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.
Tobacco harm reduction, anti-THR lies, and related topics 
Thank you Carl (and Julie and CASAA) for all of your hard work. I sure do hope that they realize (and care) how disastrous this regulation will be if allowed to go forward in its current state.
Oh, and thanks for the paginated version of the original testimony to OIRA. I had it bookmarked (the original) with the intention of getting around to reading it. Now that it is in increments I can find the time to read bits and pieces as time allows.
Whoosh! You guys really put a lot of work into this. Thanks again:-)
Excellent report Carl. Thanks for all the hard work.
Thanks for what you are doing to protect vaping
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I, too, echo what others say below. Thank you from the UK. I have always found your blog a source of vital information and analysis.
Even if the FDA leadership was genuinely committed to sensible, evidence-based regulation of vapor products, such regulation is not possible within the statutory framework of the FSPTCA of 2009. It is an astonishingly bad piece of legislation, even when applied to the actual tobacco products it was intended to govern, and which actually existed when it was promulgated.
Trying to shoehorn an entire still-emerging category of non-tobacco (and, in some cases, non-nicotine) products into the framework of a law that already uniformly fails to accomplish its own intended purpose (e.g. the establishment of common sense policy that reduces the health hazards associated with products that actually DO contain tobacco and nicotine), is akin to governing 21st century automobile traffic under the auspices of a horse-and-buggy ordinance from 1873.
As you say, the TCA is inherently a problem, and FDA has made clear that they are going to make it worse than need be despite the naive suggestions from some quarters that they will really try to make it ok. However, it is a mistake to think that the TCA is not working as intended. It is inherently anti-THR and non-regulatory — it was *designed* to gum up the market (and protect the incumbent products) and really nothing more than that. At best you can argue that some of that design was accidental rather than intentional, as you are suggesting, but I think you have a very difficult case to argue that the bugs were not intentional features in the minds of the architects.
(Note that these points appear in the report, except for explicitly stating that last bit.)
I appreciate all the time you spend to protect vaping and keep the truth visible.
I’m sure I speak for many others when I say that we are grateful that some folks, with the knowledge and experience necessary, undertook to make an intelligent and reasoned response to this madness. Thank you.
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I appreciate the effort by CASAA and well meaning groups, and I am also on board with you, calling and emailing: Senators, House Members, State, County and City elected officials, who won office through appointment, connections, good looks, gobs of money, and possibly a few through talent.
I humbly wish to kneel before them and beg for something but the fact is, I find them repulsive, and will instead order $5k in vaping products this year(raw nicotine, regulated and unregulated box mods, tanks, RDAs, cotton, and enough coil wire to reseal the border btw East and West Germany), as well as purchase chemistry lab gear to extract nicotine from tobacco to vape. No, I will not quit. Dummy up.
We are tired of your droning voices telling us what to do, and we would tell you what you can do…but, you can well imagine what that would be.
Indeed. Freedom begins when you tell Mrs. Grundy to go fly a kite.
“The Constitution is not an instrument for the government to restrain the people, it is an instrument for the people to restrain the government – lest it come to dominate our lives and interests.”
― Patrick Henry
We are engaged in an ongoing process of sacrificing our individual liberty to the rule of a vast, un-elected bureaucracy, and we are increasingly made the subjects of its arbitrary acts.
— Me
Your 57 page analysis of the deeming is spot on, very well written, and is the most comprehensive insight yet on future black/gray markets and their corresponding increased consumer risks created by the deeming rule.
I devoted much of my presentation to OMB/OIRA staff on those very same ramifications of the deeming ban.
The only statement I’d quibble with, on page 50, asserts that vapor products might be marketed as cannabis vaporizers if FDA attempts to extend the deeming ban to hardware components. Due to the federal anti drug paraphernalia law, and aggressive enforcement of that law during the Bush administration (notably US Attorney Mary Beth Buchanon’s successful prosecution of Tommy Chong for selling bongs), most head shops have signs stating that all marijuana paraphernalia is “intended for tobacco use”
to avoid federal prosecution and time in prison. While the Obama administration has not aggressively prosecuted that or other federal anti marijuana laws, nobody knows what might happen in the next administration.
Interestingly, I suspect that head shops (most of which now also call themselves vape shops) will survive and may thrive under FDA deeming
(as they’ve survived the government’s longstanding War on Drugs), although they’ll likely replace those signs (and signs for their vapor products) to say something like “intended for herbs and flavors”.
Thanks.
Keep in mind that the interesting phase is in the 2 to 5 year horizon, not tomorrow. Cannabis is becoming more decriminalized by the month. In any case, herbs and flavors will indeed probably cover it, since it seems very unlikely that FDA could win a court challenge if they tried to assert jurisdiction over zero-nic liquid. That was my lead scenario. With no jurisdiction there “not for use with nicotine-containing liquids” ought to be sufficient for a safe haven.
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The whole Crux of this disaster is that the CDC has turn this into a political football. They need to come out with a decisive statement and include in it 2 medical personnel how to treat patients who come into their office with a simple urine THC drug screen. This will be able to determine quickly and accurately the cause of these illnesses. Once it’s established that these are all related to THC and vitamin e oil then the CDC can clear vaping as not being harmful. As far as I can understand these flavors have all been registered by the FDA? In conjunction with all the cases that you have presented of ex-smokers turning to e-cigs and quitting successfully their tobacco products this should reinforce our argument. The CDC has unnecessarily caused great harm by not getting to the bottom of these illnesses and deaths.