Tag Archives: FDA

Index of my Daily Vaper articles (2)

by Carl V Phillips

In my last post, I noted that most of my writing is currently at The Daily Vaper. I also promised that I would keep an index of those publications here for those who following this and not those, highlighting the ones that fans of this blog might be particularly interested in. This also provides an option for commenting on them, which DV does not have, and a chance for me to add a bit more about some of them.

[Update: Indexing is hard and unrewarding. I stopped after this one. Maybe someday I will circle back.]

Here is my belated second entry in the series. I will try to do this more frequently so the list is not so long (sorry — maybe keep this tab open and take a few days to get to all of them you want to see).

In rough descending order of what I think regular readers of this blog would find most interesting (I expect you will want to read at least the first seven):

1. I wrote a science lesson about anchoring bias and why it means that we should really stop describing the risks from low-risk tobacco products in relation to smoking (e.g., “99% less harmful”). I have hinted at some of this here, but I have never really nailed it before. This is new analysis. Anyone interested in my evolving thinking about accurate messaging — based on more years of experience and thought than anyone else involved in this realm — should definitely read this.

2. I reported on a court ruling that is fairly obscure, but truly delightful: The usual gang of anti-tobacco groups petitioned to be co-defendants, alongside FDA, in a suit against FDA by cigar manufacturers over aspects of the deeming regulation. The judge denied it. Why should we care? Because the ruling basically said that they are not stakeholders. For those of us constantly frustrated by the bullshit suggestion that they are (let alone that the primary stakeholders, tobacco product consumers, are not), this is just too good. Unfortunately I suspect I am the only one who will try to make anything of this. I strongly encourage those of you who are involved in advocacy (and especially those involved in lawsuits) to run with it. It really is a huge potential lever.

3. This piece is about the unethical scientific practices of tobacco controllers, specifically their flouting of human subjects protection rules. These are bright-line violations of codified rules, unlike the usual unethical behavior of tobacco control which is evil but not unlawful. I mention a couple of the reports about that which I have written here along with some new material. I suggest that perhaps a blanket boycott campaign would make sense. If I have time, I will write a piece about that specifically for this blog.

4. My personal favorite is this one, where I catch FDA chief Scott Gottlieb, in congressional testimony, offering basically the NIDA definition of “addiction”, a definition that clearly excludes tobacco products (including cigarettes). As my readers know, I have made a study of what people mean when they say “addiction”, and how there is apparently no viable definition that anyone wants to defend that actually includes tobacco/nicotine. In this case, Gottlieb was stuck because he had to talk about opioid addiction, and so was forced effectively undercut all the CTP rhetoric on the subject. Well, undercut it if anyone decides to challenge them based on this, which probably will not happen. The industry is not exactly known for being that clever.

(Foreshadowing note: I actually think I have figured out how to characterize what people mean when they say smoking etc. are addictive. One of these days I hope to write a major piece on this.)

5. In what could basically be an uncharacteristically terse version of a post here, I wrote about a recent “what parents need to know” statement about vaping in JAMA Pediatrics. It was all the terrible you might expect. I shredded it. If your appreciation for shredding exceeds your inclination to be annoyed by the terrible, you should find it a satisfying little read.

6. I reported how, after Senator Chuck Schumer launched an amazingly stupid attack on vaping in a press conference, Gottlieb practically fellated him on Twitter. (No, I did not put it quite that way.) This suggests that despite all the overly-optimistic talk of regime change at FDA, nothing has really changed in terms of who they consider their political patrons. (*cough* *told you so* *cough*)

5. My most recent piece was about the FDA’s Orwellian-named “Real Cost” campaign. I noted that they are about to aim this anti-scientific propaganda campaign, currently focused on smokeless tobacco and smoking, at vaping. I recount some of the campaign’s content and assess what they will do regarding vaping. I will write more about this shortly.

6. I did some original data analysis in this article, based on a recent CDC report of vaping rates across demographics and occupations. The authors could not see past the raw vaping rates. This is merely an uninteresting echo of the smoking rates; whoever smokes most is going to vape most. I looked at the ratio of vapers to smokers, which is actually useful. I found that across almost every group, the ratio is very close to the overall average. This effectively shows that the rate of switching from smoking to vaping is about the same across the different groups. The one big exception was African-Americans, where the ratio is much lower. That is, few smokers in that population are switching to vaping. I suppose this is worth a journal article, but I do not have time. (Free easy publication for any student or academic who wants to take the lead and write that with me! Seriously, let me know if you are interested.)

