WASHINGTONWhile acknowledging that tobacco is a major health
problem, the Supreme Court has rejected the Clinton
Administrations efforts to create a new federal control effort.
It ruled 5 to 4 that Congress has clearly precluded the Food
and Drug Administration (FDA) from asserting jurisdiction to regulate
The majority, led by Justice Sandra Day OConnor, reasoned that
regulating tobacco is not within the scope of the Food, Drug, and
Cosmetics Act (FDCA). Under that law, the court reasoned, the FDA
could not simply regulate sales of tobacco to teens (as it has done
since 1997) but would have to ban cigarettes as unreasonably
dangerous. This is an outcome Congress has not permitted, the Supreme
Furthermore, the majority argued that since enactment of the FDCA,
Congress has made clear its intent to reserve regulation of tobacco
to itself by passing laws requiring warnings on cigarette packs and
tying block grant money to state laws banning sales of tobacco to
children under age 18.
President Clinton, calling the decision a setback for the
health of our children, urged Congress to pass legislation
enabling FDAs antitobacco campaign to move forward. Several
members of Congress, from both parties, did just that. However,
Senate majority leader Trent Lott (R-Miss) said he did not agree that
FDA regulation of tobacco was needed.
The case of Food and Drug Administration v. Brown & Williamson
Tobacco Corp. began when the tobacco industry challenged a 1995 FDA
decision to reverse its decades-long stand that it had no authority
over tobacco. FDA issued a proposed rule that restricted the sale,
distribution, and advertising of tobacco products to children and
A final rule was issued on August 28, 1996, after FDA determined that
nicotine is a drug, and cigarettes and smokeless tobacco products are
drug delivery devices. In issuing the rule, FDA had declared that
tobacco consumption was the single, leading cause of
preventable death in the United States.
Voters Back Giving the FDA Authority Over Tobacco
Three quarters of 800 likely voters polled 1 or 2 days after the
Support for new legislation was strong across the political spectrum,
Support was strong among both sexes and across all geographic and
A group of tobacco manufacturers, retailers, and advertisers filed
suit in the US District Court for the Middle District of North
Carolina challenging the regulations. That district court upheld
FDAs right to restrict childrens access to tobacco
products and to require labeling, but denied the agency the right to
control advertising or restrict promotions.
The Fourth US Circuit Court of Appeals reversed even the limited
regulatory powers allowed to the FDA by the lower court, holding that
Congress had not granted FDA jurisdiction to regulate tobacco products.
In agreeing with the circuit court, the Supreme Court reasoned that
there is no way that cigarettes can be made a safe device for
delivering their intended effects. Therefore, the FDCA would require
FDA to find that cigarettes are mislabeled, as there are no possible
directions for safe use. If the FDA had jurisdiction to regulate
tobacco products, Justice OConnor declared, it could not
allow them to be marketed.
She wrote for the majority: Congress, however, has foreclosed
the removal of tobacco products from the market. She also said
that Congress had addressed the problems of tobacco and health
through legislation on six occasions since 1965. The collective
premise of these statutes is that cigarettes and smokeless tobacco
will continue to be sold in the United States, she wrote.
Speaking for herself and four fellow Justices, Justice OConnor
declared that Congress has created a distinct regulatory scheme
to address the problem of tobacco and health, and that scheme, as
presently constructed, precludes any role for the FDA.
She noted that on several occasions Congress had debated giving FDA
this jurisdiction, but none of these proposals became law.
Congress had also denied the Federal Trade Commission and the
Consumer Product Safety Commission the power to regulate aspects of tobacco.
The dissenters, led by Justice Stephen Breyer, insisted that tobacco
products do fall within the scope of the law and that Congress
neither forbade nor approved an FDA role in regulating tobacco in 35
years of legislation on the subject.
This history shows only that Congress could not muster the
votes necessary either to grant or deny the FDA relevant
authority, Justice Breyer wrote.
He and three other Justices argued that the original FDCA was broad
enough to encompass tobacco. That allowed the agency to change its
mind and decide that it does have the power to act once it received
evidence that the tobacco companies knew that nicotine achieved its
appetite-suppressing and mood-altering effects through chemically
induced changes in the brain.
Justice Breyer insisted that the FDCA would not require FDA to ban
cigarettes if the FDAs actions were upheld. But even if I
am wrong about the ban, the statute would restrict only the
agencys choice of remedies, not its jurisdiction, he wrote.
Justice OConnor for the Majority
However, Justice OConnor ruled for the majority that
Congress has affirmatively acted to address the issue of
tobacco and health, relying on the representations of the FDA that it
had no authority to regulate tobacco. It has created a distinct
scheme to regulate the sale of tobacco products, focused on labeling
and advertising, and premised on the belief that the FDA lacks such
jurisdiction under the FDCA. As a result, Congress
tobacco-specific statutes preclude the FDA from regulating tobacco
products as customarily marketed.
Justice OConnor took great pains to clarify that the high court
does not question the seriousness of the problem that the FDA
has sought to address. She made it clear that tobacco use,
especially among children and adolescents, is a serious threat to
public health. But she said that Congress had not given FDA authority
to address this major public health threat.
The high courts decision negates FDA requirements that
retailers selling cigarettes check photo identification of persons
who appear younger than age 27 to determine that they are at least