Monthly Archives: September 2015

CASAA comment on proposed FDA child-safety regulations for ecigs and dissolvables

by Carl V Phillips

The CASAA statement on this docket is now available at the main CASAA blog. It also appears at the regulations.gov docket page. It is pretty self-explanatory, but for background and a link to the text of the FDA Advance Notice of Proposed Rulemaking (ANPRM) that it responds to can be found at our Call To Action for it. (Note that this is being posted about five hours before the deadline for that CTA, so chances are that when you read this it is too late for you to respond to that CTA if you did not do so. [correction: you have until midnight, not EOB today, so there is still time if you are reading this early enough today])

The very short version is: A federal mandate for child safety labeling and packaging is a good idea, so long as the very modest benefits it offers are not achieved at the expense of creating substantial burdens for consumers. We also observe that other commentators are likely to use this ANPRM as an excuse to push their unrelated agenda of intentionally lowering product quality, and that any benefits from this and other beneficial regulation are dwarfed by the enormous social harms that would be created by “deeming” these products in the first place (as that proposal is currently conceived).

Ecig consumer wants and “needs”

by Julie Woessner and Carl V Phillips

[Julie Woessner JD is the Executive Director of CASAA and President of its Board of Directors.]

One more post about GTNF2015. Julie presented in a session titled “Consumer wants and needs”. It was one of at least three sessions with titles that, if interpreted generically, made them about the general question of what consumers care about regarding developments in tobacco products (which in practice made it mostly about e-cigarettes, since that is where most of the developments are). We decided to make this talk a little more specific, and deliver one of CASAA’s key messages, by taking advantage of the exact wording of the session title.

The following (between the “—–”) is Julie’s talk. It is the prepared script, not a transcript.

——————-

The basics of what consumers and would-be consumers of low-risk tobacco products want is no mystery. You have heard it a thousand times: Consumers want high quality products, innovation, variety, and the freedom to choose which products they want to use, along with freedom from punitive taxes and other unjust laws that restrict use and enjoyment.

That being said, what do consumers need in order to get what they want?

First, industry competition, which promotes innovation, price competition, and all those other wonders of the free market system. Second, freedom to choose, both literally and practically (which means allowing sales and distribution channels for a variety of products). Third, accurate information so that consumers can make informed choices that reflect their tradeoffs, particularly information about comparative risks within and between product categories.

You might notice that I qualified the word “need” with a rather simple phrase: “in order to.” So the question becomes not simply what do consumers need, but, rather, what do consumers need in order to — in this case — get what they want. A discussion of “need” in and of itself is largely meaningless — and sometimes rather dangerous — without that “in order to” qualifier.  

In fact, presenting something in terms of “wants” and “needs” usually implies that wants are self-indulgent and frivolous while true needs are properly determined by those who are in positions of authority, since consumers can’t be relied upon to know what they need or what is truly in their best interests. This is a terrible, but common attitude. Thus, when someone asks what consumers “need” without including the all-important “in order to” clause, we should be wary of hidden agendas and moral positions.

Regarding e-cigarettes, the most common agenda among those posing the question, “what do consumers need” is that they are actually asking, “what do consumers need in order to ‘cure smoking,” or even “in order to be just good enough to cure smoking, but not any better than that.” If one sees e-cigarettes and other low-risk alternatives to smoking as simply a “cure” for smoking, then they are much like medicines. For those with this mindset, things like medicines and nourishment are “needs,” which make them somehow superior to mere wants, like enjoying life. And, of course, there is no “need” for medicines to be enjoyable. Rather, they merely need to work well enough.

And so we see regulators and many members of public health seeking to impose restrictions that make e-cigarettes less enjoyable and less acceptable because simple enjoyment and pleasure are wants, but not “needs.” Consider the EU Tobacco Products Directive where e-cigarettes as consumer products can only have a maximum level of nicotine of 2% nicotine. The rationale? “This concentration has been shown to be adequate for the majority of smokers that use an e-cigarette to substitute smoking.” (emphasis added) Leaving aside the fact that this is a mischaracterization of the science, it is troubling that anyone would consider it to be acceptable to impose limitations that have the effect of making something merely “adequate” for a “majority” of smokers.

