Category Archives: fda

FDA Loses Appeal, Can’t Ban E-Cigarettes as unapproved therapy (yet!)

[Corrected Version — see end]

A U.S. Court of Appeals today issues a judgment prohibiting the FDA (and thus the police powers of the U.S. government it was employing) from keeping NJOY (and thus others) from importing e-cigarettes into the country as an unapproved medical device/drug.   This is good news indeed for public health.

But let’s not get too excited yet. No one wants to rain on a parade, in particular when most of the news regarding this truly remarkable alternative to smoking tends to be either composed from fabricated health concerns or just dismissive.   Had this ruling gone the other way, e-cigarettes in America would truly have been in jeopardy.   So the first instinct is to be elated (and you will find plenty of that in almost every other blog about this, we would guess) but, and the metaphors are starting to pile up here, the war is not yet won.

Law and facts can change.  The appeals court emphasized that FDA had produced no evidence that anyone had ever been harmed by an e-cigarette, but the extremists tend to find whatever they are looking for, whether it is there or not, so though the evidence may not change, the “evidence” may change and another case might follow. As the appeals court pointed out, Congress can always choose to change the law so that e-cigs can be regulated however the FDA prefers, or could even ban them outright.

The law is what it is, and need not have anything to do with what is good for people. Eventually in free societies most laws find their way to being good for people, but there can be a lot of detours on the way. The court said that the law says that FDA’s new authority over tobacco means that they can only regulate e-cigs as they do other tobacco products, not as therapeutic devices (so long as the manufacturers do not make therapeutic claims). Kind of an amusing irony. But our amateur reading of the law suggested that interpretation was far from certain, and we will admit that we are not entirely sure whether an appeal to the Supreme Court or some new case might change this.

We as scientists, policy analysts, educators, and THR advocates have strong opinions about what the law should say in this matter, but find it unclear what the law actually does, let alone will, say. We were asked to file a brief in this case but declined because the decision was about what is allowed under regulatory law –something that we have some knowledge about, certainly, but cannot claim expertise. Though public health concerns entered the discussion, this was not a decision about what is right for public health or liberty.

From a public health and good government perspective what FDA did was unconscionable anti-tobacco extremism, and Americans’ health, welfare, and liberty were well served by this decision.  But the same FDA that wanted to ban these products will be regulating them as tobacco products, and is likely to target them to discourage THR and to flex its muscles, especially after being embarrassed the first time around. Among the FDA arguments leading to the decision was

“The FDA has also offered a consequentialist argument, namely, that understanding Brown & Williamson in this fashion leaves the FDA severely thwarted in any effort to nudge e-cigarettes toward relatively healthful forms (or at least away from relatively unhealthful ones).”

On the face of it, this is a rational argument for making products safer which would be to the public good. But the power to regulate is the power to destroy, and FDA can easily create safety regulations that effectively bring about the ban they wanted. Moreover, we already know that in tobacco regulation the FDA seems intent on focusing on products in isolation, making cigarettes a little bit safer and perhaps making smokeless tobacco a little bit safer, but ignoring the fact that all smokeless tobacco (or e-cigarettes) are safer than all cigarettes. In other words, the FDA claims to want to promote harm reduction at the product level but not at a user or population level. And the extremists still call the shots there, and they are far more intent on stopping people from discovering low-risk products than they are about reducing use of high-risk products.

In summary, the news is good even if it is not perfect. This has been a very good day for e-cigarette users, for smokers, and for public health in general. Let’s hope it is more than just one good day.

[This version reflects a correction of an error: We thought that this decision meant that there had to be one more final decision in the legal process to confirm it, rather than it being the final world as it is (unless the Supreme Court weighs in). This is further evidence that we should not be offering opinions about what the law says!  We will stick to assessing what it should say.  That and our main points here: our concern that the law could easily change and the concern that FDA still gets the last word.]

