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43 Wayne L. Rev. 1533 (1996-1997)
Smoke and Mirrors - An Analysis of the Food and Drug Administration's Jurisdiction over Tobacco

handle is hein.journals/waynlr43 and id is 1545 raw text is: SMOKE AND MIRRORS?
AN ANALYSIS OF THE FOOD AND DRUG
ADMINISTRATION'S JURISDICTION
OVER TOBACCO
I. INTRODUCTION
After a long history of freedom from extensive regulation, the
tobacco industry is on the verge of a new era. In August 1995, the
Food and Drug Administration (FDA) issued proposed regulations
targeted at the sale and promotion of tobacco products.1 Although
the action was widely hailed as a necessary measure to combat the
epidemic of teen smoking,2 the tobacco industry went on the
offensive, challenging both the content of the new regulations3 and
the FDA's authority to promulgate them.' The final regulations
1. See Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco Products to Protect Children and-Adolescents, 60 Fed. Reg.
41,314 (1995) (to be codified at 21 C.F.R. pts. 801, 803, 804, 897) (proposed Aug.
11, 1995).
2. See id at 41,322.The FDA's stated purpose in the proposed regulations
was to help prevent persons younger than eighteen years of age from becoming
addicted to nicotine, thereby avoiding the life-threatening consequences often
associated with tobacco use. Id
3. This Note focuses on the issue of the FDA's jurisdiction over tobacco and
whether the new regulations are an appropriate regulatory scheme. The other
challenge to the new regulations is the claim that they violate the First
Amendment because they unnecessarily restrict commercial speech. American
Advertising Federation v. Kessler, Civil Action 2:95CV00593 (M.D.N.C.). This
lawsuit was consolidated with the Coyne Beabm case. See Coyne v. Beahm, Inc.
v. FDA, 966 F. Supp. 1374, 1400 n.32, 33 (M.D.N.C. 1997).
4. The lawsuit the industry collectively filed in Federal District Court in
North Carolina against the FDA is Coyne Beahm, Inc., Brown & Williamson
Tobacco Corp., Liggett Group Inc., Lorillard Tobacco Co., Philip Morris Inc.,
and R.J. Reynolds Tobacco Co. v. United States Food & Drug Administration
and David A. Kessler, M.D., Comm'r of FDA, 966 F. Supp. 1374 (M.D.N.C.
1997). In April 1997 Judge Osteen rendered a decision in the Coyne Beabm case
on the plaintiff's motion for summary judgement. Judge Osteen denied the
motion as to the claim that the FDA did not have jurisdiction to regulate
tobacco products. See id. at 1396-97. However, the court granted plaintiff's

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