Introduction

Of the thousands of chemicals in tobacco smoke, nicotine is the most important. Nicotine makes tobacco addictive. The addictiveness of tobacco keeps people smoking long enough and heavily enough for the other chemicals in tobacco to cause heart disease, cancer, and other diseases. The documents reveal that B&W and BAT had a sophisticated and scientifically accurate understanding of nicotine pharmacology, including an explicit recognition of nicotine's addictiveness, more than thirty years ago. By 1963 B&W and BAT scientists and executives were internally acknowledging that nicotine is an addictive drug and that tobacco companies are essentially in the business of "selling nicotine." Nevertheless, the tobacco industry has publicly maintained over the years that nicotine is not addictive, and that the alkaloid merely adds "taste and flavor" to tobacco.

Addiction to a drug, also called dependence on a drug, is a condition in which an individual has lost control over the use of the drug and continues to use it despite adverse consequences. This conception is the basis for the diagnostic criteria for addiction found in the Diagnostic and Statistical Manual of the American Psychiatric Association (1). Although it has long been recognized that people cannot readily stop using tobacco products (2), the modern scientific basis for classifying nicotine as addictive was not highlighted until the 1988 Surgeon General's report, Nicotine Addiction (3).

There are several reasons why the tobacco industry has maintained so staunchly that nicotine is not addictive. First, the tobacco industry has argued in products liability lawsuits that smoking is a matter of "personal choice," and that tobacco companies should not, therefore, be held responsible for adverse health effects attributed to smoking. If the industry were to admit that nicotine is addictive, it would have a much harder time arguing that people can choose to quit smoking any time they want. In addition, if the industry were to admit that nicotine is addictive, it would open itself up to increased regulation. Under the Food, Drug and Cosmetic Act, an article (other than a food) is a drug or a device subject to regulation by the Food and Drug Administration (FDA) if its manufacturer intends that it affect the structure of function of the body when used. An intent to cause addiction would clearly qualify nicotine in tobacco products as a drug and the products themselves as drugs or devices and therefore subject to FDA regulation, just as the agency regulates nicotine chewing gum and patches. Intent to cause pharmacological effects besides addiction, such as effects on mood or weight control, would also qualify the nicotine in tobacco products as a drug. The FDA examined this question in 1994 (4, 5) and concluded that cigarettes and smokeless tobacco are, in fact, devices for the drug nicotine (6). On August 10, 1995, the agency proposed regulations under the Food, Drug and Cosmetic Act to protect children from nicotine addiction (7).

Nicotine's addictiveness also has implications for policy regarding tobacco advertising and promotion. Virtually all tobacco use begins in childhood and adolescence. Half of those who smoke cigarettes as adults have started by age 14, and most of those who will smoke as adults are already smoking every day by age 17 (8). Among young people (12–17 years old) who smoke at least twenty cigarettes daily, 84 percent reported that they "needed" or were "dependent" on cigarettes (8). Three out of four adult smokers say that they are addicted. By some estimates, as many as 74 to 90 percent are addicted. Seventeen million Americans (more than a third of all smokers) try to quit each year, but fewer than one out of ten succeeds. For every smoker who quits, nine try but fail (4). Since addiction develops insidiously, those affected only gradually come to appreciate that they cannot stop despite their intentions to do so.

Although the tobacco industry accepted the current series of rotating warnings on cigarette packages in 1984—which mention lung cancer, heart disease, prenatal problems, carbon monoxide exposure, and improved health from stopping smoking—it successfully lobbied against

having the word "addiction" appear in any warning (Matthew Myers, personal communication, January 30, 1995).

This chapter discusses what the documents reveal about the tobacco industry's knowledge of nicotine—namely, that both B&W and BAT clearly recognized that nicotine is pharmacologically active, that it is addictive, and that cigarettes are essentially nicotine delivery devices.