Court Rules FDA Cannot Regulate Tobacco

WASHINGTON -- The U.S. Supreme Court on Tuesday dealt a sharp blow to efforts by the administration of President Bill Clinton to curb smoking, ruling 5-4 that the Food and Drug Administration had never received authority from Congress to regulate tobacco products.

The decision, rejecting rules that the FDA proposed in 1995 to restrict the marketing of cigarettes to minors, hands the question of national tobacco regulation back to Congress. An effort to confer jurisdiction on the FDA won some bipartisan support in Congress in 1998 but became mired in a broader debate over whether to give the cigarette industry immunity from damage suits.

Tuesday's ruling was notable for the strong language that both the majority and the dissenting opinions used in describing the dangers of smoking, which causes some 400,000 deaths a year in the United States. Although essentially a straightforward ruling on a question of administrative law, the decision paid more than usual attention to the underlying policy issues, as if in recognition that the debate will continue elsewhere.

Justice Sandra Day O'Connor, who said in her majority opinion that the FDA had "amply demonstrated" that tobacco use was "perhaps the single most significant threat to public health in the United States," sounded at times almost apologetic for her conclusion that the Food, Drug and Cosmetic Act, which the agency used to assert jurisdiction, could not be stretched far enough to accommodate the regulations.

Justice Stephen Breyer said given nicotine's highly addictive nature and the "life-threatening harms" of smoking, the FDA's authority should be interpreted in light of "its basic purpose - the overall protection of public health." He said the court should avoid an "overly rigid" interpretation of the Food, Drug and Cosmetic Act "that is divorced from the statute's overall health-protecting purposes."

Dr. David Kessler, the former FDA commissioner who led the agency in reversing its long-held position that it could not regulate tobacco, said Tuesday that the loss in court had "in some ways moved the issue forward" through the justices' recognition of the dimensions of the problem as a public-health issue. "We're in a very different place than we were five years ago," said Kessler, now the dean of Yale Medical School.

The court majority Tuesday applied a settled principle of administrative law: If Congress has spoken clearly on a question of an agency's jurisdiction, or lack of jurisdiction, Congress has the last word. "The FDA's claim to jurisdiction contravenes the clear intent of Congress," O'Connor said. The dispute between the majority and dissent was over the clarity of Congress' intent, which the dissent found to be much less evident.

The decision upheld a 1998 ruling by the 4th Circuit U.S. Court of Appeals, in Richmond, Virginia. Four cigarette manufacturers - Brown & Williamson Tobacco Corp., Philip Morris Inc., Lorillard Tobacco Co. and U.S. Tobacco Co. - along with the National Association of Convenience Stores had gone to federal court to challenge the regulations as soon as the FDA formally issued them in 1996. A 1997 ruling by Judge William Osteen Sr. of U.S. District Court in Greensboro, North Carolina, upheld the agency's jurisdiction over controlling children's access to cigarettes, but struck down the regulations' restrictions on advertising and promotion.

Under the authority of the district court's decision, the FDA has since 1997 been spending about $34 million a year on contracts with the 50 states to help monitor compliance with state laws barring the sale of cigarettes to those under 18. The FDA began to send letters to the states announcing an "orderly shutdown" of the compliance program in light of the Supreme Court ruling.