Author Archives: Carl V Phillips

CASAA comments on FDA deeming of ecigs

by Carl V Phillips

Hello.  Sorry for the blog silence.  I was busy.

Half of it was writing our comment to the FDA about the e-cigarette deeming regulation.  You can download a copy of it here.   For the other half, see the next post I put up on EP-ology.

The CASAA comment is a few(!) blog posts worth of material for you to read, so I will end at that.  Oh, and this represents the end of this series, which was the basis for some of the comment.  I was going to do two more posts in it, but I ran out of time to do the intermediate step and that material just went straight into the comment.

 

Economic illiteracy about tobacco, from the antepode

by Carl V Phillips

The most fundamental lie of the tobacco control industry (TCI) is what I have dubbed the “demonic possession” theory of tobacco use. It is the myth that no one likes to use tobacco products.

It is obvious why they need this. If they admitted that people derived benefits from consuming tobacco, then they would have to balance the (supposed) benefits of their actions against the loss of benefits caused by the actions. More important, and the reason this myth is fundamental, is that if they admitted the truth they would have to admit to themselves that most of what they do inflicts harm — serious harm — on the hundreds of millions of people who they pretend they are trying to help. While many in the TCI are truly evil, and would not be bothered by this, many are not, and so need to preserve this fiction to be able to sleep at night. (And, no, “evil” is not hyperbole. It is clear that many people in tobacco control derive pleasure from inflicting pain on people who they consider to be The Other, exactly the same evil impulse that causes racism, homophobia, etc.) Continue reading

Predicting the black market in e-cigarettes

by Carl V Phillips

The anti-tobacco movement is fundamentally dishonest and unethical, and it is also led by minimally-skilled people who isolate themselves in an echo chamber that avoids scientific review.  As a result, it is frequently difficult to determine whether one of their false scientific claims is an intentional lie or blatant ignorance.  Most of their epidemiologic claims seem to fall into the former category.  But most of their economics-related lies seem to stem from an utter failure to understand even first-semester level economics.  Snowdon and I (mostly at EP-ology including a few days ago, but also on the present blog) have documented this extensively.

One of their fundamental failures in this area is the apparent belief that — contrary to all we know from the results of the Drug War, to say nothing of all other observations of supply and demand — that bans will eliminate supply even when there is huge demand.  One critical appearance of this ignorance relates to the current U.S. FDA draft regulation of e-cigarettes.  FDA has clearly made no attempt to consider what the real — as opposed to fantasy idealized — results of their proposed e-cigarette ban would be.  It is not difficult to understand that there will be a continuing market in e-cigarettes — mostly not actually “black” despite the shorthand in the title. Continue reading

New study shows that if you have an MI, you should hope you use tobacco

by Carl V Phillips

A recent study by Arefalk et al., published in Circulation, was claimed by the authors, the AHA, and the corporate media to show that continuing snus use after an MI (heart attack) is harmful. In reality – if we are to just blindly interpret the study results, without context or thinking, as the authors imply we should – it shows that among people who have MIs, snus users and even smokers are better off than non-users.

To explain this, start with the letter to the editor Brad Rodu and I submitted to the journal (which, given the integrity typically displayed by health sector journals when it comes to admitting errors and allowing dialog, has a 4% chance of being published). It explains the basic problems and our methodology, but due to word limits does not present the full picture, which I continue below. (Note: Brad expects to post about this too, and I will update with a link when he does.  Update:  It is now live, here.)

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Letter by Rodu and Phillips Regarding Article, “Discontinuation of Smokeless Tobacco and Mortality Risk after Myocardial Infarction”

Arefalk et al. report mortality incidence rates (deaths per 1,000 person-years at risk, PYAR) following a myocardial infarction among Swedish tobacco users who, following the MI, continued to use snus (18.7), quit snus (9.7), continued to smoke (28.4) or quit smoking (13.5) (1). We point out several significant problems with this study.

From a methodological perspective, the authors’ inclusion of women in the estimates is a mistake. The number of women among snus users is so small that the gender control variable is extremely unstable. Any gain in power is more than offset by the resulting potential bias. Moreover, combining men and women smokers assumes that the effects of product use are the same for both, which is not justified. In this and similar studies, stratified analysis by gender is always the more informative approach.

