Thank you.
In connection with the work of the NNHPD, it's our view that this directorate is experienced in the regulation of existing products but is struggling with the way to set the expectations for this new class of products. I believe we would have an approval by the national health products directorate today if the product we submitted to them formed a similar profile to nicotine gum and nicotine patches in delivering the same amount of nicotine with the same profile. They're very comfortable with that framework.
The fact that e-cigarettes provide somewhat more nicotine and do so in a different way, involving also the inhalation of nicotine, leads the agency to look toward prescription pharmaceutical guidelines for medicinal inhalers and consider whether to address standards related to pharmaceutical products. Yet they are unable, through their agreement, it seems, to take into account the risks that would be associated with someone continuing to smoke.
I feel that half of the problem is the agency's or the directorate's lack of clarity as to what standard they should be setting and enforcing in this phase. The information we've had suggests that they are looking for further guidance from the minister's office as to the standard of evidence that should be required, and also even reassurance as to whether they can be regulated as a natural health product or if they have to be a prescription product or even a tobacco product.
Despite our efforts with some very specific recommendations as to how they could put forward proper data development, the agency is really not providing us with any more guidance. We're at a stalemate at this point. The best information we've had is “keep giving us information, keep talking to the public health community, and at some stage maybe we can move forward”. I think we need to hear from your committee and we need to hear from the minister on it.