If a company were to make such a claim, it would constitute a reduced exposure claim, which is prohibited under section 911. To make matters worse, such a claim can only be approved by the FDA if the company shows that if consumers hear that the product is free of tobacco, they will not be led to believe that the product is safer. In other words, to simply make the truthful and uncontroversial claim that your electronic cigarettes are free of tobacco, you would have to first demonstrate that consumers will not interpret the absence of tobacco as indicating that the product is any safer. But we know for a fact that consumers will interpret (and should interpret) the absence of tobacco as an indication that vaping is safer than smoking. Therefore, the deeming regulations place a de facto, permanent ban on electronic cigarette companies making the simple claim that their products do not contain 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;

What this indicates is that this is not simply junk science. Rather, it is a deliberate attempt on the part of the investigators to misuse data. They are using these data to draw a conclusion about whether electronic cigarettes are effective in helping smokers quit, yet they are knowingly drawing upon data from smokers who are using e-cigarettes for other reasons, who may have simply tried an electronic cigarette once, and who most definitely were not using these products as part of a current quit attempt.

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