High Court Wary of Classifying Tobacco as Drug

The Clinton administration’s plan to regulate cigarettes as legal drugs received a surprisingly hostile hearing before the Supreme Court on Wednesday.

In skeptical questioning, most of the justices suggested that federal health regulators overreached three years ago when they claimed power over cigarettes and smokeless tobacco.

The prospect of federal control has alarmed the already beleaguered tobacco industry, which believes that such regulation would threaten its very survival.

Under a policy adopted in 1996 by the Food and Drug Administration, regulators could have ordered the industry to reduce or eliminate nicotine from cigarettes. Tobacco industry lawyers have feared that such control eventually would result in the prohibition of cigarettes.

However, those possibilities appeared to fade quickly during Wednesday’s argument.

The Supreme Court justices, looking closely at the Food, Drug and Cosmetic Act of 1938, said that they did not see how cigarettes could be classified in the same category as medicines.

“It just doesn’t fit,” Justice Sandra Day O’Connor exclaimed, describing her reaction to calling a cigarette a drug.

Under the 1938 law, federal regulators can oversee drugs that are sold to prevent diseases or cure illnesses, she said. But, she added, “it strains credibility” to say that Congress meant to include cigarettes under this rubric, since tobacco products are not sold as medicine.

And if cigarettes were covered by the law, they would “have to be banned,” O’Connor said, since their risks to health clearly outweigh their benefits.

She noted that FDA lawyers had defined their authority so broadly as to cover anything that is intended by its maker to have an effect on the body.

“Could the FDA regulate horror movies?” O’Connor wondered, since such films are designed “to get the adrenaline pumping.”

No one has seriously suggested anything of the sort, replied U.S. Solicitor Gen. Seth Waxman, representing the administration.

“Well, 30 years ago, no one suggested the government could regulate cigarettes,” interjected Chief Justice William H. Rehnquist, a regular smoker.

The skepticism from O’Connor and Rehnquist was echoed in questions from Justice Antonin Scalia, the court’s other steady smoker, as well as from those who might have been seen as more friendly to the anti-tobacco arguments, including Justices David H. Souter and Anthony M. Kennedy.

Only Justices Stephen G. Breyer and John Paul Stevens strongly defended the Clinton administration’s stand.

With control over cigarettes, FDA officials had hoped to ban most tobacco advertising, including sports promotions. They also intended to forbid the sale of cigarettes through vending machines. Retailers would be required to ask for photo identifications before selling cigarettes to anyone younger than 27.

Those proposed rules have been stalled pending the outcome of the court battle.

Last year, the U.S. Court of Appeals in Richmond, Va., struck down the FDA’s claim of authority over tobacco products, and most of the justices sounded Wednesday as though they will uphold that ruling.

If they do, the issue would move back to Congress. But the Republican-controlled Congress recently has shown no enthusiasm for bringing tobacco under the FDA’s control.

However, anti-tobacco forces have been winning on other fronts. In a series of legal settlements with the states, the major tobacco firms have agreed to pay $246 billion to cover smoking-related health costs.

The Justice Department has brought a similar federal lawsuit against the tobacco firms, and several class-action suits are pending in state courts.

In 1995, then-FDA Commissioner David A. Kessler said newly discovered evidence--industry documents--showed that tobacco industry officials had known for decades that nicotine is addictive and that the amount of nicotine in cigarettes can be manipulated.

Tobacco use “is the largest cause of preventable death in the United States,” the FDA added. Each year, more than 400,000 Americans die from smoking-related illnesses.

This new evidence, combined with the enormous health consequences of smoking, justifies a sharp change in federal policy, the administration said.

The justices were unswayed. What’s new about this, Scalia asked, since the health dangers of cigarettes have been documented for decades.

Certainly in 1964, when the surgeon general first warned Americans of the hazards of smoking, ordinary Americans--as well as the FDA--knew of the dangers, Rehnquist said.

Maybe so, Waxman said, but the leaders of the major tobacco companies testified under oath just a few years ago that they believed cigarettes were not addictive.

“No one believed them,” Scalia responded.

The sharp tone of the questioning came as a surprise. During the 1980s, when the Ronald Reagan administration’s policies were being attacked in the courts by liberal interest groups, the Supreme Court ruled that judges should defer to the decisions of executive agencies.

Waxman relied on that doctrine Wednesday, but without much success.

Instead, the justices questioned him on where the government’s anti-tobacco policy would lead.

How could cigarettes be kept on the market, they asked, if they are deemed to be drugs?

Waxman said that the agency would have to weigh the risks and would conclude, at least for now, that prohibition would be a mistake.

But the question seemed to confirm the justices in their view that cigarettes were not meant to be regulated as drugs by the FDA.

A ruling in the case (FDA vs. Brown & Williamson Tobacco, 98-1152) is expected in several months.