JUSTICES SKEPTICAL OF U.S. CLAIM ON CIGARETTES

WASHINGTON -- The Clinton Administration faced a notably skeptical Supreme
Court Wednesday as it tried to convince the justices that the Food and Drug
Administration has jurisdiction over tobacco and the authority to regulate
cigarettes as "drug delivery devices."

The crowded courtroom became, for an intense hour, the current battleground
in the tobacco wars that have swept through Congress and presidential
politics. But the familiar policy arguments took second place to a
prolonged dissection of food and drug law.

Solicitor General Seth P. Waxman labored to demonstrate that the
regulations the F.D.A.

issued in 1996, which were struck down last year by a federal appeals
court, fit comfortably within the agency's core public health mission. The
regulations placed restrictions on cigarette sales and advertising aimed at
those under the age of 18.

Richard M. Cooper, a former general counsel of the Food and Drug
Administration, now representing the five cigarette makers that challenged
the regulations, said the agency's action was "lawless" in the absence of
an explicit Congressional grant of authority.

Justice Sandra Day O'Connor, who observed several times that regulating
smoking "just doesn't fit" within the agency's statutory authority, asked
Waxman whether under his theory the agency could regulate horror movies
"because so many people go to them to get scared and get their adrenaline
pumping."

When the solicitor general replied that "no one is suggesting" that the
Food and Drug Administration regulate movies, guns and the like, Chief
Justice William H. Rehnquist interrupted to observe that "30 years ago, no
one suggested" that the agency had authority over cigarettes.

A significant hurdle for the administration was the fact that for nearly
its entire history, from its establishment under the Federal Food, Drug and
Cosmetic Act of 1938 until the mid-1990's, the agency said it had no
authority to regulate smoking.

Waxman's position is that the agency changed its mind in the face of new
and "overwhelming evidence" that nicotine is addictive and that cigarette
manufacturers "knew this and were engineering their products to deliver the
precise dose of nicotine that consumers need to obtain its effects."

The Food, Drug and Cosmetic Act defines a drug as a substance, other than
food, "intended to affect the structure or any function of the body." So
evidence not only of nicotine's properties but of the manufacturers' intent
to exploit those effects was crucial to the agency's late-day reevaluation,
Waxman said.

But his point, although he made it repeatedly, appeared lost on the
justices. "Wasn't it clear in 1938, even much earlier," that smoking was
harmful, Justice Antonin Scalia wanted to know. Even in the early 1900's,
there was a movement among the states to ban smoking, he said. "Why wasn't
the Surgeon General's report fully enough?" Justice Scalia added, referring
to the 1964 study that documented the health effects of smoking.

Another major hurdle for the administration appeared to be the F.D.A.'s
choice to regulate smoking rather than ban it. For a drug or medical device
to be marketed with the agency's approval, it must be proven "safe" and
"effective," with the health benefits for those who use it outweighing any
risks.

The industry has argued that in light of that regulatory structure and of
the agency's determination that cigarettes are not safe, it must ban them
if it has jurisdiction over them at all, a step with such drastic economic
and social policy implications that the agency must be able to point to
explicit Congressional authorization to exercise such power.

This was essentially the conclusion of the United States Court of Appeals
for the Fourth Circuit, in Richmond, which ruled against the agency's
jurisdiction in a 2-to-1 decision in August 1998.

Waxman said today that while the agency might eventually decide to ban
cigarettes, it had decided that a better approach for now was to try to
keep those under the age of 18 from starting to smoke while not interfering
with older smokers, "a majority of whom are addicted." The agency had
concluded that than letting people in that group keep smoking was safer for
them than a total ban, he said.

Justice O'Connor was unpersuaded. "It strains credibility to say that these
products can be safe," she said, adding: "I just don't understand how
someone can stand here and say that." If the agency had jurisdiction, it
would have no choice but to impose a ban, she said, "but we've certainly
operated for a long time with the understanding that this wasn't covered."

Perhaps the most devastating response to the solicitor general's
presentation came from Justice David H. Souter, who offered Waxman a
lengthy summary of the arguments. Justice Souter said the solicitor general
had "in large part answered" many of the technical legal issues in the case
but that "the global problem" still remained of whether Congress had given
the agency the power it now claimed.

"It does not seem to me reasonable at this point for the government to
assert jurisdiction," Justice Souter said.

By the time Cooper, representing the industry, began his half-hour at the
podium, his work appeared largely accomplished. But not in all respects. He
apparently failed to convince Justice Stephen G. Breyer with his assertion
that the agency could only establish a manufacturer's "intent" by pointing
to specific health claims made for a product. Since no such claims are made
for cigarettes, there is no basis for F.D.A. regulation, Cooper said.

"The unusual thing here is that we have a product that everyone knows what
it is," Justice Breyer said. "Why do you need a claim? Is the statute
supposed to stop the F.D.A. from looking at the real world?" At another
point, Justice Breyer said: "Smokers are no longer able to kid themselves
about this -- that nicotine satisfies a craving caused by chemical
addiction." That was the effect on the body that fit the definition of a
drug, Justice Breyer suggested.

A colloquy with Justice Ruth Bader Ginsburg served as a platform for
Cooper's arguments about the limits of the agency's jurisdiction. Justice
Ginsburg asked whether heroin, if it were lawful, could be regulated by the
Food and Drug Administration.

"If it doesn't purport to have a health benefit, it couldn't be regulated
by the F.D.A.," Cooper said.

Justice Ginsburg asked, "Even if the product was harmful to health?"

Cooper, offering as an example household cleaning products that are
dangerous when swallowed, said, "There are thousands of products that are
harmful to health" that fall outside the agency's jurisdiction.

Justice Ginsburg rejected that example, asking for one in which "the core
use is putting it into the body."

The agency has no jurisdiction over "street drugs," Cooper replied.

What about marijuana for which health benefits are claimed, Justice John
Paul Stevens asked.

"Oh yes," Cooper said, with such claims, the agency could assert jurisdiction.

In rebuttal, Waxman said that limiting the agency's jurisdiction to
products with explicit health claims would "revolutionize" food and drug
law and create a huge regulatory loophole.

The regulations at issue in the case, Food and Drug Administration v. Brown
and Williamson Tobacco Corporation, No. 98-1152, are based on the agency's
conclusion that people who reach the age of 18 without smoking are unlikely
to start. The regulations prohibit the sale of cigarettes or smokeless
tobacco to those under 18 and require retailers to check the identification
of those under age 27.

The regulations at issue also included restrictions on advertising, which
Judge William L. Osteen Sr. of Federal District Court in Greensboro, N.C.,
found in an earlier phase of the case to fall outside the agency's
statutory authority. The Fourth Circuit consequently did not rule on the
advertising restrictions, but if the Supreme Court rules in favor of the
agency's jurisdiction, the tobacco industry has indicated it will challenge
those restrictions on the grounds of free-speech.

In addition to Brown and Williamson, the other plaintiffs in the case are
Philip Morris Inc. the Lorillard Tobacco Company, the United States Tobacco
Company, and the National Association of Convenience Stores.