In my view, this refutation and undermining of its own black box warning violates accepted standards of pharmaceutical company conduct, and should prompt either penalties or the removal of the drug from the market. If Pfizer is going to publicly undermine the required black box warning, then clearly that warning is not adequate to protect consumers and the FDA must either penalize Pfizer so that it desists from this behavior or pull the drug from the market since it is becoming clear that the company is undermining that warning in the eyes of the public.

In order to introduce a new electronic cigarette product to the market, the manufacturer will have to demonstrate that the product is beneficial to the public's health. This does not simply mean that one must demonstrate that the product is safer than cigarettes. The applicant also needs to show that the introduction of the product into the market will not deter smokers from quitting or encourage youth to start using the product. At the present time, there is a substantial body of opinion among tobacco control experts that electronic cigarettes do not reduce population risk. Therefore, how can we expect that a manufacturer could demonstrate, at the level of proof required, something which most tobacco control experts do not even agree with?

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