May 2000

Grant Results

National Program

Tobacco Policy Research and Evaluation Program

SUMMARY

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.

Funding
RWJF supported the project with a grant of $222,173 between March 1995 and February 1997.

 See Grant Detail & Contact Information
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THE PROBLEM

Tobacco products have traditionally been subject to less regulation than other hazardous products. 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 new regulations prohibit sale to children and adolescents under age 18; require labeling to disclose the intended use and age restrictions for these products; prohibit sales through vending machines or self-service displays, unless the sales are conducted in adult-only locations; establish a minimum number of cigarettes (20) that can be sold at one time; and prohibit distribution of free samples. They represent the most significant federal regulation of tobacco since the enactment of the Cigarette Labeling and Advertising Act in 1965 and the advertising broadcast ban in 1970.

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THE PROJECT

This study provided an historical account of tobacco regulation and identified how changes in the public's understanding of tobacco products have dramatically altered the scientific, social, and political environment in which the new FDA regulations were proposed. The study analyzed First Amendment issues prompted by the tobacco advertising restrictions as well as the public health mission that justified FDA jurisdiction over tobacco. This project was partly funded by a grant from the Charles E. Culpeper Foundation, which supported the work of Allan M. Brandt, Ph.D.

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FINDINGS

  • 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.
    • Recent studies showing that most consumers use cigarettes and smokeless tobacco for pharmacological purposes, including satisfying their addiction to nicotine.
    • Industry knowledge of and intent to conceal the harmful effects of tobacco products.
  • The central question for law and social policy is the informational value of the speech that would be restricted under the FDA regulations. According to the principal investigator, for at least the following five reasons, the informational value of the regulated tobacco speech is minimal, and therefore the restrictions should be examined under a low level of constitutional review, granting deference to the FDA as a regulatory agency with a social and legislative mission to protect the public's health and safety:
    1. The FDA regulations are content-neutral and leave open alternative channels of communication; they do not prevent the kind of accurate consumer information that the constitution steadfastly protects.
    2. The evidence of substantial threat to the public health and safety negates the informational value of the regulated speech.
    3. The regulations do not affect political speech — either for or against tobacco policies — nor do they stifle the scientific or policy debate surrounding this issue.
    4. The regulations are directed at preventing the unlawful activity of underage smoking; for commercial speech to be constitutionally protected it must promote a lawful activity.
    5. Tobacco advertisements are misleading to adults and children; commercial speech is not protected if it involves fraudulent or deceptive messages.
  • 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; and conserving public resources by reducing the economic burdens on society.

Communications

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.

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GRANT DETAILS & CONTACT INFORMATION

Project

Ethical, Social, and Public Health Implications of Regulating Tobacco

Grantee

Montefiore Medical Center (Bronx,  NY)

  • Amount: $ 222,173
    Dates: March 1995 to February 1997
    ID#:  026351

Contact

Peter S. Arno, Ph.D.
(718) 652-4631

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BIBLIOGRAPHY

(Current as of date of this report; as provided by grantee organization; not verified by RWJF; items not available from RWJF.)

Articles

Arno PS, Brandt AM, Gostin LO, and Morgan J. "Tobacco Industry Strategies to Oppose Federal Regulation." Journal of the American Medical Association, 275(16): 1258–1262, 1996.

Gostin LO, Arno PS, and Brandt AM. "FDA Regulation of Tobacco Advertising and Youth Smoking: Historical, Social and Constitutional Perspectives." Journal of the American Medical Association, 277(5): 410–418, 1997. Abstract available online.

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Report prepared by: Beth Brainard
Reviewed by: Janet Heroux
Reviewed by: Marian Bass
Reviewed by: Molly McKaughan
Program Officer: Robert Hughes
Evaluation Officer: Marjorie Gutman

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