Tag Archives: FDA

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

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.

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

CASAA comments on deeming re Paperwork Reduction Act

by Carl V Phillips

Sorry for the lack of posts recently.  I have been busy.  One of the things I was busy with was those comments, which you can find here at the main CASAA blog.  It is something that might just matter.

Hamburg letter helps clarify FDA’s naivety regarding e-cigarettes

by Carl V Phillips

The great mystery of the proposed FDA regulation of e-cigarettes is what benefit they think the proposed regulations would have.  As we have pointed out (here and here), the proposed regulations seem to impose costs — in the form of what is basically busy-work — without offering any apparent benefits.  A letter to the NYT from FDA Commissioner Hamburg suggests that FDA has absurd faith in the value of that busy-work (though we cannot rule out the alternative explanation, that FDA knows as well as expert observers do that it is worthless, and they are just intentionally imposing costs and lying about their motives). Continue reading

Clueless prohibitionists: the West was not wild (but is now, due to prohibitions)

by Carl V Phillips

Frequently the scientist in me is appalled by the drivel coming from “public health” regulators and “researchers” about tobacco products.  Every now and then, the more general scholar in me is equally appalled.

In the 2000s, a popular trope was to denigrate tobacco harm reduction with the non-analogy that switching to a low-risk alternative to cigarettes was “like jumping from a 10th story window rather than 20th”.  The exact floor counts varied, but heights were always chosen such that either fall was almost inevitably fatal, which not only overstated the near-zero risk from smokeless tobacco, but also overstated the risk from smoking.

My colleagues and I got so annoyed about this that we wrote this paper, in which we did a little research and concluded that a lifetime of smoking creates about the same probability of premature death as a (non-suicidal) jump from a fourth floor window or a bit lower (this ignores the fact that a death from the fall would be almost immediate, whereas the death from smoking would occur very late in life).  By contrast, the mortality risk from smokeless tobacco was in the neighborhood of the risk from a jump of less than two stories — there is a tiny possibility it will be fatal, but it is extremely unlikely.  We pointed out that many of us have intentionally taken such a jump. Continue reading

Scientific claims in the FDA deeming regulation (part 3 of ???)

by Carl V Phillips

Continuing this series with page 21 of the draft regulations.

I will skip the paragraph that is about little cigars basically being the same as cigarettes, and thus perhaps subject to their flavor bans, but will use it to anchor one observation:  Most of the content analyzed in the previous post, as well as much of what follows, conflates observations about very different products.  FDA is cogent when making points about little cigars being basically no different from cigarettes.  But they present an utter muddle when they try to talk about, say, flavors in general, as if they have similar implications for e-cigarettes, hookahs, and cigars. Continue reading

Scientific claims in the FDA deeming regulation (part 1 of ???)

by Carl V Phillips

[Update -- this series continues with:

Some closely related posts include:

  • The three-part series about a recent collection of papers by FDA that starts here
  • Analysis of the naivety on this topic displayed in a letter by FDA Commissioner Hamburg here
  • My comments on behalf of CASAA about the inappropriateness of the economic impact statement in the context of the Paperwork Reduction Act, linked from here

]

As presumably every regular reader knows, the FDA CTP has published their draft “deeming” regulations that will bring e-cigarettes, dissolvable nicotine products, and some hypothetical other THR products (as well as some combustible products) under their jurisdiction.  You can find more about that, including our ongoing analysis of our overall assessment of the regulations, at the CASAA blog.

This post begins a series of unknown length that will analyze the scientific claims being made in the draft regulation[Update: That link is now dead, so here is the file; I prefer it because I was already using the page numbering, and it is much easier to read], the associated economic impact statement, and any other partially-scientific documents that are produced. While there is substantial unhappiness about the proposed regulations, and protests that it is just not the right thing to do, it is unlikely that these will have a large influence on FDA’s final decision or any adjudication of it.  Third party reviewers of FDA’s actions (i.e., courts) will probably be much more concerned with details of whether the science supports the claims and whether the claims support the policies.  This series focuses on those questions and attempts to avoid any normative analysis (other than about epistemology). Continue reading