– Carl V. Phillips

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Tobacco control does the easy thing, not the right thing

I recently read an article on how humans will tend to do the wrong thing, as long as it’s the easy thing.  The article reports on some research done regarding moral decisions (like whether or not to cheat on a test or help another person out), and researcher Rimma Tepper states that “People are more likely to cheat and make immoral decisions when their transgressions don’t involve an explicit action. If they can lie by omission, cheat without doing much legwork, or bypass a person’s request for help without expressly denying them, they are much more likely to do so.”  For instance, the article describes the results of an experiment where people were presented with the option to check off “Yes” or “No” in response to whether or not they would be willing to assist a learning disabled person, while others had to actively click a link to volunteer to help.  They found that it was easier for people to simply not click the link and avoid volunteering than it was for them to check off the “No” box and explicitly deny their help.   (This idea is quite similar to the organ donor question presented in a TED talk by Dan Ariely awhile back.)

That people tend to be lazy about their moral decisions may not seem all that revolutionary to some, but it is interesting, especially when thinking of this on a larger scale.  In terms of tobacco control, the easy thing to do is to go along with the status quo; smoking bans, graphical warnings, and opposition to low-risk nicotine products are all the rage right now, and it’s far easier to just go along with them all and agree than it is to point out the junk science and try to correct the massive amount of disinformation out there.  The FDA, WHO, and almost all other anti-tobacco groups have fallen in step with this, and the farther they go with their draconian anti-tobacco regulations, the harder it is to go back.  For instance, now that misleading and inaccurate textual warnings on smokeless tobacco have been rolled out, it makes it very difficult for an agency like the FDA to correct them, since it would require them to admit they made a mistake.  They have also expressly indicated their opposition to e-cigarettes, and to suddenly turn back on that decision and admit their error would make headlines all over the world.  For governments and other groups to correct this kind of disinformation would take a great deal of explaining, as well as a lot of policy reform, red-faces, and possible firings.  So, the FDA will continue to do the wrong thing when it comes to tobacco, because it’s the easy thing.

It’s a similar story for researchers in the field of tobacco.  If you decide to take a negative stance on all tobacco products, accurate or not, you will suddenly have access to tons of funding and easy acceptance into journals (no matter how rife with junk science your study may be).   On the other hand, saying truthful things about the relative risks of different tobacco products can get you exiled from conferences, journals, and tobacco control circles.

There is a comedian (I can’t remember the name) who once indicated that politicians who changed their minds about things were seen as wishy-washy, and were looked down on by the public as people who, since they were wrong about one thing, could be wrong about another.  Of course, changing one’s mind is usually a sign of intelligence, not weakness, since nobody is right about everything all the time.  And from me in particular, you won’t hear any “I told you so’s” if policy gets changed to favour tobacco harm reduction products…  I’ll just be thrilled that the right thing is finally being done.

 

-CMNissen

FCTC: Constructing a new assault on smokeless tobacco and electronic cigarettes: Background

This a first of a series on this latest development at the FCTC.

Though I am not that conversant with the World Health Organization, they seem to do some good in the world, not unlike the FDA. And just like the FDA when they turn their gaze (via the Framework Convention on Tobacco Control) onto tobacco and nicotine, it all goes to hell.

Meeting this November in Uruguay, the FCTC will have on the agenda the new report Control and prevention of smokeless tobacco products and electronic cigarettes. As indicated in the title, the path is already determined, -control and prevention. (The authors are listed as the Convention Secretariat so it is unknown as to whether these are the usual folks repeating themselves or new ones joining in on the scorched earth tobacco policy that maintains the disease levels that they themselves love to invoke as motivating their actions).

This is not unexpected.

If you examine the guiding document of the FCTC, you will already see in place injunctions against any sort of harm reduction.

For instance on page 7:

Towards this end, each Party shall, in accordance with its capabilities:
(b) adopt and implement effective legislative, executive, administrative and/or other measures and cooperate, as appropriate, with other Parties in developing appropriate policies for preventing and reducing tobacco consumption, nicotine addiction and exposure to tobacco smoke.

If you have as your stated purpose the prevention and reduction of nicotine addiction which is characterized in the new paper as “a highly toxic and addictive substance that poses a serious risk to health” you effectively remove the possibility of reducing the health risks to continuing users. The goal of “reducing tobacco consumption” also dismisses the idea of there being safer alternatives.

