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.


3 responses to “Scientific claims in the FDA deeming regulation (part 4 of ???)

  1. Pingback: Scientific claims in the FDA deeming regulation (part 1 of ???) | Anti-THR Lies and related topics

  2. Pingback: Scientific Claims In The FDA Deeming Regulation | The Spinfuel Network

  3. I still can’t wrap my head around why they consider ‘dual use’ a negative rather than a positive..

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