Tag Archives: FDA

FDA Center for Tobacco Products (mostly) know exactly what they are doing.

 

by Carl V Phillips

Clive Bates recently posted about the e-cigarette deeming regulation which started to take effect this week. Most of the post is just the 10,000th thing you have seen, dating back to before the first draft of the regulation was released, about the unfortunate consequences[*]. But in the last line he says:

I’m prepared to believe they aren’t doing it deliberately, but I just have this feeling that the big players behind the FDA’s intervention, such as Mitch Zeller and Matt Myers, do not have the faintest idea what they are actually doing.

It is a reasonable starting assumption. Never assume malice when incompetence or laziness would produce the observed result. In the comments that followed, however, enough people asserted disagreement (albeit largely without analysis) that Bates tweeted in search of anyone who agreed with his assessment. I am afraid I am going to half-disagree also, or perhaps mostly disagree, though it takes some analysis to get there.

First, we need separate the crafting of the Tobacco Control Act, which created the Center for Tobacco Products, and the current behavior of CTP. The TCA accomplished what it was supposed to at the big-picture level, while being a “not the faintest idea”-level failure at the detail level. The big-picture goals of the TCA were:

1a. Do something to please the various anti-tobacco busybodies and federal legislators who were screaming “do something!” without doing anything that would evoke serious opposition from not-anti-tobacco legislators.

…which is roughly equivalent to…

1b. Inflict substantial harm on tobacco product users, along with modest hassles for the producers, while creating barriers to market entry so that the main organized interests in the space (the incumbent major tobacco companies) favored the law.

2. Create some modest restrictions and a create a base for further operations, as per the standard nanny state script: Impose any restriction on people’s choices that is politically possible at the moment, reasonably counting on it ratcheting, before moving on to the next restriction.

3. Impose various hidden taxes on consumers and capture the money as patronage payments for tobacco control supporters.

4. Counter efforts to promote harm reduction by effectively denying different tobacco products, with their different levels of risk should be treated differently, as well as by inflicting further caused-harm on consumers.

All of these were successful. However, at the detail level the TCA was an incompetent clusterfuck, and while that has worked out just fine for the tobacco controllers and does not interfere with the above list of primary goals, it does not appear that was by design. The law contains many details about completely failed processes, such as applications and approval systems (SE, MRTP, PMTA) and assessing and regulating the chemical composition of products. As I have recounted numerous times, the approval processes are utterly dysfunctional, and have simply been a series of arbitrary ad hoc decisions. The chemistry and other scientific goals have gone nowhere. The TCA did not facilitate the creation of the necessary infrastructure to do what it claimed it would do.

The CTP that was created cannot (and thus, of course, does not) function at all as a proper regulator. It reminds me of corrupt third-world frontier guards who are just levying fees, collecting bribes, and making self-interested decisions about whether to allow passage. This week CTP tweeted that the deeming regulation now made selling all tobacco products to minors illegal. I replied by congratulating them on doubling the number of real regulatory actions they had taken in their seven-year history. In reality I was being generous, since the new rule is basically redundant with state laws.

Of course this still fails to answer the incompetence-vs-design question.

My assessment is that all those detailed rules and processes would not have been written with the expectation that they would not function at all, and would merely serve as acts of market sabotage. Those goals could have been accomplished with far less detail. The details clearly feel like an attempt to create something, whatever the motives, rather than to create a morass. So here we have a case of pure incompetence: people designing systems that simply did not work. The key problem is that they violated one of the rules of making good public policy, incrementalism. They tried to design an untested system that was a huge departure from the status quo or anything that anyone had worked out before, rather than testing smaller steps or creating the foundation for an evolving system. Of course it failed. The fundamental incompetence was not being bad at designing systems, but not understanding that almost no one is good enough at designing systems to be able to pull that off.

That is the story of the creation of CTP. What about the current behavior of CTP?

There I would say they know exactly what they are doing at the level of impacts, though they are remarkably bad at the games they are playing at the detail level. The application and approval processes were designed badly. But CTP has taken advantage of that to hand-pick exactly the approvals that serve their goals (interfering with THR, mission creep, making sure future bans were politically palatable). On the other hand, they have been needlessly ham-handed about it (letting applications languish for years, offering really stupid rationalizations for decisions when it would not have been difficult to say something more defensible).

I would say the same about e-cigarette deeming. Yes, many of the details of the deeming regulation look like they were written by interns or out-of-touch activists rather than the savvy lawyers and career operatives that CTP has. These have opened all manner of possible legitimate legal challenges that need not have been left open (some — but not all — of which the current lawsuits take aim at). Their failure to secure their own gates against obvious legal challenges can only be seen as incompetence.

But as for the broad sweep of the deeming, those supposedly “unintended” consequences are exactly the sensible thing for CTP to be imposing. CTP has developed no capacity to actually regulate, nor any apparent capacity to develop capacity. They consist of a bunch of highly-paid people who have no particular responsibility. They show remarkably little knowledge about the simple products they were originally charged with regulating, and e-cigarettes would represent a more-than-doubling of how much they need to understand. Therefore, a regulation that bans all e-cigarettes other than a few fossilized closed systems is exactly the rational thing to do.

I trust it is obvious that I mean their action is rational in terms of their own personal selfish interest (with the added bonus of pleasing the anti-tobacco busybodies). Obviously it is a terrible thing to do from the perspective of the people’s well-being, good government, public health, and so on. Our government’s agencies get a lot of criticism implying they are like the stereotypes of patronage backwaters and department of motor vehicles offices from c.1980. They get undeservedly accused of not trying to serve the public interest merely because they (inevitably) do so imperfectly or in a way that does not fit a critic’s personal political goals. But sometimes the stereotype fits.