This becomes even clearer on page 9 where signatories are commanded:

“do not promote a tobacco product by any means that are false, misleading, deceptive or likely to create an erroneous impression about its characteristics, health effects, hazards or emissions, including any term, descriptor, trademark, figurative or any other sign that directly or indirectly creates the false impression that a particular tobacco product is less harmful than other tobacco products.”

How can you create a false impression of something being true when in fact it is true? There is no doubt that some tobacco products are safer than others. Once again, if there is no allowance for safer products there can be no legitimate alternatives for smokers (other than quitting, and as we know, for some that just does not work).

But as much as they do not wish to aid smokers looking for safer alternatives, they do embrace harm reduction when it comes to displaced employment which might result as a result of their actions. From page 20:

“(ii) assisting, as appropriate, tobacco workers in the development of appropriate economically and legally viable alternative livelihoods in an economically viable manner; and (iii) assisting, as appropriate, tobacco growers in shifting agricultural production to alternative crops in an economically viable manner”

The FCTC thus is insensitive to the health concerns of recreational nicotine users but quite concerned about any effects on income. (Not that they are actually following through on this promise … see this news item).

Overall, this document is all top-down, orders from the gods above to the users who are discounted as having no contribution to make to the debate. The paternalistic tone is most obvious in this gem from page 2.

“[we are] Deeply concerned about the high levels of smoking and other forms of tobacco consumption by indigenous peoples,”

It is both criminal and sad that millions of dollars and institutional support go to this powerful institution who clearly are moving toward prohibition at all costs, who sacrifice public health in their quest for a tobacco free world, and do not understand that the use of nicotine is more than just mindless addiction.

-Paul L. Bergen

GlaxoSmithKline and the FDA entreaty

GlaxosmithKline, the maker of Nicorette and Nicoderm, have petitioned the FDA to remove dissolvable tobacco products on the grounds that a better action would be to enhance their own product and make it more widely accessible. They argue as well that there is a lack of efficacy of smokeless products in regards to smoking cessation and that they are marketed in such a way as to initiate and perpetuate smoking. (Article link here.)

(Let’s just remove that last phrase first since it has been discussed here before: tobacco companies are not allowed to market these products as cessation aids or to accurately describe them as safer; such claims might encourage switching. They are restricted to marketing their much safer than smoking products only as “for when you cannot smoke”. So it is disingenuous to criticize a company for using the only marketing hook left if they are not allowed to promote the rational use of these products.)

This message from this successful company (45 billion in revenue in 2009) has been widely criticized as trying to obtain competitive advantage at a time when smokeless products are at their most vulnerable. Not only is the FDA focusing on these products but the advisory panel is stacked with members who have financial interests in pharmaceutical products. As a business strategy, this makes sense.

What is less obvious is how amoral and possibly evil this action is. Though I hesitate to apply “evil” to these machinations, what else can you call an action that could result in many dying as a result not of their principles but of your own, and principles solely in the interest of profit?

We know that people smoke or do not smoke for many reasons. We know that they vary quite a bit in how difficult it is for those who wish to quit to do so, and that for different people, different methods are successful. It is all about individual differences. This means that some people will not be able to quit using pharmaceutical products which in itself means that if those are the only option, the people that could have succeeded by other means are needlessly doomed by removing those alternatives.

I understand the concerns of makers of these pharmaceutical nicotine products. With the new smokeless tobacco products, the distinctions between the two categories are becoming quite subtle. And if anybody has long term evidence of relative safety on their side, it is the tobacco products. We have decades of good data on populations using these products day in and day out for years and we do not have that for pharmaceutical products. They are likely to be as safe as smokeless tobacco if so used but we don’t have the proof of that because people have not been using them that way.

What we do have is evidence in support of is that smokeless tobacco products outperform pharmaceutical nicotine in helping people quit smoking (see Rodu and Phillips).

And this same press release has the temerity to use the old “Tobacco use, including smokeless tobacco, is the largest cause of preventable death and disease in the world. More than 400,000 Americans die every year from tobacco-related disease.” For one thing, the stale move of collapsing “including smokeless tobacco” into this figure is misleading (one could have included “eating apples and oranges” and the statement does not become false). But the key word as always is preventable. Is not this impeding one of the more successful means of avoiding disease while using nicotine not preventable?

