choices—runs into serious difficulty when the underlying product creates serious long-term individual and societal harms, has addictive properties, and is usually chosen by young people who fail to appreciate the associated risks.

As they are now designed, tobacco cigarettes are inherently dangerous products that would not be allowed to enter the marketplace if their effects were known and if they were being introduced for the first time. For example, the nicotine in tobacco products would meet the criteria for classification of a Schedule 1 drug under the Controlled Substances Act, tobacco smoke could be classified as a “toxic substance” posing an “unreasonable risk” under the Toxic Substances Control Act, and tobacco cigarettes (and perhaps other tobacco products) could be characterized as “unreasonably dangerous product[s]” under the Consumer Product Safety Act, if tobacco products were not exempted from regulation by the specific exclusionary language in each of these statutes. If tobacco products were within FDA jurisdiction under the Federal Food, Drug, and Cosmetics Act, pre-market approval from the FDA would be required, and it could safely be predicted that such approval would not be forthcoming in light of the addictive properties of nicotine and the multitude of dangerous constituents in tobacco smoke.

However, tobacco products were introduced into the marketplace not only before their adverse effects were understood but also before any modern consumer protection or environmental health legislation had been enacted. The early efforts to suppress the sale of cigarettes, largely on moral and hygienic grounds, occurred at the state level, but most of the early bans had been repealed by 1925. The advent of mass production capabilities in the late 19th century, waning opposition from temperance groups during the first third of the 20th century, and the explosion of smoking during and after World War II catapulted the cigarette to the status of one of the most successfully marketed consumer products in the nation’s history. Given such a deep entrenchment in the cultural, social, and commercial life of the country, it is hardly surprising that the burden of demonstrating the need for any substantial regulatory restriction has rested on the proponents of regulation. As indicated in Chapter 3, however, this burden has now been convincingly met. The harmfulness of cigarettes is no longer disputed, even by the manufacturers; and the rhetoric of personal freedom has been softened by a general recognition of the powerful grip of nicotine addiction, the purposeful manipulation of that addictive potential by the manufacturers, and the hazardous effects of secondhand smoke on nonsmokers. Hence the burden has been shifting to the tobacco companies to explain why they