Replies to post #46494 on 22nd Century Group Inc (XXII)

[esad1]

PMTA..I would say in Q1..There is nothing in the application that the FDA has not seen or paid for. If there is a panel which is customary there will be tobacco company people saying it does not work. There is so much data on XXII's VLN that it will difficult for the dark side to mount much of a complaint. Been testing it for six years. It is not a new invention. It is a better invention.

The big deal is the MRTP. That will be approved by year end in my opinion. Before the MRTP and after the PMTA approval I see the FDA mandating non-addictive combustible cigarettes giving tobacco companies time to retool. Those killing machines at MO, BTI, and PM et al have to stop. Anything short of that will be a disgrace to the health of our nation.

[Zedster]

What Happens After I Submit My Premarket Tobacco Application?

Upon receipt of an application, the FDA will determine if the application can be accepted and then filed for substantive review. FDA has refuse to accept procedures for premarket tobacco product submissions.
If the application is accepted, the FDA then will conduct a filing review to determine whether the application is complete, i.e., whether it contains all the items under Section 910(b)(1) of the FD&C Act. If not, the application is incomplete, and we will refuse to file it.

If the application is complete, FDA will file the application and begin substantive review.

As part of its review, FDA may refer the applications to the Tobacco Product Scientific Advisory Committee (TPSAC). You may also request that FDA refer the application to TPSAC.

After completing its review, FDA intends to issue an order within 180 days after receipt of the Premarket Tobacco Application that the new product may or may not be introduced or delivered for introduction to consumers.