even for a smoker. I did hear of a death where the level was 8mg/ml along with other drugs present.

- Everyone tests positive for nicotine (unless they eat no vegetables) and the usual figure accepted as typical for a normal person eating a normal diet and being neither a smoker nor someone living with a smoker is 2ng/ml nicotine blood plasma concentration.
- It is possible that a tea-drinking vegetarian might test as high as 4ng (or higher) since some vegetables (particularly aubergine/eggplant) have a particularly high level of nicotine, and some tea is also quite high.
- E-cigarette users frequently test in the 12ng to 15ng range.
- Smokers today tend to test at 15ng to 25ng levels. In the past, they tested much higher apparently, commonly 30ng but up to 50ng, and there are reports of 60ng tests.

The quote demonstrates a poor level of technical competence, a poor level of technical oversight and checking, and several loopholes that will work in the enforcer's favour and not the ecig user's.
 
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Vocalek

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My father was born in Mikula, Szatmar, Hungary in 1908 and he and his parents came to America in 1909. After WWI, the Eastern side of Hungary was given to Romania. The town is now called Micula, and the County is Satu Mare, Romania.

Family names were Rosza and Kimpan, until they were Americanized.

So hello, distant cousin.
 

MarVp

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.....either have a nicotine level exceeding 2mg, a nicotine concentration exceeding 4mg per ml or whose intended use results in a mean maximum peak plasma concentration exceeding 4 mg per ml may be placed on the market only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance.

Its obvious that they have chosen the 4mg figure so it "looks" like they are being even handed with the BP industry who have their strongest gums quoting that number. In reality, most people might use a fraction of a ml in a sitting with their e-cig, and with inefficiencies, that equates to no-where near the nicotine absorption they might get from having a combustible cigarette (or the gum), rendering the e-cig ineffective (no threat) to the two main players (BT and BP).

Looking at the figures they quote more rationally (big benefit of the doubt!), I believe they would be referring to the nicotine concentration when in the gaseous form, i.e how it is when presented to your body as a vapor. Not sure how much a ml of gas is, but if it had a 4mg concentration of nicotine I suspect you could get those 4mg/ml plasma levels they also quote!

On another tangent... I'd love to know what the mg/ml concentration of the BP inhalers are. I remember reading they contain in the order of 15mg of nicotine, and I believe their liquid content would be quite low. If it comes to it, roll on the "MOD" industry in the EU, devising a porous plug of polyethylene to contain 2mg of nicotine and a separate flavoring capsual. The porous plug needs to get replaced every half hour or so.
 
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rolygate

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This is a typo:
".....or whose intended use results in a mean maximum peak plasma concentration exceeding 4 mg per ml."

It should read 4ng/ml (4 nanogrammes). At 4mg/ml (4 milligrammes) some but not possibly not all people would be dead (some have extreme tolerance to nicotine). My maths is a bit weak but I think this is 4,000 times the level they meant to say.

A heavy vegetarian diet might get you up to 4ng, although 2ng/ml is the normal background noise from the diet (nicotine in vegetables, tea etc.). A vaper often reads about 15ng to 20ng, smokers can measure as high as 30ng although many are down around 15ng where many vapers are. In the past, when cigarettes were stronger, 50ng or even 60ng was reported.
 

Vocalek

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If the highest concentration permitted is 4 mg / ml, but the liquid in a container cannot have more than 2 mg of nicotine present, that implies cartridges with a maximum capacity of 1/2 ml. That pretty much requires liquid to only be sold in cartridges, at a typical charge of $2-$3 per cartridge.

Most folks vaporize between 1 and 3 ml of liquid per day. With pre-filled cartridges, that's a cost of up to $18 per day.

Given an intake of 2 to 6cartridges per day, the total daily nicotine intake would be down in the neighborhood of 4 mg to 12 mg and would require going through 2 to 6 cartridges. It takes about 200-300 puffs to vaporize one ml of liquid. If you use an average of 10 puffs per traditional cigarette, vaporizing a single ml of liquid takes as many puffs as smoking 20 to 30 cigarettes.

To match my intake of 24 mg of nicotine per day would require me to vaporize 6 ml of liquid and take as many puffs as someone who smokes 6 to 8 packs of cigarettes per day.

Kind of reminds me of automatically increasing from a pack a day to 2-1/2 packs per day when I switched from regular cigarettes to "Lights."

Those of us who are dependent on the beneficial effects of nicotine to be able to concentrate, remember, and pay attention would be very confused and quite unproductive trying to subsist on the same number of puffs as we take now using liquid that is only 0.4% nicotine instead of 2.4%. The most likely scenarios would be a) relapsing to smoking or b) finding a black market supplier that would supply us with adequate nicotine concentrations.
 
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