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Warning Labels and Packaging Issues—U.S. Perspective

October 26, 2000: Framework Convention on Tobacco Control

Rosemary Rosso, Esquire, Senior Attorney, Federal Trade Commission

Ms. Rosso began the session by stating that the presentation reflects her views and not necessarily those of the Federal Trade Commission (FTC) or any individual commissioner. She said the FTC has been involved in tobacco marketing since the late 1930s. Under Section 5 of the FTC Act, the agency has authority to prohibit unfair or deceptive acts or practices, including those for tobacco products. The FTC also has some responsibilities under the Smokeless Tobacco and the Cigarette Acts.

Currently, three types of tobacco products in the United States are legally required to have health warnings: cigarettes, smokeless tobacco, and cigars. Warning requirements differ between the products, primarily as a result of historical evolution. Cigarettes have required health warnings since 1964, shortly after release of the Surgeon General's Report, when the FTC issued a trade regulation rule requiring health warnings on cigarette packages and in advertising. The trade regulation never went into effect and was superseded in 1965 by the first Cigarette Act. The first Cigarette Act required a single warning on cigarette packages; there was no requirement at that time for warnings in cigarette advertising. The language for the cigarette warning changed several times during the 1960s and early 1970s.

In 1981, FTC staff issued a report concluding that the then-existing warning for cigarettes was ineffective. Consumer research conducted for the report showed that the effect of the warning had worn out over time. Consumer research also indicated that the existing warning was too vague and general. The FTC Staff Report recommended that the existing cigarette warning be replaced with shorter, more specific rotational warnings. In 1984 Congress passed amendments to the Cigarette Act requiring four rotational warnings for cigarettes. These continue to be the current warnings required on cigarette packages. The Cigarette Act gives the U.S. Department of Justice the authority to enforce the cigarette warning requirement, and the FTC has the responsibility to review and approve rotational warning plans. All cigarette manufacturers, importers, and distributors are required to file a plan showing how the company intends to comply with the rotational warning requirements.

Health warnings for smokeless tobacco were first required in 1986. There are three rotational warnings for smokeless tobacco. The Smokeless Tobacco Act directs the FTC to issue regulations implementing the format and display requirements in the statute. The FTC regulations govern issues such as the size of the warnings and the color contrast of the warning statement. Enforcement authority for health warnings on smokeless tobacco is shared by the FTC and the Department of Justice.

Cigars represent the most recent addition to the list of tobacco products requiring health warnings. This year the FTC issued consent orders against the seven largest cigar companies, whose products account for 92% of US cigar sales. The FTC closely collaborated with the Office of the Surgeon General and the Office on Smoking and Health in devising the five rotational warnings that the consent orders require to be placed on cigar packages and in advertisements. The public should start to see packages bearing the warnings sometime early in 2001. The FTC has enforcement authority over the consent orders and can obtain monetary civil penalties for violations.

The purpose of the health warnings is to educate the public, including initiating as well as existing tobacco users, about the adverse health effects of tobacco products. The goal is to give health information in order to enhance their decisions about the of these products. Hopefully, the warnings will deter some consumers from beginning to use tobacco and will encourage others to quit or at least reduce the amount of tobacco they use. Health warnings are an excellent tool for reaching consumers. For example, in 1998, the FTC reported that 558 billion cigarettes were distributed in the United States. That means there were 558 billion opportunities for the health warnings to be read and to have an impact on people. Warnings are still needed even though most surveys show that virtually everyone knows in general that tobacco is dangerous. First, those surveys also show important gaps in peoples' knowledge about the health effects of tobacco use. For example, in the 1998 Monitoring the Future Survey, only 55% of eighth graders indicated that there is a great risk from smoking a pack of cigarettes a day. Second, the surveys indicate that smokers underestimate their own personal health risks from smoking. Third, because science is always evolving, health warnings provide an opportunity to present new information about health risks to consumers. For example, the recent cigar warnings include a warning about the health effects of environmental tobacco smoke.

The FTC has said publicly that the existing system for tobacco warnings needs to be improved. Ms. Rosso noted, for example, that the warning statements for cigarettes and smokeless tobacco have not changed since the mid-1980s. The 1981 FTC staff report demonstrates that warnings lose effect over time. In addition, the scientific understanding about the adverse health effects of tobacco use has evolved since the mid-1980s and the warnings need to be updated. Thus, a reexamination of the warning statements is warranted. Under the preemption provisions of the Cigarette and Smokeless Tobacco Act, any changes to the language of the warnings requires federal legislation. Recently, some have suggested that an administrative or regulatory agency should have some responsibility for deciding the substantive language of the warnings. The suggestion merits consideration. An agency with scientific expertise may be better able to keep up with the changing science and an administrative system might be more flexible. In addition to the actual warning language, other issues merit consideration. For example, the size and prominence of the existing warnings warrant consideration as to their effectiveness. Similarly, the placement, location, and color contrast of the warnings merit attention and discussion.

Last spring the FTC began a regulatory review of the Commission's regulations for smokeless tobacco. The review sought public comment on the continuing need for the regulations and asked questions about the costs and benefits of the regulations and about their effectiveness in achieving the statutory requirements that the warnings be conspicuous and prominent. The FTC received 35 to 40 comments from a variety of sources, including CDC, the Massachusetts Department of Public Health, other state health agencies, public health organizations, consumers, and a smokeless tobacco trade association and manufacturer. These comments are being reviewed by staff, who will make recommendations to the Commission. If the Commission decides the regulations should be amended, it will begin a rulemaking proceeding. During that proceeding, the public will be asked to comment on any proposed changes.

Beyond improvements to the existing system for warnings, other issues in the area of tobacco packaging warrant discussion and consideration. For example, should the warnings include both text and graphic illustrations? Should companies be required to disclose information about the components of tobacco or tobacco smoke and, if so, what kind of disclosure should be required? Should additional health information be required on tobacco packages or in package inserts and, if so, what information? Some of these and additional issues will likely be debated as part of the Framework Convention process. But in the United States, there are limits to the government's authority to require companies to disclose information. The First Amendment protects commercial speech. The First Circuit Court recently issued a decision giving Massachusetts a fair amount of discretion under the First Amendment for its tobacco marketing restrictions (even though the court ultimately struck the cigar warning requirements under the U.S. Constitution's commerce clause). But even with discretion, the government has the burden of showing that any restrictions are necessary to support a substantial purpose and are appropriately tailored. Statutory authority is also an important limit on a government agency's ability to require the disclosure of information. A federal agency can act only to the extent of its authority. Finally, when one is working with trademarked or copyrighted materials, intellectual property issues need to be considered.

To a question on attempts by the United States to regulate labels on pipe tobacco, Ms. Rosso indicated that the FTC has not undertaken such an attempt. Pipe use is decreasing and has been for many years. In contrast, cigar use dramatically increased, especially among young adults, during the past several years.

Ms. Rosso indicated that if environmental tobacco smoke (ETS) warnings are desired for cigarettes or other tobacco products, new legislation will have to be passed. This is not the case for cigar health warnings, which do carry an ETS warning. It was pointed out that we should put warning labels on all tobacco products and not just the ones that are most often used. Ms. Rosso indicated that the McCain Bill would have required warnings on all tobacco products. Dr. Satcher added that, beyond warning labels, all children should be educated about the dangers of smoking, using the CDC guidelines. He indicated that currently only 5% of schools in the country provide that education.

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