Finally, our modern anti-tobacco culture has allowed this story to be construed only as a slightly sleazy business move but imagine if RJ Reynolds or some tobacco company had issued the same release regarding pharmaceutical products. They would actually have had the stronger case (not that any alternative should be removed) but imagine the op eds on that, the outcry from the American Heart Association and so many others.

-Paul L. Bergen

FDA and Public Health: At cross purposes

Short one today…more a pointer at a couple of posts from elsewhere.

Over at Instead titled Can We Trust The FDA To Fairly Regulate E-Cigarettes? the point is made that considering that the FDA treats snus as if it is as dangerous as smoking, we must need worry about what they will end up doing with e-cigarettes.

And then Elaine Keller has a tale to tell about the FDA’s response to her suggestion to furnish retailers with comparative risk information. As part of their open public consultation, the FDA solicited ideas which the public could vote for. Hers ended up in a limbo of “awaiting moderation” which seems to portend that they have already decided the course and that they will only post suggestions that directly contribute to that course.

These are just a couple of more stories that can be added to the original issue of whether the FDA will really serve the public interest when it comes to tobacco and smoking. For a detailed discussion of this point see Carl’s post over at E-pology: FDA is behaving normally (unfortunately)

-Paul L. Bergen

The persistence of illogical statements; three failing filters


Reading, writing and thinking about tobacco related issues has me continually circling back to wondering how so many ludicrous statements (not to mention research and policy) see the light of day, and even when exposed to the bright cruel light of reason still manage to live long and prosper.

For example, the following is taken from FDA Warns Five Electronic Cigarette Makers They’re Breaking the Law (AOL Health).

Dr. Len Horovitz, internist and pulmonary specialist at Lenox Hill Hospital in New York City, questions the effectiveness of e-cigarettes as a way to quit smoking.
“Using an e-cigarette is very much like smoking,” he told AOL Health. “The concern is that people will use this to quit smoking, but that it will simply become a substitute for the real thing. Eventually, they’ll go back to smoking because using this does not break the behavior of holding a cigarette in your hand.”

Failure #1 occurred when Dr. Horovitz formed these words and spoke them to reporter Ronnie Koenig. All things are permissible to think and ponder, and absurdity can be an aid to wisdom however in this case, looniness is just looniness. To make the point, let’s translate this into a non-tobacco passage:

“Walking somewhere is very much like driving somewhere,” he told AOL Health. “The concern is that people will do this instead, but that it will simply become a substitute for the real thing. Eventually, they’ll go back to driving because using this does not break the behavior of going from point a to point b.”

What he is saying, and this approach seems to be used quite often in regards to e-cigarettes, is that it is exactly because this option works so well as a substitute that people will then abandon it to go back to the one they know is vastly worse for them but otherwise is exactly the same.

Failure #2 occurred when reporter Ronnie Koenig incorporated this into the article without either 1. realizing it was crazy or 2. asking Horovitz if he really wanted him to print the comment (maybe this was asked, who knows). Or perhaps this failure had its genesis in journalism school. It seems that in general, with some notable exceptions, journalists, and/or editors, do not question even the most absurd of statements, and see it as one of their functions to smooth the path of all messages, meritorious or not, to an unsuspecting populace.

Failure #3 occurred everytime someone read this passage and did not find it insane. Part of this not eliciting gasps of astonishment and dismay are due to thinking that it has already passed some sort of truth standard and part of it is due to it being tobacco/smoking news. As soon as the average reader identifies it as such, the critical faculties switch off, the words are granted safe passage and the thoughts are incorporated into their world view. This is not entirely the fault of the reader; even smart and critical folks have been assaulted so often by mis and disinformation that its amazing that anyone who isn’t specifically concerned with this area will even notice anything is amiss.

-Paul L. Bergen

FDA effectively shutting down e-cigarettes


Tamping down the urge to simply rant and rage against this “regulatory wrath” I find myself somewhat at a loss regarding the legal niceties at play. I just cannot tell if the FDA is acting within or outside its jurisdiction. But even if they do have the power, this is just plain wrong.

