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.