Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 214

529US1

Unit: $U36

[09-26-01 08:36:38] PAGES PGT: OPIN

Cite as: 529 U. S. 120 (2000)

139

Opinion of the Court

economy may be . . . protected to the maximum extent con-
sistent with” consumers “be[ing] adequately informed about
any adverse health effects.” 15 U. S. C. § 1331. Congress’
decisions to regulate labeling and advertising and to adopt
the express policy of protecting “commerce and the national
economy . . . to the maximum extent” reveal its intent that
tobacco products remain on the market.
Indeed, the collec-
tive premise of these statutes is that cigarettes and smoke-
less tobacco will continue to be sold in the United States. A
ban of tobacco products by the FDA would therefore plainly
contradict congressional policy.

The FDA apparently recognized this dilemma and con-
cluded, somewhat ironically, that tobacco products are ac-
tually “safe” within the meaning of the FDCA.
In promul-
gating its regulations, the agency conceded that “tobacco
products are unsafe, as that term is conventionally under-
61 Fed. Reg. 44412 (1996). Nonetheless, the FDA
stood.”
reasoned that, in determining whether a device is safe under
the Act, it must consider “not only the risks presented by a
product but also any of the countervailing effects of use of
that product, including the consequences of not permitting
the product to be marketed.”
Id., at 44412–44413. Apply-
ing this standard, the FDA found that, because of the high
level of addiction among tobacco users, a ban would likely be
In particular, current tobacco
“dangerous.”
users could suffer from extreme withdrawal, the health care
system and available pharmaceuticals might not be able to
meet the treatment demands of those suffering from with-
drawal, and a black market offering cigarettes even more
dangerous than those currently sold legally would likely de-
velop.
Ibid. The FDA therefore concluded that, “while
taking cigarettes and smokeless tobacco off the market could
prevent some people from becoming addicted and reduce
death and disease for others, the record does not establish
that such a ban is the appropriate public health response
under the act.”

Id., at 44413.

Id., at 44398.