In January 2010, on the determination of just authority, Judge Leon ordered that:

“the FDA shall not detain or refuse admission into the United States of [Smoking Everywhere’s and NJoy’s] electronic cigarette products on the ground that those products are unapproved drugs, devices, or drug-device combinations.” (quoted in Brad Rodu’s excellent discussion of the decision)

Subsequently the FDA won a stay which allowed it to ignore the injunction until their entered appeal is heard. Since then CASAA along with Smokefree Pennsylvania, The American Council on Science and Health, National Vapers Club, Midwest Vapers Group, Michael Siegel, and Joel Nitzkin submitted an Amicus Brief in support of the Leon decision.

Now the FDA has sent warning letters to five electronic cigarette manufacturers, one being Gamucci whose website has already come down (at least this afternoon as I write this). Reading these letters indicates that the FDA is treating e-cigarettes as drug delivery devices and arguing that they have not met the appropriate regulatory standards but I suspect that some of these arguments might still hold up if these products were treated as recreational tobacco products.

For instance, the FDA takes exception to any claims that this device can facilitate quitting smoking or is safer than smoking. As a tobacco product, they would definitely not be able to make those claims, even if they had plenty of supporting evidence. However, if they were in the tobacco category, and made no health claims of any kind, or of helping people quit smoking, there should be fewer barriers to them being available and thus even if not allowed to openly claim reduced harm could still as with smokeless tobacco be used by nicotine users for that purpose.

Back in 1987, a product very much like the modern e-cigarette was also turned down for being a new drug delivery device (originally noted on the NJOY site, and here is the official document). And the concerns of safety appear to be about the nicotine being addictive.

The FDA letters sent out today sound like rational responses to new unlicensed products and in a sense they are. We should not jettison quality control simply because a great opportunity presents itself. However, this particular small minded approach does not fit the big picture issue of the ongoing burden of smoking related disease (which in other respects the FDA appears to deem important), and the way e-cigarettes have already been operating in the culture as one of the easiest and most effective ways to quit smoking (without being promoted as such).

With any luck another judicial challenge will stay the execution of this product but this brought to mind my own dystopian daydream some time ago when the MHRA challenge in Britain first arose, and in memory of the Canadian ban which came slamming down so soon when this product came out. The daydream, which echoes the 1987 stop, was of years from now looking back at this time and thinking we had had one of the best answers within our grasp and it was shut down, and ironically it was shut down through a combination of simple bureaucracy and anti-smoking sentiment (the latter being most ironic of all).

Suppose now if the 1987 e-cigarette had come out in that year and been as successful as they are now. 23 years of smokers switching over. The math is beyond me but even if 20% of smokers switched there would be hundreds of thousands more alive today.

-Paul L. Bergen

FDA: Institutional culture a bad fit for dealing with tobacco

I have another post due up soon but in the meanwhile wander over to ep-ology where Carl has a thoughtful post on how the institutional culture at the FDA does not portend for the best when it comes to determining good tobacco policy.

Excerpt:

An institution that is used to being obeyed, and that does not function well in a realm where that does not happen, and that primarily measures life years saved and dollars spent and ignores most other human desires. Merge in a political movement that has been itching for more police powers and tends toward utopian (i.e., overly optimistic fascism) extremism. I am not sure whether the better metaphor is The Drug War or Afghanistan. Either way, I fear that even most of the pessimists have not predicted just where this is going to end up.

MHRA stops threat to cigarette sales in Britain

The net has been buzzing with the release of this letter from trading standards officer Helen Wales informing that the Medicine and Healthcare products Regulation Agency (MHRA) is near the completion of its consultation and expects to apply a 21 day period for regulatory compliance for e-cigarettes in Britain after which if they have not furnished the data and fees to make the cut they will be banned.

There is good reason for some sort of standards for any widely used product. This is just a very bad way of going about it.

If cigarettes did not exist and e-cigarettes were some unique nicotine delivery device then this approach would not be entirely out of sorts. It would still be unusually demanding in its short time frame for compliance but the worry would center more around commercial concerns than concerns of health.

