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Regulation of Tobacco Products by the Food and Drug Administration

Policy Date: 1/1/1994
Policy Number: 9412

The American Public Health Association,
Reaffirming APHA’s commitment to taking a leadership role in discouraging the consumption of tobacco (APHA Policy Statement 8817: A Public Health Response to the War on Drugs: Reducing Alcohol, Tobacco, and Other Drug Problems among the Nation’s Youth), to encouraging private and public investors to divest from tobacco (APHA Policy Statement 9018: Divestment of Tobacco Stocks and Bonds), to reforming alcohol and tobacco advertising and promotions targeting youth (APHA Policy Statement 9213: Advertising and Promotion of Alcohol and Tobacco Products to Youth), and to protecting employees and the public from exposure to environmental tobacco smoke (APHA Policy Statement 9301: Environmental Tobacco Smoke); and
Noting that the US government has recognized the hazardous nature of tobacco products since the publication of the first surgeon general’s report on tobacco in 1964;1 and
Recognizing that tobacco-related illness takes the lives of nearly one-half million Americans each year;2 and
Recognizing that tobacco products are addicting and that the pharmacologic and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine;3 and
Recognizing that as many as one-half of all children and teenagers who experiment with tobacco products will become chronic users;4 and
Recognizing that tobacco is the least regulated consumer product, being specifically excluded by law from the purview of the Consumer Product Safety Commission, and has been subject to only limited regulation by the Federal Trade Commission, the Bureau of Alcohol, Tobacco, and Firearms, and Food and Drug Administration (FDA);5 and
Noting that the public has limited access to information about ingredients and chemical additives used in the manufacture of tobacco products and that there has been little evaluation of their safety;6 and
Noting that FDA Commissioner David Kessler has recently expressed interest in regulating tobacco products, stating: “This evidence, along with the growing body of data related to new products proposed for the treatment of nicotine addiction from smoking, suggests that cigarette vendors intend the obvious—that many people buy cigarettes to satisfy their nicotine addiction. Should the agency make this finding based on an appropriate record or be able to prove these facts in court, it would have a legal basis on which to regulate these products under the drug provisions of the [Food and Drug] Act.”7
Believing that the grave health hazards of tobacco warrant appropriate government regulations, therefore
l. Commends the FDA for publicly sharing its view that the agency does have authority to regulate tobacco products; and
2. Urges Congress to reaffirm that the FDA has the authority to develop an appropriate regulatory system for tobacco products and urges Congress to fund this function adequately.


  1. Smoking and Health. Report of the Advisory Committee to the Surgeon General of the Public Health Service. Atlanta, GA: Center for Disease Control; 1964. DHEW publication PHS 1103.

  2. Reducing the Health Consequences of Smoking: 25 Years of Progress. A Report of the Surgeon General. Atlanta, GA: Centers for Disease Control. DHHS publication CDC 89-8411.

  3. The Health Consequences of Smoking: Nicotine Addiction. A Report of the Surgeon General. Atlanta, GA: Centers for Disease Control; 1988. DHHS Publication CDC 88-8406.

  4. Preventing Tobacco Use Among Young People. A Report of the Surgeon General. Atlanta, GA: Centers for Disease Control and Prevention; 1994.

  5. Slade J, Connolly J, Davis RM. Report of the Tobacco Policy Research Study Group on tobacco products. Tobacco Control. 1992;1(suppl):54–59.

  6. Slade J. Nicotine Delivery Devices. In: Orleans CT, Slade J, eds. Nicotine Addiction, Principles and Management. New York, NY: Oxford University Press; 1993:3–23.

  7. Letter to Scott Ballin of the Coalition on Smoking OR Health from FDA Commissioner David Kessler, February 25, 1994.