Reynolds enters FDA modified-risk regulatory gauntlet for 6 Camel Snus styles
"Analysts have projected that the cost of a FDA regulatory review would be several million dollars for each pre-market tobacco application, or PMTA. An application is expected to be required for each flavoring and nicotine content level.
By comparison, the FDA estimates the average cost of an PTMA application at $466,563 each.
Reynolds said it has submitted more than 450,000 pages of documentation with its application.
By comparison, Swedish Match said its General Snus application contained more than 100,000 pages."
This just Doesn't Sound like Promoting THR on the FDA's part. Or a "Reasonable" implementation of what the Intent of the TCA was/is.
But hey... The FDA only has to grant 1 PMTA or MRTP order in the next 10 years so it Can't be Called a Ban.
"Analysts have projected that the cost of a FDA regulatory review would be several million dollars for each pre-market tobacco application, or PMTA. An application is expected to be required for each flavoring and nicotine content level.
By comparison, the FDA estimates the average cost of an PTMA application at $466,563 each.
Reynolds said it has submitted more than 450,000 pages of documentation with its application.
By comparison, Swedish Match said its General Snus application contained more than 100,000 pages."
This just Doesn't Sound like Promoting THR on the FDA's part. Or a "Reasonable" implementation of what the Intent of the TCA was/is.
But hey... The FDA only has to grant 1 PMTA or MRTP order in the next 10 years so it Can't be Called a Ban.