However we have been repeatedly reminded by national authorities that too many people are dying from smoking, implying that these same authorities think this is not a good thing, and also implying that they would support actions that would bring down those mortality figures.

The MHRA supposedly works in the interest of the people. It has been estimated that 400,000 of those people are using e-cigarettes. Polls of vapers have found that 1. almost every one if not all of them are ex-smokers 2. almost all of them have tried and failed at quitting using other methods 3. most of them have been able to remain cigarette free and 4. most of them believe that were e-cigarettes removed from the market they would find themselves smoking again.

No matter how politically bent or misguided the MHRA is, they no doubt know all this. They know that these people have successfully switched away from smoking but that they might return. Even if the only study they like to cite is the one negative and misleading FDA study, that every other study has shown e-cigarettes to be vastly safer than smoking. They know all this, and they know that even the FDA study showed that e-cigarettes were much safer than smoking.

So the message comes down to that they would prefer that people smoke than use e-cigarettes. A conspiracy theorist might even think that there has been a collusion between Big Tobacco and Big Pharma to head off this threat and restore the lost customers to their previous cycle of smoking and every now and then purchasing failure prone cessation therapies. What it boils down is a resounding Let them eat cake!

This is a horrible and tragic betrayal of the public trust from an agency that rubs neck and shoulders with others who love to in every tobacco related press release or report make sure to include some stats about how many people are die or will die from smoking. It is also a story you probably won’t see in the New York Times and other media.

If the MHRA follows the track it says it will, it will not generate the horrific pictures that reports from civil wars or disasters do, but the body count will be higher; it will just take longer. (And though the MHRA might not have quite the high profile the FDA does, it could have provided an international example of a common sense response to a long existing health concern, saved thousands of lives in the bargain and encouraged others to do the same but now there is every likelihood that this de facto ban will encourage other countries’ agencies to condemn e-smokers as well).

We had a real chance of something momentous happening – a new solution that people naturally gravitated to without any governmental push and now the only government involvement is the one stopping smokers from making the healthy switch.

(Back in April at the International Harm Reduction Association conference I was asked by a friend who was working in the British e-cigarette industry if I thought they would end up being banned in that country and at the time I said though I hoped terribly that I would be wrong, I suspected given the way tobacco related issues tend to turn out, that they would end up banned. I suppose there is still the slightest chance this ban will not go through and I do hope that even now on the eleventh hour I will end up being wrong.)

Settling for less…

If you have read us for any length of time, or perused our website, you have seen that we often refer to Michael Siegel’s excellent Rest of the Story, but just to stress the point, he is always worth reading.

In his latest post, False Information from Center for Tobacco Products is Concerning; FDA Actions Should Be Guided by Science, Not Politics he argues cogently that the FDA move against flavoured cigarettes can only be understood as political since it is not evidence based. Not only have youth been found to not initiate smoking with those products but they have not been available for some time.

I have an objection to this particular targeting of flavor in tobacco on other grounds. My grounds are that it is fundamentally unethical to diminish the happiness someone will experience simply because you disapprove of what they are doing.

Let’s say that an adult smoker enjoys a flavoured tobacco product (since we are pretty sure that’s who is consuming most of them).

My favourite beer style is stout. It is similar to flavoured tobacco in the sense that it is less common (other than Guinness) and when meeting friends for a beer it is often unavailable. So do I simply say “I just won’t have anything”? No, I order another type of beer because I enjoy the effects of alcohol and even if I prefer stouts I don’t hate other beer (though there certainly are exceptions). So though I get to have my beer, my pleasure quotient is slightly diminished because the establishment did not stock stouts.

Smokers who are without their own will ask other smokers for a cigarette. It is rare that any one of them will turn down a smoke simply because it is not their preferred brand.

The framers of the anti-flavour bills probably don’t care about this but I see nothing defensible in reducing the pleasure someone has in enjoying a product that they themselves do not approve of.

It reminds me of the move to modify medical marijuana so that those who are using it to combat pain or glaucoma or nausea do not inadvertently enjoy a high along with the health benefit.

And of course the irony of it all is that removing flavoured tobacco products was all funded by monies levied on the very consumers they are being taken from.

– Paul L. Bergen