[Federal Register: August 11, 1995 (Volume 60, Number 155)]
[Notices]
[Page 41460-41461]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[Note: The official version of this document was published in the
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[[Page 41460]]

INTRODUCTION

    Part One of this document (Legal Analysis of Jurisdiction over
Tobacco Products) consists of three main sections. Section I
demonstrates that nicotine's addictive and other pharmacological
properties are effects on the ``structure or any function of the body''
within the meaning of the Act's definition of a drug. Section II
demonstrates that tobacco manufacturers intend their products to have
these effects within the meaning of the Act because: these effects are
widely known and foreseeable to the industry; most consumers use
tobacco products to obtain these effects; and tobacco manufacturers
understand that consumers use tobacco products to obtain nicotine's
pharmacologic effects and design their products to be used for these
effects. Section III explains why regulation of cigarettes and
smokeless tobacco products as devices is most appropriate at this time.
    Part Two of this document (Findings) consists of two main sections.
Section I presents the scientific evidence of nicotine's addictive and
other pharmacological effects. This section also explains how marketed
tobacco products deliver pharmacologically active doses of nicotine,
and how consumers use these products to obtain various drug effects.
Section II describes the statements, extensive research, and other
actions by tobacco manufacturers regarding nicotine's pharmacological
effects. This section identifies the industry's numerous
acknowledgments that nicotine in tobacco acts as a drug and is
addictive, and the industry's extensive research on nicotine's drug
effects on the body. Section II also describes the considerable
industry research on supplying sufficient nicotine to provide
``satisfaction,'' determining the minimum and maximum dose of nicotine
required by consumers, and assessing how consumers ``compensate'' to
achieve an adequate dose of

[[Page 41461]]
nicotine.
    Section II provides further evidence that manufacturers intend to
market these products for their pharmacological effects, including
explanations of the industry's: product development research to ensure
that their products deliver doses of nicotine adequate to achieve
pharmacological effects; manipulation and control of nicotine in
marketed products; development of nicotine substitutes and alternative
products that provide nicotine's drug effects; knowledge that
nicotine's sensory effects are secondary to its pharmacological
effects; and failure to remove nicotine from tobacco despite the
available technology to do so.
    Part Three of this document (Regulatory Objectives) summarizes
FDA's objectives in regulating cigarettes and smokeless tobacco
products. This section explains why, despite the significant public
health problem caused by cigarettes and smokeless tobacco products, it
would not be appropriate to remove them from the market because
approximately 40 million Americans are addicted to these products. The
section summarizes the evidence that almost all tobacco use begins
during childhood or adolescence, and that the prevalence of tobacco use
by children and adolescents is increasing. Therefore, the goal of FDA's
regulatory action will be to reduce tobacco use by children and
teenagers and prevent future generations from becoming addicted to
nicotine-containing tobacco products.