High Court Bars FDA From Regulating Tobacco as a Drug

The Supreme Court ruled Tuesday that federal health authorities have no power to regulate the manufacture and sale of cigarettes, even though it called them America’s “single most significant threat to public health.”

Concluding that Congress never intended tobacco products to be treated as drugs under the Food, Drug and Cosmetic Act, the court ruled, 5 to 4, that the Clinton administration exceeded its authority under this law when it announced new anti-smoking regulations designed to protect the nation’s youth.

The decision blocks those rules from taking effect. They would have restricted tobacco advertising, prohibited such promotions as “Joe Camel” T-shirts and made it harder for teenagers to buy cigarettes in convenience stores and from vending machines.

But the stakes of the case went far beyond that. Had the Food and Drug Administration won power to regulate tobacco products, the agency in the future could have ordered the industry to reduce the nicotine in its cigarettes. Or it could have banned them from the market entirely as dangerous drugs.

Indeed, Justice Sandra Day O’Connor cited this prospect to show why the FDA’s move made no sense.

Everyone knows cigarettes are dangerous, she said, and they have known it for decades. Nicotine is addictive and smoking causes cancer. If tobacco products were truly drugs, like aspirin or penicillin, they would have been pulled from the market as unsafe, she said.

Cigarettes “simply do not fit” under the Food and Drug Act, said O’Connor, speaking for the court.

Of course, Congress can rewrite the law, but that is seen as unlikely, at least during this election year.

In the wake of the court’s ruling, leading Senate Democrats called for quick action.

“The responsibility is now squarely on Congress to grant the FDA the authority it needs,” said Sen. Edward M. Kennedy (D-Mass.). “Action is essential if we are serious about protecting children from the enormous health risks of smoking.”

However, key Republicans--with the exception of Sen. John McCain of Arizona--said that they are not enthusiastic.

“I’m not one of those” who favor giving the FDA control over cigarettes, Senate Majority Leader Trent Lott of Mississippi said. “I don’t think they do a very good job of what they’re supposed to be doing now, without more requirements being dumped on them.”

McCain broke with fellow Republicans on the tobacco issue in 1998 and supported giving the FDA regulatory authority. On Tuesday, he blamed big-money lobbying by the tobacco industry for the defeat of his comprehensive tobacco bill two years ago and said that nothing had changed since then.

“I’m not optimistic that we will be able to get it done until we have campaign finance reform,” McCain said.

Still, winning in the Supreme Court, and even in Congress, may not save the besieged cigarette makers.

Already, the tobacco industry’s payment of an extraordinary $246 billion to settle lawsuits filed by the states has failed as a bid to buy peace on the legal front.

Instead, with renewed energy, anti-tobacco lawyers have brought another round of lawsuits on behalf of ailing smokers. They are now armed with internal documents that reveal the industry’s efforts to hide the truth about the dangers of smoking.

Nothing in Tuesday’s victory in the nation’s highest court shields the tobacco firms from huge money judgments in the trial courts. And ultimately, ordinary jurors may speak louder than the Supreme Court justices in determining the fate of the tobacco industry.

Jurors in Miami and San Francisco are debating whether to assess punitive damages against tobacco firms. Already, those jurors have concluded that the companies should be held liable for conspiring to hide the dangers of smoking.

Punitive damages are a wild card. They can be any amount--and some experts foresee a verdict of hundreds of billions of dollars in the Florida case.

“The future of the tobacco industry is in the hands of these jurors,” said law professor Richard Daynard, who heads the Tobacco Products Liability Project at Northeastern University. “They will be told: ‘Ladies and gentlemen, you need to send a message to this industry.’ There is a real possibility the industry could be in bankruptcy within a year.”

A bankruptcy proceeding could lead to new conditions for manufacturing cigarettes, he said. Others suggested that the prospect of a multibillion-dollar punitive verdict may send the industry back to Congress in search of a deal that would limit its liability.

But one way or another, cigarettes will continue to be made and sold in the United States, as even a staunch foe of the industry said.

“There are 48 [million] to 50 million addicts in this country. Someone is going to sell the cigarettes,” said Matthew Myers, counsel for the Campaign for Tobacco-Free Kids. That reality argues for federal regulation designed to make sure cigarettes are marketed only to adults and are as safe as possible, he said.

From the start, all sides in this legal battle agreed on the dangers of smoking.

Tobacco products cause more than 400,000 deaths in the United States each year, the Clinton administration said. “Tobacco alone kills more Americans annually than AIDS, alcohol, car accidents, homicides, suicides, illegal drugs and fires combined,” the administration said in its brief.

Justice O’Connor repeated those statements in her opinion.

But the competing lawyers disagreed on whether the 1938 law gave the FDA authority to regulate tobacco.

The FDA lawyers said that it does, pointing to the broad definition of a drug. It is a substance “other than food intended to affect the structure or any function of the body.” Nicotine is such a substance, they argued.

The industry lawyers pointed to the history of the law and statements by members of Congress saying that cigarettes were not covered.

In the past, the court’s conservatives, led by Justice Antonin Scalia, have insisted on looking at the words of a law, not the sentiments of lawmakers. By contrast, the liberal justices have relied on the intent of lawmakers.

In this case, however, both sides switched.

The five conservatives formed the majority to strike down the Clinton administration’s rule. Chief Justice William H. Rehnquist and Justices Scalia, Anthony M. Kennedy and Clarence Thomas joined O’Connor’s opinion in the case (FDA vs. Brown & Williamson Tobacco, 98-1152).

The liberal-leaning dissenters were the two Clinton appointees, Justices Stephen G. Breyer and Ruth Bader Ginsburg, and veteran Republican appointees, Justices John Paul Stevens and David H. Souter.

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NEW INROADS?

Big Tobacco may have won a key bargaining chip. A6

* CALL TO ACTION

Vice President Al Gore calls for standing up to big tobacco. A6