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FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Breyer, J., dissenting

ing” that “the crux of FDA jurisdiction over drugs lay
in manufacturers’ representations as revelatory of their
intent”).

What changed? For one thing, the FDA obtained evi-
dence sufﬁcient to prove the necessary “intent” despite
the absence of speciﬁc “claims.” See supra, at 172–174.
This evidence, which ﬁrst became available in the early
1990’s, permitted the agency to demonstrate that the tobacco
companies knew nicotine achieved appetite-suppressing,
mood-stabilizing, and habituating effects through chemical
(not psychological) means, even at a time when the compa-
nies were publicly denying such knowledge.

Moreover, scientiﬁc evidence of adverse health effects
mounted, until, in the late 1980’s, a consensus on the serious-
ness of the matter became ﬁrm. That is not to say that con-
cern about smoking’s adverse health effects is a new phe-
in
nomenon. See, e. g., Higginson, A New Counterblast,
Out-door Papers 179, 194 (1863) (characterizing tobacco as
“ ‘a narcotic poison of the most active class’ ”).
It is to say,
however, that convincing epidemiological evidence began to
appear mid-20th century; that the ﬁrst Surgeon General’s
Report documenting the adverse health effects appeared in
1964; and that the Surgeon General’s Report establishing nic-
otine’s addictive effects appeared in 1988. At each stage,
the health conclusions were the subject of controversy, di-
minishing somewhat over time, until recently—and only re-
cently—has it become clear that there is a wide consensus
about the health problem. See 61 Fed. Reg. 44701–44706
(1996).

Finally, administration policy changed. Earlier adminis-
trations may have hesitated to assert jurisdiction for the rea-
sons prior Commissioners expressed. See supra, at 186–187
and this page. Commissioners of the current administration
simply took a different regulatory attitude.

Nothing in the law prevents the FDA from changing its
policy for such reasons. By the mid-1990’s, the evidence