Electronic cigarettes

It’s not often that I agree with the PSI. In fact this will probably be the first in a long time. Their latest email is that first.
It is a position paper on electronic cigarettes. I don’t think they would mind too much if I reproduce it here.

I will do my best to promise that this will be a first and last time and I will try not to make a habit of this.

“PSI position on electronic cigarettes

The PSI has recently received a number of inquiries regarding the appropriateness of electronic cigarettes (e-cigarettes) being offered for sale or supply in retail pharmacy businesses, as these products are not currently regulated under either the medicinal products or medical devices legislation.

In addition, the supply of these products in pharmacies requires consideration under the PSI Code of Conduct, as pharmacists should ensure that products supplied do not pose a hazard to a patient’s health or well-being.

Electronic cigarettes

Electronic cigarette products are typically presented in two parts, one of which is a device and the other a fill or refill consisting of a solution of various compositions containing Nicotine. These products are not currently being regulated under the medicinal products legislation, medical devices legislation or tobacco legislation. It should be noted that they do come within the scope of the Waste Electrical and Electronic Equipment (WEEE) Directive.

Agreement has not yet been reached as to the legal classification of these products, i.e. whether they are medicinal products that would require appropriate marketing authorisation, or whether they are medical devices, in which case an appropriate notification to an EU competent body would be required, including appropriate labelling, before being placed on the market.

EU Position

The PSI understands that the EU Commission has recently commenced a public consultation with respect to the possible revision of the Tobacco Products Directive 2001/37/EC, and that one of the issues being considered is the extension of the scope of that Directive to cover electronic nicotine delivery systems where such products are presented as alternatives to cigarettes. It has also been noted that these kinds of products have the potential of undermining smoking cessation policies, since they keep the smoking addiction (EC Orientation Note on Electronic Cigarettes, May 2008*).

This EC Orientation Note also gave consideration to whether or not these products can be characterised as human medicines and thereby requiring regulation as authorised medicinal ”