7. In this brief piece, I review the results of a recent paper that shows the anti-vaping bias in mainstream media reporting. It just confirms what we all know, but does a nice job of it. Most notably, it observes that anti-vaping statements tend to be attributed to people with supposedly expert credentials (though obviously they are really either clueless or liars), while the truth is attributed to advocates who the average reader will (mistakenly) consider less credible.

8. Here I analyzed a research paper out of FDA which is part of their assessment of how MRTP labeling might affect consumers. Unsurprisingly, it seems designed to make the case that allowing manufactures should not be allowed to tell the truth about their products. The study was bad, and they clearly intend to spin it worse.

9. I reported on FDA’s release of “adverse event” type records that they collect for tobacco products, which are really mostly about vapor products. I noted it is pretty much meaningless, but that it might be used in anti-vaping advocacy. I indicated my suspicion that FDA released it for just that purpose, not because of some belief it should be available because it is genuinely informative (it is not).

10. In this science lesson, I summarized my analysis that shows that the optimal tax rate for low-risk tobacco products is zero if the goal is to promote population health, or any other defensible stated goal. Not “lower than the tax on cigarettes” or “proportional to the risk”, but zero. My readers will already be familiar with these arguments, though if you are looking for a short summary, this is it.

11. I tried to assess the recent FDA “guidance” about the ban on free samples of vapor products (e.g., sampling e-liquid flavors), now that they are deemed as tobacco products, with all the rules that apply to them. I say “tried” because the guidance sort of says that it does not apply to adults-only venues (e.g., most vape shops). But how exactly this will play out — i.e., will flavor sampling be banned? — is not clear.

12. I analyzed a recent survey by BAT about beliefs about the risks from vaping. It is pretty straightforward “latest study” reporting, though I got some additional data from the researchers that allowed me to offer a better assessment than those who were just working from the press release. The main takeaway is that even in the UK, a ridiculously large portion of the population does not understand that vaping is much less harmful than smoking.

13. I introduced readers to the CASAA Testimonials collection that I created in 2013. Long-time readers of this blog will be familiar with it. I plan to publish more little articles that are excerpts from that collection.

14. Finally, I reported on the fight over vapor product taxes in Pennsylvania. The upshot is that tax structure, not just tax rates, matter a lot. A rather more interesting aspect of that story — and of another story that got spiked — does not appear there. I hope to get time to report it here sometime (ooh, more foreshadowing).

(Damn, that is a lot of material. Comments welcome. I suggest using the serial numbers if you are commenting on one in particular.)

The War on Nicotine begins

by Carl V Phillips

It has been a habit of many e-cigarette defenders to refer to recent chapters of the War on Tobacco as a war on nicotine, in part because they do not like their favored product being called a tobacco product. As for that motivation, whatever. But as for the statement, it was simply wrong.

The war on smoking in the USA morphed into a war on tobacco, which basically meant lumping in approximately-harmless smokeless tobacco with the not unreasonable original target of the war. This pretty much tracked the tobacco control industry’s professionalization (read: it went from being a noble — though obviously not universally embraced — hard-fought political cause to a venal business that had a license to print money and was constantly seeking new streams of revenue). Elsewhere in the world, the war was expanded to include Scandinavian smokeless tobacco as well as South Asian and other dip/chew products. Thus it was that for most of recent memory, the War on “Tobacco” was a ridiculously wealthy cabal of a few thousand people (with millions of useful idiots, of course) gunning for consumers and producers of smoked tobacco (tobacco, harmful), Western smokeless tobacco (tobacco, approximately harmless), and other oral products (not tobacco, often harmful).

When e-cigarettes finally became a major commercial product, after a remarkably long delay (which is, of course, a very interesting story, but not the present story), the Tobacco Warriors chose to add them to the list of targets. Thus the war became still more gerrymandered to include e-cigarettes. It was still a fairly well-defined single war, defined in much the same way that World War II was a war, despite really being two largely separate major wars and a few dozen border wars, tribal wars, and colonial struggles.  The war is and was defined in terms of what a particular faction did: it was the Anglophone major powers, plus whoever happened to fight one of the same enemies for whatever reason, versus everyone they fought.

