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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Breyer, J., dissenting

once interpreted this language as requiring it to ban any food
additive, no matter how small the amount, that appeared in
any food product if that additive was ever found to induce
cancer in any animal, no matter how large a dose needed to
induce the appearance of a single carcinogenic cell. See
H. R. Rep. No. 95–658, p. 7 (1977) (discussing agency’s view).
The FDA believed that the statute’s ban mandate was abso-
lute and prevented it from establishing a level of “safe use”
or even to judge whether “the beneﬁts of continued use out-
weigh the risks involved.”
Id., at 5. This interpretation—
which in principle could have required the ban of everything
from herbal teas to mushrooms—actually led the FDA to
ban saccharine, see 42 Fed. Reg. 19996 (1977), though this
extremely controversial regulatory response never took ef-
fect because Congress enacted, and has continually renewed,
a law postponing the ban. See Saccharin Study and Label-
ing Act, Pub. L. 95–203, § 3, 91 Stat. 1452; e. g., Pub. L. 102–
142, Tit. VI, 105 Stat. 910.

The Court’s interpretation of the statutory language be-
fore us risks Delaney-type consequences with even less lin-
guistic reason. Even worse, the view the Court advances
undermines the FDCA’s overall health-protecting purpose
by placing the FDA in the strange dilemma of either banning
completely a potentially dangerous drug or device or doing
nothing at all. Saying that I have misunderstood its conclu-
sion, the majority maintains that the FDA “may clearly reg-
ulate many ‘dangerous’ products without banning them.”
Ante, at 142. But it then adds that the FDA must ban—
rather than otherwise regulate—a drug or device that “can-
not be used safely for any therapeutic purpose.”
If I
misunderstand, it is only because this linchpin of the majori-
ty’s conclusion remains unexplained. Why must a widely
used but unsafe device be withdrawn from the market when
that particular remedy threatens the health of many and is
thus more dangerous than another regulatory response?
It
is, indeed, a perverse interpretation that reads the FDCA

Ibid.