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8 REGULATION OF THE LABELING, PACKAGING, AND CONTENTS OF TOBACCO PRODUCTS
Pages 233-254

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From page 233...
... , expressly excludes tobacco from its otherwise broad delegation of power to regulate consumer products that present an "unreasonable risk of injury." Shortly after a federal court ruled that the Consumer Product Safety Commission had jurisdiction to regulate high-tar tobacco products under the Federal Hazardous Substances Act, Congress amended that act to exclude tobacco from the definition of "hazardous substances."i Similarly, the Toxic Substances Control Act expressly exempts tobacco from regulation even though the constituents of tobacco smoke might otherwise be subject to regulation as "chemical substances which present unreasonable risk of impairing health," or as "mixtures of such substances."2 Despite its addictiveness, tobacco is also specifically exempted from the Controlled Substances Act, which regulates the medical and scientific use of other psychoactive drugs and prohibits their distribution and use for nonmedical and nonscientific purposes. It is not difficult to understand why Congress has excluded tobacco from 233
From page 234...
... Moreover, under most of these schemes, faithful adherence to the statutory criteria would authorize, or even require, the regulatory agencies to take tobacco products off the market. For example, the chronic risk of tobacco products is much greater than the hazards of other products that have been banned under the Consumer Product Safety Act, and the Consumer Product Safety Commission's priority-setting rule suggests that it would have no choice but to ban tobacco products as well.
From page 235...
... Thus, an inevitable effect of classifying nicotine-containing tobacco products as "drugs" would be to ban them. Yet, an agency ban under the FDCA arguably would be incompatible with a 30-year history of congressional action regulating the advertising and labeling of tobacco products while permitting their continued manufacture and use.
From page 236...
... Also, in 1986 Congress enacted warning requirements for smokeless tobacco products. However, Congress has never delegated the authority to update these warnings, or to evaluate their effectiveness, to a regulatory agency.
From page 237...
... The act also divested federal agencies and states of the authority to impose more stringent health warning requirements. In particular, the FTC was prohibited from requiring health warnings on tobacco advertising for four years, until July 1, 1969, although the FTC's authority to regulate unfair or deceptive advertising was left intact.
From page 238...
... In a staff report to Congress, the FTC concluded that the warning was "worn out," too abstract, difficult to remember, and not perceived as personally relevant.~3 The FTC report helped to spur Congress to enact the Comprehensive Smoking Education Act of 1984, which required four, more specific, rotating health warnings on all cigarette packages and advertisements: SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.
From page 239...
... Required warnings were extended to smokeless tobacco products by the 1986 Comprehensive Smokeless Tobacco Health Education Act. Under the act, three rotating warning labels must be displayed on smokeless tobacco packaging and advertising in the circle-and-arrow format that had been recommended by the FTC for cigarettes: WARNING: This product may cause mouth cancer.
From page 240...
... As the surgeon general recently stated, "there are no controlled studies that permit definitive assessment of the independent impact of cigarette warning labels on knowledge, beliefs, attitudes, or smoking behavior." However, a body of indirect evidence suggests that the current warnings are probably not having the desired impact on knowledge or behavior, especially among youths. It is clear, first of all, that adolescents continue to underestimate the adverse health consequences of tobacco use.
From page 241...
... They are often printed in colors that allow the warnings to blend in with packaging design or to be overwhelmed by the marketing imagery. Using an eye-tracking technique commonly used in market research, one study found that only 37% of adolescents viewing tobacco advertisements looked at the health warning long enough to read its words; 43.6% of the subjects did not look at the warning at all.2i A similar response was found in a study of smokeless tobacco product packaging, in which only 43% of subjects noticed the warning label.22 Novel, eye-catching designs, such as the circle-and-arrow format recommended by the FTC and adopted by Congress for smokeless tobacco products, may increase noticeability.23 The color and reflectiveness of the warning label in the context of the overall packaging or advertisement is also likely to affect noticeability.
