The real bottom line to this disagreement is this: The device is whatever the FDA says it is.
That agency, charged with regulating drugs among other duties, has defined it in emails to suppliers of halted shipments as a "drug delivery device" and the e-liquid as a "new drug." Now, if you disagree, or you think it's really a ...., then file a lawsuit. Expect years in court and appeals.
But note what happens in the meantime: The FDA position does not change. The goods do not get delivered. Sellers will have nothing to sell.
I agree that the marketing of the devices was flawed - and stupid in many cases. If this were merely a novelty device to blow nicotine vapor rings, this problem might have been delayed (but the anti's will come after it with all they've got, sooner or later). However ... read the patents: This is not a novelty device but a nicotine delivery system using vapor. Without nicotine, it would be just a Chinese toy with minor market appeal. I, for one, could care less about it if that were the case.
Those who think smooth e-smiling lies ahead are about two chapters behind today's reality.
TB-
Yes, the e-cig will initially be whatever the FDA says it is, and it won't be smooth sailing. But I have to disagree with your complete pessimism, for two reasons. The first is that the FDA is, in fact, interested in input and has negotiated many, many drugs for easier, faster approval. Margaret Hamburg is a well known harm-reduction advocate in public health and the e-cig is right up her alley, whether she knows it yet or not. The second is that the FDA has a very nuanced approach to enforcement and, so far, their effort has been less than half-hearted. We have no idea yet about how vigorously the FDA intends to enforce the control. They are under a lot of political pressure to enforce it and they may have the intent of putting on a good display of enforcement with no real teeth in it. In fact, the sources of political pressure may have no interest in real enforcement. Politicians are often happy with their constituents having the impression of representation (a fact well demonstrated in the FDA/Tobacco bill.)
So let's breath a bit here and see where they go with this and what discussion they can be engaged in. It doesn't take a genius to see the huge harm-reduction potential of the e-cig and, contrary to much opinion on this forum, there are many intelligent, well-intentioned and concerned people at the FDA.
Wally
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