Based on the draft copy, Snowdon reports that "nicotine containing products that 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." Because most electronic cigarettes contain more than 2 mg of nicotine, they would be regulated as medicinal products, which would require companies to conduct a long series of formal clinical trials, costing tens of millions of dollars and taking an average of eight years to complete.
Thus, for all practical purposes, if adopted as apparently drafted, the directive would essentially amount to a ban on electronic cigarettes in the European Union.
The Rest of the Story
It's hard to figure out what the purpose of this aspect of the directive is, but its effect will be to increase tobacco-related disease and death in Europe. If approved as drafted, the directive will prevent smokers from having access to a much safer alternative to cigarettes that has been shown to be effective in helping to keep smokers off of cigarettes, or at least, to cut down significantly on the amount they smoke.
Thus, the effect of this directive would be to protect cigarette sales in Europe at the expense of the public's health.
We can only hope that a more sensible strategy will be substituted for this deadly one once the proposal is fully vetted.
I will provide readers with an update, if necessary, after the directive is officially released tomorrow.