The authors report that the mortality rate for the entire sample was 18.9, which appears to be incorrect. It is based on 812 deaths and 40,370 PYAR, which actually yields 20.1. Alternatively, one of the count numbers may be wrong; for example, the rate is 18.9 if the death count is 765. The error requires correction because it affects the article’s major conclusion about snus and smoking; the reported mortality rate for the entire sample (18.9) is similar to that for continuing snus users (18.7).

Arefalk et al. did not report the mortality rate among nonusers of tobacco, which comprise more than half of the sample. We estimated the nonusers’ rate after subtracting the deaths and PYAR for snus, cigarette, and dual users from the sample totals (our estimate of deaths and PYAR among 934 dual users assumed that they were proportional to the mean of those statistics for snus users and smokers).

The estimated mortality rate among nonusers is 21.4, based on 494 deaths and 20,031 PYAR. This is higher than the rate for continuing snus users (18.7), and far higher than that for snus quitters (9.7). In addition, it is higher than the rate for smoke-quitters (13.5). The only group that fared worse than non-users was continuing smokers (28.4). (If the death count was actually 765, the non-users disadvantage would be reduced but not eliminated.)

Thus, those who quit using tobacco products reduced their mortality risk by half compared to those who continued, but also compared to non-users. By the logic of the article’s conclusions, MI victims are better off if they use tobacco so that they can experience the benefits of quitting. The authors have the data to calculate the exact mortality rate for nonusers and adjust for age (which probably does explain part of the disadvantage among nonusers) and other factors. These additional results might explain how the reported harms from snus use can be reconciled with the apparent advantages of quitting.

1. Arefalk G, Hambraeus K, Lind L, Michaelsson K, Lindahl B, Sundström J. Discontinuation of smokeless tobacco and mortality risk after myocardial infarction. Circulation, published online June 23, 2014. DOI:10.1161/CIRCULATIONAHA.113.007252

Brad Rodu, DDS, Department of Medicine, School of Medicine, University of Louisville

Carl V. Phillips, PhD, Consumer Advocates for Smoke-free Alternatives Association

———

The bottom line is that the authors tried to spin the results as suggesting that continuing snus use is bad for you after an MI. But those who did not quit snus after the MI had a lower death rate than people who did not use either snus or cigarettes at the time of their MI, and those who used snus but quit were far better off still. A simplistic interpretation of the data, then, is: “You had an MI. But the good news is that you use snus! If you now quit snus, your mortality risk compared to people who do not use snus – and thus do not have the opportunity to quit – is magically lowered by more than half. Moreover, even if you do not quit, your risk is still lower than that of non-users.” The authors really buried the lead on this one – or more accurately, did not report the lead at all.

Of course, I am not saying I believe that MI victims are genuinely better off if they use snus. But it is what these statistics suggest (and it is certainly a possibility). The authors carefully avoided reporting an obviously useful and important statistic, the mortality rate among non-users, because they presumably realized that it would call their anti-snus conclusions into question. And it does. Whatever is happening in this population, it clearly does not support the “snus is bad” message that the authors and other naive and politically-motivated commentators have presented.

There is a glaringly obvious explanation for why people who quit snus or smoking after an MI fare better than those who do not: Those who are generally healthy (except for the recent MI, of course) and expect to recover and live a long time are much more likely to take every possible precaution to minimize their risks. After being advised to give up snus, get proper physical therapy, and eat better, many of them will do it. Meanwhile, those who are sickly, have serious cancer, are depressed, etc. will have little incentive to make lifestyle sacrifices in an attempt to regain long-term health. There was no attempt to control for this obvious confounding in the study.

Of course, this would only explain the better outcomes of the quitters compared to those who continued tobacco product use, and does nothing to explain why all of them (except those who continued to smoke) fared better than the non-users. There are possible explanations for this in the form of statistical artifacts or real effects. But the key observation is that the data clearly do not support the main interpretation that the authors touted, that it is terribly bad for you to keep using snus after an MI.

