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.
Predictions about reasonableness need not be evidence-free speculation. We have the evidence of how our government has dealt with another product that is a low-risk alternative to smoking, smokeless tobacco (ST).
It is probably the case, sadly, that more than half of those 110K CASAA members, along with about 90% of the rest of the population, do not even know that ST (aka snus, dip, snuff, chew) poses a far lower risk than smoking. Fewer still realize it is so close to harmless that it is not clear whether it causes any risk for any life-threatening disease. The only serious attempt to estimate the comparative risk (mine) put the risk at about 1/100th that from smoking. That remaining bit of risk comes overwhelmingly from speculating that there is cardiovascular disease risk from the stimulant effect of nicotine (which may not really be the case, as is the current conventional wisdom about caffeine). There is no measurable cancer risk (this is more clear now than it was the last time I did the numbers), and even a worst-plausible-case scenario for cancers that are commonly blamed on ST adds up to only a tiny fraction of 1% of the risk from smoking.
It is very plausible that ST causes even less risk than 1/100th that from smoking, and, indeed, it is plausible that the net health effects are actually positive (if the known beneficial effects of smoking on neurodegenerative diseases extend to ST, which seems likely). What is not plausible is that the total risk is more than a few percent of that from smoking. From before the time I started working in this area, 15 years ago, the science clearly showed that ST is a low-risk alternative to smoking. There was no excuse for overlooking this even then, given that Brad Rodu had already been strongly advocating this message for most of a decade and a few others had joined him before I did.
Yet these conclusions were and still are denied by the US government, despite being based on a body of evidence that is far more solid than the support for most of what is considered “known” in epidemiology. Indeed, it is this evidence that allows us to conclude that e-cigarettes (for which we have almost no epidemiology) are also low risk, as is long-term use of NRT products. When coupled with the toxicology that tells us that we should not expect e-cigarettes to be too much more harmful than ST, we can safely draw the low-risk conclusion about them too.
(And yes, new readers, you read that right: E-cigarettes are almost certainly somewhat higher risk than ST. You can find more in the archives, but the short version pretty well covers it: The net health effects of the nicotine, whatever they are, are basically the same. There is so little other risk from ST, if any, that there is really no room for any nicotine consumption to get in below it. But the introduction of inhalation, along with possible effects from flavorings and pyrolysis products, adds quite a few ways that e-cigarettes could be slightly worse. Mind you, there is no reason to believe they are much worse. In particular, it is absurd to say that they are merely “95% less harmful” (i.e., 5% as bad as smoking), a claim that is currently popular.)
But the US government ignored the evidence. When I started chronicling anti-THR lies, over ten years ago, the US government was by far the worst anti-THR liar. Most of the propaganda that has successfully misled the vast majority of the population about ST was created or made possible by them. I would say that by any reasonable measure, the US government has remained the leading anti-THR liar for that entire period, though now the WHO gives it some competition for the title, and the US states and the entities that they created (including Legacy and CTFK) are in the running if considered collectively. And thus the most promising approach to THR — until the last few years, of course — was intentionally and successfully destroyed by our government(s).
Anti-THR lies about e-cigarettes are more international and also more devolved, and so the US federal government is not the stand-out liar on that topic. The NCI has been largely silent, whereas they were a major contributor to the anti-ST lies in the 2000s. Since the authoritarian EU adopted a different anti-THR tactic with respect to ST — just banning the popular forms — the European tobacco controllers largely did not bother with anti-ST lies. Still, the US CDC is arguably still the most important single contributor to anti-ecig lies, just as they were about anti-ST lies, and various federal politicians have championed the lies (along with countless state and local officials). In short, we have seen this play out once, and the influential players are not acting any different now.
But the US government’s anti-THR efforts were not limited to just lying. The 2009 Tobacco Control Act (TCA) — the law that the deeming would impose on e-cigarettes — was designed to discourage THR.
Some commentators in the e-cigarette blogosphere are fond of saying that the TCA was designed to create enormous burdens for the high-risk product (cigarette) market, and therefore it is not appropriate to include e-cigarettes. They are only half right, and the half they are wrong about is profoundly important. Yes, the TCA creates burdens for the cigarette market. Yes it is a terrible idea to subject e-cigarettes to the same provisions — assuming your goal has anything to do with people’s welfare, real public health, or good government (but none of those are the real motives of tobacco control or “public health”). But it is wrong, as is implied in the common claim, to suggest that the TCA was not designed to impose that same burden on low-risk alternatives to cigarettes.
Smokeless tobacco was not just accidentally swept up in these faux-regulations, which are really just busy-work burdens designed to gum up the free market without actually doing any proper regulation. It was explicitly included by design and from the start, and thus intentionally subject to the same burden as cigarettes. In addition the TCA mandates four rotating “warning” labels on smokeless tobacco which are all false or misleading. One of them is specifically designed to discourage THR: “This product is not a safe alternative to cigarettes.” This, of course, intentionally implies, and is generally read as saying, that ST is no safer than cigarettes. The TCA is inherently anti-THR, and not by accident.
