By publicly refuting the black box warning, Pfizer is literally spitting in the face of the FDA. This is not appropriate. The company should either be penalized and forced to discontinue its campaign of refutation of the black box warning findings, or the drug should be pulled from the market due to a finding that the company has violated the terms of the drug's approval.

While it is theoretically possible that an electronic cigarette company could some day get a full reduced risk claim approved, the regulatory burden is extreme. Not only would the company have to show that the product is safer than smoking, but the company would also have to demonstrate that the product will not deter smokers from quitting and will not introduce youth to the use of nicotine. The studies required would be substantial. For most companies, the costs would be prohibitive. It would take many years before any company could even have a reasonable chance of getting such an application approved and by then it will be too late for the market to continue to expand.

In light of these findings, the best that the study authors could do to implicate electronic cigarettes as a human health hazard was to proclaim that "e-cigarettes are not emission-free." If that is the worst thing that thsee researchers can say, then it certainly doesn't appear to rise to the level of a known health hazard for which government intervention is necessary at this time.

In a recent in Forbes magazine, Jacob Sullum reviews some of the evidence which demonstrates that many former smokers have quit smoking successfully using electronic cigarettes as a cessation aid. Sullum writes:

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