WASHINGTON -- Casting aside an array of government rules aimed at keeping children away from tobacco, a federal appeals court ruled yesterday that Congress did not give the Food and Drug Administration power to control how cigarettes or chewing tobacco are made or sold.

"We are of opinion that the FDA lacks jurisdiction to regulate tobacco products," the 4th U.S. Circuit Court of Appeals based in Richmond declared in a sweeping 2-1 decision that scuttled a partial FDA victory last year. The Clinton administration vowed to appeal.

The court did concede that "tobacco products present serious health risks for the public," but it said the FDA had tried to "stretch [the present law] beyond the scope intended by Congress."

FDA rules that were overturned by the decision would ban cigarette sales to youths under 18, require IDs for anyone under 27 trying to buy cigarettes, and eliminate advertising and promotions that enticed youths to take up smoking or chewing tobacco. Those youth-oriented regulations had been adopted by the FDA two years ago after it concluded that tobacco use "is the single leading cause of preventable death in the U.S."

Together with the defeat in Congress in June of attempts to pass national legislation to control tobacco, yesterday's decision completed the industry's rout of President Clinton's aggressive campaign to combat tobacco use among youths. It is also the most significant triumph for Big Tobacco amid a series of recent courtroom victories.

Other recent court victories for the industry nullified the government's attempt to treat second-hand tobacco smoke as a source of cancer in nonsmokers and wiped out two major damage verdicts in favor of smokers.

The only federal tobacco controls that remain are requirements that cigarette and chewing tobacco packages and ads contain warnings about the hazards of smoking, and a ban on advertising those products on radio and television.

Further appeal likely

"I am firmly committed to the FDA's rule and its role in protecting our children from tobacco," Clinton said in a statement &r; yesterday. "If the leadership in Congress would act responsibly, it would enact bipartisan comprehensive tobacco legislation to confirm the FDA's authority and take this matter out of the courtroom."

The Justice Department said it would ask the full appeals court to review yesterday's decision by a three-judge panel. A further appeal to the Supreme Court seems likely no matter which side wins in the Richmond court.

In its decision, the appeals court said that if federal drug law as written did apply to tobacco products, those products would have to be banned -- "a result not intended by Congress." Thus, it said, the law does not apply. FDA had found that the law allowed it to regulate tobacco as it would any drug, but it chose not to ban it altogether.

The decision overturns an April 1997 ruling by a federal judge in Greensboro, N.C., that said the FDA does have power to regulate tobacco products.

Five major tobacco companies, in a joint statement, said they were pleased by the appeals court's rebuff of FDA and its regulations but added that "the industry remains firmly committed to taking meaningful steps to reduce underage tobacco use."

William D. Novelli, president of the Campaign for Tobacco-Free Kids, an anti-tobacco advocacy group, called the ruling "a major setback" that created "an ugly stalemate" between the industry and the public, which "wants kids protected from tobacco."

"We believe that FDA oversight is critical," Novelli said.

Not drug-delivering devices

The FDA had opted not to ban tobacco outright. It had said such a step would cause great problems for adults who are addicted to nicotine and who could face medical risks if they were forced to quit. Instead, it chose to leave the products on the market but to regulate them as drug-delivery devices, restricting access in order to sharply reduce use by young people.

The appeals court dismissed that approach as "obvious sophistry," saying the FDA cannot both consider tobacco unsafe and leave it on the market.

"The contortions that the FDA has gone through demonstrate that Congress did not intend its jurisdictional grant to the FDA to extend to tobacco products," the majority concluded.

Under present law, the court majority said in its 44-page opinion, nicotine-containing cigarettes, as well as tobacco in chewable form, cannot be considered devices for delivering drugs to people. The FDA based its regulations on its view that they should be controlled as drug-delivery devices, though it also said that tobacco products work like a drug.

But in a curious twist, the appeals court said that if the FDA had instead followed through on its conclusion that tobacco works ,, like a drug and is unsafe, the agency would have had to ban tobacco use by everybody -- adults as well as children -- because it is hazardous to health when used as intended.

The appeals court noted that the FDA cannot allow a drug to be used by anyone under the Food, Drug and Cosmetic Act, unless it can give assurances of safety. "No assurance of safety can be given for inherently unsafe products such as tobacco," the court concluded.

Examining federal law back to its 1938 origins, the appeals panel said Congress never intended to include tobacco within the FDA's powers -- a view that the FDA itself held until 1995.

Circuit Judge H. Emory Widener Jr., of Abingdon, Va., wrote the majority opinion, joined by Senior District Judge James H. Michael of Charlottesville, Va. Senior Circuit Judge Kenneth W. Hall of Charleston, W.Va., dissented, saying the present law was broad enough to allow the FDA to control tobacco.

Though the appeals court ruling denies the FDA any role in tobacco regulation, the industry, in settling multibillion-dollar damage lawsuits with several states, has agreed to take steps to curb youth use of tobacco in those states. The companies are trying to negotiate a single overall settlement with all other states -- including Maryland -- that have pending lawsuits.

Last year, the industry and state attorneys general had negotiated a proposed nationwide settlement of all the state cases. But when Congress, in taking up that settlement, HTC appeared likely to impose much stricter controls on the industry, the industry walked away from the effort.

After wrestling with the issue for weeks, Congress dropped the tobacco question after the Senate's Republican leaders abandoned the legislation June 17.

The ruling

The federal appeals court ruling yesterday that barred government regulation of tobacco nullified these Food and Drug Administration regulations:

A nationwide minimum age of 18 to buy cigarettes and chewing tobacco, and a requirement of proof of age for anyone younger than 27 -- the only regulation to take effect so far.

Planned controls on billboard advertising and magazine ads, and bans on free samples and on sale of hats, T-shirts, gym bags and other merchandise under tobacco brand names.

Planned controls on vending machines and self-service store displays.

A future ban on the use of tobacco brand names in sponsoring sports, musical and cultural events.

Pub Date: 8/15/98