Thanks again to everyone I met at IPCPR on Sunday. One of the things that struck me in talking to industry folks is that there is an overall sense of uncertainty as to what the FDA is going to do. I even heard, several times, that people seem to think FDA will ultimately not regulate the premium cigar industry.
I encourage everyone to take a look at the FDA’s CTP reading room. If you think FDA hasn’t decided how they’ll treat SE applications or how they view the issue of HPHCs: some of the documents there will be quite enlightening. FDA knows exactly how they’re going to regulate and they’ve given us some pretty clear guidance on what is to be expected by publishing the “NSE” (no substantial equivalence) letters. These letters show each of the very specific and detailed reasons as to why many past SE reports were rejected. By analyzing the reasons for the rejections, along with the deeming rule and draft guidance documents, the blueprint for approval under the SE pathway becomes apparent!