As with WWII, the current enemies of tobacco control (which, interestingly, can also be defined largely in terms of government action by the Anglophone major powers) are increasingly not allies of one another. Perhaps that is a tactical error, but they (we) do have rather conflicting interests. But the Tobacco Warriors themselves — a fairly tightly-knit group of agencies, sock puppets, and funders, working together and maintaining remarkable party discipline — make it a war. They also draw boundaries around it: Despite this being fought like every other awful war on drugs, the people involved barely overlap with the traditional Drug War cabals (and, indeed, often actively oppose them despite looking just like them, but that is yet another story).

You can muse about whether there is a better name than “the War on Tobacco” for whatever this is. But one candidate name that was clearly wrong was “War on Nicotine”. For one thing, not all of the targets of the war even contained nicotine. But more important, nicotine in isolation was their thing. It was their peeps who praised, touted, and sold nicotine in its “proper” medicinal form (never mind that NRT is primarily used for the same purpose as the products that are the main targets of their war). One of their favorite go-to tropes was still that cigarette companies’ introduction of lower-nicotine products in the 1970s was some evil plot.

And then something very strange happened. Very strange. Over the last few months, the U.S. FDA suddenly embraced a long-discredited anti-nicotine policy proposal. They announced a policy goal of forcing cigarette manufactures to lower the nicotine content of their products. (Well, legal cigarette manufacturers. The black market would inevitably replace the banned current products — one of the many reasons why this proposal is long-discredited.) Part of this has been an unending blast of government-sponsored anti-nicotine propaganda. The propaganda asserts — without any evidentiary or serious theoretical basis, needless to say — that forced nicotine reductions in cigarettes is the silver bullet that will “keep all new generations from becoming addicted blah blah blah”.

(Aside: I cannot overstate the strangeness and suddenness of this policy. Basically the only people who still supported this zombie idea were those who stood to profit from it. And then suddenly it was at the center of — indeed, is basically the entirety of — FDA’s tobacco policy. I strongly encourage someone who has the time and platform to make it worthwhile to investigate whether there is a money trail from the very small number of companies for whom this policy is an enormous windfall to the pockets of Price or Gottlieb — it is not like there is no history of corruption there. It is probably also worth checking Zeller and company, though they are not the variable here, so that seems like a long-shot. And the Trump campaign, of course, though given that the White House has not managed to put a government in place, it would have been quite a coup to push down such detailed policy from that far up the chain.)

Meanwhile there was the recent paper from Glantz’s shop, elegantly shredded by Chris Snowdon, in which the authors feebly attempt to tar NRT (their nicotine) as part of the evil machinations of the cigarette industry in the 1990s. I won’t even try to explain — there is nothing remotely defensible about it; read Snowdon if you want details. The importance is that Glantz’s current role is as a paid surrogate for FDA. This cannot be coincidence. FDA and tobacco control cannot comfortably fight a war on nicotine when the nicotine-iest products out there are their products that they have always embraced. So they need to muddy the waters around those products. What better way than to manufacture retroactive innuendo that NRT always was a brilliant cigarette industry plot that the hapless tobacco controllers fell for, and not the colossal screw-up on their own part that it was? That exact ploy has worked for them before.

FDA’s Center for Tobacco Products has always been a propaganda shop (they have certainly never been a real regulator). But previously their propaganda was lame pointless messages pitched at ignorant consumers (who do not even know CTP exists, let alone see their messaging), perhaps to provide memes for their useful idiots to publish (and, again, not actually be seen by anyone in their target audience). The current effort is different in terms of both volume and apparent purpose. You can see the volume by checking out the Twitter feeds of @FDATobacco and FDA Director @SGottliebFDA, and also see the content there and by following the links.

This is not the usual background noise of silly anti-tobacco propaganda. This is a clear example of a fixture in the U.S. political system: a concerted push by a government faction to sell their policy. (The most recent high-profile example of this was from the faction trying to destroy the Affordable Care Act.) The target audience for this includes lazy reporters, who will just transcribe the propaganda and get a free byline, and influential pseudo-experts (aka, useful idiots) who do not know enough to not believe everything they read. The general public, the apparent target of CTP’s previous propaganda, is at most an afterthought as an audience. But the most important audience for these propaganda efforts are others in government, or who have similar levels of policy-making influence, trying to persuade those on the fence and to bludgeon those who might oppose the policy.