Another important conclusion that should be drawn from this article is just how bad the peer review process is for medical journals. The out-and-out error we discovered in the reported numbers was not some obscure statistic buried in the depths of the paper, but was the key number reported in the first short paragraph of the results section. Brad immediately noticed that the calculation appeared to be wrong on his first read-through, and it took me fifteen seconds to provide the correct arithmetic while creating the spreadsheet that is the basis for our letter. Yet the vaunted “peer review process” let the error through. Those of us who are familiar with journal peer review understand that – contrary what most people seem to believe – the reviewers and editors cannot check anything that readers cannot check for themselves, because they have access to only the same paper the reader has, not the data or calculations. Thus it is, at best, a fairly weak check. But the failures here are a reminder that reviewers seldom even check what is in the paper.

Even without correcting that error or calculating the mortality rate for non-users, the (incorrect) reported number for the population as a whole can still be compared to rates for people who used snus or cigarettes at the time of their MI. This alone is enough to raise red flags about the analysis and conclusions, since it is still higher than the rates for smokers (averaging together those who quit and those who kept smoking) and for those who kept using snus, and far higher than the rates for those who stopped using either product.

Moreover, the obvious confounding described above is not something that only leading scientific experts understand, but is so well known that it even has a name in medical research: “confounding by indication”. It is a constant source of bias when an action (e.g., a particular medical treatment, or in this case, obeying the advice to quit tobacco) is associated with how healthy someone is. A new experimental surgical technique might have a higher death rate, not because it is worse than the conventional practice, but because it is only tried on people whose condition is particularly dire. Or to take an everyday example, someone slamming on their car brakes is much more likely to crash than someone not doing it; this is because the action indicates that there is a risk of imminent crash, not because it is harmful. But the naive logic from blindly looking at the data the way these authors did would be “never slam on your brakes – it will cause you to crash.” Anyone involved in medical research should understand this common problem, and yet the authors do not so much as acknowledge the possibility of such confounding, and the editors and reviewers let them get away with that.

In sum, the way these results were presented and interpreted is a simple classic piece of anti-tobacco propaganda. Researchers who were both skilled and honest would have tried to address the reasons that MI victims who quit using snus or cigarettes fare far better than those who did not use them in the first place, and even those who did not quit snus still did a bit better (after reporting this was the case instead of hiding it, of course). Researchers who were honest but not so skilled would have just reported that result. But the authors, and the journal editors and reviewers who enabled them, instead endeavored to hide that rather remarkable result and to lie that their results showed that snus was harmful.

[Update:  Brad recalled that Arefalk is a serial producer of anti-THR junk.  He posted about a previous claim here.]

More nonsense about gateway effects – this time from ecig supporters

by Carl V Phillips

It seems that most every researcher or pundit making claims about gateway effects — that e-cigarette use causes some people to then become smokers — has no clue about what evidence would support or contradict such a claim.  It is a truly amazing and sad commentary on what passes for scientific thinking in this realm.

I have already explained at length how Glantz et al.’s claims about having found evidence of a gateway effect are fatally flawed.  But they are actually one step better than two recent claims by e-cigarette supporters that there is no gateway effect.  Glantz basically made a single observation about a statistical correlation that you would, indeed, expect to see if the gateway claim were true.  But you would also expect to see that correlation if either of two other things were true, one of which (confounding by common cause) certainly is true and the other of which (people are employing THR) is far more plausible and better supported than the gateway claim.  Basically the logic was this:  “If it is Monday at noon, there should be light coming in my window. There is light coming in my window. Therefore it is Monday at noon.”  There are obviously many more states of the world where the observation is true and the conclusion is not, so this is terrible reasoning.  I remember learning that in grade school; apparently Glantz, the faculty at UCSF, and the editors and reviewers of the junk journals he writes for missed that day of class in third grade and never took any science courses in college.

But that is not the worst reasoning one could engage in.  At least observing the sun makes it a little more likely it is Monday at noon, since it allows you to rule out many times of the week, and therefore you have increased the probability that it is Monday at noon.  Of course, you have increased the probability that it is midafternoon on Wednesday just as much.  But the observations in this study, a survey of European e-cigarette users, do not even do that much.  That has not stopped e-cigarette touters from claiming that the study shows there is no gateway effect, a claim which has made the rounds in social media.

