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.
FDA does not regulate cigarettes and smokeless tobacco now, and would not regulate e-cigarettes under the deeming — not in any normal sense of the word “regulate”. Well, I suppose you can call any government restriction on commerce “regulation” if you define it broadly enough. But few would call alcohol Prohibition, the criminalization of heroin and prostitution, or the 14th Amendment “regulation”. What FDA does with tobacco products is much closer to those examples than it is to what we normally think of as regulation, and it would be closer still for e-cigarettes (and also for premium cigars, which are included in the “deeming regulation” alongside e-cigarettes).
Any normal use of the word in the context of products refers to rules for product characteristics, performance standards, manufacturing standards, labeling, and the like, such that a product in the category must meet the rules to be allowed on the market. FDA’s tobacco “regulation” includes almost none of that. There are some packaging and labeling rules, a ban on characteristic flavoring for cigarettes, and a prohibition against selling to minors (which is redundant with state laws). There is constant chatter about some day imposing some real regulations, like limiting quantities of particular chemicals that some believe to be independent sources of health risks, but there is nothing like that now. And there may never be, because the real effect of FDA “regulation” is simply to make it nearly impossible for manufacturers to introduce a new product or even make changes to existing products. I would guess that about 99% of people who profess to have an opinion about tobacco policies do not know these basic facts (and it rises to about 100% of randomly selected survey respondents).
In the previous post, I pointed out that the US government in general, and the FDA in particular, has a consistent track record of attacking smokeless tobacco with the same vehemence that they attack cigarettes. They have tricked people into believing smokeless tobacco causes measurable disease risk and have aggressively restricted these products, successfully preventing a great deal of THR. One implication of that is that there is no reason for a rational observer to expect “moderation” in FDA regulation of e-cigarettes. If this is what they have done to a well-studied THR product that almost certainly poses lower risk than e-cigarettes, why would we expect better for e-cigarettes?
But prospects are even worse for e-cigarettes, and as a result there is not only no realistic hope for moderation, but also no realistic room for establishing a meaningful compromise. The FDA is prevented from just banning an existing smokeless tobacco product from the market except via actual product regulations (and there is no evidence that they are seriously pursuing any such). But they can ban all e-cigarette products from the market. Indeed, the proposed deeming will ban all e-cigarette products. It does not matter what details are contained in the proposed rule. It does not matter what else FDA says they are going to do with their new authority. A real regulation, one that imposes actual rules on a product, has room for compromise (“we could live with it if you changed this from 10.2 to 8.4 and allowed exceptions for…”). But in this case, the payload is basically all in the mere act of deeming, imposing the rules contained in the Tobacco Control Act (TCA) on e-cigarettes.
Allow me to unpack that a bit, though most interested readers will already be familiar: The TCA bans the sale of any tobacco product that was not on the US market as of 2007, though it theoretically grants introductions of new products via supplication through the PMTA process (which is usually spelled out as “premarket tobacco application”). Since nothing even resembling any current product meets that 2007 cutoff (called the “grandfather date”), this means that all current products would be banned. Many commentators (including us) use a shorthand along the lines of “this would ban 99% of all products on the market” (though really, 99.99% is the right order of magnitude), but it is more accurate to say that it would ban 100% of products and then, perhaps, allow 0.01% as many products as currently exist — which would be officially new — to be introduced or reintroduced through PMTA.
More on PMTA and the “perhaps” below, but the key point here is that this is not a real regulation. A real regulation would say “all of the products in the sector will have to meet the following list of standards in order to stay on the market after a grace period of X months.” But the deeming would ban all existing products unconditionally. There is no opportunity to meet regulatory standards. There is no room for negotiation or compromise.
There has been a great deal of discussion about changing the grandfather date, perhaps moving it forward to the date the TCA is applied to e-cigarettes. In addition to the obvious practical benefits, which include buying some time to try to get rational policy changes, this eliminates a Kafkaesque absurdity from the whole process (“you should have known this was coming in 2007, before your company or products even existed, and thus should have made sure to get your products on the market by then”). The grandfather date is one specific point that allows room for a sort-of-compromise. Changing it to the present would basically put e-cigarettes on the same footing as smokeless tobacco: Incumbent manufacturers cannot continue to improve their products, and no innovators can enter the market, but so long as incumbents keep the products just the same they can keep selling them.
As bad as such a compromise seems, it is not even quite as good as it might sound: It is likely that many smaller manufacturers would not be able to demonstrate that a particular product was on the market before the grandfather date or would otherwise fail to properly jump through all the hoops; they would probably keep selling it, but technically it would be illegal and eventually subject to FDA enforcement action. Many small manufacturers would just exit the market rather than even try. Moreover, FDA would undoubtedly move to impose standards (the real regulations they will not bother with if they can just ban everything) and any product that did not meet them would have to be adjusted and then (more Kafka) have to get permission for the change through the expensive, arbitrary, and usually-denied “substantial equivalence” (SE) process. In the previous post I gave an example of FDA arbitrarily denying an SE application for something that is clearly a THR product.
And note that these SE issues apply only to technical specifications, the kind that appear in real regulations. Actual prohibition efforts would also be likely, such as banning most flavor profiles. Without further policy changes, the market under a later grandfather date will converge to being quite similar to the market under the 2007 date, within only a few years, though a later date would buy some time for those policy changes.
