There is a provision for of informed consent; however, the conditions for such a waiver were not met because: (1) the level of risk was not minimal; (2) the waiver did affect the rights and welfare of the subjects; (3) the research could still practicably have been carried out with informed consent; (4) subjects were not provided with information after the study to explain what occurred.

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 no cessation aid was 1.38 (95% confidence interval, 1.08-2.93).

The truth is that Senator Rockefeller pretended to be committed to protecting the health of our nation's children, but instead, he was actually protecting Big Tobacco profits by exempting menthol from the flavoring ban. The Tobacco Act banned every imaginable flavor that was not actually being used in cigarettes (e.g., cherry, strawberry, banana, and pineaple), yet it exempted the one flavor (menthol) that was actually being used to addict children to a lifetime of smoking - a greatly shortened lifetime for many of them.

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