Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 209

529US1

Unit: $U36

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

134

FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Opinion of the Court

the FDA’s “[m]ission” to include “protect[ing] the public
health by ensuring that . . . drugs are safe and effective”
and that “there is reasonable assurance of the safety and
effectiveness of devices intended for human use.” The
FDCA requires premarket approval of any new drug, with
some limited exceptions, and states that the FDA “shall
issue an order refusing to approve the application” of a new
drug if it is not safe and effective for its intended purpose.
If the FDA discovers after approval
§§ 355(d)(1)–(2), (4)–(5).
that a drug is unsafe or ineffective, it “shall, after due notice
and opportunity for hearing to the applicant, withdraw ap-
proval” of the drug. 21 U. S. C. §§ 355(e)(1)–(3). The Act
also requires the FDA to classify all devices into one of three
categories.
§ 360c(b)(1). Regardless of which category the
FDA chooses, there must be a “reasonable assurance of
the safety and effectiveness of the device.” 21 U. S. C.
§§ 360c(a)(1)(A)(i), (B), (C) (1994 ed. and Supp. III); 61 Fed.
Reg. 44412 (1996). Even the “restricted device” provision
pursuant to which the FDA promulgated the regulations at
issue here authorizes the agency to place conditions on the
sale or distribution of a device speciﬁcally when “there can-
not otherwise be reasonable assurance of its safety and effec-
tiveness.”
21 U. S. C. § 360j(e). Thus, the Act generally re-
quires the FDA to prevent the marketing of any drug or
device where the “potential for inﬂicting death or physical
injury is not offset by the possibility of therapeutic beneﬁt.”
United States v. Rutherford, 442 U. S. 544, 556 (1979).

In its rulemaking proceeding, the FDA quite exhaustively
documented that “tobacco products are unsafe,” “danger-
ous,” and “cause great pain and suffering from illness.” 61
Fed. Reg. 44412 (1996).
It found that the consumption of
tobacco products presents “extraordinary health risks,” and
that “tobacco use is the single leading cause of preventable
death in the United States.”
It stated that
“[m]ore than 400,000 people die each year from tobacco-
related illnesses, such as cancer, respiratory illnesses, and

Id., at 44398.