In the U.S., there is an outcry against all flavors other than tobacco and menthol. Some phrase their opposition to flavors as being about protecting the children from target marketing — because the feeling is that only children could want fruit or sweet flavors. Others will acknowledge, perhaps somewhat grudgingly, that adults do enjoy such flavors, but believe that it is nonetheless acceptable and appropriate to eliminate those flavors to make the products less appealing to children. Again, they would argue that pleasant flavors — and an enjoyable product more generally — are not a “need” if one views e-cigarettes as merely being about smoking cessation.

But even if one is inclined to see the only legitimate role for e-cigarettes as a “cure” for smoking, given that there are hundreds of millions of smokers out there, any quality improvement in e-cigarettes is, for some of them, going to be the tipping point between continuing to smoke and switching. And likewise, for every restriction or limitation placed on e-cigarettes — whether it be nicotine strength, cost, flavors, or various other factors — there will be some smokers who will find e-cigarettes a less acceptable alternative to smoking.

I would suggest that when we talk about “needs” rather than “wants,” we are in danger of buying into an anti-consumer, anti-humanitarian view. There is nothing inherently wrong or immoral with consumers enjoying a consumer product, and there is absolutely no justification for purposely ignoring or deliberately reducing the enjoyment factor associated with the use of that product.

At the end of the day, the reason why e-cigarettes are such a tremendously successful alternative to smoking is because they are enjoyable, and anything we do to reduce the enjoyment will necessarily reduce their acceptability as an alternative to smoking.

——————————

Economists — which is to say, the scientists who study wants and needs and the like — generally object to the word “need” when it is used to imply something that is qualitatively different from a want. To paraphrase the great Jedi economist: Want or want more; there is no need. Of course, the word is legitimate with an “in order to” clause, whether you are talking about economics (“people need insurance to have access to modern healthcare”) or some other science (“you need to heat water to 100 degrees as standard pressure to make it boil”). But lacking such a stated condition, the word is economically meaningless. The typical response to that is “but you need food, water, shelter, oxygen, etc.” But buried in that is an implicit statement of “in order to still be alive next month.” Also, *yawn* — no one who is not discussing how to colonize Mars is ever actually talking about the minimal conditions for survival.

No, when someone uses the word “need,” there is always an implicit “in order to” statement buried there, and it is almost always “in order to get what I think they should want.” Put another way, the word is often a way of burying an illiberal and often anti-humanitarian premise that the author is trying to hide from the debate it deserves. Sustenance and medicine can be legitimately called adequate or inadequate, but such words are absurd for consumer goods. Even if you do not have the slightest urge to own a Ferrari, you do not want a car that would be described as “adequate” — which would basically mean “really lousy.” For an enthusiast, the concept becomes even more absurd.

This relates closely to the divides among different political factions that have emerged in the neighborhood of THR, but that are not actually about THR. For the first decade and a half of the THR movement (measuring from Rodu and Cole’s seminal 1994 paper), there was a pretty clear dichotomy: There were supporters of THR who were also supporters of smokeless tobacco (which was the only viable option) versus the “public health” people who opposed any tobacco product use more than they favored health. But the e-cigarette phenomenon has divided both groups.

There was no important political movement around smokeless tobacco enthusiasm — consumers merely wanting to defend their personal consumption choices, without it really being about THR, let alone “need” — but there now is for e-cigarettes. The “public health” faction also divided, with a few backing e-cigarettes as a cure for smoking, a de facto medicine. This is not about THR either, since it runs contrary to that philosophy’s ultimate grounding in individual empowerment and freedom. For this new faction of tobacco controllers, “need” is a natural concept and is used in the typical way: “needed in order to achieve what I think they should do.”

Right now, the three pro-ecig factions (consumers who are just motivated to defend their personal consumption choice, along with merchants who want to supply them; those who see them as a de facto medicine; and supporters of the THR agenda) are almost perfectly aligned in terms of practical political positions, due to the extremism and stupidity of the opposition. This has resulted in many proponents of either the enthusiast or “cure” factions, and even some who are strong supporters of the THR mission, failing to recognize the important differences among the groups’ goals, which are evident in language, occasionally manifest in practical contexts, and will become substantial divisions if the current round of fights is successful.

