[Federal Register: August 11, 1995 (Volume 60, Number 155)]
[Notices]
[Page 41471-41472]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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[[Page 41471]]

II. TOBACCO MANUFACTURERS ``INTEND'' THAT THEIR PRODUCTS HAVE ADDICTIVE
AND SIGNIFICANT PHARMACOLOGICAL EFFECTS.

    The FDCA, FDA's regulations, and judicial decisions interpreting
the Act and analogous provisions in other public welfare statutes all
demonstrate that ``intended to'' and ``intended for,'' as used in the
Act, denote objective intent, as that term has become commonly
understood by the courts. Objective intent may be determined by what a
reasonable person would understand in the circumstances presented, or
whether a ``reasonable person would believe'' that the defendant's
conduct would lead to certain events. See, e.g, United States v.
Articles of Banned Hazardous Substances * * * Baby Rattles, 614 F.
Supp. 226, 231 (E.D.N.Y. 1985) (``[t]he only rational interpretation of
the word 'intended' in the statute calls for an objective test of
intent: whether a reasonable person would believe that the object is a
toy''); W. Page Keeton et al., Prosser and Keeton on the Law of Torts
Sec. 8, at 36 (5th ed. 1984) (``relying on circumstantial evidence,
[one] may infer that the actor's state of mind was the same as a
reasonable person's state of mind would have been'').
    The courts have also described objective intent in terms of
foreseeability. For example, in United States v. Focht, the Third
Circuit held that the intent requirement in the ``intended to produce
[banned] fireworks'' language of the regulations implementing the
Federal Hazardous Substance Act (FHSA) could be satisfied by a
demonstration that it was ``foreseeable'' that the components sold by
the defendant would be used to build banned products. 882 F.2d 55, 59-
60 (3d Cir. 1989); see 15 U.S.C. Sec. 1261(q). Similarly, in defining
discriminatory intent in a voting rights case, the Fifth Circuit held
that ``[o]bjective intent * * * presumes that a person intends the
natural and foreseeable consequences of his voluntary

[[Page 41472]]
actions.'' Lee v. Lee County Bd. of Ed., 639 F.2d 1243, 1267 (5th Cir.
1981).<SUP>4

    \4\ Subjective intent, on the other hand, considers the actual
state of mind of the responsible actor. See, e.g., Ellington v.
Metropolitan Life Ins. Co., 696 F. Supp. 1237, 1242 (S.D. Ind. 1988)
(a subjective intent test requires a determination that the
defendant actually foresaw the result of his conduct and persisted
nonetheless). This standard, which focuses on the actor's actual
desires and knowledge, has been applied in certain areas of criminal
law when the critical issue is the culpability of a particular
actor. See, e.g., Morisette v. United States, 342 U.S. 246, 250-52
(1952). It is not used as a standard of proof for intent in public
health and welfare statutes such as the FDCA.
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    Subsection A, infra, demonstrates that an objective intent standard
is the appropriate standard under the FDCA. The evidence in subsection
B, infra, demonstrates that tobacco manufacturers ``intend'' cigarettes
and smokeless tobacco products to affect the structure or any function
of the body within the meaning of the FDCA.