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.
For those who may not know, the badly-named MRTP process is an element of the Tobacco Control Act that allows manufacturers to request a change in the health claims about their products (what Swedish Match has done) or to request a new product be allowed onto the market because it is “modified” risk compared to existing products (i.e., lower risk, but the ANTZ refuse to use the natural word — and so created a LOL term that implies that either decreasing or increasing the risk qualifies). The problem is that the burdens for the process are so ridiculously onerous that it is not clear any application will ever be accepted. That is why it is so important that Swedish Match has tried. It is also why they filed 110 thousand pages (almost 30 shelf-feet of paper) to make a case for some claims that anyone who knows what they are talking about already knows are true (specifically, that there is no evidence the products cause cancer or dental diseases, and that they are far lower risk than smoking).
As some, but far from all, advocates for e-cigarettes understand, the most important research informing us about the health effects of e-cigarettes is the research on the health effects of smokeless tobacco. By the same token, this application is the most important policy test of whether FDA is capable of rational regulation of e-cigarettes. If they cannot accept overwhelming evidence about the low risk of smokeless tobacco, it is difficult to imagine they will accept the evidence about e-cigarettes which will remain weaker that than for decades.
That may be moot for requests to be able to make claims under MRTP, since common knowledge about e-cigarettes will inevitably outpace the “official” claims, such that it would not be worth bothering to apply. But if this process is successful, it is possible to imagine e-cigarettes and other lower-risk products (e.g., heat-not-burn) applying for new product approval via MRTP. On the other hand, if it takes 30 feet of paper to request permission to not have to print warnings that are clearly false, it is not clear anyone could pull this off for the rather more difficult claims about a new product.
Also, that is a big “if”. Despite the fact that the claim is beyond doubt, it is quite possible that FDA will reject the application. RJR requested, through a less formalized petition process, what was basically the same changes in labeling, and got no traction. The MRTP application also has to go through the TPSAC committee, who most memorably in one meeting could not be cajoled by FDA staff to offer any concrete response whatsoever to the question “what evidence would be sufficient to show….” What is worse, the hypothetical presented by the FDA staff in that meeting was a claim that a smokeless tobacco product posed at least 90% less cancer risk than smoking, a claim that is far more modest (and thus far more obviously true) than those in the present application.
Worse still, at that meeting, Tim McAfee (the CDC’s designated ANTZ-talker, who regularly sits ex officio in TPSAC meetings) was clearly the voice of reason, alongside the (non-voting) TPSAC representatives from the (traditional) tobacco industry. It was an utter fiasco. The TPSAC members talked in circles, belying their status as hardcore ANTZ and/or ivory tower academics who do not seem to realize that the real world requires decisions and not just debating points. When CDC is the one steering the conversation back toward how it might be possible to allow a truthful claim, you know you are dealing with a process that might not offer a favorable opinion about whether the Earth is round.
FDA has about a year to act on this. If it is accepted, it will be a major boon for THR, will presumably quickly be extended to other companies’ smokeless tobacco products, and will open the door for e-cigarette manufacturers to use MRTP to try to avoid the c.2016 ban of their products proposed under the deeming regulations. If it is not accepted, it will be proof-positive that FDA is not fulfilling its stated missions of supporting public health and following the science, and that it has no business regulating tobacco products.
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Reblogged this on befrits and commented:
Hugely important on THR as a coherent movement to lessen the disease and death burden from combusted tobacco!
Thanks, Carl, for this insightful analysis. I agree with you that it is a very relevant question whether SM’s application can be a “pioneer” or a “warning to others”. For my part (though I suspect that this viewpoint is not universally held by those reading this blog!), I am optimistic that pioneer is more likely than warning!
Disclosure: My employer, PinneyAssociates, provides consulting services to GlaxoSmithKline Consumer Healthcare on their stop-smoking medications and to NJOY, Inc., on electronic nicotine delivery systems (ENDS). I also own an interest in intellectual property covering a novel nicotine medication that has not yet been commercialized.
Yeah, I am thinking that we are talking in the neighborhood of Costa Rica’s chances of winning Group D. Fivethirtyeight puts that at 34% right now, which is about 33% higher than if they had not won against Uruguay (analogy: had SM not filed), but still not exactly high.
No need for ad hom disclosures on this blog. If you have something true and useful to say, it is in no way affected by who you work for.
” I am optimistic that pioneer is more likely than warning!”
That’s how I see it too, but I expect that the resistance is going to continue to put up once hell of a fight against anything and anyone that challenges the dogmatic and outdated views that have cast such a negative shadow on nicotine, tobacco, and harm reduction in the past. Eventually they will tire…or the tide of public opinion will forces them to back down. They can hide and attempt to bury the truth for awhile, but they can’t conceal what will someday become common knowledge forever. Maybe I’m naive, but I’m one to believe that the truth eventually wins out in the end. Of course, there is a hell of a lot of pain and suffering in the interim. Not to sound cliche, but hope is what inspires many of us to even read up on what has otherwise been deemed to be a controversial (in relative terms) and verboten topic. Without hope it would just be tortured learning:-)
Gotcha, Carl–and thank you for clarifying your preferences on disclosures. Understood. As for meeting the “useful” standard, I can only promise that I will try!
As to probabilities about future outcomes, would you care to make it interesting? I’m not smart enough to figure out the best way to set up a wager, but maybe someone could build a futures market on various outcomes (e.g., what will the TPSAC vote be, will CTP issue an MRTP order?) and then folks can put their money where their mouth/fingers is/are??
Seems like an amusing thing to do. There are futures markets set up for political races and such. I believe they are based abroad to avoid pesky gambling laws, but are used for U.S. events like elections. I don’t know if they allow submissions or if the list of available markets is determined by a closed group — I suspect at least some of them are open. If one of us gets a few free minutes, it might be worth checking into.
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