FDA FDA reports it issued 125 SE orders and rejected 199 SE reports in June

[Bill Godshall]

FDA reports that “In June, FDA issued 125 Substantially Equivalent (SE) orders, which include final actions on full and streamlined SE reports. FDA also issued 8 Not Substantially Equivalent (NSE) orders, 1 Refuse-to-Accept letter for SE, and companies withdrew 190 SE reports from the review process.”
Tobacco Product Marketing Orders


Also, the FDA still hasn't accepted any PMTAs for consideration (as it refused to even file the 4 PMTAs that were submitted).

And yet, the FDA and its lackeys (and the national news media) all still claim the deeming regulation won't ban e-cigs (even though FDA needs to approve a PMTA for each different e-cig product before it could be legally sold after 2017).

 

[bigdancehawk]

I skimmed several dozen of the 2015 SE reports and it appears that virtually all involve rolling paper or tubes. It also appears that the vast majority of products found to be "substantially equivalent" are, in fact, identical to their predecessors. E.g., they merely changed the names or they put more of the exact same papers in the box. Yep, same exact product. How many bureaucrats, engineers and scientists are needed to make these complex regulatory determinations? What an utter and complete waste of time and money.