It is rather baffling.  The authors make no such suggestion in the article or their press release.  There is simply no support for the claim to be found there.  The interpretation seems to trace to this crap article in New Scientist, which makes the claim in the text, or this even worse one in International Business Times which put the claim in the headline.  Naturally, clueless people who know nothing about the topic believe whatever they read, but some people who are repeating this silly claim should know better.  (Here’s a useful little epistemic hint for future reference:  When a news story says a study was published in the non-existent Journal of Tobacco Studies, it is probably not a very good source of information.)

The “reasoning” seems to be that because only 1% of never-smokers in the survey had tried an e-cigarette, e-cigarettes must not be a gateway.  Huh?  By that logic, smoke-free tobacco products do not harm fetuses because less than 1% of pregnant women use them.  (Note: it remains unknown whether or not there is such harm.)  All the observation shows is that if there is a gateway effect, its possible absolute magnitude (so far) is capped by the fact that only a small portion of the at-risk[*] population has had the exposure.  It tells us nothing about whether there is any such effect.

[*Side note 1:  For those who may be confused due to the fact that this phrase is used incorrectly more often than correctly, "at risk" means "anyone who could become a case".  So "at risk of being a gateway case" means "not a smoker" (notice that this means that ex-smokers are at risk of becoming gateway cases, not just never smokers, so leaving them out of the "reasoning" was another error).  Thus, Glantz is at risk of becoming a gateway case, whereas someone who quit smoking using e-cigarettes is not.  The common misuse of the term is incorrectly substituting it for the intended claim that someone is at high risk of becoming a case.]

[Side note 2: I feel a personal need to point out that part of the touting of the study by pro-e-cigarette pundits is that it came out of Harvard.  I beg to differ. The authors all have some affiliation with Harvard School of Public Health, not the real Harvard.  The faculty at HSPH were serious researchers 20 years ago, and there are still a few good people from past eras (though not in the anti-tobacco and other nanny-state units), but is now it is pretty much just a school of public health, with all that implies.  Or as I put it previously,

The study, from a research group calling itself “Harvard School of Public Health”, was widely cited in the popular press.  (Note that while this organization does not seem to be related to the prestigious research institution called “Harvard University”, the allegations in the literature that it is actually a lobbying front group for shadowy government agencies and industry have not been proven, and so cannot be considered a reason to doubt their research.

Resuming….

The other common error about what constitutes evidence of no gateway, most recently committed by Siegel, is suggesting that declining smoking rates, in the context of increasing e-cigarette usage, must mean there is no gateway.  It is a fundamentally different error, though the implications are similar.  The error is a simple misunderstanding of magnitudes, statistics, and the passage of time. Even though e-cigarette use is increasing, its absolute level is still very small among those at risk of becoming gateway cases.  If every single at-risk e-cigarette user is a gateway case, the impact would not be visible in population smoking statistics.  The total number of at-risk e-cigarette users constitutes a smaller portion of the population than the statistical error in smoking prevalence surveys, to say nothing of what it would take to sort it out of the real changes in smoking rates over time.  Moreover, since “destined to start smoking due to her e-cigarette use” is not the same as “has started smoking”, the gateway cases would mostly not even be observable yet.

On top of that, e-cigarettes are causing some people to quit smoking.  So even if we had a perfect measure of smoking prevalence, and the only thing changing it over time was the effects of e-cigarettes, we would still see a decline in smoking rates even if there were a gateway effect (unless, of course, it were already so big in absolute magnitude that it exceeded the THR effect).  Thus, the “reasoning” here is an epic fail for at least three different reasons.

The reason that the implications of the two different errors described above are similar is that their proponents are really saying “the impact of the gateway effect is apparently small so far, so don’t worry about it.”  This is not a very effective argument.  There are very good reasons to believe there is not and never will be a gateway effect, or at least extremely little of it, but neither of the above are among them.  Effectively, those erroneous arguments invite the (valid) retort, “sure, we are not seeing it yet, but the way things are going, it will show up, and so we need to stop e-cigarettes before it does.”

