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.

Sadly, the agency concluded that it is not sure that e-cigarettes are any safer than tobacco cigarettes. The FDA states: "Many consumers believe that e-cigarettes are "safe" tobacco products or are "safer" than cigarettes. FDA has not made such a determination and conclusive research is not available."

Yesterday, I reported that Drs. Stan Glantz and Simon Chapman issued against Lorillard for running an inappropriate blu e-cigarette commercial (the robot sex ad). The truth is that Lorillard had nothing to do with the ad, which was produced in 2010, well before Lorillard acquired blu.

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