What the FDA is stating is that it does not believe that it would be any worse for individual X to resume cigarette smoking than for her to remain an ex-smoker by continuing to vape. The FDA is stating that it is aware of no evidence to suggest that returning to cigarette smoking would be an unwise decision for this individual.

Commenting on these results, Deborah Arnott - the chief executive of ASH - stated:

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.

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