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.
Tobacco harm reduction, anti-THR lies, and related topics 
Thank you for this Karl, and for your many previous posts, only some of which I get time to read. Have you, or anyone else, delved into the underlying political or economic reasons why governments are hostile to THR? And if so, could you point me in the right direction with regard to relevant and respected writers, journalists and the like? I understand that such issues are not necessarily and directly part of your remit, but if anyone knows of such analyses, it will be you.
Yes, I have made a serious study of that, and have been recounting it in a series here title, “Why is there anti-THR?”. One of the above links goes to it or you can search. I really am going to continue it (the mark of a true scholar: you consider everything you have ever done to be a work in progress). I have seen a few others make a partial attempt at this, and they usually get parts of it right, but generally miss the big picture.
Thank you Carl (and apologies for spelling your name incorrectly above). Don’t know how I missed your link in this post. However, I have now read each of the four posts in that series and now have a far greater understanding of the situation. Your work really is outstanding.
Nice post as always… I guess the big difference is that ST is granted access to the market by virtue of its long-standing incumbent presence. Under the current FDA plans, it looks like every vapor product will have to go through a process to gain or regain access to the market as if it was a wholly novel product – a crushingly burdensome process with impossible evidential hurdles. So I’d say they are planning to do far worse to e-cigs than they have done to ST. I agree about risk communication: FDA has made it exceedingly difficult to tell the truth about these products, and only in situations where an MRTP application provides an adequate commercial pay-off to the companies involved. Since when was it a good idea that consumers only got good risk information if it was in the interests of a tobacco company? Reynolds’ proposed approach would have been far better.
I know you don’t like the 95% lower risk claim, but it has been made with good intentions and with a view to re-anchoring consumers risk perceptions much closer to where the expert consensus about the risk and uncertainty sits. I also don’t like the way it was initially expressed as a point estimate – but I think you have to give them some credit for the intent and effort to undo the harm caused by mass mendacity about risks that has so misled consumers. CDC is a long way from doing anything about this problem in the US, other than making it worse. Would you agree with this more carefully phrased anchoring statement: “based on current knowledge of the constituents and toxicity of tobacco smoke and e-cigarette vapor, it is likely that e-cigarette use is at least 95% lower risk than cigarette smoking”?
I agree, of course, that they are planning to do worse to ecigs, but that is merely because they can. They have done as bad to ST as they could. Using the same tools against ecigs has a more extreme result, but it is still the same tools.
I really like and agree with your point about “in the interests of a tobacco company”. I should try to start using that one. (And you can use my point that TCA was designed to interfere with THR, that it was not an accident — that reference to the blogosphere CW was for you, among others ;-)
As for the 95% number, good intentions only go so far as an excuse. First, that number is harmful. The difference between 95% and 99% is the difference between something being equivalent to the choice to eat red meat or drive a lot — everyday risks — and being the second most risky consumer choice made by more than a million people in your country or mine. If it really were that bad, then the antis would have a genuinely good case for clamping down — not to the point of banning it, obviously, but quite a lot. Indeed, I have heard reports of antis repeating that number as a reason for tight regulation (and they would be right). Repeating that number constitutes damning e-cigarettes with faint praise. Second, it is not as if they could not have used something closer to the right point estimate. It would have done all those good things you note, without the damning, and with the added bonus of being right. Third, if someone is way over their heads on a point, especially when writing something that is very high stakes, their legitimate choices are to ask someone who knows more than they do or to not go there. Good intentions do not excuse making up numbers. Through the history of THR there has been someone who has made a serious study of the comparative risks (me — the only one as far as I can tell), and I would have been glad to help them out.
The alternative sentence you propose is certainly true, though I would reformulate the whereas statements to remove “tobacco smoke” from the “constituents and toxicity” clause (those are irrelevant — we have the epidemiology about smoking, so the mechanism is not part of what we use to get there, as opposed to about ecigs) and to add “the epidemiology of ST” (since that is really the key to the whole thing). But it is still faint praise. It is especially problematic when juxtaposed against the estimate for ST. Taken together, they read as saying the ecigs are enormously more risky than ST, which is almost certainly not true.
Oh, by the way, I do realise (and always did) that the FDA / FPTCA is anti-THR. The point is that it is designed against all innovation in the non-pharma nicotine space, with the implicit assumption that any innovation is bad and the status quo unimprovable unless proven otherwise through a vastly burdensome process.
So piecing that together, you suggest: “based on current knowledge of the constituents and toxicity of e-cigarette vapor and the epidemiology of smokeless tobacco, it is likely that use of e-cigarette or smokeless tobacco is at least 95% lower risk than cigarette smoking”?
If CDC made the statement above, I think that would be an important development in the US, indeed globally. It may be faint praise, but it would be a massive change in risk communication and perception.
The point is that true and useful things can be said about these products, with due recognition of the uncertainty, if done carefully. The aim being get people who matter (consumers) to have a more realistic perception and basis for informed choice. I think quantification is essential for that. Even the proposed MRTP warning which we both support: “this product presents substantially lower risks to health than cigarettes” is wildly misleading, though not actually false. Many reading that would think “yeah, perhaps 50% lower, maybe 70%” – wrong by a long way. So I think the 95% formulation properly delivered (as above) is a far more credible and more valuable risk perception anchor than the one we hope the FDA will approve.
Yes, that pieces together what I was saying. However, the addition of ST to the phrase is wrong: There is far less uncertainty about ST. There is lots of epidemiology from people trying to find signs of any disease, and they have not produced any convincing evidence of any. Thus, it would be utterly astonishing if ST were 3% as harmful as smoking, or even 2%, whereas that would not be so astonishing for ecigs (it would be surprising if it were as high as 3% but not utterly astonishing). Basically, they should not be included in the same phrase unless it is much more vague that that one. Also, now looking at it all together like that, I would be inclined to make it stronger about ecigs: I would (after striking “or smokeless tobacco”) change “is likely that” to “is almost certain that” and “at least” to “more than”.
