Tag Archives: FDA

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

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.

FDA and e-cigarettes: the dangers of radical policy action

by Carl V Phillips

If U.S. FDA had succeeded in banning e-cigarettes in 2009 as they did a decade before that, it would have been a bad policy action for many reasons. It would have served no legitimate purpose, violated the mission and spirit (and, according to Judge Leon, the letter) of the FD&C act, violated the ethical norms of free society, dramatically lowered the welfare of many people while making pretty much no one better off, and hurt the public’s health. But at least it would have been a fairly conservative incremental policy. Relatively few people were using the products and had not been doing so for very long. A few small businesses depended on it. It turns out that enormous benefits would have been lost. But at the time, the action would have been a relatively modest departure from the status quo.

This contrasts sharply with the present FDA plan to ban e-cigarettes (for that is what it is) which has all those other negative characteristics and additionally suffers from being a radical departure from a status quo in which millions of Americans use e-cigarettes at least occasionally, and probably hundreds of thousands rank them in importance below only basic necessities, friends, and family. A multifaceted industry and an entire culture have formed around them. The changes in the world that would be brought about by the ban are staggering.  Continue reading

FDA pseudo-regulation of e-cigarettes: what possible benefit?

by Carl V Phillips

Continuing the assessment of FDA’s proposed regulation (as far as we can anticipate what it says). For background, see the CASAA newsletter and the recent posts here. As already noted, the proposed “regulation” is really a ban on sales of all existing e-cigarettes with a provision that will probably (but might not) allow a handful of closed-system products, that FDA hand picks, back on the market. But whether regulation or ban, it can only be justified in order to solve problems. So what problems is it ostensibly solving? To understand the proposal or respond to it, it is necessary to identify those — as a separate point from looking at the downsides — and address what benefits might result. Continue reading

FDA’s snus PMTA approval — what it seems to mean

by Carl V Phillips

FDA issued its first ever approval of “new” tobacco products under the PMTA process that I have discussed before (most recently a few days ago in the context of their proposed ban of all existing e-cigarettes). If you were to read the FDA’s press release about it or the news stories — which basically amounts to the same thing, given the quality of health science reporting — you might come away thinking that this was something major. And it kind of is, just not for the reasons FDA wants people to believe.

The details, as best as they can be pieced together, are explained by Larry Waters, whom I trust on these matters. Basically, Swedish Match wanted to upgrade the eight snus products they sell via bricks-and-mortar stores in the U.S. market, from the 2011 versions of these products to improved current versions that are the same as (or at least more similar to — the public is not told of such details) what they are selling in Sweden now. They apparently applied through both the PMTA (premarket tobacco application) and SE (substantially equivalent) processes, and were granted the former. Note: This should not be confused with Swedish Match’s MRTP application to change the warning labels on their products, which is an entirely different matter. However, I saw a claim that the PMTA application was quietly piggybacked on their MRTP application, making it much easier for them than it would normally be — but I am really not sure of the details there. Continue reading

FDA “regulation” of e-cigarettes would not actually be regulation

by Carl V Phillips

A recent news poll asked people, “Do you believe e-cigarettes should be regulated by the FDA like tobacco products?”, and 57% said “yes”. The main lesson from that is that people who are clueless about survey research should not be allowed to do survey research. Any moderately competent researcher would realize that answers to that question are meaningless when the respondents have no idea what they are being asked. If forced to field such a question, an honest researcher would have also asked one or more questions about how FDA regulates tobacco products and, after discovering that not a single respondent was anywhere close to right (I am pretty confident that would be the result), would dismiss the responses to the first question as meaningless.

An honest and skilled researcher only asks questions such that the respondent actually knows what they are answering: “Do you believe that FDA should ban all e-cigarette products, followed by allowing a few of the largest companies to spend $20 million per product to beg permission to allow a product or two onto the market, applications which FDA would then grant or deny based not on any rules but on their political whim or political connections, with the result being less than 20 expensive and low-efficiency products remaining on the market?” That is the question the respondents were answering, they just did not know it. No doubt some respondents still would have said “yes” — haters gonna hate — but not nearly as many. Continue reading

Remember, what the US government wants to do to ecigs, they have already done to smokeless tobacco

by Carl V Phillips

Well, a lot has happened during my blog hiatus. I trust I do not need to tell anyone interested in THR that things in the US e-cigarette world “got real”, with the US FDA finally moving ahead with “deeming” e-cigarettes. Why, exactly, it was suddenly more real that it was for the last year or two — during which it was clear that this was coming soon — I will leave to the behavioral economists. But it does seem to have changed the mood. The last time I posted here, CASAA membership was about 70,000 and today is north of 110,000 and climbing fast. So this is probably a good time to give people new to this world a primer, and remind everyone else, that the US government has a long history of being hostile toward THR.

Few who actively oppose FDA’s plans need any additional reasons to object to them. It is sufficient to know that this is not actually regulation, but a de facto ban of the entire category that might — or might not — be followed by granting exceptions to the ban for a handful of closed-system e-cigarettes. (I will detail why this is the right way to think about it in my next post.) But there are people on the fence. Perhaps more important, there are many opponents of banning e-cigarettes who are naively optimistic, expecting reasonable behavior from our government once they implement this rule. Continue reading

Dear @FDATobacco: Stanton Glantz’s junk science reflects upon you

by Carl V Phillips

Dear FDA Center for Tobacco Products:

I know you did not create Stanton Glantz. His intense barrage of patently absurd junk science predates your existence. You did not cause him to become the combination of utterly innumerate and/or sociopathic (it has always been difficult to be sure how much his utter disregard for real science is explained by each of these). But you own him now, thanks to the fact that you fund him and his minions, and so his nonsense is now on you. You claim to be about science. Are you? Continue reading