The conclusion that there is no reason to expect a gateway effect is correct.  But making bad arguments in favor of a valid conclusion almost always sets up your opponent with a good argument in response, and that is certainly the case here. Moreover, if we are going to start trafficking in bad arguments, we are going to encourage and validate lying.  The other side will inevitably win the argument under those rules of engagement, because they are waaaay better at it.

Scientific claims in the FDA deeming regulation (part 4 of ???)

by Carl V Phillips

Continuing from this post in this series, with p.23 (page numbers from this version of the proposed regulations):

There are public health questions and concerns about currently unregulated tobacco products. Nevertheless, there are distinctions in the hazards presented by various nicotine- delivering products. Some have advanced views that certain new non-combustible tobacco products (such as e-cigarettes) may be less hazardous, at least in certain respects, than combustible products given the carcinogens in smoke and the dangers of secondhand smoke. To the extent that certain products are shown to be less harmful, they could help reduce the overall death and disease toll from tobacco product use at a population level in the United States. This is a function of the existence of a continuum of nicotine-delivering products that pose differing levels of risk to the individual.

Setting aside the tangential issue of the standard overstatement of the risk from ETS and the somewhat relevant issue that there is no “continuum” of risk, as I have explained at length, this is almost an acknowledgement that THR works.  However, notice the phrasing, “Some have advanced views….”  Again, we can contrast utterly speculative claims being presented as fact, as previously noted in this series, with clear facts being presented as if they were speculative minority opinions.  Notice that the rest of the sentence is not a specific claim (“99% less hazardous”) or a bold broad claim (“all smoke-free products are substantially lower risk”), but an extremely modest claim of “certain”, “may”, and “in certain respects”.  There is simply no doubt that this is true.

III. Continuum of Nicotine-Delivering Products

Cigarette smoking is the major contributor to the death and disease attributable to tobacco use. The challenge for FDA, in considering currently regulated products and any additional products that would be deemed to be subject to the FD&C Act, is that regulatory policy under the Tobacco Control Act must account for the net public health impacts at the population level. This includes impacts on initiation, cessation, and an evaluation of product harm.

Emerging technologies such as the e-cigarette may have the potential to reduce the death and disease toll from overall tobacco product use depending on who uses the products and how they are used. If such products result in minimal initiation by children and adolescents while significant numbers of smokers quit, then there is a potential for the net impact at the population level to be positive. If, on the other hand, there is significant initiation by young people, minimal quitting, or significant dual use of combustible and non-combustible products, then the public health impact could be negative.

There is a fundamental problem with this entire obsession (perhaps a legally mandated consideration, but nonetheless FDA’s specific behavior surrounding qualifies as a bizarre obsession):  FDA does not explain what “net public health impacts” means, either in this regulation or apparently anywhere else.  Sometimes, but not always, context suggests they are saying something like “add up all the years of life saved as a the result of something and subtract the number lost, and check whether that is positive or negative.”  This pure utilitarian adding-up is actually a rather difficult ethic to defend in contexts like this, but that is a matter for another day.  The fatal problem is that FDA is appealing to a standard for justification of their rules without ever explaining what that standard is.

In the second paragraph, they first spin an extreme positive scenario and inaccurately imply that something so extreme is needed to pass a utilitarian test.  In reality, if just a few smokers quit thanks to e-cigarettes then, based on any reasonable estimate of the risk they pose, no amount of adoption by would-be-never tobacco users can take away the net health benefits.  Indeed, it is probably the case that this threshold has already been reached.  The second, negative scenario is already ruled out by experience.

