Lawyers Begin Tobacco Hearing With Attack on FDA Restrictions

Round one in the long-awaited legal showdown over the Food and Drug Administration’s right to regulate cigarettes began in U.S. District Court here Monday, with tobacco industry lawyers warning that the FDA has overstepped its authority, violated the 1st Amendment and set the government on a dangerous course toward prohibition.

“We are dealing with a revolutionary expansion of FDA authority over a major industry that it has never before regulated, and its products are not medical,” said Richard Cooper, former chief counsel for the FDA and now the industry’s lead lawyer in the case. “FDA is asserting the power to ban this industry,” Cooper declared at the outset of Monday’s proceedings.

The daylong hearing before Judge William Osteen marked the first step in what is likely to be a protracted and bitter fight over the Clinton administration’s new rules, which impose strict limits on how the industry markets and advertises cigarettes. Most observers expect the case to make legal history, winding up in the U.S. Supreme Court.

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At issue is the authority of the government to enact sweeping regulations in the name of cutting down on teenage smoking that would radically alter the way one of the nation’s most powerful industries does business. The rules reverse more than two centuries of hands-off federal policy toward cigarette manufacturers.

“What is at stake,” outgoing FDA Commissioner David A. Kessler said outside the federal courthouse here, “is the future of the health of so many of our children.”

Kessler was among dozens of people--35 tobacco industry lawyers, 25 government attorneys, a dozen FDA officials, plus anti-smoking activists, financial analysts and journalists--who descended on this small southern city to hear arguments in the case. “I think it is clear that the judge came prepared to challenge both sides,” said Matthew Myers, attorney for the Campaign for Tobacco-Free Kids, which filed a brief supporting the government’s regulations.

The arguments took an unusual twist when the industry told the judge that, if the FDA was going to take jurisdiction over cigarettes--a product it has deemed unsafe--the agency would have no choice under its rules but to enact a total ban. When the government replied that a total ban would not be workable, the judge announced quizzically: “You’ve got the tobacco industry saying you ought to have a ban and then you have the FDA saying this is such a serious problem, we can’t even touch it.”

The judge, who said that he hopes to issue a ruling in five to 10 weeks, has several options. He could rule entirely in favor of the industry and strike down the FDA’s jurisdiction. He could rule entirely in favor of the government and let all the rules stand. Or, he could issue a hybrid decision, perhaps permitting the FDA to retain its authority to regulate tobacco but striking down the advertising restrictions as unconstitutional.

Monday’s hearing was the first of several crucial court battles that cigarette manufacturers will fight this year. Nearly two dozen states have sued the industry seeking reimbursement for Medicaid expenses paid to treat victims of smoking-related illnesses. The first of these cases is set for trial in June. In addition, the manufacturers face 13 class-action suits, three of which are scheduled to go to trial this year.

“This could be the make-it or break-it year for the industry,” said Dick Daynard, a law professor and tobacco litigation expert at Northeastern University.

The outcome of the FDA suit is of particular importance because of the precedent the rules set. The agency has said that if the new regulations do not cut teen smoking in half within seven years, it reserves the right to enact even stricter provisions.

“What is at risk to this whole country is the process by which the country is governed,” said Charles Blixt, general counsel for R.J. Reynolds Tobacco Co., the nation’s second-largest cigarette manufacturer, complaining that the rules are part of a plan for “backdoor prohibition.”

The FDA regulations, which apply to both cigarettes and smokeless tobacco but not to cigars, were authorized by President Clinton during a Rose Garden ceremony in August. The provisions include: a requirement that retailers require proof of age from anyone who looks younger than 27 to ensure that no one under 18 is sold cigarettes, a ban on most vending machine sales, a ban on cigarette brand sponsorship of sporting events and the elimination of cigarette logos on baseball caps, T-shirts and other merchandise. But the most controversial provision restricts nearly all tobacco advertisements and billboards to simple black-and-white text, the so-called “tombstone” format.

The proof-of-age requirement, which is not opposed by the industry, takes effect Feb. 28. Most of the other requirements would become effective Aug. 28--if the regulations stand.

The industry raises three primary objections to the rules. First, it argues that Congress has declined repeatedly to give the FDA authority to regulate tobacco. Instead, Cooper argued, Congress has crafted its own specific tobacco policy, beginning with the law passed in 1964 that put the U.S. surgeon general’s health warning on cigarette packages.

Second, the companies contend that the government “has tortured” the 1938 Food, Drug and Cosmetics Act, creating “a strange regulatory scheme” to give itself authority over tobacco.

And finally, the industry, along with a coalition of advertising and media firms, raises a constitutional objection, saying that the advertising restrictions infringe on the manufacturers’ 1st Amendment right to free speech. “A black and white ad,” industry lawyer Dan Troy said Monday, “is for all intents and purposes an invisible ad.”

The government counters that its decision to declare nicotine an addictive drug and regulate cigarettes as drug-delivery devices was not taken lightly. The FDA assembled more than 200,000 pages of evidence in drafting its rules, including thousands of pages of confidential industry documents in which tobacco executives described nicotine as “addictive” and “a very remarkable beneficent drug.”

“The commissioner [of the FDA] has not acted willy-nilly here,” Justice Department attorney Gerald Kell told the judge. “The commissioner has looked at a series of problems and determined that a set of restrictions . . . will have a positive impact on what is a very serious public health problem, a pediatric disease.”