affect the structure or function of the body. Using internal industry documents that had become available in lawsuits and from industry insiders, FDA policy makers documented in the industry’s own words how tobacco companies manipulate nicotine levels and rely on the addictive qualities of nicotine to hook users (Kessler 2000).

In the early 1990s, as the FDA tobacco team was exploring policy options, national experts on tobacco use had begun to highlight the importance of smoking among youth. Studies showed that nearly 90 percent of adult smokers began smoking by the time they were 18 years old and that every day some 3,000 young people began to smoke (DHHS 1994; IOM 1994; Pierce et al. 1989). In 1992, Congress passed the so-called Synar Amendment to limit youth access to tobacco by requiring states to control access as a condition of receiving federal substance abuse block grants (IOM 1994).

In 1994, two major reports highlighted the problem of smoking among youth: the Surgeon General issued Preventing Tobacco Use Among Young People (DHHS 1994), and the Institute of Medicine (IOM) released Growing Up Tobacco Free: Preventing Nicotine Addiction in Children and Youth (IOM 1994). Those reports described the problem of initiation of smoking and nicotine addiction among youth and the factors promoting use of tobacco use among young people. The IOM report recommended specific actions that could be used to address the problem, including proposals to curtail youth access to tobacco products, restrict youth-oriented tobacco marketing, limit advertising to a text-only format, narrow the preemption provision of the 1969 federal cigarette labeling law, and enact comprehensive federal regulation of tobacco products.

The recognition that most smokers become addicted in their teens further undermined the industry arguments against regulation based on free choice. Secondhand smoke findings demonstrated that smoking endangers nonsmokers, evidence of nicotine addiction established that the decision to continue smoking is not always a free choice, and now studies showed that the overwhelming majority of smokers are already on the path toward addiction before they turn 18 years of age (IOM 1994). The public may respond negatively to paternalistic, “Nanny State” policies aimed at changing the behavior of competent adults, but protecting children is a powerful justification for regulating dangerous products. Moreover, industry marketing in the 1990s (epitomized by R.J. Reynolds’ Joe Camel campaign) clearly had special appeal to children and teens and suggested that the industry was actually targeting young people, a suspicion subsequently borne out by internal industry documents.