by Carl V Phillips
Today, a couple of outsources. First, for those who read this blog but do not look at CASAA’s main announcements-and-such blog, you might want to check out this post about CASAA’s efforts to engage with the U.S. government. We made a nomination for the next round of the TPSAC, the external scientific panel that advises the FDA Center for Tobacco Products. The TPSAC is supposed to have a consumer representative, but does not (that slot is filled by a hard-core ANTZ who is arguably the diametric opposite of a consumer representative). But even if that slot is not available, our nominee (guess who?) is also one of the leading researchers in the field and therefore qualified to advise on the science and represent the consumers from any position on the committee (if I do say so myself :-).
We believe this puts the FDA in the position of having to step up and fulfill their stated commitment to provide a consumer voice. If they do not do this, it will be a clear indication that they do not really intend to voluntarily accept a role for consumers.
Second, CASAA met with the White House Office of Information and Regulatory Affairs (OIRA) which is currently reviewing the FDA “deeming regulation” that would regulate e-cigarettes. E-cigarette and THR advocates had been hoping to intervene at this point in the process to try to change what might be bad proposed regulations (we do not know what the content is, so this was a bit blind). However, there had been some difficulty in understanding what OIRA does and what basis they need to make decisions upon; they analyze technical and economic points about regulations, and thus cannot really act on a plea that is phrased in terms of morals and the wonderfulness of e-cigarettes. We were not optimistic OIRA was interested in acting based on what we had heard about previous meetings.
However, we had the advantage that OIRA are my peeps (my original training being in policy/regulatory economics, and a lot of my classmates and teachers spent some time in versions of that office) and so we could craft an argument based on our understanding of the specifics of what they needed to hear, not just a generic statement about e-cigarettes. I think we really nailed it (hey, as long as I have to write “if I do say so myself” this morning, I might as well go all-in). You can form your own opinion by clicking through to our talking points memo — and if you do not know too much about how the FDA tobacco regulation process is actually functioning you might find some interesting information there too. The meeting went great and we came away from it rather optimistic that OIRA might step in to help us avoid bad regulations.
Needless to say, there is no guarantee that either one of these initiatives will pay off (though the first has the benefit of giving us a clear message we can use even if it is rejected). But it is good to know that there is a system in place that offers real possibilities that the government will do the right thing. Yes, we have the most dysfunctional government in living memory due to the way our checks-and-balances are playing out, but I suspect this will generate appreciation of our system from readers in checks-and-balances-free Europe and the Commonwealth.
Speaking of, I will finish with an outsource to Freedom-2-Choose (Scotland), a quick read about an argument in Australia that nicely illustrates the moral and intellectual bankruptcy of the “public health” anti-THR liars. It speaks for itself, and I have nothing to add.
Tobacco harm reduction, anti-THR lies, and related topics 
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Excellent job team!
I don’t know if you have seen the actual ‘opinion’ from the WHO about the use of ENDS (aka ecigs). I should imagine that you have, but for your readers, here is the link to the statement of the WHO ‘opinion’:
http://www.who.int/tobacco/communications/statements/eletronic_cigarettes/en/index.html
This ‘opinion’ is important because of the octopus-like tentacles of of the WHO “Tobacco Free Initiative” organisation. It is those tentacles which are most likely to influence the judgement of politicians because of the high-powered nature of the advisers.
——
First, look at the conclusion:
Until such time as a given ENDS is deemed safe and effective and of acceptable quality by a competent national regulatory body, consumers should be strongly advised not to use any of these products, including electronic cigarettes.
So what is the justification for that conclusion?
I’ll extract a few statements from the ‘opinion’ which seem to me to have relevance.
———
First, let us extract what are claimed to be FACTS which are relevant to matters of regulation (that is, disregarding obvious descriptions of the machine and liquid and such).
1. The safety of ENDS has not been scientifically demonstrated.
2. …..scientific testing indicates that the products vary widely in the amount of nicotine and other chemicals they deliver and there is no way for consumers to find out what is actually delivered by the product they have purchased.
3. Most ENDS contain large concentrations of propylene glycol …
4. …..however, the chemicals used in electronic cigarettes have not been fully disclosed, and there are no adequate data on their emissions.
5. The efficacy of ENDS for helping people to quit smoking has not been scientifically demonstrated.
6. … But we know that for smoking cessation products to be most effectively and safely used, they need to be used according to instructions developed for each product through scientific testing.
7. There are no scientifically proven instructions for using ENDS as replacements or to quit smoking.
8. The implied health benefits associated with these claims are unsubstantiated….
9. When ENDS are used as cessations aids, they are intended to deliver nicotine directly to the lungs. None of the approved, regulated cessation aids, such as nicotine patches and chewing-gum, delivers nicotine to the lungs. Therefore, the biological mechanism by which smoking cessation might be achieved by delivery of nicotine to the lungs and its effects are unknown.
10. …..independently of the effects of nicotine, it is of global importance to study lung delivery scientifically.
11. The dose of delivered nicotine is also unknown.
———
Now let us extract POSSIBLES.
1. A number of ENDS are offered in flavours that can be particularly attractive to adolescents.
2. The manufacturers report that the cartridges typically contain between 6 and 24 mg of nicotine, but sometimes can contain more than 100 mg.
3. …..nicotine is an addictive chemical that in excessive amounts can be lethal (0.5-1.0 mg per kg of weight of the person).
4. The testing of some of these products also suggests the presence of other toxic chemicals, aside from nicotine. In addition, use of these products -when they contain nicotine- can pose a risk for nicotine poisoning (i.e. if a child of 30 Kilos of weight swallows the contents of a nicotine cartridge of 24 mg this could cause acute nicotine poisoning that most likely would cause its death) and a risk for addiction to nonsmokers of tobacco products. Nicotine, either inhaled, ingested or in direct contact with the skin, can be particularly hazardous to the health and safety of certain segments of the population, such as children, young people, pregnant women, nursing mothers, people with heart conditions and the elderly. ENDS and their nicotine cartridges and refill accessories must be kept out of the reach of young children at all times in view of the risk of choking or nicotine poisoning.
5. As ENDS do not generate the smoke that is associated with the combustion of tobacco, their use is commonly believed by consumers to be safer than smoking tobacco. This illusive ‘safety’ of ENDS can be enticing to consumers.
6. Therefore, the biological mechanism by which smoking cessation might be achieved by delivery of nicotine to the lungs and its effects are unknown. Delivery to the lung might be dangerous.
7. It is suspected that the delivered dose varies notably by product, which contain nicotine in various quantities and concentrations.
==========
What is important about the above (probably incomplete) analysis is that it illustrates the deliberate mixing of claimed (but unproven) FACTS with
POSSIBLES. The effect of this deliberate mixing of claimed facts and possibles is to create an emotional argument which has little substance. So little is the substance that the ‘conclusion’ is irrational and unjustified.
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