A while ago we posted about the FDA’s attempt to ban electronic cigarettes – essentially a way for smokers to get whatever they get from nicotine by flash vaporizing the stuff. Because there’s no smoke, these products were a way, after a fashion of “smoking everywhere” – hence the name.
As we mentioned in that post, the FDA’s nanny-state objectives were pretty well hosed in Smoking Everywhere, Inc. v. FDA, 680 F.Supp.2d 62 (D.D.C. 2010).
As a follow-up, we’re pleased to report that the opinion preventing the FDA from banning electronic cigarettes – basically because they don’t like them – has been affirmed. See Sottera, Inc. v. FDA, 2010 WL 4942132, (D.C. Cir. Dec. 7, 2010) – for the FDA, a date that will live in infamy.
These electronic cigarettes affected the FDA in a way resembling Pavlov’s dogs. The Agency hears “nicotine” and immediately starts salivating … “addiction.” That’s bad, so let’s ban it.
The FDA tried to carry out its ban by calling nicotine a “drug,” and/or an electronic cigarette a “medical device” – a means of dispensing nicotine. Sorry Charlie, this “product is marketed and labeled for ‘smoking pleasure,’ rather than as a therapeutic or smoking cessation product.” 2010 WL 4942132, at *1. That makes it tough to shoehorn electronic cigarettes into the category of “drug” or “medical device” – both of which have health claims as a prerequisite. See 21 U.S.C. §321(g)(1)(B) (drugs); 21 U.S.C. § 321(h)(2) (devices).
The FDA isn’t allowed to regulate pure hedonism. We think that’s a really good idea.
Now, it’s possible for the FDA to regulate tobacco products under a separate statute, the Tobacco Act, even where no health benefit is claimed. 2010 WL 4942132, at *3. But the FDA didn’t purport to do that, and the Act specifically doesn’t expand any other FDA authority – such as over “drugs” or “devices.” Id.
Not only that, under the Tobacco Act, the FDA would have to go through procedures (which it hadn’t done). The Act doesn’t let the FDA ban tobacco products willy-nilly. Further, the Tobacco Act has a preemption provision that may well prevents states from doing that, too. 21 U.S.C. §387p(A)(2) (states can’t “prohibit”). So there are reasons why the FDA didn’t use this avenue.
Having used drug/device regulation the FDA was stuck under FDA v. Brown & Williamson, 529 U.S. 120 (2000), where it had previously tried to exercise drug/device authority over tobacco and gotten hammered by the Supreme Court.
Turns out Brown & Williamson is the gift that keeps on giving. The FDA got hammered again:
Brown & Williamson therefore did not preclude the FDA from regulating only those products for which Congress had passed specific statutes. Rather, it recognized that Congress had consciously developed a statutory scheme for tobacco and health that distinguished tobacco products as customarily marketed from ones marketed for therapeutic purposes. “Thus, what Congress ratified was the FDA’s plain and resolute position that the FDCA gives the agency no authority to regulate tobacco products as customarily marketed.”
2010 WL 4942132, at *5 (quoting B&W)
Losing that argument, the FDA tried a “consequentialist” approach. It complained that reading Brown & Williamson as a flat restriction on FDA authority over tobacco products “leaves the FDA severely thwarted in any effort to nudge e-cigarettes toward relatively healthful forms.” 2010 WL 4942132, at *6. The court was rightly skeptical of letting let the FDA get away with ultra vires activity through this sort of ritual incantation of the “public health.” “Whether such a consequentialist argument should play any role in our interpretation of Brown & Williamson is questionable.” Id. The court left the implication at that, because, “no matter” – Congress had provided what it thought was the appropriate fix in the Tobacco Act, so the FDA – a creature of Congress – had no reason to complain. Id.
In sum: (1) the FDA had no power to regulate non-therapeutic tobacco products as drugs/devices (what it had done); (2) if a tobacco product made a therapeutic claim it could be regulated as a drug/device, and (3) the FDA could regulate non-therapeutic tobacco products under the Tobacco Act (what it hadn’t done). 2010 WL 4942132, at *6.
The FDA didn’t dispute that there were no therapeutic claims, so the electronic cigarette manufacturer was likely to win on the merits. Id.
Finally, since being put out of business altogether by the FDA’s essentially lawless act was a serious harm, the balance of harms also favored the manufacturer. Id. at *7.
Smoke ’em if ya got ’em. You should be able to get some more. Bottom line – the FDA doesn’t have unlimited discretion to ban stuff just because they don’t like it. It has to fit within one of the statutory definitions. Congress can ban whatever it wants. The FDA can’t.