A Question of Intent: A Great American Battle with a Deadly Industry (review)

A Question of Intent: A Great American Battle with a Deadly Industry. By David A. Kessler. New York: Public Affairs, 2001. Pp. 400. $27.50.

David Kessler's A Question of Intent is both a scholarly work and a delightful read. Kessler is a physician, scientist, and attorney. As commissioner of the Food and Drug Administration (FDA) from 1990 to 1997, he used his professional training to lead the effort to establish the FDA's authority to regulate tobacco based on the concept that nicotine is a drug. A Question of Intent is the story of this struggle: concept development, data collection, pitching of the idea, gaining support, and battling the industry in the hearing chamber, courtroom, and the media.

Even though many readers will know the end of the story--that the tobacco industry actively controlled the amount of nicotine in cigarettes--Kessler's historical depiction of how the FDA learned of the varied strategies used by the tobacco industry to clandestinely accomplish this end is particularly well done. Despite repeated public denials, even under oath, the industry's goal was to distribute cigarettes with sufficiently high nicotine concentration to elicit functional addiction.

Beginning well before TV reports of "spiking" tobacco by spraying concentrated nicotine on the leaves, Kessler directed the slow, deliberate investigations that led to the documentation of pH alteration to promote augmentation of free nicotine in cigarette smoke. He uncovered the industry's own biological research leading to the understanding of the heterogeneous distribution of tobacco leaf nicotine concentration on a given plant, and to the development of generally higher nicotine tobacco strains (Y-I) in the United States. He revealed how, after these specialY-I seeds were transported to Brazil for commercial agricultural development, Brazil became a growing venue from which to import high nicotine tobacco plants illegally into the United States for processing. Kessler also vividly describes the parallel events of the discovery that leaves found higher on the tobacco plant are associated with higher nicotine content and are used differentially in conjunction with "inferior" plant material, including stems, to blend commercially acceptable and addictive products that have the "correct dose of nicotine."

Kessler's report is based on participant observation, review of primary sources, and numerous interviews. He rigorously documents the process that initially led the FDA to select a regulatory approach to tobacco industry behavior. This approach developed incontrovertible evidence that the industry intentionally behaved in a manner that fulfilled federal statutory criteria defining nicotine as a drug, and in turn led to the conclusion that the FDA possessed the right to regulate this drug. FDA investigations documented that the tobacco industry's own researchers confirmed that nicotine is a physiologically active material and that its manifestations are dose-related. Furthermore, nicotine concentration in cigarette smoke intentionally was manipulated by manufacturers to promote user addiction and reduce "self-willed" behavior; furthermore, cigarettes were actively marketed to industry-defined "young adult smokers" to nurture a continually expanding market. This realization promoted an additional conclusion: cigarette smoking is a pediatric problem.

Kessler ends the story with what is essentially an interim report following two major recent events: (1) the denial by the Supreme Court by a five to four decision of the FDA's right to regulate tobacco; and (2) the multi-state settlement with the tobacco industry for billions of dollars distributed over time to individual states as partial compensation for expenditures associated with tobacco-associated health problems under Medicaid. A portion of this money is slated for public health programs to limit youth tobacco use. Interestingly, a perverse outcome of the settlement terms is that they establish an incentive for the states to promote the continued profitable existence of the tobacco industry.

After a decade of involvement, Kessler concludes that regulation of tobacco use by a government agency is appropriate, but by itself it is insufficient to enhance...