(B) does not include a
26 (ii) drug, device, or combination product approved for
27 sale by the United State Food and Drug Administration, as those terms
28 are defined in 21 U.S.C. 301-392 (Food, Drug, and Cosmetic Act); or
29 (iii) product that has been approved by the United
30 States Food and Drug Administration for sale as a smoking cessation
31 product, tobacco dependence product,
As I understand it, "drug, device, or combination product" (combination product is drug+device together) are terms the FDA uses for medical products.
So any mod/atty, device, or a self-contained cig-alike, combination product, that is approved for sale by the United State Food and Drug Administration would not be subject to this tax?
If it was approved by FDA for sale as a
medical product, it would be exempted.
But again, I think the lawmakers are talking about FDA's definitions of a
medical "drug, device, or combination product"... not our so-called "tobacco product" e-cigs.
(so NOT surprised if this is in reference to self contained systems mainly a tobacco company product with the exception of NJOY)
I don't think the section you referenced was about any recreational "e-cig" device at all, even one that is self-contained. I think those words from the part you quoted are referring only to FDA's
medical products division. Not their tobacco products division.
As a side note, if an e-cig manufacturer decided to try to go the medical route for FDA approval, the bar would be just as high (or higher) and the expense of getting it approved would be just as high (or higher) as it will be when manufacturers contemplate trying to get FDA marketing approval as a "tobacco product."
OR
if the FDA defines electronic cigarettes as a modified risk tobacco product none of it would be subject to this tax including eliquids?
Yeah, it sounds like that section would exempt an FDA approved "modified risk tobacco product from being taxed. Your guess is as good as mine as to whether that would include e-liquids. Probably a self-contained device would be the only type of e-cig that could have even a glimmer of hope of being approved for "modified risk."
A faint glimmer like that of a star thousands of light-years away.
As far as I know, and I'm sure no expert on any of this, I don't think the FDA has
ever approved any "tobacco" product as a modified risk product.
Very safe Swedish SNUS has decades of research showing it most definitely
is a Modified Risk Product, but FDA hasn't shown any sign of accepting it as an MRP.
The way the FDA keeps deliberately and systematically encouraging the worst kinds of junk science to "inform" the FDA... I don't foresee the FDA accepting e-cigs as a Modified Risk Product.
