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Smoking and Tobacco Control Monograph No. 7 Chapter 10. Sensitivity of the Federal Trade Commission Test Method to Analytical Parameters .................... 135 Introduction .............................................. 135 Standard Machine Smoking .................................. 135 Influence of Smoking Parameters ............................. 137 Influence of Human Smoking Practices ........................ 141 Conclusions .............................................. 149 Question-and-Answer Session ................................ 149 References ............................................... 149 Acknowledgments ........... .............................. 150 Chapter 11. Human Smoking Patterns ............................... 151 Introduction .............................................. 151 How Do Humans Smoke? ................................... 151 Which Human Smoking Behaviors Determine Smoke Exposure? .......................................... 152 Are Human Smoking Patterns Dynamic or Static? ................ 153 Does the FTC Method Accurately Reflect Human Smoking Pattems? ......................................... 154 Summary ................................................ 156 Question-and-Answer Session ................................ 157 References ............................................... 159 Chapter 12. Compensation for Nicotine by Smokers of Lower Yield Cigarettes ................................... 161 Background ............................................... 161 Cigarette Brand Switching in Experimental Research .............. 161 Research ..................................1.............. 162 One Repeated-Measures Study of Self-Selected ' Brand Switching ........................................... 165 Smokers Can Get High Yields From the Lowest of the Low-Yield Cigarettes: More on the Issue of Vent Blocking ......... 165 Graphic Information on Tar and Nicotine Yields: The Color-Matching Technique .............................. 166 xxiv

Contents Nicotine Content of Tobacco Vs. FTC Yield ...................... 95 Quantitating Nicotine Intake in Smokers ........................ 95 Cotinine Levels and Nicotine Intake ........................... 98 Ultralow-Yield Cigarettes .................................... 101 Nicotine Intake and Machine-Determined Yield .................. 102 Carbon Monoxide and FTC Yield .............................. 104 Tar-to-Nicotine Ratio ....................................... 104 Conclusions ............................................... 106 Question-and-Answer Session ................................. 108 References ................................................ 110 Acknowledgments .......................................... 111 Chapter 8. Pharmacology and Markers: Nicotine Pharmacology and Addictive Effects ...................... 113 Introduction .............................................. 113 Cigarette Smoking ~as Drug Dependence ......................... 113 Nicotine Delivery Systems ................................... 115 Nicotine's Effects ........................................... 116 Smoking and Nicotine Dose .................................. 119 A Proposal for More Meaningful Cigarette Labeling ............... 122 Question-and-Answer Session ................................. 122 References ................................................ 124 Chapter 9. Consumer/Smoker Perceptions of Federal Trade Commission Tar Ratings ........................... 127 Introduction .............................................. 127 Tar Level of Cigarettes ....................................... 127 Knowledge of Advertised Tar Numbers ......................... 128 Smokers' Interpretations of Tar Numbers ........... : ............ 130 Smokers' Use of Advertised Tar Numbers ........................ 132 Conclusions ............................................... 132 Question-and-Answer Session ................................. 132 Reference ................................................. 134 ot xxiii ~ Ln m Ob OD w m ~o

Chapter 1 In short, there was no clear consensus as to specific action the Commission could (or should) take to eliminate the limitations of the test method. At the same time, abandoning the testing system without instituting another method of tar testing would have been premature because then-current epidemiological evidence suggested that there had been a reduction in lung cancer deaths that might be attributable to declines in average tar levels that had occurred since the 1950's (U.S. Department of Health and Human Services, 1981).r' Accordingly, at that time the Commission made no changes to its cigarette test method to address compensatory smoking. In early 1987 the Commission decided to close its cigarette testing laboratory. The Commission found that closing the laboratory was necessary for several reasons, chiefly because the cost of the laboratory was significant and the Commission would have had to commit significant additional funds to continue its operation. The Commission also was persuaded that the same information could be obtained from other sources and that other means were available to verify the accuracy of industry testing results. In fact, the Commission's operation of a testing system for the industry at taxpayer expense was highly unusual. The common scenario is for the industry to conduct its own testing under Government-specified testing protocols. Since 1987 the Tobacco Institute Testing Laboratory (TITL) has continued to test most cigarettes, using the Commission's approved methodology; the companies report the results to the Commission pursuant to a compulsory request, and the Commission publishes the results. TITL keeps the Commission informed of proposed changes in the testing procedure and solicits Commission approval for all significant changes. TITL's work is regularly monitored by the Commission's contractor, Harold Pillsbury, Jr. (this volume), who has virtually unrestricted access to the laboratory and makes unannounced visits to inspect it and check the testing process. Mr. Pillsbury also checks the data for consistency from run to run and from year to yeat. Most industry members also have testing facilities; however, the numbers published by the Commission are primarily TITL numbers. (Generic and private label brands, as well as new cigarettes and cigarettes that are not widely available, are not tested by TITL.) Since the closing of its laboratory, the Commission has continued to review advertising for today's low- and ultralow-yield cigarettes for deceptive claims. In January 1995 the Commission approved a consent agreement with the American Tobacco Company, settling charges over advertisements that allegedly misused the Commission's tar and nicotine ratings by stating that consumers would get less tar by smoking 10 packs of Carlton brand cigarettes In 1954 the tar yield of the sales-weighted average cigarette was 37 mg (U.S. Department of Health and Human Services, 1981). By 1981 cigarettes yielding 15 mg of tar or less had 56 percent of the domestic market (Federal Trade Commission, 1984). 7

