.....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.
