Will Congressional action go up in smoke? Overcoming obstacles in granting the FDA jurisdiction over tobacco products

Georgetown Law Journal, Jul 1998 by Kamensky, Daniel B

DANIEL B. KAMENSKY*

Although the tobacco industry had fought for decades to convince the public and the public health community of the safety of tobacco,1 on August 11, 1995 the Food and Drug Administration (FDA) took the historic step of asserting jurisdiction2 over tobacco products.3 When the United States Court of Appeals for the Fourth Circuit4 failed to uphold the FDA's broad assertion of jurisdiction on August 14, 1998, Congress promised to explicitly confer jurisdiction on the agency.5 Poised to address starkly different visions of regulatory authority over tobacco products, Congress faces the difficult dilemma of overcoming historical inaction and balancing constitutional principles of accountability with the need to maintain regulatory flexibility.6

This note argues that the appellate court's refusal to uphold the FDA's broad assertion of regulatory authority over tobacco products signals a modification and improvement of the current application of the Supreme Court's decision in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc.7 Under the current application of Chevron,8 Congress would enact prescriptive tobacco legislation with burdensome procedural hurdles and high evidentiary standards. In Chevron, the Supreme Court established a two-step review process of an agency's interpretation of a statute that seemingly allows agencies to construct consistent and coherent regulatory programs.9 Under step one, the reviewing court follows the plain language of the statute-rather than the agency's interpretation-if Congress clearly expresses its policymaking preferences in unambiguous language. If congressional intent is unclear, however, the reviewing court generally defers to the agency's construction of the statute under step two.10 This two-step analysis has encouraged Congress to enact overly detailed statutes to retain control over agency actions. When the appellate court refused to defer to the FDA's construction of a seemingly ambiguous statute it altered the Chevron framework. This modified framework will permit Congress to grant the FDA broad authority to regulate tobacco products while still maintaining authority over fundamental policymaking decisions.

Part I of this note argues that Congress has an historic opportunity to assert FDA regulatory authority over tobacco products after years of acquiescence to the powerful tobacco lobby. Recent events-including the release of damaging internal tobacco company documents and the success of state-led lawsuits against the tobacco industry-have weakened the bargaining position of the once invincible tobacco lobby. Consequently, Congress should give the FDA authority to regulate tobacco in 1998 or 1999. Part II asserts that the Chevron decision has been modified to allow Congress to grant the FDA broad authority to regulate tobacco products without sacrificing its role in the agency policymaking process. Part III suggests a comprehensive legislative proposal regarding FDA jurisdiction over tobacco products that would enhance agency discretion and maintain a congressional role in agency decision making.

I.

The historic failure of regulatory agencies, such as the FDA and the Federal Trade Commission (FTC), to regulate tobacco products is largely due to congressional acquiescence to the tobacco companies' efforts to shelter the industry from burdensome requirements. The first section of this Part describes congressional and regulatory inaction spanning the last century, highlighting congressional failure to give the FDA regulatory authority over tobacco products under the Federal Cigarette Labeling and Advertising Act of 1965 (FCLAA). The second section argues that recent events have altered the political landscape, thus offering an historical opportunity finally to assert federal regulatory authority over tobacco products.

A. FAILURE OF REGULATORY AGENCIES TO REGULATE TOBACCO

The 1906 Pure Food and Drugs Act11 sought generally to protect the public from harm caused by exposure to drugs.12 Its jurisdictional scope, however, was limited to drugs and medicines recognized in a national directory of drugs13 or intended to be used for the cure, mitigation, or prevention of disease.14 In 1914, the FDA's predecessor (the Bureau of Chemistry in the Department of Agriculture) announced that it could not regulate tobacco as a drug or medicine because tobacco companies did not market tobacco products as medicine to cure disease.15 In 1929, Congress addressed this lack of jurisdiction by introducing legislation that included tobacco within the regulatory jurisdiction of the Bureau of Chemistry.16 However, Congress bowed to pressure and failed to pass the law.

In 1938, Congress amplified and strengthened the 1906 Act by enacting the Federal Food, Drug, and Cosmetic Act (FDCA or the "Act").17 The FDCA also created the FDA to ensure that drugs and devices regulated by the Act are safe, effective, and properly packaged, dispensed, labeled, and marketed. The FDCA granted the FDA jurisdiction to regulate any drug intended by the manufacturer18 to affect the structure or any function of the body, as well as any device which is intended by the manufacturer to deliver such a drug into the body.19 While these definitions broadened the authority of the FDA to regulate products,20 the Act did not explicitly give the FDA authority to regulate tobacco products. The FDA thus conceded that it still lacked jurisdiction under the Act over tobacco products because cigarette manufacturers did not intend cigarettes to be used for stimulation or to satisfy a dependence on nicotine.21