Ladyraj--the mission of the FDA is to speed innovations- Not to bog it down because they do not have "paperwork" in place.
Yes, we have Suppliers right here on this Forum who made application a long time ago and are sitting there waiting for some response.
Remember--claiming the e-cig as a tobacoo product was the legal fiction plead by SE and NJOY, and IMO is going to be a loser.
That does not negate the filing of another lawsuit with a different theory of the case. Again, trying to bootstrap on the loopholes of tobacco legislation instead of the e-cig standing in its own catagory is not the way to go IMO.
The FDA needs to practice what it preaches and help to speed innovations as it states in its mission statement.
Sun
These are the pertinent facts as I see them but please advise me if I'm way off base:
E-cigs were put on the market and avoided FDA pre-marketing approval based on the stance the PV was NOT a combo drug/medical device (nicotine delivery device) and as such didn't need pre-approval.
Health and cessation claims were made all over the internet and anti-smoking groups began crying FOUL there is no proof of reduced harm, cessation, or even safety standards.
The FDA and anti-smoking groups had been going after the legislature to put tobacco products under the FDA's purview and succeeded last year. The FDA makes it no secret they feel the PV is a combo medical device rather than a tobacco product.
Under pressure from various groups the FDA does a study of some carts and simulated vaping but never vary from the medical device stance. I believe if the analysis had been more negative...the FDA would have acted immediately to remove the product. So, though I didn't like the way the analysis was completed, presented, and interpreted...One has to wonder why it was done at all?
Now the newly formed tobacco advisary board is charged to assess the issues of the new tobacco bill which includes harm reduction. Before this board has had time to be formed and then to act...a court case against the FDA was filed.
The FDA has never waivered and what SE and NJOY had going for them is the FDA had acted prematurely before the FDA had that power granted by the bill. We knew the FDA would appeal the judge's ruling. We await the findings probably in late November.
Which way to go...medical device or tobacco product, the PV could be either. Even if a new category were created solely for the PV (which I doubt) many dollars and research with application procedures must be completed for a NEW category versus bootstapping with an existing product. So, I'm not sure going the new route is feasible.
When the FDA refers to speeding innovations what comes to mind is in cases of an epidemic, such as AIDS, when sufferers were dropping like flies and medications needed to be fast-tracked for approval...it took alot of time, advocacy, and the weighing of risks to get this to happen. The weighing of risk was certain death compared to side effects from the new drugs.
Using the Anti's rhetoric a case can be made for fast-tracking the PV to fight the declared tobacco epidemic...but 1) smokers are not a protected class with a lobby group in place, 2) there are already cessation options in place that have been tested via FDA standards...why should another intervention escape such testing? (Mr Godshall was active in getting NRT an OTC rating precisely this way).
I suspect the longer this battle goes on, the more individuals are challenged to supply product, or can't receive funds or mail packages, the less likely the product will grow a lobby group....the FDA needs only to wait us out while the anti-s plant mis-information to the populace.
