by Carl V Phillips
Four items, related primarily because they resulted from my observations over the last few days, though there is an underlying theme to be found.
Item 1: Many of you have no doubt seen this story that appeared in Business Week and various other publications via the Bloomberg feed. At the Global Tobacco Networking Forum, Reynolds CEO Susan Cameron made clear that a much-criticized line in the Reynolds comment on the FDA proposed regulation of e-cigarettes had not been misinterpreted. The line, which basically called for the banning of open-system e-cigarettes, might have been a trial balloon, but it was certainly not a gaffe. Cameron made clear Reynolds’s support for that position.
This recommendation has been widely criticized as protectionist, or at least looking like it. I tweeted about the original regulation comment with a joking question about why they did not just go ahead and recommend banning any e-cigarettes not called “Vuse”. I responded more seriously about the talk, on behalf of CASAA, as you can see at the end of the Bloomberg article. I identify both the protectionist optics that Reynolds is creating, as well as the huge harms that would come from rapidly restricting the category, whatever the motivation.
Cameron, supported on these points by the Lorillard CEO in his talk (Lorillard is set to be acquired by Reynolds), justified the recommendation in terms of fears that open systems could poison the whole category; there could be bad press resulting from unfortunate incidents or perhaps repurposing of the products to use other drugs. It is hard to not react cynically to this. Indeed, social media erupted with criticisms about it when the story hit the media, noting how these claims seem remarkably close to the ANTZ playbook and expressing particular dismay that they were made in a session that included FDA CTP Director Mitch Zeller.
There is some consolation to be found in the fact that FDA’s proposed regulation of e-cigarettes already would eliminate all open systems from the legal market, so this is not a suggestion to change the regulation. Moreover, the backing on this point by major tobacco companies — with obvious competitive motives, whatever else they are concerned about — is not exactly going to increase sympathy for FDA’s position. Moreover, defenders of open-system e-cigarettes have plenty of reasons to consider Reynolds an ally, even if an unintentional one — see below.
Some of us still hope we can talk Reynolds back a bit from this position. Arguments include the observation that there has been a lot of use of open systems without any major problem, and that the repurposing trope is silly because the production and use of devices for other drugs would be unaffected by e-cigarette regulation. The major tobacco companies must get frustrated dealing with e-cigarette manufacturers, who have been in the tobacco space for about five minutes, telling them everything they clearly should have been doing differently all along; perhaps pointing out that they are acting the same way as seen from the other side might resonate. Additionally, there is the irony that a few aggressive statements like these might poison the well for all makers of closed systems, causing damaging hostility from the politically-active vaper community who are mostly open system aficionados.
Item 2: In that same session, Zeller mostly said nothing of substance — saying nothing useful seems to be part of his job description — but he did note, “In evaluating the market, the FDA will consider addictiveness, toxicity and appeal of the products.” That is quoted from the Bloomberg story, whose author shared some observers’ assessment that this was the one really important thing that Zeller said. Toxicity, of course; addictiveness, whatever. But what is it that FDA wants to consider about appeal that makes it the third pillar there? So far, everything points to: If it is appealing, then it is bad. Zeller did not say what he meant by “consider appeal” (of course), but that seems the best interpretation. Not good.
Item 3: Those who have read the CASAA comments on the proposed e-cigarette regulation or various things I have written here will know that I am well aware that complying with FDA’s vague rules and byzantine and intentionally obstructive regulations is nearly impossible. You will recall my assessment about the SE (Substantial Equivalence) application process, summarized as “nothing is ever substantially equivalent.” And yet even I was stunned by what more I learned over the last few days. For all of you who — like I — have not been in the trenches dealing with the regulators, I am pretty sure that it is rather worse than you think. I will write more about this when I secure further information and/or the opportunity to interview some people on the record. For now I will just summarize with: The current regulatory regime basically never approves anything, or takes any other non-prohibitionist action, except when it is bright-line required to do so, and not even always then. Moreover, we might have been too optimistic when we said that the FDA regulations would ban only 99.99% of e-cigarette products on the market.
The only good news in this for those consumers and producers who hope their novel products will not be banned is that FDA’s failings fall just as heavily on established producers of traditional products, including large ones — at least the ones who are not happy with the status quo. Reynolds and Lorillard have already sued over FDA regulation. Further lawsuits from them might force FDA to back off from engaging in prohibition under the guise of regulation.