In any case, FDA has insisted that there is no room for a sort-of-compromise on the grandfather date. The absolute date is written into the enabling legislation and FDA contends that an executive agency cannot change it. They have a reasonable constitutional argument there, which is one of several reasons why we said, in our comments on the draft rule last year, that if FDA really wanted to do what they say they want to do — lowering the average risk of tobacco products, and such — they would ask Congress for new legislation before acting on e-cigarettes. Indeed, new legislation about all low risk products would be a good idea. There is a movement to get Congress to change the e-cigarette grandfather date despite FDA’s lack of support for doing so (you can voice your support for that to your legislators here).
But the constitutional issue is really a rationalization for FDA’s real reasons for absolutely not wanting to compromise on this. They have clearly indicated that they do not want to really regulate e-cigarettes. More details can be found via the links in the above link to our comments, but basically the problem is that e-cigarettes are complicated, unlike the tobacco products FDA currently regulates. FDA is flustered and floundering on the subject. They tried to educate themselves via workshops, which involved the presentation of “information” that was about 66% already common knowledge among real experts, 33% wrong, and 1% genuinely educational. There is limited science about the category in general, much of which is crap, and specific research about approximately 0% of the individual products. Really regulating e-cigarettes would be a lot of hard work, upsetting the rather cushy job of “regulating” tobacco products. On top of that, moving the grandfather date much would increase the number of individual tobacco products that FDA must deal with by an order of magnitude. They could not even handle the resulting registration paperwork. And they know it.
Much easier, then, is to ban all e-cigarette products and then hand-pick a few individual products to enter the market. No real regulation is needed because the exact product has to be pre-approved and no changes are allowed. As an added bonus, no research effort is needed because FDA can just tell the PMTA applicants to proactively provide every bit of research FDA might want, and then make them go back for more if so desired. And that, in turn, has the delightful effect of making every application cost millions of dollars, which will keep the total number FDA has to deal with down to 10 or 20 (their estimate, which seems about right). It is truly elegant bureaucracy — in the derogatory sense of the term, a la the cartoon version of trying to renew your driver’s license c.1980. Indeed, departments of motor vehicles could only dream of so effectively offloading the job they were supposed to be doing onto the customers they were supposed to be serving.
So what would FDA then do with those massive research-dense filings? Whatever they wanted to do.
I used the words “supplication” and “hand-pick” to describe the approval process. That is because there are no clear rules about what any tobacco product application needs to achieve to be accepted. Indeed, the “guidance” documents that FDA has produced call for inclusion of several pieces of evidence that are literally impossible to generate. This makes it rather easy for FDA to reject any application they want to reject. Oh, but they can still accept it, because FDA explicitly states that these are just guidance and are not binding on either FDA or the applicant. In other words, the instructions for PMTA applications are “do all this — or not, your choice — and we will then accept the application or bounce it back for more information — our choice — and if we accept it we will make a final decision based on something.” I have heard from industry that for something in the range of 80% of serious SE applications that FDA bounced or rejected, FDA’s stated reasons for doing so were something that FDA had never before communicated was required of the applicant.
Granted, any regulatory process that involves complicated science is going to have some fuzzy edges. The FDA drug approval process, which the FDA tobacco regulators are inappropriately trying to ape, inherently includes the necessarily subjective step of deciding whether the imperfect body of available evidence is convincing. But at least there are pretty good rules, and a consistent pattern of constructive engagement with the regulated companies to try to deal with the fuzziness in ways that (mostly) serve the public interest. The major tobacco companies can afford to maintain constructive engagement with FDA, but no more than a handful of other companies in the e-cigarette sector have that capacity (and there is no concern whatsoever for consumers’ interest). Even with that engagement, though, given the expense and vagueness of the PMTA process, it is easy to believe that even the big companies with individual products whose sales could justify the PMTA application expense (which would only be mass-market closed-system cigalikes) might not want to bother with it.
Well, that is not entirely true. Because FDA probably wants a few e-cigarettes approvals, to demonstrate that they are not really banning the category, and also to be able to gather data (they are curious human beings, after all). So if it is looking like they will not get enough applications to hand-pick from, they will lean on the companies they regulate in other tobacco product sectors to file them. Thus there probably will be a few closed-system cigalikes on the market when the dust clears, though perhaps not, depending on the political winds. (There will also be thriving shadow markets for open system products, some of which will be full on black markets, and some of which will be technically legal depending on exactly which bits of open systems FDA asserts authority over. Needless to say, this market shift would benefit no one other than the criminally inclined.)
What is critical to understand here is that every FDA action on a PMTA application, as with their actions on SE and MRTP applications, is purely a policy decision. A small cabal of unelected government officials have a free hand to make whatever choices they think will make the tobacco product market more like they want. There is no process, just policy. This is bad governance at its worst. There are steps that resemble a process, and can be used to pretend there is a process, but fulfilling those steps is really just the price of admission. Once that price is paid, it is purely a matter of supplication. We are talking about something akin to licensing authorities in a command economy (and if that brought to mind phrases like “political connections” and “crony capitalism”, you are thinking down the right path).
So, surveys show that a majority of the population — people who have no stake in this — thinks e-cigarettes should be regulated. What really matters is that most actual consumers — I would guess easily 90% — would like some real regulation of what they are putting in their bodies. Reputable merchants benefit from real regulation too. But none of them will actually get what they want under the current FDA regime. The only ones getting what they want will be the tobacco controllers who want all tobacco users to be smokers and the hand-picked PMTA grantees who will enjoy their new oligopoly profits.