Food & Drug Administration v. Brown & Williamson Tobacco Corp. (03/21/2000)

By: Robin Terry, Medill News Service

Questions presented

Are tobacco products subject to regulation by the Food and Drug Administration under the Food, Drug, and Cosmetic Act as ""drugs"" and ""devices?""

Brief

In 1998, the tobacco industry agreed to pay 46 states a total of $246 billion as compensation for the costs of smoking-related illness and death, but the nations raging tobacco debate did not end there.

For years, the Food and Drug Administration claimed it did not have the authority to regulate tobacco products, but a slow reversal of this stance came to fruition on August 24, 1996, when the agency issued, ""Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.""

According to the Washington Post, the regulations would prohibit tobacco advertising within 1,000 feet of schools and playgrounds, limit advertisers to black and white ads, ban most cigarette vending machines, prevent tobacco brand names from appearing on some sports gear and require retailers to ensure that cigarette purchasers are at least 18 years old.

The same year, cigarette and tobacco manufacturers joined with convenience store retailers and advertisers in filing suit against the FDA in U.S. District Court. The businesses moved for summary judgment, claiming the FDA had overreached the authority granted to the agency by Congress.

The FDA argued, however, that tobacco does fall within its jurisdiction under the 1938 Federal Food, Drug and Cosmetic Act. The act authorizes the FDA to regulate ""drugs"" and ""devices,"" which are ""intended to affect the structure or any function of the body."" The FDA claimed that it could legally regulate tobacco as a combination product, categorizing it as both a drug and a device.

In 1997, the district court denied the tobacco companies motion for summary judgment in part and granted it in part, ruling that the FDA had jurisdiction over tobacco as a device, but that the agency had overstepped its authority in attempting to restrict tobacco advertising. The court delayed implementation of the regulations until the appeals of the case had been decided.

Both sides appealed.

On Aug. 14, 1998, the 4th Circuit Court of Appeals reversed, holding that Congress had not intended to give the FDA jurisdiction over tobacco. In a 2 to 1 decision, the court found that the FDAs definition of tobacco as a device was flawed because the agency could not prove that the impact of tobacco products on the body was""intended"" under the act.

Furthermore, the court found that the agencys regulations were contradictory and inconsistent. For example, the opinion stated that the FDA found tobacco to be ""inherently unsafe and dangerous,"" but the government agency failed to carry out the act's mandate requiring that such dangerous products be removed from the market.

""A faithful application of the statutory language would lead to a ban on tobacco products - a result not intended by Congress,"" the opinion stated.

""Based on the FDAs characterization of tobacco products as unsafe, it is impossible to create regulations which will provide a reasonable assurance of safety. Thus, the FDA cannot comply with the terms of the very statutory provision it has chosen as its basis for regulation,"" the opinion said.

The FDA appealed the case to the U.S. Supreme Court. According to the New York Times, 39 states filed a brief to encourage the justices to take the case. The Supreme Court granted certiorari on April 26, 1999.

On March 21, 2000, the Court, divided along ideological lines held 5-4 that Congress had not given the FDA the authority to regulate tobacco products as customarily marketed.

""By no means do we question the seriousness of the problem that the FDA has sought to address,"" Justice Sandra Day O'Connor wrote for the majority. ""Theagency has amply demonstrated that tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States.""

Nonetheless, O' Connor wrote, ""Congress, for better or for worse, has created a distinct regulatory scheme for tobacco products, squarely rejectedproposals to give the FDA jurisdiction over tobacco, and repeatedly acted to preclude any agency from exercising significant policymaking authority in the area."" She noted that since 1965, Congress had enacted six distinct statutes addressing tobacco use and public health, including those requiring warnings on cigarette packs and prohibiting broadcast advertising.

Chief Justice William Rehnquist and Justices Antonin Scalia, Anthony Kennedy and Clarence Thomas joined the majority opinion.

In announcing the Court's opinion, Justice Stephen Breyer read aloud from portions of his dissent, in which Justices John Paul Stevens, David Souter and Ruth Bader Ginsburg joined.

He criticized the majority for reaching a ""perverse result"" in which the Court should have interpreted the laws ""in light of Congress' overall desire to protect health"" and deferred to the FDA's interpretation of its own governing statute.

""The upshot is that the court today holds that a regulatory statute aimed at unsafe drugs and devices does not authorize regulation of a drug (nicotine) and a device (a cigarette0 that the court itself finds unsafe,"" Breyer wrote in dissent. ""Far more than most, this particular drug and device risks the life-threatening harms that administrative regulation seeks to rectify. The majority's conclusion is counter-intuitive.""