Acknowledgments Chapter 2. Review of the Fede.•al Trade Commission Method for Determining Cigarette Tar and Nicotine Yield Chapter 3. Changes in Cigarette Design and Composition Over Time and How They Influence the Yields of Smoke Constituents Chapter 4. Attitudes, Knowledge, and Beliefs About Low-Yield Cigarettes Among Adolescents and Adults Harold C. Pillsbury, Jr. Rockville, MD Dietrich Hoffmann, Ph.D. American Health Foundation Valhalla, NY Mirjana V. Djordjevic, Ph.D. American Health Foundation Valhalla, NY Klaus D. Brunnemann, M.S. American Health Foundation Valhalla, NY Gary A. Giovino, Ph.D., M.S. Centers for Disease Control and Prevention Atlanta, GA Scott L. Tomar, D.M.D., Dr.P.H. Centers for Disease Control and Prevention Atlanta, GA Murli N. Reddy, M.S. Centers for Disease Control and Prevention Atlanta, GA John P. Peddicord, M.S. Centers for Disease Control and Prevention Atlanta, GA Bao-Ping Zhu, Ph.D., M.B.B.S., M.S. Centers for Disease Control and Prevention Atlanta, GA Luis G. Escobedo, M.D., M.P.H. Centers for Disease Control and Prevention Atlanta, GA Michael P. Eriksen, Sc.D. Centers for Disease Control and Prevention Atlanta, GA xiii

Chapter 2 Review of the Federal Trade Commission Method for Determining Cigarette Tar and Nicotine Yield Harold C. Pillsbury, Jr.l The "Federal Trade Commission (Commission or FTC) method" is the methodology that the Commission adopted almost 30 years ago for testing cigarettes. This methodology is still used today by the Tobacco Institute Testing Laboratory (TITL), with some minor modifications. The FTC method determines the relative yield of individual cigarettes by smoking them in a standardized fashion, according to a predetermined protocol, on a smoking machine. The FTC test method was based on the "Cambridge Filter method" developed by Ogg (1964), which called for 2-second, 35-mL puffs to be taken until a 23-mm butt length remained on the cigarette. More about how these parameters were selected is presented below. For the testing procedure, as implemented initially by the FTC's cigarette testing laboratory and currently by TITL, cigarettes are collected by an independent firm that purchases two packages of each cigarette variety2 in each of 50 locations throughout the United States. (If some varieties or brands are not available In certain locations, additional packs will be purchased in locations where they are available.) They are mailed to the testing laboratory; the postmark serves as verification that they were purchased in different locations. Individual cigarettes to be tested are selected on a random basis, two from each pack. Before being smoked, the cigarettes are "conditioned" by being placed on storage trays in a room maintained at 75 °F and 60 percent relative humidity for not less than 24 hours. The machine used in the Commission's laboratory had 20 "ports" (openings); the smoking machine currently used by TITL also has 20 ports. Each opening is fitted with a filter holder, into which a cigarette is inserted for smoking, and a filter pad, on which particulate matter from the cigarette smoke is collected. Gases pass through the pad and are collected in specially designed plastic bags. ' These remarks are the views of the staff of the Bureau of Consumer Protection. They do not necessarily represent the view of the Commission or any individual commissioner. 2 A particvlar brand of cigarettes may have more than a dozen varieties, depending on whether it is available in different lengths, in regular and menthol flavors, in hard and soft packaging, and in regular, light, and ultralight versions. For example, the Commission's 1994 tar and nicotine report lists 20 varieties of Marlboro. 9

