[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] [Note: The official version of this document was published in the Federal Register from camera copy provided by the Food and Drug Administration (FDA). The graphic (TIFF) files are scanned images of those Federal Register Pages. This ASCII text version of the document (TEXT) is not an official copy and has not been certified as identical to the text published in the Federal Register. The ASCII text was provided by FDA at a later time solely to facilitate online access.] [[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).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. --------------------------------------------------------------------------- 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.