The Supreme Court rules that the FDA has no authority to regulate tobacco - FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (U.S.2000)

No product is more closely intertwined with the history of the United States than tobacco. From early colonial days, tobacco was a major export. In some colonies, tobacco was legal tender and the colonies paid their own debts in tobacco, at governmentally recognized rates denominated in pounds and barrels and hogsheads. During the revolutionary period, tobacco was valued more highly than continental money - Wharton v. Morris 1 U.S. 125, 1 Dall. 125, 1 L.Ed. 65 (Mem) Pa. Apr Term 1785. During this long history, the federal government's regulation of the health effects of tobacco have only been before the United States Supreme Court in one previous case, Cipollone v Liggett Group, Inc. 505 U.S. 504 (US 1992), which dealt with whether Congressional regulation of tobacco advertising and promotion preempted state tort claims against cigarette manufacturers.

FDA v. Brown & Williamson arose from the FDA's assertion of authority over the production and sale of cigarettes. This was based on finding that nicotine was a drug and that cigarettes were thus a drug delivery system. The FDA proposed to regulate cigarettes as a hybrid involving both a drug and a medical device. The FDA proposed rules through notice and comment rulemaking and when these rules were finalized, Brown & Williamson moved to have them enjoined because they exceeded the FDA's statutory authority. The District Court found most of the rules valid, but held that some exceeded the FDA's authority. The 4th Circuit reversed, finding that the FDA had no authority to regulate tobacco. The United States Supreme Court accepted cert., and announced its ruling in this case.

The question before the court was simple: does the Food Drug and Cosmetics Act (FDCA), as amended, give the FDA the legal authority to regulate tobacco? The court reviewed using classic administrative law precedents, beginning with the two-step analysis from Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 (1984). The first step of Chevron is to determine whether the plain language of the statute allows the agency's action. If that statute is silent on the matter at issue, then the second step is to determine if the agency's assertion of authority is permissible under the statute, considering the plain language of the statute, possible conflicting statutes, and relevant constitutional limitations.

Ironically, the majority opinion and the dissent agreed on the basic issue that tobacco is an extremely dangerous product that should be regulated: "This case involves one of the most troubling public health problems facing our Nation today: the thousands of premature deaths that occur each year because of tobacco use." The importance of tobacco regulation drove the majority to conclude that if Congress intended for the FDA to regulate tobacco, it should say so. In contrast, the dissent believed that tobacco regulation is so important that the FDA should have the right to regulate tobacco unless Congress forbids it that right. Jurisprudentially, the case is interesting because the judges reverse their usual roles. Scalia, who usually demands that the court look only to the words of the statute, signs on without separate comment to a majority opinion steeped in legislative history. Breyer, who usually cares more about what Congress thought about than what it wrote, dissents because the court ignores the plain meaning of the statute and delves into the morass of congressional intent.

Both the majority and the dissent concede that congress has been silent as regards the FDA's authority to regulate tobacco. The only mention of the FDA by congress in regard to tobacco was a statement that a particular labeling regulation did not affect the FDA's authority over tobacco, whatever it might be. At the same time, both the majority and dissent agree that the plain language of the FDCA seems to give the FDA the authority to regulate nicotine, and, through that, cigarettes. The problem with this plain reading is that for nearly 50 years the FDA denied that the FDCA gave it authority over tobacco. While agencies may change their minds as politics change, such a shift undermines their claim for deference because of their expertise in the subject. The majority focuses on history of tobacco regulation by Congress and finds that Congress has passed tobacco regulations six times since 1965. During this period Congresses accepted the FDA's assurance that it had not jurisdiction over tobacco and in none of these laws did it give any power to the FDA to regulate tobacco. Since tobacco regulation is such an important issue, this failure to give authority to the FDA in previous tobacco regulatory law convinces that majority that Congress could not have intended such an important task to fall the FDA through inadvertence.

The majority also looks at the logic of the FDCA and what it would mean to regulate tobacco under it. The FDCA gives the FDA the power to assure that drugs and medical devices in interstate commerce are safe and effective. The Act clearly deals with therapeutically valid drugs and devices and seems to leave no room for the sale of substances such as tobacco that have no therapeutic value. (Ignoring the very limited therapeutic role for nicotine itself.) The dissent disagrees, reading into the FDCA a cost benefit analysis based on allowing bad substances because not having them will be worse. Under this analysis, the FDA would not ban tobacco because of the potential risks of smuggling and other tobacco- related illegal activity. The dissent does not discuss that this particular theory has been completely rejected in American drug policy, with its focus on prohibition except for very strictly controlled medical use. Short of methadone clinics, there is no useful analogy for the dissent to draw on.

The core of the majority's reasoning is that Congress is aware of the need to regulate tobacco as evidenced in the other tobacco regulations it has passed and that tobacco regulation is very complex and not well-suited to the provisions of the FDCA. The majority opinion is a call to Congress to step in and pass a law clearly stating its views on further regulation of tobacco. The dissent would prefer to allow the FDA to proceed, thus forcing Congress to act if it disapproves of the FDA position. Given that this case is a close call, both of these views are supportable under traditional administrative law jurisprudence. The court's choice is a political one, and it implicitly recognizes this by pushing the decision back to Congress. Since the court found that the FDA had no authority over tobacco, all of the FDA regulations affecting tobacco are now voided. The FDA's retains it's authority to regulated nicotine, which does have some therapeutic uses beyond its use as an anti-smoking agent, but it cannot use this authority to regulate tobacco products. It is not clear what role the FDA has as regard to "smokeless" cigarettes, which are very clearly a nicotine delivery device and do not involve the a traditional use for tobacco. This opinion does not affect state level regulation of tobacco, to the extent that it does not conflict with other state laws, nor does it affect the FTC and other agencies that do have statutory authority over tobacco.