Tag Archives: FDA

Random observations about e-cigarette policy, terminology, and relationships

by Carl V Phillips

Four items, related primarily because they resulted from my observations over the last few days, though there is an underlying theme to be found.

Item 1: Many of you have no doubt seen this story that appeared in Business Week and various other publications via the Bloomberg feed. At the Global Tobacco Networking Forum, Reynolds CEO Susan Cameron made clear that a much-criticized line in the Reynolds comment on the FDA proposed regulation of e-cigarettes had not been misinterpreted.  The line, which basically called for the banning of open-system e-cigarettes, might have been a trial balloon, but it was certainly not a gaffe. Cameron made clear Reynolds’s support for that position. Continue reading

FDA signals that nothing is ever “substantially equivalent”

by Carl V Phillips

The FDA Center for Tobacco Products (CTP) recently ruled on “Substantial Equivalence” (SE) applications about a group of smokeless tobacco products in the Ariva/Stonewall family. They ruled that these are not substantially equivalent to predicate products, which is an Orwellian way of saying they are banning them. In a week filled with bad news about supposedly health-oriented organizations threatening people’s health and welfare with anti-THR lies, this perhaps passed unnoticed by many. It should not have. It is by far the worst news of the week for Americans. We are still trying to make sense of the details as they relate to the particular products (note all the complexities below), but one implication is clear: FDA plans to use the SE process to block the introduction of THR products. Continue reading

FDA is complicit in CDC’s lies; grossly inappropriate behavior for a regulator

by Carl V Phillips

The neglected half of the story about CDC’s latest lies about e-cigarettes — and it is fully half of what is important, at least — is FDA’s complicity in it. As I recounted in the last two posts, and Brad Rodu expanded upon, the latest CDC claims about kids’ use of e-cigarettes are based on a shoddy and misleading study (presumably intentionally so). It is full of lies in itself, and those were then further exaggerated and made more inaccurate in CDC’s press release. It is certainly not acceptable that our government officials at CDC are acting as blatant propagandists for a special-interest position. It is probably illegal and is certainly unethical. But we have come to expect this from CDC — they have been one of the leading anti-THR liars for 15 years. It is far more troubling that the agency that is supposed to be the impartial regulator of such products, FDA, is complicit in the lies. Continue reading

CDC press release about e-cigarettes: blatant lying by government officials

by Carl V Phillips

Yesterday I peer reviewed the latest journal article about by CDC and FDA about kids’ use of e-cigarettes, pointing out the massive methodological flaws, inaccurate conclusions, Orwellian language, and overt political advocacy that it contained. I mentioned CDC’s associated press release, but did not go into details. But the press release is arguably a far greater crime (and that is not hyperbole — it is criminal for the US government to lie to the people), and calls for a post of its own. Continue reading

CDC refines their lies about kids and e-cigarettes

by Carl V Phillips

I will interrupt my series on the failures of peer review to look at a great example of the failures of peer review, a new broadside (I hesitate to call it a study) from the CDC that appears in Nicotine and Tobacco Research, an alarmist piece about kids’ reported use of e-cigarettes.  Here is the official abstract at the paywalled journal page.  And here is a bootleg copy of the full manuscript (the US government does not let you hide your work behind paywalls if it comes from taxpayer-funded grants, and so I am not going to let them do it when we are paying for it directly). Continue reading

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.

 

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.