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I believe that such a modified, randomized clinical study is essential to add another line of evidence with which to evaluate the potential benefits of electronic cigarettes. Yes, there are limitations to RCTs, but it makes no sense to throw out the baby with the bath water.

Moreover, the FDA's actions are sending the wrong message to the public. First, the FDA is indicating to the public that there is such a thing as a safer cigarette. The FDA is insinuating that even small changes in cigarette design can result in drastic differences in the public health safety of cigarettes.

First, he cites the JAMA Pediatrics article in which Glantz and Dutra conclude that electronic cigarettes are exaggerating, rather than ameliorating smoking among youth. Clive writes: "somehow you have managed to position this study as showing there is a gateway from e-cigarette use to smoking. NOTHING in the study or the underlying data suggests this. You would need information on how smoking, e-cigarette use and abstinence evolved over time to test these hypotheses, but your study does not have that."

I am not aware of any other federal law or regulation that prohibits companies from telling consumers the truth about their products as it relates to the primary benefit of the product. Hopefully, the FDA will see the error in its proposal and will reconsider its decision to subject electronic cigarettes to the provisions of section 911.


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