by Carl V Phillips
A topic came up that made me really want to suspend my blog hiatus. The deeming regulation, the most chatter-inducing event in the history of THR, was not that topic. But I figured if I simply posted on another topic right now I would get asked why. I started to write this as a prologue to the other post, but that was distracting, so here it is.
Why is the deeming regulation not really worth a full post here? Because there is basically nothing that can be said in a summary post, or five, that I did not already write in mid-2014, and certainly not by late-2015. Anyone who is shocked by what was released last week was not paying attention. I have seen literally nothing in the deluge of writings since the regulation was released that I and CASAA (and others, of course) did not already point out: Open systems cannot possibly get approval under PMTA — check. FDA is intentionally eliminating most of the market — check (I seem to be the only one who has pointed out that they lack the organizational capacity to regulate a large market). Legal market will be devastated — check. Inevitably creates alternative supply chains — check. Does not solve any real problems — check. All cost with no benefit — check. And so on.
Of course, there was a bit of value in getting some simplified summaries into the mainstream media. But only a bit: For readers who were not already interested in the topic, that content will soon fade into a vague recollection that something is going on. A few summaries circulating within our echo chamber are also worthwhile, since many people are interested but uninformed. But I am not going to write one. Been there, wrote that. I do not even have the slightest inclination to write an “I told you so” post; that is just not very interesting to do when it was always so clear what was going to happen.
There were necessarily a few either-or scenarios in the prospective analyses, of course, and the final rule resolved them. Was it as bad as it seemed like it would be, or did they back off some like some commentators insisted they would? The former, as I confidently predicted. Did they overreach their statutory authority and declare jurisdiction beyond nicotine-containing liquid and devices, forcing litigation to strip away those provisions, or save everyone a step and just leave that out? The former (I was sufficiently unsure of this one to leave it as an either-or). The only surprise I have seen is that FDA declared they would not attempt to ban interesting flavors immediately, as they had signaled they would, and are instead waiting for the blanket ban in 2018 (this is not binding, so they could still do it, but it is easy to see why an agency that barely has the organizational capacity to find its own ass in the dark would choose the easy path).
This is not to say there is no interesting analysis to be done. I could spend months poring over the details and challenging the scientific, logical, ethical, and policy analysis claims on a sentence-by-sentence basis. Someone will either fund me to do that or not. In the meantime, there is simply nothing interesting to say at the 2000-word post level that I have not already said, so moving on to the next topic….