by Carl V Phillips
By now, many of you are already aware that CASAA met with OIRA, the White House office that vets proposed regulations to make sure — or, at least so the intention of the office goes — the benefits exceed the costs, and that some other alternative would not have greater net benefits still. We gave a brief presentation and delivered a written report which appeared at the main CASAA blog a few days ago (here is a paginated PDF version if you share my preference for not reading 57 pages as one long scroll). We also delivered a copy of the CASAA testimonials collection, all four shelf-feet of paper (photo) for dramatic effect and as a seasonally-appropriate homage (to Miracle on 34th Street), along with an electronic copy. I am guessing they are not going to be reading 8000 pages of testimonials, but they are now a matter government record.
I made sure to emphasize in the report and presentation a few points that I suspect were unique, and at least avoided being yet another redundant pleading about how this is really a ban and how much harm it will do. We covered those points too, of course. In particular, I repeatedly pointed out that this ban is not real regulation, a point that I think has been lost in the noise. Real regulation of products involves standards that manufacturers can endeavor to meet (and can know when they have met). FDA has engaged in no real regulating of tobacco products so far, and this would be no exception.
We reported some results from the CASAA member survey, which you can find in the report (someone will be putting together a more complete reporting shortly). We point out that ours is the first survey of e-cigarette users that got a decent response rate from a reasonably well-defined population — vapers who are CASAA members — and that we believe it is therefore fairly representative of the most of a million enthusiastic American vapers. Most notable among the results was that 90% of respondents indicated they would turn to alternative markets — black markets, self-importing, and/or do-it-yourself manufacturing — and keep using their preferred products if FDA banned all e-cigarettes, banned all but a few approved cigalikes, or even if they merely banned interesting flavors for e-cigarette liquid (which might happen before the total ban took effect).
We presented a real policy analysis, explaining why the emergence of the alternative markets is inevitable, and then assessing what will actually happen under the rule. This is something that FDA should have done, but never did (which we emphasize is a fatal flaw in itself, a sufficient reason for sending this back to the drawing board). As far as I know, it is something no one else has done either.
That analysis shows that literally none of the stated or implicit goals of FDA’s action appear to be furthered by the rule. Most of them would pretty clearly be set back by the rule. For most, this would be due to the creation of alternative markets (which, e.g., would have lower manufacturing quality and much greater potential for accidents, and are easily accessible by minors). Though some of the supposed goals would not actually be furthered by FDA’s rule even in their mythical world in which only their approved products existed (most notably, population health would clearly be harmed by encouraging more smoking).
I emphasized that our analysis does not contradict FDA’s own analysis that says their goals would be furthered, because there is no such analysis. They did not present even a prima facie case that they will accomplish anything. Indeed, I would characterize (just here — I did not use this in the report) their approach as the passive-aggressive alternative to policy analysis: It is akin to someone who just complains about something, without stepping up to actually offer a request, suggestion, or order about changing it, nor even make the case that change should happen, and instead just thinks those around them should respond to the complaint by just “doing what they obviously should be doing.” All FDA has done is list supposed problems, without even establishing that they really are problems, and imply that these would somehow be solved without actually ever suggesting how this might occur.
Because there was no reason to believe that any of the supposed benefits would happen — and lots of reasons to believe they would not — I described this as a rare case of a literally unmitigated disaster. That is, there are no benefits that would even partially offset the enormous costs.
That was the reason for another point that I am guessing we were unique in emphasizing: pointing out that the most difficult thing about analyzing this proposal is accepting the fact that it really is as bad as all that. (I put several slides in the powerpoint we prepared that repeated this message. We did not end up doing a slide show, but it is still the outline of the talk I gave if you want to see it (pdf).) In the presentation I played the “I am like you…Kennedy School graduate…policy professor…done a million of these…” card, and pointed out that I know it is a very rare case when a rule does not have something going for it, even when the costs clearly exceed the benefits. The difficult part is not assessing the costs (they are huge) or quantifying the benefits (there are none), but believing that an agency would put forward a rule quite this bad.
We pointed out the obvious, much-discussed costs, of course (encouraging people to return to smoking, discouraging smoking cessation, wiping out businesses). We explained that the alternative markets would thrive, but still be inferior to the status quo in almost every way. We also noted many more subtle costs and violations of proper policy-making, such as creating a crony-capitalist oligopoly in the remaining legal market, creating a legal and enforcement nightmare, turning otherwise law-abiding citizens into scofflaws, harming the reputation of U.S. regulators in general, and increasing health disparities, as well as FDA actively and blatantly misrepresenting a blanket ban as real regulation.
Related to the latter, we also emphasized a new favorite point of mine: Because this rule (if actually enforceable) would deprive millions of people of something important to them — for many, the most important thing in their lives after basic sustenance, friends, and family — its real impact is greater than any domestic policy in recent memory other than the ACA. Even if the impacts were positive, they are so huge that this should not be sneaking through as if it were a mere technical action on the way to start imposing real regulations, as FDA has misrepresented it.
Our “ask”, which we acknowledged was a big one, was that the rule be delayed. Nothing else would really help; there are no details that matter, because the entire payload (the ban) is built into the deeming itself and FDA’s process of ridiculously costly applications that are usually just arbitrarily denied. The delay would need to last until such a time that FDA demonstrates that they can and will engage in real regulating (e.g., have a track record of approvals processes with clear rules for submissions and acceptances, neither of which exist for tobacco products now) and that FDA offers policy analyses that assess the real results of whatever rules they then propose, and that these suggest the impacts will be positive.
If anything good comes of this process (and I am not saying I am optimistic — sorry), it will be because of the crux step of OIRA understanding that this really is as bad as all that.