FDA concedes it will regulate e-cigarettes as tobacco products; the devil awaits

by Carl V Phillips

As those of you who read this blog presumably already know, the US FDA announced that it had decided to treat electronic cigarettes as tobacco products for regulatory purposes, which effectively legalizes them, contrary to FDA’s original plan.  Well, “decided” is not really the right word, given that a court ruling already told them they would have to do that.  This is basically good, though not really good news (even the timing was predestined – yesterday was the day by which FDA had to commit to the sensible course of not appealing the court ruling to the US Supreme Court).  But I have to say that I have not seen anything in the details or anyone else’s analysis that gives any indication of whether this is really good or not.  The devil is in the details, and we have precious few of those.

Ironically, this means that the three most newsworthy acts of the FDA’s new tobacco regulators have been to:

  • ban flavored cigarettes that really did not exist (as mandated by the enabling legislation),
  • declare certain smokeless tobacco products to not be tobacco products (apparently to delay having to deal with making some of the tougher rules required by the legislation)
  • and, now, to declare certain non-tobacco products to be tobacco products (as mandated by a court).

If you step back and do not take the whole thing to seriously, it is actually pretty funny.

FDA’s statement was widely reported (here is the AP story and see my Unhealthful News post for others) and commented on (Godshall, Rodu, CASAA, Michael Siegel).  It suggests, as Rodu also notes, that there is the possibility of sensible quality-control based regulation, which is better than no regulation at all.  Rodu also suggests that this invites pharma companies to remove medicinal labeling and market their nicotine products in the same niche as e-cigarettes (that is as regularly self-administered recreational or “lifestyle” drugs), though Godshall argues that it spells doom for their products.  An in-between version might be that licensees or spin-off companies could market versions of those products if the pharma companies are simply not able to function in the fast moving consumer goods market.

But FDA could still seriously mess with the selling of e-cigarettes if that is what they want.  I did not see any evidence this week of pro-THR thinking or a plan to be any more favorable toward e-cigarettes than is absolutely required by the court ruling.  This means, for example, that any product that is not almost exactly the same as something that was on the market before February 2007 might be required to go through new product applications which would be largely prohibitive.  This could easily include most of the current high-end and creative products, as well as most refill liquid (aka “juice”, “e-liquid”) .

Like I said, the devil is in the details, some of which we do not even have hints about yet.

It seems almost certain that FDA will cling to its nutty anti-scientific position that marketing statements that make even the obviously accurate claim that e-cigarettes are a way to not smoke, at least at the same time you are using the e-cigarette, will be prohibited.  FDA’s signals to date suggest that they would declare even that statement to be an unproven therapeutic claim that needs to be proven with randomized trials.  FDA has never been known for having the firmest possible grasp of the obvious, let alone an understanding of the inappropriateness of randomized trials in many cases.  This probably will not matter much, since manufacturers can just avoid saying anything at all about the product, leaving that to user groups, social networks, blogs, and other sources of information.

But the FDA could probably require labeling that says that the devices are not a safe alternative, have particular risks (even if there is no evidence of such risks, as with the labeling on smokeless tobacco), are not useful for quitting smoking, or other anti-THR statements.  Again, it probably would not matter much, but it might encourage smokers who pick up a disposable e-cigarette to get them through the day to keep smoking.  So far, only one anti-tobacco extremist group, Campaign for Tobacco-Free Kids, has spoken up against the FDA announcement, since their goal is to make sure that smokers keep smoking unless they become completely abstinent (as I have discussed at length, the only lever the prohibitionists have is making sure that nicotine use remains deadly).  CTFK condemned FDA for embracing reality rather than try to take the case to the Supreme Court.

Finally, it seems likely that this paves the way for unified treatment of products, which has some bad implications for e-cigarette supporters.  The piecemeal regulation by local governments of e-cigarettes, both the reasonable and the anti-THR bits, could be replaced by template-based legislation that is adopted almost everywhere, restricting e-cigarette and nicotine solution sales to the same customers, sales venues, delivery methods, etc. that are allowed for cigarettes, as well as similar taxation.  This could put a serious crimp in the current distribution network and reduce many of the advantages of e-cigarettes.  And the CTFK-types will probably get rules that favor cigarettes over e-cigarettes inserted in many jurisdictions.

Of course, such rules might be a bit difficult to enforce for anything other than packaged disposables, since the self-fillable products are just electrical devices.  Regulating “paraphernalia” is extremely difficult (witness the thriving market for legals devices to smoke the largely illegal cannabis).  The battleground then would become nicotine solutions which opens up interesting possibilities since to make this enforceable.  Probably nicotine itself — a cheap, easily available chemical — would have to be made a controlled substance, which there are no provisions for.  So far.