But wait, some commentators will say, FDA has repeatedly stated their support for THR. The head of the FDA Center for Tobacco Products, Mitch Zeller, is always speaking about the continuum of risk (which is really a myth created by regulators and cigarette companies for their political convenience, but that is another story). So maybe their hands were just partially tied by the legislation, but they really will work to promote THR when they can. Um, nope. Talk is cheap.
Swedish Match (SM), the leading ST company in Sweden but a small player in the USA, has spent millions on a “modified-risk tobacco product” (MRTP) application — one of the absurd grinding processes that await e-cigarettes under deeming — seeking to remove two of the labels that are clearly unsupported by the science (about causing oral cancer and dental diseases), and to change the one quoted above to, “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” (More about this here, and you can find the testimony CASAA filed in support of the MRTP application here.) The decision on that is still pending, but the FDA hearing on the subject was not exactly promising.
But here’s the thing: Even if the entire application is accepted, it will apply only to SM’s products, and there is little chance anyone else could make a similarly strong MRTP application (for reasons explained in the above links), even though there is no evidence that SM’s products are lower risk than the ST variations that are popular in the USA. But FDA had the opportunity to remove these anti-THR lies from the warning labels for the entire category when Reynolds submitted an earlier application for the same changes via a more ad hoc process. FDA denied the request and told them they must do a full massive MRTP application instead (SM’s application was 130K pages long), which would then apply only to the specific Reynolds products covered in the application. But if FDA had wanted to promote THR, they could have decided differently.
These FDA processes and decisions are entirely arbitrary. They make up the rules as they go along. That means that every decision is simply what they want to make happen, a pure policy decision, not adherence to a real regulatory process that is based on rules. Yes, they would have had to deal with screaming from scientifically illiterate politicians and lying tobacco controllers if they had decided differently about the Reynolds petition. But even if that were their motive, it offers no reason for hope: That is the exact same screaming they will face in the unlikely event they approve the MRTP — or if, for e-cigarettes, they take the steps necessary to avoid effectively banning the category.
But maybe that was too just big and visible, with too much chance they would get sued by the tobacco controllers because of the lack of official channel filings. And maybe it was just because most of the ST market belongs to the major tobacco companies who are a lightning rod. Maybe they will really do the right thing when it comes to comes to something that flies below the radar and does not involve the majors. Um, nope.
Last year, FDA ruled on a different kind of application, a “substantial equivalence” (SE) application for a line of dissolvable ST products made by a very small manufacturer that has never been in the cigarette business. Most experts would guess that these are the lowest-risk tobacco products on the market (they have less of some chemicals found in ST that may — or may not — cause some immeasurably small cancer risk; they are basically a “whole tobacco alkaloid” version of NRT lozenges). The application, which merely asked permission to keep selling some new flavors, was denied by FDA. Moreover, FDA then aggressively went after retailers who still had the new flavors on their shelves rather than just quietly letting them sell off their stock. This is not the behavior of an agency that is in favor of THR.
The decision was rationalized on the grounds that of one relatively unimportant molecule was present at greater concentration and thus the new flavors were not equivalent enough to be “substantially equivalent”, and perhaps also because the application did not offer evidence that the new variations would not attract any non-users of tobacco to use them. In case it is not obvious, any change in a product will increase the concentration of at least one molecule and it is literally impossible to offer evidence that a product introduction or change will not attract any new users (though FDA “guidance” statements say that all applications must do just that). But, again, these decisions are arbitrary; there is no law or proper regulation that says that if those standards are not met, the application must be rejected. FDA could have issued the opposite decision. This was purely a policy decision, and it was about as blatantly anti-THR as can be.
Might it be different with e-cigarettes? Well, of course, it might. But why would it be? Because they are known to be low risk? Well, actually the evidence is much better and the risk is probably lower for ST. Because “they are not really tobacco products!!!”? The law says otherwise (and a recognition of reality makes clear that such semantics matter not at all). Because the government is more positively disposed toward them? Nope, no evidence of that. Because of the limits of the law? Actually that cuts the other way; FDA did not have the option of just banning ST or cigarettes, but they have that option with e-cigarettes and have indicated just such a plan. Because of popular opinion?
Yes, well, maybe that: There has never been any effective organization of ST consumers even though they still outnumber e-cigarette consumers in the USA, but the latter are making their voices heard. That could change everything via political channels. It is still our government, after all, at least sometimes, when we bother to stand up and demand it. But if that does change anything it will be because those who control the relevant levers of power are prevented from doing what they really want to do, what they have been doing all along.