Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 254.0

529US1

Unit: $U36

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

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

179

Breyer, J., dissenting

1/1,000, and 2/1,000 respectively. A “speciﬁc” risk to an indi-
vidual consumer and “aggregate” risks are two sides of the
same coin; each calls attention to the same set of facts.
While there may be a theoretical distinction between the
risk of the product itself and the risk related to the presence
or absence of an intervening voluntary act (e. g., the search
for a replacement on the black market), the majority does
not rely upon any such distinction, and the FDA’s history of
regulating “replacement” drugs such as methadone shows
that it has long taken likely actual alternative consumer be-
havior into account.

I concede that, as a matter of logic, one could consider the
FDA’s “safety” evaluation to be different from its choice of
remedies. But to read the statute to forbid the agency from
taking account of the realities of consumer behavior either
in assessing safety or in choosing a remedy could increase
the risks of harm—doubling the risk of death to each “indi-
vidual user” in my example above. Why would Congress
insist that the FDA ignore such realities, even if the conse-
quent harm would occur only unusually, say, where the FDA
evaluates a product (a sleeping pill; a cigarette; a contact
lens) that is already on the market, potentially habit forming,
or popular?
I can ﬁnd no satisfactory answer to this ques-
tion. And that, I imagine, is why the statute itself says
nothing about any of the distinctions that the Court has tried
to draw. See 21 U. S. C. § 360c(a)(2) (instructing FDA to de-
termine the safety and effectiveness of a “device” in part by
weighing “any probable beneﬁt to health . . . against any
probable risk of injury or illness . . .” (emphasis added)).

Third, experience counsels against an overly rigid inter-
pretation of the FDCA that is divorced from the statute’s
overall health-protecting purposes. A different set of
words, added to the FDCA in 1958 by the Delaney Amend-
ment, provides that “no [food] additive shall be deemed to
be safe if it is found [after appropriate tests] to induce cancer
§ 348(c)(3). The FDA
when ingested by man or animal.”