Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 252.0

529US1

Unit: $U36

[09-26-01 08:36:39] PAGES PGT: OPIN

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

177

Breyer, J., dissenting

directions when regulated so as to render it as harmless as
possible. And surely the agency can determine that a sub-
stance is comparatively “safe” (not “dangerous”) whenever it
would be less dangerous to make the product available (sub-
ject to regulatory requirements) than suddenly to withdraw
it from the market. Any other interpretation risks substan-
tial harm of the sort that my sleeping pill example illus-
trates. See supra, at 174–175. And nothing in the statute
prevents the agency from adopting a view of “safety” that
would avoid such harm.
Indeed, the FDA already seems to
have taken this position when permitting distribution of
toxic drugs, such as poisons used for chemotherapy, that are
dangerous for the user but are not deemed “dangerous to
health” in the relevant sense. See 61 Fed. Reg. 44413 (1996).
The tobacco companies point to another statutory provi-
sion which says that if a device “would cause serious, adverse
health consequences or death, the Secretary shall issue” a
cease distribution order. 21 U. S. C. § 360h(e)(1) (emphasis
added). But that word “shall” in this context cannot mean
that the Secretary must resort to the recall remedy when-
ever a device would have serious, adverse health effects.
Rather, that language must mean that the Secretary “shall
issue” a cease distribution order in compliance with the sec-
tion’s procedural requirements if the Secretary chooses in
her discretion to use that particular subsection’s recall rem-
edy. Otherwise, the subsection would trump and make
meaningless the same section’s provision of other lesser rem-
edies such as simple “notice” (which the Secretary similarly
can impose if, but only if, she ﬁnds that the device “presents
an unreasonable risk of substantial harm to the public”).
§ 360h(a)(1). And reading the statute to compel the FDA to
“recall” every dangerous device likewise would conﬂict with
that same subsection’s statement that the recall remedy
“shall be in addition to [the other] remedies provided” in the
statute.

§ 360h(e)(3) (emphasis added).