Abstract
In FDA v. Brown & Williamson Tobacco Corp., the Supreme Court considered whether Congress had granted the FDA authority to regulate tobacco and tobacco products. The Court held, in a 5-4 decision, that Congress had not granted such authority. Writing in dissent, Justice Breyer primarily relied on the text of the Food, Drug, and Cosmetic Act (FDCA). The FDCA granted authority to the FDA to regulate “drugs” and “devices.” Nicotine is a drug; a cigarette is a device to deliver nicotine. Justice Breyer wrote: “In short, I believe that the most important indicia of statutory meaning—language and purpose—along with the FDCA’s legislative history . . . are sufficient to establish that the FDA has authority to regulate tobacco.”
In an opinion written by Justice O’Connor and joined by, among others, Justices Scalia and Thomas, the majority looked beyond the statutory language “in isolation” and held that, after examining the FDCA as a whole, the FDA’s own statements on the limits of its jurisdiction, and 35 years of tobacco-specific legislation (as well as legislative history and bills proposed but not adopted), “it is clear that Congress intended to exclude tobacco products from the FDA’s jurisdiction.” In short, notwithstanding that nicotine is a drug and a cigarette is a drug delivery device (at least in the normal sense of those words), that’s not what Congress meant.