The FDA’s Attempt to Scare the Smoke Out of You: Has the FDA Gone Too Far with the Nine New Cigarette Warning Labels

Summer 2012, Volume 117, Issue 1

The FDA’s Attempt to Scare the Smoke Out of You:  Has the FDA Gone Too Far with the Nine New Cigarette Warning Labels?
Kristin M. Sempeles 117 Penn St. L. Rev.223 (2012)
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ABSTRACT

The Family Smoking Prevention and Tobacco Control Act (“The Act”)[1] of June 2009 marked the first change to cigarette warning labels in the United States in over 25 years.[2]  The Act, for the first time, gave the Food and Drug Administration (FDA) authority to regulate tobacco products.[3]  In June 2011, under The Act, the FDA introduced the Required Warnings for Cigarette Packages and Advertisements (“The Rule”),[4] which imposed new regulations on cigarettes.[5]

Under The Rule, one of nine new graphic warning labels is required to appear on all cigarette packages and advertisements by September 2012.[6]  The Rule requires the warning labels to include colored images such as a plume of cigarette smoke enveloping an infant who is receiving a kiss from her mother; a healthy lung adjacent to a diseased lung; an image of the inside of a mouth afflicted with cancerous lesions; a bare-chested male cadaver lying in the morgue; and a woman weeping uncontrollably.[7]  In addition to the graphic warnings, The Rule mandates that all cigarette packages display both a direct exhortation to smokers to quit[8] and one of the nine specified textual warnings required by The Act.[9]  The warnings include “Cigarettes cause cancer,” “Smoking during pregnancy can harm your baby,” and “Smoking can kill you.”[10]  Under The Act, the warning labels must be prominently displayed on the top 50 percent of the front and back panels of all cigarette packages and advertisements.[11]  Unlike previous warning labels, which conveyed purely factual information, the new warning labels cross over the line of informative warnings into anti-smoking advocacy.[12]  While The Act dictates many of the requirements for The Rule and provides the FDA with the power to regulate cigarettes, The Rule proposed by the FDA goes beyond its regulatory authority and imposes additional restrictions on the speech of tobacco companies.[13]

To further explore whether The Rule is constitutional or whether the courts should permanently enjoin the FDA from enforcing The Rule, this Comment will first outline the history of the FDA and relevant tobacco regulations in Section II.  Specifically, Subsection II.A will discuss the history of the FDA’s regulatory authority on tobacco products, and, in addition, will provide an overview of relevant legislative acts that have been enacted to regulate tobacco products.  Subsection II.B will analyze The Act,[14] the federal government’s most recent and controversial legislative act designed to impose new regulations on tobacco products.  In addition, Subsection II.C will examine The Rule[15] enacted by the FDA requiring tobacco companies to adhere nine new graphic warning labels to all cigarette packaging and advertisements.

Section III of this Comment will examine the development of the commercial freedom of speech doctrine[16] under the First Amendment.  Specifically, Subsection III.A will discuss the landmark case on commercial freedom of speech, Central Hudson Gas and Electric Corporation v. Public Service Commission of New York.[17]  This Supreme Court case provided a four-part test for determining the constitutionality of free speech, which will also be analyzed further.[18]  This analysis is followed by Subsection III.B, which examines Lorillard Tobacco Corporation v. Reilly,[19] one of the Supreme Court’s most recent commercial free speech cases.

Section IV will analyze whether The Rule is constitutional.  First, the analysis will assess The Rule under the Central Hudson four-part test[20] to determine if it violates the tobacco companies’ First Amendment rights.  Next, the analysis will focus on whether the FDA is overstepping its regulatory authority with the new restrictions[21] it imposes on tobacco companies under The Rule.

Section V of this Comment will address alternatives that the FDA can use to inform consumers about the adverse health effects of cigarettes without violating tobacco companies’ First Amendment rights.  This Comment will conclude with Part VI, which summarizes why The Rule will likely be found unconstitutional, the direction the government should take to benefit public health and safety, and why it is in the best interest of the public for the Supreme Court to grant a permanent injunction on the FDA’s Rule.