Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 253.0

529US1

Unit: $U36

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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Breyer, J., dissenting

The statute’s language, then, permits the agency to choose
remedies consistent with its basic purpose—the overall pro-
tection of public health.

The second reason the FDCA does not require the FDA
to select the more dangerous remedy, see supra, at 175, is
that, despite the majority’s assertions to the contrary, the
statute does not distinguish among the kinds of health ef-
fects that the agency may take into account when assessing
safety. The Court insists that the statute only permits the
agency to take into account the health risks and beneﬁts of
the “product itself ” as used by individual consumers, ante,
at 140, and, thus, that the FDA is prohibited from consider-
ing that a ban on smoking would lead many smokers to suffer
severe withdrawal symptoms or to buy possibly stronger,
more dangerous, black market cigarettes—considerations
that the majority calls “the aggregate health effects of al-
Ibid. But the FDCA
ternative administrative actions.”
expressly permits the FDA to take account of compara-
tive safety in precisely this manner. See, e. g., 21 U. S. C.
§ 360h(e)(2)(B)(i)(II) (no device recall if “risk of recal[l]” pre-
sents “a greater health risk than” no recall); § 360h(a) (notiﬁ-
cation “unless” notiﬁcation “would present a greater danger”
than “no such notiﬁcation”).

Moreover, one cannot distinguish in this context between
a “speciﬁc” health risk incurred by an individual and an “ag-
gregate” risk to a group. All relevant risk is, at bottom,
risk to an individual; all relevant risk attaches to “the prod-
uct itself ”; and all relevant risk is “aggregate” in the sense
that the agency aggregates health effects in order to deter-
mine risk to the individual consumer.
If unregulated smok-
ing will kill 4 individuals out of a typical group of 1,000 peo-
ple, if regulated smoking will kill 1 out of 1,000, and if a
smoking ban (because of the black market) will kill 2 out of
1,000; then these three possibilities mean that in each group
four, one, and two individuals, on average, will die respec-
tively. And the risk to each individual consumer is 4/1,000,