Of specific note is the reference to dual use.  At face value it is nonsense, because there is no reason to believe that dual use produces any negative synergies, and smoking less (as you get with partial substitution) is clearly better than smoking more.  But this seems to be a vague allusion to the claim by some ANTZ that use of e-cigarettes keeps smokers who would otherwise quit from quitting entirely; usually such claims refer to e-cigarettes undermining the attempts to intentionally harm smokers (with place bans and such) so that they suffer so much they decide to quit.  If so, it is grossly inappropriate in a document like this simply because it is vague allusion.  It is also based on whole-cloth speculation — there is simply no support for those claims about e-cigarettes whatsoever, and plenty of evidence to the contrary, such as the tendency for smokers who try them to “accidentally” quit.  Finally, if it were true, it would be even more true of NRT (which FDA endorses) and smokeless tobacco (which CTP regulates and does not attempt to ban) since these — unlike e-cigarettes — can be used on airplanes and all other places where smokers are forced to become miserable enough that they might be bludgeoned into quitting.

FDA is aware that some e-cigarettes (as well as other products that would be deemed under this proposed rule) are being marketed with flavors that may be attractive to young people. FDA asks for comments, data, and research to determine whether the Agency’s evaluation of the relative risk or potential for harm reduction of such a product should be different in the presence of flavors in these products, especially if there is evidence that these flavors make the products more attractive to children. Because e-cigarettes are not currently subject to FDA jurisdiction (unless they are marketed for therapeutic purposes), FDA currently lacks the authority to collect vital information about these products. Deeming these products would permit us to collect information about their ingredients to ensure that other potentially harmful constituents are not present. Deeming would also allow us to collect information regarding health and behavioral effects of these products.

This is one of the few claims about what these regulations would do that might be useful, and like the others, it is vague, tenuous, and minimally beneficial at best.  In other words, FDA is planning to ban 99.9% of the products on the market and do untold damage to consumer welfare based on vague sort-of-maybe claims like this.   Moreover, this particular claim is false.

FDA lacks the authority to demand that manufacturers provide them with information about their products, it is true.  However, collecting that information would in no way ensure anything about improving the chemical profile.  The regulations contain nothing about imposing requirements, only about collecting the data.  The HPHC (as this data collection is called) process is already in place for the tobacco products FDA regulates, and has proven to be absolutely useless.  No one knows how much particular quantities of the measured chemicals matter for health or, indeed, what to do with that information at all.  No action has been taken based on it.  It is just busy work that serves only to harass manufacturers.  However, what we do know from substantial research is that the levels of the potentially harmful chemicals in e-cigarettes is trivial compared to that from cigarettes, and appears to consistently be below the levels that are considered to pose any actionable health threat.  (We know the latter from the Burstyn paper which, incidentally, is not cited anywhere in the proposed regulations.)  HPHC reporting will not contribute to this knowledge or do anything to make e-cigarettes better.

Moreover, deeming would not create the opportunity to collect information on health and behavioral effects because that is already being done (as is chemical analysis, for that matter).  FDA has given enormous grants to researchers to pursue those questions.  We can certainly question the quality of those researchers, but the point is that it is already being done by FDA and is not contingent on deeming.  Other government agencies are also pursuing such research, as are numerous independent researchers, as well as some larger companies (many of whom will make their research public).  There is no apparent justification for the innuendo (that again) that this will be done better if FDA deems the products.

And before moving, I should note that I did not omit the references from this section.  There were none.

The next section (p.24) is

IV. Deeming Tobacco Products To Be Subject to the FD&C Act

It starts by describing the mandatory provisions under the TCA act of any deemed product.  It is these regulations that would impose the ban-by-paperwork of most e-cigarettes.  It then goes on to make claims about the supposed public health benefits of this.  This, even worse than the background information, is full of scientifically unsupported claims.

A. Public Health Benefits of Deeming
Deeming “tobacco products” (except accessories) to be subject to the FD&C Act would result in significant benefits for the public health. Once deemed, tobacco products become subject to the FD&C Act and its implementing regulations, affording FDA additional tools to use to reduce the number of illnesses and premature deaths associated with the use of tobacco products. For example, it would provide FDA with critical information regarding the health risks of the proposed deemed tobacco products including information derived from ingredient listing submissions and reporting of hazardous and potentially hazardous constituents required under the FD&C Act.

