Thread by @GregTHR

SCOOP: Turning Point Brands files emergency motion for a stay and for expedited review in their case pending before the 6th Circuit Court of Appeals.

"This is a quintessential case for staying unlawful administrative action pending judicial review."

drive.google.com/file/d/1dXNj7c… $TPB

TPB spent $12 million supporting its PMTA submissions, which totaled 81,000 pages in length.

In the end, all their science meant nothing because the FDA, years after announcing companies would be required to submit PMTAs, decided to set a new product standard. #FDALawsuits

"FDA failed to consider the consequences of an across-the-board prohibition on flavored ENDS for millions of adult former smokers who will suddenly lose access to the products they have depended on to quit."

"A mass exodus...also risks pushing countless
smokers back to [cigs]."

A sample of what TPB spent $12 million on, only to have some junior level bureaucrat do a bare minimum review so nearly every application they filed could be denied.

How long did it take Matt Holman from the FDA CTP Office of 'Science' to concur with recommendations to deny TPB's PMTAs?

An hour.

And all this after FDA wouldn't even meet with TBP pre-COVID to discuss what studies would be required.

As TPB points out, the FDA acknowledged that it was not until they began reviewing PMTAs that they decided to change their requirements for authorization.

"FDA cannot now penalize TPB for following FDA's instructions."

How intensive was the FDA's review process?

Products with identical formulations but different names received different outcomes.

Authentic Tobacco? Banned. Classic Tobacco? Maybe.