Still, the statement as you write it is not false (just understated and thus does not communicate fully accurately) and it would be great if CDC admitted it. That would be quite a change for them and a boon to helping people learn. Similarly the label change would be an improvement (though it is also still wrong in another way: we do not actually know that no tobacco product is safe, if that is interpreted to mean “does not cause net harm”, and have good reason to believe otherwise). Those are not analogous to the PHE report claim, however, since (a) those are literally accurate, and the version you wrote and proposed for CDC is a stronger statement than in the PHE report, and (b) CDC saying that or a label change would be a major official walk-back that opening admits than their own entrenched and touted claim was wrong, whereas the independent report commissioned by an agency that was not so committed to lies had the opportunity to really get it right.
Again, the point is not whether someone believing 95% is better than believing 50% or 0%. The point is: Why the hell would you want to quote (let alone struggle to defend) a clearly incorrect made-up number that grossly understates the benefits of a policy you support, rather than replace it with an claim that is both more accurate and makes the case better?
Indeed Carl, thank you!
I recently had cause to research the original hearings on SB 625, the original Family Smoking Prevention and Tobacco Control Act introduced Feb. 15, 2007 (Yes, that date ought to be familiar). In doing so I reviewed the transcript of the hearings and the written responses to questions. Contained therein was this little gem, by Dr. Alan Blum in response to one of Sen. Enzi’s questions. I think this puts paid to everything you have said above by exposing the truth that the originators of the bill were indeed aware of the effects but choose to ignore them anyway:
“Indeed, according to Professor Michael Siegel of Boston University
School of Public Health (personal communication, March 3, 2007), this
legislation is likely to result in increased, not decreased, deaths
from tobacco products for the following reasons:
a. The bill will make it virtually impossible to research, develop,
introduce, and market new potentially less hazardous tobacco products. It essentially freezes the market as it is and entrenches existing high-risk products into the market. It puts an end to any meaningful possibility of harm reduction as a tobacco control approach.
b. It will undermine current and future litigation: the companies
will be able to argue successfully that they are already regulated to stave off injunctive relief and substantial punitive damages in litigation by appealing to jurors’ perceptions that the problem is being solved. The grossly exaggerated claims by health organizations supporting this bill of the bill’s positive impact on public health are only contributing to this perception.
c. It will reduce the public’s perception of the inherent harmfulness of cigarettes. By promulgating health standards, FDA will be giving the public the perception that cigarettes are now safer to smoke.
d. Most importantly, there are no documented mechanisms by which the legislation will save lives. Health groups supporting this bill have not produced a single evidence-based argument of how it will save lives.
Dr. Siegel points out that there are only three ways that this
could occur:
First, the bill could save lives if the performance standards reduced the relative risk of smoking-related diseases. There is no evidence whatsoever that this is the case.
Second, the bill could save lives if it encouraged the research, development, and marketing of actual reduced risk products. But the bill does the opposite by setting up an almost impossible barrier to the creation of such products.
Third, the bill could save lives if it reduced youth smoking. It has been well-documented that youth access restrictions, implemented in actual widespread practice, do not reduce youth smoking. The very access restrictions that could potentially reduce youth smoking have been precluded by the bill (namely, raising the legal age of purchase and restricting the types of establishments, such as pharmacies, that sell cigarettes).”
For those wanting to read the hearing transcript: http://www.gpo.gov/…/CHRG…/html/CHRG-110shrg33769.htm
I strongly urge folks to at least skim it, noting the arguments given at the time and by whom.
Interesting find. Point a is the key, of course; interesting to see how explicitly this was presented from day 1. Point d is good too. (Point b is just the standard tobacco control games, and really makes no sense — punitive damages are neither a good way to make policy nor a rational decision. Point c has been proven wrong and there was no reason to believe it at the time.)
Okay, very little can perfectly correct and usefully understood – and I’m not defending the use of a point estimate, but a careful rephrasing of that claim to be more correct, to better reflect uncertainty and to still be actually useful in anchoring perceptions. What I am defending is PHE’s good intentions and motivation for doing this, which deserves recognition, not least for its contrast with CDC.
In terms of informed choice, I don’t think differences within the range 95-100% lower risk lower are as important as helping consumers get on to roughly that ballpark in the first place – and I’ve not seen many other good ideas for doing that. And it is certainly not where they are now.
Carl , thank you.
From the perspective of somebody who lives in the Australian state of New South Wales (NSW) it looks like things are likely to get a bit strange, in practice.
The recent NSW legislation on e-cigs, essentially only bans e-cig sales to minors ,their use in cars while children are present and some restrictions on display-advertising . Under the act e-cigs are not treated as ‘smoking’ re where you can or cannot use them. There are certainly no requirements re ‘certification’.
The government that passed this act (against stubborn resistance by the authoritarian left ) is popular and likely to be re-elected in a few years time. And since the passage of the Act, media interest has dropped off- e-cigs are hardly a threat to civilization as we know it.
While other Australian state governments have introduced what are effectively bans on the sale of e-cigs etc, constitutionally (and practically) they cannot ban trade between the states of our federation, so NSW retailers etc can supply to the rest of Australia.
Therefore if you are correct (guess you are) it is likely that the legal approach to e-cigs in our respective countries will effectively be diametrically opposed, could be interesting.
For example does anybody know if the carve-outs re restrictions of trade in actual cigarettes, from the proposed free trade agreement also apply to smokeless products and e-cigs? ( would be surprised if any of our negotiators have even heard of e-cigs)
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