Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 197

529US1

Unit: $U36

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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Syllabus

See 15 U. S. C. § 1331. Thus, an FDA ban would plainly contradict con-
gressional intent. Apparently recognizing this dilemma, the FDA has
concluded that tobacco products are actually “safe” under the FDCA
because banning them would cause a greater harm to public health than
leaving them on the market. But this safety determination—focusing
on the relative harms caused by alternative remedial measures—is not
a substitute for those required by the FDCA. Various provisions in
the Act require the agency to determine that, at least for some consum-
ers, the product’s therapeutic beneﬁts outweigh the risks of illness or
serious injury. This the FDA cannot do, because tobacco products are
unsafe for obtaining any therapeutic beneﬁt. The inescapable conclu-
sion is that there is no room for tobacco products within the FDCA’s
regulatory scheme.
If they cannot be used safely for any therapeu-
tic purpose, and yet they cannot be banned, they simply do not ﬁt.
Pp. 133–143.

(c) The history of tobacco-speciﬁc legislation also demonstrates that
Congress has spoken directly to the FDA’s authority to regulate tobacco
products. Since 1965, Congress has enacted six separate statutes ad-
dressing the problem of tobacco use and human health. Those statutes,
among other things, require that health warnings appear on all packag-
ing and in all print and outdoor advertisements, see 15 U. S. C. §§ 1331,
1333, 4402; prohibit the advertisement of tobacco products through any
electronic communication medium regulated by the Federal Communica-
tions Commission, see §§ 1335, 4402(f); require the Secretary of HHS
to report every three years to Congress on research ﬁndings concern-
ing tobacco’s addictive property, 42 U. S. C. § 290aa–2(b)(2); and make
States’ receipt of certain federal block grants contingent on their prohib-
iting any tobacco product manufacturer, retailer, or distributor from
selling or distributing any such product to individuals under age 18,
§ 300x–26(a)(1). This tobacco-speciﬁc legislation has created a speciﬁc
regulatory scheme for addressing the problem of tobacco and health.
And it was adopted against the backdrop of the FDA consistently and
resolutely stating that it was without authority under the FDCA to
In fact, Congress
regulate tobacco products as customarily marketed.
several times considered and rejected bills that would have given the
FDA such authority.
Indeed, Congress’ actions in this area have evi-
denced a clear intent to preclude a meaningful policymaking role for any
administrative agency. Further, Congress’ tobacco legislation prohibits
any additional regulation of tobacco product labeling with respect to
tobacco’s health consequences, a central aspect of regulation under the
FDCA. Under these circumstances, it is evident that Congress has rat-
iﬁed the FDA’s previous, long-held position that it lacks jurisdiction to
regulate tobacco products as customarily marketed. Congress has