Smoking and Tobacco Control Monograph No. 7 Lynn T. Kozlowski, Ph.D. Professor and Head Department of Biobehavioral Health Pennsylvania State University University Park, PA C. Lee Peeler, Esq. Associate Director Division of Advertising Practices Federal Trade Commission Washington, DC Harold C. Pillsbury, Jr. Rockville, MD Jonathan M. Samet, M.D., M.S.. Chairman Department of Epidemiology Johns Hopkins University School of Hygiene and Public Health , Baltimore, MD James P. Zacny, Ph.D. Assistant Professor Department of Anesthesia and Critical Care University of Chicago Chicago, IL Tobacco Industry J. Donald deBethizy, Ph.D. Representatives Vice President, Product Evaluation R J. Reynolds Tobacco Company Bowman Gray Technical Center Winston-Salem, NC David E. Townsend, Ph.D. Principal Scientist R.J. Reynolds Tobacco Company Bowman Gray Technical Center Winston-Salem, NC The Coordinator and STCP staff members also gratefully acknowledge the authors who made this monograph possible. Attributions for those chapters with authors folloW. Chapter 1. Cigarette Testing and the C. Lee Peeler, Esq. Federal Trade Commission: Federal Trade Commission A Historical Overview Washington, DC xii

L Acknowledgments The FTC Cigarette Test Method for Determining Tar, Nicotine, and Carbon Monoxide Yields of U.S. Cigarettes: Report of the NCI Expert Committee was developed under the general editorship of the Smoking and Tobacco Control Program (STCP), National Cancer Institute (NCI), Donald R. Shopland, Coordinator. In organizing the December 5-6, 1994, meeting of the NCI Ad Hoc Committee of the President's Cancer Panel on the FTC Test Method for Determining Tar, Nicotine, and Carbon Monoxide Levels in Cigarettes, NCI had the expert advice and assistance of many individuals both in and out of Government service. In particular, the Coordinator and STCP staff members would like to acknowledge the following individuals who served as part of an informal planning group for the conference: Judith Wilkenfeld, Esq. Food and Drug Administration Rockville, MD Jack E. Henningfield, Ph.D. Addiction Research Center National Institute on Drug Abuse Baltimore, MD Michael P. Eriksen, Sc.D. Centers for Disease Control and Prevention Atlanta, GA Shira D. Modell, Esq. Federal Trade Commission Washington, DC Special recognition is due John M. Pinney and Joseph G. Gitchell, Pinney Associates, Bethesda, MD, for their help with overall conference organization and planning. Mr. Pinney also served as facilitator for all consensus deliberations by the expert panel. We would like to express our sincere appreciation to the following members of the NCI Ad Hoc Committee of the President's Cancer Panel. Chairman, Harold P. Freeman, M.D. President's Cancer Panel Director of Surgery Harlem Hospital Center New York, NY Executive Secretary, Maureen O. Wilson, Ph.D. President's Cancer Panel National Cancer Institute Bethesda, MD ix

Chapter 2 that 100 are successfully smoked. Common technical problems that can cause a filter pad to be discarded include lighting failures and port leaks. During the last year of the FTC laboratory's operation, fewer than 300 varieties of cigarettes were tested, and the testing cycle (which included curing, marking, and smoking the cigarettes, etc.) lasted approximately 12 months. There were 933 cigarette varieties rated by the TITL in the Commission's 1994 report. The author once had the opportunity to ask Dr. Ogg (who worked as a tobacco chemist for the U.S. Department of Agriculture) how he came up with the specific parameters of his protocol. He said that he had based them on observations of how people smoke under different conditions. He had spent a lot of time watching people smoke (at the office, on the street, etc.), sometimes timing them with a stopwatch. His observations told him that people smoked differently under different conditions. For example, someone deep in thought might take only one or two puffs before the cigarette burned out, whereas someone who seemed extremely nervous might puff constantly. In short, there was no such thing as an "average" smoker and no way to derive a set of testing parameters that would replicate actual human smoking, so Dr. Ogg had to select parameters that seemed reasonable in light of his observations.6 Dr. Ogg also collected cigarette butts from ash trays in hotels, restaurants, and offices and measured how long they were; the resulting average length became the butt length called for by his protocol. When the Commission adopted a slightly modified version of the Cambridge Filter method in 1967 for use in its newly opened cigarette testing laboratory, it was the author's opinion that the Commission's procedures (as implemented on the 20-port smoking machine selected by the Commission) were clearly superior to all other methods currently in use at that time. The FTC method had its limitations, most significantly that the information it generated would not tell any individual smoker how much tar and nicotine he or she would get from a particular brand of cigarette. However, there was simply no way to get that information, and the FTC method did provide a smoker with accurate comparative information about the relative amounts of tar and nicotine delivered by various cigarettes when they were smoked in precisely the same manner. In addition, it provided a uniform analytical procedure that could be replicated in different laboratories simultaneously and in the same laboratory over time; therefore, not only could many brands of cigarettes be compared with each other at any time, but long-term pictures of tar and nicotine levels over the years also were possible. 6 During the December 5-6, 1994, National Cancer Institute conference, it was learned that a protocol using the same parameters for the testing of cigarettes had been proposed by The American Tobacco Company researchers many years before Dr. Ogg published his article (Bradford et al., 1936) ("arbitrarily" selecting a 2-second, 35-mL puff once a minute, although another researcher who had studied human smoking habits used a 40-mL puff). 11