For example, there was this from NCI (part of the National Institutes of Health, which along with FDA is part of HHS) that came out just after the Glantz propaganda dropped and as it was being touted by FDA and their surrogates.

The cabal at FDA will find it hard to run a full-on War on Nicotine if NCI actively opposes them. Similarly, there are presumably a lot of tobacco controllers further down in government, and in political organizations, who still embrace the old (correct) notion that nicotine — especially their nicotine — is not the problem. Most of them are just puppets, and will dutifully recite that we have always been at war with Eastasia …er, with nicotine, as soon at they get the message. Others can simply be silenced by the deluge from the agency that has more money than the rest of tobacco control combined. That is the playbook for this kind of inward-directed propaganda.

And so we have, for the first time, an actual War on Nicotine. Note that this does not mean the whole war can be relabeled The War on Nicotine for reasons noted above. This is just part of it. We are still stuck with “War on Tobacco (etc.)” for the larger effort unless someone can come up with something better.

Some commentators who focus only on e-cigarettes appear unaware of what is really happening. Gottlieb and FDA substantially delayed the implementation of the stealth ban on e-cigarettes and have made various noises about embracing e-cigarettes as a low-risk alternative to smoking. So, hey, everything looks good for e-cigarettes! Some of those commentators have even bought into the FDA propaganda that the FDA policies support harm reduction (at utterly Orwellian claim which I will address in my next post or you can check out my Twitter thread). However, since e-cigarettes are basically a nicotine delivery device, how can there be both a war on nicotine and a more pro-ecig policy?

Indeed, how?

One possible explanation is that FDA is signaling a plan to shift toward the position of British tobacco controllers who have seized control of the vaping mindspace there, intending to use e-cigarettes as just another weapon against smoking and smokers. That playbook involves keeping just enough of a boot on vaping to keep it from being accepted as a normal personal choice (it is only a smoking cessation medicine!), and staying in a position to squash it when supporting it becomes no longer politically expedient.

It could be that. But I find it genuinely hard to find that explanation in what we are seeing.

The two messages are simply too flatly contradictory. It is not exactly novel to see messaging from governments that includes policy proposals alongside stated support for goals that are antithetical to those policy proposals. Especially from this government and from this agency — after all, we heard basically the same happy talk about e-cigarettes even as FDA was marching toward a total ban as rapidly as they could. Obviously anyone other than lazy reporters and political actors who are looking for plausible deniability when they fall in with their faction’s bad policies should focus on the policy, not the contradictory happy talk.

But many do not. Thus this happy talk serves the rather obvious purpose of getting e-cigarette advocates — the most vocal and potentially politically effective opponents of a new War on Nicotine — to sit on their hands until the actual policy goal (whatever its crazy or corrupt motivation) has enough momentum. So we can expect no overt anti-ecig actions by FDA for a while. They still will not approve any new products (so there will be those temporarily grandfathered into minimal paperwork in 2016, and an a high-paperwork probably-denial grey-zone for later products, still leading to the full-ban in 2022) or allow any merchant claims about the low risk. They are just pausing, not retreating. They might withdrawal their proposed de facto ban of most smokeless tobacco, issued under the guise of being a health and safety regulation, though frankly that would probably only be because it will never survive judicial review (smokeless tobacco and harm reduction advocates are a much smaller voice than e-cigarette advocates).

But if they gain momentum for their War on Nicotine policy, things will probably go downhill quickly. Implementing a substantive policy (for the first time ever) will empower FDA to go ahead and fight the e-cigarette advocates they temporarily appeased. It seems impossible that a hugely impactful and crazy expensive policy of cigarette nicotine reduction, for the chiiiildren, will not spawn limits on e-cigarette nicotine density and “child friendly” flavors. With the delay of the full-on e-cigarette ban they no longer have the luxury of not even trying to actually regulate the products; FDA will be wanting to hurt vapers through other means.

