Conclusion

A 1973 handout for a talk by Dr. S. J. Green, who headed R&D at BAT in the 1970s, at a conference of industry executives includes the following definition of nicotine:

A pharmacologically active material present in tobacco and tobacco smoke. It can act as a stimulant or depressant depending very much upon the person and the situation. In even small quantities it is a poison but it is metabolized rapidly by humans and not stored in tissue. When smoke is inhaled the nicotine is largely retained by the smoker. {1184.01, p. 4}

There is no mention of any taste or flavor value for nicotine, only its pharmacological effects. The definition assumes that inhalation is a normal way to ingest this "pharmacologically active material."

The private papers of Dr. Green include a revealing diagram of the importance he accorded nicotine {1186.08}. It is undated, but it uses company jargon from the early 1970s. Titled "Approaches to Problems in the Association of Smoking and Disease," the schematic places "nicotine administration" at the top, as the overall goal to be achieved. The very bottom of the diagram indicates that nicotine is to be administered to the mouth, in the case of noninhalable forms of tobacco, or to the mouth and lungs if the product is to be inhaled (i.e., cigarettes).

Strategic research was to involve nicotine itself (including "dosing" issues), "alternative pharmacological agents," and "health-oriented

cigarettes" (cigarettes that produce less disease). Tactical research and product development included "re-assurance" or "health-image" cigarettes and ways of responding to public health pressures such as the publication of tar and nicotine yields. "Health-image" cigarettes, as discussed in chapter 4, were intended to provide the appearance of reduced harm.

Again and again, the documents demonstrate the central importance of nicotine to the normal use of tobacco products. The role of nicotine in tobacco products is that of a pharmacological agent: B&W and BAT value nicotine not for its taste and flavor but for what it does to the brain. The dose of nicotine absorbed by the consumer is a factor to be considered in product design. Moreover, at least in the early 1960s, some B&W and BAT officials almost seemed to take pride in the addictive nature of nicotine.

Taste is irrelevant to nicotine as it is discussed in these documents. Sensory panels occasionally described in the documents were not asked to measure taste. Rather, they were concerned with the level of irritation nicotine in different forms causes, or with whether it has a certain "impact." Whereas taste is irrelevant, the documents demonstrate that inhalation is essential to the normal functioning of a cigarette. Inhalation is essential for nicotine absorption from a cigarette. It has no other purpose.

BAT's idealized cigarette was Ariel, a product designed to minimize toxic smoke components and deliver but one main active ingredient: nicotine. While not as fully laid out for BAT as for Philip Morris, the nicotine analogue program betrays the same focus: the purpose of the product is the delivery of a pharmacologically active substance to the brain—preferably a substance with lower toxicity to the heart and blood vessels. The logical goal of Project Ariel (provide a smoke-free nicotine aerosol), combined with the analogue work (find a less hazardous form of nicotine), is the creation of a product that delivers a nicotine analogue and no other active ingredient.

The public relations posture of B&W differs markedly from the internal working views expressed within B&W and BAT over the years. While the public posture has been that nicotine is not addicting and the company does not intend any of the pharmacological effects that occur, the internal writings consistently assume addiction and throughout demonstrate a keen interest in all aspects of the pharmacology of nicotine.

The contract work and the internal company research projects reviewed here have not been published in the scientific literature. Often,

the work was well ahead of its time. The Battelle work in Geneva was at the cutting edge of pharmacological work on nicotine at the time. The work on smoker compensation in the 1970s preceded the main published reports by a decade. Today B&W accepts one, and only one, conclusion from the 1964 Surgeon General's report: that nicotine is a habituating, not an addicting, drug. Yet high-level executives at B&W and BAT did not accept this conclusion in 1964.

In early 1992, BAT considered whether to purchase a manufacturer of nicotine patches (37). B&W's chief attorney, Mick McGraw, objected because of the unwanted attention such a move might draw to the cigarette business from the FDA. He also felt that selling a nicotine patch to help people manage withdrawal symptoms as they tried to stop smoking would undercut the company position that people choose to smoke and that they can stop at will. In contrast to McGraw's feelings, Patrick Dunn, the head of research at the Canadian subsidiary, Imperial Tobacco, regarded the patch business as a natural extension of the cigarette business. A scientific analysis of the nicotine patch prepared by B&W staff compared the nicotine delivery rate from a cigarette with that from a patch. These candid appraisals of the nicotine patch, written in 1992, demonstrate that the perspectives on nicotine reflected in the documents from the early 1960s through the mid-1980s, which have been reviewed in this chapter, were still operative at BAT and at its subsidiaries only two years before Thomas Sandefur, B&W's CEO, told Congress, "I believe that nicotine is not addictive."

Are cigarettes drugs? Do cigarette manufacturers intend that their products affect the structure or function of the body? The documents reviewed in this chapter, taken as a whole, demonstrate that, for B&W and for BAT at least, the answer is yes. This answer, in turn, means that cigarettes made by these companies come under the jurisdiction of the FDA through the federal Food, Drug and Cosmetic Act.