From 1995 to 1997, researchers at Montefiore Medical Center, Bronx, N.Y., undertook an historical analysis of federal tobacco regulation and provided historical, social, and constitutional perspectives on the new Food and Drug Administration (FDA) regulation of tobacco advertising and youth smoking.

New regulations issued by the FDA in August 1996 restrict the marketing and availability of nicotine-containing cigarettes and smokeless tobacco as "restricted devices" under the Food, Drug, and Cosmetic Act, an important shift in regulatory approaches to tobacco.

The project was part of the Robert Wood Johnson Foundation's (RWJF) national program Tobacco Policy Research and Evaluation Program.

Key Findings: The results of the study appeared in the April 24, 1996 issue of The Journal of the American Medical Association (JAMA) and in a related article, "FDA Regulation of Tobacco Advertising and Youth Smoking," in JAMA's February 5, 1997 issue.

• In the last decade, justification for more intensive federal regulation of tobacco products has increased and the idea of cigarettes as a "voluntary" health risk has begun to erode based on several developments:
  • Emerging evidence of health risks to others.
  • Scientific consensus that nicotine is addictive.
  • The targeted marketing to and vulnerability of young people.
• The central question for law and social policy is the informational value of the speech that would be restricted under the FDA regulations.
• Several interrelated governmental interests support regulation of tobacco advertisements and promotions:
  • Safeguarding the public health.
  • Protecting children and adolescents since the age of smoking initiation has been shown to influence adult smoking patterns and ultimately the risk of tobacco-related morbidity and mortality.
  • Conserving public resources by reducing the economic burdens on society.