From page 242...
... Novel formatting is more likely to capture attention.27 The retention of the original rectangular shape of the pre1985 warning may have diminished the potential communication effectiveness of the more explicit rotating warnings.28 Periodically altering the format of the warnings may help to refresh their impact.29 Preliminary studies on the effects of labels on alcoholic beverage containers suggest that warnings on health risks are likely to be most effective in increasing awareness of the least-known risks. Although warnings can serve as a reminder of already known hazards (such as impaired driving)
From page 243...
... These investigators concluded that it is "certainly plausible that rotating messages so as to keep them 'fresh' while increasing exposure to lesser known facts, could be a useful strategy to consider, and rigorously evaluate, in the future."3i Even when tobacco health warnings are noticeable and legible enough to be read, research suggests that the current warnings are not framed to be optimally understandable, believable, persuasive, and memorable.32 In a recent study using standard market research techniques for evaluating advertisements, the congressionally mandated warnings performed poorly in communicating specific risk information. Although 79% of subjects exposed to the warnings reported the presence of a health message, only 15% reported the concept of the message and only 6% reported its exact content.
From page 244...
... Display of information regarding the toxic constituents present in cigarette smoke is also required.36 Also, in Canada the Tobacco Products Control Act required outdoor billboards erected after January 1, 1991, to carry a health message equal to 20% of the top portion of the sign. Billboards began disappearing, as manufacturers were unwilling to risk the impact of large health warnings on sales.37 Australia has recently strengthened its regulation of tobacco warning labels and packaging.
From page 245...
... Promotional items are often especially appealing to children and youths and project positive lifestyle images of the decision to use tobacco products without a counterbalancing health message. This is why Congress decided to require manufacturers of smokeless tobacco products to affix health warnings on promotional items using their insignia, logos, and trademarks.
From page 246...
... Once the continued lawfulness of tobacco products is acknowledged, legislative architects must confront a daunting challenge of regulatory design. As a nation, we have experience in designing and administering regulatory schemes under which dangerous products are not lawfully available outside tightly controlled channels of distribution.
From page 247...
... The Regulatory Agency Authority to regulate tobacco products should be exercised by a public health agency within the Department of Health and Human Services. Whether such authority should be delegated to the FDA or to a free-standing tobacco control agency requires careful study by the Secretary of HHS and by the Congress.
From page 248...
... There is evidence that reduction of cigarette yields, particularly comparing the older unfiltered cigarettes to the modern filtered ones, has somewhat reduced the risks of lung cancer and chronic lung disease, although not the risk of coronary heart disease, caused by cigarette smoking.40 It is unknown if different brands of modern filtered cigarettes with different yields of tar and nicotine produce different risk levels for disease. In -any case, it is possible that products with particularly low yields, if the yields are confirmed to be low by measurements in human smokers, would have some advantage in public health terms for smokers who are unable to quit.
From page 249...
... in advertising or on packaging, and should be authorized to require the use of standard terms. If the regulatory agency finds that reduction of tar and/or nicotine yields would reduce morbidity or mortality associated with use of tobacco products, it should be authorized to prescribe ceilings of tar and/or nicotine yields and to develop a regulatory program of phased reductions in those ceilings over time.
From page 250...
... If the regulatory agency were to use a threshold concept of addiction as a basis for regulatory action, it might gradually depress the ceiling of allowable nicotine yield toward that threshold over a 10- to 15-year period. A series of reductions in tar and/or nicotine yields would have to be carefully planned and gradually implemented.
From page 251...
... 15. Comprehensive Smokeless Tobacco Health Education Act of 1986.
From page 252...
... Health Warnings and Contents Labelling on Tobacco Products. For Ministerial Council on Drug Strategy, Tobacco Task Force on Tobacco Health Warnings.
From page 253...
... REGULATION OF TOBACCO PRODUCTS 253 41. See for example: Kozlowski, Lynn.


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