Monthly Archives: December 2015

CASAA comments on FDA proposed “intended use” regulation of ecigs

by Carl V Phillips

CASAA recently submitted its comment about an FDA proposed rule, something they presumably intend to implement as soon as they “deem” e-cigarettes (and thus before they ban ~99.99% of them outright). The rule basically attempts to claw back much of what FDA was declared to not have the authority to do in Judge Leon’s landmark ruling. You can read more and link through to the FDA proposal at our Call To Action (which you can still respond to at the time of this writing, through Wednesday).

The short version is that not only would be e-cigarette manufacturers and vendors be prohibited from communicating the clearly accurate message that e-cigarettes are a low-risk alternative to cigarettes, as they are already prevented from doing, to the great detriment of real public health. But under this rule they would not even be able to suggest that e-cigarettes merely are a substitute for cigarettes. If they do, the FDA wishes to assert, this would be a disease treatment claim and thus subject their products to pharmaceutical regulation (which really means they would be banned immediately).

Um, yeah. Our submitted comment is posted at the main CASAA blog. (It is short enough to read in that format, unlike the last one, but if you prefer the formatted version it is here (pdf).) The highlights: Continue reading

Xmas gift from Iowa for all the good little ecig fans

by Carl V Phillips

No, I am not talking about the chocolates that Julie Woessner sent out to CASAA workers and BOD members. (Thanks for those Julie. And also, you’re welcome — for me making the effort to point this out to the world, thereby making sure anyone who you missed will get in touch with you and help you correct your oversight. :-)

I am talking about this pro-ecig press release from Iowa Attorney General Thomas J. Miller. It has some mildly incorrect and naive bits, though none that are intentionally anti-THR. I am also a wee bit annoyed about the formatting that does not allow copy-paste. But I am going to just go positive today and quote (retype :-< ) the good bits. Continue reading

Utter innumeracy: six impossible claims about tobacco most “public health” people believe before breakfast

by Carl V Phillips

As anyone with a modest understanding of the science knows, tobacco controllers and other “public health” people make countless statements that are utterly false. The tobacco control industry depends on making claims that flatly contradict what the science shows. But there is a special class of claims that are not wrong just because they contradict particular empirical evidence; rather, everyone should know they are wrong based merely on understanding some basics of how the world works. Many such claims are constantly repeated as if they were self-evidently true even though they are actually self-evidently false. I was having trouble defining the category until I recalled the quote from Alice in Wonderland alluded to in the title. Continue reading

Peer review in “public health” — Tobacco Control journal own-goal edition

by Carl V Phillips

Clive Bates prods me to write something about this editorial in the journal/political magazine/comic book, Tobacco Control, by Editor-in-Chief Ruth Malone, honoring their “top reviewers”. (Oh, wait, it is a British publishing house, so that should be: “honouring their toup reviewers”.) You can view it yourself, because it is open access, unlike their regular articles which they hide behind a paywall to inhibit real peer review (very few libraries subscribe to Tobacco Control, to their great credit). They really should have hidden this one from scrutiny too. Continue reading

CASAA analysis of what will really happen under ecig deeming

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.

Sweden pulls up the drawbridge behind them (outsource)

by Carl V Phillips

Sorry for the blog silence. Busy. It will continue for a few days. In the meantime, I recommend reading this post by Erik (Atakan) Befrits about Sweden caving to WHO pressure to try to use warning labels to try to scare people away from THR. It contains some important perspective that many of my readers my not normally get. (Obvious disclaimer: I don’t necessarily agree with every word of the post.)

The crux:

Make no mistake about this: This new law on snus will have exactly ZERO effect here in Sweden where ZERO people die from using snus. It will however have devastating effects for the health of smokers and users of toxic smokeless formulations in THE 193 OTHER recognized countries in the world.