188
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 evidence 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 companies were publicly denying such knowledge.
Moreover, scientific evidence of adverse health effects mounted, until, in the late 1980's, a consensus on the seriousness of the matter became firm. That is not to say that concern about smoking's adverse health effects is a new phenomenon. See, e. g., Higginson, A New Counterblast, in 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 nicotine's addictive effects appeared in 1988. At each stage, the health conclusions were the subject of controversy, diminishing somewhat over time, until recently—and only recently—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 administrations may have hesitated to assert jurisdiction for the reasons 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
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