If the proposed policy is quashed things are a bit harder to predict. Perhaps FDA will be shy to take on more fights. Perhaps there could be a real change of heart, but it would be the height of foolishness to read that into the same old rhetoric. Perhaps the political party that controls our government is really so deeply dedicated to consumer welfare and free choice, as some advocates seemed to think before the election, and they will clean house at CTP and change its direction (haha — kidding, of course — if that turns out to be the case, I vow to print this out and eat it).

But it seems most likely we would still see e-cigarette “regulation” that serves only as harassing partial bans as soon as they are no longer all-hands-on with their current policy. That is consistent with everything they have done so far. Moreover, it seems especially difficult for them to walk back on e-cigarettes after campaigning for a War on Nicotine for a year and convincing their useful idiots that we have always been at war with nicotine.

FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (postscript)

by Carl V Phillips

For completion of this series (with this footnote), the following is what I submitted to FDA. My comment does not yet(?) appear on the public docket as of this writing. But I got a confirmation (confirmation code 1k1-8xfb-dhwh if you want to search for it later). It has a bit of extra content beyond what I already presented. Continue reading

Sunday Science Lesson: toxicology and “the chains” in American football

by Carl V Phillips

Those of you who read my series on fatal flaws in FDA’s proposed rule about limiting the nitrosamine NNN in smokeless tobacco (and presumably anyone reading this quick little tangent read those important and carefully crafted posts) might have tripped up over an oddity from the third post in the series. I quoted this from FDA’s proposed rule about how their key number, used for estimating the risk of cancer caused by some quantity of NNN, was calculated: Continue reading

FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 3)

by Carl V Phillips

In Part 1 of this series, I described FDA’s proposed rule that would require smokeless tobacco products (ST) to have no more than 1 ppm of NNN (a tobacco-specific nitrosamine or TSNA) dry weight. I discussed some of the political and policy implications of this, and reasons why the rule will probably not survive. I also noted that almost no current products meet that standard, and that American-style ST probably cannot meet it. Despite the proposed rule probably being mooted, I noted there is still value in examining just how bad the ostensibly scientific analysis behind it is. In Part 2, I noted that the FDA’s estimate the standard would save 115 lives per year is premised on their estimate for the risk of oral cancer caused by ST use. But, in fact, the evidence does not support the claim that ST use causes any oral cancer risk. I then focused on why, even if one believes there is some such risk, the method used to calculate FDA’s quantitative estimate is utter junk science. Continue reading

FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 2)

by Carl V Phillips

In the previous post, I gave some background about the new proposed rule from FDA’s Center for Tobacco Products (CTP) that would cap the concentration of the tobacco-specific nitrosamine (TSNA) known as NNN allowed in smokeless tobacco products (ST). Naturally, I think you should read that post, but to follow the scientific analysis which begins here, you do not need to.

Before even getting to the even worse nonsense about NNN itself, it is worth addressing CTP’s key premise here: They claim that ST causes enough cancer risk, specifically oral cancer, that reducing the quantity of the putatively carcinogenic NNN could avert a lot of cancer deaths. Continue reading

FDA’s proposed smokeless tobacco nitrosamine regulation: innumeracy and junk science (part 1)

by Carl V Phillips

I am a bit late to analyze this proposed FDA rule, which was promulgated on Inauguration Day. But it is still open for comments, and I will be submitting these posts (though for reasons I will get to shortly, these and all other comments are probably moot except as for-the-record background).

Before getting to the substance it is worth noting that this is really the first bit of genuine regulation proposed by the FDA Center for Tobacco Products (CTP) in its eight years. Despite CTP reportedly approaching $4 billion in cumulative expenditures, it has only implemented a few inconsequential rules that were specifically required by the enabling legislation, and has never actually created a standard or specific requirement like a real regulator. Instead, everything it has done has been what I have dubbed weaponized kafkaism. The variation on the word “kafkaesque” refers, of course, to Kafka’s horror stories of bureaucratic (in the pejorative sense) rules that create injustice via impossible procedural burdens. “Weaponized” refers to turning something that is harmful but not malign into a tool for intentionally inflicting harm. CTP has turned filing and paperwork hurdles into a weapon. Continue reading

The year tobacco control officially came to own e-cigarettes

by Carl V Phillips

I have seen several year-end posts about the state of e-cigarettes, most from cheerleaders who naturally made optimistic predictions. Overly optimistic, I would say. Continue reading