Smoking and Tobacco Control Monograph No. 7 QUESTION-AND-ANSWER SESSION DR. HARRIS: I was curious about the very last statement on the tape: The results are sent to the cigarette manufacturers who, in turn, report the numbers to the Federal Trade Commission? MR. PILLSBURY: Yes. We get the tar and nicotine data directly from the cigarette manufacturers so that we can hold them responsible if there is anything wrong with the numbers. DR. HARRIS: To your knowledge, do the numbers reported under the compulsory process by the manufacturers ever deviate from those that are measured in the Tobacco Institute laboratory? MR. PILLSBURY: The only thing I can tell you is that they are checked. DR. STITZER: Could you remind us how the original Cambridge Filter method was altered when the FTC method was developed? MR. PILLSBURY: The original smoking machine was a four-port smoker that used a column of water to draw from the cigarettes. When this new machine came out, the filter pads and the holders were pretty much the same. The only thing that has been changed is that the machine has been modified so that carbon monoxide can be analyzed at the same time that the cigarettes are being smoked. DR. STITZER: So, there wasn't a puffing protocol that went along with the original method? MR. PEELER: We published, at the time that we adopted the method, a fairly detailed protocol for how the test was supposed to be done. I suppose the question is, did that protocol that we published differ from the original method in the parameters that were required? MR. PILLSBURY: No. They were pretty much the same as in the original method. DR. RICKERT: How much of a difference would you have to have in tar yields between two brands before they would be considered to be different in the statistical sense? MR. PEELER: We publish the numbers and try to have a large enough sample so that there are differences in those numbers. But the question of whether there is a significant difference in those numbers is what we need to know from you. 0 DR. RICKERT: What I am referring to is that on the tables in the UK there is a footnote that reads, "Ignore differences in 2 mg in tar and CO," and I was wondering whether that is the same sort of position that we have here? MR. PILLSBURY: The only thing that is done is they are rounded. Five and above are rounded up; four and down are rounded down. We make no criteria as to whether one with 14 mg is better for you than one with 15 mg. We are just publishing the ratings of the cigarettes as they fall. 12

Contents Summary ................................................ 168 Question-and-Answer Session ................................ 168 References ............................................... 171 Chapter 13. Cigarette Design Technologies Reduce Smoke Yield and Expand Consumer Choices: The Role and Utility of the FTC Test Method ....................... 173 BAckground .............................................. 173 Cigarette Design and Changes in the Cigarette Market ............ 174 Utility of the FTC Test Method ............................... 176 Question-and-Answer Session ................................ 180 References ............................................... 191 SECTION II. Transcript of Second-Day Discussion ...................... 193 SECTION III. Recommendations and Findings .......................... 239 SECTION IV. Overview of 1980 to 1994 Research Related to the Standard Federal Trade Commission Test Method for Cigarettes ................................... 249 Introduction .............................................. 249 Parameters of the FTC Test Method and Current Smoking Patterns .......................................... 250 Impact of Changing Parameters of the FTC Test Method on Absolute Yields of a Cigarette Brand and Relative Yields of Different Brands ......................................... 252 Tar and Nicotine Yield by'the FTC Test Method and Amounts Delivered to Smoker ................................ 253 Relative Yields of Different Brands by the FfC Test Method and Amount of Nicotine Absorbed by Smokers ........... 257 Yield by the FI'C Test Method and Absorption of Nicotine in Switchers .............................................. 259 Yields by the FTC Test Method and Other Constituents Using FTC Puff Profile ...................................... 270 Proposals To Change the FTC Test Method ..................... 273 References ............................................... 273 xxv co w J N