HIGH COURT FINDS FLAWS IN CASE AGAINST TOBACCO

Doubts Cast on U.S. Agency's Effort to Regulate

By WASHINGTON - The Supreme Court appeared highly skeptical Wednesday of
the Food and Drug Administration's proposal to regulate nicotine in
cigarettes as a drug.

During one of the most vigorous oral arguments at the court in months, the
justices suggested by their questions that they were almost certain to
invalid ate the agency's effort, to exert control over a product that
medical experts consider a primary cause of preventable disease and death.

Justices across the ideological spectrum focused on several flaws in the
federal government's argument, notably that the agency had for decades said
it lacked authority over tobacco; and that the agency regulates items
intended to make people healthier, and cigarettes arguably do the opposite.

"It just doesn't fit," Justice Sandra Day O'Connor said of the agency's
1996 assertion of authority and proposed rules to restrict the marketing
and sale of tobacco products to young people.

The case began three years ago when the agency declared that it could
regulate the nicotine, in cigarettes and smokeless tobacco products under
the 1938 Food, Drug and Cosmetic Act. That law gives the agency
jurisdiction over drugs and devices "intended to affect the structure or
any function of the body. " The action marked a decisive moment for the
government in its struggle to address tobacco's ills and to stop people
from becoming addicted.

But after the proposed regulation was challenged by tobacco companies, a
federal appeals court in Virginia ruled that the agency lacks authority
over tobacco.

The appeal Wednesday of that case pitted two leading advocates, Solicitor
General Seth Waxman, for the Food and Drug Administration, and Richard
Cooper, for Brown and Williamson and the other tobacco companies that sued
the agency.

Mr. Waxman contended that the agency sought to regulate nicotine as it does
other substances that are addictive or act as a stimulant or sedative. He
asserted at one point that tobacco is the only ingested product "regulated
and inspected by no agency and yet is so dangerous."

Many of the justices suggested they thought the agency could only regulate
drugs deemed to be safe. Chief Justice William Rehnquist challenged Mr.
Waxman's claim that it was only in the 1990s that the agency found the
scientific evidence that cigarettes were addictive and seriously affected
the body. He referred to the surgeon general's report and other findings in
earlier years about cigarettes' harms.

For his part, Mr. Cooper contended that Congress never intended to delegate
authority over-cigarettes but rather sought to regulate them through a
series of tobacco-specific statutes, for example, one governing package
labeling. He also emphasized that cigarette makers do not promise certain
health effects about their products, as do the manufacturers of other drugs
and items that the agency is charged with overseeing. "The FDA comes in
when there is a claim of a health benefit," Mr. Cooper said.