[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.
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.
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.