Wednesday, February 03, 2010

Smoke 'Em If You Got 'Em (The FDA May Try To Take Them Away)

What does a smokeless “electronic cigarette” have to do with drugs and medical devices?  Well, according to the FDA, an electronic cigarette is a "drug-device combination."  Lately, however, it seems that the Agency’s position has become a strategic misstep. It gave rise to this a recent opinion by Judge Richard Leon, Smoking Everywhere, Inc. v. FDA, ___ F.Supp.2d ___, 2010 WL 129667 (D.D.C. Jan. 14, 2010).  Although the effect of the opinion was recently stayed pending appeal, we think it could prove useful in off-label cases down the road – you know, off-label cases involving real drugs and devices.

The Smoking Everywhere case involved two electronic cigarette manufacturers who sought to enjoin the FDA from regulating electronic cigarettes as drug-device combinations and denying entry of those products into the US (the functional effect of removing them from the market). First of all, what the heck is an “electronic cigarette”? As far as we can tell, it’s little machine designed to look like a cigarette that vaporises nicotine extracted tobacco and delivers it by mouth to the user. There’s no smoke, so it can be used in increasingly prevalent “no smoking” areas – hence the name “Smoking Everywhere.”  2010 WL 129667, at *1.  It’s a frankly recreational product, offering to smokers the “pleasures” they associate with cigarettes when they can’t (or don't want to) light up.  Id.

The FDA decided to consider that a “drug/device combination,” rather than a “tobacco” product. The court said “unh-unh,” granted the preliminary injunction, and concluded:

[T]he plaintiffs are substantially likely to succeed on their claim that FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA.
2010 WL 129667, at *10.

There’s a lot of discussion in Smoking Everywhere about the 2009 Tobacco Act and the extent to which the FDA may regulate “tobacco products.”  We're staying away from that.  First, it's all very interesting but not really the focus of this blog.  Second, we've got tobacco industry clients.

What caught our eye about the opinion was the discussion about whether the manufacturers were making “therapeutic” claims about their electronic cigarettes.  The argument the court rejected was classic FDA-speak:  We have already concluded that electronic cigarettes appear to be “intended…to prevent, mitigate, or treat the withdrawal symptoms of nicotine addiction.” Id. at *8. Therefore, electronic cigarettes aren’t “tobacco products” but are instead drug-device combinations that are being marketed for unapproved uses in violation of the FDCA. And don’t you dare second-guess us, because we’re the FDA and our opinions are entitled to “Chevron deference.” That last bit is FDA jargon for the deference accorded to certain administrative agency decisions by Chevron USA, Inc. v. Natural Resources Defense Council, Inc., 467 US 837 (1984). If you’re interested in that, we’ve ventured into that a number of times, including here.  Also, if you’re interested in that – get a life.

Not so fast, said Judge Leon. “Intended use” doesn’t turn on FDA diktat – rather, “[t]he ‘intended use’ of a product is determined by ‘the objective intent of the persons legally responsible’ for labeling the product.” 2010 WL 129667, at *8 (quoting 21 C.F.R. §201.128). Oops. The court took the FDA to task for advancing a position that was “unsupported by substantial evidence,” id., where the best the FDA could do (other than relying on its own prior conclusion that electronic cigarettes are intended to prevent nicotine withdrawal) was point to a couple of advertisements suggesting electronic cigarettes as “an alternative – albeit a healthier alternative – to traditional cigarettes.” Id. at *9. Ouch.

“Objective” intent in the context of off-label promotion claims is of significant interest to us.

So what should court look to as evidence of “objective intent” when determining the intended use of a drug or device?
  • “‘Labeling claims, advertising matter, or oral or written statements’ by the labeler;” id. at *8; or
  • “‘by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.’” Id.

