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Tobacco: Selected Legal Issues
Introduction
Over the past decade, the courts and the Congress have been grappling with
tobacco-related issues. Among these issues are the Food and Drug Administration's
attempt to regulate tobacco under the Federal Food, Drug, and Cosmetic Act; the
Master Settlement Agreement that resulted from lawsuits by states attorneys general
against tobacco companies; federal, private party, and foreign lawsuits against
tobacco companies; limits on tobacco advertising; and restrictions on selling and
distributing tobacco to minors. During the 110th Congress, legislators have
introduced several bills that address some of the above issues, including H.R. 1108,
H.R. 2633, H.R. 3043, S. 625, S. 1162, S. 1342, S. 1834, and S.Con.Res. 21.
The FDA's Ability to Regulate Tobacco Products
Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA) in 1938
in response to a tragedy in which 100 people died after taking a drug containing a
highly toxic substance. The statute increased the Food and Drug Administration's
(FDA) enforcement power, gave the FDA jurisdiction over previously unregulated
cosmetics and devices, and instituted safety measures such as requiring instruction
labels on drugs and a pre-market approval process for new drugs.2 Since 1938, the
law has been amended numerous times.3
The FDCA is organized into chapters that address drugs, devices, food, and
cosmetics, as well as statutory definitions, actions prohibited by the FDCA, the
FDA's general authorities, imports and exports, and other miscellaneous issues. In
order to understand how the FDA attempted to regulate tobacco, one must first
understand the definitions of "drug" and "device." Under the FDCA, "drugs" fall
into three categories or an inclusive fourth category comprised of articles intended
to become a component of any of the other three categories. These three categories
are (1) "articles recognized in the official United States Pharmacopoeia" or a similar
standard-setting body for prescriptions and over-the-counter medications;
(2) "articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in man or other animals"; and (3) "articles (other than food)
1 21 U.S.C. 301 et seq.
2 James T. O'Reilly, Food and Drug Administration, 3.4 (2005).
3 Amendments to the FDCA have included a broad range of topics such as food and color
additives, animal drugs, drug abuse control, infant formula, saccharin labeling, orphan
drugs, nutrition information and food allergen labeling, prescription drug marketing and
importation, safe medical devices, and dietary supplements.
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Tobacco: Selected Legal Issues, report, September 3, 2008; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc819771/m1/4/: accessed March 19, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.