Document ID: ./input/supremecourt_opinions/opinions/boundvolumes/529bv.pdf
Page Number: 245

529US1

Unit: $U36

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170

FDA v. BROWN & WILLIAMSON TOBACCO CORP.

Breyer, J., dissenting

plainly is not a “food,” its chemical effects sufﬁce to establish
that it is as a “drug” (and the cigarette that delivers it a
drug-delivery “device”) for the purpose of the FDCA.

B

The tobacco companies’ principal deﬁnitional argument fo-
cuses upon the statutory word “intended.” See 21 U. S. C.
§ 321(g)(1)(C). The companies say that “intended” in this
context is a term of art. See Brief for Respondent Brown &
Williamson Tobacco Corp. 2. They assert that the statutory
word “intended” means that the product’s maker has made
an express claim about the effect that its product will have
Indeed, according to the companies, the
on the body.
FDA’s inability to prove that cigarette manufacturers make
such claims is precisely why that agency historically has said
it lacked the statutory power to regulate tobacco. See id.,
at 19–20.

Ibid.

The FDCA, however, does not use the word “claimed”; it
uses the word “intended.” And the FDA long ago issued
regulations that say the relevant “intent” can be shown not
only by a manufacturer’s “expressions,” but also “by the cir-
cumstances surrounding the distribution of the article.” 41
Fed. Reg. 6896 (1976) (codiﬁed at 21 CFR § 801.4 (1999)); see
also 41 Fed. Reg. 6896 (1976) (“objective intent” shown if
“article is, with the knowledge [of its makers], offered and
used” for a particular purpose). Thus, even in the absence
of express claims, the FDA has regulated products that af-
fect the body if the manufacturer wants, and knows, that
consumers so use the product. See, e. g., 60 Fed. Reg.
41527–41531 (1995) (describing agency’s regulation of topical
hormones, sunscreens, ﬂuoride, tanning lamps, thyroid in
food supplements, novelty condoms—all marketed without
express claims); see also 1 O’Reilly § 13.04, at 13–15 (“Some-
times the very nature of the material makes it a drug . . .”).
Courts ordinarily reverse an agency interpretation of this
kind only if Congress has clearly answered the interpretive