“We show that the FDA is wrong on key factual and scientific points. Our comments review the many flaws in and evidence contradicting the FDA’s allegations regarding such matters as tobacco growing, cigarette manufacturing and addiction.”

Steven Parrish, senior vice president, Philip Morris. 2 January 1996.1

Despite the release of secret documents showing that many tobacco industry scientists and officials have long considered nicotine to be addictive,2 some industry executives still insist that smoking is just a habit that should not be classified with other forms of drug dependency.3 In April 1999, cigarette manufacturer Brown & Williamson unveiled a web site <www.brownandwilliamson.com> that contests the modern definition of addiction and argues that “the issue should be whether consumers are aware that smoking may be difficult to quit (which they are) and whether there is anything in cigarette smoke that impairs smokers from reaching and implementing a decision to quit (which we believe there is not).”

Such claims may confuse the general public and delay the enactment of effective tobacco control measures—especially those that take direct aim at nicotine addiction by regulating nicotine levels in tobacco products.4 Given the high level of public attention to nicotine, it is useful to review the scientific credibility of the industry’s contention that nicotine is not addictive.

In January 1996, as volume III of their objections to proposed regulation by the United States Food and Drug Administration, cigarette manufacturers produced a 213-page brief primarily aimed “to address FDA’s contention that nicotine has a significant effect on the structure or function of the body, including so-called nicotine addiction”5 (page 2). With scientific prose and 644 footnotes, the industry argued that nicotine is nothing more than a harmless ingredient present in tobacco products for flavour.

Although the FDA responded point …