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