Intended for healthcare professionals


Supreme Court rules that FDA cannot regulate tobacco industry

BMJ 2000; 320 doi: (Published 01 April 2000) Cite this as: BMJ 2000;320:894
  1. Scott Gottlieb
  1. New York

    The United States Supreme Court, rejecting the Clinton administration's unprecedented effort to control how cigarettes are sold and marketed in the United States, has ruled that the Food and Drug Administration (FDA) lacks the power to regulate tobacco.

    In the 5 to 4 ruling, the judges said that the FDA overreached its authority when it reversed a decades old policyin 1996 and sought to crack down on cigarette sales to minors.

    “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 court. “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.”

    However, she added, “It is plain that Congress has not given the FDA the authority that it seeks to exercise here.”

    Justice O'Connor was joined in her opinion by the Supreme Court's more politically conservative jurists—Chief Justice William Rehnquist and Justices Antonin Scalia, Anthony Kennedy, and Clarence Thomas. Dissenting were Justices Stephen Breyer, John Paul Stevens, David Souter, and Ruth Bader Ginsburg.

    Writing on behalf of the four dissenters, Justice Breyer said that federal law does allow the FDA to regulate tobacco. “Far more than most, this particular drug and device risks the life threatening harms that administrative regulation seeks to rectify,” he added.

    The FDA's antismoking initiative would have required retailers to check the identification of cigarette buyers under the age of 27 and would have prohibited cigarette vending machines except in bars and other adult only places. Although the rules were restrained by some standards, they had far more symbolic importance as the first test of FDA authority to control the powerful tobacco industry.

    The Clinton administration called the 1996 initiative the FDA's most important public health and safety effort in the past 50 years. The best way to cut down on smoking was to reduce the number of teenagers who started the habit, officials contended.

    The FDA has said for decades that under a 1938 law it lacked authority to regulate tobacco as long as cigarette makers did not claim that smoking provided health benefits. But the agency reversed its view in 1996, saying that it could regulate tobacco because of new evidence that the industry intended its products to feed consumers' nicotine habits.

    Tobacco companies sued, and the 4th US Circuit Court of Appeals ruled in 1998 that the FDA could not regulate tobacco. The court said that regulations on tobacco were the responsibility of Congress, which previously had banned broadcast advertising of tobacco, prohibited smoking on airlines, and required warning labels on cigarette packages.

    During an appeal of that ruling before the Supreme Court last December, the solicitor general, Seth Waxman, argued on behalf of the Clinton administration that the FDA could regulate tobacco as a drug because nicotine was “highly addictive.” It also acted as a stimulant, a sedative, an appetite suppressant, and fed smokers' addictions.

    Forty states backed the government's appeal. But the tobacco industry's lawyer argued that if FDA regulations were allowed, the government would be forced to ban tobacco products because they had not been shown to be safe.

    Embedded Image


    Traders on the New York stock exchange—on the day that tobacco shares rose because the Supreme Court ruled that the FDA could not regulate tobacco

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