Hi John.... welcome to the forum.
It appears, they want us to totally quit... or keep smoking tobacco. There is no middle ground whatsoever. We have had conversations with several groups and they all believe that if it isn't tobacco cigarettes, it should be FDA regulated smoking cessation device. Sad isn't it?
Lacey,
I'm really asking a question here, in hopes that it will help clarify ECA policy and approaches or help me clarify my misunderstandings.
I agree that there are many people in public health that want us to just quit both tobacco and nicotine (the abstinence people, who are in the mainstream of public health in the U.S.). Although the actual result of banning the e-cig might be that many of us would return to tobacco, I don't think that is their actual intent--even if they know that would happen. Their position would be that we always have the option of quitting and that is what they want. (Incidentally, I think that what will actually happen for many of us is that we will continue to import nicotine illegally and use it and that the FDA both knows that and tacitly condones it.) I make the distinction between what will happen and "what they want us" to do because the statement that they want us to smoke tobacco will seem ludicrous to them, to legislators and to the public at large.
The related question here, and I guess the real one, is what do we want them to do? If the e-cig is to be sold as a cessation device, it will obvious have to go throught a standard series of trials like anything else that makes a medical claim. If the e-cig is to be sold as a nicotine delivery device it will have to go through the same studies unless we feel it should somehow be grandfathered in with tobacco. All forms of nicotine other than tobacco are, in fact, regulated by the FDA. The e-cig seems novel enough to me that I can't imagine it being treated as tobacco.
So, my question is, what are we hoping for? I'd like to see the FDA just take a hike on this and leave us alone, but that isn't what's going to happen. So what do we want from them? As an example, one possibility would be special waivers as were granted for the early HIV anti-virals. They skipped over certain study requirements because the consequences of not using an antiviral were so dire and there were no other alternatives for infected people. That would require convincing the FDA that people who "cannot" stop smoking are comparable to people with HIV infection. But there are certainly other ideas like this, including claims for the e-cig as a special case because the tobacco cigarette is a special case and the basic science suggests that e-cig is very likely to be safer than the other.
Perhaps this is not quite the forum for this question, but I am trying to understand the conceptual issues. To put my questions in perspective, let me say that I have smoked tobacco for decades, very seriously tried to stop a number of times and am now, for the first time in my life, completely content without tobacco. I will use an e-cig if it is at all possible to do so and regardless of the law.
Thanks,
Wally
