EMBARGOED FOR RELEASE: 3 p.m. (CT) Tuesday, February 4, 1997
Media Advisory: To contact David A. Kessler M.D., call James O'Hara III at 301/443-1130. To contact Lawrence O. Gostin, J.D., call Jim Jaffe at 202/662-9500.
FDA Explains Decision To Regulate Tobacco Products Judiciary should defend FDA's action
There are legal and scientific bases for the Food and Drug Administration's (FDA) move to assert jurisdiction over cigarettes and smokeless tobacco, according to an article in this week's issue of The Journal of the American Medical Association (JAMA).
David A. Kessler, M.D., FDA Commissioner, and colleagues conducted a two-and-a-half year investigation of tobacco products. They conclude: "Cigarettes and smokeless tobacco are subject to FDA jurisdiction because they contain a 'drug,' nicotine, and a 'device' for delivering this drug to the body."
They write: "When FDA last considered this issue, it declined to assert jurisdiction over cigarettes because it lacked evidence that cigarettes were intended to affect the structure or function of the body. Since that time, however, substantial new evidence became available to FDA. This evidence included the emergence of a scientific consensus that the nicotine in cigarettes and smokeless tobacco causes and sustains addiction, as well as the disclosure of thousands of pages of internal tobacco company documents revealing that the tobacco manufacturers know that nicotine causes significant pharmacological effects, including addiction, and design their products to provide pharmacologically active doses of nicotine.
"This new evidence demonstrated to FDA that (1) nicotine in cigarettes and smokeless tobacco does 'affect the structure or any function of the body' and (2) these effects on the structure and function of the body are 'intended' by the manufacturers." Addressing nicotine's ability to affect the structure or any function of the body, they cite the U.S. Surgeon General's report indicting that nicotine exerts psychoactive (or mood altering) effects on the brain that motivate repeated, compulsive use of the substance; that under some circumstances and doses, it has either a sedating or tranquilizing effect or a stimulating or arousal-inducing effect on mood and brain activity; and that it affects body weight.
In reviewing the evidence to determine if the effects of nicotine are intended, the FDA categorized the evidence into three areas: (1) evidence that the pharmacological effects and uses of cigarettes and smokeless tobacco are foreseeable to a reasonable manufacturer; (2) evidence that consumers actually use cigarettes and smokeless tobacco predominantly for pharmacological purposes; and (3) evidence of the statements, research and actions of the manufacturers themselves.
They write: "The agency determined that, whether considered independently or cumulatively, this evidence demonstrated that cigarettes and smokeless tobacco are in fact 'intended' to be used for pharmacological purposes."
Judiciary Should Defend FDA's Action
In a separate article in this week's JAMA, Lawrence O. Gostin, J.D., from the Georgetown/Johns Hopkins University Program on Law and Public Health, Washington, D.C., and Baltimore, Md., and colleagues write that when the FDA issued regulations on Aug. 28, 1996, restricting the sale, distribution, promotion, and advertising of nicotine-containing cigarettes and smokeless tobacco to minors, it was "the most significant federal regulation of tobacco since the enactment of the Cigarette Labeling and Advertising Act in 1965."
They add that justifications for and approaches to federal regulation of cigarettes have varied in the three decades since the first Surgeon General's report was released in 1964. "In the immediate period after the report's release, most strategies to control cigarette use focused on the need to educate smokers about the harms associated with tobacco use ... In the last decade, arguments for more intensive regulation have increased, and the idea of cigarettes as a 'voluntary' health risk has begun to erode. Justifications for an increased federal regulatory role began to rely on emerging evidence of health risks to others; the addictive quality of nicotine; the vulnerability and exploitation of young people; and industry knowledge and intent of the harmful effects of tobacco products." The issue of government control over tobacco's promotion has been debated by tobacco companies for years. But the authors say government is within its constitutional limits. "When the government regulates, but does not completely ban, commercial messages 'to protect consumers from misleading, deceptive, or aggressive sales practices or requires the disclosure of beneficial consumer information,' the Supreme Court uses a less stringent, more deferential standard of review ... The central question for law and social policy is the informational value of tobacco advertising in a robust democracy and specifically, the informational value of the speech to be regulated by the FDA."
The authors list the following reasons they feel the informational value of the regulated speech about tobacco is minimal and that restrictions ought to 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 public health: (1) FDA regulations are content neutral, impose reasonable time, place, and manner restrictions, and leave open alternative channels of communication; (2) The underlying public health harms must be considered; (3) Political speech opposing tobacco policy is not regulated; (4) Tobacco advertisements are misleading; (5) The regulations are directed at preventing the unlawful sale of tobacco products to minors.
The authors contend that few observers would seriously dispute the existence and strength of the interests asserted by the FDA including those of safeguarding the public health, protecting children and adolescents, and conserving public resources. They use the traditional test for commercial speech, Central Hudson Gas and Electric Corp. vs. Public Service Commission of New York, which requires that government restrictions be no more extensive than necessary to serve the asserted interests.
"The FDA regulations specifically target those elements of advertising and promotion that are seen by children and adolescents, while seeking to preserve avenues of communication that provide information to adults. Each of the major restrictions on advertising imposed by the FDA are reasonably related to young persons."
They conclude: "The regulations meet the traditional criteria for regulating commercial speech, in that the government 's asserted interest is strong, the agency's regulations directly advance that interest, and the regulations are no more extensive than necessary. Thus, the judiciary should defend the FDA's historical, social and legislative mission to protect the public health."
# For more information: contact the AMA's Scot Roskelley at 312/464-4431. email: [email protected] AMA web site: http://www.ama-assn.org
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