Some interesting things are in store.  This week’s event is largely just a reminder of that fact.

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  • GC  On April 26, 2011 at 7:56 pm

    Great post Carl. You brought up a couple possible implications that I really had not thought much about. There’s a lot of work on e-cigarettes still ahead for the tobacco harm reduction community.

  • Bill Godshall  On April 27, 2011 at 1:02 pm

    While Carl is correct that the devil is in the details, most of the details are clearly stipulated in the FSPTCA, and those details benefit tobacco harm reduction (in contrast to the spin by FDA and CTFK, much of which was repeated by the lazy news media).

    The good news includes:
    – e-cigarettes are now totally unregulated by the FDA and are likely to remain unregulated for at least the next year or two,
    – the FSPTCA states that the FDA can only approve a new tobacco regulation if they determine (based upon scientific evidence) that the new tobacco regulation is likely to reduce tobacco morbidity/mortality (and/or reduce tobacco usage),
    – the only way FDA can determine that a new regulation will benefit public health is if the agency determines (based upon scientific evidence) that the product(s) in question is/are known to pose health/safety risks, and
    – there is no evidence that e-cigarettes (nor other noncombustible nicotine products) have harmed anyone.

    It is critically important to note that unregulated tobacco products (including e-cigarettes) are not subject to any regulations in Chapter IX of the FSPTCA (e.g. warning labels, advertising restrictions, modified risk claims, substantial equivalence provisions, the Feb 15, 2007 grandfathering clause date, etc.).

  • Carl V Phillips  On April 27, 2011 at 2:23 pm

    I am not sure whether to interpret your comment as predicting that US governments will not take any action that will significantly interfere with the e-cigarette market in the near future. I would definitely be willing to place a wager that there will be some major anti-e-cig action of one of the types I suggested in my two posts (highly discouraging warning labels, sales restrictions, impossible research or purity hurdles, template for highly restrictive legislation for states, etc.) within 1.5 years.

    This does not change the fact that the news is good and the reprieve from the ban as a medicine will not allow further solidifying of the market. But when the same faction controls the science, rules on to interpret the science, dominates the mainstream media, is considered to define “public health”, etc., they can act if they want to. The courts will not intervene against everything. Perhaps there has been a change somewhere in that bloc to give up and embrace e-cigs, in which case I would lose my wager. I am still willing to make it though.

  • Marvin Schroeder  On May 23, 2011 at 10:02 am

    As the author points out, there may yet be many ways the FDA could still suppress ecigarette distribution. The next year window could be a back room deal to allow market penetration.
    Why? To make future nicotine regulation more likely. I say this because I agree with the author’s ‘paraphrenalia’ observation. Many users, like myself, don’t use nicotine in ecigarettes and I predict more and more consumers will switch to that type of usage. If I’m right, it’ll quickly become apparent that handling nicotine requires much tougher regulations than handling cigarettes now requires. That’s because raw nicotine can be Immediately Dangerous to Life & Health (IDLH).

  • AE  On July 7, 2011 at 3:57 pm

    I have attended several FDA webinars on tobacco and have specifically asked them about how they are going to classify Ecigs and they say that they are working on it. Looks like they are pretty much going to tax them. Don’t know when, but it’s coming.

  • Paul Westphalen  On July 29, 2011 at 3:58 pm

    I smoked for over 15 years, and I’ll have to admit, I loved it. But they were killing me, I could feel it. I decided to give e-cigarettes a try because nothing else worked for me to quit smoking. For more than two years I’ve been using e-cigarettes as a replacement. In fact, when I try real cigarettes I think they are terrible compaired to my e-cigarette. I agree that e-cigarettes are a substitute for real cigarettes. So technically they do help people quit smoking. So now what? Does the FDA need to regulate vaping?

  • Matthew  On October 5, 2011 at 5:43 pm

    Paul Westphalen, I compleatly agree with you e-cigarettes have changed my life. I also have been vaping for 2 years now and I must say all the benifites of replacing normal cigarette’s with my e-cig are countless (ripple effect). I would say the biggest benifit is I can actualy breathe now. I couldnt even go up a flight of stairs without geting out of breathe. It felt like I was going to die! Seriously e-cigs are the greatest invention in a long time! Going from not being able to climb a flight of stairs to now working out for an hour 4-5 times a week. I love them so much I oppened up my own store just for electronic cigarettes in Canada.


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