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.

The odds ratio for successful quitting for the e-cigarette group compared to subjects who used NRT was 2.23 (95% confidence interval, 1.70-2.93).

The black box warning for Chantix, which is required by the FDA to be placed on this smoking cessation drug made by Pfizer, notes the following:

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