Tobacco - Federal Regulation Of Tobacco As A Drug

In 1988, the SURGEON GENERAL of the United States issued a report detailing the addictive effects of nicotine. Later scientific studies confirmed this finding. Despite this research the tobacco companies continued to deny that any relation existed between smoking and disease or that smoking was addictive. In an April 1994 congressional hearing on nicotine manipulation, the chief executive officers of seven tobacco companies testified under oath that they believed nicotine is not addictive and that smoking has not been shown to cause cancer. Later, however, some former tobacco company officials publicly confessed that cigarette manufacturers had long known about the health hazards of smoking and had deliberately concealed that information from the public.

The first and perhaps best known of these officials was Jeffrey Wigand, the former head of research at Brown and Williamson, one of the large tobacco companies. Voluminous internal records showing that cigarette manufacturers were aware of the dangers of smoking, including the addictive properties of nicotine, were also leaked to the public. One paralegal at Brown and Williamson copied more than four thousand documents and provided them to tobacco opponents. An annotated compilation of those documents was published, in 1996, under the title The Cigarette Papers. As a direct result of this growing body of information demonstrating that the manufacturers knew that nicotine in smoking and chewing tobacco can lead to addiction, the FDA, in 1994, began examining whether nicotine qualified as a drug under the Food, Drug and Cosmetic Act (21 U.S.C.A. §§ 301 et seq.), and thus could be regulated as such by the FDA.

The FDA had formerly asserted jurisdiction over tobacco products only to the extent that they carried therapeutic claims. By 1996, however, the FDA had determined that cigarettes and other tobacco products are intended by their manufacturers to be delivery devices for nicotine, a drug resulting in significant pharmacological effects on the body, including addiction. Based on the Food, Drug and Cosmetic Act definition of a drug as an article "intended to affect the structure or any function of the body" and on the FDA's determination that the cigarette and smokeless tobacco manufacturers "intend" these effects, the FDA declared, in August 1996, that it had jurisdiction to regulate tobacco products.

The FDA then announced that it would begin by regulating the sale and distribution of cigarettes and smokeless tobacco products to children and adolescents. The issue of children smoking has aroused widespread concern. Studies in the 1990s demonstrated that despite state laws prohibiting the use of tobacco before the age of 18, children had easy access to tobacco products and many had become regular smokers before their eighteenth birthday. In 1996, the FDA estimated that 4.5 million children and adolescents in the United States smoke and that another 1 million children use smokeless tobacco. Accordingly, the FDA promulgated a proposed rule to reduce children's access to tobacco and limit its appeal to them. The final FDA rule treated nicotine addiction as a pediatric disease because the use of tobacco products and the resulting nicotine addiction begin predominantly in children and adolescents. The FDA concluded that children do not fully understand the risks associated with consuming tobacco and that they are vulnerable to the sophisticated marketing techniques used by the tobacco industry. As a result, the FDA regulations governed tobacco products' promotion, labeling, and accessibility to children and adolescents.

The tobacco companies sued in federal court, arguing that the FDA lacked the statutory authority to impose regulations on tobacco The Supreme Court, in FDA v. Brown & Williamson Tobacco Corp. 529 U.S. 120, 120 S. Ct. 1291, 146 L. Ed. 2d 121 (2000), struck down the FDA regulations. The Court, in a 5–4 decision, held that the Food, Drug, and Cosmetic Act, read as a whole, along with recent tobacco legislation passed by Congress, clearly showed that the FDA did not have the authority to regulate tobacco products. The Court acknowledged that the case involved "one of the most troubling public health problems facing our Nation today: the thousands of premature deaths that occur each year because of tobacco use." Yet, the Court also pointed out that "Congress, for better or for worse, has created a distinct regulatory scheme for tobacco products," and that it has "repeatedly acted to preclude any agency from exercising significant policymaking authority in the area."