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.

You are here because you are a smoker and you are looking for helpful information about e-cigarettes.

I can't add anything to this fine piece, so I'll leave it for readers to examine. I'll just close with the final paragraph of Newman's piece, which summarizes the situation incisively:

All in all, the deeming regulations are a disaster. However, they are not as much of a disaster as they could have been. The positive side is that internet sales, marketing to adult consumers, and flavors are still allowed and that no products will immediately be taken off the market. The negative side is that new products will require pre-approval, virtually every product on the market will require a substantial equivalence determination (if not a new product approval), and that manufacturers will be forced to implicitly lie about the intended purpose and relative safety of the product by not being allowed to correctly point out that these products are much safer than tobacco cigarettes.

Despite its massive 978-page length, the new Surgeon General's - released last Friday - fails to include any mention of the many population-based studies which have shown that unaided smoking cessation is superior to the use of nicotine replacement therapy (NRT).

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