The Supreme Court, rejecting the Clinton administration's unprecedented effort to control how cigarettes are sold and marketed, ruled yesterday that the Food and Drug Administration lacks the power to regulate tobacco.
The ruling, 5 to 4 along ideological lines, raised the stakes in the politically charged debate over tobacco, especially on the issue of smoking by young people, and renewed calls for Congress to control a product that is considered the primary cause of preventable disease and death. The decision was a victory for the once invincible industry, which has been besieged by lawsuits in recent years and which agreed to pay $246 billion to states to compensate them for the costs of treating smoking-related illnesses.
Writing for the majority, Justice Sandra Day O'Connor said federal law and the FDA's history preclude the agency from taking control over tobacco. But in the opinion, as well as in emphatic remarks from the bench, she recognized the public health issue.
"By no means do we question the seriousness of the problem that the FDA has sought to address," O'Connor wrote. "The agency 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."
Within hours of the ruling, which culminates a four-year court battle over the rules aimed at youth smoking, Democrats announced plans to introduce legislation for broader FDA authority, and Vice President Gore challenged Texas Gov. George W. Bush and the Republican-led Congress to "show their independence from Big Tobacco." Senate Majority Leader Trent Lott (R-Miss.) said he opposes enlarging the FDA's jurisdiction.
Comprehensive tobacco legislation collapsed in Congress in 1998, and further efforts were effectively on hold while the court case was pending. Former FDA commissioner David A. Kessler, who had signed the proposed rules at issue in the case, said yesterday that "Congress has a moral responsibility to act." President Clinton also called on lawmakers "to protect our children," noting that more than 400,000 Americans die of tobacco-related diseases each year and that an estimated 80 percent of them began smoking as children.
Tobacco executives praised the ruling for reining in the FDA, but some conceded there may be a role for FDA regulation if carefully dictated by Congress. The industry has lost numerous personal injury lawsuits in recent years and will soon face a verdict in a Miami class-action suit that could financially cripple cigarette companies.
The high court said that Congress, through existing laws, had effectively prevented the FDA from regulating the nicotine in cigarettes as a drug. The court invalidated the FDA's 1996 initiative to restrict the marketing and sale of tobacco products to youths, which flowed from the agency's determination that nicotine is a drug and that cigarettes and smokeless tobacco are "drug-delivery devices."
"Congress, for better or for worse, has created a distinct regulatory scheme for tobacco products, squarely rejected proposals to give the FDA jurisdiction over tobacco, and repeatedly acted to preclude any agency from exercising significant policymaking authority in the area," O'Connor wrote. She observed that since 1965, Congress had passed six laws addressing tobacco use and public health, including those requiring warnings on cigarette packs.
O'Connor was joined by the court's more conservative jurists: Chief Justice William H. Rehnquist and Justices Antonin Scalia, Anthony M. Kennedy and Clarence Thomas.
In a dramatic moment yesterday, Justice Stephen G. Breyer read from the bench portions of his opinion for the dissent. He referred to the "perverse result" of the majority's views. He said it should have interpreted the relevant statutes "in light of Congress' overall desire to protect health" and deferred to the FDA's interpretation of its governing statute. Signing onto his opinion were Justices John Paul Stevens, David H. Souter and Ruth Bader Ginsburg.
The FDA's anti-smoking initiative would have required retailers to check the identification of cigarette and smokeless-tobacco buyers under age 27 and prohibited cigarette vending machines except in bars and other adults-only places. But the rules were more important as the first test of FDA authority to control the powerful tobacco industry.
In the first round, a federal trial judge sided with the government. But the 4th U.S. Circuit Court of Appeals reversed that ruling, declaring that the relevant law and FDA practice before 1996 lead to the conclusion that the agency lacks jurisdiction over tobacco products as drugs.
In affirming that decision yesterday, the Supreme Court noted that the purpose of the 1938 Food, Drug and Cosmetic Act, under which the FDA operates, is to ensure that any product regulated by the FDA is "safe" and "effective"--characteristics that cannot describe cigarettes.
The FDA has acknowledged the extraordinary health risks of tobacco, but it argued that because an outright ban on cigarettes would leave too many smokers with dangerous withdrawal symptoms, it was taking a less dangerous approach in trying to regulate and reduce cigarette use. To that, O'Connor wrote, "Although the FDA has concluded that a ban would be 'dangerous,' it has not concluded that tobacco products are 'safe' as that term is used throughout the Act."
The case raised a recurring question about how much discretion agencies have to interpret their power under federal statute, and the Justice Department had urged the court to give the FDA considerable deference. But O'Connor wrote, "This is hardly an ordinary case. Contrary to its representations to Congress since 1914, the FDA has now asserted jurisdiction to regulate an industry constituting a significant portion of the American economy."
For decades the FDA resisted pressure from public health groups to regulate cigarettes, saying it lacked the authority. When it changed course in 1996, it said it was because of new studies showing how nicotine affected the body.
Dissenting justices in Food and Drug Administration v. Brown & Williamson Tobacco Corp. were sympathetic to that position, pointing out that only in recent years did the agency obtain "solid, documentary evidence" about cigarettes' habit-forming effects and how manufacturers wanted their products to chemically affect a smoker.
Wrote Breyer, "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 cigarette] that the court itself finds unsafe. 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."
Staff writer Marc Kaufman contributed to this report.
Big Tobacco on Trial
August 1996: Food and Drug Administration formally asserts authority to regulate nicotine in cigarettes as a drug and proposes restrictions on the sale, marketing and advertising of tobacco products to young people.
April 1997: U.S. District Judge William L. Osteen Sr. upholds FDA power to regulate sale and marketing of tobacco but invalidates advertising restrictions.
June 1998: Comprehensive tobacco legislation collapses in Congress.
August 1998: U.S. Court of Appeals for the 4th Circuit rules the FDA lacks authority over tobacco.
November 1998: 46 states and major cigarette companies reach a $206 billion settlement over the costs of treating smoking-related illnesses. Four other states had earlier settled for about $40 billion.
Yesterday: The Supreme Court rules that the FDA lacks authority to regulate tobacco.