HIGH COURT: FDA CAN'T REGULATE TOBACCO AS DRUG

WASHINGTON -- The Supreme Court on Tuesday dealt a sharp blow to the
Clinton administration's efforts to curb smoking, ruling 5-4 that the
Food and Drug Administration had never received authority from
Congress to regulate tobacco products.

The decision, rejecting rules that the FDA proposed in 1995 to
restrict the marketing of cigarettes to minors, hands the question of
national tobacco regulation back to Congress. An effort to confer
jurisdiction on the FDA won some bipartisan support in Congress in
1998 but became mired in a broader debate over whether to give the
cigarette industry immunity from damage suits.

Tuesday's ruling was notable for the strong language that both the
majority and the dissenting opinions used in describing the dangers of
smoking, which causes about 400,000 deaths a year in the United
States. Although essentially a straightforward ruling on a question of
administrative law, the decision paid more than usual attention to the
underlying policy issues, as if in recognition that the debate will
continue elsewhere.

The ruling was welcomed by the industry, but it left cigarette makers
still obligated to pay hundreds of billions of dollars to settle
lawsuits to recover state health care costs. It also prompted both
Vice President Al Gore and Texas Gov. George W. Bush to call for
congressional enactment of stricter controls on tobacco products.

Justice Sandra Day O'Connor, who said in her majority opinion that the
FDA had ``amply demonstrated'' that tobacco use was ``perhaps the
single most significant threat to public health in the United
States,'' sounded at times almost apologetic for her conclusion that
the Food, Drug and Cosmetic Act, which the agency used to assert
jurisdiction, could not be stretched far enough to accommodate the
regulations.

In the dissenting opinion, Justice Stephen Breyer said that given
nicotine's highly addictive nature and the ``life-threatening harms''
of smoking, the FDA's authority should be interpreted in light of
``its basic purpose: the overall protection of public health.'' He
said the court should avoid an ``overly rigid'' interpretation of the
Food, Drug and Cosmetic Act ``that is divorced from the statute's
overall health-protecting purposes.''

David Kessler, the former FDA commissioner who led the agency in
reversing its long-held position that it could not regulate tobacco,
said Tuesday that the loss in court had ``in some ways moved the issue
forward'' through the justices' recognition of the dimensions of the
problem as a public-health issue.

Question of intent

``We're in a very different place than we were five years ago,'' said
Kessler, now the dean of Yale Medical School.

The court majority Tuesday applied a settled principle of
administrative law: If Congress has spoken clearly on a question of an
agency's jurisdiction, or lack of jurisdiction, Congress has the last
word. ``The FDA's claim to jurisdiction contravenes the clear intent
of Congress,'' O'Connor said. The dispute between the majority and
dissent was over the clarity of Congress' intent, which the dissent
found to be much less evident.

The decision upheld a 1998 ruling by the 4th Circuit U.S. Court of
Appeals, in Richmond, Va. Four cigarette manufacturers -- Brown &
Williamson Tobacco Corp., Philip Morris Inc., Lorillard Tobacco Co.
and U.S. Tobacco Co. -- and the National Association of Convenience
Stores had gone to federal court to challenge the regulations as soon
as the FDA formally issued them in 1996. A 1997 ruling by Judge
William L. Osteen Sr. of U.S. District Court in Greensboro, N.C.,
upheld the agency's jurisdiction over controlling children's access to
cigarettes, but struck down the regulations' restrictions on
advertising and promotion.

Under the authority of the District Court's decision, the FDA has been
spending about $34 million a year since 1997 on contracts with the 50
states to help monitor compliance with state laws barring the sale of
cigarettes to those under 18. The FDA on Tuesday began to send letters
to the states announcing an ``orderly shutdown'' of the compliance
program in light of the Supreme Court ruling.

O'Connor's majority opinion in the case, Food and Drug Administration
vs. Brown & Williamson, No. 98-1152, was joined by Chief Justice
William Rehnquist and by Justices Antonin Scalia, Anthony Kennedy and
Clarence Thomas. Justices John Paul Stevens, David Souter and Ruth
Bader Ginsburg joined Breyer's dissenting opinion.

FDA's premise

The FDA regulations were based on the premise that most people who
become lifelong smokers start smoking in their early teens. To
discourage teenage smoking, the regulations prohibited the sale of
cigarettes to those under 18; the distribution of free samples or the
sale of packages of fewer than 20 cigarettes; and the use of
self-service displays or vending machines except in adults-only locations.

Retailers were required to verify, through photo identification, the
age of all purchasers younger than 27. There were also restrictions on
outdoor advertising near playgrounds and schools and on promotional
items and sponsorship of various events by cigarette companies.