Federal Judge Rebukes FDA for Seizing E-Cigarettes


Yesterday a federal judge granted a preliminary injunction to electronic cigarette manufacturers who are fighting the Food and Drug Administration's seizure of their products as "an unapproved drug-device combination." U.S. District Judge Richard Leon concluded that the two companies, NJOY and Smoking Everywhere, have a substantial likelihood of prevailing against the FDA's claim that it has authority over e-cigarettes under the Food, Drug, and Cosmetic Act (FDCA). Leon suggested that e-cigarettes, battery-powered devices that deliver nicotine vapor, instead are covered by the Family Smoking Prevention and Tobacco Control Act, the 2008 law that authorized the FDA to regulate conventional cigarettes and other tobacco products. The act defines a tobacco product as "any product made or derived from tobacco that is intended for human consumption." Since the nicotine in e-cigarettes is derived from tobacco, this broad definition certainly seems to fit. More to the point, e-cigarettes are marketed as a smoke-free alternative to cigarettes, not as a medicine or even as a smoking cessation tool.

The FDA argued that e-cigarettes qualify as drug delivery devices under the FDCA because they are intended to affect the structure or function of the human body. Leon noted that the agency had used the same argument when it unsuccessfully tried to assert authority over conventional cigarettes under the FDCA, a gambit that was shot down by the Supreme Court:

This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA. Ironically, notwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred. Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable.

Leon also was not impressed by the FDA's argument that the public health benefit from blocking importation of e-cigarettes outweighs the costs imposed on the industry:

While FDA's interest in protecting public health and safety is, in the abstract, paramount to plaintiffs' purely economic interests, given the particular facts and circumstances of this case, I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public.

In fact, as I've noted before, there is no question that puffing on a smoke-free e-cigarette is much less hazardous than lighting tobacco (or anything else) on fire and sucking the combustion products into your lungs. This is a point so obvious that only the FDA and a certain brand of zero-tolerance anti-tobacco activist would try to deny it. Assuming that e-cigarettes do end up being regulating under the Family Smoking Prevention and Tobacco Control Act, Michael Siegel argues, the law allows them to remain on the market as a pre-existing tobacco product, provided their manufacturers stop talking about (or implying) their safety advantages. Under one of the law's many destructive, consumer-hostile provisions, that sort of comparison would render e-cigarettes a "modified risk tobacco product," meaning they could not be sold until their manufacturers had met a prohibitive burden of proof.

Leon's ruling is here (PDF). Previous coverage of e-cigarettes here.