That Tobacco Products Directive clause is an example of the stupidity that maintains the alliance. As alluded to in the talk, it is not actually the case that 2% nicotine is adequate to provide a cure for smoking. The rule was slapped together by people who are clueless about nicotine use. We can guess that the thinking was that smokers should be forced to “step down” their consumption as they would with NRT. But the reality is that the ceiling increases the chance that a heavy smoker will try e-cigarettes and not compensate with enough extra puffing, and find that they do not deliver enough nicotine to make switching attractive. Meanwhile, experienced users who want more nicotine can just consume greater quantities, though this might not be what they really want. Thus, this rule pointlessly interferes with both wants and “needs”. But if the rule had been made thoughtfully by smart tobacco controllers who did not want to derail this cure for smoking — those from the faction that accepts e-cigarettes as a needed cure for smoking, but nothing more — they might have focused on a floor rather than ceiling. That is, they might have attempted to allow only the high concentrations that are the better “cure for smoking” while banning the low concentrations that could arguably be said to be used for the “mere want.”

The response might be that some people “need” the ritual or whatever to stay off cigarettes, but that is a difficult case to back (unlike the case higher concentrations being useful for transitioning smokers). The real objection to such a restriction, from the consumer or enthusiast perspective, is “I want to puff copious quantities of my 0.3%, and what possible business do you have telling me I can’t?” But if the “need” faction were ascendant (i.e., those who are pro-ecig as a medical cure for smoking), then this “mere want” would not be considered important.

Sunday Science Lesson: How they estimate deaths from smoking etc.

by Carl V Phillips

This continues, and finishes, the series that started here and continued here. (FWIW, the second one is probably more interesting than either the first or this one, if you want to read just one.) Recall that this series is the very long answer to a question along the lines of “how do they determine how many deaths among smokers, and especially among ex-smokers, are attributable to smoking?” In the first post, I discussed the causal contrast that anyone addressing that question should be thinking of (but probably is not), and noted that the outcome is badly defined (caused the death to occur how much sooner? they never say and probably do not even understand that is an important question).

Continue reading

Is “ecigs are a gateway” the new “addiction”? (i.e., fiercely debated in the absence of defining the term)

by Carl V Phillips

Just a quick note to vent my amusement about the never-ending war of commentaries about whether e-cigarettes are a gateway to smoking. That war apes a scientific debate, but it is not one for several reasons. Most notably, no one (on either side) ever explains what they would mean by “there is a gateway effect.” There are also serious problems about what would constitute useful evidence.

I suppose you don’t vent amusement, do you? You vent frustration. And it is frustrating that I recently spelled most of this out and yet even the ostensible scientists in the debate do not seem to have bothered to read that or any of the other serious scientific analysis on the topic. And they won’t read this either, so it does not seem to merely be a matter of tl;dr. I blame social media and the motivations it creates to write without doing the reading. And the thirty-second news cycle. And blogs. And Twitter. Also, would you kids please be so kind as to get off my lawn. Continue reading

Complaints about conflict of interest are designed to maximize conflict of interest

by Carl V Phillips

A colleague who found himself the target of the “you have a conflict of interest!” bullshit game was invited to write his analysis of the nature of conflict of interest as it relates to e-cigarette research. He asked me for input and several points occurred to me. I am writing them up here, in an admittedly disorganized fashion, for possible use in that project. Continue reading

Toward beneficial and practical standards for e-cigarettes

by Carl V Phillips

At the GTNF2015 conference I was on a panel discussing e-cigarette standards. The standards being discussed include manufacturing practices (e.g., clean rooms, hardware materials), specific technologies (e.g., whether a heating coil is capable of overheating, safe batteries), and ingredients (e.g., the perennial debates about whether some flavoring agents pose too much of a hazard). I decided to take the approach of addressing what the proper role for standards is, from a political economy perspective. What follows is the talk I gave (not word-for-word, and with a few additions to make it a document better suited for reading, taking advantage of the lack of time limit here). I follow that with some additional thoughts I voiced during the course of the Q&A and discussion. Continue reading

Sunday Science Lesson: Efforts to lower quality of tobacco products are poor substitutes for taxes

by Carl V Phillips

I am back from Italy and the GTNF2015, and mostly recovered. I have more to say about that meeting, particularly posting the content of my talk, and a backlog of a dozen unrelated or semi-related posts I want to write. Not knowing where to start, and it being Sunday, I will go for a science lesson. And, yes, I know I am in the middle of a science lesson series (and being a proper scholar, I am also in the middle of numerous other series) — next week, I hope.