What’s not on that list? FDA conclusions about the “intended use” of the product. Of course, even these indicia of “objective intent” are subject to criticism because of their vagueness, as Allergan is pointing out in their case against the FDA (previous discussions here, here, here (way at the end), and here). But at a minimum, the FDA’s own conclusions shouldn’t be considered probative, let alone conclusive, of the “intended use” of a product.


This is an important point, particularly with the FDA unleashing its minions to issue enforcement letters without legal oversight, as we discussed in considerable detail in a recent WLF Legal Backgrounder.  So FDA letters need to be analyzed appropriately if they depend on "intended use" - it's the manufacturer's "objective" actions, not some bureaucrat's subjective reaction, that matters.  The Smoking Everywhere opinion will be of use to anyone who seeks to challenge FDA enforcement efforts based solely on the FDA's own views of a product's intended use.



3d animation courses said...

But plain ol' cancer sticks, a.k.a. coffin nails, you know, the ones that have killed all those people over the years, will still be perfectly legal.

There's no way they're giving up all that tobacco tax money, public health be damned. But they'll happily screw with the small minority who enjoy the occasional clove or bidi so they can pretend to be upstanding and moral.

Electric Monkey said...

The -cigs have done a lot of good and should not be regulated by the FDA. They may not be harmless, but they are definitely a better alternative to smoking then the tobacco cig.

electronic cigarette said...

The FDA's assertion that the intent of the electronic cigarette is to help users quit smoking is simply not a legal argument. Drug addiction (nicotine) is the disease, not smoking. I read this blog post: Why The Electronic Cigarette Is NOT a New Drug and found it interesting that even the CDC does not consider smoking a disease.

Shilpa said...

that would be avoid the many suffer from smoke. thanks for given the post

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Chiropractic Marketing said...

Drug Addiction is now a global problem. This social cancer has spread its poisonous claw all over the world. Frustration is the cause of this Addiction unemployment problem, political cataclysm, lack of family ties, lack of love affection etc gives rise to frustration. Again this addiction gives rise to social crimes. When the addicted can’t afford to buy drugs, they commit many kinds of social crimes. Like hijacking, looting, plundering, killing, robbery etc. Drugs bear a terrible effect on human body. They kill them slowly but surely. No physician can stop the changes that take place in the body of a drug addict. Drug addicted people feel drowsy, lose appetite and sleep. The skins of their bodies began change it’s color. Drugs also damage the brain and all internal function of the body.
However this curse shouldn’t be allowed to go on unchecked. At any cost we must get rid of this social cancer by highlighting its dangerous effects on human body and society. The remedy for drug addiction is not very easy. Greed of drug traders has grasped the whole world. Drug business should must be is punishable and the highest punishment is death sentence in any Country. This law must be enforced immediately. Our young generation must be aware of the dire consequence of drug abuse. Parents must be careful of their treatment to children. Feelings of security under loving parents may hinder children from being victims of drugs. Religious and social values must be taught from early childhood. When each and every person is sincere to drive this curse of drug addiction from the society, human beings can get rid of it.

Electronic Cigarette said...

The FDA is refusing to listen to the AAPHP, shame on them

E. Cigs said...

FDA's assertion that the intent of the electronic cigarette is to help users quit smoking is simply not a legal argument.There's no way they're giving up all that tobacco tax money, public health be damned.

electronic cigarette said...

The FDA is Socialism, Why not go after the real deadly product called a traditional cigarette which is responsible for millions of lives annually! An electronic cigarette is a simply a harmless device which happens to contain nicotine which can be addictive, But Overall it is a million times safer than conventional burning cigarettes!!! So let's all stand as one & make our resolution count, & not wait for the FDA to make it's corrupt decisions for us! electronic cigarette vaping is for the Future...

cell phone locator said...

this could be the result of a strong lobby from tobacco companies i guess they are threatened with this new technology.

respiratory therapist job illinois said...

if i were you, you should think twice before doing it. FDA has said e-cig contains harmful chemicals so think twice before using your e-cig

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