The current rules are bad for harm reduction, but that is a feature for CTP, not a bug, because they are demonstrated opponents of harm reduction. The rules will replace a thriving legal market with a thriving black market. But that is exactly what CTP needs because they do not have to deal with the black market beyond sending out a few cease-and-desist letters when something becomes too glaring to ignore. They lack the capacity to regulate the legal market. They could not even process all the product registrations for all e-cigarette products, let alone do anything of substance. So their only (self-interestedly) rational choice is to pare the legal market down to a level they can handle. (Note that this does not imply they will handle what remains in an informed or public-interest manner, but at least they would have the capacity to create an illusion of doing so that will fool non-experts.)

None of that will come as news to anyone who has paid attention to what I have written on this topic for the last two and a half years. But because most of the stakeholders and pundits in this area do not pay much attention, they can be persuaded by CTP’s sort-of-pro harm reduction rhetoric, claims that the black market will be minor, and so on. At the very least, they can be persuaded that CTP really believes their own statements.

But I find it impossible to believe that CTP actually believe what they are saying. When looking at the statements, we are not talking about someone taking on a task and not being competent to pull it off. We are not talking about the musings of random Dunning-Kruger-ized “experts” who have spent a few tens of hours reading about the topic. We are talking about a simple matter of understanding, and about professionals whose full-time job is working on this. Assuming incompetence is a good default hypothesis, but the sheer enormity of the required incompetence in this case, along with the fact that the outcomes are in the actors’ selfish interest, argue strongly for “know exactly what they are doing”.

 

[UPDATE – an extended footnote that is a bit of a mini-post on a different topic: In response to Clive taking some offense at middle sentence of the first paragraph, I wanted to expand upon it. I am not sure whether this will eliminate the offense, but at least if offense remains, it will be based on what I really think, rather than an attempt to interpret those few words.

It is true that this was motivated by me not wanting to recommend reading the post. Please note that this contrasts with 90% of Clive’s posts which I strongly recommend. This includes the ones I take issue with — they are still worth reading. In this case, however, I was basically trying to placate my own not wanting to link to a post that I did not recommend. I felt like I had to say something, even if it was impenetrable.

Why did I feel that way? Part of it is my concern about the flood of generic “deeming [or whatever restriction on e-cigarettes] is bad because it encourages smoking” posts. Even when there is nothing wrong with the content, I feel like the churning of the generic message is contributing to a harmful echo chamber. Moreover, I think the hundreds of monologue posts written without reference to what has been previously figured out create further harm by under-informing readers about the knowledge base. There are way too many commentators (Clive not among them!) who try to write big-picture analyses when they would be much better off just posting “go read this which someone else has already written”, rather than badly reinventing the wheel as an act of self-indulgence, and thereby leaving their readers believing they have a better understanding than they do.

There is a tiny fraction of what is written in this arena that I would ever recommend reading. This probably consists of many works that I never actually recommend because I do not see them. That too is part of the problem: there is so much pabulum that important new insights get lost. Note that the preceding is generic observation; Clive is one of those who advances knowledge, presents new observations, and draws upon and references the knowledge base. So read his stuff if you don’t. Still, because of these concerns, my default reaction (to tie to a theme of the actual post here) is that such a post does little good and possible harm.

(Note that this refers to insider communications. If you want to write something for a newspaper, or slip it in as an off-topic post in your blog about dog training, thus reaching a new audience, by all means do it. But if the only people reading something are already well-read in the field, then more generic broadsides are not useful.)

So, taking this back to the particular post, what did it contain. The content was mainly quotes from the RCP report and a security saleswoman. The former quote was standard generic stuff, but it was anchored on an actively harmful misuse of the concepts of precaution and risk aversion. (This misuse suggests that restrictions on e-cigarettes have potential legitimate justifications that they really do not.) The latter author is has a rather, ahem, dubious record of making proclamations that are wrong and/or based on nothing.

But the real problem here is the tendency — common in public health as well as poor journalism — of suggesting that something is informative or persuasive just because it was written down. Clive is more of an expert on these matters than either the authors of the RCP report or the banker. He could make better and more authoritative statements on these exact points than those he quoted. Indeed, he has done so. Thus the presentation of them mainly serves as an endorsement of the toxic mentality of “I believe something; someone else wrote down a generic brief assertion of the same sentiment; therefore my own opinion is vindicated”. (For a good example of why this is so toxic, see Clive’s own next post.) It is especially toxic when it is done by someone whose analysis should be more trusted than those he is quoting.

Anyway, I was not sufficiently motivated by that to write this as so much as a comment on Clive’s post, let alone write a post about it. However, since this turned into a Twitter discussion/debate, here it all is.

End update.]

Ecig deeming regulation — nothing new to see here

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. Continue reading

Economic innumeracy in public health, with an emphasis on tobacco harm reduction

by Carl V Phillips

I recently had the opportunity to give a talk at what was basically the wake for the end of the quarter-century run of the wonderful Robert Wood Johnson Foundation Scholars in Health Policy Research program at the University of Michigan. I chose to put together some themes from my work as a tribute to one of the goals of that program, bringing the thinking of serious social scientists into health policy arenas where it is desperately lacking. Alas, most of my fellow alumni focus on engineering a better medical system or medical financing, with few choosing to try to deal with public health (let alone “public health”). Medical practice is obviously extremely important, but not so desperately in need of imported thinkers. Well, at least you have me.

I got some great feedback on this talk making that alone well worth my effort. (Thanks to all my colleagues. And it was great seeing you. We’ll be in touch.) But I wanted to also share what I created more broadly here. The following are my slides from the talk, with some text to explain what is not fully contained in the slides, along with a bit of extra material that was not in the talk. 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

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