I went to an interesting session about “plain products”, which was a cryptic way of referring to the intentional lowering of the quality of products, using anything from unattractive packaging, to limitations on flavoring, to lowering nicotine concentration. Interestingly, none of the presenters actually came out and said “lowering the quality of products” until I pushed them to adopt such plain language in the Q&A. I suppose their oft-repeated “affecting the value proposition” is the British synonym for that more pointed American phrase. But the former just does not seem to make it clear enough that these tactics are about lowering the benefits that are experienced by consumer — i.e., intentionally hurting consumers in order to manipulate their behavior. Continue reading

Attacking ecigs to encourage continued smoking: predatory lawsuit and goofy California law edition

by Carl V Phillips

I have finally realized that there is an answer to “what benefit results from FDA jurisdiction over tobacco products?” FDA regulation (and I use that term very loosely) has harmed consumers and commerce by gumming up free markets, damaged public health by interfering with THR, and threatens to do far more of each in the future, all for no apparent benefit. When asked to explain what they have accomplished, even FDA CTP or their umbrella agencies have no answer. They invariably lead with the banning of flavored cigarettes when trying to brag about their accomplishments, even though this happened basically on day one, was specifically mandated by Congress, and did not do anything other than deprive the few thousand adult smokers who actually used those products of a bit of life’s pleasure. I would have to call that self-damning with faint praise.

But there is an answer to the question: Without federal preemption, California would have a free hand to regulate these products.

I am obviously not saying this justifies the enormous social harm that has been and will be caused by FDA “regulation” of tobacco products. After all, most of us think of Californians much as we do Saudi Arabians or Australians — we might feel a bit sympathy about their welfare-reducing governments, but their lives are still better than most humans’, so it is hard to feel too bad. But still it is the answer to the “name even a single benefit” question.

California has a law known as Proposition 65 whose anti-science is just one step better than executing people for witchcraft. It requires that every building that the public is allowed in post a warning that there are chemicals present that are known to cause cancer and reproductive harm. Ok, strictly speaking it requires that only if those chemicals are present, but since they always are present everywhere, that is a distinction without a difference. This is not a warning about actual risk — an inconsequential quantity of one chemical that breaks the ridiculously low threshold requires the same warning as the air being thick with toxins — so this obviously serves no useful purpose. There is a similar requirement for many consumer products. Selfish lawyers can make a nice living shaking down businesses that violate the utterly useless provisions of Prop 65.

Ironically, cigarettes do not have to have the California warning about carcinogens or harm to fetuses, thanks to federal preemption. At the moment, though, e-cigarettes do not benefit (and, again, I refer to a single benefit, not overall net benefit) from that preemption. Thus, some lawyers — in this case operating under the guise of being a public interest charity — are using Prop 65 to shake down e-cigarette manufacturers. The group fancies itself “The nonprofit health watchdog Center for Environmental Health” (CEH), even though most of its income from the last year reported came from awards from lawsuits and “fees” (which I am guessing are shakedown payments, since it is not clear who they could be legitimately charging for their “services”) and it was described as the “most predatory litigant” in the Prop 65 space. They describe themselves thusly:

The Center for Environmental Health (CEH) is the leading national nonprofit committed to ending health threats from toxic chemicals in our air, water, food and in products we use every day. CEH protects children and families from harmful chemicals by working with communities, consumers, workers, and government to demand and support safer business practices. We also work with major industries and leaders in green business to promote healthier alternatives to toxic products and practices.

