The US Supreme Court has handed the tobacco industry a major victory by ruling that the Food and Drug Administration does not have authority to regulate tobacco.
In a long-awaited decision, the nation's highest court split 5 to 4 in determining that national lawmakers in Congress - rather than unelected bureaucrats at the FDA - hold the power to regulate Big Tobacco.
The March 21 decision deals a severe blow to President Clinton in his efforts to curb youth smoking. It puts the issue of regulation back in the aisles of Congress.
In its ruling, the court said regulation may be accomplished through direct legislation or by expanding the FDA's mandate to include federal rules governing products containing addictive nicotine, such as cigarettes. But failing such a direct grant of FDA authority, the agency is powerless to act on its own, even for the most noble of causes.
"Congress, for better or worse, has created a distinct regulatory scheme for tobacco products [and] squarely rejected proposals to give the FDA jurisdiction over tobacco," Justice Sandra Day O'Connor writes for the majority.
"Owing to its unique place in American history and society, tobacco has its own unique political history," she says. "Given this history and the breadth of the authority that the FDA has asserted, we are obliged to defer not to the agency's expansive construction of the statute, but to Congress' consistent judgment to deny the FDA this power."
The question now is: If the FDA is powerless to enforce regulations aimed at protecting children, will Congress take any action? Antitobacco activists say that is unlikely in an election year, in part because of substantial and well-placed campaign contributions made by Big Tobacco.
"Tobacco has lots of friends in the Congress," says Kathryn Kahler Vose of the Campaign for Tobacco-Free Kids. "They've spent years and millions of dollars buying lots of influence. Clearly, passing legislation will be a battle."
But, she adds, "The public feels strongly that tobacco should be regulated."
The high-court ruling comes as Philip Morris, the nation's largest tobacco company, is suggesting a dialogue with Congress and the public-health community to discuss some form of regulation.
"We are ready and eager to engage in a useful and positive discussion on these issues," said a statement issued by Philip Morris. "Federal regulation of cigarettes - as cigarettes dealing with youth smoking while respecting an adult's right to smoke - makes sense for smokers and manufacturers alike."
The industry's conciliatory stance may be intended to head off an antitobacco backlash in the wake of the Supreme Court decision, say analysts say. They see the move as consistent with an industry public-relations campaign to boost its image after damaging revelations about Big Tobacco deception over research findings and marketing techniques.
Skeptical antitobacco activists say the industry wants to position itself to play a role in a regulation process that may become inevitable. Regulations, they say, could actually make it easier for the tobacco industry to sell and market certain kinds of cigarettes.
"The more the public engages on this issue - when they realize tobacco is a rogue product, promoted by a rogue industry, exempt from consumer-protection and health-and-safety laws - then we think there will be a lot of support [for congressional legislation]," says Paul Billings of the American Lung Association.
Ms. Vose agrees. "Tobacco is the only product that, when used as intended, kills. The hand lotion that you use has more regulation than tobacco," she says. "There is something wrong with that."
In 1996, when the FDA announced its anti-tobacco campaign, antismoking advocates and public-health officials praised the Clinton administration's proposed regulations as an important step in protecting American children from becoming smokers. The FDA antismoking campaign came amid revelations about the tobacco industry covering up its own research findings about adverse health effects to smokers and the addictive nature of nicotine.
In the US, estimates are that more than 40 million people are addicted to nicotine - and that up to 80 percent of all smokers are addicted.
The FDA regulation case has been called the most important public-health issue considered by the high court in the past 50 years.
Traditionally, the tobacco industry has been regulated through congressionally mandated cigarette-pack warning labels, which advise prospective smokers that cigarettes could be hazardous to their health. Congress also banned radio and TV advertising of tobacco products.
It was a regulatory approach that fit with a laissez-faire philosophy to allow adults the freedom to decide for themselves whether to smoke.
But that approach began to unravel amid criticism that the tobacco industry was waging a multibillion-dollar marketing campaign targeting children and teens.
In addition, class-action lawsuits filed by state attorneys general were beginning to uncover internal industry documents suggesting top tobacco officials covered up their own research findings to avoid losing customers.
In 1996, the FDA first proposed a series of regulations aimed at reducing teen smoking. The new rules restricted the sale of cigarettes through vending machines and banned tobacco advertising on billboards and in magazines directed at young viewers.
The tobacco industry challenged the FDA regulations, arguing successfully in a federal appeals court in Richmond, Va., that the FDA had exceeded its authority. It also argued that the FDA had consistently declined to exert jurisdiction over tobacco throughout most of the agency's history, and had only recently expressed any interest in regulating cigarettes and tobacco.
Government lawyers countered that an extensive investigation of smoking by FDA and other experts uncovered new facts about the addictive effects of nicotine.
FDA officials concluded the agency had the authority to regulate tobacco sales and advertisements under the Food, Drug, and Cosmetic Act. They could do it by classifying nicotine as a drug and cigarettes as drug-delivery devices.
Lawyers for the tobacco industry countered that if the agency wanted to regulate tobacco under its existing authority, the agency has the power only to enact an all-out ban of tobacco products.
The government has rejected an outright ban out of concern it would create a huge black market for cigarettes.
* Ron Scherer in New York contributed to this report.
(c) Copyright 2000. The Christian Science Publishing Society