Supreme Court Overrides FDA -- Condemns Tobacco Industry
Tuesday, March 21, 2000
U.S. Supreme Court: FDA Cannot Regulate Tobacco as Drug
WASHINGTON (AP) - The Supreme Court today rejected
the Clinton administration's main anti-smoking initiative,
ruling the government lacks authority to regulate tobacco
as an addictive drug. Ruling 5-4, the justices said the Food
and Drug Administration overreached when it reversed a
decades-old policy in 1996 and sought to crack down on
cigarette sales to minors.
"We believe that Congress has clearly precluded the FDA
from asserting jurisdiction to regulate tobacco products,"
Justice Sandra Day O'Connor wrote for the court.
"By no means do we question the seriousness of the
problem that the FDA has sought to address," O'Connor
said. "The agency has amply demonstrated that tobacco
use, particularly among children and adolescents, poses
perhaps the single most significant threat to public health
in the United States."
However, she added, "it is plain that Congress has not
given the FDA the authority that it seeks to exercise here."
O'Connor's opinion was joined by Chief Justice William
H. Rehnquist and Justices Antonin Scalia, Anthony
M. Kennedy and Clarence Thomas.
Dissenting were Justices Stephen G. Breyer, John Paul
Stevens, David H. Souter and Ruth Bader Ginsburg.
Writing for the four, Breyer said federal law allows the FDA
to regulate tobacco. "Far more than most, this particular
drug and device risks the life-threatening harms that
administrative regulation seeks to rectify," he added.
The Clinton administration called the 1996 initiative the
FDA's most important public health and safety effort in the
past 50 years. The best way to cut down on smoking is to
reduce the number of teen-agers who start, officials
The tobacco industry has been under increasing pressure
for selling a product the American Cancer Society calls
the leading cause of cancer. The Justice Department is
suing the industry, which already has agreed to pay the
states $246 billion for the cost of treating smoking-related
The nation's largest cigarette maker, Philip Morris Co.,
acknowledged last October that smoking is addictive and
causes cancer. The third-biggest company, Brown &
Williamson Tobacco, said in April 1999 that smokers
"are taking significant health risks."
In February, a Philip Morris Co. executive said the company
was willing to discuss some government regulation of the
tobacco industry, but that the company still opposed the
FDA's effort to regulate tobacco as a drug.
The FDA said for decades that it lacked authority under a
1938 law to regulate tobacco so long as cigarette makers
did not claim that smoking provided health benefits.
But it reversed itself in 1996, saying it could regulate
tobacco because of new evidence that the industry
intended its products to feed consumers' nicotine habits.
All 50 states already ban tobacco sales to anyone under
18. In addition to adopting that as a federal rule, the FDA
required stores to demand photo I.D. from all tobacco
purchasers under age 27 and limited vending-machine
cigarette sales to adults-only locations, such as bars.
Tobacco companies sued, and the 4th U.S. Circuit Court
of Appeals ruled in 1998 that the FDA could not regulate
tobacco. The court said that decision is up to Congress,
which previously has banned broadcast advertising of
tobacco, prohibited smoking on airlines and required
warning labels on cigarette packages.
During arguments before the Supreme Court last
December, Solicitor General Seth Waxman said the
FDA can regulate tobacco as a drug because nicotine
is "highly addictive" and acts as a stimulant, a sedative
and an appetite suppressant, and also feeds smokers'
addictions. Forty states backed the government's appeal.
But the tobacco industry's lawyer argued that if FDA
regulation were allowed, the government would be forced
to ban tobacco products because they have not been
shown to be safe. O'Connor's opinion noted that the
FDA has concluded that cigarettes are unsafe and
dangerous. As a result, she said, federal law "would
require the FDA to remove them from the market entirely."
"The inescapable conclusion is that there is no room for
tobacco products within the (federal law's) regulatory
scheme," she wrote. "If they cannot be used safely for
any therapeutic purpose, and yet they cannot be banned,
they simply do not fit."
Breyer said he did not believe the law would require a
ban on cigarettes. He also said the fact that only a 2.5% of smokers manage
to quit each year "illustrates a certain reality - the reality
that the nicotine in cigarettes creates a powerful
physiological addiction flowing from chemically induced
changes in the brain."
All 50 states have reached settlements in which tobacco
companies will pay them $246 billion for the cost of
treating smoking-related illnesses. Cigarette billboards
around the country were taken down last year as part of
The Justice Department also sued the industry last
September, seeking additional billions of dollars to repay
federal health-insurance costs.
A Florida jury ruled in a class-action lawsuit last July that
the five largest cigarette makers produced a defective
and deadly product. A jury is considering damages that
industry lawyers say could exceed $300 billion.
Among the Supreme Court's nine justices, Rehnquist and
Scalia are smokers, while Thomas used to smoke cigars.
The case is FDA vs. Brown & Williamson Tobacco Corp., 98-1152.
source: Bill Godshall