FDA CAN CONTROL TOBACCO, JUSTICE DEPT. ASSERTS IN COURT

Regulation: Appellate judges hear challenge to ruling giving
agency power over industry. In Congress, Senate agrees to key
amendments to legislation.

CHARLESTON, W.Va.--In a case whose potential importance grows as the
fate of comprehensive tobacco legislation remains uncertain in
Congress, the Justice Department told a federal appeals court Tuesday
that the Food and Drug Administration has the authority to regulate
cigarettes and other tobacco products.

Attorneys for tobacco companies, retailers and advertisers countered
that the FDA is attempting to exert powers that Congress never
intended. They urged a three-judge panel of the U.S. 4th Circuit Court
of Appeals to overrule a lower court ruling.

In Washington, meanwhile, progress resumed on the tobacco control bill
as the Senate reached agreement on key amendments that Republicans had
been pushing on how to spend money the measure would produce. Still,
the legislation's ultimate prospects are murky.

The legal case that is playing out here stems from the tobacco
industry's challenge to the FDA's assertion of regulatory authority
over tobacco. In federal district court in North Carolina--the tobacco
industry's home turf--Judge William L.

Osteen held last year that the agency does have the authority to
govern the tobacco industry--including the nicotine content of cigarettes.

If the government continues to prevail, it will be able to impose a
host of new rules enabling the FDA to regulate cigarettes as drug
delivery systems. Ultimately, the agency could compel the cigarette
companies to reduce or even eliminate nicotine, which could lead to a
significant reduction in sales and profits for the companies.

After the hearing ended, both sides declared that they were pleased
with how the argument had gone but neither was willing to predict victory.

"I thought [Justice Department lawyer] Gerald Kell did a brilliant job
of laying out the law," said David A. Kessler, who had pressed for
tobacco regulation as FDA commissioner until early last year.

But he cautioned: "This is a long haul. I've learned never to get up
or down on the basis of any one point."

Charles A. Blixt, R.J. Reynolds Tobacco Co.'s general counsel, lauded
the presentation of the industry's lead lawyer, Richard M.

Cooper, but added: "You never can tell how the arguments are
going."

The judges could take several months to issue a decision and, given
the stakes, any ruling is likely to be appealed to the Supreme Court.
The panel also will rule on the government's appeal of the other major
lower-court ruling in the case--striking down FDA regulations that
severely restrict cigarette advertising and promotion to young people.

Questions posed by Judge James H. Michael, 79, indicated that he was
skeptical about the government's position, while Judge K.K.

Hall, 80, appeared sympathetic to the FDA. Judge H. Emory Widener Jr.,
75, asked the fewest questions and did not indicate how he was
leaning, prompting some observers to predict that his might be the
pivotal vote.

Tuesday's proceedings marked the second time the case had been heard
by the 4th Circuit. The appeal of Osteen's decision was first argued
before a three-judge panel last August, but before the panel could
render a decision, one of the three judges, 92-year-old Donald S.
Russell, died. Widener replaced Russell.

Kell, the Justice Department lawyer, said that the basic issue of FDA
authority was clearly resolved by the language of the 1938 Federal
Food, Drug and Cosmetic Act, which gives the agency authority to
regulate articles "intended to affect the structure or any function of

the body."

Citing internal industry documents, Kell said that new information
developed by the FDA revealed that nicotine is addictive and that the
tobacco manufacturers designed their products with the goal of
satisfying smokers' addiction.

Cooper, representing the industry, said that the history of the 1938
act and subsequent laws show that Congress never intended to give the
FDA authority to regulate the design, content or advertising of cigarettes.

"What's at stake is the FDA's power to ban tobacco," said Cooper, a
former FDA general counsel who is now a partner at Williams &
Connolly, one of Washington's most influential law firms.

In distinct contrast to the hearing last year, when the judges
peppered Justice Department lawyer Walter Dellinger with questions
from the outset of his argument, Kell was able to complete his entire
opening statement without interruption.

However, he had a difficult moment when Judge Michael asked him
whether nicotine is a "dangerous drug"--a thorny question since the
1938 Food and Drug law does not permit the marketing of products found
unsafe by the FDA.

If Kell had answered yes, it would follow that the agency would have
to ban nicotine. But he had already stated the FDA's consistent
position that it had no intention to ban tobacco, an action that would
have drastic consequences for the more than 40 million American smokers.

Kell responded that nicotine was not dangerous "per se." Rather, he
said, cigarettes are a dangerous product and, since nicotine is
addictive, that gives the agency the lever to regulate it.

Michael tried two more times to get a yes answer and finally said: "I
admire your ability to escape declaring it [nicotine] is a dangerous
drug."

Cooper called the FDA's stance "bizarre" and "nonsensical."

Copyright Los Angeles Times

Checked-by: (trikydik)