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

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Comments

  • Kate  On September 9, 2010 at 3:54 pm

    From reading this it appears to me that this particular company was making medical claims and more or less invited the FDA to regulate them as medical products:

    With the amount of quit smoking hype from traders I’m surprised the FDA is only insisting on truthful advertising from so few.

    Unfortunately it’s the irresponsible traders who will set the precedent and it’s hard to see how consumer protection laws can find anything other than unproven medical claims. If the products had been properly and proportionately regulated from introduction the runaway scams and dodgy advertising wouldn’t have carried on so long. Maybe the consumer product regulators let that happen deliberately so the FDA would have to step in.

    All this over a commodity that is similar to caffeine – outrageous claims and oppressive regulation. Sad.

    • Paul  On September 10, 2010 at 10:35 am

      I must admit, and I felt the post had already been rather long, that some of the FDA objections were common sense. You do need the quality control and some of these were pushing the envelope in ways that were both intriguing (why not use ecig technology to deliver drugs of other kinds) and of concern (is the drug safe under those conditions). Its partly that we know the governing mindset and where it is trying to go even if they say they are not banning I feel they may be trying to do exactly that.

      And the horrible thing is that, and I realize this is a rather unscientific thing to say, is that we all know that this is an incredibly effective means to quit smoking and the way this is going, the one thing that could save so many lives (or even just make those lives more pleasurable) and reduce the worries of 2nd hand smoke for others, is the one thing they will not be able to use to promote the product. I notice too that even though there is a lot of grassroots communication going on, its still pretty common for smokers to not know anything about these alternatives. And we’ve already seen that happen with too many other alternatives.

      • Kate  On September 10, 2010 at 10:52 am

        It’s pretty clear that the FDA have been suppressing smokeless cigarettes since at least 1987 by over regulating and making them unprofitable.

        They claim that cessation is a medical phenomena and nothing can be sold for that purpose without medical licensing. I don’t agree with that position, I think it’s rent seeking for pharm companies and not doing the public any favours.

        … But that’s the definition we have and it’s not going to be easy to over turn – even in the interest of public health. Traders really need to abide with that position and sell in a way that complies, or they need to make a proper legal challenge. Just making claims anyway is not doing anybody any favours and will definitely give regulators a lever to medicalise nicotine completely.

  • Kate  On September 9, 2010 at 4:15 pm

    Sorry for the double post. All the FDA letters sent today are here – http://www.scribd.com/document_collections/2615272

    I’ve read two and both seem to be based on advertising claims.

  • Elaine Keller  On September 11, 2010 at 4:53 pm

    I sincerely wish someone could pin down an FDA official and ask: “Would you approve a smoking cessation treatment that worked by providing the user with all the nicotine they wanted, for as long as they wanted?”

    I’m betting that the answer would be an emphatic “No”. And if you asked “Why not?” you would be told that such a treatment doesn’t cure the underlying nicotine addiction. And this is where a huge communication problem lies.

    The FDA has mislabeled their group of treatments. The patch, gum, etc., are not “smoking cessation” products, because “smoking” is not a disease. The disease the FDA wants to treat is actually nicotine addiction; therefore their group of products would more accurately be called “nicotine cessation” products.

    If Coca-Cola advertised that switching to their Original Coke could help people stop drinking Latte Grandes, would that be a health claim? Of course not. But what if “caffeine addiction” were an official diagnosis? Then would it be a health claim? Again, no, because switching to Coke would be just changing the delivery vehicle for the caffeine.

    So why, pray tell, is it considered a health claim to truthfully observe that many of one’s customers have managed to easily stop smoking by using one’s product?

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