It would be funny if they were not so harmful. You would think that the “leading national nonprofit” would be a household name. Had you ever heard of them before this week? I didn’t think so. You probably have heard of the NRDC — there is a lot bad to say about them too, but at least when they use the word “leading” you do not giggle. I also like the “children and families” bit — if you are single, then you can just go suck benzene. But of course, the real problem is the claim that forcing business to put an utterly pointless “warning” everywhere — a statement which ACSH cleverly describes as “ignored by the populace, except for Prop. 65 lawyers” — does anything whatsoever to help anyone other than the lawyers.

It was CEH that attacked e-cigarette manufacturers over Prop 65 warnings earlier this year. At least that produced some humor. But their true harmful nature came out this week when they not only filed a notice that makes demands of and threatens legal action against numerous of e-cigarette companies which would provide no conceivable health benefits, but released a “report” (which is really a marketing-style brochure) that made junk science claims that would tend to scare smokers away from switching to e-cigarettes. In particular, their headline claim in their press release was “High Levels of Cancer-Causing Chemicals in the Majority of Nearly 100 E-cigarettes Tested”. How high? They offer absolutely no context for that word in the press release and nothing clear in the “report”.

We know that the real answer is “not high enough to worry about”. The two chemicals they are talking about are formaldehyde and acetaldehyde, which have been measured in pretty much every study of e-cigarette emissions and found not to be present at levels that pose a concern. The thing is, the Prop 65 exposure limits for these are such that everyone will exceed them. You exceed the formaldehyde threshold merely by breathing (and recall that dead people were not included in that list with children and families). So their vague reporting of how many multiples of these meaningless numbers they found are not informative about their results, and offers no support for their attempts to scare consumers.

Your first question about how they got their results might be what lab methodology did they use to produce those quantities? They do not say, other than saying it was done using smoking machines, which very likely resulted in the overheating that produces far more pyrolysis products than actual vaping does. They insist that they did not overheat the devices, but offer no substantive support for this dubious assertion. But those observations are not anywhere near the top of their failures to report their methods. That list starts with them not even reporting what quantity of consumption generates the supposed results. As far as we know, they estimated the total exposure that would result from taking every waking breath as a puff on an e-cigarette. The failures continue from there. Gregory Conley sought more information about their methodology, but reports that they refused to provide it. Not exactly surprising.

Of course, those problems are only failures if one models their behavior as attempting to help people or to do science, rather than to shake down manufacturers for a few million dollars, and perhaps get a piece of the tobacco control industry gravy train. Since most of their “report” has nothing to do with their actual Prop 65 complaint, but is just a simplistic shoveling of every anti-ecig myth and complaint that tobacco controllers recite, it seems like the latter is part of the goal.

I am not sure whether CEH ever did anything that actually improved anyone’s health. But if they did, any such benefit could easily be swamped by what they are doing now. If the public even notices this money-grab, and if they believe the claims (or others cause them to), it will probably cause a lot of would-be vapers to smoke instead.

Already a few ANTZ are gleefully reporting on this travesty as if it has information value about e-cigarettes causing harm. We can come back to that question I started with, “is there any benefit whatsoever?” In this case, there is information value: Anyone who touts this anti-scientific attack as if it were informative is making clear their utter scientific illiteracy and lack of ethics. Not just the tobacco control standard level of illiteracy, lack of ethics, and generally cluelessness, but something deeper still. They are repeating meaningless rhetoric that is based on completely unreviewed assertions whose actual meaning cannot even be determined because of missing information. This does not even rise to the level of being junk science — it is non-science, as should be obvious to anyone who reads even the press release.  Moreover, that claim comes from an organization with no scientific credibility, and for whom the term “conflict of interest” does not even apply because their only apparent interest is bolstering their legal claims.

So which particular bottom feeders sunk to this new depth? That would be the World Health Organization (FCTC), as well as a few of the worst pseudoscientists (GlantzChapman, Malone) and others among the least credible anti-THR activists (World Lung Foundation, Leno (this guy)). But most of the other usual suspects have been sensibly silent about this travesty, refusing to stoop to quite this level. We can thus now have a new measure — the CEH Test — for differentiating standard tobacco control levels of evil and/or stupidity from the worst of them. Let’s see if anyone else sinks below this line by citing the CEH claim.