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Unit: $U36

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

129

Opinion of the Court

manufacturer from sponsoring any athletic, musical, artistic,
Id.,
or other social or cultural event using its brand name.
at 44617–44618. The labeling regulation requires that the
statement, “A Nicotine-Delivery Device for Persons 18 or
Older,” appear on all tobacco product packages.
Id., at
44617.

The FDA promulgated these regulations pursuant to its
authority to regulate “restricted devices.” See 21 U. S. C.
§ 360j(e). The FDA construed § 353(g)(1) as giving it the
discretion to regulate “combination products” using the Act’s
drug authorities, device authorities, or both, depending on
“how the public health goals of the act can be best accom-
61 Fed. Reg. 44403 (1996). Given the greater
plished.”
ﬂexibility in the FDCA for the regulation of devices, the
FDA determined that “the device authorities provide the
most appropriate basis for regulating cigarettes and smoke-
Id., at 44404. Under 21 U. S. C. § 360j(e), the
less tobacco.”
agency may “require that a device be restricted to sale, dis-
tribution, or use . . . upon such other conditions as [the FDA]
may prescribe in such regulation, if, because of its potential-
ity for harmful effect or the collateral measures necessary to
its use, [the FDA] determines that there cannot otherwise
be reasonable assurance of its safety and effectiveness.”
The FDA reasoned that its regulations fell within the au-
thority granted by § 360j(e) because they related to the sale
or distribution of tobacco products and were necessary for
providing a reasonable assurance of safety. 61 Fed. Reg.
44405–44407 (1996).

Respondents, a group of tobacco manufacturers, retailers,
and advertisers, ﬁled suit in United States District Court for
the Middle District of North Carolina challenging the regula-
tions. See Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374
(1997). They moved for summary judgment on the grounds
that the FDA lacked jurisdiction to regulate tobacco prod-
ucts as customarily marketed, the regulations exceeded the
FDA’s authority under 21 U. S. C. § 360j(e), and the advertis-