Item 4: It is looking likely that the dominant name for the e-cigarette category will soon be “vapor products” or just “vapor”. The majors seem dedicated to the use of that terminology (“e-vapor”, which they are also toying with, seems very unlikely to stick). Speculating at the motives, it is obvious that those who are expanding into non-electronic “e-cigarettes” might not like the “e”, and they all probably feel that “vapor” offers better optics for them than “e-cigarette”. The media is likely to follow their lead. Enough of those in the activist community already prefer “vapor products”, mostly for similar optics issues, so there will not be much push-back from users.
It was always clear that some term would be adopted to refer to the entire space of nicotine aerosolizers (and their nicotine-free variants). Until recently, I would have bet on “e-cigarette” surviving as the dominant term, referring also to products that are not electronic, with the meaning of the “e” becoming merely historical. The current trend changes that. This is bad news for those activists who want to draw a line between “e-cigarettes” and “vapor products”, with the former referring to cigalikes, the latter referring to the most advanced systems, and the line being drawn at some personally-preferred spot in between. The concerted effort by the majors pretty much guarantees that term, assuming it sticks, will refer to the entire category.
Also, those who were motivated by literal accuracy should not be claiming victory: “E-cigarette” is obviously a metaphor, and thus not technically right or wrong (even if expanded to include non-electronic devices). “Vapor”, on the other hand, is technically a misnomer for matter that is almost entirely aerosol. It will be interesting to see whether makers of new heat-not-burn products, which are designed to avoid pyrolysis and produce only aerosol and distillate (some of which might actually be delivered in vapor phase — perhaps someone with better knowledge of the p-chem than I have can help me with that), will seek to position them as “vapor products” too, and whether that will stick.
Left behind in all this are likely to be some regulators and the ANTZ. FDA is fairly committed to sticking with “e-cigarettes” while the deeming process plays out. The ANTZ went all-in for the absurd and unethical “ENDS”, which is even worse than “e-cigarette” for accuracy since it pretends to be a technical term, while being even less technically correct than the metaphor was in the first place. They are going to have a hard time retreating from that.
As for me personally, I suspect that in non-technical writing I will continue to default to habit with “e-cigarettes”, except in contexts where deferring to “vapor products” seems useful for clarity. I will, however, follow the trend before this becomes an odd idiosyncrasy. Ultimately they are both coined terms, and thus mean whatever they are currently understood to mean, so I see no reason to not just go with the one that is best understood. Of course, this changes dramatically for scientific or technical writing, where the author should always take care to define potentially ambiguous terms.
[Please note: as is always the case with this blog, comments on the content of the post — whether they are positive, negative, or otherwise — are always most welcome. However, please do not mistake Item 4 for being about “what one personally thinks the category should be called” or “what one thinks would be tactically best to call the category.” I am sure there are entire forums on Reddit or ECF dedicated to thousands-posts-a-day arguments about those, so please take such points there instead.]
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Every time I see new statements from the FDA, I think “Well, I hope we get a sympathetic judge” just a little bit harder. Is there any win condition for us anymore that doesn’t come from a gavel?
It is possible that FDA will choose to do the right thing. (Stop laughing — it is possible.) More realistically, OMB/OIRA could send it back to be fixed in much the same way a court could. Finally, there is the possibility of getting the Congress to change the law.
How does one productively apply personal influence OMB/OIRA? Is it productive to contact them in the way you would contact a congressperson?
I know you lean left, and I don’t mean this to be partisan, but I only see the congress fix working if A. Republicans take the Senate (fivethirtyeight puts the chances of that ~56%) and B. They decide to take it up as an eff-you partisan action against the democrats. That’s possible, but I’m not incredibly hopeful about either side wanting to take the time to explain to the public why they aren’t supporting Big Tobacco by supporting ecigs.
I doubt there will be any path for mass appeals to OIRA to be useful. It is a technical office with a very technical mandate. CASAA will make every effort to present them with information to inform their decision when the time comes. We did that re the draft regulation and there will be another review for the final version.
I agree that it will be much easier if the Rs take the Senate. Either way, though, without an active champion for THR in either chamber (which describes the situation for the last several years), the starting point probably is F-you hearings (which could still be done in the House even if the Senate does not turn over). Those could illustrate how the current FDA process completely defies the apparent intent of the TCA (at least what the Act pretends the intent is). That could get some attention. Then it would be a matter of trying to get some members to step up and offer a rational alternative regulation for ecigs, probably not framed in terms of reducing regulation, but in terms of enabling better regulation.
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