Once again, their foremost example of the supposed benefits relies on faith in the proven-useless HPHC process.  By contrast, the listing of ingredients is genuinely potentially useful.  It is CASAA’s position that ingredients should be listed on the products themselves so that consumers have access to this information.  Of course, most consumers cannot make much use of that information, but the expert opinion leaders in the consumer community can probably do a better job of it than FDA can.  Unfortunately, this disclosure of ingredients to the FDA is a markedly inferior alternative to mandatory listing.  And it is not nearly such a benefit as to justify the costs.

Deeming would provide FDA with information on the location and number of regulated entities and allow the Agency to establish effective compliance programs.

This is largely legitimate, albeit unacceptably vague.  It is apparent that what CTP really seems to care about, above all else, as the justification for this regulation, is their desperation to be able to inspect and shut down a manufacturer if a serious problem is suspected.  This is what FDA does for food, although usually after most of the horses have already left the barn.  They are not so good about drugs and devices because they are not all that good at exerting power over pharmaceutical companies.  They have never, as far as the public knows, exerted this authority for any tobacco product.  Still, it makes sense to have such a backstop against disaster.  Of course, the reality is that the regulation will really just eliminate all but three or four manufacturers (or take the others out of FDA’s jurisdiction thanks to black markets and other maneuvers, which I will take up in future writings), making the right to inspect and shut them down largely moot.

Deeming also would help to correct consumer misperceptions, due to variations in the regulatory status of tobacco products, that tobacco products not currently regulated by FDA are safe alternatives to currently regulated tobacco products (see section V.C).

We will see V.C later, but suffice to say for now that there is no evidence that there are consumer misperceptions and nothing in the regulation or FDA’s skill set that would do anything about it if there were.

In addition, it would reduce the use of misleading claims on the products to allow for better-informed decision-making by consumers and would prohibit these products from being targeted to youth populations.

Again, this assumes facts not in evidence.  It is not clear what misleading claims exist.  I would guess they are referring to claims that e-cigarettes are a proven effective way for many people to quit smoking.  That is already not allowed, of course, though it happens to not be misleading at all.  There would be very little in the way of decision-making by consumers because there would be only one simple type of product in the FDA-regulated sector of the market.  There is no evidence there is targeting to youth other than by a few fringe players (which would be solved by the ban — except for that pesky black market problem).  If there were really serious problems to address, there is once again nothing in the regulation that suggests FDA knows how to do anything about it.

It would prevent new products from entering the market that are not appropriate for the protection of public health or are not substantially equivalent to a predicate product already on the market.

This is out-and-out dishonest.  What it would do is eliminate products that exist in the market, not merely prevent new ones from entering.  And once again there is the unacceptable vagueness:  What is “appropriate for the protection of public health”?

Newly deemed tobacco products also may be subject to future regulations if FDA determines that such regulation would be appropriate for the protection of the public health (section 906(d) of the FD&C Act).

Translation: We really have no idea what we could do that might be useful, otherwise we would have proposed it in this document rather than making this vacuous allusion to it.

This section to be continued in the next post in the series.

Supposed THR supporter demonstrates he still thinks like an ANTZ

by Carl V Phillips

I consider Mike Siegel to be a friend and he does a lot of good work documenting lies by the ANTZ.  With that out of the way, I found his latest blog post to be a particularly disturbing disregard of science in favor of the ANTZ propaganda that he used to embrace.  In that brief post, he flat-out declares that the death from oral cancer of a prominent baseball player was caused by smokeless tobacco use and indicates his contempt for the best-proven method of tobacco harm reduction (which is, of course, replacement of smoking with smokeless tobacco).  He employs the ANTZ propaganda tactic of elevating unsupportable sensationalist specific claims over the evidence. Continue reading

Why the most important ecig news of the week is Swedish Match’s MRTP application

by Carl V Phillips

Swedish Match broke the ice for the FDA’s “Modified Risk Tobacco Products” process this week, boldly applying for the removal of misleading warning labels on their smokeless tobacco products in the USA.  There is no point in me writing about the details of that, since Rodu already covered it nicely (read that if you do not already know about it).  But no THR blog could possibly let this enormous event pass without comment, so I will take another angle on it, to point out why those interested in e-cigarettes (most of the readers of this blog) should consider this important news (good and bad) regarding e-cigarettes. Continue reading