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Tobacco adversaries square off in appeals court


FDA's intent to regulate cigarettes at issue

August 11, 1997
Web posted at: 10:02 p.m. EDT (0202 GMT)

WARM SPRINGS, Virginia (CNN) -- A historic courthouse here provided a rustic backdrop Monday for a dramatic legal confrontation that could undo a major victory won earlier this year by anti-tobacco forces.

Acting U.S. Solicitor General Walter Dellinger was peppered with questions by 4th U.S. Circuit Court of Appeals judges Monday over the government's intent to regulate tobacco products.

At issue was a split decision rendered April 25 by U.S. District Judge William Osteen in Greensboro, North Carolina. Osteen ruled that the U.S. Food and Drug Administration could regulate cigarettes because their nicotine was addictive, but refused to give it the right to limit cigarette advertising and sales practices.

The government and an alliance of tobacco companies and advertising and convenience-store trade groups both appealed portions of Osteen's decision, hence their presence in Warm Springs.

Although the case has taken a back seat to the proposed $368.5 billion settlement reached by the attorneys general of many states and the tobacco industry, the outcome of the case could be powerful ammunition for either side.

"The tobacco settlement is a long way off," points out Bill Novelli of the Campaign for Tobacco-Free Kids. "It faces an uncertain future. That's why this FDA decision is going to be so important."

Judges challenge government attorney


Arguing his last case for the government, Dellinger insisted that there was an extraordinary scientific consensus emerging that cigarettes are addictive and that they have been engineered exactly for that purpose. He also said that cigarette consumption among children is increasing.

Dellinger asked the court to endorse Osteen's ruling and restore the provisions controlling advertising and sales.

The FDA's rules -- meant to regulate access to cigarettes and chewing tobacco by people under 18 -- went into effect in February. But the rules doing away with cigarette vending machines and marketing tools cannot be put in place because of Osteen's ruling.

Two of the three judges challenged Dellinger often, asking in particular what right the FDA had to regulate nicotine nearly 60 years after the passage of the FDA law regulating food, medicine and cosmetics.

Dellinger said the 1938 law did not mention tobacco specifically, and that recent research has shown it to be highly addictive.

The judges also asked why regulating tobacco should not be undertaken by Congress. Dellinger said the FDA did not intend to ban smoking, and that passing legislation in Congress was unnecessary.

Richard Cooper, the lead attorney for the tobacco industry, accused the FDA of exceeding the authority granted it by Congress. He argued that the proposed FDA regulations would allow it to ban cigarettes, trampling on the constitutional rights of individuals, advertisers and merchants.

'A strange and wonderful day'

Cooper said that if the FDA were given the regulatory control it seeks, it would have no choice but to ban cigarettes because it could not declare them safe.

"No drug or device has been regulated like this," Cooper said. "It begs the question: Who gets to decide, Congress or FDA?"

Dellinger called it "a strange and wonderful day" when the tobacco industry says the government must ban tobacco.

And Frank Unger of the U.S. Justice Department said after the hearing that the government didn't plan to ban cigarettes. "That's been the FDA's position, and we're confident that the court understood that," he said.

"The FDA got its butt kicked," one stock analyst said after the hearing.

But others warned against reading too much into the judges' questions. It was pointed out that Osteen himself had asked tough questions of the government lawyers before issuing what was widely regarded as a victory for the government and anti-tobacco forces.

It could be a month or more before the appeals court makes its ruling, and no matter which side wins, the outcome seems destined for the U.S. Supreme Court.

Correspondent Jeff Levine and Reuters contributed to this report.

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