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.

1. Between 2003 and 2008, one of the authors performed consultation services for R.J. Reynolds and Lorillard and conducted research at his medical school which was funded by R.J. Reynolds, Brown & Williamson, and Liggett. The total annual amount of his consulting payments from Big Tobacco was as high as $40,000. While the amount of grant funding received from tobacco companies is not clear, one of the anti-smoking groups has documented that the level of funding in 2005 was $400,000 and in 2004 was $1 million.

However, the "health" advocates want e-cigarettes to be defined as tobacco products. Even though they are not tobacco products and do not contain any tobacco.

(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;

"The FDA erred in concluding that current, ongoing financial relationships with drug manufacturers did not constitute a conflict. Since manufacturers of smoking-cessation drugs compete with manufacturers of DTPs, ... and since Dr. Benowitz stood to profit from the sale of NRT drugs, he faced a conflict with regard to providing advice in the TPSAC's report on DTPs. ... the TPSAC was charged with studying the public health impact of a drug (i.e., DTPs), and Dr. Benowitz had an ongoing business relationship (i.e., consulting work) with companies developing "alternative" or competing drugs (i.e., smoking-cessation drugs). Accordingly, I find that the FDA's conclusion with regard to Dr. Benowitz was a 'clear error of judgment.'"

Why would we want to suppress the provision of this information to the public? And what justification is there for a government-mandated suppression of the truth?

"Short term use of e-cigarettes has been shown to increase respiratory resistance and impair lung function, which may result in difficulty breathing."

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